Patient Medication Information: uses, side effects, how to take - Lamivudine Oral Solution
ABOUT THIS MEDICATION
What the medication is used for:
The Human Immunodeficiency Virus (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.
Lamivudine oral solution belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and is used in combination with other antiretrovirals to treat HIV infection.
What it does:
Lamivudine oral solution is not a cure for HIV infection or AIDS; it reduces the amount of virus in your body, and keeps it at a low level. Lamivudine oral solution 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:
Lamivudine oral solution should not be taken if
you previously had an allergic reaction (hypersensitivity)
to the active ingredient lamivudine which is included in medicines called TRIZIVIR®, COMBIVIR® or KIVEXA®, or any other ingredients found in lamivudine oral solution. (see “What the important nonmedicinal ingredients are” sections).
What the medicinal ingredient is:
Lamivudine oral solution contains 150 mg of lamivudine in each tablespoon (15 ml).
What the important nonmedicinal ingredients are:
Lamivudine oral solution also contains artificial strawberry and banana flavours, citric acid (anhydrous), methylparaben, propylparaben, propylene glycol, sodium citrate (dihydrate), sucrose and purified water. Each 150 mg (15 mL) contains 3 g of sucrose.
What dosage forms it comes in:
Oral solution, 10 mg/mL.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- Lactic acidosis (too much acid in the blood) and swollen and fatty liver (hepatomegaly with steatosis), including fatal cases, have been reported with the use of nucleoside analogues alone or in combination. If you suffer symptoms (see Serious Side Effects table), contact your doctor.
- If you also have a hepatitis B infection, you should not stop taking lamivudine oral solution without instructions from your doctor as your hepatitis may worsen/reoccur. Your doctor will monitor your condition for several months after stopping treatment with lamivudine oral solution.
- Parents or guardians should be advised to monitor pediatric patients for signs and symptoms of pancreatitis (inflammation of the pancreas; see Serious Side Effects table). If symptoms of pancreatitis occur, contact your doctor.
Before taking lamivudine oral solution, tell your doctor or pharmacist:
- About all your medicines and medical conditions, including vitamins, herbal supplements and nonprescription drugs
- If you have kidney or liver disease (including hepatitis B or C)
- If you have had previous use of any NRTI class medicine
- If you are pregnant, planning to become pregnant,
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breastfeeding, or planning to breastfeed
Other Special Warnings
Remember that treatment with lamivudine oral solution 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 transfer and you should use appropriate precautions.
Some people taking medicines for HIV infection develop other conditions, which can be serious, such as reduction in blood count, pancreatitis, fatty liver, and old infections flaring up. You need to know about important signs and symptoms to look out for while you’re taking lamivudine oral solution. Read the SIDE EFFECTS AND WHAT TO DO ABOUT THEM section.
It is important that your doctor know about all your symptoms even if you think they are not related to HIV infection. Your doctor may need to change the dose of your medicine.
If you are a diabetic, please note that 150 mg (15 mL) of lamivudine oral solution contains 3 g of sugar.
Due to the sugar content of lamivudine oral solution, you should clean your teeth regularly to reduce the risk of tooth decay.
Patients with HIV-1/HCV (hepatitis C) co-infection should be informed that hepatic decompensation (a severe liver problem – sometimes fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin. If you suffer liver symptoms such as nausea, fatigue, abdominal pain, jaundice (yellowing of the eyes or skin) or lack of appetite, contact your doctor immediately.
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 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 lamivudine in pregnancy has not been established. Your doctor will decide whether you should continue to be treated with lamivudine oral solution if you are pregnant. If you take lamivudine oral solution 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 lamivudine are not known.
It is recommended that HIV-infected women do not breastfeed their infants in order to avoid transmission of HIV from mother to child. The active substance in lamivudine oral solution is found in human breast milk.
You are recommended not to breastfeed your baby while taking lamivudine oral solution.
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.
INTERACTIONS WITH THIS MEDICATION
It is important that your doctor knows about all your medicines so that you get the best possible treatment. Tell your doctor about all your medicines, including vitamin supplements, herbal remedies or homeopathic remedies, including those you have bought yourself.
Lamivudine oral solution should not be taken with emtricitabine.
Some medicines may affect how lamivudine works, or make it more likely that you’ll have side effects. These medicines include:
- sorbitol-containing medicines (usually liquids) used regularly.
- trimethoprim-sulphamethoxazole (also known as co-trimoxazole; an antibiotic used to treat Pneumocystis jiroveci pneumonia (often referred to as PCP) or toxoplasmosis).
PROPER USE OF THIS MEDICATION
Usual dose:
Take lamivudine oral solution exactly as your doctor has advised you, and try not to miss any doses. If you are
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unsure about how to take it, ask your doctor or pharmacist.
Lamivudine oral solution can be taken with or without food.
Adults, Adolescents and Children (weighing at least 25 kg): One tablespoonful (15 mL) of oral solution, two times a day. For once-a-day dosing: take two tablespoonfuls (30 mL) of oral solution once a day.
| Dosing Schedule | Solution |
| Once a day | Two tablespoons = 30 mL of solution |
| Twice a day | One tablespoon = 15 mL of solution |
If you have a kidney problem, your dose may be altered. Please follow the instructions of your doctor.
Children (aged 3 months and older and weighing less than 25 kg): if you are giving lamivudine oral solution to a child, carefully follow the instructions of your doctor.
The recommended oral dose of lamivudine oral solution for children 3 months of age and older and weighing less than 25 kg is 4 mg/kg twice daily (up to a maximum of 15 mL twice daily) or 8 mg/kg once daily (up to a maximum of 30 mL once daily).
Overdose:
If you think you have taken too much lamivudine oral solution, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose:
It is important to take this medicine as prescribed to ensure you get maximum benefit. If you forget to take a dose, take it as soon as you remember, and then continue as before. Do not double dose to make up for forgotten individual doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, lamivudine oral solution can have side effects. For this reason it is very important that you inform your doctor about any changes in your health.
Consult your doctor at your next visit if any of the following undesirable events occur:
Headaches, nausea, vomiting, upper abdominal pain,
diarrhea, fever, rash, fatigue, a general feeling of being unwell, or a numbness, tingling sensation or sensation of
weakness in your limbs.
Lamivudine oral solution may also cause a decrease in certain types of blood counts (including red blood cells, white blood cells and platelets) and increase in certain liver enzymes.
Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Grave's disease (which affects the thyroid gland), Guillain-Barre syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling, or fatigue or any new symptoms contact your doctor straight away.
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 that you do not understand, tell your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN 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 | |||||
| Rare | Allergic reactions and symptoms such as swelling of eyes, face, lips, throat, sudden wheeziness, chest pain and tightening, skin rash or hives anywhere on the body. | √ | ||||
Lactic acidosis (high level of lactic acid in the blood) and symptoms such as | ||||||
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| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
Symptom / effect weight loss, fatigue, malaise, nausea, vomiting, abdominal pain, and shortness of breath. Swollen and fatty liver (severe hepatomegaly with steatosis) and symptoms such as nausea, vomiting, abdominal pain, weakness and diarrhea. Blood problems and symptoms such as anemia (lowered red blood cell count) resulting in fatigue, breathlessness, and low white blood cell count making you more prone to infections. Pancreatitis (inflammation of the pancreas) and symptoms such as severe stomach cramps, nausea, vomiting. | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
| Only if severe | In all cases | |||||
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| √ | ||||||
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HOW TO STORE IT
Lamivudine oral solution should be stored between 15 - 25oC.
As with all medicines, keep lamivudine oral solution out of
the reach and sight of children.
Do not take your medicine after the expiry date shown on the bottle and/or 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.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
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 lamivudine oral solution.
If you want more information about Lamivudine oral solution:
- 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc,
3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8
CANADA