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

Logo PLASMOQUINE CAPSULES

SCHEDULING STATUS
Schedule 1 : Prophylaxis
Schedule 4 : Treatment

PROPRIETARY NAME
(and dosage form):

PLASMOQUINE CAPSULES

COMPOSITION
PLASMOQUINE capsules contain 200 mg
chloroquine sulphate monohydrate which is equivalent to 146,7 mg chloroquine base.

PHARMACOLOGICAL CLASSIFICATION
A 20.2.6 Medicines against Protozoa.

PHARMACOLOGICAL ACTION:
Chloroquine sulphate is an anti-malarial agent with rapidly acting blood schizonticidal and some gametocyticidal activity. It is not effective against exoerythrocytic tissue stages of plasmodia.

INDICATIONS
Malaria prophylaxis in areas where chloroquine resistance is not encountered. Treatment of malaria where clinical symptoms and parasitaemia are rapidly controlled provided that the patient did not contract malaria in a chloroquine-resistant area and was not using chloroquine as prophlaxis for malaria.

CONTRA-INDICATIONS
Hypersensitivity to chloroquine.

WARNINGS
Plasmoquine should only be used during pregnancy if unavoidable and if the risk of malaria is more hazardous than the potential damage of chloroquine to the fetus. Chloroquine may temporarily affect visual accommodation and patients undergoing treatment should not take charge of vehicles or machinery until the effect of treatment is evident.

Long-term, large-dose therapy may cause ocular disturbances (damage to eyesight) and for this reason opthalmological examinations are recommended every 3 to 6 months during treatment.

Care is necessary in administering chloroquine to patients with impaired liver or renal function or with porphyria or psoriasis. Chloroquine should be used with extreme caution in epileptic patients as chloroquine may interfere with seizure control. Resistance of Plasmodium falciparum to chloroquine may develop.

No malaria prophylaxis is fully effective and therefore the prevention of mosquito bites remains the most important malaria preventative measure. Preventative measures which should be taken are:
  Visit areas where malaria is prevalent during the dry season or when rainfall is low
  Sleep under a mosquito net which is tucked in under the mattress
  Install screening in doors and windows
  Regularly apply mosquito repellant to exposed skin
  Spray living quarters with insecticide in the late afternoon
  Use mosquito coils or pads
  Limit outdoor activities after sunset when mosquitoes are more active
  Wear long-sleeved shirt and trousers when outdoors between dusk and dawn
  High risk persons should avoid malaria areas altogether
High risk persons include:
  Babies and children under the age of 5 years
  Pregnant women
  The elderly (older than 65 years)
  Immunocompromised individuals such as cancer patients on chemotherapy individuals on long term steroid therapy, AIDS patients and persons who have had spleens removed.
Upon returning from a malaria area be particularly aware of symptoms such as fever, which may alternate with chills and shivers, joint and muscular pains, severe headache, nausea, diarrhoea and fatigue (flu-like symptoms). If these symptoms are experienced, inform your doctor that you have been to a malaria area.

DOSAGE AND DIRECTIONS FOR USE
The dosages for children 6 - 12 years for malaria prevention and treatment, must be carefully calculated according to body-mass as indicated.

MALARIA PREVENTION:
ADULTS AND CHILDREN OVER 12 YEARS
2 capsules per week.
Recommended paediatric dose: 5 mg base per kg body-mass per week.

GENERAL GUIDELINE FOR CHILDREN 6 - 12 YEARS
1 capsule per week (147 mg base)

It is advisable to start taking PLASMOQUINE one or two weeks before entering a malaria area. Thereafter repeat dosage at strictly adhered to weekly intervals during exposure to risk and for four to six weeks after exposure. The medication should be taken on the same day of each week.

MALARIA TREATMENT:
ADULTS AND CHILDREN OVER 12 YEARS
4 capsules taken as a single dose followed by 2 capsules six hours later and then 2 capsules daily for the following two days.

Recommended paediatric dose: 10 mg base per kg body-mass, followed by 5 mg per kg after 6 hours, then 5 mg per kg daily for 2 days.

GENERAL GUIDELINE FOR CHILDREN 6 - 12 YEARS
2 capsules (294 mg base taken as a single dose followed by 1 capsule (147 mg base) six hours later and then 1 capsule (147 mg base) daily for the following two days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
SIDE EFFECTS
Side effects occurring with antimalarial doses are usually reversible upon withdrawal of the medicine and include headache, gastro-intestinal disturbances such as nausea, vomiting and diarrhoea, pruritus and skin eruptions. Less frequently a range of mental changes have been reported, including psychotic episodes, anxiety and personality changes.

Prolonged treatment with high doses may lead to visual disturbances such as blurred vision and difficulty in focusing caused by corneal and retinal changes. Corneal opacities are normally reversible upon withdrawal of treatment whereas retinal changes resulting in severe visual impairment, may progress after discontinuation of treatment and are generally irreversible. The risk of retinal changes occur when the total cumulative dose ingested exceeds 100 g and especially when high daily dosages are used. Hypotension and ECG changes may occur at higher doses.

Blood disorders have been reported including aplastic anaemia, reversible agranulocytosis, thrombocytopenia and neutropenia. Other side effects that may occur after prolonged use: loss of hair, bleaching of hair pigment, blue-black pigmentation of mucous membranes and skin, photosensitivity, neuritis, reduced hearing, nerve deafness, neuromyopathy and myopathy.

SPECIAL PRECAUTIONS
Regular examination for ocular disturbances should be carried out every 3 to 6 months in patients receiving long courses of treatment. Patients with glucose-6-phosphate dehydrogenase deficiency should be observed for haemolytic anaemia during chloroquine treatment.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
SYMPTOMS OF OVERDOSAGE
Overdosage with chloroquine is dangerous and may lead to death within a few hours. Small children seem to be particularly sensitive to the adverse effects of chloroquine. Acute overdosage can cause headache, gastro-intestinal disturbances, drowsiness, dizziness, a fall in blood pressure, visual disturbances with sudden loss of vision.

The chief symptom of chloroquine overdosage is cardiovascular collapse progressing to convulsions, cardiac and respiratory arrest, and death. Cardiac arrhythmias also may occur.

TREATMENT OF OVERDOSAGE
Overdosage with chloroquine can be rapidly fatal and therefore treatment should be administered promptly. Treatment is symptomatic and supportive.

IDENTIFICATION
Hard gelatin capsules with white bodies and light blue caps.

PRESENTATION
Plastic containers of:
20 x 200 mg
100 x 200 mg
500 x 200 mg

STORAGE INSTRUCTIONS
Store below 25°C.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER
Z/20.2.6/127

NAME AND ADDRESS OF APPLICANT
Medchem Pharmaceuticals (Pty) Ltd
Langenhof
1A Witkoppen Road
Paulshof
Sandton

DATE OF PUBLICATION OF THIS PACKAGE INSERT
5 October 1992 Q12810

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