Combivir

DRUG DESCRIPTION

COMBIVIR: COMBIVIR Tablets are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR) and zidovudine (RETROVIR, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1.

COMBIVIR Tablets are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

Lamivudine: The chemical name of lamivudine is (2R,cis)-4-amino-1-(2hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-) enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2',3'-dideoxy, 3'thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula:

Lamivudine Structural Formula Illustration

Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20C.

Zidovudine: The chemical name of zidovudine is 3'-azido-3'-deoxythymidine. It has a molecular formula of C10H13N5O4 and a molecular weight of 267.24. It has the following structural formula:

Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg/mL in water at 25C.

What are the possible side effects of lamivudine and zidovudine (Combivir)?

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

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble...

Read All Potential Side Effects and See Pictures of Combivir

What are the precautions when taking lamivudine, zidovudine (Combivir)?

Before taking lamivudine/zidovudine, tell your doctor or pharmacist if you are allergic to either drug; 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), disease of the pancreas (pancreatitis), alcohol use, low red/white blood cell counts.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Also limit alcohol because it can increase the...

Read All Potential Precautions of Combivir


Combivir Consumer (continued)

SIDE EFFECTS: See also Warning and How to Use sections.

Headache, tiredness, loss of appetite, nausea, vomiting, diarrhea, trouble sleeping, dizziness, stuffy nose, or cough 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), numbness/tingling of hands/feet, signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever), easy bruising/bleeding, skin/nail color changes.

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.

This medication can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.

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 lamivudine/zidovudine, tell your doctor or pharmacist if you are allergic to either drug; 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), disease of the pancreas (pancreatitis), alcohol use, low red/white blood cell counts.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Also limit alcohol because it can increase the risk of liver problems and pancreatitis.

Children may be more sensitive to the side effects of this drug, especially pancreatitis.

Before having surgery, tell your doctor 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.

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. Lamivudine/zidovudine may be part of that treatment. Discuss the risks and benefits with your doctor.

Lamivudine and zidovudine pass into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Combivir Patient Information Including Side Effects

Brand Names: Combivir

Generic Name: lamivudine and zidovudine (Pronunciation: la MIV ue deen and zye DOE vue deen)

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

What is lamivudine and zidovudine (Combivir)?

Lamivudine and zidovudine are antiviral medications. They are in a group of human immunodeficiency virus (HIV) medicines called reverse transcriptase inhibitors. This medication helps keep the HIV virus from reproducing in the body.

The combination of lamivudine and zidovudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

Lamivudine and zidovudine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of lamivudine and zidovudine (Combivir)?

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

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • slow or uneven heart rate.

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

  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • trouble swallowing, trouble standing up or climbing stairs;
  • liver problems (stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes));
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate); or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk);
  • mild nausea, vomiting, diarrhea;
  • numbness or tingling;
  • sleep problems (insomnia);
  • headache, dizziness, tired feeling; or
  • cough, runny or stuffy nose.

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 lamivudine and zidovudine (Combivir)?

The combination of lamivudine and zidovudine (Combivir) should not be taken together with any other medications that contain either of these two drugs. This includes Epivir, Retrovir, Epzicom (abacavir and lamivudine), and Trizivir (abacavir, lamivudine, zidovudine).

Before taking lamivudine and zidovudine, tell your doctor if you have kidney disease, liver disease, a pancreas disorder, bone marrow suppression, or problems with your muscles.

Lamivudine and zidovudine can lower the blood cells in your body that help you fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

If you have hepatitis B you may develop liver symptoms after you stop taking lamivudine and zidovudine, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

Some people have developed a life-threatening condition called lactic acidosis while taking lamivudine and zidovudine. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

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