What is the most important information I should know about raltegravir?
Raltegravir may cause a severe skin reaction that can be fatal. Stop taking this medicine and get emergency medical help if you have skin redness or a rash that spreads and causes blistering and peeling.
What is raltegravir?
Raltegravir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.
Raltegravir is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Raltegravir is not a cure for HIV or AIDS.
Raltegravir is for use in adults and children who weigh at least 4.4 pounds (2 kilograms).
Raltegravir may also be used for purposes not listed in this medication guide.
What should I discuss with my health care provider before taking raltegravir?
You should not use raltegravir if you are allergic to it.
To make sure raltegravir is safe for you, tell your doctor if you have ever had:
- a muscle disorder;
- kidney disease (or if you are on dialysis);
- liver disease; or
- mental illness or depression.
Raltegravir chewable tablets contain phenylalanine. Talk to your doctor before using this form of raltegravir if you have phenylketonuria (PKU).
It is not known whether raltegravir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of raltegravir on the baby.
Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
How should I take raltegravir?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take raltegravir with or without food.
The raltegravir chewable tablet may be chewed or swallowed whole.
Do not crush, chew, or break a regular tablet. Swallow it whole.
Raltegravir oral suspension is a powder that must be mixed with water before you take it. Mix 1 packet of this powder with 1 teaspoon (5 milliliters) of water. Measure this mixture with the dosing syringe provided, and give the medicine by mouth within 30 minutes after mixing. Do not save any of the mixed medicine for later use.
If a child is using this medicine, tell your doctor if the child has any changes in weight. Raltegravir doses are based on weight in children, and any changes may affect your child's dose.
If your doctor changes your brand, strength, or type of raltegravir, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of raltegravir you receive at the pharmacy.
Use raltegravir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Keep the chewable tablets in their original container, along with the packet or canister of moisture-absorbing preservative.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking raltegravir?
Avoid taking an antacid that contains aluminum or magnesium within 2 hours before or 2 hours after you take raltegravir. This includes antacids such as Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others. Aluminum or magnesium antacids can make it harder for your body to absorb raltegravir.
Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
What are the possible side effects of raltegravir?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; upper stomach pain, vomiting, loss of appetite; dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); swelling of your face, lips, tongue, or throat.
Raltegravir may cause a severe skin reaction that can be fatal. Stop taking this medicine and get emergency medical help if you have a fever, general ill feeling, muscle or joint pain, extreme tiredness, trouble breathing, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Raltegravir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with raltegravir. Tell your doctor if you have:
- signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;
- chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
- cold sores, sores on your genital or anal area;
- rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
- trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
- swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.
In rare cases, raltegravir can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.
Common side effects may include:
- nausea;
- headache, dizziness;
- tired feeling; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect raltegravir?
Tell your doctor about all your current medicines and any you start or stop using, especially:
- fenofibrate or gemfibrozil;
- rifampin;
- zidovudine; or
-
a "statin" cholesterol-lowering medicine --Crestor, Lipitor, Pravachol, Vytorin, Zocor, and others.
This list is not complete. Other drugs may interact with raltegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about raltegravir.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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