Adverse reactions- summary -

+ Atorvaquone

Metoclopramide-
concomittant treatment associated with decreased bioavailability of atovaquone.
Use only if other antiemetics are not available

Rifabutin/Rifampin-
concomittant admin of rifabutin/rifampin  reduce atovaquone  levels. Concomittant use not
recommended

Tetracycline-
Concomittant treatment with tetracycline has been associated with reduction in plasma
concentration of atovaquone. Closely monitor parasitemia in patients receiving tetracycline

Zidovudine-
zidovudine concentration may be elevated increasing zidovudine toxicity

Drug /Food reactions- dietary fat taken with atovaquone increases rate and extent of absorption
Atovaquione /proguanil tablets should be taken with food or milky drink.

Malaria

Adverse reactions-

GI - abdominal pain  4%  diarrhea  2%  dyspepsia 3% gastritis 2%    vomiting < 1%

Respiratory -  cough <1%  

Miscellaneous -  fever 1%   headache  6%

Hypersensitivity to atovaquone, proguanil or other ingredients of the formulation

Special precautions-

Cerebral malaria - patients with cerebral malaria are not suitable for oral therapy

Diarhea/vomiting- in patients with severe or persistent diarrhea or vomiting , alternative
antimalarial therapy may be required.

Relapse- in cases where recurrent P faliciparum infections after treatment or failure of
chemoprophylaxis with atovaquone/proquanil ,treat patients with a different blood
schizontides

Renal function impairment - do not use for malaria prophylaxis in patients with severe
renal impairment.

Pregnancy- maternal death and fetal loss are known complications of falciparum malaria
in pregnancy. If pregnant women who must travel to malaria personal protection measures
should always be employed. 

Lactation- excercise caution when atovaquone/praquanil combination is administred to nursing
women.

Children- safety and efficacy of the combination has not been established in children.

Indication-

Malaria

Dosage-

Start prophylactic treatment 1 or 2 days before entering a malaria-endemic area and conitinue
daily during the stay and for 7 days after return

Adults- 1 tablet per day
Children- the dosage for prevention of malaria in pediatric patients is based upon weight

11 to 20kg  atoaquone/proguanil 62.5mg + 25mg  1 pediatric tablet daily
21 to 30                                           125mg + 50mg    2 pediatric tablets as a single daily dose
31 to 40                                          187.5mg + 75mg  3 pediatric tablets as a single daily dose
more than 40                                 250mg + 100mg   1 tablet adult strength as a single dose

1.Take atovaquaone /proquanil combination tablets at the same time each day with food
    or a milky drink.

2. Take repeat dose of the combination if vomiting occurs within 1 hour after dosing.

3. Consult your physician regarding alternative forms of prophylaxis if prophylaxis with
   the combination is prematurely discontinued for any reason.

4.Include protective clothing, insect repellant and bed nets as important components of
   malaria prophylaxis

5. No chemoprophylaxis regimen is 100% effective, therfore, consult your physician
   for any febrile illness that occurs during or after return from malaria -endemic area
   and inform your physician that you have exposed to malaria.  

Drug /Food reactions-
Dietary fat taken with atovaquone increases rate andextent of absorption
Atovaquione /proguanil tablets should be taken with food or milky drink.

Pregnancy-
Maternal death and fetal loss are known complications of falciparum malaria
in pregnancy. If pregnant women who must travel to malaria personal protection measures
should always be employed. 

Lactation-
Excercise caution when atovaquone/praquanil combination is administred to nursing
women.

Children-
Safety and efficacy of the combination has not been established in children.