ALBENZA Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Συγγραφείς
Amneal Pharmaceuticals LLC
Λέξεις κλειδιά
64896-693
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1. Indications and Usage
1.1 Neurocysticercosis ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, <em>Taenia solium</em>. 1.2 Hydatid Disease ...
2. Dosage and Administration
2.1 Dosage Dosing of ALBENZA will vary depending upon the indication. ALBENZA tablets may be crushed or chewed and swallowed with a drink of water. ALBENZA tablets should be taken with food <em>[see Clinical ...
3. Dosage Forms and Strengths
<u>Tablet:</u> 200 mg.
4. Contraindications
ALBENZA is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of ALBENZA.
5. Warnings and Precautions
5.1 Bone Marrow Suppression Fatalities associated with the use of ALBENZA have been reported due to granulocytopenia or pancytopenia. ALBENZA may cause bone marrow suppression, aplastic anemia, and agranulocytosis. ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ALBENZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Dexamethasone Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when 8 mg dexamethasone was co-administered with each dose of albendazole (15 mg/kg/day) in 8 neurocysticercosis ...
8.1. Pregnancy
Risk Summary There are limited data on use of ALBENZA in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published studies, single-dose albendazole exposure during ...
8.2. Lactation
Risk Summary There are no data on the presence of albendazole in human milk, the effects on the breast-fed infant or the effects on milk production. Albendazole is excreted in animal milk. The developmental ...
8.3. Females and Males of Reproductive Potential
Pregnancy Testing Obtain pregnancy test prior to prescribing ALBENZA to women of reproductive potential. Contraception Females Advise women of reproductive potential to use effective birth control for ...
8.4. Pediatric Use
Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of ALBENZA in children appears to be similar to that in adults.
8.5. Geriatric Use
In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of ALBENZA is different from that of younger ...
8.6. Renal Impairment
The pharmacokinetics of ALBENZA in patients with impaired renal function has not been studied.
8.7. Hepatic Impairment
Patients with Extra-Hepatic Obstruction In patients with evidence of extrahepatic obstruction (n=5), the systemic availability of albendazole sulfoxide was increased, as indicated by a 2-fold increase ...
10. Overdosage
In case of overdosage, symptomatic therapy and general supportive measures are recommended.
11. Description
ALBENZA (albendazole) is an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C<sub>12</sub>H<sub>15</sub>N<sub>3</sub>O ...
12.1. Mechanism of Action
ALBENZA (albendazole) is a synthetic, antihelminthic drug of the class benzimidazole <em>[see Clinical Pharmacology (12.4)]</em>.
12.3. Pharmacokinetics
Absorption Albendazole is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Albendazole concentrations are negligible or undetectable in plasma as it is rapidly converted ...
12.4. Microbiology
Mechanism of Action ALBENZA binds to the colchicine-sensitive site of β-tubulin inhibiting their polymerization into microtubules. The decrease in microtubules in the intestinal cells of the parasites ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies were conducted in mice and rats. No evidence of increased incidence of tumors was found in the mice or rats at up to 400 mg/kg/day or 20 mg/kg/day respectively (2 times ...
16.1. How Supplied
Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with ap and 550 and contains 200 mg of albendazole. Bottles of 2 Tablets NDC 64896-693-49. Distributed by: ...
16.2. Storage and Handling
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
17. Patient Counseling Information
Patients should be advised that: Some people, particularly children, may experience difficulties swallowing the ALBENZA tablets whole. Take ALBENZA with food. ALBENZA may cause fetal harm, therefore, obtain ...