Patient Medication Information: uses, side effects, how to take - Auro-Lamivudine/Zidovudine
Serious Warnings and Precautions
Lactic Acidosis and Severe Liver Problems: The class of medicines to which Auro-Lamivudine/Zidovudine belongs (NRTIs) can cause a condition called lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver. Symptoms of lactic acidosis include feeling of weakness, loss of appetite, sudden unexplained weight loss, upset stomach and difficulty breathing. This rare but serious side effect occurs more often in women. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with Auro-Lamivudine/Zidovudine your healthcare professional will monitor you closely for any signs that you may be developing lactic acidosis. Worsening of Hepatitis B: If you have hepatitis B infection, you should not stop Auro-Lamivudine/Zidovudine without instructions from your healthcare professional, as you may have recurrence of your hepatitis. Pancreatitis in Pediatric Patients: Auro-Lamivudine/Zidovudine should be used with caution in pediatric patients with a history of prior antiretroviral drug exposure or a history of pancreatitis (inflammation of the pancreas). Treatment with Auro-Lamivudine/Zidovudine should be stopped immediately if signs of pancreatitis occur, such as nausea, vomiting and severe stomach cramps. |
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What is Auro-Lamivudine/Zidovudine used for?
Auro-Lamivudine/Zidovudine is used with other antiretrovirals to treat Human Immunodeficiency Virus (HIV) infection.
How does Auro-Lamivudine/Zidovudine work?
Auro-Lamivudine/Zidovudine contains the medicinal ingredients lamivudine and zidovudine. This belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), which are used to treat HIV infection.
HIV is a retrovirus (a type of virus). Infection with HIV damages the immune system and can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses.
Auro-Lamivudine/Zidovudine does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body fight infection.
What are the ingredients in Auro-Lamivudine/Zidovudine?
Medicinal ingredients: lamivudine and zidovudine.
Non-medicinal ingredients: Cellulose Microcrystalline (Avicel PH 101), Cellulose Microcrystalline (Avicel PH 102), Hypromellose (6cP), Magnesium stearate (Ligarned MF-2-V), Macrogol 400, Polysorbate 80, Sodium Starch Glycolate (Promojel Type A), Silica colloidal anhydrous (Aerosil 200 pharma), Titanium Dioxide.
Auro-Lamivudine/Zidovudine comes in the following dosage forms:
150 mg lamivudine and 300 mg zidovudine tablets.
Do not use Auro-Lamivudine/Zidovudine if:
- you have had an allergic reaction to Auro-Lamivudine/Zidovudine or to any of the ingredients in the product.
- you have a very low red blood cell count (anemia) or very low white blood cell count (neutropenia).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-Lamivudine/Zidovudine. Talk about any health conditions or problems you may have, including if you:
- ever had to stop taking this or another medication for this illness because you were allergic to them or they caused problems.
- have any kidney issues.
- have any liver issues, particularly hepatitis B or C infection.
- have a very low red blood cell count (severe anemia), very low white blood cell count (neutropenia) or any type of blood disorder.
Other warnings you should know about:
Auro-Lamivudine/Zidovudine can cause serious side effects, including:
Risk of Infections: While taking Auro-Lamivudine/Zidovudine or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. Therefore, you should keep in regular contact with your healthcare professional.
Your healthcare professional will arrange regular blood tests to check for side effects.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Blood Tests: Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your healthcare professional may order blood tests for you.
Pregnancy and Newborns: If you are pregnant, or planning to become pregnant soon, tell your healthcare professional before taking any medicine. The safe use of Auro-Lamivudine/Zidovudine in pregnancy has not been established. Your healthcare professional will decide whether you should continue to be treated with Auro-Lamivudine/Zidovudine if you are pregnant. If you take Auro-Lamivudine/Zidovudine while you are pregnant, talk to your healthcare professional about how you can be included in the Antiretroviral Pregnancy Registry.
Breastfeeding: It is recommended that HIV infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV from mother to child. The active substances in Auro-Lamivudine/Zidovudine are likely to be found in breast milk. You are recommended not to breastfeed your baby while taking Auro-Lamivudine/Zidovudine.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Auro-Lamivudine/Zidovudine should not be taken with stavudine, emtricitabine, ribavirin, lamivudine or zidovudine.
The following may interact with Auro-Lamivudine/Zidovudine:
- phenytoin, valproic acid, to treat epilepsy
- oxazepam, lorazepam, to treat anxiety and sleep problems (insomnia)
- codeine, morphine, methadone, acetylsalicylic acid, indomethacin, ketoprofen, naproxen, to treat pain
- dapsone, to prevent pneumonia and treat skin infections
- rifampicin, co-trimoxazole (trimethoprim and sulfamethoxazole), fluconazole, amphotericin, flucytosine, to treat bacterial and fungal infections
- vincristine, vinblastine, doxorubicin, to treat cancer
- cimetidine, to treat heartburn and ulcers
- probenecid, to treat gout
- clofibrate, to treat high cholesterol
- atovaquone, pentamidine, pyrimethamine, to treat parasitic infections
- interferon, ganciclovir, to treat viral infections
- isoprinosine, to treat viral infections
- clarithromycin to be taken 2 hours before or 2 hours after taking Auro-Lamivudine/Zidovudine, to treat bacterial infections
- sorbitol-containing medicines (usually liquids) used regularly
How to take Auro-Lamivudine/Zidovudine:
- Take your medicine as your healthcare professional has told you. If you are not sure, ask your healthcare professional.
- Never share your medicine with someone else. It may harm them even if their symptoms are the same as yours.
You can take Auro-Lamivudine/Zidovudine with or without food
Usual dose:
Adults and Adolescents weighing at least 30 kg:
One tablet by mouth twice a day at the same time each day.
If you have kidney or liver problems and your dose needs to be reduced your healthcare professional may have you take lamivudine and zidovudine as separate medicines.
Overdose:
| If you think you, or a person you are caring for, have taken too much Auro-Lamivudine/Zidovudine, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you forget to take your medicine, take it as soon as you remember. Then continue as before. Do not double dose to make up for a forgotten dose.
What are possible side effects from using Auro-Lamivudine/Zidovudine?
These are not all the possible side effects you may have when taking Auro-Lamivudine/Zidovudine. If you experience any side effects not listed here, tell your healthcare professional.
Treatment with Auro-Lamivudine/Zidovudine or other medicines that contain zidovudine may cause a loss of fat from legs, arms and face (lipoatrophy). Your healthcare professional should monitor for signs of lipoatrophy. Tell your healthcare professional if you notice any loss of fat from your legs, arms, and face. When these signs occur, your healthcare professional will assess if Auro-Lamivudine/Zidovudine should be stopped and your HIV treatment changed. If you stop taking Auro-Lamivudine/Zidovudine, it may take several months to see any lost fat return. You may not regain all of your lost body fat.
Side effects may include:
Very common side effects (> 1 in 10 people)
- headache
Common side effects (≤ 1 in 10 people)
- feeling dizzy
- hair loss
Common side effects that may show up in blood tests are:
- an increase in the level of liver enzymes
Uncommon side effects (≤ 1 in 100 people)
- wind/gas (flatulence)
- itching
Uncommon side effects that may show up in blood tests are:
- a decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia).
Rare side effects (≤ 1 in 1000 people)
- difficulty in sleeping (insomnia)
- fits (convulsions)
- feeling depressed or anxious, not being able to concentrate, feeling drowsy
- indigestion, taste disturbance
- changes in the colour of your nails, your skin, or the skin inside your mouth
- a flu-like feeling — chills and sweating
- loss of appetite
- breakdown of muscle tissue
- passing urine more often
- enlarged breasts in men
- cough
- sweating
- itchy, bumpy rash (hives)
- tingly feelings in the skin (pins and needles)
Rare side effects that may show up in blood tests are:
- increase in an enzyme called amylase
- a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Very rare side effects that may show up in blood tests are:
- a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Serious allergic reaction and symptoms of sudden wheeziness and chest pain or tightening, swelling of eyelids, face or lips, skin rash or ‘hives’ anywhere on the body. | √ | ||
| UNCOMMON | |||
| Blood problems and symptoms such as anemia (lowered red blood cell count) resulting in fatigue, breathlessness, or neutropenia (low white blood cell count), making you prone to infections. | √ | ||
| RARE | |||
| Pancreatitis (inflammation of the pancreas and symptoms such as nausea, vomiting and severe stomach cramps). | √ | ||
| Lactic acidosis (high level of acid in the blood) and Liver Problems: weight loss, fatigue, malaise, abdominal pain, shortness of breath, severe hepatomegaly (swollen liver), with symptoms of liver problems such as nausea, vomiting, abdominal pain, weakness and diarrhea. | √ | ||
| FREQUENCY NOT KNOWN | |||
| Immune Reconstitution Inflammatory Syndrome and Autoimmune Disorders: fever, redness, rash or swelling, fatigue, joint or muscle pain , numbness or weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, chest pain or rapid heart rate, yellowing of the eyes and skin | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store at room temperature (15oC to 30 oC).
As with all medicines, keep Auro-Lamivudine/Zidovudine out of reach and sight of children.
Do not take your medicine after the expiry date shown on the bottle label, blister foil and their carton.
If you want more information about Auro-Lamivudine/Zidovudine:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug- product-database.html); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.