Lamivudine-Zidovudine

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. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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).

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: orlistat, probenecid, ribavirin, sorbitol, stavudine, drugs that may decrease bone marrow function or lower blood cell counts (such as ganciclovir, trimethoprim, cancer chemotherapy including doxorubicin).

Other medications can affect the removal of zidovudine from your body, which may affect how lamivudine/zidovudine works. Examples include rifampin, valproic acid, among others.

If you are also taking clarithromycin, take this medication at least 2 hours apart from your clarithromycin dose.

Do not take other products that contain either lamivudine or zidovudine with this medication.

Emtricitabine is similar to lamivudine and should not be taken with this medication.

Do not share this medication with others.

Lab and/or medical tests (such as blood cell counts, liver/kidney function, viral load, T-cell counts) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the refrigerator or at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Read the Patient Information Leaflet if available from your pharmacist before you start taking lamivudine/zidovudine, and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually 2 times daily. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise.

Because this combination product has fixed doses of lamivudine and zidovudine, it should only be used if your doctor has determined that the doses of both medications in this product are right for you. This product is not to be used by children weighing less than 30 kilograms (66 pounds).

It is very important to keep taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same times every day.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Zidovudine, one of the medications in this product, can decrease bone marrow function, which may lead to low numbers of red and white blood cells. A low number of red blood cells can lead to anemia. A low number of white blood cells can decrease your body's ability to fight serious, life-threatening infections. These serious side effects occur more often in people with advanced HIV disease (AIDS). Tell your doctor right away if you develop any signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat) or signs of infection (such as sore throat that doesn't go away, fever, chills). Your doctor will check your blood cell counts while you are taking this medication to decrease the risk of these side effects.

Zidovudine may also cause muscle problems. Tell your doctor right away if you develop signs of muscle problems (such as wasting or decrease in muscle size, weight loss, muscle weakness/pain/tenderness).

Rarely, lamivudine and zidovudine have caused severe (sometimes fatal) liver problems and a certain metabolic problem (lactic acidosis). Get medical help right away if you develop symptoms of liver problems (such as nausea that doesn't stop, vomiting, stomach/abdominal pain, pale stools, dark urine, yellowing eyes/skin, unusual tiredness), or of lactic acidosis (such as stomach discomfort, nausea, vomiting, fast/difficult breathing, drowsiness, muscle pain, weakness, cold skin). These serious side effects may occur more often in women and obese patients.

If you have hepatitis B infection and HIV, you may have a serious worsening of hepatitis symptoms if you stop taking lamivudine. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop lamivudine. Tell your doctor right away if you develop symptoms of worsening liver problems.

See also Warning section.

Headache, tiredness, loss of appetite, nausea, vomiting, diarrhea, trouble sleeping, dizziness, or stuffy nose may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as sore throat that doesn't go away, fever, chills, swollen lymph nodes, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat).

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression), signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever), easy bruising/bleeding, skin/nail color changes.

Loss of body fat (such as in the face, arms, legs, and buttocks) may occur while you are taking this medication. This effect may be permanent. Tell your doctor right away if you notice any changes in body fat.

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. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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