Drug Interaction:
Alcohol may cause decreased elimination of abacavir Lactic acid acidosis with nucleoside analogues concomittantly. Decreased serum concentration of merthadone
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 119
Name of the Drug- Abacavir Sulphate syrup 20mg/ml Pharmacological Classification- For HIV infection
Date of Approval- 29-08-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
New drugs approved For Marketing by Drug Conttroller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1. Abacavir 22-03-2002
Anti-HIV
2. Abacavir Sulfate tablets 60mg 1-08-2009
For the treatment of HIV -1 infection in combination with other Anti-ret-
roviral agents
3. Abacavir Sulfate syrup 250mg/ml 29-06-2006
For HIV infection
Adverse Reaction:
Anorexia, headache, nausea, vomiting, diarrhoea, rash, fever, cough, dyspnoea, fatigue, malaise lethargy, abdominal pain
Pancreatitis and elevated blood glucose and TG concentrations.
Severe hypersensitivity reactions.
Contra-Indications:
Moderate to severe renal and hepatic impairment and renal disease History of hypersenstivity reactions.
Special precautions-
Renal and mild liver impairment
Discontinue when hepatomegaly and unexplained metabolic acidosis develops. or liver functions deteritorates.
May impair ability to drive or engage in tasks requiring alertness.
Discontinue treatment as soon as hypersensitivity is suspected.
Dosages/ Overdosage Etc:
Indication
HIV infection.
Dosage
Take with or without food
1 tab twice daily Children 3 months to 12 years 8mg/kg twice daily Max 600mg daily
Patient Information:
1. Inform patients that some HIV medicines, including Abacavir may cause a rare but
serious condition called lactic acid acidosis with liver enlargement(hepatomegaly)
2. Abacavir is not a cure for HIV infection, and patients may continue to experience
illness associated with HIV infection, including oppurtunistic infection.
3.Patients should remain under the care of a healthcare provider when using Abacavir
4.Advice patients that the use of Abacavir has not shown to reduce the risk of
transmission of HIV to others through sexual contact or blood donation.
5.Inform patients that redistribution or body fat may occur in patients receiving
antiretroviral therapy, and the cause and long term health effects of these
conditions are not known at this time.
6. Advice patients of the importance of taking HIV medicines as prescribed
Interaction with Food:
Take with or without food
Pregnancy and lactation:
Pregnancy-
No adequate and well-controlled studies in pregnant wome.Use Abacavir in pregnancy only if the potentialbenefits outweigh the risks.
Lactation-
The centre for disease Control and PreventionsRecommend that HIV infected mothers not breast feeftheir infants to avoid risking postnatal transnission of HIV infection
Manufacturer Details