Isentress Tablets (Raltegravir Potassium) - Product Information
Isentress (Raltegravir Potassium tablets), a human immunodeficiency virus integrase strand transfer inhibitor is used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
Isentress tablets are manufactured by Merck Sharp & Dohme Corp. in the strengths of 400 mg. We also have in stock Generic Viread (Tenvir Tablets) which is used in combination with other medicines to treat HIV-1 infection and chronic hepatitis B in adult patients as well as children.
Name of the Drug
We supply original Isentress tablets manufactured by Merck Sharp & Dohme Corp.
Manufacturer of Isentress Tablets
Merck Sharp & Dohme Corp., India
Website: www.msdindia.in
Active Ingredient present in Isentress Tablets
The active ingredient present in Isentress tablets is Raltegravir Potassium. Each Isentress tablet contains 400 mg of Raltegravir.
Isentress Tablets (Raltegravir) - Dosage
Isentress (Raltegravir tablets) can be taken with or without food. The adult dosage of Isentress tablets is given below.
The adult oral dosage is one 400 mg film-coated tablet orally, twice daily. In case Raltegravir tablets are being coadministered with rifampin in adults, the dosage is 800 mg twice daily.
Isentress Tablets Contraindications
Isentress tablets are contraindicated in patients with a hypersensitivity to Raltegravir Potassium or any inactive ingredient present in Isentress tablets.
Warnings and Precautions When Using Isentress Tablets
The warnings and precautions when undergoing treatment with Isentress tablets (Raltegravir) are:
- Severe, potentially life-threatening and fatal skin reactions have been reported by patients undergoing treatment with Raltegravir Potassium tablets (). This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolys. Stop treatment with Isentress tablets and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develops and monitor clinical status.
- Regular monitoring has to be done for Immune Reconstitution Syndrome.
- Patients with Phenylketonuria have to be informed that the 100 mg and 25 mg chewable tablets contain phenylalanine.
- Administration of Isentress tablets along with other medicines may change the plasma concentration of Raltegravir, the active ingredient. The possibility for such drug-drug interactions must be considered before and during treatment.
- Administration of Isentress tablets along with with medicines that are strong inducers of UGT1A1, such as Rifampin, can result in reduced plasma concentrations of Raltegravir.
Isentress Side Effects
The most common side effects caused by Isentress (Raltegravir Potassium tablets) of moderate to severe intensity reported by 2% or more of the patients being treated are insomnia, headache, dizziness, nausea and fatigue.
Raltegravir Potassium tablets were generally well tolerated when used along with an optimized background therapy regimen in Potassium tablets patients with HIV-1 infection during trials which lasted for a period of upto 48 weeks. Creatine kinase elevations were reported in patients who were administered Raltegravir tablets (Isentress). Myopathy and rhabdomyolysis have also been reported. Isentress tablets have to be used with caution in patients at increased risk of myopathy or rhabdomyoly.
Overdosage
There is no specific information available on the treatment of overdosage with Isentress (Raltegravir Potassium tablets). Doses as high as 1600-mg single dose and 800-mg twice-daily multiple doses were studied in healthy volunteers without any evidence of toxicity. Occasional doses of up to 1800 mg per day were administered during the clinical studies of HIV-1 infected patients without evidence of toxicity.
Isentress During Pregnancy
Isentress Has been classified by the US FDA as Pregnancy Category C. Animal reproduction studies have demonstrated an adverse effect on the fetus and there are no adequate and well-controlled studies conducted in pregnant women, but potential benefits may justify use of this medicine in pregnant women despite the possible risks.
Developmental toxicity studies were carried out in rabbits (at oral doses up to 1000 mg/kg/day) and rats (at oral doses up to 600 mg/kg/day). The reproductive toxicity study in rats was performed with pre-, peri-, and postnatal valuation. The highest doses administered in these studies produced systemic exposures in these species approximately 3-times to 4-times the exposure at the recommended human dose. In both rabbits as well as rats, no treatment-related adverse effects on embryonic/fetal survival or fetal weights were reported. Additionally, no treatment-related external, visceral, or skeletal changes were seen in rabbits. However, treatment-related increases over controls in the incidence of supernumerary ribs were observed in rats at 600 mg/kg/day (exposures 3-times the exposure at the recommended human dose).
Placenta transfer of this medicine was demonstrated in both rats as well as rabbits.
Isentress Nursing Considerations
Breastfeeding is not recommended during treatment with Raltegravir tablets. This medicine is excreted into human milk.
In addition, it is recommended that HIV-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1.
Buy Isentress 400 mg Tablets Online at Only $9.16 per Pill
You can buy Isentress 400 mg tablets online from Clear Sky Pharmacy at a cheap price. Isentress 400 mg pills, manufactured by Merck Sharp & Dohme Corp., India are supplied in a bottle of 60 tablets. The 400 mg tablets cost only $9.16 per unit when you place an order for 120 tablets.
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The above information is provided to the best of our knowledge and in good faith, it is without a warrant of any kind, expressed or implied.
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