NIVAQUINE SYRUP
Chloroquine Sulphate BP 68 mg/5 ml
Pack size: 100ml
NIVAQUINE SYRUP
Chloroquine Sulphate BP 68 mg/5 ml
Pack size: 100ml
Therapeutic indications
Nivaquine is a 4-aminoquinoline compound which has a high degree of activity against the asexual erythrocytic forms of all species of malaria parasites. It is indicated for the suppression and clinical cure of all forms of malaria and, in addition, produces radical cure of falciparum malaria.
Nivaquine also exerts a beneficial effect in certain collagen diseases and protects against the effects of solar radiation. It is employed in the treatment of rheumatoid arthritis, juvenile arthritis, discoid and systemic lupus erythematosus and skin conditions aggravated by sunlight.
Nivaquine is also active against Entamoeba histolytica and Giardia lamblia and when Flagyl (metronidazole) is not available it may be used in hepatic amoebiasis and giardiasis.
Packs for supply directly to the public: For the prevention of malaria.
Route of administration: oral.
Posology and method of administration
Rheumatoid arthritis
Adults: 3 x 5 ml Nivaquine Syrup (150 mg chloroquine base) daily.
Children: 3 mg/kg bodyweight daily. Treatment should be discontinued if no improvement has occurred after 6 months.
Systemic lupus erythematosus
Adults: 3 x 5 ml Nivaquine Syrup (150 mg chloroquine base) daily until maximum improvement is obtained followed by smaller maintenance dosage.
Children: 3 mg/kg bodyweight daily. Treatment should be discontinued if no improvement has occurred after 6 months.
Light sensitive skin eruptions
Adults: 3 to 6 x 5 ml Nivaquine Syrup (150 mg to 300 mg chloroquine base) daily during the period of maximum light exposure.
Children: 3 mg/kg body weight daily. Treatment should be discontinued if no improvement has occurred after 6 months.
Suppression of malaria
Adults: 6 x 5 ml Nivaquine Syrup (300 mg chloroquine base) to be taken once a week on the same day each week.
Infants and children up To 12 years: 5 mg chloroquine base per kg bodyweight to be taken once a week on the same day each week.
It is advisable to start taking Nivaquine 1 week before entering an endemic area and to continue for 4 weeks after leaving.
Treatment of malaria
1. Partially immune adults
A single dose of 12 x 5 ml Nivaquine Syrup (600 mg chloroquine base) will provide a safe and effective course of treatment.
2. Non-immune adults
Day 1: 12 x 5 ml Nivaquine Syrup (600 mg chloroquine base) in one dose followed by a further 6 x 5 ml syrup (300 mg chloroquine base) six hours later.
Day 2: 6 x 5 ml Nivaquine Syrup (300 mg chloroquine base).
Day 3: 6 x 5 ml Nivaquine Syrup (300 mg chloroquine base).
The above dosage is intended as a guide in the treatment of Plasmodium falciparum malaria. However, due to a variation in the strain sensitivity, it may sometimes be necessary to increase the duration of treatment by administering 6 x 5 ml Nivaquine Syrup (300 mg chloroquine base) daily on days 4 to 7.
3. Non-immune or partially immune infants and children
Nivaquine Syrup can be conveniently used in patients in this age group to permit flexibility of dosage.
Day 1: 10 mg chloroquine base/kg bodyweight (maximum 600 mg base) followed by 5 mg chloroquine base/kg bodyweight (maximum 300 mg base) six hours later.
Day 2: 5 mg chloroquine base/kg bodyweight (maximum 300 mg base).
Day 3: 5 mg chloroquine base/kg bodyweight (maximum 300 mg base).
Contraindications
The use of chloroquine is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.
Nivaquine is generally contraindicated in pregnancy. However, clinicians may decide to administer Nivaquine to pregnant women for the prevention or treatment of malaria. Ocular or inner ear damage may occur in infants born of mothers who receive high doses of chloroquine throughout pregnancy.
Special warnings and precautions for use
Nivaquine should be used with care in patients with a history of epilepsy as it has been reported to provoke seizures. Caution is advised in cases of porphyria (precipitated disease may be especially apparent in patients with a high alcohol intake), hepatic disease (particularly cirrhosis) or renal disease, severe gastrointestinal, neurological and blood disorders and in patients receiving anticoagulant therapy.
Nivaquine should be used with care in patients with psoriasis as the condition may be exacerbated.
Although Nivaquine may have a temporary effect on visual accommodation during short term treatment, irreversible retinal damage may occur with prolonged treatment (see sections 4.7 and 4.8, below). Therefore, patients should be advised to discontinue the medication and seek immediate medical advice if they notice any deterioration in their vision which persists for more than 48 hours. Ophthalmological examination should always be carried out before and regularly (3-6 monthly intervals) during prolonged treatment. Retinal damage is particularly likely to occur if treatment has been given for longer than one year, or if the total dosage has exceeded 1.6 g/kg bodyweight. These precautions also apply to patients receiving chloroquine continuously at weekly intervals as a prophylactic against malarial attack for more than three years.
Bone marrow depression, including aplastic anaemia occurs rarely. Full blood counts should therefore be carried out regularly during extended treatment. Caution is required if drugs known to induce blood disorders are used concurrently.
Resistance of Plasmodium falciparum to chloroquine is well documented. When used as malaria prophylaxis official guidelines and local information on prevalence of resistance to anti-malarial drugs should be taken into consideration.
Interaction with other medicinal products and other forms of interaction
Concomitant administration of chloroquine with magnesium-containing antacids or kaolin may result in reduced absorption of chloroquine. Chloroquine should, therefore, be administered at least two hours apart from antacids or kaolin.
Concomitant use of cimetidine and chloroquine may result in an increased half-life and a decreased clearance of chloroquine.
Chloroquine and mefloquine can lower the convulsive threshold. Co-administration of chloroquine and mefloquine may increase the risk of convulsions. Also, the activity of antiepileptic drugs might be impaired if co-administered with chloroquine.
There have been isolated case reports of an increased plasma ciclosporin level when ciclosporin and chloroquine were co-administered.
Chloroquine may affect the antibody response to rabies vaccine (HDCV).
Caution is advised in patients receiving anticoagulant therapy.
Co-administration of chloroquine and other drugs that have arrhythmogenic potential (e.g. amiodarone) may increase the risk of cardiac arrhythmias.
Concomitant administration of chloroquine and digoxin may increase plasma concentrations of digoxin.
Concomitant use of chloroquine with neostigmine or pyridostigmine has the potential to increase the symptoms of myasthenia gravis and thus diminish the effects of neostigmine and pyridostigmine
Pregnancy and lactation
Nivaquine is generally contraindicated in pregnancy. However, clinicians may decide to administer Nivaquine to pregnant women for the prevention or treatment of malaria. Ocular or inner ear damage may occur in infants born of mothers who receive high doses of chloroquine throughout pregnancy.
Although chloroquine is excreted in breast milk, the amount is insufficient to confer any benefit on the infant. Separate chemoprophylaxis for the infant is required. When used for rheumatoid disease breast feeding is not recommended
Undesirable effects
Cardiovascular
- cardiomyopathy has been reported during long term therapy at high doses,
- cardiac dysrhythmias at high doses can occur,
- hypotension.
Central Nervous System (See Section 4.4)
- seizures,
- convulsions have been reported rarely (these may result from cerebral malaria. Such patients should receive an injections of phenobarbital to prevent seizures, in a dose of 3.5mg/kg in addition to intravenous administration of Nivaquine),
- psychiatric disorders such as anxiety, confusion, hallucinations, delirium.
Eye disorders (See Sections 4.4 and 4.7)
- transient blurred vision and reversible corneal opacity,
- cases of retinopathy as well as cases of irreversible retinal damage have been reported during long term, high dose therapy.
- macular defects of colour vision, optic atrophy, scotomas, field defects, blindness and pigmented deposits, difficult in focusing, diplopia.
Gastro-intestinal
- gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal cramps.
General
- headache.
Haematological (See Section 4.4)
- bone marrow depression, including aplastic anaemia, agranulocytosis, thrombocytopenia, neutropenia occurs rarely.
Hepatic
- changes in liver function, including hepatitis and abnormal liver function tests, have been reported rarely.
Hypersensitivity
- allergic and anaphylactic reactions, urticaria and angiodema have occurred rarely.
Hearing disorders
- ototoxicity such as tinnitus, reduced hearing, nerve deafness.
Muscular
- neuropathy, myopathy.
Skin (See Section 4.4)
- skin eruptions, pruritis, depigmentation, loss of hair, exacerbation of psoriasis, photosensitivity, pigmentation of the nails and mucosae (long term use).
- Rare reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and similar desquamation-type events.
