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Albendazole (Albendazole)

Trade Name : Albendazole

Northstar Rx LLC.

TABLET, FILM COATED

Strength 200 mg/1

ALBENDAZOLE Anthelmintic [EPC],Cytochrome P450 1A Inducers [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Albendazole (Albendazole) which is also known as Albendazole and Manufactured by Northstar Rx LLC.. It is available in strength of 200 mg/1 per ml. Read more

Albendazole (Albendazole) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Albendazole tablets are an anthelmintic drug indicated for:
  • Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, . ()
  • Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, . ()
  • Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole tablets should be taken with food. ()
  • See additional important information in the Full Prescribing Information. ()
  • Hydatid disease: 28-day cycle followed by 14-day albendazole-free interval for a total of 3 cycles. ()
  • Neurocysticercosis: 8 to 30 days. ()
  • Albendazole tablets USP, 200 mg are white to off-white, round, film coated tablets debossed '1021' on one side and plain on the other side.
  • Tablet: 200 mg ()
  • Albendazole tablets are contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole tablets.
  • Patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole tablets. ()
  • No data
  • Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy. Discontinue albendazole if clinically significant changes in blood counts occur. (, )
  • Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy. ()
  • Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retinal lesions before initiating therapy for neurocysticercosis. ()
  • Hepatic Effects. Elevations of liver enzymes may occur. Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on albendazole therapy and discontinue if clinically significant elevations occur. ()
  • ID101
  • To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. ()
  • Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs. ()
  • No data
  • Dexamethasone: Steady-state trough concentrations of albendazole sulfoxide were about 56% higher when dexamethasone was coadministered with each dose of albendazole. ()
  • Praziquantel: In the fed state increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects. ()
  • Cimetidine: Increased albendazole sulfoxide concentrations in bile and cystic fluid by about 2-fold in hydatid cyst patients. ()
  • Theophylline: Albendazole induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment. (,)
  • No data
  • In case of overdosage, symptomatic therapy and general supportive measures are recommended.
  • Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5u00a0- (propylthio)-2-benzimidazolecarbamate. Its molecular formula is CHNOS. Its molecular weight is 265.34. It has the following chemical structure:
  • Albendazole, USP is a white to faintly yellowish powder. It is freely soluble in anhydrous formic acid, very slightly soluble in ether and in methylene chloride, practically insoluble in alcohol and water.
  • Each film-coated tablet contains albendazole USP, 200 mg and inactive ingredients: colloidal silicon dioxide, corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone K-30, saccharin sodium, sodium lauryl sulfate, sodium starch glycolate type A (botanical source: potato), talc and titanium dioxide.
  • No data
  • 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 and 0.2 times the recommended human dose on a body surface area basis).
  • In genotoxicity tests, albendazole was found negative in an Ames Salmonella/Microsome Plate mutation assay, Chinese Hamster Ovary chromosomal aberration test, and mouse micronucleus test. In the BALB/3T3 cells transformation assay, albendazole produced weak activity in the presence of metabolic activation while no activity was found in the absence of metabolic activation.
  • Albendazole did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg/day (0.32 times the recommended human dose based on body surface area in mg/m).
  • No data
  • Patients should be advised that:
  • Manufactured for:
  • Northstar Rx LLC
  • Memphis, TN 38141.
  • Manufactured by:
  • Cadila Healthcare Ltd.
  • Ahmedabad, India.
  • Rev.: 07/19
  • NDC 16714-907-01
  • Albendazole Tablets USP, 200 mg
  • Bottle of 2 tablets (1 x 2 unit-dose blister pack) with child-resistant closure
  • Rx only
  • Northstar

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