Patient Medication Information: uses, side effects, how to take - Isotamine (Bausch Health, Canada, 500 G)
What is ISOTAMINE used for?
ISOTAMINE is used in adults, children and infants:
- together with other anti-tuberculosis medicines to treat tuberculosis infections.
- alone, to protect against tuberculosis infection.
Antibacterial drugs like ISOTAMINE treat only bacterial infections. They do not treat viral infections.
How does ISOTAMINE work?
ISOTAMINE contains isoniazid, an antibiotic that kills the bacteria that causes tuberculosis.
What are the ingredients in ISOTAMINE?
Medicinal ingredients: isoniazid
Non-medicinal ingredients:
Syrup: artificial and natural strawberry flavor, citric acid USP, glycerine USP, methylparaben NF, propylparaben, NF, sodium citrate USP
Tablets: colloidal silicon dioxide NF, magnesium stearate NF, microcrystalline cellulose NF.
ISOTAMINE comes in the following dosage forms:
Tablets: 300 mg
Syrup: 50 mg/5 mL
Do not use ISOTAMINE if you:
- are allergic to isoniazid or to any of the other ingredients in ISOTAMINE or the materials of the container.
- have liver disease.
- have a history of liver injury caused by ISOTAMINE or another similar medicine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ISOTAMINE. Talk about any health conditions or problems you may have, including if you:
- have kidney problems
- have liver problems
are pregnant or plan to become pregnant
- are breast-feeding or plan to breast-feed
- drink alcohol or suffer from alcoholism
- suffer from seizure or fits
- have HIV
- have diabetes
- are underweight or malnourished
- have numbness and/or tingling of arms or legs (peripheral neuropathy)
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with ISOTAMINE
- Anti-Seizure medicines such as carbamazepine, primidone or phenytoin
- Aluminum hydroxide gel, an antacid used to treat heartburn, and other antacids
- Other antibiotics used to treat tuberculosis such as cycloserine and rifampin
- Disulfiram used to treat alcoholism
- Ketoconazole used to treat fungal infections
- Acetaminophen used to treat pain and fever
- Alfentanil used to control pain
- Corticosteroids used to treat inflammation
- Benzodiazepines used to treat anxiety and insomnia
- Diazepam used to treat anxiety and other mental health problems
- Blood thinners used to prevent clots
- Theophyllines used to treat breathing problems
- Cheese (Swiss, Cheshire)
- Fish (Tuna, Skipjack, Sardinella)
- Alcohol
How to take ISOTAMINE
ISOTAMINE tablets & syrup should be taken at regular times, preferably after meals.
- Although you may feel better early in treatment, ISOTAMINE should be used exactly as directed.
- Do not stop taking ISOTAMINE without talking to your healthcare professional.
- Misuse or overuse of ISOTAMINE could lead to the growth of bacteria that will not be killed by ISOTAMINE (resistance). This means that ISOTAMINE may not work for you in the future
- Do not share your medicine.
Usual dose:
Treatment of Tuberculosis Infection (together with other anti-tuberculosis medicines)
Adult: Your healthcare professional will tell you how much ISOTAMINE to take based on your weight up to a maximum of 300 mg daily.
Children and Infants: Your healthcare professional will tell you how much ISOTAMINE to give your child based on their weight up to a maximum of 300-500 mg daily.
To Protect Against Tuberculosis Infection
Adults: 300 mg once a day.
Children and Infants: Your healthcare professional will tell you how much ISOTAMINE to give your child based on their weight up to a maximum of 300 mg daily.
Treatment can continue for 6 to 12 months.
Overdose:
| If you think you have taken too much ISOTAMINE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Symptoms of an overdose may include:
- nausea
- vomiting
- dizziness
- slurred speech
- blurred vision
- visual hallucinations (including bright colors and strange designs)
Overdose can lead to coma and seizures.
Missed Dose:
If you missed a dose of ISOTAMINE, take it as soon as you remember.
What are possible side effects from using ISOTAMINE?
These are not all the possible side effects you may feel when taking ISOTAMINE. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Nausea
- Vomiting
- Stomach upset and/or pain
- Dry mouth
- Enlarged breast tissue in men
- Muscle twitching
- Ringing in the ears
- Dizziness
ISOTAMINE can cause abnormal blood test results. Your healthcare professional will decide when to perform blood tests and will interpret the results.
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 | |||
| Peripheral Neuropathy: numbness and/or | ✓ | |||
| tingling in the hands and feet | |||
| Liver Problems that Can Lead to Death: fatigue, weakness, loss of appetite, stomach pain, nausea, vomiting, yellowing of the skin or eyes, dark urine | ✓ | ||
| Eye Problems: loss of vision in one, or both eyes, eye pain that is worse when you move your eye, not seeing colours correctly | ✓ | ||
| Toxic Psychosis: mood changes (anxiety and/or depression), trouble sleeping, nausea, vomiting, hallucinations (hearing or seeing things that aren’t there), seizures | ✓ | ||
| Toxic Encephalopathy: memory loss, personality changes, irritability, depression, trouble concentrating, involuntary movements, fatigue, arm weakness, seizures | ✓ | ||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficult breathing or swallowing, swollen lymph nodes, fever | ✓ | ||
| Seizures or fits | ✓ | ||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | ✓ | ||
| Anemia: fatigue, loss of energy, weakness, shortness of breath | ✓ | ||
| Increased Blood Sugar: frequent urination, thirst, and hunger | ✓ | ||
| Systemic Lupus Erythematosus-Like Syndrome: joint pain, muscle pain, fatigue, rash, fever, swollen lymph nodes | ✓ | ||
| Urinary Retention (in males): inability to urinate, passing very little urine | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to 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 at 15 to 30°C. Store in a well-closed, light-resistant container.
Keep out of reach and sight of children.
If you want more information about ISOTAMINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer 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) or by calling 1-800-361-4261.