Dapsone Tablets USP 100mg Taj Pharma

Dapsone Tablets USP  100mg

  1. Name of the medicinal product

Dapsone Tablets USP 50mg Taj Pharma
Dapsone Tablets USP 100mg Taj Pharma

  1. Qualitative and quantitative composition

Each tablet contains
Dapsone                        50mg
Excipients                      q.s

Each tablet contains  
Dapsone                        100mg
Excipients                      q.s

  1. Pharmaceutical form

Uncoated tablets.

  1. Clinical particulars

4.1 Therapeutic indications

1) As part of a multi-drug regimen in the treatment of all forms of leprosy.

2) Treatment of dermatitis herpetiformis and other dermatoses.

3) Prophylaxis of malaria in combination with pyrimethamine.

4) Prophylaxis of Pneumocystis carinii pneumonia in immunodeficient subjects, especially AIDS patients.

4.2 Posology and method of administration

Posology

Adults and children over 12 years:

Multibacillary leprosy (3-drug regimen): 100mg daily for at least two years.

Paucibacillary leprosy (2-drug regimen): 100mg daily for at least six months.

Malaria prophylaxis: 100mg weekly with 12.5mg pyrimethamine.

Dermatitis herpetiformis: Initially 50mg daily, gradually increased to 300mg daily if required. Once lesions have begun to subside, the dose should be reduced to a minimum as soon as possible, usually 25-50mg daily, which may be continued for a number of years. Maintenance dosage can often be reduced in patients receiving a gluten-free diet.

Pneumocystis carinii pneumonia: In combination with trimethoprim, 50-100mg daily; 100mg twice weekly or 200mg once weekly.

Children 6-12 years:

Multibacillary leprosy (3-drug regimen): 50mg daily for at least two years.

Paucibacillary leprosy (2-drug regimen): 50mg daily for at least six months.

Elderly: Dosage should be reduced in the elderly where there is an impairment of hepatic function.

Method of Administration

For oral administration.

4.3 Contraindications

Known hypersensitivity to sulfonamides, sulfones, or any of the excipients; severe anaemia; porphyria; severe glucose-6-phosphate dehydrogenase deficiency.

Dapsone contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

4.4 Special warnings and precautions for use

Dapsone should be used with caution in patients with cardiac or pulmonary disease.

It is recommended that regular blood counts be performed during treatment with dapsone. Patients deficient in glucose-6-phosphate dehydrogenase, or methaemoglobin reductase, or with haemoglobin M are more susceptible to the haemolytic effects of dapsone.

Dapsone should be used with caution in anaemia. Severe anaemia should be treated before starting Dapsone.

4.5 Interaction with other medicinal products and other forms of interaction

Excretion of dapsone is reduced and plasma concentrations are increased by concurrent administration of probenecid. Rifampicin has been reported to increase the plasma clearance of dapsone.

Increased dapsone and trimethoprim concentrations have been reported following concurrent administration in AIDs patients.

4.6 Pregnancy and lactation

It is now generally considered that the benefits of dapsone in the treatment of leprosy outweigh any potential risk to the pregnant patient. Some leprologists recommend 5mg folic acid daily for leprosy patients receiving dapsone during pregnancy.

Dapsone diffuses into breast milk and there has been a report of haemolytic anaemia in a breast fed infant. While some feel that dapsone should not be used in lactating mothers, in general treatment for leprosy is continued in such patients.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Dapsone should be discontinued or reduced in dosage if severe lepra reactions affecting the eyes or nerve trunks occur.Varying degrees of dose-related haemolysis and methaemoglobinaemia are the most frequently reported adverse effects of dapsone and occur in most subjects given more than 200mg daily; doses of up to 100mg daily do not cause significant haemolysis but subjects deficient in glucose-6-phosphate dehydrogenase are affected by doses above about 50mg daily. Hypoalbuminaemia and haemolytic anaemia has also been reported.

Although agranulocytosis has been reported rarely with dapsone when used alone, reports have been more common when dapsone has been used with other agents in the prophylaxis of malaria.

Rash, photosensitivity and pruritis may develop. Serious cutaneous hypersensitivity reactions occur rarely and include maculopapular rash, exfoliative dermatitis, toxic epidermal necrolysis, and Stevens-Johnson syndrome. Fixed drug eruptions have occurred.

A “dapsone syndrome” may occur after 3-6 weeks therapy; symptoms include rash, which is always present, fever, and eosinophilia. If dapsone is not stopped immediately, the syndrome may progress to exfoliative dermatitis, hepatitis, albuminuria and psychosis. Deaths have been recorded. Most patients require steroid therapy for several weeks, possibly due to the prolonged elimination time of the drug.

Peripheral neuropathy with motor loss has been reported in patients on dapsone for dermatological conditions. Peripheral neuropathy may occur as part of leprosy reaction states and it is not an indication to discontinue dapsone. Other adverse effects occur infrequently and include anorexia, headache, hepatitis, jaundice, changes in liver function tests, insomnia, nausea, psychosis, tachycardia and vomiting.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms are hypoxia, methaemoglobinaemia and haemolytic anaemia. In severe overdosage the stomach should be emptied by gastric lavage. Administration of activated charcoal by mouth has been shown to enhance the elimination of dapsone and its monoacetyl metabolite. Methaemoglobinaemia has been treated with slow IV injections of methylene blue 1-2mg/kg bodyweight, repeated after one hour if necessary. Methylene blue should not be administered to patients with glucose-6-phosphate dehydrogenase deficiency since it will not be effective. Haemolysis has been treated by infusion of concentrated human red blood cells to replace the damaged cells.

Supportive therapy includes oxygen to alleviate hypoxia, and administration of fluids to maintain renal flow and promote the elimination of dapsone.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Dapsone is a sulfone active against a wide range of bacteria.

Dapsones mechanism of action is probably similar to that of the sulfonamides which involves inhibition of folic acid synthesis in susceptible organisms. It is usually considered to be bacteriostatic against M leprae although it may also possess weak bactericidal activity. It is also active against Plasmodium and Pneumocystis carinii. As with sulfonamides, antibacterial activity is inhibited by p-aminobenzoic acid.

5.2 Pharmacokinetic properties

Dapsone is almost completely absorbed from the GI tract with peak plasma concentrations occurring about 2-8 hours after a dose. Steady-state concentrations are not obtained until after at least 8 days of daily administration; doses of 100mg daily provide trough concentrations of 0.5 micrograms/ml. About 50-80% of dapsone in the circulation is bound to plasma proteins and nearly 100% of its monoacetylated metabolite is bound. Dapsone undergoes enterohepatic recycling. It is widely distributed; is present in saliva, breast milk and crosses the placenta. The half-life ranges from 10-80 hours. Dapsone is acetylated to monoacetyldapsone, the major metabolite, and other mono and diacetyl derivatives. Acetylation exhibits genetic polymorphism. Hydroxylation is the other major metabolite pathway resulting in hydroxylamine dapsone which may be responsible for dapsone-associated methaemoglobinaemia and haemolysis. Dapsone is mainly excreted in the urine, only 20% of a dose as unchanged drug.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

  1. Pharmaceutical particulars

6.1 List of excipients

Also contains: Lactose, Magnesium stearate, Maize starch, Sodium lauryl sulfate

6.2 Incompatibilities

None known.

6.3 Shelf life

PVC Blister Packs Three years.

All other packs Eighteen months.

6.4 Special precautions for storage

Store below 25°C in a dry place.

6.5 Nature and contents of container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

Blister pack

Pack sizes: 7s, 10s, 14s, 21s, 28s, 30s, 56s, 60s, 84s, 100s, 112s, 250s, 500s, 1000s, 5000s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 200,000.

6.6 Special precautions for disposal and other handling

Not applicable.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

 

Dapsone Tablets USP 50mg,100mg

Package leaflet: Information for the user

Dapsone 50mg and 100mg Tablets Taj Pharma

Dapsone

  • Read all of this leaflet carefully before you start taking this medicine  because  it  contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It  may harm them, even if their signs of illness are the same as yours.
  • If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Index

  1. What Dapsone tablets are and what they are used for
  2. Before you take
  3. How to take
  4. Possible side effects
  5. How to store
  6. Further information

 

  1. What Dapsone tablets are and what they are used for

Dapsone belongs to a group of medicines called

antibacterials. It works by stopping the production of folic acid in certain bacteria, therefore stopping them growing.

Dapsone may be used for:

  • leprosy
  • skin problems
  • the prevention of malaria in combination with pyrimethamine
  • the prevention of pneumonia in immunodeficient patients, especially in AIDS patients.

 

  1. Before you take

Do not take Dapsone tablets and tell your doctor if you:

  • are allergic (hypersensitive) to dapsone, any of the other ingredients in the tablet, or to similar medicines such as sulfonamide or sulfone (see section 6) An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
  • suffer from severe anaemia
  • have porphyria (a genetic or inherited disorder of the red blood pigment, haemoglobin)
  • suffer from severe glucose-6-phosphate
    dehydrogenase deficiency (G6PD), this can cause episodes of anaemia after eating certain foods such as fava beans (favism).

 

Take special care with Dapsone tablets and
tell your doctor if you:

  • suffer from other blood disorders
  • suffer from heart or lung disease.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other

medicines, including medicines obtained without a prescription. Especially:

  • probenecid (to treat gout)
  • rifampicin or trimethoprim (antibiotics to treat infections).

Ask your doctor or pharmacist for advice before taking any medicines.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, your doctor may prescribe you folic acid supplements.

Dapsone can be present in breast milk. There has been a report of anaemia in an infant being breast fed by a mother taking Dapsone tablets.

If you are concerned, check with your doctor or pharmacist.

Ask your doctor or pharmacist for advice before taking any medicines.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

  1. How to take

Always take Dapsone tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets with some water.

The usual doses are:

  • Adults and children over 12 years:

Multibacillary leprosy:

100mg daily for at least two years. Paucibacillary leprosy:

100mg daily for at least six months.

Malaria prophylaxis:

100mg weekly with 12.5mg pyrimethamine.

Dermatitis herpetiformis:

Initially 50mg daily which may be gradually increased to 300mg daily and then reduced to a usual maintenance dose of 25mg-50mg daily.

Pneumocystis carinii pneumonia:

In combination with trimethoprim, 50-100mg daily or 100mg twice weekly or 200mg once weekly.

  • Elderly

If you have a damaged liver your doctor may give you a lower dose.

  • Children 6-12 years:

Multibacillary leprosy:

50mg daily for at least two years.

Paucibacillary leprosy:

50mg daily for at least six months.

Continue to take them for as long as your doctor tells you to, it may be dangerous to stop without their advice.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

  1. Possible side effects

Like all medicines, Dapsone tablets can cause side effects, particularly when you first start taking it, although

not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

Contact your doctor at once if the following occur:

  • Dapsone syndrome: a ‘dapsone syndrome’ may occur after 3-6 weeks of treatment. Symptoms always include rash, fever and changes in blood cells. It is important to seek medical help immediately as severe skin reactions, inflammation of the liver, kidney damage and mental illness have occurred if treatment is not stopped or reduced. Some deaths have been reported.
  • Effects on your leprosy: if you are being treated for leprosy and your condition does not improve or you get eye or nerve damage, talk to your doctor.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

  • Effects on the blood: anaemia caused by destruction of red blood cells, changes in the type and number of other blood cells (you may develop ulcers in your mouth or on your skin).
  • Effects on the skin: rash which can be raised, discoloured, tender, destructive or itchy, sensitivity to sunlight or artificial light such as sun-bed (symptoms such as tingling, burning or redness of the skin). Rarely skin conditions may be associated with fever, malaise, lung or kidney damage.
  • Effects on the nervous system: headache, difficulty sleeping, nerve damage which may cause tingling in your arms or legs and some weakness.
  • Effects on the gastrointestinal system: loss of appetite, feeling or being sick, inflammation of the liver.
  • Other effects: fast heart beat, mental disturbances, changes in liver function tests, jaundice.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store

Keep out of the sight and reach of children. Store below 25°C in a dry place.

Do not use Dapsone tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

  1. Further information

What Dapsone tablets contain

  • The active substance (the ingredient that makes the tablets work) is Dapsone. Each tablet contains either 50mg or 100mg of the active ingredient.
  • The other ingredients are lactose, magnesium stearate, maize starch, sodium lauryl sulfate.

What Dapsone tablets look like and

contents of the pack

Dapsone tablets are a circular, white uncoated tablet. Pack sizes are 28

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

 

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