Delavirdine Mesylate Oral tablet

What is this medicine?

DELAVIRDINE (de la VIR deen) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• achlorhydria

• liver disease

• an unusual or allergic reaction to delavirdine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. This medicine can be taken with or without food. If you have a hard time swallowing this medicine, the 100 mg tablets can be dissolved in water. Ask your pharmacist for instructions. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• alprazolam

• certain medicines for cholesterol like cerivastatin, lovastatin, simvastatin

• certain medicines for irregular heart beat like dofetilide, encainide, flecainide

• certain medicines for seizures like carbamazepine, ethotoin, fosphenytoin, phenobarbital, phenytoin

• cisapride

• medicines for headaches like dihydroergotamine, ergonovine, ergotamine, methylergonovine

• midazolam

• pimozide

• ranolazine

• red yeast rice

• rifabutin

• rifampin

• rifapentine

• St. John's wort

• triazolam

This medicine may also interact with the following medications:

• amphetamines

• clarithromycin

• cyclosporine

• dexamethasone

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• fluticasone

• medicines for blood pressure, heart disease, or irregular heart beat

• medicines for cholesterol

• medicines for depression, anxiety, or psychotic disturbances

• medicines for erectile dysfunction

• medicines for sleep

• medicines that decrease stomach acid like antacids, cimetidine, famotidine, omeprazole, lansoprazole

• methadone

• other medicines for HIV

• rapamycin

• tacrolimus

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.

HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.

Avoid taking any antacids or acid blockers within 1 hour of taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• dark urine

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite, nausea

• muscle pain or weakness

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• right upper belly pain

• trouble passing urine or change in the amount of urine

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• depressed mood

• diarrhea

• difficulty sleeping

• headache

• nausea, vomiting

• weight gain around waist, back, or thinning of face, arms, legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.