Rescriptor

DRUG DESCRIPTION

RESCRIPTOR Tablets contain delavirdine mesylate, a synthetic non-nucleoside reverse transcriptase inhibitor of the human immuno deficiency 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]-,monomethane sulfonate. Its molecular formula is C22H28N6O3SE CH4O3S, and itsmolecular weight is 552.68. The structural formula is:

RESCRIPTOR (delavirdine mesylate) Structural Formula Illustration

Delavirdine mesylate is an odorless white-to-tan crystalline powder. The aqueous solubility of delavirdine free base at 23 C is 2942 g/mL at pH 1.0, 295 g/mL at pH2.0, and 0.81 g/mL at pH 7.4.

Each RESCRIPTOR (delavirdine mesylate) Tablet, for oral administration, contains 100 or 200 mg of delavirdine mesylate (hence forth referred to as delavirdine). Inactive ingredients consistof lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, and carnauba wax. In addition, the 100 mg tablet contains Opadry White YS-1-7000-E and the 200 mg tablet contains hypromellose, Opadry White YS-1-18202-A and Pharmaceutical Ink Black.

What are the possible side effects of delavirdine (Rescriptor)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Rescriptor

What are the precautions when taking delavirdine mesylate (Rescriptor)?

Before taking delavirdine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to...

Read All Potential Precautions of Rescriptor


Rescriptor Consumer (continued)

SIDE EFFECTS: See also the How to Use section.

Nausea, diarrhea, headache, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression), signs of liver problems (such as persistent nausea, vomiting, stomach/abdominal pain, severe tiredness, yellowing eyes/skin, dark urine).

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Delavirdine can commonly cause a rash that is usually not serious. A rash may occur within 1 to 3 weeks after you start delavirdine treatment. It appears mainly on the upper body and arms, but may also appear on the neck and face. After consultation with the doctor, most people can continue taking delavirdine and treat the rash if it is not severe. Non-serious rashes usually last less than 2 weeks. However, a severe rash or a rash with signs of a severe reaction requires immediate medical attention. Signs of a severe reaction that usually appear within the first 3 days of a serious rash include: fever, blisters, mouth sores, eye redness/swelling, swelling in other areas of the body, or muscle/joint pain. Since you may not be able to tell a common rash apart from a rare rash that could be a sign of a severe reaction, always seek immediate medical attention if you develop any rash or any of these symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking delavirdine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.

To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Delavirdine may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known if delavirdine passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Rescriptor Patient Information Including Side Effects

Brand Names: Rescriptor

Generic Name: delavirdine (Pronunciation: de la VIR deen)

  • What is delavirdine (Rescriptor)?
  • What are the possible side effects of delavirdine (Rescriptor)?
  • What is the most important information I should know about delavirdine (Rescriptor)?
  • What should I discuss with my healthcare provider before taking delavirdine (Rescriptor)?
  • How should I take delavirdine (Rescriptor)?
  • What happens if I miss a dose (Rescriptor)?
  • What happens if I overdose (Rescriptor)?
  • What should I avoid while taking delavirdine (Rescriptor)?
  • What other drugs will affect delavirdine (Rescriptor)?
  • Where can I get more information?

What is delavirdine (Rescriptor)?

Delavirdine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Delavirdine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Delavirdine is not a cure for HIV or AIDS.

Delavirdine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of delavirdine (Rescriptor)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild nausea, vomiting, stomach pain, or bloating;
  • diarrhea or constipation;
  • headache, mood changes;
  • blurred vision;
  • cough, stuffy nose;
  • muscle or joint pain;
  • sleep problems (insomnia), unusual dreams;
  • tired feeling, trouble concentrating; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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 is the most important information I should know about delavirdine (Rescriptor)?

Do not take delavirdine with pimozide (Orap), alprazolam (Xanax), midazolam (Versed), triazolam (Halcion), or ergot medicines such as dihydroergotamine (D.H.E. 45), ergonovine (Ergotrate), ergotamine (Ergomar, Cafergot, Wigraine), or methylergonovine (Methergine).

These drugs can cause life-threatening side effects if you use them while you are taking delavirdine.

There are many other medicines that can interact with delavirdine, or make it less effective. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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