ADEFOVIR DIPIVOXIL

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Overview

What is ADEFOVIR DIPIVOXIL?

Adefovir Dipivoxil is a diester prodrug of adefovir. Adefovir is an acyclic nucleotide analog with activity against human hepatitis B virus (HBV).

The chemical name of adefovir dipivoxil is 9-[2-[[bis[(pivaloyloxy)methoxy]-phosphinyl]-methoxy]ethyl]adenine. It has a molecular formula of CHNOP, a molecular weight of 501.48 and the following structural formula:

Adefovir dipivoxil is a white to off-white powder with an aqueous solubility of 19 mg/mL at pH 2.0 and 0.4 mg/mL at pH 7.2. It has an octanol/aqueous phosphate buffer (pH 7) partition coefficient (log p) of 1.91.

Adefovir Dipivoxil Tablets are for oral administration. Each tablet contains 10 mg of adefovir dipivoxil and the following inactive ingredients: copovidone, anhydrous lactose, microcrystalline cellulose, silicon dioxide, crospovidone and magnesium stearate.

What does ADEFOVIR DIPIVOXIL look like?

What are the available doses of ADEFOVIR DIPIVOXIL?

Tablets: 10 mg ()

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

See for PATIENT COUNSELING INFORMATION and FDA-Approved Patient Labeling.

How should I use ADEFOVIR DIPIVOXIL?

Adefovir Dipivoxil Tablets are indicated for the treatment of chronic hepatitis B in patients 12 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.

This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg- chronic hepatitis B with compensated liver function, and with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.

For patients 12 to less than 18 years of age, the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus infection with compensated liver function.

The recommended dose of Adefovir Dipivoxil Tablets in chronic hepatitis B patients for patients 12 years of age and older with adequate renal function is 10 mg, once daily, taken orally, without regard to food. The optimal duration of treatment is unknown.

Adefovir Dipivoxil Tablets is not recommended for use in children less than 12 years of age.

What interacts with ADEFOVIR DIPIVOXIL?

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What are the warnings of ADEFOVIR DIPIVOXIL?

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What are the precautions of ADEFOVIR DIPIVOXIL?

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What are the side effects of ADEFOVIR DIPIVOXIL?

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What should I look out for while using ADEFOVIR DIPIVOXIL?

Adefovir Dipivoxil Tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.

Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including Adefovir Dipivoxil Tablets. 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, resumption of anti-Hepatitis B therapy may be warranted .

In patients at risk of or having underlying renal dysfunction, chronic administration of Adefovir Dipivoxil Tablets may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment .

HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with antihepatitis B therapies, such as therapy with Adefovir Dipivoxil Tablets, that may have activity against HIV .

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals .

What might happen if I take too much ADEFOVIR DIPIVOXIL?

Doses of adefovir dipivoxil 500 mg daily for 2 weeks and 250 mg daily for 12 weeks have been associated with gastrointestinal side effects. If overdose occurs the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.

Following a 10 mg single dose of Adefovir Dipivoxil Tablets, a four-hour hemodialysis session removed approximately 35% of the adefovir dose.

How should I store and handle ADEFOVIR DIPIVOXIL?

StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See .] StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See .] Adefovir Dipivoxil is available as tablets. Each tablet contains 10 mg of adefovir dipivoxil. The tablets are white are to off-white, round, flat faced beveled edged tablets, debossed "∑ 3" on one side and plain on the other side. They are packaged as follows: Bottles of 30 tablets (NDC 42794-003-08) containing polyester and desiccant and closed with a child-resistant closure.Store in original container at 25 °C (77 °F), excursions permitted to 15° to 30 °C (59° to 86 °F) (see USP Controlled Room Temperature).Do not use if seal over bottle opening is broken or missing.Adefovir Dipivoxil is available as tablets. Each tablet contains 10 mg of adefovir dipivoxil. The tablets are white are to off-white, round, flat faced beveled edged tablets, debossed "∑ 3" on one side and plain on the other side. They are packaged as follows: Bottles of 30 tablets (NDC 42794-003-08) containing polyester and desiccant and closed with a child-resistant closure.Store in original container at 25 °C (77 °F), excursions permitted to 15° to 30 °C (59° to 86 °F) (see USP Controlled Room Temperature).Do not use if seal over bottle opening is broken or missing.Adefovir Dipivoxil is available as tablets. Each tablet contains 10 mg of adefovir dipivoxil. The tablets are white are to off-white, round, flat faced beveled edged tablets, debossed "∑ 3" on one side and plain on the other side. They are packaged as follows: Bottles of 30 tablets (NDC 42794-003-08) containing polyester and desiccant and closed with a child-resistant closure.Store in original container at 25 °C (77 °F), excursions permitted to 15° to 30 °C (59° to 86 °F) (see USP Controlled Room Temperature).Do not use if seal over bottle opening is broken or missing.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Adefovir is an antiviral drug.

Non-Clinical Toxicology

Adefovir Dipivoxil Tablets are contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the product.

Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including Adefovir Dipivoxil Tablets. 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, resumption of anti-Hepatitis B therapy may be warranted .

In patients at risk of or having underlying renal dysfunction, chronic administration of Adefovir Dipivoxil Tablets may result in nephrotoxicity. These patients should be monitored closely for renal function and may require dose adjustment .

HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated Human Immunodeficiency Virus (HIV) infection treated with antihepatitis B therapies, such as therapy with Adefovir Dipivoxil Tablets, that may have activity against HIV .

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs alone or in combination with other antiretrovirals .

The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Severe acute exacerbation of hepatitis has been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with Adefovir Dipivoxil Tablets. Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least several months in patients who discontinue Adefovir Dipivoxil Tablets. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

In clinical trials of Adefovir Dipivoxil Tablets, exacerbations of hepatitis (ALT elevations 10 times the upper limit of normal or greater) occurred in up to 25% of patients after discontinuation of Adefovir Dipivoxil Tablets. These events were identified in studies GS-98-437 and GS-98-438 (N=492). Most of these events occurred within 12 weeks of drug discontinuation. These exacerbations generally occurred in the absence of HBeAg seroconversion, and presented as serum ALT elevations in addition to re-emergence of viral replication. In the HBeAg-positive and HBeAg-negative studies in patients with compensated liver function, the exacerbations were not generally accompanied by hepatic decompensation. However, patients with advanced liver disease or cirrhosis may be at higher risk for hepatic decompensation. Although most events appear to have been self-limited or resolved with re-initiation of treatment, severe hepatitis exacerbations, including fatalities, have been reported. Therefore, patients should be closely monitored after stopping treatment.

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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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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Interactions

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