Camosunate Amodiaquine Base and Artesunate Tablet and Sachet

CAMOSUNATE

 

DESCRIPTION OF THE DRUG

• Brand name: CAMOSUNATE

• Generic name: ARTESUNATE/AMODIAQUINE

• Dosage form and strength: Tablet/Sachet

• Net content: Amodiaquine base/Artesunate respectively:
Each tablet/linked sachet contains:

 

Amodiaquine base

Camosunate adult (12 tablets) 300mg

Camosunate junior (6 tablets) 300mg

Camosunate children (Pleasantly Flavoured) 150mg

Camosunate paediatric (Pleasantly Flavoured) 75 mg

Artesunate

Camosunate adult (12 tablets) 100mg

Camosunate junior (6 tablets) 100mg

Camosunate children (Pleasantly Flavoured) 50mg

Camosunate paediatric (Pleasantly Flavoured) 25 mg

 

CLINICAL PHARMACOLOGY

CAMOSUNATE is a synergistic combination of artemisinin derivative (artesunate) and an antimalarial (amodiaquine). CAMOSUNATE is very potent against the asexual forms of plasmodium, schizonts and gametocytes. The schizonticidal action of CAMOSUNATE insures a rapid clearance of parasitaemia, ensuring a rapid clinical recovery, and its gametocidal action prevents the infestation. The half life of artesunate is short whereas amodiaquine is long. The absorption of CAMOSUNATE after oral administration is rapid and complete; it is extensively distributed in all tissues.

 

THERAPEUTIC INDICATIONS

CAMOSUNATE is indicated for the treatment of acute uncomplicated malarial attacks, including multi drug resistant strains of P. falciparum.

 

CONTRAINDICATIONS

Linking to Amodiaqulne

CAMOSUNATE must not be used in the following cases namely: hypersensitivity to one of the constituents, history of fever disease or blood impairment during an anterior treatment with amodiaquine and retinopathy (in the event of frequent treatment). Do not use this medicine during the pregnancy and the lactation.

Linking to Artesunate

For now no recorded contraindication is reported, however, this drug must not be used in case of hypersensitivity to one of the constituents.

 

INTERACTIONS

There have been no reports of negative drug interactions to date. For the combination with Amodiaquine, there was a significant improvement of the cure rates at different stages of the clinical tests.

 

WARNINGS AND PRECAUTIONS

Use in Pregnancy

Use of the product is not recommended during the organogenesis period except if, in the doctors opinion, the benefits outweigh the risks as seen with cerebral malaria.

Administration of the drug during the first trimester must be avoided.

Breast-feeding

Artesunate is not known to cross into maternal milk.

Do not exceed the recommended dose without seeking further medical advice.

 

Keep this medicine out of the reach of children.

 

ADVERSE REACTIONS

Undesirable effects of Artesunate are generally rare at the therapeutic recommended dose. In rare cases, however, slight changes to haematology values have been seen, including a reduction in the number of reticulocytes as well as a slight increase in transaminase. These signs, however, do not generally give rise to any noticeable clinical manifestations. In rare cases, a slight but transient reduction in sinus heart has been observed. Abdominal cramps and mild diarrhoea have been reported at elevated doses.

Since amodiaquine may concentrate in the liver, the drug should be used with caution in patients with hepatic diseases or alcoholism, and patients receiving hepatotoxic drugs.
After the intake of Amodiaquine neurological effects such as lethargy and drowsiness have been reported at therapeutic doses. Also patients can experience involuntary movements.

Patients with hypersensitivity to Amodiaquine can develop hepatitis. Nausea, vomiting and diarrhoea have also been reported. In a number of cases it has been seen that Amodiaquine causes agranulocytosis and other blood dyscrasias.

 

SYMPTOMS OF OVERDOSE

You should stop the treatment and consult immediately a Doctor or a Pharmacist in case of headache, dizziness, visual disturbances, convulsions. These symptoms usually indicate an overdosage.

 

DOSAGE AND ADMINISTRATION

Under one year: Each paediatric sachet containing Artesunate 25 mg and Amodiaquine base 75 mg should be dissolved in 10 ml clean water and taken daily for 3 days.

1-6 years: Each children sachet containing Artesunate 50 rag and Amodiaquine base 150 mg should be dissolved in 30 ml clean water and taken daily for 3 days.

7-13 years: One tablet of each white tablet (Artesunate 100 mg) and one tablet of each yellow tablet (Amodiaquine hydrochloride equivalent to Amodiaquine base 300 mg) daily for 3 days.

14 years and above: One tablet of each white tablet (Artesunate 100 mg) and One tablet of each yellow tablet (Amodiaquine hydrochloride equivalent to Amodiaquine base 300 mg) in the morning and evening daily for 3 days.

 

PREPARATION FOR USE

Under one year: Each paediatric sachet containing Artesunate 25 mg and Amodiaquine base 75mg should be dissolved into 10 ml clean water and taken daily for 3 days.

1-6 years: Each children sachet containing Artesunate 50 mg and Amodiaquine base 150 mg should be dissolved in 30 ml clean water and taken daily for 3 days.

 

PHARMACEUTICAL FORMS AND PRESENTATIONS

TABLETS

1 blister of 12 tablets contains 6 white Artesunate tablets and 6 yellow Amodiaquine tablets (ADULT).

1 blister of 6 tablets contains 3 white Artesunate tablets and 3 yellow Amodiaquine tablets (JUNIOR).

SACHETS

One box of 6 sachets contains 3 white labelled Artesunate sachets and 3 black labelled Amodiaquine sachets.

 

STORAGE CONDITIONS

Do not exceed the expired date indicated on the outside packaging. Keep it in the original packet and store dry below 30oC.

 

DATE OF LEAFLET REVISION

June 2009

 

NAME AND ADDRESS OF MANUFACTURER

ADAMS PHARMACEUTICAL (ANHUI) CO., LTD.

Xuancheng Economic and Technical Development Zone, Anhui, China.

 

NAME AND ADDRESS OF MARKETING HOLDER

Marketed by

Geneith PHARM. LIMITED

12 Adewale Crescent, Off Ewenla Street,

Off Oshodi-Apapa – Exp.Way,

Oshodi Lagos

geneith@geneithpharm.com

www.geneithpharm.com

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