Patient Medication Information: uses, side effects, how to take - 3Tc
What is 3TC used for?
3TC is used to treat Human Immunodeficiency Virus (HIV) infection in:
- Adults
- Children 3 months of age and older and adolescents.
It is used along with other medicines used to treat HIV.
How does 3TC work?
3TC is a type of medicine known as an antiretroviral. 3TC is not a cure for HIV infections or AIDS; it reduces the amount of virus in your body and keeps it at a low level. 3TC maintains or 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 3TC?
Tablets (150 mg and 300 mg)
Medicinal ingredients: lamivudine.
Non-medicinal ingredients (150 mg): hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
Serious Warnings and Precautions
- Worsening of hepatitis B: If you also have a hepatitis B infection, your hepatitis may become worse after stopping treatment with 3TC. Your healthcare professional will monitor your condition for several months after stopping treatment with 3TC.
- Pancreatitis in children and adolescents: Children and adolescents should be monitored for signs and symptoms of pancreatitis (inflammation of the pancreas; see Serious Side Effects table). If symptoms of pancreatitis occur, children and adolescents should get immediate medical help.
Non-medicinal ingredients (300 mg): black iron oxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
Oral Solution
Medicinal Ingredients: lamivudine
Non-medicinal Ingredients: artificial strawberry and banana flavours, citric acid (anhydrous), hydrochloric acid, methylparaben, propylparaben, propylene glycol, sodium citrate (dihydrate), sodium hydroxide, sucrose and water. Each 150 mg (15 mL) contains 3 g of sucrose.
3TC comes in the following dosage forms:
150 mg tablets, 300 mg tablets, 10 mg/mL oral solution
Do not use 3TC if:
- you are allergic to lamivudine or to any of the other ingredients in 3TC
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take 3TC. Talk about any health conditions or problems you may have, including if you:
- have kidney problems
- have liver problems (including hepatitis B or C)
- have had previous use of any NRTI class medicine
- have diabetes (since the oral solution contains 3 grams of sugar in each 150 mg dose (15 mL))
- are obese
Other warnings you should know about:
Lactic acidosis and liver problems: 3TC can cause a serious condition called lactic acidosis together with hepatomegaly (swollen and enlarged liver). Lactic acidosis is where you have too much lactic acid in your blood. Symptoms include weakness, loss of appetite, sudden unexplained weight loss, upset stomach and difficulty breathing or rapid breathing. Talk to a healthcare professional right away if you get any symptoms of lactic acidosis. Lactic acidosis occurs more often in women and in obese people. If you have liver problems you may also be more at risk of getting this condition. While you are being treated with 3TC your healthcare professional will monitor you closely for signs of lactic acidosis.
Blood tests: Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your liver enzyme values might change too. Your doctor may order blood tests for you and will interpret the results.
Resistant hepatitis B infection: If you are also infected with hepatitis B virus, the virus can change during your treatment with 3TC. This might make it harder to treat (resistant). If this happens, your hepatitis might get worse.
Pregnancy and birth defects: Tell your doctor if you are pregnant, think you might be pregnant or are planning to become pregnant. You should not take 3TC while you are pregnant unless your healthcare professional tells you to. This is because 3TC can harm an unborn baby.
Pregnancy registry: There is a pregnancy registry for women who take antiretroviral medicines while they are pregnant. The purpose of this registry is to collect information about the health of you and your baby. If you do become pregnant while taking 3TC, talk to your healthcare professional about taking part in this registry.
Breastfeeding: Do not breastfeed while taking 3TC. Women who are HIV positive should not breastfeed because HIV infection can be passed to the baby through breast milk. 3TC can also pass into breast milk and harm your baby. Talk to your healthcare professional about how to feed your infant.
Immune System Changes: 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 health 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 symptoms such as:
- high temperature (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
If you notice these or any other symptoms of inflammation or infection, tell your healthcare professional immediately.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
3TC should not be used:
- with other products containing lamivudine including HEPTOVIR Tablets and Oral solution, COMBIVIR Tablets, KIVEXA Tablets, TRIUMEQ Tablets, or DOVATO Tablets because it may interact with 3TC.
- with products containing emtricitabine, including ATRIPLA Tablets, EMTRIVA Capsules, TRUVADA Tablets, COMPLERA Tablets, STRIBILD Tablets, GENVOYA Tablets, DESCOVY Tablets, BIKTARVY Tablets, SYMTUZA Tablets or ODEFSEY Tablets because it may interact with 3TC.
The following may interact with 3TC:
- medicines containing sorbitol, these are usually liquids.
- trimethoprim-sulphamethoxazole (also known as co-trimoxazole), an antibiotic used to treat pneumonia.
How to take 3TC:
- Always take 3TC exactly as your healthcare professional has told you to.
- Check with your healthcare professional if you are not sure.
You can take 3TC with or without food.
- Swallow 3TC tablets whole with water.
Usual Dose
Adults, Adolescents and Children (weighing at least 25 kg): Twice-a-day dosing: swallow one tablet (150 mg) or one tablespoonful (15 mL) of oral solution, two times a day. For once-a-day dosing: swallow one tablet (300 mg) or two tablespoonfuls (30 mL) of oral solution once a day.
| Dosing Schedule | Tablets | Solution |
|---|---|---|
| Once a day | One 300 mg tablet | Two tablespoons = 30 mL of solution |
| Twice a day | One 150 mg tablet | One tablespoon = 15 mL of solution |
If you have a kidney problem, your dose may be altered. Please follow the instructions of your healthcare professional.
Children (aged 3 months and older and weighing less than 25 kg): if you are giving 3TC to a child, carefully follow the instructions of your healthcare professional.
Tablets:
For children able to swallow tablets as determined by the healthcare professional/parent:
Children weighing 14 kg to less than 20 kg: one-half of a scored 3TC tablet twice daily or one tablet taken once daily.
Children weighing at least 20 kg and less than 25 kg: one-half of a scored 3TC tablet taken in the morning and one whole tablet taken in the evening or one and a half tablets taken once daily.
Oral Solution: The recommended oral dose of 3TC for children 3 months of age and older and weighing less than 25 kg is 5 mg/kg (0.5 mL/kg) twice daily or 10 mg/kg (1 mL/kg) once daily.
Overdose:
| If you think you, or a person you are caring for, have taken too much 3TC, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you forget to take a dose, take it as soon as you remember. Then continue as before. Do not take a double dose to make up for a forgotten dose.
What are possible side effects from using 3TC?
These are not all the possible side effects you may have when taking 3TC. If you experience any side effects not listed here, tell your healthcare professional.
Side effects include:
- headaches
- nausea
- vomiting
- upper abdominal pain
- diarrhea
- fever
- rash
- hair loss or thinning of hair
- fatigue
- a general feeling of being unwell
- numbness
- tingling sensation or sensation of weakness in your limbs
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 | ||
| RARE | |||
| Allergic reactions: 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): weight loss, fatigue, malaise, nausea, vomiting, abdominal pain, and shortness of breath. | ✓ | ||
| Severe hepatomegaly with steatosis (swollen and fatty liver): | ✓ | ||
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 | ||
| nausea, vomiting, abdominal pain, weakness and diarrhea. | |||
| Anemia (decrease in red blood cell count): fatigue, breathlessness, weakness. | ✓ | ||
| Thrombocytopenia (Reduction in the number of platelets. Platelets are cells that make the blood clot): more likely to bruise (due to reduction of platelets). | ✓ | ||
| Neutropenia (low white blood cell count): fatigue, fever, infections. | ✓ | ||
| Breakdown of muscle tissue: muscle tenderness or pain, and weakness. | ✓ | ||
| Pancreatitis (inflammation of the pancreas): abdominal pain, nausea, vomiting. | ✓ | ||
| FREQUENCY NOT KNOWN | |||
| Immune System Changes (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, rapid heart rate. | ✓ | ||
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. |
Storage:
Store 3TC tablets between 2° and 30°C.
Store 3TC oral solution between 2° and 25°C.
Keep out of reach and sight of children. Do not take your medicine after the expiry date shown on the bottle and/or the carton.
If you want more information about 3TC:
- 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.viivhealthcare.ca, or by calling 1-877-393-8448.
Last Revised: May 3, 2023
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