Estradot Transdermal Therapeutic System

Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)

Commonly used brand name(s)

In the U.S.

• Alora


• Cenestin


• Climara


• Divigel


• Elestrin


• Emcyt


• Enjuvia


• Esclim


• Estinyl


• EstroGel


• Evamist


• Femtrace


• Gynodiol


• Menest


• Menostar


• Ogen .625


• Ogen 1.25


• Ogen 2.5


• Premarin


• Vivelle


• Vivelle-Dot

In Canada

• Estraderm


• Estradot Transdermal


• Estradot Transdermal Therapeutic System


• Estradot Transdermal Therapeutic System


• Estrogel


• Oesclim


• Rhoxal-Estradiol Derm 50


• Rhoxal-Estradiol Derm 75


• Roxal-Estradiol Derm 100


• Vivelle 100 Mcg


• Vivelle 25 Mcg

Available Dosage Forms:

• Tablet


• Patch, Extended Release


• Gel/Jelly


• Spray


• Emulsion


• Tablet, Enteric Coated


• Capsule

Uses For Estradot Transdermal Therapeutic System

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).


• To help prevent weakening of bones (osteoporosis) in women past menopause.


• In the treatment of selected cases of breast cancer in men and women.


• In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:

• Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman's lifestyle, sees himself as a woman, and feels like a woman instead of a man.


• Osteoporosis caused by lack of estrogen before menopause.


• Turner's syndrome (a genetic disorder).

Before Using Estradot Transdermal Therapeutic System

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.

This medicine may be used to start puberty in teenagers with some types of delayed puberty.

Geriatric

Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Boceprevir


• Felbamate


• Influenza Virus Vaccine, Live


• Isotretinoin


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Paclitaxel


• Paclitaxel Protein-Bound


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• St John's Wort


• Theophylline


• Tizanidine


• Tranexamic Acid


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

For all patients

• Asthma or


• Calcium, too much or too little in blood or


• Diabetes or


• Epilepsy or seizures or


• Heart problems or


• Kidney problems or


• Liver tumors, benign or


• Lupus erythematosus, systemic or


• Migraine headaches—Estrogens may worsen these conditions.

• Blood clotting problems, or history of during previous estrogen therapy—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.

• Breast cancer or


• Bone cancer or


• Cancer of the uterus or


• Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

• Bulging eyes or


• Double vision or


• Migraine headache or


• Vision changes, sudden onset including or


• Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

• Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

• Endometriosis or


• Gallbladder disease or gallstones, or history of or


• High cholesterol or triglycerides, or history of or


• Liver disease, or history of or


• Pancreatitis (inflammation of pancreas) or


• Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.

• Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

For males treated for breast or prostate cancer:

• Blood clots or


• Heart or circulation disease or


• Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Estradot Transdermal Therapeutic System. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

This medicine usually comes with patient information or directions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

For patients taking any of the estrogens by mouth or by injection:

• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch):

• Wash and dry your hands thoroughly before and after handling the patch.


• Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.


• Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.


• Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.


• If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.


• Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion):

• Washing and drying hands thoroughly before each application.


• Apply while you are sitting comfortably. Apply one pouch to each leg every morning.


• Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.


• Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.


• Rub any remaining emulsion on both hands on the buttocks.


• Washing and drying hands thoroughly after application.


• To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

If you are using the Evamist® transdermal spray:

• Spray the medicine on your skin on the inside of your forearm, between the elbow and the wrist.


• Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid to come nearer with your child, wear clothes with long sleeves to cover the application site.


• If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.


• Do not allow your pets to lick or touch the arm where the medicine was sprayed.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For conjugated estrogens


• For oral dosage form (tablets):
  
  • For treating breast cancer in women after menopause and in men:
    
    • Adults—10 milligrams (mg) three times a day for at least 3 months.
    
    
  
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    
    • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
    
    
  
  
  • To prevent loss of bone (osteoporosis):
    
    • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
    
    
  
  
  • For treating ovary problems (female hypogonadism or for starting puberty):
    
    • Adults and teenagers—0.3 to 0.625 milligram (mg) a day. Your doctor may want you to take the medicine only on certain days of the month.
    
    
  
  
  • For treating ovary problems (failure or removal of both ovaries):
    
    • Adults—1.25 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—1.25 to 2.5 milligram (mg) three times a day.
    
    
  
  


• For injection dosage form:
  
  • For controlling abnormal bleeding of the uterus:
    
    • Adults—25 milligrams (mg) injected into a muscle or vein. This may be repeated in six to twelve hours if needed.
    
    
  
  

• For esterified estrogens


• For oral dosage form (tablets):
  
  • For treating breast cancer in women after menopause and in men:
    
    • Adults—10 milligrams (mg) three times a day for at least three months.
    
    
  
  
  • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
    
    • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating ovary problems (failure or removal of both ovaries):
    
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating ovary problems (female hypogonadism):
    
    • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating symptoms of menopause:
    
    • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—1.25 to 2.5 mg three times a day.
    
    
  
  

• For estradiol


• For oral dosage form:
  
  • For treating breast cancer in women after menopause and in men:
    
    • Adults—10 milligrams (mg) three times a day for at least 3 months.
    
    
  
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
    
    • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least 3 months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—1 to 2 milligrams (mg) three times a day.
    
    
  
  
  • To prevent loss of bone (osteoporosis):
    
    • Adults—0.5 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  


• For topical emulsion dosage form (skin lotion):
  
  • For treating symptoms of menopause:
    
    • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.
    
    
  
  


• For transdermal dosage form (skin patches):
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
    
    • For the Climara patches
    
    
    • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
    
    
    • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
    
    
    • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
    
    
  
  

• For estradiol cypionate


• For injection dosage form:
  
  • For treating ovary problems (female hypogonadism):
    
    • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.
    
    
  
  
  • For treating symptoms of menopause:
    
    • Adults—1 to 5 milligrams (mg) injected into a muscle every 3 to 4 weeks.
    
    
  
  

• For estradiol valerate


• For injection dosage form:
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
    
    • Adults—10 to 20 milligrams (mg) injected into a muscle every 4 weeks as needed.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—30 milligrams (mg) injected into a muscle every 1 or 2 weeks.
    
    
  
  

• For estrone


• For injection dosage form:
  
  • For controlling abnormal bleeding of the uterus:
    
    • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.
    
    
  
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    
    • Adults—0.1 to 0.5 milligram (mg) injected into a muscle 2 or 3 times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
    
    
  
  
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    
    • Adults—0.1 to 1 milligram (mg) a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—2 to 4 milligrams (mg) injected into a muscle 2 or 3 times a week.
    
    
  
  

• For estropipate


• For oral dosage form (tablets):
  
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    
    • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    
    • Adults—1.5 to 9 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • To prevent loss of bone (osteoporosis):
    
    • Adults—0.75 milligram (mg) a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.
    
    
  
  

• For ethinyl estradiol


• For oral dosage form (tablets):
  
  • For treating breast cancer in women after menopause and in men:
    
    • Adults—1 milligram (mg) three times a day.
    
    
  
  
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    
    • Adults—0.05 milligram (mg) one to three times a day for 3 to 6 months. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  
  • For treating prostate cancer:
    
    • Adults—0.15 to 3 milligrams (mg) a day.
    
    
  
  
  • For treating symptoms of menopause:
    
    • Adults—0.02 to 0.05 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
    
    
  
  

• For ethinyl estradiol and norethindrone


• For oral dosage form (tablets):
  
  • For treating symptoms of menopause:
    
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
    
    
  
  
  • To prevent loss of bone (osteoporosis):
    
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Estradot Transdermal Therapeutic System

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are using this medicine before having any laboratory test because some results may be affected.

Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to Evamist® transdermal spray.

Do not allow your pets to lick or touch the arm where Evamist® transdermal spray was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.

Estradot Transdermal Therapeutic System Side Effects

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

Check with your doctor immediately if any of the following side effects occur:

More common

• Breast pain (in females and males)


• fast heartbeat


• fever


• hives


• hoarseness


• increased breast size (in females and males)


• irritation of the skin


• itching of the skin


• joint pain, stiffness, or swelling


• rash


• redness of the skin


• shortness of breath


• swelling of the eyelids, face, lips, hands, or feet


• swelling of the feet and lower legs


• tightness in the chest


• troubled breathing or swallowing


• weight gain (rapid)


• wheezing

Less common or rare

• Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)


• chest pain


• chills


• cough


• heavy non-menstrual vaginal bleeding


• lumps in, or discharge from, breast (in females and males)


• pains in the stomach, side, or abdomen


• yellow eyes or skin

Rare - for males being treated for breast or prostate cancer only

• Headache (sudden or severe)


• loss of coordination (sudden)


• loss of vision or change of vision (sudden)


• pains in the chest, groin, or leg, especially in the calf of leg


• shortness of breath (sudden and unexplained)


• slurring of speech (sudden)


• weakness or numbness in the arm or leg

Incidence not known

• Abdominal or stomach bloating


• abdominal or stomach cramps


• acid or sour stomach


• anxiety


• backache


• belching


• blindness


• blistering, peeling, or loosening of the skin


• blue-yellow color blindness


• blurred vision


• change in vaginal discharge


• changes in skin color


• changes in vision


• chest discomfort


• clay-colored stools


• clear or bloody discharge from nipple


• confusion


• constipation


• convulsions


• dark urine


• decrease in the amount of urine


• decreased vision


• depression


• diarrhea


• difficulty with breathing


• difficulty with speaking


• dimpling of the breast skin


• dizziness


• double vision


• dry mouth


• eye pain


• fainting


• fluid-filled skin blisters


• full feeling in upper abdomen or stomach


• full or bloated feeling or pressure in the stomach


• headache


• heartburn


• inability to move the arms, legs, or facial muscles


• inability to speak


• incoherent speech


• increased urination


• indigestion


• inverted nipple


• irregular heartbeats


• light-colored stools


• lightheadedness


• loss of appetite


• loss of bladder control


• lump under the arm


• metallic taste


• migraine headache


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle pain


• muscle spasm or jerking of all extremities


• muscle weakness


• nausea


• noisy breathing


• numbness or tingling of the hands, feet, or face


• pain in the ankles or knees


• pain or discomfort in the arms, jaw, back or neck


• pain or feeling of pressure in the pelvis


• pain, tenderness, swelling of the foot or leg


• painful or tender cysts in the breasts


• painful, red lumps under the skin, mostly on the legs


• pains in the chest, groin, or legs, especially calves of the legs


• partial or complete loss of vision in the eye


• pelvic pain


• persistent crusting or scaling of nipple


• pinpoint red or purple spots on the skin


• prominent superficial veins over affected area


• red, irritated eyes


• redness or swelling of the breast


• sensitivity to the sun


• severe headaches of sudden onset


• skin thinness


• skin warmth


• slow speech


• sore on the skin of the breast that does not heal


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• stomach discomfort, upset, or pain


• sudden loss of consciousness


• sudden loss of coordination


• sudden onset of shortness of breath for no apparent reason


• sudden onset of slurred speech


• sudden vision changes


• swelling of the abdominal or stomach area


• swelling of the fingers or hands


• thirst


• tremor


• unpleasant breath odor


• unusual tiredness or weakness


• vomiting


• vomiting of blood


• weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal growth filled with fluid or semisolid material


• accidental injury


• bladder pain


• bloated full feeling


• bloody or cloudy urine


• body aches or pain


• coating or white patches on tongue


• congestion


• cough producing mucus


• decrease in amount of urine


• difficult, burning, or painful urination


• discouragement


• dryness of the throat


• ear congestion or pain


• excess air or gas in the stomach or intestines


• fear


• feeling of warmth


• feeling sad or empty


• frequent urge to urinate


• general feeling of discomfort or illness


• headache, severe and throbbing


• increased clear or white vaginal discharge


• irritability


• itching of the vaginal, rectal or genital areas


• lack of appetite


• lack or loss of strength


• loss of interest or pleasure


• mild dizziness


• neck pain


• nervousness


• pain


• pain during sexual intercourse


• painful or difficult urination


• pain or tenderness around the eyes and cheekbones


• passing gas


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• skin irritation or redness where skin patch was worn


• shivering


• sleeplessness


• sneezing


• sore mouth or tongue


• stuffy nose


• sudden sweating


• tender, swollen glands in the neck


• thick, white vaginal discharge with no odor or with a mild odor


• tiredness


• trouble concentrating


• trouble sleeping


• unable to sleep


• voice changes

Less common

• Blemishes on the skin


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• burning or stinging of the skin


• diarrhea (mild)


• difficulty with moving


• dizziness (mild)


• increased hair growth, especially on the face


• lower abdominal or stomach pain or pressure


• mood or mental changes


• muscle stiffness


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• pimples


• pounding in the ears


• problems in wearing contact lenses


• slow heartbeat


• tooth or gum pain


• unusual decrease in sexual desire (in males)


• unusual increase in sexual desire (in females)


• white or brownish vaginal discharge

Incidence not known

• Abnormal turning out of cervix


• changes in appetite


• dull ache or feeling of pressure or heaviness in the legs


• flushed, dry skin


• fruit-like breath odor


• increased hunger


• irritability


• large amount of triglyceride in the blood


• leg cramps


• patchy brown or dark brown discoloration of the skin


• poor insight and judgment


• problems with memory or speech


• trouble recognizing objects


• trouble thinking and planning


• trouble walking


• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs


• unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of the scalp hair in some people.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Epinephrine

Class: alpha- and beta-Adrenergic Agonists
VA Class: AU100
CAS Number: 51-43-4
Brands: Adrenalin Chloride, EpiPen Auto-Injector, EpiPen Jr., Primatene

Introduction

Epinephrine is an endogenous catecholamine that is the active principle of the adrenal medulla; epinephrine acts directly on both α- and β-adrenergic receptors.

Uses for Epinephrine

Bronchospasm

Has been used as as a quick-relief bronchodilator for symptomatic treatment of acute symptoms and exacerbations of bronchial asthma and reversible bronchospasm associated with chronic bronchitis, emphysema, and other obstructive pulmonary diseases.^{a 160 162 166 168} However, generally should be used only when selective β₂-agonists are not readily available, since excessive cardiac stimulation (e.g., increased heart rate, myocardial irritability, increased oxygen demand) can occur with nonselective agents, particularly at high doses.^{160 162 174 d}

Orally inhaled selective β₂-agonists currently are recommended for prehospital management of asthma exacerbations (e.g., in emergency medicine facilities and/or ambulances) and for acute asthma management in emergency rooms and hospitals.^{160 161 162} Reserve sub-Q epinephrine for severe exacerbations when selective agents are not readily available or are ineffective.^{160 161 162 174 d} No proven advantage of systemically administered (e.g., sub-Q) epinephrine therapy over orally inhaled therapy for the acute management of asthma exacerbations.^{160 162} Parenteral epinephrine may be particularly useful in treating anaphylaxis and angioedema coexisting with asthma.¹⁷⁴

Nebulized bronchodilator therapy generally should be reserved for patients who are unable to coordinate inhalation via an MDI because of their age, agitation, or exacerbation severity.¹⁶⁰

Regular, daily use of a short-acting, inhaled β-agonist generally is no longer recommended for maintenance therapy of asthma.¹⁶⁰ Current asthma guidelines emphasize long-term control with anti-inflammatory agents (e.g., corticosteroids), and concomitant anti-inflammatory therapy with an inhaled corticosteroid is recommended whenever inhaled β-agonist bronchodilators are used for maintenance.^{130 131 132 138 140 141 147 148}

Sensitivity Reactions

Drug of choice in the emergency treatment of severe acute anaphylactic reactions, including anaphylactic shock, which can be profound and life-threatening.^{a 161 163 164 d}

May relieve anaphylactic symptoms (e.g., urticaria, pruritus, angioedema, wheezing, dyspnea, hypotension, swelling of the lips, eyelids, and tongue) caused by reactions to drugs, contrast media, sera, insect stings or bites, foods (e.g., milk, eggs, fish, shellfish, peanuts, tree nuts), latex, or other allergens as well as idiopathic or exercise-induced anaphylaxis.^{a 161 163 d}

Give to all patients with signs of shock, airway swelling, or definite breathing difficulty.^{161 d} Drug of choice for the treatment of both vasodilation/hypotension and cardiac arrest associated with anaphylaxis.^{161 d}

Parenteral administration (IM route favored)^d is preferred for the treatment of anaphylaxis.^{a d} Administer IV if anaphylaxis appears to be severe with immediate life-threatening manifestations.^{161 d} Absorption and subsequent achievement of peak plasma concentrations after sub-Q injection is slower and may be substantially delayed in patients with shock.^{161 d}

High IV doses (i.e., rapid progression to high dose) should be used without hesitation in any patient in full cardiac arrest.^{161 d}

If necessary, institute other measures for management of cardiac arrhythmias, laryngeal edema, or bronchospasm.^a Once adequate ventilation is ensured, maintenance of BP in anaphylactic shock should be achieved with other pressor agents (e.g., norepinephrine, metaraminol).^a

Close monitoring critical; fatal overdose of epinephrine reported.^d

Risk of paradoxical response to epinephrine in patients receiving β-adrenergic blocking agents; consider glucagon and/or ipratropium for treatment of anaphylaxis in these patients.^d Increased incidence and severity of anaphylaxis in patients receiving β-adrenergic blocking agents.^d

CPR and Cardiac Arrhythmias

Used for its α-adrenergic stimulatory effects to increase blood flow in ACLS during CPR.^{a 161 d} The principal beneficial effects in patients with cardiac arrest result from increases in aortic diastolic blood pressure and in myocardial and cerebral blood flow during resuscitation.^{a 161 d} The value and safety of the β-adrenergic effects are controversial because they may increase myocardial work and reduce subendocardial perfusion.^{161 d}

A drug of choice and a high priority for ACLS in cardiac arrest to facilitate return of spontaneous circulation (ROSC); generally used after failure of artificial ventilation, external or internal cardiac compression, and initial defibrillation to restore effective circulation.^{a 161 d}

Cardiac arrest: May be administered IV, intraosseously, or intracardially or by direct instillation into the tracheobronchial tree via an endotracheal tube to restore cardiac rhythm as an adjunct in the management of cardiac arrest.^{a 161 169 170 d}

Asystole: Restores cardiac electrical activity in asystole and, in some cases, restores myocardial contractility in electromechanical dissociation.^{a 161}

Impending pulseless electrical activity: May produce beneficial vasopressor effects in patients who are not in cardiac arrest but who have other indications for vasopressor therapy¹⁶¹ (e.g., in those with severe bradycardia and hypotension who are close to pulseless electrical activity or even asystole).^a

Bradycardia: Treatment of symptomatic bradycardia unresponsive to atropine, as a temporizing measure while awaiting availability of a pacemaker (e.g., out-of-hospital setting) or if pacing ineffective.^d

Drug-induced cardiovascular emergencies or altered vital signs: May consider use in bradycardia or shock associated with β-adrenergic or calcium-channel blocking agent or tricyclic antidepressant toxicity.^d

Anesthesia accidents: May be useful in treating cardiac arrest following anesthesia accidents, but should be used with extreme caution, if at all, in patients receiving cyclopropane or halogenated hydrocarbon general anesthetics.^a (See General Anesthetics under Interactions.)

Heart block: Has been used in the treatment of syncope and/or bradycardia resulting from AV nodal block, but has largely been replaced by isoproterenol.^a Electrical cardiac pacemakers have largely replaced drug therapy in third-degree AV nodal block (complete heart block).^a

Radiographic Uses

Has been given intra-arterially† as an adjunct to radiographic contrast media in arteriography†.^a

GI and Renal Hemorrhage

Has been administered intra-arterially† via the celiac artery, inferior mesenteric artery, or superior mesenteric artery to control hemorrhage in patients with severe GI bleeding†.^a

Has been administered intra-arterially† via the renal artery to control hemorrhage in patients with renal arterial bleeding†.^a

Radiation Nephritis

Has been injected into a renal artery prior to and during irradiation of the abdominal area to protect the kidney from radiation nephritis†.^a

Adjunct to Local Anesthesia

May be added to solutions of some local anesthetics to decrease the rate of their vascular absorption (to localize and prolong the duration of anesthesia and decrease the risk of systemic toxicity).^a

Superficial Bleeding

May be applied topically to control superficial bleeding from arterioles or capillaries in the skin, mucous membranes, or other tissues.^a Bleeding from larger vessels is not controllable by topical application.^a

Cardiogenic, Hemorrhagic, and Traumatic Shock

Should not be used in cardiogenic shock (because it increases myocardial oxygen demand) or in hemorrhagic or traumatic shock.^a

Premature Labor

Has been used to relax uterine musculature and inhibit uterine contractions in premature labor† (tocolysis); however, the cardiovascular and other adverse effects limit its usefulness.^a (See Pregnancy under Cautions.) Other β-agonists (e.g., terbutaline) preferred.^{165 173}

Hypoglycemia

Has been used parenterally to correct hypoglycemia† in insulin shock; however, dextrose and/or glucagon is more effective.^a

Epinephrine Dosage and Administration

Administration

Administer by sub-Q, IM, or IV injection or by IV infusion.^{a 160 161 162 163 164 169 d} Also may be administered intra-arterially† (e.g., for radiography, for local control of bleeding).^a

In extreme cardiac emergencies, may be administered intracardially, via an endotracheal tube, or by intraosseous infusion†.^{a 161 169 170} Although endotracheal administration of epinephrine is possible, IV or intraosseous† administration is preferred because of more predictable drug delivery and pharmacologic effect.^d

Rapid IV injection (bolus dose) or endotracheal administration of epinephrine may cause failure of exhaled carbon dioxide detectors (used to confirm endotracheal tube placement in the trachea during cardiac arrest) despite adequate placement (i.e., false-negative reading).^d Use a second method to confirm tube placement.^d

For bronchodilation, administer by oral inhalation via a metered-dose inhaler (MDI), nebulization, or intermittent positive-pressure breathing (IPPB) apparatus or inject sub-Q or IM.^{a 160 162 166 168}

Apply topically to the skin and mucous membranes for local hemostasis.^a

Sub-Q Injection

Injections containing 1 mg/mL preferably are administered sub-Q.^{a 160 162 169} However, absorption and subsequent achievement of peak plasma concentrations is slower and may be substantially delayed if shock is present.^{a 161 d}

IM Injection

Injections containing 1 mg/mL also may be injected IM, but IM injection into the buttocks should be avoided.^{a 160 161 162 169 172 d}

For self-medication, instruct patients and their caregivers about proper administration techniques using the auto-injector provided by the manufacturer.^{163 164 d} First aid providers should be familiar with the auto-injector in order to assist patients having an anaphylactic reaction with self-medication, and they should be able to administer the auto-injector, if a patient is unable to self-administer, provided that state law permits it and valid prescription exists.^d

Technique for Using Auto-injector

Inject the age-appropriate dose IM only into the anterolateral aspect of the thigh.^{163 164}

The patient should grasp the prefilled auto-injector with the black tip pointed downward; the grey activation cap should be removed.¹⁶⁴ Point the black tip toward the outer thigh, swing and jab it firmly into the outer thigh so that the auto-injector is perpendicular (90° angle) to the thigh, and hold firmly in the thigh for several seconds until the dose is delivered.¹⁶⁴ Administer through clothing if necessary.¹⁶³ Massage injection area for several seconds.¹⁶⁴ If the needle is not exposed at the black tip, repeat administration.¹⁶⁴

Never put thumb, fingers, or hand over the black tip.¹⁶⁴

Do not remove the grey activation cap until ready to use.¹⁶⁴

The auto-injector is overfilled and most of the solution (90%) will remain after injection of the age-approriate dose and cannot be reused.¹⁶⁴

After use, bend the needle back against a hard surface.¹⁶⁴ Then, deliver the used auto-injector to a health-care provider for proper disposal.¹⁶⁴

IV Administration

Emergency situations: Inject very slowly IV as a dilute solution or infuse slowly IV.^a When injected peripherally, 1–2 minutes generally are required to reach central circulation.^{161 d}

Severe asthma or anaphylaxis: IV therapy may be necessary (e.g., for severe anaphylactic shock with immediate life-threatening manifestations) when drug absorption from sub-Q or IM injection is likely to be impaired.^{a d}

CPR: When a vein has not been cannulated prior to the arrest, a peripheral vein (antecubital or external jugular in adults and the largest most accessible vein that does not interrupt resuscitation in pediatric patients) is preferred since central venous access requires interruption of chest compressions, is technically more difficult, and is associated with an increased risk of complications.¹⁶¹ Venous access can be challenging in infants and children during an emergency, whereas intraosseous access can be easily achieved.^d Limit the time attempting venous access; if reliable access cannot be achieved quickly, establish intraosseous access.^d

If a central venous catheter is already in place at the time of arrest, it can be used because of more rapid onset (in adults), more secure access to circulation, and avoidance of tissue infiltration.^{161 d} Tissue infiltration may lead to local ischemia, tissue injury, and ulceration.^d Avoid central venous line placement in patients who are candidates for pharmacologic reperfusion (e.g., with thrombolytic therapy).^{161 d}

Dilution

Prepare infusion solutions containing 2 or 4 mcg/mL by adding 1 mg to 500 or 250 mL of a compatible IV solution, respectively.^{a 101 d}

Prepare solutions containing 0.05 mg/mL by adding 0.5 mg (0.5 mL of a 1:1000 injection) to 10 mL of 0.9% sodium chloride injetion.¹⁶⁹

Prepare a 1:10,000 solution (0.1 mg/mL) by diluting 1 mL of a commercially available 1:1000 injection (1 mg/mL) with 10 mL of water for injection or 0.9% sodium chloride injection.^a Alternatively, a commercially available 1:10,000 (0.1 mg/mL) injection can be used.¹⁷⁰

Prepare a 1:100,000 solution (0.01 mg/mL) by diluting 0.1 mL of a commercially available 1:1000 injection (1 mg/mL) with 10 mL of 0.9% sodium chloride injection.^a

Rate of Administration

Severe asthma or anaphylaxis: Inject IV slowly (e.g., over 5–10 minutes) or administer by rapid IV injection (i.e., bolus).^{a 101}

Alternatively in adults, infuse IV at an initial rate of 1 mcg/minute, increasing to 4 mcg/minute as needed.^a

In children after an initial 1-mcg/kg IV bolus, infuse IV at an initial rate of 0.1 mcg/kg per minute, increasing gradually up to 1.5 mcg/kg per minute as needed.¹⁰¹

CPR: Inject doses by IV push in adults, repeating at 3- to 5-minute intervals as needed;^{161 170 d} follow each dose injected peripherally with a 20-mL flush of IV fluid to ensure distribution into the central compartment;^{161 d} if injected IV in an extremity, elevate the extremity for 10–20 seconds.^d

In children, infuse IV at an initial rate of 0.1 mcg/kg per minute, increasing gradually to a maximum of 1 mcg/kg per minute as needed for CPR.^{a d}

Bradycardia or hypotension (i.e., nonarrest rate): In adults, infuse IV at an initial rate of 1 mcg/minute, titrating to hemodynamic response at rates ranging from 2–10 mcg/minute.^{161 d} Assess intravascular volume and support as needed.^d

In children, infuse IV at a rate of 0.1–0.2 mcg/kg per minute for refractory bradycardia.¹⁶¹

Intra-arterial Administration

Injections have been administered intra-arterially† for local effects (e.g., to control local bleeding, prevent radiation nephritis, as an adjunct to arteriography).^a

Rate of Administration

GI hemorrhage: 8–20 mcg/minute infused into the celiac or inferior or superior mesenteric artery†.^a

Renal hemorrhage: 10 mcg/minute infused into the renal artery†.^a

Radiation nephritis: 3–7.6 mcg/minute infused into the renal artery†.^a

Adjunct to arteriography: 8–12 mcg/minute infused into the celiac or superior mesenteric artery†.^a

Intracardiac Injection

Limit intracardiac injection to personnel well trained in the technique and generally use only during open cardiac massage or when other routes of administration are persistently inaccessible.^{a 161 170}

Inject into the left ventricular chamber.¹⁷⁰

Follow intracardiac administration by external cardiac massage to ensure entry of the drug into the coronary circulation.^a

Suspensions must not be administered intracardially.^a

Administration Risks

Hazards include coronary artery laceration, cardiac tamponade, pneumothorax, and the need to interrupt external chest compressions and ventilation during the period of administration.^{a 161}

Endotracheal Administration

Limit endotracheal administration to personnel well trained in the technique.^{a 161}

In intubated patients, doses can be instilled directly into the bronchial tree via the endotracheal tube.¹⁷⁰

Pass a catheter beyond the tip of the tracheal tube, stop chest compressions, inject the drug solution directly into the tracheal tube, follow immediately with several quick insufflations to create a rapidly absorbed aerosol, and then resume compressions.^{161 d}

For pediatric patients, flush with a minimum of 5 mL of 0.9% sodium chloride injection after each dose.^d

For pediatric patients, administration via a tracheal tube is preferred to a catheter or feeding tube because these latter 2 methods often are cumbersome and depend on finding the correct-size catheter to place through the tracheal tube.¹⁶¹

Dilution

Adults: Dilute dose in 5–10 mL of 0.9% sodium chloride or sterile water.^{a d} Systemic absorption may be increased by diluting in sterile water instead of 0.9% sodium chloride;^{a d} however, sterile water may have a more negative effect on arterial oxygen pressure (PaO₂) than sodium chloride.^a Alternatively, a commercially available 1:10,000 (0.1 mg/mL) injection may be administered undiluted via the endotracheal tube.¹⁷⁰

Intraosseous Administration

When IV administration is not possible, epinephrine may be given by intraosseous administration for emergency uses such as CPR.^{161 d}

Limit intraosseous administration to personnel well trained in the technique.^{a 161}

Place a cannula in a noncollapsible marrow venous plexus; such access often can be achieved in 30–60 seconds.¹⁶¹

Use a rigid needle, preferably a specially designed intraosseous or Jamshidi-type bone marrow needle; a styleted needle is preferred to prevent obstruction of the needle with cortical bone.¹⁶¹

Insert the intraosseous needle into the anterior tibial bone marrow; alternatively, the distal femur, medial malleolus, or anterior superior iliac spine can be used.¹⁶¹

In older children and adults, intraosseous cannulas also have been inserted successfully into the distal radius or ulna as well as the proximal tibia.¹⁶¹

Successful intraosseous placement outside the hospital (e.g., by emergency medical services) generally is more difficult in older than in younger children.¹⁶¹

Onset of action and systemic concentrations are comparable to those achieved with central venous administration.^{161 d}

Administration Risks

Complications are uncommon (less than 1% of patients), and include tibial fracture, lower-extremity compartment syndrome, extravasation, and osteomyelitis; careful technique can minimize the risk.¹⁶¹ Local effects on bone marrow and bone growth appear to be minimal.¹⁶¹ Risk of microscopic pulmonary fat and bone marrow emboli does not appear to be increased.¹⁶¹

Oral Inhalation

Epinephrine base or hydrochloride may be administered via oral inhalation using a nebulizer, aerosol (metered-dose inhaler [MDI]), or intermittent positive-pressure breathing (IPPB) apparatus.^{a 166 168}

For nebulization, use a glass or plastic nebulizer capable of delivering a very fine mist and that works effectively with a very small volume of solution.¹⁶⁸ Place the dose in the nebulizer reservoir and then place the nozzle just inside the partially opened mouth.¹⁶⁸ Squeeze the bulb once or twice, inhaling deeply to draw the vaporized solution into the lungs.¹⁶⁸ Rinse mouth with water immediately to prevent oropharyngeal dryness.¹⁶⁸

Solutions intended for oral inhalation are more concentrated than those intended for injection and must not be administered parenterally.^{a 168}

Do not administer oral inhalation solutions intranasally.¹⁶⁸

Topical Administration

Apply solutions topically as a spray or on cotton or gauze to the skin, mucous membranes, or other tissues.^a

Dosage

Available as epinephrine and epinephrine hydrochloride; dosage expressed in terms of epinephrine.^{a 163 166 168}

Pediatric Patients

Bronchospasm

Treatment of Acute Exacerbations of Asthma

Oral Inhalation

Children ≥4 years of age: 220 mcg (1 inhalation) of epinephrine via an MDI, repeated once if necessary after at least 1 minute; do not administer subsequent doses for at least 3 hours.^{a 166}

Children ≥4 years of age: After placing approximately 10 drops of 1% (1:100) epinephrine in the nebulizer reservoir, administer 1–3 deep inhalations via the hand-bulb.^{a 168} Do not repeat more often than every 3 hours; use the least number of inhalations producing relief.^{a 168}

Sub-Q

For severe asthma, inject 0.01 mg/kg (0.01 mL/kg of a 1:1000 injection)^{a 160 162} or 0.3 mg/m² (0.3 mL/m² of a 1:1000 injection) sub-Q.^{a 169}

Single pediatric doses should not exceed 0.3–0.5 mg every 20 minutes as needed for up to 3 consecutive doses.^{160 162 a 160 162 169}

IV

Neonates: Inject 0.01 mg/kg IV.^{170 172}

Infants: Inject 0.05 mg IV initially, repeated at 20- to 30-minute intervals as needed.^{170 172}

Sensitivity Reactions

Anaphylaxis

IM

Inject 0.01 mg/kg (0.01 mL/kg of a 1:1000 injection) (up to 0.5 mg/dose), repeated every 10–20 minutes as needed for up to 3 consecutive doses.¹⁰¹

For self-administration using a prefilled auto-injector (e.g., EpiPen), inject 0.15 or 0.3 mg, depending on body weight; a dose of 0.01 mg/kg generally is recommended.¹⁶³ Clinicians may recommend higher or lower doses depending on individual patient needs and considering the life-threatening nature of anaphylaxis.¹⁶³ The 0.15-mg dose may be more approriate for children <30 kg.¹⁶³ If doses <0.15 mg are considered more appropriate, alternative injectable forms of the drug should be used.¹⁶³ For severe persistent anaphylaxis, repeated doses may be needed.¹⁶³

Sub-Q

Inject 0.01 mg/kg (0.01 mL/kg of a 1:1000 injection) or 0.3 mg/m² (0.3 mL/m² of a 1:1000 injection) sub-Q.^{a 169} Single pediatric doses should not exceed 0.5 mg, repeated as needed at 20-minute to 4-hour intervals depending on the severity of the condition and the response of the patient.^{a 169}

IV

In severe anaphylactic shock, IV administration may be necessary since absorption may be impaired with sub-Q or IM administration.^{a 101}

If necessary, inject an initial dose of 10 mcg/kg (0.1 mL/kg of a 1:10,000 dilution), followed by a continuous IV infusion at an initial rate of 0.1 mcg/kg per minute (using a diluted solution containing 4 mcg/mL); the infusion may be increased as necessary to a maximum of 1.5 mcg/kg per minute to maintain BP.¹⁰¹

Neonates, alternatively: Inject 0.01 mg (10 mcg)/kg.^{170 172}

Infants, alternatively: Inject 0.05 mg (50 mcg) initially, repeated at 20- to 30-minute intervals as needed.^{170 172}

CPR and Cardiac Arrhythmias

Bradycardia and Pediatric Advanced Life Support

IV

Neonates: The usual dose is 0.01–0.03 mg/kg (0.1–0.3 mL/kg of a 1:10,000 injection),^d repeated every 3–5 minutes if necessary for CPR or bradycardia.^{a 161} Higher IV doses are not recommended^{161 d} because of risk of exaggerated hypertension, decreased myocardial function, and worsening neurologic function.^d

Pediatric Patients: The usual initial dose is 0.01 mg/kg (0.1 mL/kg of a 1:10,000 injection), up to a maximum single dose of 1 mg, for CPR or bradycardia,^{a 161 d e} repeated every 3–5 minutes as needed.^{161 d} Higher IV doses not recommended; use a standard dose for the first and subsequent doses.^d No survival benefit from routine use of high-dose epinephrine; may be harmful, particularly in asphyxia.^d Risk of exaggerated hypertension, decreased myocardial function, and worsening neurologic function with high doses.^d May consider high-dose epinephrine in certain circumstances (e.g., β-adrenergic blocking agent overdose).^d

Pediatric Patients: Alternatively, infuse at an initial rate of 0.1 mcg/kg per minute; increase the rate in increments of 0.1 mcg/kg per minute, if necessary, to a maximum of 1 mcg/kg per minute.^{a d} Low-dose infusions (<0.3 mcg/kg per minute) generally produce predominantly β-adrenergic effects,¹⁶¹ while higher-dose infusions (>0.3 mcg/kg per minute) generally result in α-adrenergic vasoconstriction, but there is substantial interindividual variation in catecholamine response, and infusion dosage should be titrated to the desired effect.^d

Pediatric patients: For refractory bradycardia, consider continuous infusion^d at a rate of 0.1–0.2 mcg/kg per minute.¹⁶¹

Intraosseous

Pediatric patients: The usual initial dose is 0.01 mg/kg (0.1 mL/kg of a 1:10,000 injection), up to a maximum single dose of 1 mg, for CPR or bradycardia,^{a 161 d e} repeated every 3–5 minutes as needed.^{161 d} Higher intraosseous doses are not recommended; use a standard dose for the first and subsequent doses.^d No survival benefit from routine use of high-dose epinephrine; may be harmful, particularly in asphyxia.^d Risk of exaggerated hypertension, decreased myocardial function, and worsening neurologic function with high doses.^d May consider high-dose epinephrine in certain circumstances (e.g., β-adrenergic blocking agent overdose).^d

Endotracheal

Optimum dose not established.^{a 161 d}

Neonates: IV administration (of 0.01–0.03 mg/kg per dose [0.1–0.3 mL/kg of a 1:10,000 injection])¹⁶¹ is the preferred route.^{a d} If the endotracheal route is used, doses of 0.01 or 0.03 mg/kg will likely be ineffective.^d Although safety and efficacy have not been established, consider endotracheal administration of a higher dose (up to 0.1 mg/kg) while access is being obtained.^{a d}

Pediatric patients: The usual initial dose is 0.1 mg/kg (0.1 mL/kg of a 1:1000 injection), up to a maximum single dose of 10 mg, for CPR or bradycardia,^{a 161 d e} repeated every 3–5 minutes as needed.^{161 d}

Generally flush the dose with a minimum of 5 mL of 0.9% sodium chloride injection followed by 5 assisted manual ventilations to promote absorption.^{161 a d}

Intracardiac

Pediatric patients: 0.005–0.01 mg/kg (0.05–0.1 mL/kg of a 1:10,000 injection).^a

Adults

Bronchospasm

Treatment of Acute Exacerbations of Asthma

Oral Inhalation

220 mcg (1 inhalation) of epinephrine via an MDI, repeated once if necessary after at least 1 minute; do not administer subsequent doses for at least 3 hours.^{a 166}

After placing approximately 10 drops of 1% (1:100) epinephrine in the nebulizer reservoir, administer 1–3 deep inhalations via the hand-bulb.^{a 168} Do not repeat more often than every 3 hours; the least number of inhalations producing relief should be used.^{a 168}

Sub-Q

For severe asthma, the usual initial dose is 0.1–0.5 mg (0.1–0.5 mL of a 1:1000 injection).^a Initial doses should be small and may be increased if necessary, but single doses should not exceed 1 mg.^a

May give at 20-minute to 4-hours intervals depending on the severity of the condition and patient response.^a

Alternatively, may administer 0.01 mg/kg (concentration of 1:1000) divided into 3 doses of approximately 0.3 mg, given at 20-minute intervals.^{a d}

IM

For severe asthma, the usual initial dose is 0.1–0.5 mg (0.1–0.5 mL of a 1:1000 injection).^a Initial doses should be small and may be increased if necessary, but single doses should not exceed 1 mg.^a

IV

0.1–0.25 mg injected slowly.¹⁷⁰

Sensitivity Reactions

Anaphylaxis

IM

The usual initial dose is 0.1–0.5 mg (0.1–0.5 mL of a 1:1000 injection).^a

For the treatment of reactions caused by drugs that were given IM, epinephrine may be administered at the site of injection of the other drug to minimize further absorption.^a

Initial doses should be small and may be increased if necessary, but single doses should not exceed 1 mg.^a

Alternatively, inject 0.3–0.5 mg (0.3–0.5 mL of a 1:1000 injection),¹⁶¹ repeated every 15–20 minutes, as needed.^d

For self-administration using a prefilled auto-injector (e.g., EpiPen), inject 0.3 mg.¹⁶³ Clinicians may recommend higher or lower doses depending on individual patient needs and considering the life-threatening nature of anaphylaxis.¹⁶³

For severe persistent anaphylaxis, repeated doses may be needed.¹⁶³

Sub-Q

Consider the possibility that drug absorption from sub-Q injection may be inadequate in anaphylaxis, particularly with shock.^{161 d}

The usual initial dose is 0.1–0.5 mg (0.1–0.5 mL of a 1:1000 injection).^a For the treatment of reactions caused by drugs that were given sub-Q, epinephrine may be administered at the site of injection of the other drug to minimize further absorption.^a

Initial doses should be small and may be increased if necessary, but single doses should not exceed 1 mg.^a

May be given at 20-minute to 4-hours intervals depending on the severity of the condition and patient response.^a

Alternatively, inject 0.3–0.5 mg every 20 minutes as needed for up to 3 doses.^{160 162}

IV

In severe or life-threatening anaphylaxis, IV administration may be necessary since absorption may be impaired with sub-Q or IM administration.^{a 101 161 d}

If necessary, inject 0.1–0.25 mg^{a 161 172 d} (e.g., 1–2.5 mL of a 1:10,000 injection or dilution) slowly and cautiously (e.g., over 5–10 minutes), and repeat every 5–15 minutes as necessary or follow by a continuous infusion at an initial rate of 1 mcg/minute, increasing the rate to up to 4 mcg/minute as necessary.^{a 161 d} Individual doses up to 0.5 mg also have been used.¹⁶¹

To optimally control administration, some clinicians recommend an initial dose of 0.1 mg (10 mL of a 1:100,000 injection or dilution) given over 5–10 minutes, followed by a continuous infusion as necessary.¹⁰⁰

Alternatively, 0.025–0.05 mg (0.25–0.5 mL of a 1:10,000 injection) be given every 5–15 minutes following initial sub-Q or IM administration of 0.5 mg.^a

CPR and Cardiac Arrhythmias

The optimum dose of epinephrine during CPR remains controversial.^{103 104 115 116 117 118 119 120 121 122 123 125 126 127} The usual dose of 0.5–1 mg has been questioned since it is not based on body weight^{103 104 117 119 120} and may be lower than necessary for optimum cardiovascular effects.^{103 104 117 119 121 127}

CPR (Cardiac Arrest)

IV

Inject 1 mg every 3–5 minutes.^{161 d}

Has been infused at an initial rate of 1 mcg/minute and, increased to 3–4 mcg/minute as needed, via a central line to reduce the risk of extravasation and ensure good bioavailability.¹⁶¹

Higher (>1-mg) doses may be indicated in certain circumstances, (e.g., β-adrenergic or calcium-channel blocking agent overdose).^d

Intraosseous

Intraosseous doses generally are the same as those administered IV.^{a d}

Usually, 1 mg every 3–5 minutes.^d

Endotracheal

Optimum dose not established.^{a 161 d}

If IV or intraosseous access is delayed or cannot be established,^d endotracheal doses 2–2.5 times those administered IV (i.e., 2–2.5 mg) are recommended.^{a 161 d}

Intracardiac

Inject 0.1–1 mg (usually as 1–10 mL of a 1:10,000 injection) into the left ventricular chamber.^{a 161 170 172}

Sub-Q

Following initial IV administration, 0.3 mg may be injected sub-Q.^a

Persistent or Recurrent Ventricular Fibrillation/Tachycardia

IV

Inject 1 mg by rapid injection (IV push) every 3–5 minutes.^{161 d}

Pulseless Electrical Activity

IV

Inject 1 mg by rapid injection (IV push) every 3–5 minutes.^{161 d}

Asystole

IV

Inject 1 mg by rapid injection (IV push) every 3–5 minutes.^{161 d}

Bradycardia:

IV

For symptomatic bradycardia without cardiac arrest, infuse at an initial rate of 1 mcg/minute; subsequent dosage is adjusted according to the patient’s response and generally ranges from 2–10 mcg/minute.^{a 161 d}

Radiographic Use

Arteriography

IV

As an adjunct in arteriography†, 16–24 mL of sodium chloride injection containing 1 mcg of epinephrine per mL has been infused into the celiac or superior mesenteric artery† over 2 minutes; the radiographic contrast medium was administered 7–10 minutes later.

Hemorrhage

GI

Intra-arterial

To control GI bleeding†, infuse into the celiac artery†, inferior mesenteric artery†, or superior mesenteric artery† at a rate of 8–20 mcg/minute for 4 minutes to 3 hours.

Renal

Intra-arterial

To control bleeding from the kidney†, infuse into the renal artery† at a rate of 10 mcg/minute for 10 minutes.^a

Radiation Nephritis

Abdominal Irradiation

Intra-arterial

To prevent radiation nephritis†, infuse into the renal artery† at a rate of 3–7.6 mcg/minute for 4–10 minutes prior to and continued during the period of abdominal irradiation.^a

Adjunct to Local Anesthesia

Local Injection

To localize and prolong the duration of local anesthesia, epinephrine may be used in concentrations of 1:500,000 to 1:50,000; 1:200,000 is used most commonly.^{a 172}

Superfic

Egrifta

Generic Name: tesamorelin (TES a moe REL in)

Brand Names: Egrifta

What is tesamorelin?

Tesamorelin is made with growth hormone-releasing factor (GRF).

Tesamorelin is used to reduce excess fat around the stomach that is caused by taking certain HIV medications. This condition is also called lipodystrophy (LYE-poe-DIS-troe-fee).

Tesamorelin is not a weight-loss medication and should not be used to treat obesity.

What is the most important information I should know about tesamorelin?

Tesamorelin can harm an unborn baby or cause birth defects. Do not use if you are pregnant. You should not use tesamorelin if you are allergic to it, or if you have a history of tumor or surgery of your pituitary gland, a history of head injury or radiation treatment,

Before using tesamorelin, tell your doctor if you have heart disease, high blood pressure, kidney disease, diabetes, epilepsy, asthma, migraines, an adrenal gland disorder, or if you have ever had cancer, any type of tumor, or open heart surgery.

Also tell your doctor about any major illness or recent trauma or medical emergency.

What should I discuss with my healthcare provider before using tesamorelin?

You should not use tesamorelin if you are allergic to it, or if you have:

• 
  

  cancer;

  
  


• 
  

  a pituitary gland disorder;

  
  


• 
  

  a history of pituitary gland tumor or surgery;

  
  


• 
  

  a history of head injury or radiation treatment; or

  
  


• 
  

  if you are pregnant.

  
  

To make sure you can safely take tesamorelin, tell your doctor if you have any of these other conditions:

• 
  

  a history of cancer or any tumor (either benign or malignant);

  
  


• 
  

  heart disease, high blood pressure;

  
  


• 
  

  kidney disease;

  
  


• 
  

  diabetes, eye problems caused by diabetes;

  
  


• 
  

  epilepsy

  
  


• 
  

  asthma;

  
  


• 
  

  migraine headaches;

  
  


• 
  

  adrenal gland disorder;

  
  


• 
  

  if you have ever had open heart surgery; or

  
  


• 
  

  if you have any major illness, or a recent trauma or medical emergency.

  
  

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use tesamorelin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Do not give this medicine to a child without medical advice.

How tesamorelin given?

Tesamorelin is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

This medication comes with injection instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Tesamorelin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. After mixing tesamorelin with a diluent, you must use it right away. Do not store the mixture for later use.

Tesamorelin is usually given once per day. Follow your doctor's dosing instructions very carefully.

Use a different place on your stomach each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Never share a tesamorelin syringe with another person, even if you change the needle. Sharing syringes or needles can allow HIV or other diseases to pass from one person to another.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any follow-up visits to your doctor.

Store vials of tesamorelin powder in the refrigerator, do not freeze. Store the diluent at room temperature away from moisture, heat, and light.

Throw away any unused vials after the expiration date on the label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of tesamorelin.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using tesamorelin?

Do not inject this medicine into scar tissue or on skin that is bruised. Do not inject directly into your navel (belly-button).

Tesamorelin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using tesamorelin and call your doctor at once if you have a serious side effect such as:

• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  pain or stiffness in your muscles or joints;

  
  


• 
  

  pain in your arms or legs;

  
  


• 
  

  wrist pain or numbness;

  
  


• 
  

  numbness or tingling in your hands or fingers;

  
  


• 
  

  pounding heartbeats or fluttering in your chest;

  
  


• 
  

  high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);

  
  

Less serious side effects may include:

• 
  

  depressed mood, sleep problems (insomnia);

  
  


• 
  

  night sweats;

  
  


• 
  

  mild rash or itching;

  
  


• 
  

  muscle spasm;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  pain, redness, itching, swelling, bruising, bleeding, or other irritation where the injection was given;

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tesamorelin?

Tell your doctor about all other medicines you use, especially:

• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  testosterone or hormone replacement therapy;

  
  


• 
  

  seizure medication;

  
  


• 
  

  steroids (prednisone and others);

  
  

This list is not complete and there are many other drugs that can interact with tesamorelin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Egrifta resources

• Egrifta Side Effects (in more detail)
• Egrifta Use in Pregnancy & Breastfeeding
• Egrifta Drug Interactions
• Egrifta Support Group
• 2 Reviews for Egrifta - Add your own review/rating

• Egrifta Prescribing Information (FDA)


• Egrifta Consumer Overview


• Egrifta Advanced Consumer (Micromedex) - Includes Dosage Information


• Egrifta MedFacts Consumer Leaflet (Wolters Kluwer)


• Tesamorelin Professional Patient Advice (Wolters Kluwer)

Compare Egrifta with other medications

• Lipodystrophy

Where can I get more information?

• Your pharmacist can provide more information about tesamorelin.

See also: Egrifta side effects (in more detail)

Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Address Ortho-McNeil-Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Road, P.O. Box 200 Titusville, NJ 08560-200 Contact Details Phone: (0800) 526-7736 Website: http://www.ortho-mcneil.com/ortho-mcneil/ Careers: http://www.ortho-mcneil.com/ortho-mcneil...

Embeline Cream

Pronunciation: kloe-BAY-tah-sahl
Generic Name: Clobetasol
Brand Name: Examples include Embeline and Temovate

Embeline Cream is used for:

Reducing itching, redness, and swelling associated with many skin conditions.

Embeline Cream is a topical corticosteroid. It works by decreasing certain immune responses, which reduces redness and itching of skin.

Do NOT use Embeline Cream if:

• you are allergic to any ingredient in Embeline Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Embeline Cream:

Some medical conditions may interact with Embeline Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have measles, tuberculosis (TB), chickenpox, shingles, or have had a recent vaccination


• if you have a skin infection or thinning of the skin (atrophy)

Some MEDICINES MAY INTERACT with Embeline Cream. However, no specific interactions with Embeline Cream are known at this time.

Ask your health care provider if Embeline Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Embeline Cream:

Use Embeline Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands immediately after applying Embeline Cream, unless your hands are part of the treated area. Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• Treatment must be limited to 2 consecutive weeks.


• If you miss a dose of Embeline Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Embeline Cream.

Important safety information:

• Do not use more than 50 grams per week.


• Avoid contact with the eyes.


• Do not use Embeline Cream for other skin conditions at a later time.


• Do not use Embeline Cream for diaper rash.


• Embeline Cream has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid (eg, hydrocortisone) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Embeline Cream.


• Embeline Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Embeline Cream while you are pregnant. It is not known if Embeline Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Embeline Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Embeline Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Irritation; stinging.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning; itching; redness; skin thinning or discoloration; swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Embeline side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Embeline Cream may be harmful if swallowed.

Proper storage of Embeline Cream:

Store Embeline Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not use near an open flame. Keep Embeline Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Embeline Cream, please talk with your doctor, pharmacist, or other health care provider.


• Embeline Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Embeline Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Embeline resources

• Embeline Side Effects (in more detail)
• Embeline Use in Pregnancy & Breastfeeding
• Embeline Drug Interactions
• Embeline Support Group
• 1 Review for Embeline - Add your own review/rating

Compare Embeline with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Planus
• Lichen Sclerosus
• Psoriasis

CheeTah Rasberry oral and rectal

Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)

Brand Names: Anatrast, Baricon, Baro-Cat, Barosperse, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, E-Z AC, E-Z Dose Kit with Polibar Plus, E-Z-Cat, E-Z-HD, E-Z-Paque, Eneset 2, Entero-H, Entrobar, Esopho-Cat, Liqui-Coat HD, Liquid Polibar, Medebar Plus, Medebar Super 250, Readi-Cat, Readi-Cat 2, Scan C, Smoothie Readi-Cat 2, Sol-O-Pake, Tonojug, Tonopaque, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen

What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

Barium sulfate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about barium sulfate?

You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?

You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:

• 
  

  asthma, eczema, or allergies;

  
  


• 
  

  a blockage in your stomach or intestines;

  
  


• 
  

  cystic fibrosis;

  
  


• 
  

  a colostomy;

  
  


• 
  

  rectal cancer;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  Hirsch sprung's disease (a disorder of the intestines);

  
  


• 
  

  a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);

  
  


• 
  

  a recent history of surgery on your esophagus, stomach, or intestines;

  
  


• 
  

  a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;

  
  


• 
  

  if you have recently had a rectal biopsy;

  
  


• 
  

  if you have ever choked on food by accidentally inhaling it into your lungs;

  
  


• 
  

  if you are allergic to simethicone (Gas-X, Phazyme, and others); or

  
  


• 
  

  if you are allergic to latex rubber.

  
  

It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.

How should I use barium sulfate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Store this medication at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.

What should I avoid before or after using barium sulfate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Barium sulfate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe stomach pain;

  
  


• 
  

  severe cramping, diarrhea, or constipation;

  
  


• 
  

  sweating;

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  confusion, fast heart rate; or

  
  


• 
  

  pale skin, weakness.

  
  

Less serious side effects may include:

• 
  

  mild stomach cramps;

  
  


• 
  

  nausea, vomiting;

  
  


• 
  

  loose stools or mild constipation.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect barium sulfate?

There may be other drugs that can interact with barium sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More CheeTah Rasberry resources

• CheeTah Rasberry Side Effects (in more detail)
• CheeTah Rasberry Use in Pregnancy & Breastfeeding
• CheeTah Rasberry Support Group
• 0 Reviews for CheeTah Rasberry - Add your own review/rating

Compare CheeTah Rasberry with other medications

• Computed Tomography

Where can I get more information?

• Your doctor or pharmacist can provide more information about barium sulfate.

See also: CheeTah Rasberry side effects (in more detail)