Isentress (Raltegravir Potassium Tablets) is a human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients.

1. Isentress (Raltegravir Tablets)
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Isentress (Raltegravir Potassium Tablets) is a human
immunodeficiency virus integrase strand transfer
inhibitors (HIV-1 INSTI) used in combination with other
antiretroviral agents for the treatment of HIV-1 infection
in adult patients.

2. Isentress Tablets
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Isentress Tablets are manufactured
by Merck Sharp & Dohme Corp.,
India.
(Website: www.msdindia.in)

3. Raltegravir Potassium Tablets – Brand Names
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Raltegravir Potassium tablets are
available as Isentress and Zepdon.

4. Active Ingredient
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The active ingredient contained in
Isentress is Raltegravir Potassium.
Each Isentress tablet contains 400 mg of
Raltegravir.

5. Chemical Structure
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The structure of Raltegravir Potassium is
given below:

6. Uses of Isentress Tablets
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Isentress (Raltegravir Potassium Tablets) is
used in combination with other anti-HIV
medications to treat adults, adolescents and
children 2 years of age and older who are
infected with HIV.
Isentress belongs to a group of medicines
called integrase inhibitors. It works by blocking
HIV integrase, one of the enzymes that is
needed during the replication process for HIV to
make more virus. When integrase is blocked by
this medicine, the virus is not able to reproduce
normally. This helps reduce the amount of virus
in the blood.

7. Isentress Tablets Dosage
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➢Treatment-naïve patients or patients who
are virologically suppressed on an initial
regimen of Isentress 400 mg twice daily: 1200
mg (2 x 600 mg) film-coated tablet orally, once
daily or 400 mg film-coated tablet orally, twice
daily
➢Treatment experienced patients: 400 mg film
coated tablet orally, twice daily.
➢During coadministration with Rifampinin
adults, 800 mg (2 x 400 mg) twice daily
The dosage of Isentress tablets (Raltegravir
Potassium ) for adult patients is given below:

8. Raltegravir Tablets Dosage
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➢If weighing at least 40 kg, and either treatment-naïve
patients or patients who are virologically suppressed on
an initial regimen of 400 mg twice daily: 1200 mg (2 x
600 mg) film-coated tablet orally, once daily or 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
The dosage of Raltegravir Potassium tablets
(Isentress) for pediatric patients is given below:

9. Storage Instructions
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Isentress (Raltegravir Potassium
Tablets) have to be stored at controlled
room temperature i.e. from 20°C to 25°C
(68°F to 77°F) with excursions permitted
between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.
Store in the original package with the
bottle tightly closed. Keep the desiccant
in the bottle to protect from moisture.

10. Warnings
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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 Isentress
(Raltegravir Potassium Tablets) 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

11. Isentress Tablets
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Contraindications
Isentress is contraindicated in patients with a
hypersensitivity to Raltegravir Potassium or any
other component of this medication.

12. Isentress Side Effects
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➢The most common Raltegravir Potassium side
effects of moderate to severe intensity with an
incidence rate of 2% or more are are insomnia,
headache, dizziness, nausea and fatigue.
➢Creatine kinase elevations were observed in
patients who received Isentress (Raltegravir
Potassium Tablets). 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 and patients
with a history of rhabdomyolysis, myopathy or
increased serum creatine kinase.

13. Isentress Tablets Overdose
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No specific information is available on the
treatment of overdosage with Raltegravir
(Isentress Tablets) .
Doses as high as 1600-mg single dose and
800-mg twice-daily multiple doses were
studied in healthy volunteers without
evidence of toxicity.
Occasional doses of up to 1800 mg per day
were taken in the clinical studies of HIV-1
infected subjects without evidence of
toxicity.

14. Raltegravir Overdose
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In the case of an overdose, it is
reasonable to employ the standard
supportive measures, e.g., remove
unabsorbed material from the
gastrointestinal tract, employ clinical
monitoring (including obtaining an
electrocardiogram), and institute
supportive therapy if necessary. The
extent to which Isentress tablets may be
dialyzable is unknown.

15. Raltegravir During Pregnancy
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Raltegravir Potassium (Isentress Tablets) has
been classified by the US FDA as Pregnancy
Category C.
This medicine should be used during pregnancy
only if the potential benefit justifies the potential
risk to the fetus.
There are no adequate and well-controlled
studies conducted in pregnant women.
In addition, there have been no pharmacokinetic
studies conducted in pregnant patients.
Breastfeeding is not recommended while taking
Isentress tablets.

16. Isentress Tablets
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Isentress (Raltegravir Potassium Tablets)
by Merck Sharp & Dohme Corp., India.