Details for: AURO-LAMIVUDINE/ZIDOVUDINE
Company: AURO PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02414414 | AURO-LAMIVUDINE/ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150 MG; 300 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
AURO-LAMIVUDINE/ZIDOVUDINE is used in the treatment of the Human Immunodeficiency Virus (HIV) infection. HIV infection damages the immune system and can lead to Acquired Immune Deficiency Syndrome (AIDS) and other illnesses.
AURO-LAMIVUDINE/ZIDOVUDINE belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and is used in combination with other antiretrovirals to treat Human Immunodeficiency Virus (HIV) infection.
What it does
AURO-LAMIVUDINE/ZIDOVUDINE does not cure AIDS or kill the HIV virus, but helps to prevent further damage to the immune system by slowing down the production of new viruses.
AURO-LAMIVUDINE/ZIDOVUDINE 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.
When it should not be used
Do not use AURO-LAMIVUDINE/ZIDOVUDINE.
- If you previously had an allergic reaction to AURO-LAMIVUDINE/ZIDOVUDINE or to any of the ingredients in the product (See What the important nonmedicinal ingredients are).
- If you have a very low red blood cell count (anemia) or very low white blood cell count (neutropenia).
What the medicinal ingredient is
Each AURO-LAMIVUDINE/ZIDOVUDINE tablet contains 150 mg of lamivudine and 300 mg of zidovudine.
What the non-medicinal ingredients are
Each AURO-LAMIVUDINE/ZIDOVUDINE tablet also contains the nonmedicinal ingredients Cellulose, Microcrystalline (Avicel PH 101), Sodium Starch Glycolate (Promojel Type A), Cellulose, Microcrystalline (Avicel PH 102), Silica colloidal anhydrous (Aerosil 200 pharma), Magnesium stearate (Ligarned MF-2-V), Hypromellose (6cP), Macrogol 400, Titanium Dioxide, Polysorbate 80.
What dosage form it comes in
Each AURO-LAMIVUDINE/ZIDOVUDINE tablet contains 150 mg of lamivudine and 300 mg of zidovudine.
Warnings and precautions
Serious Warnings and Precautions
- lactic acidosis (high levels of acid in the blood) with severe hepatomegaly with steatosis (swollen and fatty liver) (See WARNINGS AND PRECAUTIONS, SIDE EFFECTS).
- worsening of hepatitis B (See WARNINGS AND PRECAUTIONS, SIDE EFFECTS).
- pancreatitis (inflammation of the pancreas) in children (See WARNINGS AND PRECAUTIONS, SIDE EFFECTS)
BEFORE you use AURO-LAMIVUDINE/ZIDOVUDINE talk to your doctor or pharmacist if:
- You ever had to stop taking this or another medication for this illness because you were allergic to them or they caused problems.
- You had, or you have, any diseases of the kidney.
- You had, or you have, any diseases of the liver, particularly hepatitis B or C infection.
- You had, or you have, very low red blood cell count (severe anemia), very low white blood cell count (neutropenia) or any type of blood disorder.
- You are taking ribavirin as it could cause or worsen anemia (symptoms of tiredness, shortness of breath). Your doctor will advise whether you should stop taking AURO-LAMIVUDINE/ZIDOVUDINE.
- You are taking interferon
Remember that treatment with AURO-LAMIVUDINE/ZIDOVUDINE does not reduce the risk of passing the infection onto others. You will still be able to pass HIV by sexual contact or by blood transfusion and you should use appropriate precautions, for example:
- Use a condom when you have oral or penetrative sex.
- Don’t risk blood transfer - for example, don’t share needles.
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 the doctor who is treating your condition.
Your doctor will arrange regular blood tests to check for side effects. See SIDE EFFECTS section for more details.
Use of this medicine during pregnancy and breastfeeding
If you are pregnant, or planning to become pregnant soon, you must inform your doctor before taking any medicine. The safe use of AURO-LAMIVUDINE/ZIDOVUDINE in pregnancy has not been established. Your doctor 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 doctor about how you can be included in the Antiretroviral Pregnancy Registry.
Babies and infants exposed to Nucleoside Reverse Transcriptase Inhibitors (NRTIs) during pregnancy or labour, show minor temporary increases in blood levels of lactate. The clinical importance of these temporary increases is unknown.
These findings do not affect current recommendations to use antiretroviral therapy in pregnant women to prevent transmission of HIV to their babies. There have been very rare reports of disease that affect the neonatal (babies) nervous system such as delayed development and seizures. The long term effects of AURO-LAMIVUDINE/ZIDOVUDINE are not known.
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
REMEMBER: This medicine is for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
Pancreatitis in Pediatric Patients
In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, AURO-LAMIVUDINE/ZIDOVUDINE should be used with caution. Treatment with AURO-LAMIVUDINE/ZIDOVUDINE should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur (see ADVERSE REACTIONS section).
Other special warnings
Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your doctor may order blood tests for you.
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 doctor will monitor you closely for any signs that you may be developing lactic acidosis See SIDE EFFECTS section for additional information.
If you have hepatitis B infection, you should not stop AURO-LAMIVUDINE/ZIDOVUDINE without instructions from your doctor, as you may have recurrence of your hepatitis. This may occur due to you suddenly stopping the active substance lamivudine in AURO-LAMIVUDINE/ZIDOVUDINE.
Interactions with this medication
Tell your doctor about all your medicines, including vitamin supplements, herbal remedies or homeopathic remedies, including those you have bought yourself. AURO-LAMIVUDINE/ZIDOVUDINE should not be taken with stavudine, emtricitabine, ribavirin, lamivudine or zidovudine
It is important that you tell your doctor if you are taking any of the medicines below:
- phenytoin, valproic acid,
- oxazepam, lorazepam
- codeine, morphine, methadone
- acetylsalicylic acid, indomethacin, ketoprofen, naproxen
- rifampicin, co-trimoxazole (trimethoprim and sulfamethoxazole), dapsone, pentamidine
- ganciclovir, fluconazole, amphotericin, flucytosine
- vincristine, vinblastine, doxorubicin
- cimetidine
- probenecid
- clofibrate
- atovaquone, pyrimethamine
- interferon
- isoprinosine
- clarithromycin to be taken 2 hours before or 2 hours after taking AURO LAMIVUDINE/ZIDOVUDINE
- sorbitol-containing medicines (usually liquids) used regularly
Proper use of this medication
Take your medicine as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Usual Dose
For Adults and Adolescents weighing at least 30 kg:
One tablet by mouth twice a day at the same time each day. AURO-LAMIVUDINE/ZIDOVUDINE tablet can be taken with or without food.
If you have kidney or liver problems and your dose needs to be reduced your doctor may have you take lamivudine and zidovudine as separate medicines.
Overdose
If you think you have taken too much AURO-LAMIVUDINE/ZIDOVUDINE, contact your health care professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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.
Side effects and what to do about them
Consult your doctor at your next visit if any of the following undesirable events occur:
Headaches, nausea, vomiting, diarrhea, fever, rash, fatigue, a general feeling of being unwell, or a numbness, tingling sensation or sensation of weakness in your limbs.
AURO-LAMIVUDINE/ZIDOVUDINE may also cause a decrease in certain types of blood counts (including red blood cells, white blood cells and platelets) and an increase in certain liver enzymes.
Treatment with AURO-LAMIVUDINE/ZIDOVUDINE or other medicines that contain zidovudine may cause a loss of fat from legs, arms and face (lipoatrophy). Your doctor should monitor for signs of lipoatrophy. Tell your doctor if you notice any loss of fat from your legs, arms, and face. When these signs occur, your doctor 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.
Changes to your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
Autoimmune disorders (when the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection. Examples of this include: Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system), polymyositis (which affects the muscles), or autoimmune hepatitis (which affects the liver). Autoimmune disorders may occur many months after the start of treatment. Look for any other symptoms such as:
- high temperature (fever), redness, rash or swelling
- 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 If you notice these or any symptoms of inflammation or infection, tell your doctor immediately
Lactic acidosis is a rare but serious side effect.
Some people taking AURO-LAMIVUDINE/ZIDOVUDINE, or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver.
Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few months of treatment. It can be lifethreatening, causing failure of internal organs.
Lactic acidosis is more likely to develop in people who have liver disease, especially women.
Signs of lactic acidosis include:
- deep, rapid, difficult breathing
- drowsiness
- numbness or weakness in the limbs
- feeling sick (nausea), being sick (vomiting)
- stomach pain.
During your treatment, your doctor will monitor you for
signs of lactic acidosis. If you have any of the
symptoms listed above or any other symptoms that
worry you:
See your doctor as soon as possible.
Always tell your doctor or pharmacist about any undesirable effects, even those not mentioned in this leaflet.
If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your doctor immediately. Listed below are some side effects that have been noted:
Very common side effects
These may affect more than 1 in 10 people:
- headache
- feeling sick (nausea)
Common side effects
These may affect up to 1 in 10 people:
- being sick (vomiting)
- diarrhea
- stomach pains
- feeling dizzy
- tiredness, lack of energy
- fever (high temperature)
- general feeling of being unwell
- muscle pain and discomfort
- joint pain
- skin rash
- hair loss
Common side effects that may show up in blood tests are:
- a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)
- an increase in the level of liver enzymes
- an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow
- increased levels of lactic acid in the blood.
Uncommon side effects
These may affect up to 1 in 100 people
- shortness of breath
- wind/gas (flatulence)
- itching
- muscle weakness
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
These may affect up to 1 in 1,000 people
- difficulty in sleeping (insomnia)
- lactic acidosis
- liver disorders, such as an enlarged liver or fatty liver
- inflammation of the pancreas (pancreatitis)
- chest pain; disease of the heart muscle (cardiomyopathy)
- 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
These may affect up to 1 in 10,000 people
- Damage to nerves (peripheral neuropathy) which may include the following:
- sensation of weakness in the limbs
- numbness
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).
| Side Effect/ Symptom | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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, 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 symptoms such as 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. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking AURO-LAMIVUDINE/ZIDOVUDINE, contact your doctor or pharmacist.
How to store
Store at room temperature (15°C to 30°C).
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.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-healthproducts/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
Remember this medicine is for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.
This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about anything, then ask your doctor or pharmacist.
You may need to read this leaflet again. Please do not throw it away until you are no longer taking AURO-LAMIVUDINE/ZIDOVUDINE (lamivudine and zidovudine).
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 consumer information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: August 30, 2019