Retrovir

DRUG DESCRIPTION

RETROVIR is the brand name for zidovudine (formerly called azidothymidine [AZT]), a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3' -azodp-3'-deoxythymidine; it has the following structural formula:

RETROVIR (zidovudine)  Structural Formula Illustration

Zidovudine is a white to beige, odorless, crystalline solid with a molecular weight of 267.24 and a solubility of 20.1 mg/mL in water at 25C. The molecular formula is C10H13N5O4.

RETROVIR Tablets are for oral administration. Each film-coated tablet contains 300 mg of zidovudine and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

RETROVIR Capsules are for oral administration. Each capsule contains 100 mg of zidovudine and the inactive ingredients corn starch, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 100-mg empty hard gelatin capsule, printed with edible black ink, consists of black iron oxide, dimethylpolysiloxane, gelatin, pharmaceutical shellac, soya lecithin, and titanium dioxide.

RETROVIR Syrup is for oral administration. Each teaspoonful (5 mL) of RETROVIR Syrup contains 50 mg of zidovudine and the inactive ingredients sodium benzoate 0.2% (added as a preservative), citric acid, flavors, glycerin, and liquid sucrose. Sodium hydroxide may be added to adjust pH.

What are the possible side effects of zidovudine (Retrovir)?

Stop using this medication and 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 other serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing,...

Read All Potential Side Effects and See Pictures of Retrovir

What are the precautions when taking zidovudine (Retrovir)?

Before taking zidovudine, 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: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), alcohol use, low red/white blood cells.

Liquid products may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit sugar in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctors or dentist about all the products you use (including...

Read All Potential Precautions of Retrovir


Retrovir Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, nausea, vomiting, trouble sleeping, or loss of appetite may occur. If any of these effects persist or worsen, notify 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, anxiety, confusion), tingling/numbness of hands or feet, easy bruising/bleeding, skin/fingernail color changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures.

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

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 zidovudine, 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: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), alcohol use, low red/white blood cells.

Liquid products may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit sugar in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug.

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. Zidovudine may be part of that treatment. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Retrovir Patient Information Including Side Effects

Brand Names: Retrovir

Generic Name: zidovudine (oral) (Pronunciation: zye DOE vyoo deen)

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

What is zidovudine (Retrovir)?

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

Zidovudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Zidovudine is also given during pregnancy to prevent an HIV-infected woman from passing the virus to her baby. Zidovudine is not a cure for HIV or AIDS.

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

What are the possible side effects of zidovudine (Retrovir)?

Stop using this medication and 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 other serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, and fast or uneven heart rate;
  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
  • easy bruising or bleeding, unusual weakness, pale skin;
  • white patches or sores inside your mouth or on your lips;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may be more likely to occur, such as:

  • sleep problems (insomnia), strange dreams;
  • mild nausea, vomiting, stomach pain, constipation;
  • muscle or joint pain;
  • headache, tired feeling;
  • skin rash; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about zidovudine (Retrovir)?

Zidovudine may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis symptoms can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Call your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.

Zidovudine can also cause severe or life-threatening effects on your liver. Call your doctor at once if you have any of these symptoms while taking zidovudine: nausea and vomiting, diarrhea, loss of appetite, stomach pain, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Do not use zidovudine together with other combination drugs that contain zidovudine, such as Combivir or Trizivir.

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. Be sure to read the medication guide or patient instructions provided with each of your medications. 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.

Taking zidovudine will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. Sharing drug or medicine needles is never safe, even for a healthy person.

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