Patient Medication Information: uses, side effects, how to take - PDP-Isoniazid
What is pdp-ISONIAZID used for?
pdp-ISONIAZID is used in adults and children:
- together with other anti-tuberculosis medicines to treat tuberculosis infections.
- alone, to protect against tuberculosis infection.
Antibacterial drugs like pdp-ISONIAZID treat only bacterial infections. They do not treat viral infections.
How does pdp-ISONIAZID work?
pdp-ISONIAZID contains isoniazid which is an antibiotic that kills the bacteria that causes tuberculosis. It is not known exactly how isoniazid works.
What are the ingredients in pdp-ISONIAZID?
Medicinal ingredients: Isoniazid
Non-medicinal ingredients:
Tablets: Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose
Oral Solution: Artificial Raspberry Flavor, Citric Acid Anhydrous, Glycerin, Purified Water, Sodium Benzoate, Sodium Cyclamate, Sorbitol Solution
pdp-ISONIAZID comes in the following dosage forms:
Tablets: 50 mg, 100 mg, 300 mg
Oral Solution: 50 mg / 5 mL
Do not use pdp-ISONIAZID if you:
- are allergic to isoniazid or to any of the other ingredients in pdp-ISONIAZID
- develop a serious allergic reaction (hypersensitivity) to isoniazid, including liver problem
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pdp-ISONIAZID. 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
- suffer from seizure or fits
- have HIV
- 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 pdp-ISONIAZID:
- Anti-Seizure medicines such as carbamazepine, primidone or phenytoin
- Aluminium hydroxide gel, an antacid used to treat heartburn
- 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
- Corticosteroids used to treat inflammation
- Diazepam used to treat anxiety and other mental health problems
- Blood thinners used to prevent clots
- Theophyllines used to treat breathing problems
How to take pdp-ISONIAZID:
pdp-ISONIAZID should be taken once a day on an empty stomach. It can be taken with food if stomach upset occurs.
- Although you may feel better early in treatment, pdp-ISONIAZID should be used exactly as directed.
- Misuse or overuse of pdp-ISONIAZID could lead to the growth of bacteria that will not be killed by pdp-ISONIAZID (resistance). This means that pdp-ISONIAZID 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)
Adults and Children: Your healthcare professional will tell you how much pdp-ISONIAZID to take based on your weight up to a maximum of 300 mg once a day.
Treatment should be continued for 6 to 9 months, or longer.
Twice weekly dose after 2 months of daily dosing)
Adults and Children: Your healthcare professional will tell you how much pdp-ISONIAZID to take based on your weight up to a maximum of 900 mg per dose.
To Protect Against Tuberculosis Infection:
Adults: 300 mg once a day
Children: Your healthcare professional will tell you how much pdp-ISONIAZID to take based on your weight up to a maximum of 300 mg a day.
Treatment can continue for 6 to 12 months.
Overdose:
| If you think you have taken too much pdp-ISONIAZID, 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,
What are possible side effects from using pdp-ISONIAZID?
These are not all the possible side effects you may feel when taking pdp-ISOZIAZID. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Nausea
- Vomiting
- Stomach upset and/or pain
- Enlarged breast tissue in men
pdp-ISONIAZID 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 | √ | ||
| Inflammation of the pancreas: severe pain in the abdomen and back | √ | ||
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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
Tablets: Store between 15°C and 30°C.
Oral Solution: Store between 15°C and 25°C.
Keep out of reach and sight of children.
If you want more information about pdp-ISONIAZID:
- 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); or by calling the manufacturer at 1-888-550-6060.
PENDOPHARM, Division de/of Pharmascience Inc.
Montréal, Québec, Canada
H4P 2T4