Sign In
 
Register
 
Complaints
 
Contact
SEARCH  
 
 
   
 
   
   
   
 
PRODUCT DETAIL
 
   
 


DART®

Composition
A Dart® pack contains:
I.  3 yellow Amodiaquine caplets each containing 780mg Amodiaquine Hydrochloride equivalent to 600 mg  Amodiaquine base.                                     

II. 3 white Artesunate caplets each containing 200mg Artesunate base.

Properties, effects
Dart®  exerts it’s antimalarial effect through the synergistic activity of all its components (Artesunate and Amodiaquine).
Amodiaquine is a 4 aminoquinoline antimalarial with schizonticidal activity similar to chloroquine.  Like chloroquine, it also possesses antipyretic and anti-inflammatory properties.  It is effective against the erythrocytic stages of all four species of plasmodium (P. falciparum, P. vivax, P. ovale, P. malariae) except mature gametocytes of P. falciparum. Amodiaquine accumulates in the lysosomes of the parasites and results in loss of function.  The parasite is unable to digest haemoglobin which it depends on for its energy.

Artesunate has a rapid and potent schizonticidal activity against malaria parasites.  It  has a peroxide bond which breaks up inside the parasite forming singlet oxygen as well as free radicals.  Both exert a direct cytotoxic effect on the cells.  By virtue of this marked synergistic action, Dart® is also effective against strains that are resistant to other commonly used antimalarial drugs such as chloroquine and other 4 aminoquinoline derivatives, proguanil and sulfonamide-pyrimethamine combinations.
Dartâ being an Artemisinin based combination product has marked reduction of the likelihood of resistance development to the individual components.

Pharmacokinetics:
Amodiaquine Hydrochloride is rapidly absorbed after oral administration, it is also extensively metabolised in the liver to its pharmacologically active metabolite desethylamodiaquine, the parent compound being detectable for no longer than 8 hours.  Desethylamodiaquine is concentrated in erythrocytes and is slowly eliminated with a terminal elimination half-life of up to 18 days.  About 5% of the total administered dose is recovered in urine while the rest is metabolised in the body.  Amodiaquine and desethylamodiaquine have been detected in the urine several months after administration.  Artesunate is rapidly hydrolyzed to the active metabolite dihydro-artemisinin.   Peak serum levels occur within one hour of an oral dose of Artesunate and persist for  up to 4 hours.  In humans, binding of plasma protein is about 50% for Artesunate. Elimination half-life of Artesunate is approximately 2 to 4 hours.

Indications:
Dart® is indicated for the treatment of all forms of malaria due to P.falciparum; P. vivax, P. ovale, P. malariae.

Contraindications:
Dartâ is contraindicated in patients who are hypersensitive to any of its active substances or to any of its excipients.
Amodiaquine is not recommended for  prophylaxis of malaria because of resistance and risk of major toxicity.
Amodiaquine is also contraindicated in patients with hepatic disorders.

Dosage and administration:
Adult dose: (Above 12 years)
1 yellow Amodiaquine caplet and 1 white  Artesunate caplet to be taken daily for 3 days.

Caution:
Dart®  should be taken only in doses recommended.

Side effects:
In the recommended dosage Dartâ is generally well tolerated. However, the most common adverse reactions to the treatment dose of Amodiaquine are nausea, vomiting, abdominal pain, diarrhoea, itching.  A less common effect is bradycardia.
Amodiaquine can induce toxic hepatitis and fatal agranulocytosis following its use for malaria chemoprophylaxis.  Artesunate and other related artemisinin derivatives have been widely used in China, with no reports of any serious adverse reactions.  Drug induced fever may occur.  Neurotoxicity has been observed in animal studies but not in humans.  In view of  the uncertainty about  toxic effects, caution should be exercised when more than one 3 day treatment is given.  Cardiotoxicity has been observed following administration of high doses.

Possible drug related, adverse effects include dizziness, itching, vomiting, abdominal pain, flatulence, headache, body ache, diarrhoea, tinnitus, and increased hair loss, macular rash, reduction in neutrophil counts and convulsions.  However, it is likely that many of these effects are disease related rather than drug induced. 
Occassional skin rash has been observed with Artesunate.

Storage:
The tablets should preferably be kept dry and in their original package.  They should be stored below 300C.

Stability:
See expiry date on the outside of the pack.