MARAVIROC- maraviroc tablet, film coated
i3 Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Maraviroc (mə-RAV-i-rok) tablets |
||
What is the most important information I should know about Maraviroc?
Maraviroc can cause serious side effects including serious liver problems (liver toxicity). Some people who take Maraviroc can develop a severe rash or an allergic reaction before liver problems happen and may be life-threatening. Stop taking Maraviroc and call your healthcare provider right away if you get any of the following signs or symptoms of liver problems: |
||
|
|
|
Your healthcare provider will do blood tests to check your liver before you begin treatment with Maraviroc and as needed during treatment with Maraviroc. | ||
What are Maraviroc tablets? | ||
Maraviroc tablet is a prescription Human Immunodeficiency Virus-1 (HIV-1) medicine given with other HIV-1 medicines to treat CCR5-tropic HIV-1 infection in adults and children 2 years of age and older weighing at least 22 lb (10 kg). | ||
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Use of Maraviroc is not recommended in people with dual/mixed- or CXCR4‑tropic HIV‑1. Maraviroc tablets should not be used in children weighing less than 22 pounds (10 kg). |
||
Do not take Maraviroc if youhave severe kidney problems or are on hemodialysis and are also taking certain other medications. | ||
Before you take Maraviroc, tell your healthcare provider about all of your medical conditions, including if you: • have or have had liver problems including hepatitis B or C virus infection. • have heart problems.
|
||
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. • Some medicines may interact with Maraviroc. Keep a list of your medicines to show your healthcare provider and pharmacist. • You can ask your healthcare provider or pharmacist for a list of medicines that interact with Maraviroc. |
||
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Maraviroc with other medicines. Your healthcare provider may need to change your dose of Maraviroc when you take it with certain medicines. You should not take Maraviroc if you also take St. John’s wort ( Hypericum perforatum). | ||
How should I take Maraviroc tablets? • Take Maraviroc exactly as your healthcare provider tells you. • Do not change your dose or stop taking Maraviroc without first talking with your healthcare provider.
|
||
What are the possible side effects of Maraviroc?
|
||
• See “What is the most important information I should know about Maraviroc?” | ||
•
Severe skin rash and allergic reactions. Severe and potentially life-threatening
|
||
|
|
|
• Heart problemsincluding heart attack. •
Low blood pressure when standing up(postural hypotension)that can cause dizziness or fainting. You should avoid driving or operating heavy machinery if you have dizziness during treatment with Maraviroc.
|
||
The most common side effects of Maraviroc in adults include coldsand cold- like symptoms, cough, fever, rash, bloating and gas, indigestion, constipation, and dizziness.
The most common side effects of Maraviroc in children includevomiting, abdominal pain, diarrhea, nausea, and dizziness.
|
||
How should I store Maraviroc? • Store Maraviroc tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep Maraviroc and all medicines out of the reach of children. |
||
General information about the safe and effective use of Maraviroc | ||
Medicines are sometimes prescribed for purposes other than those mentioned in a Medication Guide. Do not use Maraviroc for a condition for which it was not prescribed. Do not give Maraviroc to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for the information about Maraviroc that is written for health professionals. |
||
What are the ingredients in Maraviroc? | ||
Active ingredient: maraviroc | ||
Inactive ingredients:
Tablets: Dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Tablet film-coating contains: FD&C blue # 2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. |
||
Manufactured and distributed by: i3 Pharmaceuticals, LLC
|
||
This Medication Guide has been approved by the U.S. Food and Drug Administration.
|