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Isentress HD

Isentress HD

Raltegravir belongs to the class of medications called antiretrovirals. It is used in combination with other antiretroviral medications to treat HIV infection in adults and in children at least 2 years of age, weighing at least 7 kg.

Available form

Dosage

Tablet

600MG

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Isentress HD information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

The usual dose of raltegravir for adolescents and adults is one 400 mg tablet, taken by mouth, 2 times daily or two 600 mg tablets taken once daily. The dose of chewable tablets for children more than 2 years old but less than 12 years of age is based on the child's body weight. Do not switch between the 400 mg tablets, 600 mg tablets, or the chewable tablets without checking with your doctor first.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor. It is important to take Isentress Hd exactly as prescribed by your doctor. The amount of HIV virus in your blood can increase if Isentress Hd is stopped for even a short period of time. Taking Isentress Hd exactly as prescribed will also decrease the chance of drug resistance (i.e., the medication stops working to fight HIV).

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Isentress Hd in its original package at room temperature and keep it out of the reach of children. Keep the desiccant in the bottle to protect it from moisture.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Isentress Hd. If you are concerned about side effects, discuss the risks and benefits of Isentress Hd with your doctor.

The following side effects have been reported by at least 1% of people taking Isentress Hd. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal pain
back pain
cough
Diarrhea
difficulty sleeping
dizziness
fatigue
Fever
headache
heartburn
nasal and throat irritation
nausea
rash
shaking
vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

decreased coordination
decreased concentration
signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
signs of infection (e.g., fever, chills, sore throat, mouth ulcers, cough)
signs of kidney problems (e.g., nausea, loss of appetite, weakness, passing little or no urine, shortness of breath)
signs of liver problems (e.g., nausea, vomiting, loss of appetite, feeling unwell, fever, itching, yellowing of the skin or whites of eyes, dark urine)
speech difficulties
unexplained muscle weakness, tenderness, or pain

Stop taking the medication and seek immediate medical attention if any of the following occur:

severe chest pain
signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Isentress Hd.

Chewable tablet

25 mg
Each pale yellow, round, flat-faced, bevelled-edge tablet debossed with the Merck logo on one side and "473" on the other contains 27.16 mg of raltegravir as potassium salt, equivalent to 25 mg of raltegravir. Nonmedicinal ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking), oleic acid, phenylalanine (as part of the artificial sweetener, aspartame), saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose, and yellow iron oxide.

100 mg
Each pale orange, oval, scored tablet debossed with the Merck logo on one side of the score and "477" on the other side of the tablet contains 108.6 mg of raltegravir as potassium salt, equivalent to 100 mg of raltegravir. Nonmedicinal ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking), oleic acid, phenylalanine (as part of the artificial sweetener, aspartame), saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose, yellow iron oxide, and red iron oxide.

Tablet

400 mg
Each pink, oval, film-coated tablet marked with "227" on one side contains 434.4 mg of raltegravir potassium as salt, equivalent to 400 mg of raltegravir. Nonmedicinal ingredients: microcrystalline cellulose, lactose monohydrate, calcium phosphate dibasic anhydrous, hypromellose 2208, poloaxamer 407 (contains butylated hydroxytoluene as antioxidant), sodium stearyl fumarate, magnesium stearate; film-coating: polyvinyl alcohol, titanium dioxide, Polyethylene Glycol 3350, talc, red iron oxide, and black iron oxide.

600 mg
Each yellow, oval, film-coated tablet, debossed with Merck logo and "242" on one side, contains 651.6 mg of raltegravir potassium as salt, equivalent to 600 mg of raltegravir. Nonmedicinal ingredients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose; film coating: black iron oxide, carnauba wax, hypromellose 2910, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Isentress Hd.

Hypersensitivity syndrome: A Anaphylaxis (severe allergic reaction) called hypersensitivity syndrome has occurred for some people with the use of raltegravir. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Immune reconstitution inflammatory syndrome: Isentress Hd may cause immune reconstitution inflammatory syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections (e.g., pneumonia, herpes, or Tuberculosis) that have been present without symptoms. Report any new symptoms to your doctor immediately.

Muscle pain: Occasionally, raltegravir causes breakdown of muscle tissues, which can be fatal. Report any symptoms of severe, unexplained muscle pain to your doctor as soon as possible.

Phenylketonuria (PKU): People with phenylketonuria, a disorder where the body cannot break down the amino acid phenylalanine, should not use the chewable tablets. The artificial sweetener in the chewable tablets contains phenylalanine and will be harmful to someone with PKU.

Skin reactions: Raltegravir may cause skin rash or itchiness with or without a rash. On rare occasions, people taking raltegravir experience a severe skin reaction that can be life-threatening. If you experience a rash that gets worse, or develops into blisters or sores on the lips or eyes, or covers a large area of the body, contact your doctor immediately.

Pregnancy: There are no studies evaluating the use of Isentress Hd by pregnant women. Isentress Hd is not recommended during pregnancy. If you become pregnant while taking Isentress Hd, contact your doctor immediately.

Breast-feeding: It is not known if Isentress Hd passes into breast milk. However, breast-feeding is not recommended for HIV-positive women since the virus can be passed to the baby through breast milk.

Children: The safety and effectiveness of using Isentress Hd have not been established for children less than 2 years old.

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