Details for: DAPSONE
Company: JACOBUS PHARMACEUTICAL COMPANY, INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02041510 | DAPSONE | DAPSONE | 100 MG | TABLET | 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
DAPSONE is used to treat
- leprosy
- dermatitis herpetiformis (a skin condition)
- actinomycotic mycetoma (a fungal disease)
This medication is sometimes prescribed for other uses; ask your doctor for more information.
Antibacterial drugs like Dapsone treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Dapsone should be used exactly as directed. Misuse or overuse of Dapsone could lead to the growth of bacteria that will not be killed by Dapsone (resistance). This means that Dapsone may not work for you in the future. Do not share your medicine.
What it does
- DAPSONE works by killing the bacteria or fungi causing your infection.
- When used for the treatment of dermatitis herpetiformis (a skin condition), Dapsone reduces the skin blisters and skin itch.
When it should not be used
- You are allergic to DAPSONE, to sulfones, or to any ingredient in this formulation. (See What are the ingredients in DAPSONE)
- You have high amyloid levels or advanced amyloidosis of the kidneys.
What the medicinal ingredient is
Medicinal ingredient: Dapsone
What the non-medicinal ingredients are
Non-medicinal ingredients: Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate, Microcrystalline Cellulose.
What dosage form it comes in
Tablet 100 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DAPSONE. Talk about any health conditions or problems you may have, including if you have:
- heart problems
- lung disease
- liver disease
- kidney problems
- anemia
- lack of the enzyme glucose-6-phosphate dehydrogenase in the body, so that red blood cells don’t work properly.
DAPSONE may cause blood cell problems such as:
- Hemolytic anemia - red blood cells are destroyed so that they do not do their job carrying oxygen in the body
- Methemoglobinemia – where a high amount of methemoglobin is made in the blood, and this prevents oxygen release into body tissues
- Lack of the enzyme glucose-6-phosphate dehydrogenase can worsen the above blood cell problems.
Your doctor will do routine blood work during DAPSONE treatment to watch for blood problems and changes in liver function.
Other warnings you should know about:
Don’t use DAPSONE while pregnant unless advised by your doctor. If you become pregnant
while taking DAPSONE, tell your doctor immediately
DAPSONE is excreted in breast milk. Your doctor will decide with you if you should continue breastfeeding or stop taking DAPSONE.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- rifampicin
- probenecid
- chloroquine
- primaquine
These medicines may be affected by DAPSONE, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your healthcare professional will advise you.
Proper use of this medication
Take DAPSONE at the same time each day. The tablet should be swallowed with a full glass of water, with or after food.
DAPSONE should be taken exactly as directed, for as long as your healthcare professional tells you to. Do not stop taking DAPSONE even if you begin to feel better, unless advised by your healthcare professional.
Usual dose
Leprosy:
When used for the treatment of leprosy, DAPSONE is usually taken with one or more other
drugs, to prevent the development of resistance.
The usual dose of DAPSONE in adults is 100 mg daily. DAPSONE dosing in children is based on the child’s body weight.
Dermatitis Herpetiformis:
The usual adult dose is 50 mg to 100 mg DAPSONE daily, but a dose as little as DAPSONE 50
mg once a week may be adequate.
Actinomycotic Mycetoma:
The usual adult dose is 100 mg DAPSONE taken twice a day.
Overdose
Missed Dose
If you missed a dose of this medication, take it as soon as you remember. This will help to keep a constant amount of medication in your blood. But, if it is almost time for your next dose, skip the missed dose, and continue with your next scheduled dose. Do not take two doses at the same time.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking DAPSONE. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
DAPSONE may cause:
- loss of appetite
- nausea
- vomiting
- headache
- dizziness
- nervousness
- difficulty sleeping
| Symptom / effect | 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 | |||
| Anemia symptoms (ie: hemolysis, methemoglobinemia) - rapid heart rate - shortness of breath - unusual tiredness or weakness - jaundice, or yellowing of the skin and eyes - dark coloured urine - bluish colouring of the skin |
✔ | ||
| UNCOMMON | |||
| Low white blood cell symptoms - persistent fever - chills - increased infections (eg sore throat, mouth sores, swollen lymph glands) - weakness - bleeding gums |
✔ | ||
| Mood or other mental changes | ✔ | ||
| Numbness, tingling, pain, burning or weakness in hands and feet | ✔ | ||
| Rare | |||
| Hypersensitivity reaction - fever - flu-like symptoms - rash |
✔ | ||
| Skin reactions - severe skin rash - itching, redness, scaling or peeling of skin - painful blisters |
✔ | ||
| Kidney problems - back pain - swollen, puffy skin especially in the face, arms, legs (feet and ankles) and belly area - change in appearance of urine - painful and frequent urination |
✔ | ||
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.
How to store
DAPSONE tablets should be stored at room temperature and protected from light.
Keep out of reach and sight of children.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and
unexpected side effects to Health Canada. Your report may help to identify new side effects
and change the product safety information.
3 ways to report:
- Online at MedEffecthttp://www.hc-sc.gc.ca/dhp-mps/medeff/index-eng.php
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada Postal Locator 0701E
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffectt.
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.
More information
- 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( http://hc-sc.gc.ca/index-eng.php)
- For questions or to report problems, please contact
Jacobus Pharmaceutical Company Inc.,
2000 Ellesmere Road,
Scarborough, ON, M1H 2W4
1-800-539-0801
This leaflet was prepared by Jacobus Pharmaceutical Company Inc.
Last Revised: January 9, 2018