Dapsone Tablet belongs to a class of drugs known as anti-leprotic medicines. It is used to treat leprosy and acne. It works by stopping the growth of disease causing organisms in the body. It also helps to reduce redness and swelling associated with acne (commonly known as pimples).

Dapsone Tablet should be used in the dose and duration as advised by your doctor. It should be taken with or without food, preferably at a fixed time. Avoid skipping any doses and finish the full course of treatment even if you feel better. Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.

Some people may develop a skin rash and fever as the side effects of this medicine. Please consult your doctor if these side effects bother you or persist for a longer duration. Use caution while treating patients with hypersensitivity to sulfa drugs.

Composition

Each tablet contains:

• Active ingredient: Dapsone 50 mg. Or 100 mg.
• Inactive ingredients: Calcium phosphate dibasic anhydrous , Starch maize, Lactose monohydrate, Sodium starch glycolate , Magnesium stearat & Hydroxy propyl methyl cellulose 615 .
• Pharmaceutical form :Tablets.

Indications

1. Treatment of leprosy alone or in combination with other antileprotic agents, in the treatment of all types of leprosy caused by mycobacterium leprae.
2. Dermatitis herpetiformis.
3. Subcortical pustular dermatosis.
4. In combination with pyrimethamine in the prophylaxis of chloroquine – resistant malaria.
5. In combination with pyrimethamine and chloroquine in prophylaxis of malaria caused by plasmodium vivax.
6. Pemphigoid lesions with oral manifestations.
7. In combination with trimethoprim in the treatment of pneumonia caused by pneumocystis carinii.
8. Relapsing polychondritis.
9. Pyoderma gangrenosum.

Dosage and administration

Adults

• Antileprosy: In combination with other drugs 100 mg daily.
• For dermatitis herpetiformis: initially 50 mg and dose may be increased to 300 mg daily or higher, then reduced to the lowest effective maintenance dose as soon as possible.
• For prophylaxis of malaria: 100 mg once every 7 days in conjunction with pyrimethamine therapy.

Pediatrics

• For Leprosy :- In addition to other drugs : 1.4 mg / Kg body weight daily.
• Skin inflammations :- like adults.

Contraindications

• Hypersensitivity to dapsone and its derivatives.
• Severe anaemia.
• Deficiency of glucose – 6 – phosphate dehydrogenase (Favism) or methemoglobin reductase deficiency.
• Hepatic and renal functions impairment.

Side effects

Adverse effects to Dapsone are dose related: Blood dyscrasia, peripheral motor weakness and serious cutaneous reactions.

Pharmacological action

Dapsone a sulfone, is bactericidal as well as bacteriostatic and probably acts by a mechanism similar to that of sulfonamides. Both have a similar range of antibacterial activity. Dapsone may also act as a dihydrofolate reductase inhibitor.

Pharmacokinetics

• Its absorption from the gastrointestinal tract is rapid and nearly complete. It is well distributed throughout the body especially liver, muscle, kidneys, and skin.
• Approximately (70- 90) % of Dapsone is plasma protein bound.
• Dapsone is metabolized in the liver & excreted mainly in urineز
• The plasma half life ranges from (10 – 50) hours.

Drug interactions

Do not use the drug with: PABA, Bone marrow depressants, other haemolytics, rifampicin.

Pregnancy and lactation

• Dapsone should be given to pregnant women only if clearly needed.
• For nursing mothers it may be necessary to discontinue either the breast feeding or the medication.

warnings and Precautions

• Special blood determinations (Kidney and liver function tests) should be conducted before and during use of Dapsone.
• Give with caution if the patient is exposed to other agents or conditions such as infection or diabetic ketosis capable of hemolysis.

Package and storage

• Carton box containing 2 or 100 ( AL/PVC ) strips each of 10 tablets and inner pamphlet .
• Store at temperature not exceeding 30’C , in a dry place preserve in well closed container and away from light .

Instructions to patients

• Do not use except under medical supervision.
• Keep out of reach of children.
• Manufactured by El- NILE Co. for Pharmaceuticals and Chemical Industries Cairo – A.R.E.

Dapsone – Information Leaflet

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