What is Rescriptor?
Rescriptor is a prescription medicine that is used to treat HIV infection.
RESCRIPTOR Tablets contain delavirdine mesylate, a synthetic non-nucleoside reverse transcriptase inhibitor (NNRTI) of the human immunodeficiency virus type 1 (HIV-1). The chemical name of delavirdine mesylate is piperazine, 1-[3-[(1-methyl-ethyl)amino]-2- pyridinyl]-4-[[5-[(methylsulfonyl)amino]-1H-indol-2-yl]carbonyl]-, monomethanesulfonate. Its molecular formula is C22H28N6O3S • CH4O3S, and its molecular weight is 552.68. The structural formula is:
Delavirdine mesylate is an odorless white-to-tan crystalline powder. The aqueous solubility of delavirdine free base at 23°C is 2,942 mcg/mL at pH 1.0, 295 mcg/mL at pH 2.0, and 0.81 mcg/mL at pH 7.4.
Each RESCRIPTOR Tablet, for oral administration, contains 100 or 200 mg of delavirdine mesylate (henceforth referred to as delavirdine). Inactive ingredients consist of carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, and microcrystalline cellulose. In addition, the 100-mg tablet contains Opadry White YS-1-7000-E and the 200-mg tablet contains hypromellose and Opadry White YS-1-18202-A.
Before taking Rescriptor, tell your doctor:
- If you are allergic to Rescriptor; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you are taking or will be taking another drug like this one.
- If you take any drugs (prescription, OTC, natural products, vitamins) that must not be taken with Rescriptor, like certain drugs that are used for high cholesterol, seizures, migraines, or rifampin. There are many drugs that must not be taken with Rescriptor.
- If you are taking St. John’s wort. Do not take St. John’s wort with Rescriptor. This medicine may not work as well.
- If you are breast-feeding. Do not breast-feed while you take Rescriptor.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Rescriptor with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Rescriptor?
- Tell all of your health care providers that you take Rescriptor. This includes your doctors, nurses, pharmacists, and dentists.
- Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take Rescriptor. Tell your doctor right away if you have any new signs after you start Rescriptor, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
- This medicine interacts with many other drugs. The chance of Rescriptor’s side effects may be raised or how well Rescriptor works may be lowered. The chance of the other drugs’ side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take Rescriptor with all of your other drugs (prescription or OTC, natural products, vitamins).
- Do not run out of Rescriptor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine is not a cure for HIV. Stay under the care of your doctor.
- This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
- Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Rescriptor while you are pregnant.
How is Rescriptor best taken?
Use Rescriptor as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- Take with or without food.
- Keep taking Rescriptor as you have been told by your doctor or other health care provider, even if you feel well.
- It is important that you do not miss or skip a dose of Rescriptor during treatment.
- If you have low stomach acid levels, take Rescriptor with an acidic drink like orange or cranberry juice.
- Do not take didanosine within 1 hour of Rescriptor.
- Do not take antacids within 1 hour before or 1 hour after taking Rescriptor.
100 mg tablet:
- You may put the tablets in at least 3 ounces of water then let it sit for a few minutes. Mix until the tablets dissolve and drink. Rinse glass with more water and drink.
200 mg tablet:
- Swallow whole. Do not chew, break, or crush.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- If you miss taking Rescriptor for a few days in a row, call your doctor before you start taking it again.
What are the side effects of Rescriptor that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- A burning, numbness, or tingling feeling that is not normal.
- Not able to pass urine or change in how much urine is passed.
- Feeling confused.
- Change in balance.
- A heartbeat that does not feel normal.
- Hallucinations (seeing or hearing things that are not there).
- Memory problems or loss.
- Mood changes.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Pale skin.
- Any unexplained bruising or bleeding.
- Feeling very tired or weak.
- Change in eyesight, eye pain, or very bad eye irritation.
- Change in body fat.
- Severe diarrhea.
- Black, tarry, or bloody stools.
- Throwing up blood or throw up that looks like coffee grounds.
- Not able to control eye movements.
- Muscle or joint pain.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of Rescriptor?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
- Feeling tired or weak.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Rescriptor?
- Store at room temperature.
- Keep lid tightly closed.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.