Raltegravir Tablets (Isentress) – Product Information
Raltegravir Tablets (Isentress) are used together with other antiretroviral medicines for the treatment of human immunodeficiency virus (HIV-1) infection in patients 2 years of age and older and weighing at least 10 kg. The use of other antiretroviral medicines with Isentress is associated with a greater likelihood of treatment response.
Name of Drug
We supply Isentress tablets manufactured by Merck Sharp & Dohme Corp.
Manufacturer of Isentress Tablets
Merck Sharp & Dohme Corp., India
Active Pharmaceutical Ingredient
The active pharmaceutical ingredient contained in Isentress tablets is Raltegravir Potassium. Each Isentress tablet contains 400 mg of Raltegravir.
Mechanism of Action
Raltegravir is an HIV-1 antiviral medicine. Raltegravir Potassium targets integrase, an HIV enzyme that integrates the viral genetic material into human chromosomes, a critical step in the development of the HIV disease. Isentress is metabolized away via glucuronidation.
The rapid antiviral activity was proved during a study conducted using Raltegravir tablets (400 mg twice daily) as monotherapy.
Raltegravir Tablets - Contraindications
Raltegravir Tablets (Isentress) are contraindicated in patients with a history of allergic reactions to Raltegravir Potassium or any inactive ingredient present in Isentress tablets.
Raltegravir Tablets (Isentress) - Dosage
Raltegravir tablets (Isentress) can be taken with or without meals. The dosage of Isentress tablets is given below.
In case Raltegravir tablets are being coadministered with rifampin in adults, the dosage is 800 mg twice daily.
Dosage for Children (12 to 18 years) :
The oral dosage is one film-coated 400 mg tablet twice daily, regardless of the weight of the child.
Storage Instructions for Raltegravir Tablets
Store Raltegravir tablets at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Keep away from children and pets.
Warnings and Precautions to be taken when using Raltegravir Tablets
Before using Raltegravir tablets (Isentress) please inform your doctor about all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies. The other 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 (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema) or liver aminotransferase elevations develops and monitor clinical status.
- Regular monitoring has to be done for Immune Reconstitution Syndrome during the early part of the treatment. It has been observed that during the early phase of treatment, patients responding to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections.
- 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 vary 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.
Raltegravir Side Effects
Raltegravir Potassium tablets were generally well tolerated when used along with an optimized background therapy regimen in patients with HIV-1 infection during trials which lasted for a period of upto 48 weeks. The most common side effects caused by Raltegravir Potassium tablets (Isentress) of moderate to severe intensity reported by 2% or more of the patients being treated are insomnia, headache, dizziness, nausea and fatigue.
Creatine kinase elevations were reported in some 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.
Raltegravir During Pregnancy and Breastfeeding
Raltegravir has been classified by the US FDA as Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies conducted in pregnant women, but potential benefits could justify use of this medicine in pregnant women despite the possible risks.
Breastfeeding is not recommended during treatment with Raltegravir tablets. Additionally, it is recommended that HIV-1-infected mothers should not breastfeed their infants to avoid risking postnatal transmission of HIV-1.
Buy Raltegravir 400 mg Tablets (Isentress) Online
You can buy Raltegravir 400 mg tablets online at a Cheap rate from the Swiss Pharmacy. Isentress is available in pills of 400 mg . The pills are priced at only $9.16 per unit if you place an order for 120 tablets.
This Product was added to our catalogue on Tuesday, 17. November 2015.
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