INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LENNON - DAPSONE 100 MG TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

LENNON - DAPSONE 100 MG TABLETS

COMPOSITION:
Tablets containing 100 mg of
dapsone

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.4 Leprostatics.

PHARMACOLOGICAL ACTION:
Dapsone, a sulphone, is bacteriostatic in vitro and probably acts by preventing the use of certain bacteria of metabolites essential for their normal development. Dapsone is effective "in vitro" against a wide range of gram-positive and gram-negative bacteria but it is for its action against Mycobacterium leprae that it is mainly employed.

INDICATIONS:
Dapsone is indicated in the treatment of all types of leprosy; especially lepromatous and tuberculoid leprosy. In addition it has also been found of value in the treatment of dermatitis herpetiformis. It is also of value in the treatment of toxoplasmosis and mycetoma (maduromycosis) and it has a suppressive action on malarial plasmodia.

CONTRA-INDICATIONS:
Dapsone is contra-indicated in persons who have shown a previous hypersensitivity to the drug. It should be used with caution in patients with cardiac or pulmonary disease, porphyria and patients with severe anaemia.

DOSAGE AND DIRECTIONS FOR USE:
It is important to not miss any doses and to take the tablets at the same time everyday. Complete the course.

1 Leprosy: (Hansen's disease):
  Adult:
Oral, in combination with one or more other antileprosy agents, 50 to 100 mg of dapsone once a day; or 1,4 mg per kg of body weight once a day.
  Paediatric:
Dosages must be reduced in children and low-weight patients
Oral, in combination with one or more other antileprosy agents, 1,4 mg of dapsone per kg of body weight, once a day.
2. Dermatitis herpetiformis suppressant:
Adult:
Start with 50 mg daily gradually increased to 300 mg or more if required. This dose should be reduced to a minimum as soon as possible.
Maintenance dosage can often be reduced in patients receiving a gluten-free diet.
  Paediatric:
Dosages must be reduced in children and low-weight patients.
Oral, initially 2 mg per kg of body weight daily. Doses may be increased if symptoms are not completely controlled. The dose should then be reduced to the lowest effective maintenance dose as soon as possible.
3. When used for the treatment of toxoplasmosis, mycetoma (maduromycosis) and for its suppressive action on malaria plasmodia, the maximum dosage may be attained much more quickly and is about 200 mg daily.
  The tablets should always be taken with plenty of water.
For children the dose should be suitably adjusted to the body mass.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Varying degrees of dose-related haemolysis and methaemoglobinaemia are the most frequently reported adverse effect.
Agranulocytosis has occurred less frequently following dapsone use in Leprosy and skin disease. Aplastic anaemia has been reported. Peripheral neuropathy with motor loss has been reported in patients on dapsone for dermatological conditions. It may occur as part of leprosy reaction states and is not an indication to discontinue dapsone.
Rash and pruritus may develop. Other adverse effects such as maculopapular rash, exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, nausea, vomiting, anorexia, headache, hepatitis and psychosis occur infrequently. Fixed drug eruptions have occurred.
Dapsone syndrome is a less frequent hypersensitivity reaction although it has been suggested that the incidence has increased since the introduction of multidrug therapy for Leprosy. It occurs in the first 6 weeks of therapy and symptoms include rash, which is always present, fever, jaundice and eosinophilia.
Serious cutaneous reactions such as: Exfoliative dermatitis, toxic erythema, erythema multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions and erythema nodosum may occur
Dapsone should not be used in patients with severe anaemia. It is recommended that regular blood counts be performed during treatment. Patients deficient in glucose-6-phosphate dehydrogenase or methaemoglobin reductase, or with haemoglobin M are more susceptible to the haemolytic effect’s of dapsone.
The benefits of dapsone in the treatment of leprosy outweigh any potential risk to the pregnant patient. Some leprologists recommend folic acid 5 mg 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. In general treatment with dapsone for leprosy is continued in lactating mothers.
Excretion of dapsone is reduced and plasma concentrations are increased by concurrent administration of probenecid. Rifampicin increases the plasma clearance of dapsone. Increased dapsone and trimethoprim concentrations have been reported following concurrent administration in AIDS patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Vomiting, severe abdominal pain, tachycardia, jaundice, hyperexcitability leading to depression, electrolyte imbalance, convulsions, purpuric spots, haematuria, cyanosis from methaemoglobinaemia, and coma.
Treatment is symptomatic and supportive.

IDENTIFICATION:
100 mg: Plain white, biconvex bisected tablets.

PRESENTATION:
Securitainers of 100

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
100 mg: J/20.2.4/431

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Korsten
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
24.5.77
        G843

Updated on this site: December 2000

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