CHLOROQUINE PHOSPHATE

Posology a. Treatment of malaria: i) P. falciparum and P. malariae infections Adults: A single dose of four tablets, followed by two tablets six hours later and then two tablets a day for two days.

Paedriatric population:

A single dose of 10mg base/kg, followed by 5mg base/kg six hours later and then 5mg base/kg a day for two days. Age (years) Initial dose Second dose 6 hours after first Dose on each of the two subsequent days 1 – 4 1 Tablet ½ Tablet ½Tablet 5 – 8 2 Tablets 1 Tablet 1 Tablet 9 -14 3 Tablets 1½ Tablets 1½ Tablets ii) P.

vivax and P. ovale infections Adults: A single dose of four tablets, followed by two tablets six hours later and then two tablets a day for two days. Follow with a course of treatment with primaquine if a radical cure is required.

Paedriatric population:

A single dose of 10mg base/kg, followed by 5mg base/kg six hours later and then 5mg base/kg a day for two days. Follow with a course of treatment with primaquine if a radical cure is required.

Elderly Patients:

There are no special dosage recommendations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.

Hepatic or Renally Impaired Patients:

Caution is necessary when giving Chloroquine phosphate to patients with renal disease or hepatic disease. b) Prophylaxis and suppression of malaria Adults: Two tablets taken once a week, on the same day each week. Start one week before exposure to risk and continue until four weeks after leaving the malarious area.

Paediatric population:

A single dose of 5mg chloroquine base/kg per week on the same day each week. Start one week before exposure to risk and continue until four weeks after leaving the malarious area. For practical purposes, children aged over 14 years may be treated as adults.

The dose given to infants and children should be calculated on their body weight and must not exceed the adult dose regardless of weight. 1 - 4 years 5 - 8 years 9 - 14 years ½ tablet 1 tablet 1½ tablets Elderly Patients: There are no special dosage recommendations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.

Summary of safety profile:

The adverse reactions which may occur at doses used in the prophylaxis or treatment of malaria are generally not of a serious nature. e. in the treatment of rheumatoid arthritis, adverse reactions can be of a more serious nature. Undesirable effects are listed by MedDRA System Organ Classes.

Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥1/10,000 to <1/1,000 Very rare: <1/10,000 Not known: cannot be estimated from the available data Tabulated list of adverse reactions: System Organ Class Undesirable Effect and Frequency Blood and lymphatic system disorders Not known Bone marrow failure Aplastic anaemia Agranulocytosis Thrombocytopenia Neutropenia Pancytopenia Immune system disorders Not known Hypersensitivity and anaphylactic reactions, including urticaria, angioedema and vasculitis.

4). Psychiatric Disorders Rare Hallucinations Not known Psychotic disorder including anxiety, personality change, Insomnia, Confusion, Depression, Suicidal behaviour, psychosis, aggression, delusion, paranoia, mania, attention deficit, sleep disorders.

9) Vascular Disorders Not known Hypotension Respiratory, thoracic and mediastinal Not known Diffuse parenchymal lung disease Gastrointestinal disorders: Not known Gastrointestinal disorder Nausea Vomiting Diarrhoea Abdominal pain Hepatobiliary disorders Rare Changes in liver function, including hepatitis and abnormal liver function tests Skin and subcutaneous tissue disorders Not known Macular, urticarial and purpuric skin eruptions Alopecia Erythema multiforme Drug reaction with eosinophilia and systemic symptoms syndrome (DRESS) Stevens-Johnson syndrome (SJS) Toxic epidermal necrolysis (TEN) Precipitation of psoriasis Pruritus Photosensitivity reaction Lichenoid keratosis Pigmentation disorder * Exfoliative dermatitis Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders Not known Myopathy Investigations Not known Electrocardiogram change** * Long term use **At high doses Reporting of side effects Reporting suspected adverse reactions after authorisation of the medicinal product is important.

When used as malaria prophylaxis official guidelines and local information on prevalence to resistance to anti-malarial drugs should be considered. Chloroquine has been shown to cause severe hypoglycaemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications.

Patients treated with chloroquine should be warned about the risk of hypoglycaemia and the associated clinical signs and symptoms. Patients presenting with clinical symptoms suggestive of hypoglycaemia during treatment with chloroquine should have their blood glucose level checked and treatment reviewed as necessary.

8), including in patients with no prior history of psychiatric disorders. Patients should be advised to seek medical advice promptly if they experience psychiatric symptoms during treatment. Prolongation of QTc interval Chloroquine has been shown to prolong the QTc interval in some patients.

g. 5) as this may lead to an increased risk for ventricular arrhythmias, sometimes with fatal outcome. The magnitude of QT prolongation may increase with increasing concentrations of the drug. 9). If signs of cardiac arrhythmia occur during treatment with chloroquine, treatment should be stopped and an ECG should be performed.

9). If signs and symptoms of cardiomyopathy occur during treatment with chloroquine, treatment should be stopped. Caution is necessary when giving Chloroquine to patients with impaired hepatic function, particularly when associated with cirrhosis.

Caution is also necessary in patients with porphyria. Chloroquine may precipitate severe constitutional symptoms and an increase in the amount of porphyrins excreted in the urine. This reaction is especially apparent in patients with high alcohol intake.

A small number of cases of diffuse parenchymal lung disease have been identified in patients taking chloroquine. A response after therapy with steroids has been observed in some of these cases. Cases of drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been identified in patients taking chloroquine alone or in combination with proguanil.

5).