Friday, 27 April 2012

Etopophos


Generic Name: etoposide (Intravenous route)

e-TOE-poe-side

Intravenous route(Solution)

Severe myelosuppression with resulting infection or bleeding may occur with etoposide .


Intravenous route(Powder for Solution)

Severe myelosuppression with resulting infection or bleeding may occur with etoposide phosphate .



Commonly used brand name(s)

In the U.S.


  • Etopophos

  • Vepesid

In Canada


  • Dom-Etoposide

  • Eposin

  • Etoposide

  • Pms-Etoposide

Available Dosage Forms:


  • Solution

  • Powder for Solution

Therapeutic Class: Antineoplastic Agent


Pharmacologic Class: Mitotic Inhibitor


Uses For Etopophos


Etoposide injection (also known as VP-16) is used in combination with other cancer medicines to treat cancer of the testicles and small cell lung cancer. It is also sometimes used to treat some other kinds of cancer in both males and females.


Etoposide belongs to the group of medicines known as antineoplastic agents. The exact way that etoposide acts against cancer is not known. However, it seems to interfere with the growth of the cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by etoposide, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.


Before you begin treatment with etoposide, you and your doctor should talk about the benefits of this medicine as well as the risks of using it.


This medicine is to be administered only by or under the immediate supervision of your doctor.


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, etoposide is used in certain patients with the following medical conditions:


  • Autoimmune deficiency syndrome (AIDS)—associated Kaposi's sarcoma (a type of cancer of the skin and mucous membranes that is more common in patients with AIDS).

  • Cancer in the bone.

  • Cancer of the adrenal cortex (the outside layer of the adrenal gland).

  • Cancer of the endometrium.

  • Cancer of the lung (a certain type of lung cancer usually associated with prior smoking, passive smoking, or radon exposure).

  • Cancer of the lymph system (a part of the body's immune system) that affects the skin.

  • Cancer of the ovaries (a type of cancer found in the egg-making cells).

  • Cancer of the stomach.

  • Cancer of unknown primary site.

  • Cancers of the blood and lymph system.

  • Cancers of the soft tissues of the body, including the muscles, connective tissues (tendons), vessels that carry blood or lymph, or fat.

  • Ewing's sarcoma (a type of cancer found in the bone).

  • Gestational trophoblastic tumors (tumors in the uterus or womb).

  • Hepatoblastoma (a certain type of liver cancer that occurs in children).

  • Multiple myeloma (a certain type of cancer of the blood).

  • Myelodysplastic syndromes (MDS).

  • Neuroblastoma (a cancer of the nerves that usually occurs in children).

  • Retinoblastoma (a cancer of the eye that usually occurs in children).

  • Thymoma (a cancer of the thymus, which is a small organ that lies under the breastbone).

  • Tumors in the brain.

  • Wilms' tumor (a cancer of the kidney that usually occurs in children).

Before Using Etopophos


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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


Appropriate studies have not been performed on the relationship of age to the effects of etoposide injection in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etoposide injection in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., infection, nausea and vomiting, hair loss), and have age-related kidney, liver, or heart problems, which may require caution in elderly patients receiving etoposide injection.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


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 receiving this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Rotavirus Vaccine, Live

Using this medicine 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

  • Aprepitant

  • Bacillus of Calmette and Guerin Vaccine, Live

  • Cyclosporine

  • Fosaprepitant

  • Glucosamine

  • Influenza Virus Vaccine, Live

  • Measles Virus Vaccine, Live

  • Mumps Virus Vaccine, Live

  • Rotavirus Vaccine, Live

  • Rubella Virus Vaccine, Live

  • Smallpox Vaccine

  • St John's Wort

  • Typhoid Vaccine

  • Valspodar

  • Varicella Virus Vaccine

  • Warfarin

  • 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Grapefruit Juice

Other Medical Problems


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


  • Low serum albumin (protein in the blood)—May experience increased side effects.

  • Infection—Etoposide may decrease your body's ability to fight infection.

  • Kidney disease—Use with caution. The effects of etoposide may be increased because of slower removal from the body.

Proper Use of etoposide

This section provides information on the proper use of a number of products that contain etoposide. It may not be specific to Etopophos. Please read with care.


A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 to 60 minutes.


Etoposide is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to remember to take your medicines at the right times.


Etoposide often causes nausea, vomiting, and loss of appetite, which may be severe. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.


Precautions While Using Etopophos


It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


Etoposide can temporarily lower the number of white blood cells in your blood, increasing the chance of your getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:


  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.

  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.

  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

  • Avoid contact sports or other situations where bruising or injury could occur.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have chills; fever; lightheadedness, dizziness, or fainting; fast, pounding heartbeat; swelling of the face, tongue, and throat; or trouble with breathing after you receive the medicine.


Injection site reactions may occur while you are receiving this medicine. Tell your doctor right away if you notice swelling, pain, or redness at the injection site.


This medicine may cause leukemia (cancer of the blood or bone marrow) in rare cases. Talk with your doctor about any concerns you have about this.


Talk with your doctor before getting flu shots or other vaccines while you are receiving this medicine because there are certain vaccines that you should not receive.


Etopophos Side Effects


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.


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


More common
  • Black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • chest pain

  • chills

  • cough

  • fever

  • painful or difficult urination

  • pale skin

  • pinpoint red spots on the skin

  • shortness of breath

  • sore throat

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

  • swollen glands

  • troubled breathing with exertion

  • unusual bleeding or bruising

  • unusual tiredness or weakness

Less common
  • Blurred vision

  • confusion

  • cough or hoarseness, accompanied by fever or chills

  • difficulty with swallowing

  • dizziness

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • face is warm or hot to touch

  • fast heartbeat

  • headache

  • hives

  • itching

  • lower back or side pain, accompanied by fever or chills

  • nervousness

  • numbness or tingling in the fingers or toes

  • pain or redness at the site of injection

  • pale skin at the site of injection

  • pounding in the ears

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • redness to face

  • skin rash

  • slow or fast heartbeat

  • sweating

  • tightness in the chest

  • wheezing

Rare
  • Back pain

  • difficulty with walking

  • loss of consciousness

  • swelling of the face or tongue

  • tightness in the throat

Incidence not known
  • Abdominal or stomach pain, severe

  • blindness

  • blistering, peeling, or loosening of the skin

  • blue-yellow color blindness

  • dark urine

  • decreased vision

  • difficult with breathing

  • eye pain

  • joint or muscle pain

  • loss of appetite

  • nausea or vomiting

  • red, irritated eyes

  • red skin lesions, often with a purple center

  • seizures

  • yellow eyes or skin

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
  • Bad, unusual, or unpleasant (after) taste

  • change in taste

  • constipation

  • cracked lips

  • hair loss or thinning of the hair

  • lack or loss of strength

  • swelling or inflammation of the mouth

  • weight loss

This medicine often causes a temporary loss of hair. After treatment with etoposide has ended, normal hair growth should return.


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.

See also: Etopophos side effects (in more detail)



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More Etopophos resources


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


  • Etopophos Prescribing Information (FDA)

  • Etopophos Concise Consumer Information (Cerner Multum)

  • Etopophos MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Etopophos with other medications


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Tuesday, 24 April 2012

Elestrin


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 Elestrin


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 Elestrin


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 Elestrin. 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 Elestrin


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.


Elestrin 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.

Monday, 23 April 2012

Chantix Start Month Pak



Generic Name: varenicline (Oral route)

var-EN-i-kleen

Oral route(Tablet)

Serious neuropsychiatric events (eg, depression, suicidal ideation, suicide attempt and completed suicide) have been reported in patients taking varenicline. All patients being treated with varenicline should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. Drug discontinuation, ongoing monitoring, and supportive care is advised if symptoms develop. These symptoms, as well as worsening of preexisting psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking varenicline in the postmarketing experience. The risks of varenicline should be weighed against the benefits of its use .



Commonly used brand name(s)

In the U.S.


  • Chantix

  • Chantix Start Month Pak

Available Dosage Forms:


  • Tablet

Therapeutic Class: Smoking Cessation Agent


Uses For Chantix Start Month Pak


Varenicline is used together with a support program to help you stop smoking. The program will include counseling and educational materials.


This medicine is available only with your doctor's prescription.


Before Using Chantix Start Month Pak


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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


Appropriate studies have not been performed on the relationship of age to the effects of varenicline in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of varenicline in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving varenicline.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Angina (severe chest pain), history of or

  • Heart attack, history of or

  • Heart or blood vessel problems or

  • Stroke, history of—May increase risk to have more serious side effects.

  • Depression, history of or

  • Mental problems (e.g., psychosis), history of—Use with caution. May make these conditions worse.

  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of varenicline

This section provides information on the proper use of a number of products that contain varenicline. It may not be specific to Chantix Start Month Pak. Please read with care.


Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. It is also important to participate in a stop-smoking program while you use this medicine. This will make it easier for you to quit smoking.


This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


You should set a date to stop smoking. Start taking varenicline one week before this date.


Your doctor may also tell you to start taking this medicine anytime and then to stop smoking between days 8 and 35 of treatment.


You may be told to take this medicine for 12 weeks. Even if you have already stopped smoking by this time, your doctor may tell you to take this medicine for 12 more weeks to help you keep off smoking.


Take this medicine after eating, and with a full glass of water.


Dosing


The dose of this medicine 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 this medicine. 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 oral dosage form (tablets):
    • To stop smoking:
      • Adults—
        • Days 1 to 3: 0.5 milligram (mg) once a day.

        • Days 4 to 7: 0.5 mg two times per day.

        • Days 8 to end of treatment: 1 mg two times per day.


      • Children—Use and dose must be determined by your doctor.



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.


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 Chantix Start Month Pak


It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine. This will allow for changes in your dose and to help reduce any side effects.


This medicine may increase your risk of having a heart attack in certain patients with heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; pain in your legs when walking; shortness of breath; sweating; or troubled breathing.


This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, stop taking this medicine and tell your doctor right away.


This medicine may cause serious types of allergic reactions, including angioedema. Stop taking this medicine and tell your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.


Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.


This medicine may cause some people to become drowsy or dizzy, or to have problems with concentration. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or thinking clearly.


Tell your doctor if you have nausea or sleep problems (trouble sleeping or unusual dreams) while you are using this medicine. The dose of this medicine may need to be adjusted.


Chantix Start Month Pak Side Effects


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.


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


Less common
  • Difficult or labored breathing

  • hyperventilation

  • shortness of breath

  • tightness in the chest

  • wheezing

Incidence not known
  • Anger

  • anxiety

  • behavior changes

  • depression

  • discouragement

  • feeling sad or empty

  • feelings of panic

  • hallucinations

  • irregular heartbeats

  • irritability

  • loss of interest or pleasure

  • mood swings

  • nervousness

  • restlessness

  • thoughts of killing oneself

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 dreams

  • bloated or full feeling

  • change in taste

  • difficulty having a bowel movement (stool)

  • dry mouth

  • excess air or gas in the stomach or intestines

  • general feeling of discomfort or illness

  • headache

  • lack or loss of strength

  • loss of taste

  • nausea

  • passing gas

  • sleeplessness

  • stomach pain

  • trouble sleeping

  • unable to sleep

  • unusual tiredness or weakness

Less common
  • Acid or sour stomach

  • belching

  • body aches or pain

  • chills

  • cough

  • decreased appetite

  • dizziness

  • ear congestion

  • fever

  • heartburn

  • increased appetite

  • indigestion

  • itching skin

  • loss of appetite

  • loss of voice

  • nightmares

  • rash

  • runny nose

  • sleepiness or unusual drowsiness

  • sneezing or sore throat

  • stomach discomfort or upset

  • stuffy nose

  • trouble concentrating

  • unusual drowsiness, dullness, or feeling of sluggishness

  • vomiting

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.

See also: Chantix Start Month Pak side effects (in more detail)



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.


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Friday, 20 April 2012

Ergocalciferol



Class: Vitamin D
ATC Class: A11CC01
VA Class: VT504
CAS Number: 50-14-6
Brands: Drisdol

Introduction

A vitamin D analog.a


Uses for Ergocalciferol


Hypoparathyroidism and Pseudohypoparathyroidism


Management of hypocalcemia and its clinical manifestations in patients with postsurgical or idiopathic hypoparathyroidism and pseudohypoparathyroidism. a b c d


Familial Hypophosphatemia


Treatment of familial hypophosphatemia (vitamin D resistant rickets). a b c d


Because the large doses of ergocalciferol needed in this disorder often cause toxicity and persistent hypercalcemia, some clinicians prefer dihydrotachysterol or calcitriol and phosphate supplements.c


Familial Hypophosphatemia associated with Fanconi syndrome


Has been used with treatment of acidosis, to manage hypophosphatemia associated with Fanconi syndrome.a


Nutritional Rickets or Osteomalacia


Has been used in the treatment of nutritional rickets or osteomalacia.a c


Also has been used in the management of tetany and rickets in vitamin D-deficient infants.a c


Anticonvulsant-induced Rickets and Osteomalacia


Has been used in the treatment of rickets or osteomalacia secondary to long-term high-dose anticonvulsant therapy.a c


May be used in the prevention of anticonvulsant-induced rickets and osteomalacia (particularly in those receiving 2 or more anticonvulsants and who have inadequate nutrition and exposure to UV light such as institutional patients).a c Adequate vitamin D supplementation usually prevents associated osteomalacia.


Vitamin D-dependent Rickets


Has been used in the treatment of Vitamin D-dependent Rickets.a c


Renal Osteodystrophy or Hypocalcemia Secondary to Chronic Renal Disease


Has been used in the treatment of early renal osteodystrophy.a c


Osteoporosis


Has been used in conjunction with calcium in the treatment of osteoporosis.a c


Dietary and Replacement Requirements


Adequate intake (AI) (minimum daily intake) of vitamin D is needed to support calcium metabolism and bone health, particularly in the young and old, and thus prevent rickets in children and osteomalacia in adults.


In addition, AI of vitamin D prevents secondary hyperparathyroidism and associated abnormalities in calcium metabolism that can result in porotic bone changes.


Ergocalciferol Dosage and Administration


General


Measure serum calcium, phosphorus, and BUN concentrations every 2 weeks or more frequently if needed.a b d


The manufacturers recommend radiographic examination of the bones in patients with familial hypophosphatemia or hypoparathyroidism every month until the condition stabilizes and is corrected.a b d


Adequate dietary calcium is necessary for clinical response to vitamin D therapy.b d


Administration


Usually administered orally once daily.a May be administered IM in some patients (e.g., those with GI, liver, or biliary disease associated with malabsorption of vitamin D analogs), and according to the manufacturers, these patients should not receive oral ergocalciferol.a


Dosage


Activity of ergocalciferol may be expressed in terms of USP or International Units (IU, units) which are equivalent; 1 unit of vitamin D equals the biologic activity of 25 ng.c


Each mg of ergocalciferol is equivalent to 40,000 USP units; each mcg of the drug is equivalent to 40 USP units.a


Dosage expressed by weight (mg, mcg) or units.a


Dosage depends on nature and severity of hypocalcemia.a c Individualize dosage to maintain serum calcium concentrations of 9–10 mg/dL.a c


Pediatric Patients


Hypoparathyroidism and Pseudohypoparathyroidism

Oral

1.25–5 mg daily with calcium supplements.a


Prolonged administration of dosages >2.5 mg daily may increase risk of toxicity; gradually decrease dosage as serum calcium concentrations approach normal. a


Familial Hypophosphatemia (Vitamin D-Resistant Rickets)

Oral

Initially, 1–2 mg daily with phosphate supplements.a


May increase daily dosage in 250- to 500-mcg increments at 3- to 4-month intervals until an adequate response is obtained.a


After growth is complete, may reduce dosage.a


Familial Hypophosphatemia associated with Fanconi syndrome

625 mcg to 1.25 mg daily have been used. a


Nutritional Rickets and Osteomalacia

Normal GI absorption

Oral

25 mcg daily has been used and resulted in normal serum calcium and phosphate concentrations in about 10 days, radiographic evidence of bone healing within 2–4 weeks, and complete healing within 6 months.a


50–125 mcg daily has been used for 6–12 weeks for more prompt healing.a


May discontinue drug, if healing has occurred with therapy and correction of diet.a


Malabsorption

Oral

Children: 250–625 mcg daily.a


A single 7.5- to 15-mg dose (in oil solution) has been given when compliance was not predictable.a


Infants with tetany and rickets: Initially administer calcium to control tetany then 50–125 mcg daily (until bones have healed) or 250 mcg daily for about 3 weeks.a


Vitamin D-Dependent Rickets

Oral

75–125 mcg daily; some may require up to 1.5 mg daily.a


Renal Osteodystrophy or Hypocalcemia Secondary to Chronic Renal Disease

Oral

0.1–1 mg daily has been used to maintain normal serum calcium concentrations.a


Dietary and Replacement Requirements

AAP recommends that all infants, children, and adolescents have a minimum intake of 400 units daily. Replaces the previous recommendation of a minimum intake (adequate intake) of 200 units daily.


Breastfed or partially breastfed infants: AAP recommended supplemental dosage is 400 units daily; start in the first few days of life. Continue until the child is weaned and consumes ≥1 L or quart of vitamin D-fortified formula or milk daily.


Infants and older children who consume <1 L of vitamin D-fortified formula or milk daily: AAP recommends supplemental dosage of 400 units daily.


Adolescents who do not consume 400 units of vitamin D daily from vitamin D-fortified milk or foods: AAP recommends supplemental dosage of 400 units daily.


Children at increased risk for vitamin D deficiency (e.g., those with fat malabsorption, those receiving anticonvulsant therapy): Higher dosages may be needed.


Adults


Hypoparathyroidism and Pseudohypoparathyroidism

Oral

625 mcg to 5 mg (up to 10 mg) daily with calcium supplements and/or IM or IV PTH.a b d


Prolonged administration of dosages >2.5 mg daily may increase risk of toxicity; gradually decrease dosage as serum calcium concentrations approach normal.a


Familial Hypophosphatemia (Vitamin D-Resistant Rickets)

Oral

250 mcg to 1.5 mg (up to 12.5 mg) daily with phosphate supplementsa c d (usually 1–2 g of elemental phosphorus daily) to maintain serum phosphorus concentrations of at least 3 mg/dL.c


Familial Hypophosphatemia associated with Fanconi syndrome

1.25–5 mg (up to 10 mg) daily have been used along with treatment for acidosis.a


Nutritional Rickets and Osteomalacia

Normal GI absorption

Oral

25 mcg daily has been used resulting in normal serum calcium and phosphorus concentrations in about 10 days, radiographic evidence of bone healing within 2–4 weeks, and complete healing within 6 months.a


50–125 mcg daily has been used for 6–12 weeks for more prompt healing.a


May discontinue drug, if healing has occurred with therapy and correction of diet.a


Severe Malabsorption

Oral

250 mcg to 7.5 mg.a


IM

250 mcg daily.a


Anticonvulsant-Induced Rickets and Osteomalacia

Oral

50 mcg to 1.25 mg daily.a


25 mcg daily or 250 mcg weekly has been used for prevention in those receiving long-term anticonvulsant therapy.a


Vitamin D-Dependent Rickets

Oral

250 mcg to 1.5 mg daily; some may require up to 12.5 mg daily.a


Prolonged administration of dosages >2.5 mg daily may result in toxicity.a


Renal Osteodystrophy or Hypocalcemia Secondary to Chronic Renal Disease

Oral

Initially, 500 mcg daily for early renal osteodystrophy then adjust according to serum calcium concentration.a


May require 250 mcg to 7.5 mg daily (up to 12.5 mg daily to maintain normal serum calcium concentrations).a


Osteoporosis

25–250 mcg daily or 1.25 mg 2 times weekly has been used with calcium and fluoride supplements.a


Dietary and Replacement Requirements

The AI of vitamin D (in terms of cholecalciferol or ergocalciferol) to prevent osteomalacia in healthy adults through 50 years of age is 5 mcg (200 units) daily, while for healthy adults 51–70 or older than 70 years of age is 10 (400 units) or 15 mcg (600 units) daily, respectively.


Because exposure to sunlight is decreased markedly during the winter, adults can become vitamin D deficient. Therefore, to cover the needs of nearly all adults, they should get supplementation. Pregnant and lactating women do not appear to have an increased requirement for vitamin D; however, daily vitamin D supplied by postnatal vitamins is not considered excessive.


















Supplemental Dosage in Adults

Age



Geographical Location or other Conditions



AI



19–50 years



Regardless of extent of sun exposure



5 mcg (200 units) daily



51–70 years



Regardless of extent of sun exposure



10 mcg (400 units) daily



>70 years of age



Regardless of extent of sun exposure



15 mcg (600 units) daily



Regardless of age



Severe malabsorption syndromes



250 mcg to 2.5 mg (10,000–100,000 units) daily


Prescribing Limits


Pediatric Patients


Infants and children

Oral

Chronic daily ingestion of 25 mcg daily may result in hypervitaminosis D.c


Adults


Oral

Chronic daily ingestion of 1.25–2.5 mg daily may result in hypervitaminosis D.c


Cautions for Ergocalciferol


Contraindications



  • Hypercalcemia or malabsorption syndrome.b d




  • Malabsorption syndrome.b d




  • Known abnormal sensitivity to toxic effects of vitamin D and hypervitaminosis D.b d




  • Hypervitaminosis.b d



Warnings/Precautions


Warnings


Concomitant Diseases

Administer with extreme caution, if at all, to patients with impaired renal function and with extreme caution in patients with heart disease, renal stones, or arteriosclerosis.c


Hypercalcemia

Acute or chronic administration of excessive doses of vitamin D analogs or enhanced responsiveness to physiologic amounts of ergocalciferol or cholecalciferol may lead to hypervitaminosis D manifested by hypercalcemia.c


Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia.b d Restrict use of vitamin D in these cases. b d


Acute hypercalcemia may increase risk of cardiac arrhythmiasc and seizures,e and result in cardiac arrhythmias in presence of cardiac glycosides.c e


Sensitivity Reactions


Tartrazine Sensitivity

Drisdol capsules contain tartrazine (FD&C yellow No. 5), which may cause allergic-type reactions including bronchial asthma in susceptible individuals. b Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.b


General Precautions


Hyperphosphatemia

In patients with hyperphosphatemia (e.g., those with renal osteodystrophy) use a phosphate binder and a low-phosphate diet to control serum phosphate concentrations to prevent metastatic calcification.b d


Specific Populations


Pregnancy

Category C.b d


Lactation

Distributed into milk.b d Caution if used in nursing women.b d Do not administer large doses of vitamin D analogs.c


Pediatric Use

Individualize pediatric doses.b d


Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults;b however, other experience indicate no substantial differences in safety and efficacy relative to younger adults.b


Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.b


Renal Impairment

Administer with caution, if at all, to patients with impaired renal function.c


Common Adverse Effects


Possible hypervitaminosis D effects: polyuria,b d nocturia,b d polydipsia,b d hypercalciuria,b d reversible azotemia,b d hypertension,b d nephrocalcinosis,b d generalized vascular calcification,b d irreversible renal insufficiency (may be fatal),b d mental retardation,b d widespread soft tissue calcification,b d osteoporosis,b d dwarfism,b d vague aches,b d stiffness,b d weakness,b d nausea,b d anorexia,b d constipation,b d mild acidosis,b d anemia,b d weight loss.b d


Interactions for Ergocalciferol


Specific Drugs

































Drug



Interaction



Comments



Cardiac glycosides



Concurrent use of vitamin D analogs and cardiac glycosides may result in cardiac arrhythmiasc



Use concomitantly with cautionc



Cholestyramine



Intestinal absorption of the vitamin D analog may be decreasedc



Allow as long a time interval as possible between ingestion of ergocaciferol and cholestytaminec



Colestipol



Intestinal absorption of the vitamin D analog may be decreasedc



Allow as long a time interval as possible between ingestion of the vitamin D analog and colestipolc



Corticosteroids



Corticosteroids may counteract effects of Vitamin D analogsc



Mineral oil



Interferes with absorption of vitamin D preparationsb d



Thiazide diuretics



Risk of hypercalcemia (may be transient and self-limited)c



May require discontinuance of the vitamin D analog c



Phenobarbital



Plasma concentrations of 25-hydroxylated ergocalciferol may be decreasedc



Phenytoin



Plasma concentrations of 25-hydroxylated ergocalciferol may be decreasedc



Orlistat



Potential interaction with drugs affecting lipid absorption (e.g., orlistat), resulting in decreased absorption of the oral vitamin D analog



Allow at least 2 hours between ingestion of the vitamin D analog and orlistat


Ergocalciferol Pharmacokinetics


Absorption


Bioavailability


Readily absorbed (about 80%) from GI tract (mainly in the small intestine);c presence of bile required.c


Onset


Hypercalcemic action: 10–24 hours.c


Maximal hypercalcemic effects occur about 4 weeks after daily administration of a fixed dose.c


Duration


Hypercalcemic action: ≥2 months.c


Special Populations


Extent of GI absorption may be decreased in patients with hepatic, biliary, or GI disease (e.g., Crohn’s disease, Whipple’s disease, sprue).c


Not known whether aging alters GI absorption of physiologic amounts of vitamin D; however, limited data indicate that absoption may be decreased in geriatric patients.b


Distribution


Extent


Enters blood via chylomicrons of lymph and then associates mainly with a specific α-globulin (vitamin D-binding protein).c


25-Hydroxyergocalciferol (metabolite) may be distributed into milk after administration of large doses.c


Elimination


Metabolism


In the liver, metabolized to 25-hydroxy derivatives by vitamin D 25-hydroxylase enzyme;c hepatic microsomal enzymes may be involved in degrading ergocalciferol metabolites.c Further metabolized in kidneys to 1,25 dihydroxyvitamin D.b d


Stability


Storage


Oral


Capsules and Solution

Tight, light resistant containersd at 25°Cb (may be exposed to 15–30°C).a b d


ActionsActions



  • A vitamin D analog.a




  • Ergolciferol increases intestinal absorption of calcium and phosphate and elevates serum calcium and phosphate concentrations sufficiently to permit bone mineralization.b d




  • Also promotes calcium reabsorption by the kidneys;b c d importance of this effect is not known.c




  • Activated form of ergocalciferol, may have a negative feedback effect on PTH production.c



Advice to Patients



  • Importance of diet and calcium supplementation regimen adherence to achieve a clinical response to vitamin D therapy.c




  • Importance of immediate reporting of potential manifestations of hypercalcemia.c




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b d




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast feed.b d




  • Importance of informing patients of other precautionary information.b d (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

































Ergocalciferol

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Bulk



Powder*



Oral



Capsules, liquid-filled



1.25 mg (50,000 units)*



Drisdol (with parabens and tartrazine)



Sanofi-Aventis



Ergocalciferol Capsules



Banner Pharmacaps, Barr



Solution



200 mcg (8000 units) per mL



Calciferol Drops (with propylene glycol)



UCB



Drisdol (with propylene glycol)



Sanofi-Aventis


Ergocalciferol is also commercially available in combination with other vitamins and minerals, analgesic-antipyretics, amino acids, infant formulas, laxatives, and protein supplements.



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



a. AHFS drug information 2007. McEvoy GK, ed. Ergocalciferol. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007: 3643-4.



b. Sanofi-Synthelabo. Drisdol (ergocalciferol) capsules prescribing information. New York, NY; 2003 Dec.



c. AHFS drug information 2007. McEvoy GK, ed. Vitamin D analogs general statement. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007:3634-40.



d. Banner Pharmacaps. Ergocalciferol capsules prescribing information. High Point, NC; 2005 Dec.



e. Genzyme. Hectorol (doxercalciferol) capsules prescribing information. Cambridge, MA; 2006 Jun.



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Compare Ergocalciferol with other medications


  • Familial Hypophosphatemia
  • Hypocalcemia
  • Hypoparathyroidism
  • Hypophosphatemia
  • Osteomalacia
  • Renal Osteodystrophy
  • Rickets
  • Vitamin D Deficiency
  • Vitamin/Mineral Supplementation and Deficiency