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 Zambia HIV National Guidelines
 


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 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS
 

 

 

Drugs>Antimicrobial Agents>
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Amodiaquine

Alice M. Jenh, Pharm.D. and Paul A. Pham, Pharm.D.
08-11-2008

Zambia Specific Information

  • Available formulation in Zambia:  Tablet: 153 mg or 200 mg (as hydrochloride). Coarsucam™ (artesunate + amodiaquine fixed-dose combination) = 50 mg artesunate/153 mg amodiaquine per tablet
  • Must be used in combination with artesunate 50 mg
  • Treatment of falciparum malaria and uncomplicated chloroquine-resistant vivax malaria: 10 mg/kg daily for 3 days. (Note: Treatment of vivax malaria must be followed by radical cure with primaquine).
  • Recommended dosing for Coarsucam™ (artesunate + amodiaquine fixed-dose combination): >40 kg should receive 4 tablets of each product per day.
  • May be used alone for the treatment of P. vivax, P. ovale and P. malariae infections.
  • With EFV co-administration, amodiaquine AUC increased by 114% and 302% in 2 subjects and resulted in significant LFTs elevations. Avoid co-administration or use with close monitoring.

Basis for Recommendations

Zambia Information Author: Alice M. Jenh

INDICATIONS

FDA

  • Not available in the U.S.
NON-FDA APPROVED USES

  • Treatment of falciparum malaria and uncomplicated chloroquine-resistant vivax malaria

USUAL ADULT DOSING

  • Dosages expressed in mg of amodiaquine base (amodiaquine hydrochloride 260 mg equivalent to 200 mg of amodiaquine base).
  • Treatment of falciparum malaria and uncomplicated chloroquine-resistant vivax malaria: 10 mg/kg daily for 3 days. (Note: Treatment of vivax malaria must be followed by radical cure with primaquine).
  • Artesunate + amodiaquine fixed-dose combination: pts weighing >40 kg should receive 4 tablets of each product per day.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

Usual dose

DOSING FOR GLOMERULAR FILTRATION OF 10-50

No data. Usual dose likely.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

No data. Usual dose likely.

DOSING IN HEMODIALYSIS

No data. Dose post-HD on days of HD.

DOSING IN PERITONEAL DIALYSIS

No data

DOSING IN HEMOFILTRATION

No data

ADVERSE DRUG REACTIONS

GENERAL

OCCASIONAL

  • Hepatitis: associated with use in malaria prophylaxis, higher risk than with chloroquine
  • Agranulocytosis and neutropenia: associated with use in malaria prophylaxis, possibly secondary to an immunological reaction leading to greater tendency to induce agranulocytosis vs. chloroquine
  • Risk of a serious adverse drug reaction with prophylactic use (which is no longer recommended) appears to be between 1 in 1000 and 1 in 5000; not clear whether risks are lower when used to treat malaria.
RARE

  • Syncope, spasticity, convulsions, and involuntary movements with overdose.
  • QTc prolongation (without Torsades).

DRUG INTERACTIONS

CYP2C8 substrate

  • Drug-drug interaction with PIs and NNRTIs unlikely.
  • Rifampin may decrease amodiaquine serum concentrations.

SPECTRUM

  • Plasmodium malariae; P. falciparum;P. vivax; P. ovale

RESISTANCE

  • Active against chloroquine-sensitive and resistant strains of Plasmodium falciparum , although partial cross-resistance between amodiaquine and chloroquine exists.

PHARMACOLOGY

Pharmacology

COMMENTS

  • Artemisinin-based combination therapy (ACT) is currently WHO recommended treatment of choice for uncomplicated falciparum malaria: based on the level of resistance, in Africa, artemether-lumefantrine and artesunate + amodiaquine are the ACTs of choice; amodiaquine + sulfadoxine-pyrimethamine may be considered as an interim option in situations where ACTs cannot be made available. Amodiaquine not recommended for the prophylaxis of malaria because of resistance and risk of major toxicity.

REFERENCES

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