Camosunate Paediatric Granules

SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the medicinal product
INN Name: Amodiaquine and Artesunate Granules
Trade mark name : CAMOSUNATE（Paediatric）
2. Qualitative and quantitative composition

Each Amodiaquine Granules contains Amodiaquine base 75mg and each
Artesunate Granules contains Artesunate 25mg
3. Pharmaceutical form
Granules
4. Clinical particulars
4.1 Therapeutic indications
CAMOSUNATE is indicated for treatment of uncomplicated malarial attacks, including
multi drug resistant strains of P.falciparum.
4.2 Posology and method of administration

Under one year-Each paediatric sachet containing Artesunate 25mg and Amodiaquine
base 75mg should be dissolved in 10ml clean water and taken daily for 3 days.
1-6 years-Each childer sachet containing Artesunate 50mg and Amodiaquine
Hydrochloride base 150mg should be dissolved in 30 ml clean water and taken daily for
3 days.
7-13 years- One tablet of each white tablet(Artesunate 100mg) and one tablet of each
yellow tablet (Amodiaquine hydrochloride equivalent to Amodiaquine base 300mg)daily
for 3 days.
14 years and above- One tablet of each white tablet(Artesunate 100mg) and one tablet of
each yellow tablet (Amodiaquine hydrochloride equivalent to Amodiaquine base 300mg)
in the morning and evening daily for 3 days.
4.3 Contraindication
Linking to Amodiaquine: 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.
4.4 Special warnings and precautions for use
Do not exceed the recommended dose without seeking further medical advise.
Keep this medicine out of the reach of childreen.
4.5 Interaction with other medical products and other forms of interaction
None known.
4.6 Pregnancy and lactation

Use in Pregnancy: Use of the product is not recommended during the organogenesis
period except if, in the doctor is opinion, the benefits outweigh the risks as seen with
cerebral malaris. Administration of the drug during the first trimester must be avoided.
Breast-feeding: Artesunate is not known to cross into maternal milk.
4.7 Effects on ability to drive and use machines
There have been no reports of negative drug interactions to date. For the combination
with Amodiaquine Hydrochloride, these was a significant improvement of the cure rates
at different stages of the clinical tests.
4.8 Undesirable effects
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 heats 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. Ina number of case it has been seen that
Amodiaquine causes agranulocytosis and other blood dyscrasias.
4.9 Overdose
You should stop the treament and consult immediately a doctor or a pharmacist in case
of headache, dizziness, visual disturbances, convulsion. These symptoms usually
indicate an overdosage.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Artesunate The plasma concentration-time curve when Artesunate was given orally to
human beings followed a one-compartment open model. The mean time to peak was 53
minutes, peak level was 1.94Чg/ml and the elimination half-life t½ß was 41.33 minutes.
The plasma concentration-time curve when Artesunate was given i.v. followed a two
compartment model. The mean last phase elimination half-life was 38 minutes.
Excretion in the urine reached a maximum after 30-60minutes .
Amodiaquine readily absorbed from the GI tract and is rapidly converted in the liver to
the active metabolite desethyl amodiaquine.
5.2 Pharmacokinetic properties
Blood Concentration: After an oral dose of 10mg/kg, plasma concentrations of 300-560

ng/ml are attained in 4 hours; therapeutic concentrations are attained 1-2 hours after
dosing.
Distribution: Widely distributed throughout the tissues; high concentrations are found in
the liver, spleen, kidneys, and lungs with smaller amounts in the brain and cerebrospinal
fluid; in the blood, higher concentrations are found in red cells than in the plasma.
Excretion: Slowly excreted in the urine but the rate may be increased if the urinary pH is
decreased.
For interchangeable multi-source pharmaceutical products (generics), bioequivalence

data shall be required. 2 This shall include a comparative study with the innovator
product.
5.3 Preclinical safety data
Particulars referring to the tests which have been performed on animals/humans

regarding the efficiency of the drug and the purpose(s) for which it will be promoted,
with special reference to the dosage and method of administration (pharmacological
trial)
Clinical evaluation of therapeutic regimens is required to validate clinical efficacy of

this promising drug (Oduola et al 1998). Artemisinin has a quick onset of action thereby,
stoping the parasites from developing and cytoadherence is not reached. Drug
disposition of Artemisinin after oral administration has been determined, using a
one-compartment model with separate pharmacokinetic estimates for children and adults.
The population estimates for Artemisinin clearance and distribution volume,
respectively, were 432 Lh-1 and 1600 L for adults and 14.4 Lh-1 kg-1 and 37.9 Lkg-1
for children, with an inter-subject variability (collectively for both age groups) of 45%
and 104%, respectively. The oral bioavailability was estimated to decrease from Day 1
to Day 5 by a factor of 6.9, a value found to be similar for children and adults (Sidhu et
al. 1998). Half-lives of Artemisinin is 4hrs, artesunate, 45 min and artemether, 4-11 hrs
(Batty et al 1998). Findings like this have advocated the dosing of Artemisinin to
children according to bodyweight and to adults according to a standard dose.
6. Pharmaceutical particulars
6.1 List of excipients
Maize Starch, Sodium Starch Glycolate, Disodium Edetate, Acesulfame Potassium, 95%
Ethanol, Purified Water, Pulverous Orange flavor, Aspartame.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life

36 months
6.4 Special precautions for storage

Do not exceed the expired date indicated on the outside packaging. Keep it in the
original packed and store below 30°C.
6.5 Nature and contents of container

PET/LDPE laminating film bag
(3+3) link-sachet/box, 240boxes/carton.
6.6 Special precautions for disposal and other handing

If a reaction suggesting sensitivity or severe irritation occurs, use of the medication
should be discontinued. If the degree of local irritation warrants, patients should be
directed to use the medication less frequently, to discontinue use temporarily, or to
discontinue use altogether. CAMOSUNATE should not come into contact with the eyes,
mouth, nostrils or mucous membranes. If product enters the eye, wash immediately with
warm water.
7. Registrant
Applicant: GENEITH PHARMACEUTICALS LIMITED.
Address: No. 12 Adewale Crescent,Off Ewenla Street, Behind Unity Secondary School,
Near Charity Bus Stop,Oshodi-Apapa Expressway, Oshodi, Lagos, NIGERIA
E-mail: [email protected]
Contact person : EMMANUEL ELOCHUKWU UMENWA
Tel: 08129008556
8. Manufacturer
Manufacturer name: Front Pharmaceutical PLC
Physical address: Xuancheng Economic and Technical Development Zone, Anhui,

China
Tel: 86-0563-2625199
Fax: 86-0563-2625199
E-mail: [email protected]
9. Date of revision of the text
June 2021
10. DOSIMETRY (IF APPLICABLE)

N/A
11. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)
N/A

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SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the medicinal product

INN Name: Amodiaquine and Artesunate Granules

Trade mark name : CAMOSUNATE（Paediatric）

2. Qualitative and quantitative composition

4.2 Posology and method of administration

Linking to Artesunate: For now no recorded contraindication is reported, however,this

4.4 Special warnings and precautions for use

Keep this medicine out of the reach of childreen.

4.6 Pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

Undesirable effects of Artesunate are generally rare at the therapeutic recommended

Patients with hypersensitivity to Amodiaquine can develop hepatitis. Nausea, vomiting

5.1 Pharmacodynamic properties

Excretion in the urine reached a maximum after 30-60minutes .

5.2 Pharmacokinetic properties

Blood Concentration: After an oral dose of 10mg/kg, plasma concentrations of 300-560

For interchangeable multi-source pharmaceutical products (generics), bioequivalence

5.3 Preclinical safety data

Particulars referring to the tests which have been performed on animals/humans

Clinical evaluation of therapeutic regimens is required to validate clinical efficacy of

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Special precautions for disposal and other handing

Applicant: GENEITH PHARMACEUTICALS LIMITED.

Contact person : EMMANUEL ELOCHUKWU UMENWA

Physical address: Xuancheng Economic and Technical Development Zone, Anhui,

9. Date of revision of the text

10. DOSIMETRY (IF APPLICABLE)

11. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

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