Details for: APO-ZIDOVUDINE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01946323 | APO-ZIDOVUDINE | ZIDOVUDINE | 100 MG | CAPSULE | 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
The name of your medicine is APO-ZIDOVUDINE.
APO-ZIDOVUDINE can only be obtained with a prescription from your doctor. APO-ZIDOVUDINE is an antiretroviral medication. It is used together with other antiviral medicines to delay the progression of HIV infection.
APO-ZIDOVUDINE is prescribed to slow down the effects of HIV virus; it is not a cure.
What it does
The Human Immunodeficiency Virus (HIV) is a retrovirus.
Infection with HIV damages the immune system and can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses.
APO-ZIDOVUDINE is an antiretroviral medication. It is used together with other antiviral medicines to delay the progression of HIV infection. APO-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.
When it should not be used
APO-ZIDOVUDINE should not be used in patients:
- who have potentially life-threatening allergic reactions to any component of the formulations (see what the important nonmedicinal ingredients are).
- with low blood cell counts (anemia) or low hemoglobin levels (blood component which carries oxygen in the blood).
What the medicinal ingredient is
APO-ZIDOVUDINE contains zidovudine.
What the non-medicinal ingredients are
Each capsule contains the non-medicinal ingredients colloidal silicon dioxide, microcrystalline cellulose, starch and stearic acid . The capsule, imprinted with edible black ink, contains gelatin and titanium dioxide.
What dosage form it comes in
APO-ZIDOVUDINE is available as zidovudine capsules USP (100 mg/capsule)
Warnings and precautions
BEFORE you use APO-ZIDOVUDINE talk to your doctor or pharmacist if:
- you are allergic to any ingredient in this medicine.
- you have bone marrow problems (low blood cell counts).
- you have hepatomegaly (enlarged liver), hepatitis (inflamed liver) or other known risk factors for liver disease.
- you have kidney disease.
- you are taking other drugs (see Interactions with this medication).
- you are pregnant or breastfeeding.
- your baby or infant was exposed to Nucleoside Reverse Transcriptase Inhibitors (NRTIs) during pregnancy or labour.
- you are taking ribavarin as it could cause or worsen anemia (symptoms of tiredness, shortness of breath). Your doctor will advise whether you should stop taking APO-ZIDOVUDINE.
Illness associated with HIV infection, including other infections, may still happen. Therefore, it is very important to keep appointments with your doctor and to report any change in your health as it occurs.
Zidovudine has been extensively studied in humans for limited periods of time. Studies have shown that treatment will benefit your health. However, the effectiveness and overall safety of zidovudine is unknown beyond the length of time for which it has been studied.
The effectiveness and overall safety of zidovudine in women, intravenous drug users, and ethnic minorities are not different than that observed in white males.
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.
Use of This Medication During Pregnancy and Breast Feeding
Before you use APO-ZIDOVUDINE, talk to your doctor or pharmacist if you are pregnant, planning to become pregnant, or become pregnant while taking APO-ZIDOVUDINE. It is not known if APO-ZIDOVUDINE can harm your unborn child. You and your doctor will need to decide if taking APO-ZIDOVUDINE is right for you. If you take APO-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.
There have been very rare reports of diseases that affect the nervous system such as delayed development and seizures.
These findings do not affect current recommendations to use antiretroviral therapy in pregnant women to prevent transmission of HIV to their babies.
HIV-infected women should not breastfeed in order to prevent transmission of HIV to a child who may not yet be infected. The ingredients in APO-ZIDOVUDINE can also pass into your breast-milk.
Interactions with this medication
Some drugs may change the usefulness and safety of APO-ZIDOVUDINE. It is therefore very important that you tell your doctor before you decide to take any new drugs, even if these are available without a prescription.
Drugs that may interact with APO-ZIDOVUDINE include: atovaquone, bone marrow suppressive agents/cytotoxic agents, clarithromycin, fluconazole, ganciclovir, interferon-alpha, lamivudine, methadone, phenytoin, probenecid, stavudine, valproic acid, and others such as trimethoprim- sulfamethoxazole, pyrimethamine, acyclovir and rifampin.
For patients receiving combination therapy with APO-ZIDOVUDINE and zalcitabine, it is important to understand that the major toxicity of zalcitabine is peripheral neuropathy. Pancreatitis is another serious and potentially life-threatening toxicity that has been reported in less than 1% of patients treated with zalcitabine alone. Symptoms of peripheral neuropathy include tingling, burning, pain, or numbness in the hands or feet. Symptoms of pancreatitis include abdominal pain, nausea and vomiting. These symptoms should be promptly reported to your physician. Since the development of peripheral neuropathy seems to be dose-related to zalcitabine, you should follow your physician’s instructions regarding the prescribed dose. The long-term effects of zalcitabine in combination with APO-ZIDOVUDINE are presently unknown. If you are a female of child-bearing age, you should use effective contraception while using zalcitabine.
An additional precaution is that some other drugs may change the usefulness and safety of APO-ZIDOVUDINE.
Proper use of this medication
Usual dose
You should be counselled about the use of APO-ZIDOVUDINE.
It is important to take APO-ZIDOVUDINE exactly as prescribed. Altering the dose without the direct advice of your physician is unwise, as is sharing your medication with others.
Oral Administration
Adults and Adolescents 30 kg and Over
The recommended total oral daily dose of APO-ZIDOVUDINE is 600 mg per day in divided doses in combination with other antiretroviral agents. Suggested Dosing Regimens:
- three 100 mg APO-ZIDOVUDINE capsules every 12 hours; OR two 100 mg APO-ZIDOVUDINE capsules every 8 hours.
If you are also taking clarithromycin, your doctor may advise you to take this medication at least 2 hours before or 2 hours after APO-ZIDOVUDINE, to avoid a drug interaction.
Overdose
If you think you have taken too much APO-ZIDOVUDINE, contact your healthcare professional,, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them
Side-effects of APO-ZIDOVUDINE include nausea, vomiting, fever, headache, stomach pain, loss of appetite, muscle pain, low white blood cell count (neutropenia or leucopenia), decrease in the number of cells involved in blood clotting (thrombocytopenia) or in all kinds of blood cells (pancytopenia), reduction in the number of red blood cells (pure red cell aplasia), failure of the bone marrow to produce new blood cells (aplastic anemia), an increase in lactic acid, feeling depressed or anxious, dizziness, not being able to sleep, tingly feelings in the skin (pins and needles), not being able to concentrate, feeling drowsy, seizures, disease of the heart muscle, cough, intestinal gas, changes in the colour of the nails, skin, or the skin inside the mouth, taste disturbance, indigestion, skin rash (red, raised or itchy skin), sweating, passing urine more often, enlarged breasts in men, general aches and pain, chills, chest pain, flu-like feeling. If these become bothersome, consult your doctor.
Treatment with APO-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 APO-ZIDOVUDINE should be stopped and your HIV treatment changed. If you stop taking APO-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, 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
If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.
| Side Effect/ Symptoms (2 or more of the following) |
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 | |||
| Lowered red blood cell count (anemia) – resulting in fatigue, breathlessness. Low white blood cell count (neutropenia) - making you more 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 and enlarged liver) with symptoms of liver problems such as nausea, vomiting, abdominal pain, weakness and diarrhea. | ✔ | ||
An important but reversible side-effect of zidovudine, particularly in patients with more severe disease, can be a decrease in certain types of blood counts (including red blood cells, white blood cells and platelets) and increase in certain liver enzymes. Since a reduction in these cells can directly affect your health, it is important to have your blood tested as often as your doctor requests it. In some cases, it may be necessary to adjust the dose of the drug, temporarily discontinue the drug, give a blood transfusion, or stop the drug altogether.
It is important to understand that although these blood effects can occur at any stage, they are much more common in advanced disease and in patients who start zidovudine therapy late in their illness.
Contact your doctor if you experience muscle weakness, shortness of breath, symptoms of hepatitis or pancreatitis (which include very severe stomach cramps) or any other unexpected adverse events while being treated with APO-ZIDOVUDINE.
This is not a complete list of side effects. For any unexpected effects while taking APO-ZIDOVUDINE, contact your doctor or pharmacist.
How to store
APO-ZIDOVUDINE Capsules should be stored at room temperature between 15ºC to 25ºC and protected from light and moisture.
As with all medicines, keep APO-ZIDOVUDINE out of reach and sight of children.
Do not take your medicine after the expiry date shown on the bottle and the 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/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.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
HIV is usually spread by sexual contact or by contaminated needles. This risk still exists during APO-ZIDOVUDINE therapy; thus, the practice of ‘safe sex’ and avoidance of sharing needles is imperative.
If you want more information about APO-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). Find the Consumer Information on the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: November 21, 2019