Online PLR Content Directory Canada: March 2012

Friday 30 March 2012

Embeda

Generic Name: morphine and naltrexone (MOR feen and nal TREX one)

Brand Names: Embeda

What is morphine and naltrexone?

Morphine is in a group of drugs called narcotic pain relievers.

Naltrexone is a special narcotic drug that blocks the effects of other narcotic medicines and alcohol.

The combination of morphine and naltrexone is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long time period.

Morphine and naltrexone is not for treating pain just after surgery unless you were already taking morphine and naltrexone before the surgery.

Morphine and naltrexone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about morphine and naltrexone?

Do not use morphine and naltrexone if you have ever had an allergic reaction to a narcotic medicine, if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Before taking morphine and naltrexone, tell your doctor if you have a breathing disorder, liver or kidney disease, underactive thyroid, curvature of the spine, a history of head injury or brain tumor, gallbladder or pancreas disorders, a blockage in your stomach or intestines, Addison's disease, enlarged prostate, urination problems, a seizure disorder, a debilitating condition, mental illness, or a history of drug or alcohol addiction.

Do not drink alcohol while you are using morphine and naltrexone. Dangerous side effects or death can occur.

Never take more than your prescribed dose of morphine and naltrexone. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

What should I discuss with my healthcare provider before using morphine and naltrexone?

You may not be able to take this medicine unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Do not use morphine and naltrexone if you have ever had an allergic reaction to a narcotic medicine. Opioid medicines include codeine (Tylenol #3), hydrocodone (Vicodin), oxycodone (OxyContin, Percocet), propoxyphene (Darvon, Darvocet), morphine (Kadian, MS Contin, Oramorph), and many others.

You should also not take morphine and naltrexone if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Do not use morphine and naltrexone if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use morphine and naltrexone before the MAO inhibitor has cleared from your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take morphine and naltrexone:

asthma, COPD, sleep apnea, or other breathing disorders;

liver or kidney disease;

underactive thyroid;

curvature of the spine;

a history of head injury or brain tumor;

gallbladder or pancreas disorders;

a blockage in your stomach or intestines;

Addison's disease or other adrenal gland disorders;

enlarged prostate, urination problems;

epilepsy or other seizure disorder;

any type of debilitating condition; or

mental illness or a history of drug or alcohol addiction.

Morphine and naltrexone may be habit-forming and should be used only by the person it was prescribed for. Morphine and naltrexone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. FDA pregnancy category C. This medication may cause addiction or withdrawal symptoms in a newborn. Before you receive morphine and naltrexone, tell your doctor if you are pregnant. Morphine and naltrexone should not be used during labor and delivery. Morphine and naltrexone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

How should I use morphine and naltrexone?

Use this medication exactly as it was prescribed for you. Never take morphine and naltrexone in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Each dose should be spaced at least 12 hours apart.

Do not crush, chew, or dissolve the medicine pellets inside an extended-release capsule. If possible, swallow the pill whole. Crushing or chewing the medicine pellets would cause too much of the drug to be released at one time, which may cause a life-threatening overdose.

To make swallowing easier, you may open the extended-release capsule and sprinkle the medicine into a spoonful of applesauce. Mix only one dose and swallow this mixture right away without chewing. Drink a glass of water to make sure all the medicine has been swallowed. Flush the empty capsule down a toilet.

Do not stop using morphine and naltrexone suddenly. Talk to your doctor about how to avoid withdrawal symptoms. Store this medication at room temperature, away from heat, moisture, and light. Keep track of how many pills have been used from each new bottle of this medicine. Morphine and naltrexone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet. Throw away any unused liquid morphine and naltrexone that is older than 90 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Morphine and naltrexone is not for use on an as-needed basis for pain.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of morphine and naltrexone can be fatal. Overdose symptoms may include extreme drowsiness or limp feeling, pinpoint or dilated pupils, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while using morphine and naltrexone?

Do not drink alcohol while you are taking this medication. Dangerous side effects or death can occur when alcohol is combined with morphine and naltrexone. Morphine and naltrexone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Morphine and naltrexone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fast or pounding heartbeats, chest pain, difficulty breathing; dizziness, extreme fear; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

mood changes, hallucinations (seeing or hearing things), confusion;

slow heart rate, weak pulse, fainting, weak or shallow breathing (breathing may stop);

seizure (convulsions); or

severe constipation or stomach pain.

Less serious side effects may include:

drowsiness, dizziness, anxiety, tired feeling;

nausea, vomiting, constipation, diarrhea;

blurred vision, headache; or

sleep problems (insomnia).

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 morphine and naltrexone?

Before taking this medication, tell your doctor if you take other medications that can make you sleepy or slow your breathing. This includes cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety.

Also tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex).

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

a diuretic (water pill);

quinidine (Quinaglute, Quinidex, Quin-Release);

atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva);

ulcer or irritable bowel medication;

bladder or urinary medications such as tolterodine (Detrol);

an antibiotic such as clarithromycin (Biaxin) or erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);

heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), or verapamil (Calan, Covera, Isoptin, Verelan);

HIV or AIDS medication such as indinavir (Crixivan) or ritonavir (Kaletra, Norvir); or

medicines used to prevent organ transplant rejection.

This list is not complete and there may be other drugs that can interact with morphine and naltrexone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Embeda resources

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

Embeda Prescribing Information (FDA)

Embeda Advanced Consumer (Micromedex) - Includes Dosage Information

Embeda Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Embeda Consumer Overview

Compare Embeda with other medications

Pain

Where can I get more information?

Your pharmacist can provide more information about morphine and naltrexone.

See also: Embeda side effects (in more detail)

Loxapine Succinate

Class: Antipsychotics, Miscellaneous
VA Class: CN709
Chemical Name: 2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine
Molecular Formula: C₁₈H₁₈ClN₃O•C₄H₆O₄
CAS Number: 27833-64-3
Brands: Loxitane

Special Alerts:

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .

[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: , and .

Introduction

Tricyclic dibenzoxazepine-derivative, conventional (prototypical, first-generation) antipsychotic agent; structurally related to amoxapine, clozapine, and olanzapine.^a ^b ^e ^g ^h ⁱ ^j ^q ^r ^s ^u ^v ^w ^x

Uses for Loxapine Succinate

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Psychotic Disorders

Symptomatic management of psychotic disorders (i.e., schizophrenia).^a ^b ^e ^g ^h ⁱ ^j ^q ^r

Has been used in the management of refractory or treatment-resistant schizophrenia.^b ^s ^v

Mental Retardation

Efficacy not established for the management of behavioral complications in patients with mental retardation.^a ^b ^g ^h

Loxapine Succinate Dosage and Administration

General

Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.^a ^b ^g ^h ^j ^q ^r ^v

Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued.^a ^g ^h ^aa (See Tardive Dyskinesia under Cautions.)

For symptomatic relief of psychotic disorders, initial therapeutic response to antipsychotic therapy usually occurs within 2–4 weeks and optimum therapeutic response occurs within 6 months or longer.^b ⁱ ^q ^aa ^v

Administration

Oral Administration

Loxapine succinate is administered orally, usually in divided doses 2–4 times daily.^a ^b ^g ^h ^j ^v Loxapine hydrochloride has been given orally and parenterally, but no longer is commercially available in the US.^b ^e ^j ^k

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as loxapine succinate; dosage expressed in terms of loxapine.^a ^b ^g ^h ^k

Adults

Psychotic Disorders

Oral

Initially, 10 mg given twice daily.^a ^b ^g ^h ^j ^q ^r ^v

In severely schizophrenic patients, an initial dosage of up to 50 mg daily may be preferable.^a ^b ^g ^h ^j ^q ^r ^v

May increase dosage fairly rapidly during the first 7–10 days of therapy according to patient response and tolerance.^a ^b ^g ^h ^j ^q ^r ^v

Usual maintenance dosage: 60–100 mg daily; some patients respond to a lower dosage and others require a higher dosage.^a ^b ^g ^h ⁱ ^j ^q ^r ^t ^v For severely ill patients with chronic schizophrenia, some clinicians recommend maintenance dosages of 100–200 mg daily.^b

Prescribing Limits

Adults

Psychotic Disorders

Oral

Maximum 250 mg daily.^a ^b ^g ^h ^v

Special Populations

Geriatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

No specific dosage recommendations for geriatric patients, but generally select dosage at the lower end of recommended range; increase dosage more gradually and monitor closely.ⁱ ^j ^r ^aa ^dd (See Geriatric Use under Cautions.)

Cautions for Loxapine Succinate

Contraindications

Comatose or severe drug-induced (e.g., alcohol, barbiturates, narcotics) depressed states.^a ^g ^h (See Specific Drugs under Interactions.)

Known hypersensitivity to loxapine or other dibenzoxazepines (e.g., amoxapine).^a ^g ^h

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Shares the toxic potentials of other antipsychotic agents (e.g., phenothiazines); observe the usual precautions associated with therapy with these agents.^b ⁱ

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, may develop in patients receiving antipsychotic agents, including loxapine.^a ^g ^h ⁱ ^r Consider reducing loxapine dosage or discontinuing drug and possibly switching to a second-generation (atypical) antipsychotic agent.^a ^b ^g ^h ⁱ

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported with antipsychotic agents, including loxapine.^a ^b ^g ^h ^s ^bb

CNS Depression

May impair mental and/or physical abilities, especially during the first few days of therapy; use caution with activities requiring alertness (e.g., operating vehicles or machinery).^a ^b ^g ^h ^aa

Response to CNS depressants and alcohol may be potentiated.^a ^b ^g ^h (See Specific Drugs under Interactions.)

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarity in spelling of Loxitane (loxapine succinate) and Soriatane (acitretin) and availability of same strengths and dosage forms may result in errors.^cc

Sensitivity Reactions

Hypersensitivity and Cross-sensitivity

Possible sensitivity reactions (e.g., jaundice, hepatitis, blood dyscrasias, skin reactions [dermatitis, rashes, facial edema, pruritus]).^a ^b ^e ^g ^h ^q

Possible cross-sensitivity with dibenzoxazepines (e.g., amoxapine).^a ^g ^h (See Contraindications.)

Photosensitivity

Consider that phototoxicity and/or photosensitivity reactions may occur with loxapine.^b

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Seizures

Loxapine lowers seizure threshold; seizures reported even during maintenance of routine anticonvulsant therapy.^a ^b ^g ^h ^j ^r ^q ^v Use with extreme caution in patients with a history of seizure disorders.^a ^b ^g ^h ^q (See Specific Drugs under Interactions.)

Extrapyramidal Effects

Extrapyramidal symptoms occur frequently and usually are reversible; persistent reactions usually can be controlled by concomitant therapy with an antiparkinsonian drug and subsequent dosage reduction.^a ^b ^e ^g ^h ⁱ ^q ^r ^v ^aa

Incidence of extrapyramidal symptoms may be greater with IM administration (IM dosage form of loxapine hydrochloride no longer commercially available in the US) than oral administration.^a ^b ^g ^h

Cardiovascular Effects

Possible tachycardia and/or hypotension; use with caution in patients with cardiovascular disease.^a ^b ^g ^h ^q ^r ^v

If severe hypotension occurs, administer norepinephrine or phenylephrine; epinephrine or dopamine should not be used.^a ^b ^g ^h ^aa (See Specific Drugs under Interactions.)

Prolactin Secretion

Elevated prolactin concentrations reported; elevation persists during chronic administration.^a ^g ^h ^aa

Clinical importance unknown; consider that approximately one-third of human breast cancers are prolactin dependent when prescribing loxapine in patients with previously detected breast cancer.^a ^g ^h ^aa

Galactorrhea, amenorrhea, gynecomastia, and impotence reported.^a ^g ^h ^aa

Anticholinergic Effects

Possible anticholinergic effects (e.g., dry mouth, blurred vision, mydriasis, constipation, urinary retention).^a ^b ^g ^h ^q ^r ^aa

Use with caution in patients with glaucoma or a tendency toward urinary retention.^a ^b ^g ^h ^aa (See Specific Drugs under Interactions.)

Ocular Effects

Pigmentary retinopathy and lenticular pigmentation reported with prolonged therapy with other antipsychotic agents; possibility of ocular toxicity with loxapine cannot be excluded.^a ^b ^g ^h ^q ^aa Periodic ophthalmologic examinations recommended in patients receiving prolonged loxapine therapy.^a ^b ^g ^h

Other Precautions

Antiemetic effects may mask signs of overdosage of other drugs (e.g., antineoplastic agents) or obscure cause of vomiting in various disorders (e.g., intestinal obstruction, Reye’s syndrome, brain tumor).^a ^b ^g ^h ^aa

Specific Populations

Pregnancy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Category C.^c

Lactation

Loxapine and its metabolites distributed into milk in dogs; not known whether distributed into human milk.^a ^c ^g ^h Avoid loxapine in nursing women if clinically possible.^a ^g ^h ⁿ

Pediatric Use

Safety and efficacy not established in pediatric patients.^a ^g ^h

Geriatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Geriatric patients appear to be particularly sensitive to adverse CNS (e.g., tardive dyskinesia, parkinsonian manifestations, akathisia, sedation), anticholinergic, and cardiovascular (e.g., orthostatic hypotension) effects of antipsychotic agents.^a ^g ^h ⁱ ^aa (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Extrapyramidal reactions (e.g., Parkinson-like symptoms, dystonia, akathisia, tardive dyskinesia), drowsiness or sedation, anticholinergic effects (e.g., dry mouth, blurred vision), orthostatic hypotension, tachycardia.^a ^b ^e ^g ^h ^q ^r ^s

Interactions for Loxapine Succinate

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions with inhibitors of CYP2D6, CYP3A4, or CYP1A2 are possible.^s

Specific Drugs

Drug	Interaction	Comments
Alcohol	Potential additive CNS depressant effects^a ^b ^g ^h ^j ^q ^r ^v	Use with caution^a ^b ^g ^h
Anticholinergic drugs	Possible potentiated anticholinergic effects^a ^b ^g ^h	Use with caution^a ^b ^g ^h
Anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin)	Anticonvulsants may decrease plasma loxapine concentrations^s Loxapine may lower seizure threshold^a ^b ^g ^h ^j ^q ^r Phenytoin: Loxapine may decrease serum phenytoin concentrations^q ^r	Dosage adjustment of anticonvulsants may be necessary during concomitant use^j ^s
Beta-blockers (e.g., propranolol)	Possible further lowering of BP^r ^v	Use with caution and consider reduced loxapine dosage^r ^v
CNS depressants (e.g., antihistamines, barbiturates, general anesthetics, opiate analgesics, sedative/hypnotics)	Possible additive effects or potentiated action of other CNS depressants^a ^b ^g ^h ^j ^q ^r	Use with caution to avoid excessive sedation or CNS depression^a ^b ^g ^h ^r
Epinephrine or dopamine	Possible further lowering of BP^a ^b ^g ^h ^aa	Do not use epinephrine or dopamine for loxapine-induced hypotension^a ^b ^g ^h ^aa (see Cardiovascular Effects under Cautions)
Lithium	An acute encephalopathic syndrome reported occasionally, especially when high serum lithium concentrations present ^j ^aa	Observe patients receiving combined therapy for evidence of adverse neurologic effects; promptly discontinue if such signs or symptoms appear^aa
Lorazepam	Possible respiratory depression, stupor, and/or hypotension^a ^g ^h ^p ^s

Loxapine Succinate Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed from GI tract following oral administration.^a ^b ^g ^h ^q ^r ^u Almost completely absorbed following IM administration (IM dosage form of loxapine hydrochloride no longer commercially available in the US).^a ^b ^g ^h Appears to undergo first-pass metabolism.^s ^t ^w ^x

Peak serum concentrations generally attained within 1–3 hours after oral administration;^b ^q ^s ^t ^x considerable interindividual variation in peak concentrations reported.^w ^x

Onset

Onset of sedation usually occurs within 20–30 minutes and is most pronounced within 1.5–3 hours following single-dose, oral administration.^a ^b ^g ^h ^s

Antipsychotic effects usually are apparent within 2–4 weeks after initiation of oral therapy, and optimum therapeutic response usually occurs within 6 months or longer.^b ⁱ ^q ^aa

Duration

Duration of sedation following single-dose, oral administration is approximately 12 hours.^a ^b ^g ^h

Distribution

Extent

In animals, loxapine and/or its metabolites are widely distributed into body tissues, including lungs, brain, spleen, heart, liver, pancreas, and kidneys.^a ^b ^g ^h ^q ^u Loxapine crosses blood-brain barrier.^b

Although no human data are available, animal studies indicate that loxapine crosses the placenta.^b ^c Loxapine and its metabolites distribute into milk in dogs; not known whether distributed into human milk.^a ^b ^c ^g ^h ^j

Elimination

Metabolism

Rapidly and extensively metabolized in the liver by aromatic hydroxylation, N-demethylation, and N-oxidation to active metabolites 8-hydroxyloxapine and 7-hydroxyloxapine and inactive metabolites 8-hydroxydesmethylloxapine, 7-hydroxydesmethylloxapine, and loxapine N-oxide.^a ^b ^g ^h ^j ^q ^r ^t ^u ^x Significant amounts of the N-oxides of the hydroxyloxapines also present.^b

Elimination Route

Loxapine and its metabolites are excreted in urine and feces.^a ^b ^g ^h ^q ^r ^t

Half-life

Biphasic; half-life of initial phase is approximately 5 hours and half-life of terminal phase is approximately 19 hours.^b

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 15–30°C.^a ^b ^g ^h ^k

ActionsActions

Produces pharmacologic effects similar to those of other conventional antipsychotic agents (e.g., phenothiazines, butyrophenones, thioxanthenes, molindone).^b ⁱ ^j ^s ^v

Precise mechanism(s) of antipsychotic action not determined, but may be principally related to antidopaminergic and antiserotonergic effects; other neurotransmitter systems may be involved.^a ^b ^e ^g ^h ^q ^r ^s

Antagonism of α₁-adrenergic receptors and cholinergic receptors may contribute to adverse effects (e.g., orthostatic hypotension, dry mouth, blurred vision).^a ^b ^e ^g ^h ^j ^r ^s

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.^a ^g ^h

Importance of avoiding alcohol during loxapine therapy.^a ^g ^h ^r

Importance of clinicians informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.^a ^g ^h

Importance of clinicians informing patients of risk of extrapyramidal reactions and providing reassurance that these reactions usually can be controlled by administration of antiparkinsonian drugs (e.g., benztropine) and by subsequent dosage reduction.^a ^g ^h ^aa

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease, seizure disorder).^a ^g ^h

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a ^g ^h

Importance of informing patients of other important precautionary information.^a ^g ^h (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

Loxapine Succinate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	5 mg (of loxapine)*	Loxapine Succinate Capsules	Amide, Mylan, Watson
			Loxitane	Watson
		10 mg (of loxapine)*	Loxapine Succinate Capsules	Amide, Mylan, Watson
			Loxitane	Watson
		25 mg (of loxapine)*	Loxapine Succinate Capsules	Amide, Mylan, Watson
			Loxitane	Watson
		50 mg (of loxapine)*	Loxapine Succinate Capsules	Amide, Mylan, Watson
			Loxitane	Watson

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Loxapine Succinate 5MG Capsules (WATSON LABS): 30/$25.99 or 90/$55.97

Loxapine Succinate 50MG Capsules (WATSON LABS): 30/$39.99 or 90/$99.97

Loxitane 5MG Capsules (WATSON LABS): 60/$91.99 or 180/$258.95

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 March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. The United States pharmacopeia, 22nd rev, and the national formulary, 17th ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1989 (Suppl 3):2356-7.

101. The USP Drug Nomenclature Committee. Nomenclature policies and recommendations: I. Review and current proposals and decisions. Pharmacopeial Forum. 1991; 17:1509-11.

102. Loxitane (loxapine succinate) prescribing information. In: Barnhart ET, publisher. Physicians’ desk reference. 44th ed. Oradell, NJ: Medical Economics Company Inc; 1991:1181-2.

a. Watson Laboratories, Inc. Loxapine capsules prescribing information. Corona, CA; 2005 Sept.

b. AHFS drug information 2007. McEvoy GK, ed. Loxapine succinate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2459-61.

c. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:949.

d. American Academy of Pediatrics. Use of psychoactive medication during pregnancy and possible effects on the fetus and newborn. Pediatrics. 2000; 105:880-87. [PubMed 10742343]

e. Chakrabati A, Bagnall A, Chue P et al. Loxapine for schizophrenia. Cochrane Database Systematic Reviews. 2007; Issue 4:Article No.: CD001943. DOI: 10.1002/14651858.CD001943.pub2.

f. The United States Pharmacopeial Convention, Inc. USAN and the USP Dictionary drug names. Rockville, MD: United States Pharmacopeial Convention, Inc; 2007:509-10.

g. Watson Laboratories, Inc. Loxitane (loxapine succinate) capsules prescribing information. Corona, CA; 2007 Oct.

h. Mylan Pharmaceuticals Inc. Loxapine capsules prescribing information. Morgantown, WV; 2004 Apr.

i. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia, second edition. From the APA website:

j. AMA Division of Drugs. AMA drug evaluations. ed. City: American Medical Association; 1994:1-29.

k. Lederle Laboratories. Loxitane (loxapine) capsules, oral concentrate, and injection prescribing information. Pearl River, NY; 1983 Sep.

l. Cohen LS, Heller VL, Rosenbaum JF. Treatment guidelines for psychotropic drug use in pregnancy. Psychosomatics. 1989; 30:25-33. [PubMed 2643809]

m. Calabrese JR, Gulledge AD. Psychotropics during pregnancy and lactation: a review. Psychosomatics. 1985; 26:413-26. [PubMed 2859631]

n. Goldberg H, Nissim R. Psychotropic drugs in pregnancy and lactation. Int J Psychiatry Med. 1994; 24:129-49. [PubMed 7960421]

o. Altshuler LL, Cohen L, Szuba MP et al. Pharmacologic management of psychiatric illness during pregnancy: dilemmas and guidelines. Am J Psychiatry. 1996; 153:592-606. [PubMed 8615404]

p. Battaglia J, Thornton L. Loxapine-lorazepam-induced hypotension and stupor. J Clin Psychopharmacol. 1989; 9:227-8. Letter. [PubMed 2738184]

q. Heel RC, Brogden RN, Speight TM et al. Loxapine: a review of its pharmacological properties and therapeutic efficacy as an antipsychotic agent. Drugs. 1978; 15:198-217. [PubMed 25167]

r. DePaulo JR, Ayd FJ. Loxapine: fifteen years’ clinical experience. Psychosomatics. 1982; 23:261-71. [PubMed 7041162]

s. Ereshefsky L. Pharmacologic and pharmacokinetic considerations in choosing an antipsychotic. J Clin Psychiatry. 1999; 60(Suppl 10):20-30. [PubMed 10340684]

t. Milton GV, Jann MW. Emergency treatment of psychotic symptoms: pharmacokinetic considerations for antipsychotic drugs. Clin Pharmacokinet. 1995; 28:494-504. [PubMed 7656507]

u. Gershon S, Hekimian LJ, Burdock EI et al. Antipsychotic properties of loxapine succinate. Cur Ther Res Clin Exp. 1970; 12:280-5.

v. Ayd FJ. Loxapine update: 1966-1976. Dis Nerv Syst. 1977; 38:883-7. [PubMed 410614]

w. Midha KK, Hubbard JW, McKay G et al. The role of metabolites in a bioequivalence study 1: loxapine, 7-hydroxyloxapine and 8-hydroxyloxapine. Int J Clin Pharmacol Ther Toxicol. 1993; 31:177-83. [PubMed 8500919]

x. Cooper SF, Dugal R, Bertrand MJ. Determination of loxapine in human plasma and urine and identification of three urinary metabolites. Xenobiotica. 1979; 9:405-14. [PubMed 494666]

y. Prakash R, Reed RM, Bass AD. Loxapine yields amoxapine. J Clin Psychopharmacol. 1984; 4:363-4. [PubMed 6512010]

z. Chong LS, Abbott PM. Neuroleptic malignant syndrome secondary to loxapine. Br J Psychiatry. 1991; 159:572-3. [PubMed 1751872]

aa. AHFS drug information 2007. McEvoy GK, ed. Phenothiazines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2439-50.

bb. Ewert AL, Klock J, Wells B et al. Neuroleptic malignant syndrome associated with loxapine. J Clin Psychiatry. 1983; 44:37-8. Letter. [PubMed 6822486]

cc. Food and Drug Administration. Important prescribing notice. Rockville, MD; 1998. From the FDA web site: .

dd. Howard R, Rabins PV, Seeman MY and the International Late-Onset Schizophrenia group. Late-onset schizophrenia and very-late-onset schizophrenia like psychosis: an international consensus. Am J Psychiatry. 2000; 157:172-8. [PubMed 10671383]

More Loxapine Succinate resources

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

Loxapine Prescribing Information (FDA)

Loxapine Professional Patient Advice (Wolters Kluwer)

loxapine Concise Consumer Information (Cerner Multum)

Loxapine MedFacts Consumer Leaflet (Wolters Kluwer)

loxapine Advanced Consumer (Micromedex) - Includes Dosage Information

Loxitane Prescribing Information (FDA)

Compare Loxapine Succinate with other medications

Schizophrenia

Thursday 29 March 2012

Up and Up Acid Controller Complete

Dosage Form: tablet
Target Corp. Acid Controller Complete Drug Facts

Active ingredient (in each chewable tablet)

Famotidine 10 mg

Calcium carbonate 800 mg

Magnesium hydroxide 165 mg

Purpose

Acid reducer

Antacid

Uses

relieves heartburn associated with acid indigestion and sour stomach

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

with other acid reducers

Ask a doctor before use if you have

had heartburn over 3 months. This may be a sign of a more serious condition.

heartburn with lightheadedness, sweating, or dizziness

chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

frequent chest pain

frequent wheezing, particularly with heartburn

unexplained weight loss

nausea or vomiting

stomach pain

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if

your heartburn continues or worsens

you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over:

do not swallow tablet whole: chew completely

to relieve symptoms, chew 1 tablet before swallowing

do not use more than 2 chewable tablets in 24 hours

children under 12 years: ask a doctor

Other information

each tablet contains: calcium 320 mg; magnesium 65 mg

Phenylketonurics: Contains Phenylalanine 2.2 mg per tablet

read the directions and warnings before use

read the bottle label. It contains important information.

store at 20°-25°C (68°-77°F)

protect from moisture

Inactive ingredients

aspartame, dextrates, flavor, glyceryl monostearate, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyacrylate dispersion, polysorbate 80, povidone, pregelatinized starch, red iron oxide, sodium starch glycolate, talc

Questions?

Call 1-800-910-6874

Principal Display Panel

Dual Action

Acid Controller Complete

Famotidine 10 mg/Calcium Carbonate 800 mg/Magnesium Hydroxide 165 mg Tablets

Acid Reducer + Antacid

Compare to active ingredients in Pepcid® Complete

Just One Tablet Relieves Heartburn Due to Acid Indigestion

Mint Flavor

# Tablets (Replace "#" with amount in package)

Acid Controller Complete Label

Up and Up Acid Controller Complete DUAL ACTION
famotidine, calcium carbonate, magnesium hydroxide tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	11673-546
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (FAMOTIDINE)	FAMOTIDINE	10 mg
CALCIUM CARBONATE (CARBONATE ION)	CALCIUM CARBONATE	800 mg
MAGNESIUM HYDROXIDE (MAGNESIUM HYDROXIDE)	MAGNESIUM HYDROXIDE	165 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	ORANGE (PEACH WITH WHITE SPECKLES)	Score	no score
Shape	ROUND	Size	18mm
Flavor	MINT	Imprint Code	L546
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	11673-546-71	50 TABLET In 1 BOTTLE	None
2	11673-546-78	2 BOTTLE In 1 CARTON	contains a BOTTLE
2		50 TABLET In 1 BOTTLE	This package is contained within the CARTON (11673-546-78)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077355	07/31/2009

Labeler - Target Corporation (006961700)

Revised: 07/2009Target Corporation

More Up and Up Acid Controller Complete resources

Up and Up Acid Controller Complete Use in Pregnancy & Breastfeeding
Up and Up Acid Controller Complete Drug Interactions
Up and Up Acid Controller Complete Support Group
0 Reviews for Up and Up Acid Controller Complete - Add your own review/rating

Compare Up and Up Acid Controller Complete with other medications

GERD

Monday 26 March 2012

eletriptan

Generic Name: eletriptan (EL e TRIP tan)

Brand Names: Relpax

What is eletriptan?

Eletriptan is a headache medicine that narrows blood vessels around the brain. Eletriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Eletriptan is used to treat migraine headaches. Eletriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Eletriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

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

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

You should not take this medication if you are allergic to eletriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, severe liver disease, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches. Do not take eletriptan within 24 hours before or after using another migraine headache medicine, including almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Treximet), zolmitriptan (Zomig), or ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine). Do not use eletriptan within 72 hours before or after taking ketoconazole (Extina, Ketozole, Nizoral, Xolegal), itraconazole (Sporanox), nefazodone, clarithromycin (Biaxin), ritonavir (Norvir, Kaletra), or nelfinavir (Viracept).

Before taking eletriptan, tell your doctor if you have liver or kidney disease, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Also tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

Eletriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After taking an eletriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 80 mg of eletriptan in 24 hours.

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

You should not use this medication if you are allergic to eletriptan, or if you have:

coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

a history of heart disease, heart attack, or stroke, including "mini-stroke";

severe or uncontrolled high blood pressure;

severe liver disease;

ischemic bowel disease; or

a headache that seems different from your usual migraine headaches.

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

liver disease;

kidney disease;

high blood pressure, a heart rhythm disorder; or

coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category C. It is not known whether eletriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Eletriptan can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to anyone under 18 years old.

How should I use eletriptan?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.

Take eletriptan as soon as you notice headache symptoms, or after an attack has already begun.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.

Take one eletriptan tablet whole with a full glass of water.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet two (2) hours after the first. Do not take more than 80 mg of eletriptan in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Contact your doctor if you have more than three headaches in one month (30 days).

If you use eletriptan long-term, your doctor may want to check your heart function using an electrocardiograph or ECG (sometimes called an EKG), a machine that measures electrical activity of the heart. This will help your doctor determine if it is still safe for you to use this medication. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since eletriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using eletriptan.

After taking an eletriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 80 mg of eletriptan in 24 hours.

What happens if I overdose?

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

Overdose could cause high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, or seizure).

What should I avoid while using eletriptan?

Do not take eletriptan within 24 hours before or after using another migraine headache medicine, including:

almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex, Treximet), or zolmitriptan (Zomig); or

ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Do not use eletriptan within 72 hours before or after taking any of the following medicines:

ketoconazole (Extina, Ketozole, Nizoral, Xolegal), itraconazole (Sporanox);

nefazodone;

clarithromycin (Biaxin); or

ritonavir (Norvir, Kaletra), nelfinavir (Viracept).

Eletriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Eletriptan 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. Stop using eletriptan and call your doctor at once if you have a serious side effect such as:

feeling of pain or tightness in your jaw, neck, or throat;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

sudden and severe stomach pain and bloody diarrhea;

numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or

(if you are also taking an antidepressant) - agitation, high fever, sweating, fast or pounding heartbeats, nausea, vomiting, diarrhea, loss of balance or coordination, overactive reflexes, hallucinations, fainting.

Less serious side effects may include:

mild headache (not a migraine);

pressure or heavy feeling in any part of your body;

dry mouth, upset stomach, stomach pain or cramps;

dizziness, drowsiness, weakness; or

warmth, redness, or mild tingling under your skin.

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.

Eletriptan Dosing Information

Usual Adult Dose for Migraine:

In the acute treatment of migraine with or without aura:

40 mg orally once

or

20 mg orally once

If after the initial dosage, the headache improves but then returns, a repeat dose may be beneficial. If a second dose is needed, it should be taken at least two hours after the initial dose.

The maximum daily dose should not exceed 80 mg.

The safety of treating an average of more than three headaches in a thirty day period has not been established.

What other drugs will affect eletriptan?

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

conivaptan (Vaprisol);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

an antibiotic such as dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone, paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor);

antifungal medicine such as miconazole (Oravig) or voriconazole (Vfend);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), or saquinavir (Invirase).

This list is not complete and there may be other drugs that can interact with eletriptan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More eletriptan resources

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

eletriptan Advanced Consumer (Micromedex) - Includes Dosage Information

Eletriptan MedFacts Consumer Leaflet (Wolters Kluwer)

Eletriptan Hydrobromide Monograph (AHFS DI)

Relpax Prescribing Information (FDA)

Relpax Consumer Overview

Compare eletriptan with other medications

Migraine

Where can I get more information?

Your pharmacist can provide more information about eletriptan.

See also: eletriptan side effects (in more detail)

Saturday 24 March 2012

Avage Topical

Generic Name: tazarotene (Topical route)

taz-AR-oh-teen

Commonly used brand name(s)

In the U.S.

Avage

Tazorac

Available Dosage Forms:

Gel/Jelly

Cream

Therapeutic Class: Dermatological Agent

Chemical Class: Retinoid

Uses For Avage

Tazarotene is used to treat acne on the face and and to treat psoriasis.

It works to help clear acne on the face partly by keeping skin pores clear. It works in the treatment of psoriasis by making the skin less red and reducing the number and size of lesions of the skin.

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

Before Using Avage

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

Studies of this medicine have been done only in adult patients, and there is no specific information comparing use of tazarotene in children up to 12 years of age (gel) and up to 18 years of age (cream) with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether or not they work in exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of tazarotene in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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.

Proper Use of tazarotene

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

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

Read the patient information that will come with your medicine.

For acne—Before applying tazarotene to acne areas of the skin, wash the skin with a mild soap or cleanser and warm water, then gently pat dry. Wait at least 20 to 30 minutes before applying this medicine.

For acne or psoriasis—Do not use this medicine in or around the eyes or lips, or inside of the nose. Spread the medicine away form these areas when applying

Do not apply this medicine to windburned or sunburned skin or on open wounds.

When using tazarotene, apply medicine to dry skin. If skin has just been washed and dried, wait at least 20 to 30 minutes before applying this medicine. Applying to wet or damp skin may cause skin irritation.

Apply a thin layer of this medicine only to lesions of psoriasis on the body or areas on face prone to developing acne. Rub medicine in gently and well. Wash medicine off skin areas not intended to be treated.

After applying the medicine, wash your hands to remove any medicine that might remain on them.

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 topical dosage form (gel):
- For acne:
  - Adults and children 12 years of age and older—Apply 0.1% tazarotene to clean, dry affected areas of the face once a day, usually in the evening or at bedtime.
  - Children up to 12 years of age—Use and dose must be determined by the doctor.
- For psoriasis:
  - Adults and children 12 years of age and older—Apply 0.05% or 0.1% tazarotene to dry affected areas of the body once a day, usually in the evening or at bedtime. Do not treat a larger area of the skin than your doctor tells you to treat.
  - Children up to 12 years of age—Use and dose must be determined by the doctor.

For topical dosage form (cream):
- For psoriasis:
  - Adults and children 18 years of age and older—Apply 0.05% or 0.1% tazarotene to dry affected areas of the body once a day, usually in the evening or at bedtime. Do not treat a larger area of the skin than your doctor tells you to treat.
  - Children up to 18 years of age—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of this medicine, 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.

Precautions While Using Avage

If you think that you may be pregnant, stop using the medicine immediately and check with your doctor.

If you are using this medicine to treat acne of the face, your condition may seem to worsen at first before it begins to improve in about 4 weeks. Check with your doctor if your condition does not improve within 8 to 12 weeks.

If your are using this medicine to treat psoriasis, scaly patches on skin may begin to improve in about 1 to 4 weeks but redness may take longer to improve. Check with your doctor if your condition becomes worse.

Do not cover the treated area with a bandage.

When using tazarotene, do not use skin products such as abrasive soaps or cleansers; alcohol-containing products; cosmetics or soaps that dry the skin; hair products that are irritating, such as permanents or hair removal products; skin products containing spices, limes, or other ingredients that may make the skin more sensitive to the sun; or other topical medicine for the skin on the same area as tazarotene, unless otherwise directed. To do so may cause severe irritation of the skin.

Ask your doctor before taking vitamin A supplements by mouth while using this medicine.

During treatment with this medicine, avoid exposing the treated areas to sunlight when possible, since the skin may be more likely to become sunburned. Do not use a sunlamp.

Some people who use this medicine may become more sensitive to wind or cold weather, as well as to sunlight. Avoiding exposure to these conditions by using sunscreen products with a sun protection factor (SPF) of 15 or more and wearing protective clothing will help protect your skin against becoming too dry, irritated, or sunburned.

Avage Side Effects

It is likely that your skin may become irritated with normal use of this medicine. You should not stop using tazarotene unless your skin becomes too red, dry, puffy, or otherwise irritated. If severe irritation occurs, contact your doctor.

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 as soon as possible if any of the following side effects occur:

More common

Burning or stinging of the skin (severe)

changes in color of treated skin

deep grooves or lines in skin

dryness, itching, peeling, or redness of the skin (severe)

pain or swelling of treated skin

skin rash (in patients with psoriasis only)

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

Burning or stinging after application

dryness, itching, peeling, or redness of the skin (mild)

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: Avage Topical 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.

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.

Compare Avage Topical with other medications

Facial Wrinkles