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ENTECAVIR

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Overview

What is ENTECAVIR?

Entecavir is a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[()-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6-purin-6-one, monohydrate. Its molecular formula is CHNO•HO, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula:

Entecavir is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25C ± 0.5C.

Entecavir film-coated tablets, USP, are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir. Entecavir 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, talc, polyethylene glycol 3350, lecithin (soya), polyvinyl alcohol-part hydrolyzed, and iron oxide red (1 mg tablet only).

USP dissolution test pending.



What does ENTECAVIR look like?



What are the available doses of ENTECAVIR?

What should I talk to my health care provider before I take ENTECAVIR?

How should I use ENTECAVIR?

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating therapy with entecavir:

Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).


What interacts with ENTECAVIR?

Sorry No Records found


What are the warnings of ENTECAVIR?

Sorry No Records found


What are the precautions of ENTECAVIR?

Sorry No Records found


What are the side effects of ENTECAVIR?

Sorry No records found


What should I look out for while using ENTECAVIR?

None.


What might happen if I take too much ENTECAVIR?

There is limited experience of entecavir overdosage reported in patients. Healthy subjects who received single entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days had no increase in or unexpected adverse events. If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.

Following a single 1 mg dose of entecavir, a 4-hour hemodialysis session removed approximately 13% of the entecavir dose.


How should I store and handle ENTECAVIR?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Revised: 06/12CTI-12 Rev. C Entecavir tablets, USP, are available in the following strengths:StorageEntecavir tablets should be stored in a tightly closed container at 20-25C (68-77F); excursions permitted between 15-30C (59-86F) [see USP Controlled Room Temperature]. Keep the container out of light.Entecavir tablets, USP, are available in the following strengths:StorageEntecavir tablets should be stored in a tightly closed container at 20-25C (68-77F); excursions permitted between 15-30C (59-86F) [see USP Controlled Room Temperature]. Keep the container out of light.Entecavir tablets, USP, are available in the following strengths:StorageEntecavir tablets should be stored in a tightly closed container at 20-25C (68-77F); excursions permitted between 15-30C (59-86F) [see USP Controlled Room Temperature]. Keep the container out of light.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Entecavir is an antiviral drug

Non-Clinical Toxicology
None.

No drug interactions have been identified. Studies with famotidine in man, in animal models, and have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir . Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

The following adverse reactions are discussed in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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