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Adovir- 10 mg Tablet/pcs
- Brand: Renata Limited
Generic Name: Adefovir Dipivoxil
Generic Name: Adefovir Dipivoxil
Therapeutic class: Antivirals (Systemic Antifungal, Antiviral and Antiprotozoal Agents)
Manufacturer: Renata Limited
SKU: Adovir- 10 mg Tablet Categories: Adefovir Dipivoxil, Antiviral (Systemic Antifungal, Antiviral and Antiprotozoal Agents), Tablet Tags: Adefovir Dipivoxil, Renata Limited
Adefovir Dipivoxil is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
The recommended dose of Adefovir in chronic hepatitis B patients with adequate renal function is 10 mg, once daily, taken orally, without regard to food.
The most common side effects of adefovir dipivoxil are weakness, headache, stomach pain and nausea. Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B therapy, including therapy with adefovir dipivoxil. In patients at risk of or having underlying renal dysfunction, chronic administration of adefovir dipivoxil may result in nephrotoxicity. 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.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Adefovir dipivoxil should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits. It is not known whether adefovir is excreted in human milk. Mothers should be instructed not to breast-feed if they are taking adefovir dipivoxil.
Precautions & Warnings
Patients who discontinued adefovir dipivoxil should be monitored at repeated intervals over a period of time for hepatic function. The patients at risk of or having underlying renal dysfunction should be monitored closely for renal function and may require dose adjustment.
Use in Special Populations
Pediatric use: Safety and effectiveness in pediatric patients have not been established.
Geriatric use: In general, caution should be exercised when prescribing to elderly patients since they have greater frequency of decreased renal or cardiac function due to concomitant disease or other drug therapy.
Dose Adjustment in Renal Impairment: the dosing interval of Adefovir should be adjusted in patients with baseline creatinine clearance <50 ml/min using the following suggested guidelines:
- CrCl ≤ 50 ml/min: 10 mg
- CrCl 20-49 ml/min: 10 mg every 48 hours
- CrCl 10-19 ml/min: 10 mg every 72 hours
- Haemodialysis patients: 10 mg every 7 days following dialysis
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.
Store at cool and dry place. Protect from light and moisture. Keep all the medicines out of the reach of children.
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