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Monday, September 19, 2016

Albendazole

Class: Anthelmintics
VA Class: AP200
Chemical Name: [5-(Propylthio)-1H-benzimidazol-2-yl]-carbamic acid methyl ester
Molecular Formula: C₁₂H₁₅N₃O₂S
CAS Number: 54965-21-8
Brands: Albenza

Introduction

Anthelmintic agent; benzimidazole derivative.¹ ⁴

Uses for Albendazole

Neurocysticercosis

Treatment of parenchymal neurocysticercosis resulting from active lesions caused by Cysticercus cellulosae, the larval form of Taenia solium (pork tapeworm).¹ ⁵ ⁷ ⁸ ¹³

Albendazole and praziquantel are drugs of choice, but treatment of neurocysticercosis is controversial.⁸ ¹³ (See Precautions Related to Treatment of Neurocysticercosis under Cautions.)

Corticosteroids usually used concomitantly to reduce frequency and severity of adverse nervous system effects (CSF reaction syndrome).¹ ⁵ ⁷ ⁸ ¹³ Anticonvulsant therapy also may be necessary.¹ ⁵ ⁷ ⁸ ¹³

If retinal lesions are present, weigh risk versus benefit.¹ ⁵ ⁸ Ocular and spinal cysts generally are not treated with anthelmintic drugs since irreparable damage may occur, even with concomitant corticosteroids.⁸ ¹³

Hydatid Disease

Treatment of cystic hydatid disease (unilocular hydatid disease) of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm (Echinococcus granulosus).¹ ³ ⁵ ⁷ ⁸ ¹³

Surgery is the treatment of choice when medically feasible;¹ ³ ⁵ ⁷ ⁸ ¹¹ ¹² ¹³ perioperative use of an anthelmintic may be indicated to minimize the risk of intraoperative dissemination of daughter cysts.⁷ ⁸ ¹¹ Albendazole is drug of choice when an antihelmintic is indicated.⁷ ⁸ ¹¹ ¹²

Has been used for treatment of alveolar hydatid disease† caused by Echinococcus multilocularis.³ ⁵ ⁷ ⁸ ¹² ¹³ Surgical excision of the larval mass is the recommended and only reliable treatment.⁸ ¹³ Although efficacy has not been definitely established, continuous albendazole (or mebendazole) therapy has been associated with clinical improvement in some nonresectable cases.¹³

Ascariasis

Treatment of ascariasis† caused by Ascaris lumbricoides.⁸ ¹³ Albendazole, mebendazole, and ivermectin are drugs of choice.⁸ ¹³

Baylisascariasis

Has been used for treatment of baylisascariasis† caused by Baylisascaris procyonis.⁸ ¹³ ¹⁸

Although no drug has been proven effective,⁸ ¹⁸ immediate albendazole treatment (within 1–3 days of infection) is recommended in cases of probable infection, including known exposures such as ingestion of raccoon stool or contaminated soil.⁸ ¹⁸ Ivermectin, mebendazole, thiabendazole, and levamisole (not commercially available in the US) are alternatives.⁸ Concomitant corticosteroid therapy may be helpful, especially in ocular and CNS infections.⁸

Additional information on baylisascariasis can be obtained at

Enterobiasis

Treatment of enterobiasis† caused by Enterobius vermicularis (pinworm).⁸ ¹³ Albendazole, mebendazole, and pyrantel pamoate are drugs of choice.⁸ ¹³

Filariasis

Treatment of filariasis† caused by Mansonella perstans.⁸ Albendazole and mebendazole are drugs of choice.⁸ Antihistamines or corticosteroids also may be indicated to decrease allergic reactions secondary to disintegration of microfilariae following treatment.⁸

Treatment of filariasis† caused by Wuchereria bancrofti or Brugia malayi.⁸ ¹³ ²⁰ ²¹ ²² ²³ Diethylcarbamazine (available in the US from the CDC) is the drug of choice.⁸ ¹³ Ivermectin (with or without albendazole) has been used.⁸ ¹³ ²⁰ ²¹ ²² ²³ A single dose of albendazole used in conjunction with either a single dose of diethylcarbamazine or ivermectin may be more effective than any one drug alone for suppression of microfilaremia caused by these organisms.⁸ ¹³ ²⁰ ²¹ ²²

Has been used to reduce microfilaremia in the treatment of loiasis† caused by Loa loa.⁸ Diethylcarbamazine (available in the US from the CDC) is the drug of choice;⁸ albendazole may be useful when diethylcarbamazine is ineffective or cannot be used, but repeated courses may be necessary.⁸

Hookworm Infections

Treatment of cutaneous larva migrans† (creeping eruption) caused by dog and cat hookworms.⁸ ¹³ Usually self-limited with spontaneous cure after several weeks or months; albendazole, ivermectin, or topical thiabendazole (not commercially available in the US) are drugs of choice when treatment is indicated.⁸ ¹³

Treatment of intestinal hookworm infections† caused by Ancylostoma duodenale or Necator americanus.⁸ ¹³ Albendazole, mebendazole, and pyrantel pamoate are drugs of choice.⁸ ¹³

Treatment of eosinophilic enterocolitis† caused by Ancylostoma caninum (dog hookworm).⁸ Treatment of choice is albendazole, mebendazole, pyrantel pamoate, or endoscopic removal of worms.⁸

Toxocariasis (Visceral Larva Migrans)

Treatment of toxocariasis† (visceral larva migrans) caused by Toxocara canis or T. cati (dog and cat roundworms).⁸ ¹³ Albendazole and mebendazole are drugs of choice.⁸ ¹³ Concomitant corticosteroids may be indicated in severe cases with cardiac, ocular, or CNS involvement.⁸ ¹³ Treatment may not be effective for ocular larva migrans; inflammation may be reduced by corticosteroid injections and surgery may be necessary for secondary damage.¹³

Strongyloidiasis

Treatment of strongyloidiasis† caused by Strongyloides stercoralis (threadworm).⁸ ¹³ Drug of choice is ivermectin; albendazole and thiabendazole are alternatives.⁸ ¹³

Trichinellosis

Treatment of trichinellosis† (trichinosis) caused by Trichinella spiralis.⁸ ¹³ Drug of choice is mebendazole; albendazole is an alternative.⁸ Concomitant corticosteroids usually recommended, especially for severe disease.⁸ ¹³ Corticosteroids alleviate symptoms of the inflammatory reaction and can be lifesaving when cardiac or CNS systems are involved.¹³

Trichostrongyliasis

Treatment of trichostrongyliasis† caused by Trichostrongylus.⁸ Pyrantel pamoate is drug of choice; albendazole and mebendazole are alternatives.⁸

Trichuriasis

Treatment of trichuriasis† caused by Trichuris trichiura (whipworm).⁸ ¹³ Mebendazole is drug of choice; albendazole and ivermectin are alternatives.⁸ ¹³

Capillariasis

Treatment of capillariasis† caused by Capillaria philippinensis.⁸ Mebendazole is drug of choice; albendazole is an alternative.⁸

Gnathostomiasis

Treatment of gnathostomiasis† caused by Gnathostoma spinigerum.⁸ Albendazole or ivermectin (with or without surgical removal) is recommended.⁸

Gongylonemiasis

Treatment of gongylonemiasis† caused by Gongylonema.⁸ Albendazole or surgical removal is recommended.⁸

Oesophagostomiasis

Treatment of oesophagostomiasis† caused by Oesophagostomum bifurcum.⁸ ¹⁹ Albendazole or pyrantel pamoate may be effective.⁸ ¹⁹

Trematode (Fluke) Infections

Treatment of infections caused by Clonorchis sinensis† (Chinese liver fluke).⁸ Albendazole and praziquantel are drugs of choice.⁸ Other anthelmintics (usually praziquantel) are recommended for all other fluke infections.⁸

Giardiasis

Treatment of giardiasis† caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis).⁸ ¹³ Metronidazole, tinidazole, and nitazoxanide are drugs of choice.⁸ ¹³ Albendazole (alone or in conjunction with metronidazole) is an alternative;⁸ ¹³ may be particularly useful in children.¹³

Microsporidiosis

Treatment of intestinal microsporidiosis† caused by Encephalitozoon intestinalis.⁸ ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ Albendazole is drug of choice,⁸ ¹³ but organism not eradicated in all patients and recurrence of diarrhea is common after therapy is stopped.¹³

Treatment of ocular microsporidiosis† caused by Encephalitozoon hellem, E. cuniculi, or Vittaforma corneae.⁸ ¹⁴ ¹⁵ ¹⁶ ¹⁷ Albendazole in conjunction with topical fumagillin (not commercially available in the US) has been recommended,⁸ but topical fumagillin generally not effective for lesions caused by V. corneae and keratoplasty may be necessary.⁸

Treatment of disseminated microsporidiosis† caused by E. hellem, E. cuniculi, E. intestinalis, Pleistophora, Trachipleistophora, or Brachiola vesicularum.⁸ ¹⁴ ¹⁵ ¹⁶ ¹⁷ Albendazole is drug of choice.⁸

Albendazole Dosage and Administration

Administration

Oral Administration

Administer orally with food.¹ Food, especially fatty food, increases bioavailability.¹ ³ ⁷

In patients (particularly young children) who have difficulty swallowing tablets whole, tablets may be crushed or chewed and swallowed with a drink of water.¹

Dosage

Pediatric Patients

Neurocysticercosis

Oral

Children weighing <60 kg: 15 mg/kg daily (up to 800 mg daily), administered as 2 equally divided doses with meals, for 8–30 days.¹ ⁸ Repeat as necessary.⁸

Children ≥6 years of age and weighing ≥60 kg: 400 mg twice daily with meals for 8–30 days.¹ ⁸ ⁵ Repeat as necessary.⁸

Hydatid Disease

Oral

Children <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals for 28 days, followed by a 14-day albendazole-free interval.¹ Repeat for a total of 3 dosage cycles.¹

Children ≥6 years of age and weighing ≥60 kg: 400 mg twice daily with meals for 28 days, followed by a 14-day albendazole-free interval.¹ Repeat for a total of 3 dosage cycles.¹

Alternatively, 15 mg/kg daily (up to 800 mg daily) for 1–6 months has been recommended for treatment of hydatid cyst disease in pediatric patients.⁸

Ascariasis†

Oral

Single 400-mg dose.⁸

Baylisascariasis†

Oral

25–50 mg/kg daily for 10 days.¹⁸ Some clinicians recommend a 20-day regimen.⁸

Immediate treatment is recommended if infection is probable; treatment should not be delayed until patient is symptomatic.¹⁸

Enterobiasis†

Oral

400-mg initial dose followed by a second 400-mg dose given 2 weeks later.⁸

Consider treating household contacts, especially in situations in which multiple or repeated symptomatic infections occur.⁸ ¹³

Filariasis†

Filariasis Caused by Mansonella perstans†

Oral

400 mg twice daily for 10 days.⁸

Hookworm Infections†

Cutaneous Larva Migrans (Creeping Eruption)†

Oral

400 mg once daily for 3 days.⁸

Intestinal Hookworm Infections†

Oral

Single 400-mg dose.⁸

Perform a repeat stool examination (using a concentration technique) for eggs of Ancylostoma duodenale or Necator americanus 2 weeks after treatment; repeat dose if results are positive.¹³

Eosinophilic Enterocolitis Caused by Ancylostoma caninum†

Oral

Single 400-mg dose.⁸

Toxocariasis (Visceral Larva Migrans)†

Oral

400 mg twice daily for 5 days.⁸ Optimum duration of therapy not known; some clinicians recommend up to 20 days of treatment.⁸

Strongyloidiasis†

Oral

400 mg twice daily for 2 days.⁸

Repeated or prolonged therapy or use of other agents may be necessary in immunocompromised individuals or those with disseminated disease.⁸ ¹³

Trichinellosis†

Oral

400 mg twice daily for 8–14 days.⁸

Trichostrongyliasis†

Oral

Single 400-mg dose.⁸

Trichuriasis†

Oral

400 mg once daily for 3 days.⁸

Capillariasis†

Oral

400 mg once daily for 10 days.⁸

Gnathostomiasis†

Oral

400 mg twice daily for 21 days.^a

Gongylonemiasis†

Oral

10 mg/kg daily for 3 days.⁸

Trematode (Fluke) Infections†

Oral

10 mg/kg daily for 7 days.⁸

Giardiasis†

Oral

400 mg daily for 5 days (alone or in conjunction with metronidazole).⁸

Adults

Neurocysticercosis

Oral

Adults <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals, for 8–30 days.¹ ⁸ Repeat as necessary.⁸

Adults ≥60 kg: 400 mg twice daily with meals for 8–30 days.¹ ⁸ ⁵ Repeat as necessary.⁸

Hydatid Disease

Oral

Adults <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals for 28 days, followed by a 14-day albendazole-free interval.¹ Repeat for a total of 3 dosage cycles.¹

Adults ≥60 kg: 400 mg twice daily with meals for 28 days, followed by a 14-day albendazole-free interval.¹ Repeat for a total of 3 dosage cycles.¹

Alternatively, 400 mg twice daily for 1–6 months has been recommended for treatment of hydatid cyst disease in adults.⁸

Ascariasis†

Oral

Single 400-mg dose.⁸

Baylisascariasis†

Oral

25–50 mg/kg daily for 10 days.¹⁸ Some clinicians recommend a 20-day regimen.⁸

Enterobiasis†

Oral

400-mg initial dose followed by a second 400-mg dose given 2 weeks later.⁸

Consider treating household contacts, especially in situations in which multiple or repeated symptomatic infections occur.⁸ ¹³

Filariasis†

Filariasis Caused by Mansonella perstans†

Oral

400 mg twice daily for 10 days.⁸

Hookworm Infections†

Cutaneous Larva Migrans (Creeping Eruption)†

Oral

400 mg once daily for 3 days.⁸

Intestinal Hookworm Infections†

Oral

Single 400-mg dose.⁸

Perform a repeat stool examination (using a concentration technique) for eggs of Ancylostoma duodenale or Necator americanus 2 weeks after treatment; repeat dose if results are positive.¹³

Eosinophilic Enterocolitis Caused by Ancylostoma caninum†

Oral

Single 400-mg dose.⁸

Toxocariasis (Visceral Larva Migrans)†

Oral

400 mg twice daily for 5 days.⁸ Optimum duration of therapy not known; some clinicians recommend up to 20 days of treatment.⁸

Strongyloidiasis†

Oral

400 mg twice daily for 2 days.⁸

Repeated or prolonged therapy or use of other agents may be necessary in immunocompromised individuals or those with disseminated disease.⁸ ¹³

Trichinellosis†

Oral

400 mg twice daily for 8–14 days.⁸

Trichostrongyliasis†

Oral

Single 400-mg dose.⁸

Trichuriasis†

Oral

400 mg once daily for 3 days.⁸

Capillariasis†

Oral

400 mg once daily for 10 days.⁸

Gnathostomiasis†

Oral

400 mg twice daily for 21 days.^a

Gongylonemiasis†

Oral

10 mg/kg daily for 3 days.⁸

Trematode (Fluke) Infections†

Oral

10 mg/kg daily for 7 days.⁸

Giardiasis†

Oral

400 mg daily for 5 days (alone or in conjunction with metronidazole).⁸

Microsporidiosis†

Intestinal Microsporidiosis†

Oral

400 mg twice daily for 21 days.⁸

Ocular Microsporidiosis†

Oral

400 mg twice daily.⁸

Disseminated Microsporidiosis†

Oral

400 mg twice daily.⁸

Prescribing Limits

Pediatric Patients

Neurocysticercosis

Oral

Children weighing <60 kg: Maximum 800 mg daily.¹ ⁸

Hydatid Disease

Oral

Children weighing <60 kg: Maximum 800 mg daily.¹ ⁸

Adults

Neurocysticercosis

Oral

Adults weighing <60 kg: Maximum 800 mg daily.¹ ⁸

Hydatid Disease

Oral

Adults weighing <60 kg: Maximum 800 mg daily.¹ ⁸

Special Populations

No special population dosage recommendations at this time.

Cautions for Albendazole

Contraindications

Hypersensitivity to benzimidazole derivatives or any component in the formulation.¹

Warnings/Precautions

Warnings

Myelosuppression

Can cause bone marrow suppression, aplastic anemia, and agranulocytosis in patients with or without underlying hepatic dysfunction.¹ Reversible leukopenia has occurred in <1% of patients receiving the drug;¹ granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia reported rarely.¹ Rare fatalities reported due to granulocytopenia or pancytopenia.¹

Monitor blood counts at the beginning of each 28-day cycle of albendazole treatment and every 2 weeks during treatment.¹ Closer monitoring of blood counts is recommended in patients with liver disease, including hepatic echinococcosis, since these individuals may be more susceptible to bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia.¹

Discontinue albendazole if clinically important decreases in blood cell counts occur.¹

Fetal/Neonatal Morbidity and Mortality

Teratogenic effects (embryotoxicity, skeletal malformations) reported in rats and rabbits.¹

Exclude pregnancy before initiating albendazole.¹ Avoid pregnancy during and for at least 1 month after treatment.¹ If patient becomes pregnant, immediately discontinue the drug and apprise patient of the potential hazard to the fetus.¹ (See Pregnancy under Cautions.)

General Precautions

Precautions Related to Treatment of Neurocysticercosis

Adverse CNS effects (e.g., seizures and/or hydrocephalus) resulting from inflammatory reactions to damaged intracerebral cysts may occur when albendazole is used for treatment of neurocysticercosis.⁵ ⁷ Use appropriate corticosteroid and anticonvulsant treatment as required.¹ ⁵ ⁷ ⁸ Consider oral or IV corticosteroid therapy during the first week of treatment to prevent cerebral hypertension.¹

Destruction of cysticercal lesions by albendazole may cause retinal damage.¹ ⁵ ⁸ Prior to treatment of neurocysticercosis, examine patient for retinal lesions.¹ In those with such lesions, weigh the need for treatment against the possibility of irreparable retinal damage.¹ ⁵ ⁸

Hepatic Effects

Mild to moderate increases of hepatic enzymes occurred in about 16% of patients in clinical trials.¹ Hepatic enzymes generally return to normal when the drug is discontinued, but acute liver failure of uncertain casualty and hepatitis have been reported.¹

Perform liver function tests (hepatic transaminase concentrations) prior to each cycle of albendazole treatment and at least every 2 weeks during treatment.¹ If hepatic enzymes exceed twice the ULN, consider discontinuing the drug based on the individual patient circumstance.¹ Decisions to reinstitute albendazole when hepatic enzymes return to pretreatment levels should be individualized taking into account the risks and benefits of further albendazole treatment.¹ If the drug is reinstituted, perform laboratory tests frequently.¹

Specific Populations

Pregnancy

Category C.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Use during pregnancy only if benefits justify risks to the fetus and only when no alternative management is appropriate.¹

Use in women of childbearing age only after a negative pregnancy test; caution women against becoming pregnant while receiving albendazole and for at least 1 month after completing treatment.¹

Discontinue immediately if patient becomes pregnant.¹

Lactation

Distributed into animal milk; not known whether distributed into human milk.¹ Use with caution in nursing women.¹

Pediatric Use

Only limited experience in children <6 years of age.¹

Has been used for treatment of neurocysticercosis in pediatric patients as young as 1 year of age; efficacy appeared to be similar to that in adults and no unusual problems were reported.¹

Has been used without unusual problems for treatment of hydatid disease in infants and young children.¹

Geriatric Use

Experience in patients ≥65 years of age is limited.¹ Has been used without unusual problems for treatment of neurocysticercosis or hydatid disease in geriatric adults.¹

Hepatic Impairment

Individuals with hepatic impairment are at increased risk for hepatotoxicity and bone marrow suppression during albendazole treatment.¹

Discontinue albendazole if hepatic enzymes exceed twice the ULN or if clinically important decreases in blood cell counts occur.¹

Renal Impairment

Not studied, but clearance of albendazole unlikely to be affected.¹

Common Adverse Effects

Treatment of hydatid disease: Abnormal liver function test results, abdominal pain, nausea, vomiting, reversible alopecia, headache, dizziness.¹

Treatment of neurocysticercosis: Headache, nausea, vomiting, raised intracranial pressure, meningeal signs.¹

Interactions for Albendazole

Induces CYP1A isoenzyme.¹

Specific Drugs

Drug	Interaction	Comments
Cimetidine	Increased albendazole sulfoxide concentrations in bile and cystic fluid in hydatid cyst patients receiving cimetidine; plasma concentrations of albendazole sulfoxide unchanged¹
Dexamethasone	Increased albendazole trough concentrations¹
Praziquantel	Increased plasma concentrations and AUC of albendazole sulfoxide; time to peak concentrations and plasma elimination half-life of albendazole sulfoxide unchanged¹
Theophylline	Single albendazole dose does not affect theophylline metabolism; potential for interaction exists since albendazole induces CYP1A¹	Monitor theophylline concentrations during and after albendazole therapy¹

Albendazole Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from GI tract because of low aqueous solubility.¹

Rapidly converted to active metabolite (albendazole sulfoxide) before reaching systemic circulation.¹ Peak plasma concentrations of albendazole sulfoxide attained 2–5 hours after a dose.¹

Food

Oral bioavailability enhanced by coadministration with fatty meal (estimated fat content 40 g); plasma concentrations up to fivefold higher compared with administration in fasted state.¹

Distribution

Extent

Widely distributed throughout body.¹ Detected in urine, bile, liver, cyst wall, cyst fluid, and CSF.¹

Plasma Protein Binding

70% bound to plasma protein.¹

Elimination

Metabolism

Rapidly converted in liver to active metabolite (albendazole sulfoxide) which is responsible for anthelmintic activity.¹ Further metabolized to albendazole sulfone and other primary oxidative metabolites.¹

Elimination Route

Albendazole is undetectable in urine; <1% of albendazole sulfoxide detectable in urine.¹ Albendazole sulfoxide partially eliminated in bile.¹

Half-life

Albendazole sulfoxide: 8–12 hours.¹

Special Populations

Patients with extrahepatic obstruction: Increased albendazole sulfoxide serum concentration and prolonged half-life.¹ Elimination half-life may be 31.7 hours.¹

Patients with renal impairment: Pharmacokinetics not studied to date.¹

Geriatric patients: Pharmacokinetics not fully evaluated; data from patients up to 79 years of age with hydatid cysts suggest pharmacokinetics similar to young, healthy adults.¹

Stability

Storage

Oral

Tablets

20–25°C.¹

Actions and SpectrumActions

Broad-spectrum anthelmintic agent.¹

Benzimidazole derivative¹ ⁴ structurally related to thiabendazole and mebendazole.⁴

Principal anthelmintic effect of benzimidazoles appears to be specific, high-affinity binding to free β-tubulin in parasite cells,¹ ³ ⁴ resulting in selective inhibition of parasite microtubule polymerization,¹ ³ ⁴ and inhibition of microtubule-dependent uptake of glucose.² ³ ⁶

Benzimidazole derivatives bind to the β-tubulin of parasites at much lower concentrations than to mammalian β-tubulin protein;⁴ the drugs do not inhibit glucose uptake in mammals, and do not appear to have any effect on blood glucose concentrations in humans.² ⁶

Active against the larval forms of Echinococcus granulosus and Taenia solium.¹

Advice to Patients

Importance of taking with food to increase oral bioavailability.¹

Advise patients who experience difficulty swallowing the tablets whole (particularly young children) that the tablets may be crushed or chewed and swallowed with a drink of water.¹

Importance of completing full course of therapy, even if feeling better after a few days.¹

Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.¹

Importance of initiating albendazole therapy in women of childbearing age only after a negative pregnancy test is obtained.¹

Importance of cautioning women of childbearing age against becoming pregnant while receiving albendazole or within 1 month of completing treatment.¹

Importance of routine (every 2 weeks) monitoring of blood counts and liver function tests to detect harm to the bone marrow or liver.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

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

Albendazole
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	200 mg	Albenza (with povidone)	GlaxoSmithKline

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Albenza 200MG Tablets (AMEDRA PHARMACEUTICALS): 12/$39.99 or 36/$109.97

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 January 2008. 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.

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20. Beach MJ, Streit TG, Addiss DG et al. Assessment of combined ivermectin and albendazole for treatment of intestinal helminth and Wuchereria bancrofti infections in Haitian schoolchildren. Am J Trop Med Hyg. 1999; 60:479-86. [IDIS 427901] [PubMed 10466981]

21. Simonsen PE, Magesa SM, Dunyo SK et al. The effect of single dose ivermectin alone or in combination with albendazole on Wuchereria bancrofti infection in primary school children in Tanzania. Trans R Soc Trop Med Hyg. 2004; 98:462-72. [IDIS 517713] [PubMed 15186934]

22. Makunde WH, Kamugisha LM, Massaga JJ et al. Treatment of co-infection with bancroftian filariasis and onchocerciasis: a safety and efficacy study of albendazole with ivermectin compared to treatment of single infection with bancroftian filariasis. Filaria J. 2003; 2:15. [PubMed 14613509]

23. Bockarie MJ, Alexander NDE, Hyun P et al. Randomised community-based trial of annual single-dose diethylcarbamazine with or without ivermectin against Wuchereria bancrofti infection in human beings and mosquitoes. Lancet. 1998; 351:162-8. [IDIS 398928] [PubMed 9449870]

a. AHFS drug information 2007. McEvoy GK, ed. Albendazole. Bethesda, MD: American Society of Health-System Pharmacists; 2007:45–7.

More Albendazole resources

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

Albendazole Professional Patient Advice (Wolters Kluwer)

Albendazole MedFacts Consumer Leaflet (Wolters Kluwer)

albendazole Concise Consumer Information (Cerner Multum)

albendazole Advanced Consumer (Micromedex) - Includes Dosage Information

Albenza Prescribing Information (FDA)

Compare Albendazole with other medications

Ascariasis
Capillariasis
Cutaneous Larva Migrans
Cysticercus cellulosae
Echinococcus
Filariasis, Elephantiasis
Giardiasis
Gnathostomiasis
Hookworm Infection, Necator or Ancylostoma
Hydatid Disease
Liver Fluke

A-Methapred

Generic Name: methylprednisolone (Injection route)

meth-il-pred-NIS-oh-lone

Commonly used brand name(s)

In the U.S.

A-Methapred

Depo-Medrol

Solu-Medrol

Available Dosage Forms:

Powder for Solution

Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For A-Methapred

Methylprednisolone injection provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, eye or vision problems, lupus, skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Methylprednisolone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

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

Before Using A-Methapred

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylprednisolone injection in children. However, pediatric patients are more likely to have slower growth and bone problems if methylprednisolone injection is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Depo-Medrol® and some strengths of Solu-Medrol® injection should not be used in premature infants. Both brands of methylprednisolone injection contain benzyl alcohol, which may cause serious unwanted effects in premature infants.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Aldesleukin

Bupropion

Fluindione

Quetiapine

Telaprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol

Alatrofloxacin

Alcuronium

Aprepitant

Aspirin

Atracurium

Balofloxacin

Carbamazepine

Cinoxacin

Ciprofloxacin

Clarithromycin

Clinafloxacin

Cyclosporine

Dalfopristin

Diltiazem

Enoxacin

Erythromycin

Fleroxacin

Fluindione

Flumequine

Fosphenytoin

Gallamine

Gemifloxacin

Grepafloxacin

Hexafluorenium

Itraconazole

Ketoconazole

Levofloxacin

Licorice

Lomefloxacin

Metocurine

Mibefradil

Moxifloxacin

Nefazodone

Norfloxacin

Ofloxacin

Pefloxacin

Phenobarbital

Primidone

Prulifloxacin

Quinupristin

Rifampin

Rosoxacin

Rufloxacin

Saiboku-To

Sparfloxacin

Temafloxacin

Tosufloxacin

Troleandomycin

Trovafloxacin Mesylate

Warfarin

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 methylprednisolone

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

A nurse or other trained health professional will give you this medicine. This medicine may be given through a needle placed in one of your veins, as a shot into a muscle or joint, or as a shot into a lesion on your skin.

Your doctor may give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using A-Methapred

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood or urine 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 this medicine, tell your doctor right away.

If you are using this medicine for a long time, the skin at the injection site may become slightly depressed or wrinkled. Talk to your doctor if you notice any of these changes at the injection site: depressed or indented skin; or pain, redness, or sloughing (peeling) of the skin.

If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

This medicine may cause you to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

Tell your doctor if you or your child have recently spent time in a tropical climate or have unexplained diarrhea before receiving this medicine.

While you are being treated with methylprednisone injection, do not have any immunizations (vaccines) without your doctor's approval. Methylprednisone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while using this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.

Do not stop using this medicine without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

A-Methapred 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

Aggression

agitation

anxiety

blurred vision

decrease in the amount of urine

dizziness

fast, slow, pounding, or irregular heartbeat or pulse

headache

irritability

mental depression

mood changes

nervousness

noisy, rattling breathing

numbness or tingling in the arms or legs

pounding in the ears

shortness of breath

swelling of the fingers, hands, feet, or lower legs

trouble thinking, speaking, or walking

troubled breathing at rest

weight gain

Incidence not known

Abdominal cramping and/or burning (severe)

abdominal pain

backache

bloody, black, or tarry stools

cough or hoarseness

darkening of skin

decrease in height

decreased vision

diarrhea

dry mouth

eye pain

eye tearing

facial hair growth in females

fainting

fatigue

fever or chills

flushed, dry skin

fractures

fruit-like breath odor

full or round face, neck, or trunk

heartburn and/or indigestion (severe and continuous)

increased hunger

increased thirst

increased urination

loss of appetite

loss of sexual desire or ability

lower back or side pain

menstrual irregularities

muscle pain or tenderness

muscle wasting or weakness

nausea

pain in back, ribs, arms, or legs

painful or difficult urination

skin rash

sleeplessness

sweating

trouble healing

trouble sleeping

unexplained weight loss

unusual tiredness or weakness

vision changes

vomiting

vomiting of material that looks like coffee grounds

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

Increased appetite

Incidence not known

Abnormal fat deposits on the face, neck, and trunk

acne

dry scalp

lightening of normal skin color

pain, redness, or hard skin at the injection site

pitting or depression of the skin at the injection site

red face

reddish purple lines on the arms, face, legs, trunk, or groin

swelling of the stomach area

thinning of the scalp hair

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.

ammonium lactate and urea topical

Generic Name: ammonium lactate and urea (topical) (a MOE nee um LAK tate and YOO ree a TOP i kal)

Brand names: Carb-O-Lac HP, Carb-O-Lac5, Ultralytic, Ultralytic 2, Utralytic

What is ammonium lactate and urea topical?

Ammonium lactate is a moisturizer.

Urea loosens thick or scaly skin cells and allows them to shed.

The combination of ammonium lactate and urea topical (for the skin) is used to treat rough or scaly skin caused by such conditions as eczema or psoriasis. This medicine will also help soften cracked skin or calluses.

Ammonium lactate and urea may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ammonium lactate and urea?

You should not use this medication if you have ever had an allergic reaction to ammonium lactate or urea.

Before using this medication, tell your doctor about any other medications you are using on your skin.

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

Apply ammonium lactate and urea to the skin in the amount your doctor has prescribed for you. Rub the medicine in gently until it is completely absorbed.

Avoid getting this medication in your eyes, nose, mouth, or on your lips. If this does happen, rinse with water. Avoid exposure to sunlight or tanning beds. This medicine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime. Avoid using other medications on the areas you treat with ammonium lactate and urea unless you doctor tells you to.

What should I discuss with my health care provider before using ammonium lactate and urea?

You should not use this medication if you have ever had an allergic reaction to ammonium lactate or urea.

Before using this medication, tell your doctor about any other medications you are using on your skin.

FDA pregnancy category C. It is not known whether ammonium lactate and urea will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ammonium lactate and urea passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use ammonium lactate and urea?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Apply ammonium lactate and urea to the skin in the amount your doctor has prescribed for you. Rub the medicine in gently until it is completely absorbed.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking ammonium lactate and urea?

Ammonium lactate and urea side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

stinging;

burning;

itching; or

other skin irritation.

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.

Ammonium lactate and urea Dosing Information

Usual Adult Dose for Dermatitis:

Ammonium lactate-urea topical 12%-20% cream and Ammonium lactate-urea topical 12%-20% foam:
Apply topically 2 times daily. Rub in until completely absorbed.

Ammonium lactate-urea topical 5%-20% topical cream:
Apply topically 2 times daily.

Usual Adult Dose for Eczema:

Usual Adult Dose for Psoriasis:

What other drugs will affect ammonium lactate and urea?

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

More ammonium lactate and urea resources

Ammonium lactate and urea Use in Pregnancy & Breastfeeding
Ammonium lactate and urea Support Group
0 Reviews for Ammonium lactate and urea - Add your own review/rating

Compare ammonium lactate and urea with other medications

Dermatitis
Eczema
Psoriasis

Where can I get more information?

Your pharmacist can provide more information about ammonium lactate and urea.

Aygestin Oral, Parenteral, Vaginal

Generic Name: progestin (Oral route, Parenteral route, Vaginal route)

Commonly used brand name(s)

In the U.S.

Aygestin

Camila

Crinone

Errin

First-Progesterone VGS

Jolivette

Megace

Megace ES

Next Choice

Ovrette

Plan B

Prochieve

Prometrium

In Canada

Alti-Mpa

Megace Os

Available Dosage Forms:

Tablet

Suspension

Capsule, Liquid Filled

Gel/Jelly

Cream

Suppository

Uses For Aygestin

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. .

To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body.

To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT).

To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs.

To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle.

To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor.

To test the body's production of certain hormones such as estrogen.

To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

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

Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins 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, progestins are used in certain patients with the following medical conditions:

Carcinoma of the prostate

Corpus luteum insufficiency

Hot flashes

Polycystic ovary syndrome

Precocious puberty

Before Using Aygestin

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

Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures.

Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy.

Breast Feeding

Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

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.

Boceprevir

Dofetilide

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.

Felbamate

Isotretinoin

Theophylline

Tizanidine

Tranexamic Acid

Interactions with Food/Tobacco/Alcohol

Proper Use of progestin

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

To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. 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.

Progestins are often given together with certain 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. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

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 medroxyprogesterone

For oral dosage form (tablets):
- For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
  - Adults and teenagers—5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor.
- For preparing the uterus for the menstrual period:
  - Adults and teenagers—10 milligrams (mg) per day for five or ten days as directed by your doctor.
- For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women:
  - Adults—When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them.

For intramuscular injection dosage form:
- For treating cancer of the kidneys or uterus:
  - Adults and teenagers—At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month.

For subcutaneous injection dosage form:
- For treating pain related to endometriosis:
  - Adults and teenagers—104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years.

For megestrol

For oral dosage form (suspension):
- For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS):
  - Adults and teenagers—800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months.

For oral dosage form (tablets):
- For treating cancer of the breast:
  - Adults and teenagers—160 milligrams (mg) a day as a single dose or in divided doses for two or more months.
- For treating cancer of the uterus:
  - Adults and teenagers—40 to 320 milligrams (mg) a day for two or more months.
- For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer:
  - Adults and teenagers—400 to 800 milligrams (mg) a day.

For norethindrone

For oral dosage form (tablets):
- For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
  - Adults and teenagers—2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed.
- For treating endometriosis:
  - Adults and teenagers—At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time.

For progesterone

For oral dosage form (capsules):
- For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women:
  - Adults—200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month.
- For treating unusual stopping of menstrual periods (amenorrhea):
  - Adults—400 milligrams (mg) per day at bedtime for ten days.

For vaginal dosage form (gel):
- For treating unusual stopping of menstrual periods (amenorrhea):
  - Adults and teenagers—45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed.
- For use with infertility procedures:
  - Adults and teenagers—90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks.

For injection dosage form:
- For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea):
  - Adults and teenagers—5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine.

For vaginal dosage form (suppositories):
- For maintaining a pregnancy (at ovulation and at the beginning of pregnancy):
  - Adults and teenagers—25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks.

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.

For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose 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.

For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule.

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Aygestin

It is very important that your doctor check your progress at regular visits. This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often.

The Prometrium® capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin.

Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. 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.

Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor:

If unusual or unexpected vaginal bleeding continues for an unusually long time.

If your menstrual period has not started within 45 days of your last period.

Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor. Your doctor will let you know if you should continue taking the progestin.

If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results.

In some patients, 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.

You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active.

If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone.

Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women.

Aygestin Side Effects

Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used.

The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention.

Get emergency help immediately if any of the following side effects occur:

Rare

Symptoms of blood clotting problems, usually severe or sudden, such as:

headache or migraine

loss of or change in speech, coordination, or vision

numbness of or pain in chest, arm, or leg

unexplained shortness of breath

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods)

symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst)

Less common

Mental depression

skin rash

unexpected or increased flow of breast milk

RareFor megestrol—During chronic treatment

Backache

dizziness

filling or rounding out of the face

irritability

mental depression

nausea or vomiting

unusual decrease in sexual desire or ability in men

unusual tiredness or weakness

More common

Abdominal pain or cramping

bloating or swelling of ankles or feet

blood pressure increase (mild)

dizziness

drowsiness (progesterone only)

headache (mild)

mood changes

nervousness

pain or irritation at place of injection site

swelling of face, ankles, or feet

unusual or rapid weight gain

Less common

Acne

breast pain or tenderness

brown spots on exposed skin, possibly long-lasting

hot flashes

loss or gain of body, facial, or scalp hair

loss of sexual desire

trouble in sleeping

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect:

For megestrol

Dizziness

nausea or vomiting

unusual tiredness or weakness

Delayed return to fertility

stopping of menstrual periods

unusual menstrual bleeding (continuing)

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.