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Logo NIVAQUINE TABLETS

SCHEDULING STATUS:
S1 PROPHYLAXIS
S4 TREATMENT

PROPRIETARY NAME:
(and dosage form)

NIVAQUINE TABLETS

COMPOSITION:
NIVAQUINE tablets contain 200 mg chloroquine sulphate (equivalent to 150 mg
chloroquine base).

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.6 Medicine against Protozoa.

PHARMACOLOGICAL ACTION:
Chloroquine is a 4-aminoquinoline derivative with activity against the blood forms of species of Plasmodium. It destroys the blood forms after their release from tissue schizonts.

INDICATIONS:
MALARIA PROPHYLAXIS:
Malaria prophylaxis in areas where chloroquine resistance is not encountered.

MALARIA TREATMENT:
Treatment of malaria where the 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 prophylaxis for malaria.

GENERAL MEDICINE:
NIVAQUINE is indicated in the adjuvant management of rheumatoid arthritis and discoid and systemic lupus erythematosus.

CONTRA-INDICATIONS:
Persons with a known allergy to chloroquine.
Chloroquine is contra-indicated in the presence of any retinal or visual field changes.

WARNINGS:
WHEN NIVAQUINE IS USED FOR PREVENTION OVER A VERY LONG PERIOD OF TIME, THERE HAVE BEEN CASES OF RETINOPATHY (DAMAGE TO THE EYESIGHT). IT IS RECOMMENDED THAT IF NIVAQUINE IS TAKEN WITHOUT A BREAK FOR 3 YEARS, THE EYES SHOULD BE EXAMINED BY A SPECIALIST. SUCH AN EXAMINATION SHOULD BE REPEATED AT INTERVALS OF NOT LONGER THAN 6 MONTHS.
Resistance of Plasmodium falciparum to chloroquine has been reported.
It is recommended that a doctor be informed immediately, should flu-like symptoms appear in a patient who has been to a malarious area.
Care is necessary in administering chloroquine to patients with impaired liver or renal function, or to those with porphyria, psoriasis or a history of epilepsy, as seizures have been reported.
NIVAQUINE should only be used during pregnancy when unavoidable, if the risk of malaria is more hazardous than the potential damage of NIVAQUINE to the foetus.
Chloroquine has been implicated in precipitating or exacerbating myasthenia gravis or a myasthenia-gravis-like syndrome and should therefore be used with caution in patients with an underlying history of myasthenia gravis.

DOSAGE AND DIRECTIONS FOR USE:
MALARIA: Prevention.
Adults and Children over 12 years:
2 tablets in a single dose once a week.

Infants and Children up to 12 years:
5 mg/kg bodymass of chloroquine base weekly.
The above dose should be taken on the same day each week, with food. It is advisable to start taking NIVAQUINE 1 to 2 weeks (if not possible, at least 24 hours) before entering an endemic area and to continue for at least 4 to 6 weeks after leaving.

MALARIA: Treatment.
Adults and Children over 12 years:
The course consists of 4 tablets (600 mg) in one dose followed by 2 tablets six to eight hours later and then 2 tablets daily for the next two days. The pattern of chloroquine treatment should be adjusted to the severity of the infection, the condition, and the age and weight of the patient.

Infants and Children up to 12 years:
10 mg base per kg body mass, followed by 5 mg/kg bodymass after 6 to 8 hours and then 5 mg/kg body mass daily for 2 days.

GENERAL MEDICINE:
Rheumatoid arthritis:
The usual dose is 1 tablet (150 mg base) daily. The maximum dose is 2 tablets (300 mg base).

Discoid and Systemic Lupus Erythematosus:
1 to 2 tablets (150 mg - 300 mg base) daily, reducing gradually once symptoms are controlled.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Side-effects experienced with dosage regimens of chloroquine used in the treatment and prophylaxis of malaria are generally less common and less severe than those associated with the larger doses used for prolonged periods in rheumatoid arthritis.
Frequent adverse effects of chloroquine include headache, various skin eruptions, pruritus and gastro-intestinal disturbances such as nausea, vomiting, and diarrhoea. Less frequently mental changes including psychotic episodes, anxiety and personality changes may occur.
Seizures have been reported.
Visual disturbances such as blurred vision and difficulty in focusing have occurred but these are more common with larger doses, when they may be associated with keratopathy or retinopathy. Keratopathy usually occurs in the form of corneal opacities and is normally reversible when chloroquine is withdrawn. Retinopathy is the most serious adverse effect of chloroquine on the eyes and it can result in severe visual impairment. Changes may be irreversible and can even progress after chloroquine is discontinued. Those taking large doses of chloroquine for prolonged periods appear to be at greatest risk of developing retinopathy.
Other adverse effects from prolonged use include loss of hair, bleaching of hair pigment, bluish-black pigmentation of the mucous membranes and skin, photosensitivity, tinnitus, reduced hearing, nerve deafness, neuromyopathy, and myopathy.
Blood disorders have been reported less frequently. They include aplastic anaemia, reversible agranulocytosis, thrombocytopenia and neutropenia.
Special Precautions:
The eyes should be examined before starting longterm treatment and should be monitored subsequently. Visual disturbances may render patients unfit to take charge of vehicles or machinery.
Patients with glucose-6-phosphate dehydrogenase deficiency should be observed for haemolytic anaemia during chloroquine treatment.
Because no form of prophylaxis is fully effective, the prevention of mosquito bites should form the mainstay of malaria prophylaxis. The following preventative measures to prevent mosquito bites should be taken:
i Endemic areas should preferably be visited during the dry season or in years when the rainfall is low.
ii High risk patients should avoid malaria areas altogether. High risk persons include:
babies and young children less than 5 years of age;
pregnant women;
immunocompromised individuals such as those on longterm steroids, cancer patients and those on chemotherapy; AIDS patients and those who have had their spleens removed.
iii Not going outside between dusk and dawn, when mosquitoes are most active.
iv Applying insect repellant to exposed skin and clothing.
v Wearing long sleeves and trousers at night:
vi Using mosquito nets, screens, coils or pads.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Acute overdosage with chloroquine is extremely dangerous and death can occur within a few hours. Initial effects include headache, gastrointestinal disturbances, drowsiness, and dizziness. Visual disturbances may be dramatic with a sudden loss of vision. However, the main effect of overdosage with chloroquine is cardiovascular toxicity with hypotension and cardiac arrhythmias progressing to cardiovascular collapse, convulsions, cardiac and respiratory arrest, and death.
Since acute overdosage with chloroquine can be rapidly lethal, intensive symptomatic supportive treatment should be commenced immediately.
The first steps should be to maintain adequate respiration and to correct any cardiovascular disturbances. Early administration of adrenaline with diazepam may minimise the cardiotoxicity of chloroquine and control the arrhythmias.
The stomach should then be emptied by gastric lavage if ingestion has occurred recently; activated charcoal may be left in the stomach to limit any further absorption. Other methods to increase the elimination of chloroquine, such as dialysis, are probably of little use.
Further treatment is symptomatic and supportive.

IDENTIFICATION:
NIVAQUINE tablets: White biconvex tablets

PRESENTATION:
NIVAQUINE Tablets: containers of 14, 100 and 500 tablets.

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

APPLICATION NUMBER:
NIVAQUINE tablets: A147 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Aventis Pharma (Pty) Ltd
2 Bond Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 June 1968

        NE2-A0002
        Pro-Print

New addition to this site: December 2004
Source: Community Pharmacy

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