×
Components:
Dapsone
Method of action:
Antimiycobacterials
Available in countries
See all
close
Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.09.18

Name of the medicinal product

Acnesone

Qualitative and quantitative composition

Dapsone

Therapeutic indications

The information provided in Therapeutic indications of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

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.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

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.

Contraindications

The information provided in Contraindications of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

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

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

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

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

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

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

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

None known.

Undesirable effects

The information provided in Undesirable effects of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

Acnesonee 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 Acnesonee 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 Acnesonee when used alone, reports have been more common when Acnesonee 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 "Acnesonee syndrome" may occur after 3-6 weeks therapy; symptoms include rash, which is always present, fever, and eosinophilia. If Acnesonee 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 Acnesonee for dermatological conditions. Peripheral neuropathy may occur as part of leprosy reaction states and it is not an indication to discontinue Acnesonee. 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

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 Acnesonee 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 Acnesonee.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

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

Acnesonee's 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.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

Acnesonee 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 Acnesonee in the circulation is bound to plasma proteins and nearly 100% of its monoacetylated metabolite is bound. Acnesonee 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. Acnesonee is acetylated to monoacetylAcnesonee, the major metabolite, and other mono and diacetyl derivatives. Acetylation exhibits genetic polymorphism. Hydroxylation is the other major metabolite pathway resulting in hydroxylamine Acnesonee which may be responsible for Acnesonee-associated methaemoglobinaemia and haemolysis. Acnesonee is mainly excreted in the urine, only 20% of a dose as unchanged drug.

Preclinical safety data

The information provided in Preclinical safety data of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

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

Incompatibilities

The information provided in Incompatibilities of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

None known.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acnesone is based on data of another medicine with exactly the same composition as the Acnesone of the medicine (Dapsone). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acnesone directly from the package or from the pharmacist at the pharmacy.
more... close

Not applicable.

Administrative data