Raltegravir

  • Medicine name- Isentress
  • API- Raltegravir
  • Pack Size- 60 tablets
  • Strength- 400 mg
  • Marketed By: MSD Pharmaceuticals Pvt Ltd
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Description

Raltegravir is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated:  

  • In combination with other antiretroviral agents for the treatment of HIV-1 infection. 
  • The safety and efficacy of Raltegravir have not been established in children less than 2 years of age

Dosage and Side Effects

Raltegravir can be administered with or without food.

Raltegravir 400 mg film-coated tablets cannot be substituted with Raltegravir 25 mg and 100 mg chewable tablets. 

Adults  

  • 400 mg film-coated tablet orally, twice daily.
  • During coadministration with rifampin in adults, 800 mg twice daily.

Children and Adolescents 

  • 12 years of age and older: One 400 mg film-coated tablet orally, twice daily.
  • 6 to less than 12 years of age:  If at least 25 kg in weight: One 400 mg film-coated tablet orally, twice daily OR Chewable tablets: weight based to maximum dose 300 mg twice daily.
  • If less than 25 kg in weight: Chewable tablets: weight based to maximum dose 300 mg twice daily.

2 To less than 6 years of age:  

  • If at least 10 kg in weight: Chewable tablets: weight based to maximum dose 300 mg twice daily.
  • The most common adverse reactions of moderate to severe intensity which occurred at a higher rate than the comparator are insomnia and headache.

Creatine kinase elevations were observed in subjects who received Raltegravir. Myopathy and rhabdomyolysis have been reported. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions.

Warning and Precautions

  • Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with Raltegravir and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develops and monitor clinical status, including liver aminotransferases closely.  

  • Monitor for Immune Reconstitution Syndrome.

  • Inform patients with phenylketonuria that the 100 mg and 25 mg chewable tablets contain phenylalanine.

FAQ's

Is raltegravir FDA approved?

Yes the medicine Raltegravir was approved by the FDA.

What class of drug is raltegravir?

Raltegravir belongs to the class of HIV integrase inhibitors.

When was raltegravir approved?

The FDA approved Raltegravir in 2007.