Amodiaquine Hydrochloride Tablets USP & Artesunate Tablets
DESCRIPTION
Amodiaquine is a 4-aminoquinoline antimalarial with a similar mode of action to chloroquine.
Drug - resistant Plasmodium falciparum malaria is a major contributor to the increasing malaria related morbidity and mortality. Combination of conventional antimalarial drugs with artemisinin derivatives is a treatment option for resistant P. falciparum. Amodiaquine-artesunate is a potential combination for inhibiting intensification of drug resistance and for decreasing malaria transmission levels. The combination shows improved treatment efficacy.
Artesunate is an antimalarial agent. It is a water-soluble hemisuccinate derivative of artemisinin. Artemisinin is a sesquiterpene lactone isolated from Artemisia annua, a herb that has traditionally been used in China for the treatment of malaria. Artesunate and its active metabolite dihydroartemisinin are potent blood schizonticides, active against the ring stage of the parasite. Artesunate is ideal for the treatment of severe malaria, including cerebral malaria. It is also active against chloroquine and mefloquine resistant strains of P. falciparum.
COMPOSITION
Each tablet contains
Artesunate 50mg
Amodiaquine hydrochloride USP equivalent to amodiaquine base 153.1mg
CLINICAL PHARMACOLOGY
Amodiaquine is an antimalarial with schizonticidal activity. It is effective against the erythrocytic stages of all 4 species of plasmodium falciparum. It is as effective as chloroquine against chloroquine-sensitive strains of Plasmodium falciparum and is also effective against some chloroquine-resistant strains. Amodiaquine accumulates in the lysosomes and brings about loss of function. The parasite is unable to digest haemoglobin on which it depends for its energy.
In general, 4-aminoquinoline derivatives appear to bind to nucleoproteins and inhibit DNA and RNA polymerase. High drug concentrations are found in the malaria parasite's digestive vacuoles.
Artesunate is a potent blood schizonticide agent for P. falciparum. Artesunate binds tightly to parasitized erythrocyte membranes. The functional group responsible for antimalarial activity of artesunate is endoperoxide bond. Release of an active oxygen species from this bond kills the parasite if accumulated in the erythrocytic cells.
It also suppresses the production or activity of antioxidant enzymes in the erythrocytes, causing lysis of the parasitic cell due to the highly reactive free oxygen radicals. It reduces gametocyte carriage rate.
PHARMACOKINETICS
Amodiaquine hydrochloride is readily absorbed from gastrointestinal tract. Amodiaquine is rapidly converted in the liver to the active metabolite desethylamodiaquine, only a negligible amount of amodiaquine is being excreted unchanged in the urine. The plasma elimination half-life of desethylamodiaquine has varied from 1 to 10 days or more. 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.
Pharmacokinetic data for Artesunate in humans are sparse, with no data demonstrating the rate or extent of absorption or the systemic distribution of artesunate. Artesunate is rapidly hydrolyzed to the active metabolite dihydroartemisinin. The oral formulation is probably hydrolysed completely before entering the systemic circulation. Peak serum levels occur within one hour of an oral dose of artesunate and persist for up to 4 hours. Dihydroartemisinin has a plasma elimination half-life of less than 2 hours, which may slow the development of resistance to artesunate.
INDICATIONS
Amodiaquine - artesunate combination kit is indicated in the treatment of uncomplicated cases of malaria caused by Plasmodium falciparum.
CONTRAINDICATIONS
Amodiaquine - artesunate combination kit is contraindicated in patients with known hypersensitivity to amodiaquine or 4-aminoquinolines and artesunate or artemisinin derivatives. Because of resistance and risk of major toxicity, amodiaquine is not recommended for the prophylaxis of malaria. Amodiaquine is also contraindicated in patients with hepatic disorders.
PRECAUTIONS
They are mainly pertaining to amodiaquine in the amodiaquine - artesunate combination kit.
Amodiaquine is no longer recommended for chemoprophylaxis of falciparum malaria because its use is associated with hepatic toxicity and agranulocytosis.
Severe neutropenia can occur. Large doses of amodiaquine have been reported to produce syncope, spasticity, convulsions and involuntary movements.
Amodiaquine may cause blood dyscrasias, hepatitis, peripheral neuropathy and haemolytic anaemia. If long term therapy is given, regular ophthalmic examination is recommended.
Because amodiaquine may concentrate in the liver, the drug should be used with caution in patients with hepatic disease or alcoholism and in patients receiving hepatotoxic drugs.
Since hemolysis and acute renal failure has been reported to occur in a few patients with glucose 6-phosphate dehydrogenase deficiency receiving chloroquine, this should also be considered when using amodiaquine.
Usage in pregnancy
Although no data are available for amodiaquine, chloroquine, a structurally similar 4-aminoquinoline with the same spectrum of activity and similar adverse reaction profile is known to cross the placental barrier. Caution should be observed when the drug is administered during pregnancy.
Little experience has been gained with the use of artesunate in pregnancy. It should be used with extreme caution in pregnancy during the first trimester.
Therefore, risk benefit ratio should be considered before administering amodiaquine - artesunate combination kit in pregnancy as enough safety data is not available.
Drug interactions
The incidence of agranulocytosis is higher when amodiaquine is combined with other antimalarials. Idiosyncratic drug induced involuntary movements have occurred when amodiaquine is combined with chloroquine.
Since magnesium trisilicate and kaolin are known to decrease the gastrointestinal absorption of chloroquine when administered simultaneously, it is likely that this also follows for amodiaquine.
Concomitant administration of chloroquine at recommended doses for malaria chemoprophylaxis during pre-exposure prophylaxis of rabies with intradermally administered rabies vaccine may interfere with the antibody response to the vaccine. However, the clinical significance of this interaction remains to be clearly established but should be considered and may have relevance in the case of amodiaquine.
Artesunate has a minimal effect on hepatic cytochrome P450 activity and does not appear to influence the metabolism of mefloquine, a drug likely to be used in combination with artesunate.
Artesunate does not inhibit the formation of carboxy-primaquine, a metabolite of primaquine.
ADVERSE EFFECTS
Agranulocytosis and other blood dyscrasias, hepatitis and peripheral neuropathy have been reported occasionally after amodiaquine usage alone. Administration of quinoline type drugs has been associated with hemolytic anaemia.
In therapeutic doses used for malaria. amodiaquine may occasionally cause nausea, vomiting, diarrhoea, vertigo and lethargy. Abdominal pain, headache and photosensitivity have been reported with amodiaquine. When given for long periods, it sometimes causes corneal deposits, visual disturbances and bluish - grey pigmentation of the finger nails, skin and hard palate. These reactions clear somewhat slowly, on stopping treatment. However, because of the occasional development of irreversible retinopathy, regular ophthalmic examinations should be carried out if the drug is used over a long period. The drug can also cause irregular heart beats and tremors.
Prophylactic use of amodiaquine is associated with an unacceptably high incidence of serious toxicity. Approximately 1 in 2000 patients develop agranulocytosis. Serious hepatotoxicity has also been reported. Minor adverse effects are similar to those of chloroquine, although pruritus is less of a problem.
Artesunate and other related artemisinin derivatives have been widely used in China, with no reports of any serious adverse reactions. Drug induced fever can 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.
In healthy volunteers, a reversible reduction in reticulocyte counts was the dose limiting adverse effect of artesunate, occurring with doses of 16.88mg/Kg.
Possible drug related adverse effects include dizziness, itching, vomiting, abdominal pain, flatulence, headache, bodyache, 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.
Occasional skin rash and pruritus has been observed with artesunate.
DOSAGE AND ADMINISTRATION
Amodiaquine -Artesunate combination kit contains 2 types of co - packaged blister packs:
1. 12 tablets of amodiaquine and 12 tablets of artesunate.
2. 6 tablets of amodiaquine and 6 tablets of artesunate.
Adults
12 tablets of amodiaquine and 12 tablets of artesunate is the total dose for treating an adult patient of Plasmodium falciparum malaria. This entire dose is to be given in equally divided doses over 3 days.
Amodiaquine 2 tablets twice daily and artesunate 2 tablets twice daily are given for 3 days.
Adult Tablet (Tab) Blister Pack
Artesunate (50mg) Amodiaquine
153.1mg(base)
Blister Pack content
(To allow for equal daily divided doses for 3 days) 12 tabs 12 tabs
Children
For children above 6 months of age and above 5Kg bodyweight, the dosage of artesunate is 4mg/Kg bodyweight and of amodiaquine is 10mg/Kg bodyweight for 3 consecutive days.
OVERDOSAGE
This is mainly pertaining to amodiaquine in the amodiaquine - artesunate combination.
Intoxication with amodiaquine is far less frequent than chloroquine poisoning. However, large doses of amodiaquine have been reported to produce syncope, spasticity, convulsions and involuntary movements.
The usual signs and symptoms of an overdose are headache, vertigo and vomiting; the more severe manifestations including cardiac arrhythmias, convulsions and coma. The most dramatic feature is visual disturbance, including sudden loss of vision, which is usually transitory.
Other symptoms include itching, cardiovascular abnormalities, dyskinesia, neuromuscular and haematological disorders and hearing loss.
Nausea, vomiting, diarrhoea, headache, drowsiness, blurred vision, blindness, convulsions, coma, hypotension, cardiac arrhythmias, cardiac arrest, and impaired respiration are the characteristic features of amodiaquine poisoning. ECG may show inverted or flattened T waves, widening of QRS, ventricular tachycardia and fibrillation. Hypokalemia may be present.
No data available for overdosage of artesunate.
Treatment of overdosage
Treatment of overdosage is supportive and must be prompt since acute toxicity can progress rapidly, possibly leading to vascular collapse and respiratory and cardiac arrest.
Early endotracheal intubation and mechanical ventilation may be necessary. Early gastric lavage followed by administration of activated charcoal may provide some benefit in reducing absorption of the drug. These should be preceded by measures to correct cardiac and severe cardiovscular disturbances, if present and by respiratory support. Diazepam IV may control seizures and other manifestations of CNS stimulation. Seizures caused by anoxia should be corrected by oxygen and other respiratory support. Defibrillators and cardiac pacemakers may be required.
Storage
Keep in a cool, dry, dark place.
Presentation
Blisters: 1x6+6 & 1x12+12 tablets
Blisters: 10x1x6+6 & 10x1x12+12 tablets.
This is a Generic drug and not a brand name medicine; because of it's generic form a compulsary licence(s) were issued in numerous countries allowing their fabrication, importation and distribution where they are legally permitted; and not in violation of any accords in regards to trademarks and patents. Be sure you are able to import these generic pharmaceuticals into your country prior to ordering; as some countries will not allow their importation.
Treatment Options
Acute
| Patient Group |
Tx Line
| Treatment |
|
P falciparum: uncomplicated disease, able to take orally
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|
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infection originating in chloroquine-sensitive region: nonpregnant or pregnant
|
1st |
chloroquine
-
Although chloroquine resistance is widespread in most regions of the world, there have been no reports of chloroquine resistance in infections acquired in parts of Central America (west of Panama Canal), Haiti, Dominican Republic, and most of the Middle East, although information is scanty. Infections acquired in these regions may be assumed to be chloroquine-sensitive and treated with chloroquine (preferred) or hydroxychloroquine.
- Primary Options
-
- chloroquine phosphate : children: 10 mg base/kg orally as a single dose initially, followed by 5 mg base/kg at 6, 24, and 48 hours, total dose 25 mg base/kg; adults: 600 mg base orally as a single dose initially, followed by 300 mg base at 6, 24, and 48 hours
- Secondary Options
-
- hydroxychloroquine : children: 10 mg base/kg orally as a single dose initially, followed by 5 mg base/kg at 6, 24, and 48 hours, total dose 25 mg base/kg; adults: 620 mg base orally as a single dose, followed by 310 mg base at 6, 24, and 48 hours
|
|
infection originating in chloroquine-resistant region: nonpregnant
|
1st |
antimalarial combination tx
-
Chloroquine resistance is widespread in most regions of the world (except Central America west of Panama Canal, Haiti, Dominican Republic, and most of the Middle East).
Doxycycline or tetracycline are preferred to clindamycin, due to the availability of more data. However, use of doxycycline or tetracycline should be avoided in children because these drugs are deposited in growing bones and teeth.
Artimisinin combination therapies (e.g., artemether/lumefantrine) are widely recommended as first-line therapy. [36] There is evidence to suggest that they are safe and effective for uncomplicated malaria in endemic areas and in nonimmune travelers. [47] [48] However, in many countries they are not licensed or available.
All regimens are recommended equally except mefloquine which, due to increased rates of neuropsychiatric complications, should be used only if the other options are not available. In addition, due to drug resistance, mefloquine is not recommended for infections acquired in southeast Asia.
For infections acquired in southeast Asia, quinine treatment should continue for 7 days. For infections acquired elsewhere, quinine treatment should continue for 3 days.
- Primary Options
-
- quinine sulfate : children: 8.3 mg base/kg orally every 8 hours for 3 or 7 days; adults: 542 mg base orally every 8 hours for 3 or 7 days
- -- AND --
- doxycycline : adults: 100 mg orally twice daily for 7 days
or
- tetracycline : adults: 250 mg orally four times daily for 7 days
or
- clindamycin : children and adults: 20 mg base/kg/day orally given in 3 divided doses for 7 days
-
- atovaquone/proguanil : children 5-8 kg: (62.5/25 mg tablet) 2 tablets orally once daily for 3 days; children 9-10 kg: (62.5/25 mg tablet) 3 tablets orally once daily for 3 days; children 11-20 kg: (250/100 mg tablet) 1 tablet orally once daily for 3 days; children 21-30 kg: (250/100 mg tablet) 2 tablets orally once daily for 3 days; children 31-40 kg: (250/100 mg tablet) 3 tablets orally once daily for 3 days; children >40 kg and adults: (250/100 mg tablet) 4 tablets orally once daily for 3 days
-
- artemether/lumefantrine : children and adults: (20/120 mg tablet) 1 dose initially followed by another dose at 8 hours then 1 dose twice daily for 2 days, total 6 doses; children 5-15 kg: 1 tablet per dose; children 15-25 kg: 2 tablets per dose; children 25-35 kg: 3 tablets per dose; children >35 kg and adults: 4 tablets per dose
- Secondary Options
-
- mefloquine : children: 13.7 mg base/kg orally initially, followed by 9.1 mg base/kg 6-12 hours after initial dose; adults: 684 mg base orally initially, followed by 456 mg base 6-12 hours after initial dose
|
|
infection originating in chloroquine-resistant region: pregnant
|
1st |
quinine plus clindamycin
-
Treatment of malaria in pregnancy must be managed together with an infectious diseases specialist.
In cases of uncomplicated malaria, if there is Plasmodium falciparum chloroquine resistance, quinine sulfate plus clindamycin are recommended for 7 days.
For infections acquired in southeast Asia, quinine treatment should continue for 7 days. For infections acquired elsewhere, quinine treatment should continue for 3 days.
- Primary Options
-
- quinine sulfate : adults: 650 mg salt orally every 8 hours for 3 or 7 days
and
- clindamycin : adults: 20 mg base/kg/day orally given in 3 divided doses for 7 days
|
|
P falciparum: severe disease or unable to take orally
|
|
|
|
nonpregnant
|
1st |
combination antimalarial regimen
-
Patients with severe disease should be treated aggressively with parenteral antimalarial therapy. [23] Parenteral therapy may also be used for those patients who cannot tolerate orally.
Delays in antimalarial therapy may increase morbidity and mortality. [24]
There is strong evidence to support the use of intravenous artesunate (artemisinin derivative) over intravenous quinine for severe malaria. Evidence However, in many countries this drug is not licensed or available.
In the US intravenous artesunate is not yet FDA-approved, but can be used for severe malaria on contacting the CDC. [CDC - Malaria: Artesunate] If this delays starting treatment by more than 6 hours, intravenous quinidine should be started in the interim.
If intravenous artesunate is the regimen chosen, oral adjunctive antimalarials (e.g., atovaquine/proguanil or doxycyline or mefloquine) should be commenced following intravenous artesunate or when the patient is able to tolerate orally.
Intravenous quinidine or quinine should be continued until parasitemia is <1% and the patient can tolerate orally. It can then be switched to oral quinine. Intravenous antimalarials adjunctive to this regimen (doxycycline or tetracycline or mefloquine) should be switched to oral therapy as soon as the patient can tolerate orally. The entire treatment course should be 7 days.
Patients taking parenteral quinidine or quinine should receive a loading dose unless they have already received quinidine, quinine, or mefloquine in the preceding 12 hours. In addition, they should be monitored for hypoglycemia, hypotension, and ECG changes (widening of QRS complex and prolongation of QTc interval).
Doxycycline or tetracycline should be avoided in children because these drugs are deposited in growing bones and teeth.
- Primary Options
-
- artesunate: consult specialist for guidance on dose
- -- AND --
- atovaquone/proguanil : children 5-8 kg: (62.5/25 mg tablet) 2 tablets orally once daily for 3 days; children 9-10 kg: (62.5/25 mg tablet) 3 tablets orally once daily for 3 days; children 11-20 kg: (250/100 mg tablet) 1 tablet orally once daily for 3 days; children 21-30 kg: (250/100 mg tablet) 2 tablets orally once daily for 3 days; children 31-40 kg: (250/100 mg tablet) 3 tablets orally once daily for 3 days; children >40 kg and adults: (250/100 mg tablet) 4 tablets orally once daily for 3 days
or
- doxycycline : adults: 100 mg orally twice daily for 7 days
or
- mefloquine : children: 13.7 mg base/kg orally initially, followed by 9.1 mg base/kg 6-12 hours after initial dose; adults: 684 mg base orally initially, followed by 456 mg base 6-12 hours after initial dose
-
- quinidine gluconate : children and adults: 6.25 mg base/kg intravenously given over 1-2 hours as a loading dose, followed by 0.0125 mg base/kg/minute given as a continuous infusion for at least 24 hours; switch to oral quinine if parasitemia <1% and oral medication tolerated
or
- quinine sulfate : children: consult specialist for guidance on dose; adults: 20 mg/kg (maximum 1.4 g) intravenously given over 4 hours, followed by 10 mg/kg (maximum 700 mg) over 4 hours three times daily for 7 days total; switch to oral quinine if parasitemia <1% and oral medication tolerated
- -- AND --
- doxycycline : adults: 100 mg intravenously twice daily for 7 days; switch to oral doxycycline as soon as patient can take oral medication
or
- tetracycline : adults: 250 mg intravenously four times daily for 7 days; switch to oral tetracycline as soon as patient can take oral medication
or
- clindamycin : children and adults: 10 mg base/kg intravenously as a loading dose, followed by 5 mg base/kg every 8 hours for 7 days; switch to oral clindamycin as soon as patient can take oral medication
|
|
plus |
supportive care +/- intensive care
-
Supportive therapy is vital and is aimed at correcting complications. It includes careful fluid management, often with renal support; airway protection; control of seizures; and transfusion of blood products. Hypoglycemia may be worsened by quinine-induced hyperinsulinemia, so should be monitored closely.
Severe falciparum malaria is a medical emergency. Consider admission to an intensive care unit. Patients with hyperparasitemia, jaundice, anemia, and renal impairment do not necessarily require intensive care; however, such features are often associated with other complications. Some patients may be able to be managed on an experienced ward or high care unit. The decision to admit to intensive care should be discussed with an infectious diseases specialist.
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|
pregnant
|
1st |
intravenous antimalarial regimen
-
Treatment of malaria in pregnancy must be managed together with an infectious diseases specialist.
Complicated P falciparum infection should be initially treated aggressively with parenteral therapy. Doxycycline or tetracycline are preferred to clindamycin in nonpregnant adults due to the availability of more data. However, doxycycline and tetracycline are not recommended for use in children or pregnant women; clindamycin is therefore the preferred option.
Intravenous quinidine or quinine should be continued until parasitemia is <1% and the patient is able to tolerate orally. It can then be switched to oral quinine. The entire course should be 7 days. Patients should receive a loading dose unless they have already received quinidine, quinine, or mefloquine in the preceding 12 hours.
Intravenous artesunate may be used as an alternative to intravenous quinidine or quinine (not yet FDA-approved, but can be used for severe malaria on contacting the CDC). [CDC - Malaria: Artesunate] This is generally preferred in the second and third trimesters due to recurrent hypoglycemia associated with quinine therapy. [36] There are insufficient safety data regarding the use of artesunate during the first trimester. However, the WHO states that "weighing these risks against the evidence that artesunate reduces the risk of death from severe malaria, both artesunate and quinine may be considered as options until more evidence becomes available." [36]
- Primary Options
-
- quinidine gluconate : adults: 6.25 mg base/kg intravenously given over 1-2 hours as a loading dose, followed by 0.0125 mg base/kg/minute given as a continuous infusion for at least 24 hours; switch to oral quinine if parasitemia <1% and oral medication tolerated
or
- quinine sulfate : adults: 20 mg/kg (maximum 1.4 g) intravenously given over 4 hours, followed by 10 mg/kg (maximum 700 mg) over 4 hours three times daily for 7 days total; switch to oral quinine if parasitemia <1% and oral medication tolerated
- -- AND --
- clindamycin : adults: 10 mg base/kg intravenously as a loading dose, followed by 5 mg base/kg every 8 hours for 7 days; switch to oral clindamycin as soon as patient can take oral medication
-
- artesunate: adults: consult specialist for guidance on dose
|
|
plus |
supportive + intensive care
-
Pregnant patients with severe disease should be treated aggressively with parenteral antimalarial therapy and transferred to the intensive care unit for intensive monitoring and support. [23] Delays in antimalarial therapy may increase morbidity and mortality. [24]
Supportive therapy is vital and is aimed at correcting complications. It includes careful fluid management, often with renal support; airway protection; control of seizures; and transfusion of blood products. Hypoglycemia may be worsened by quinine-induced hyperinsulinemia, so should be monitored closely.
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P ovale
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nonpregnant
|
1st |
chloroquine plus primaquine
|
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pregnant
|
1st |
chloroquine alone
-
Rarely life-threatening and can usually be managed on an outpatient basis unless comorbidities are present.
Primaquine should not be used in pregnancy in case of undetected G6PD deficiency in the fetus, which can result in hemolysis. [55]
Patients should be maintained on chloroquine prophylaxis once weekly until after delivery.
- Primary Options
-
- chloroquine phosphate : adults: 600 mg base orally as a single dose initially, followed by 300 mg base at 6, 24, and 48 hours, and once weekly for duration of pregnancy thereafter
- Secondary Options
-
- hydroxychloroquine : adults: 620 mg base orally as a single dose, followed by 310 mg base at 6, 24, and 48 hours
|
|
P vivax
|
|
|
|
infection originating in chloroquine-sensitive region: nonpregnant
|
1st |
chloroquine plus primaquine
-
Rarely life-threatening and can usually be managed on an outpatient basis unless comorbidities are present.
G6PD levels should be checked, as primaquine therapy will be necessary to eradicate hypnozoite forms and hemolysis may occur in patients who are deficient in G6PD.
- Primary Options
-
- chloroquine phosphate : children: 10 mg base/kg orally as a single dose initially, followed by 5 mg base/kg at 6, 24, and 48 hours, total dose 25 mg base/kg; adults: 600 mg base orally as a single dose initially, followed by 300 mg base at 6, 24, and 48 hours
and
- primaquine : children: 0.5 mg base/kg orally once daily for 14 days; adults: 30 mg base orally once daily for 14 days
- Secondary Options
-
- hydroxychloroquine : children: 10 mg base/kg orally as a single dose initially, followed by 5 mg base/kg at 6, 24, and 48 hours, total dose 25 mg base/kg; adults: 620 mg base orally as a single dose, followed by 310 mg base at 6, 24, and 48 hours
and
- primaquine : children: 0.5 mg base/kg orally once daily for 14 days; adults: 30 mg base orally once daily for 14 days
|
|
infection originating in chloroquine-sensitive region: pregnant
|
1st |
chloroquine alone
-
Rarely life-threatening and can usually be managed on an outpatient basis unless comorbidities are present.
Primaquine should not be used in pregnancy in case of undetected G6PD deficiency in the fetus, which can result in hemolysis. [55]
Patients should be maintained on chloroquine prophylaxis once weekly until after delivery.
- Primary Options
-
- chloroquine phosphate : adults: 600 mg base orally as a single dose initially, followed by 300 mg base at 6, 24, and 48 hours, and once weekly for duration of pregnancy thereafter
- Secondary Options
-
- hydroxychloroquine : adults: 620 mg base orally as a single dose, followed by 310 mg base at 6, 24, and 48 hours
|
|
infection originating in chloroquine-resistant region: nonpregnant
|
1st |
antimalarial combination treatment including primaquine
-
Rarely life-threatening and can usually be managed on an outpatient basis unless comorbidities are present.
There have been reports of chloroquine-resistant P vivax, particularly from Indonesia and Papua New Guinea, and high rates of treatment failure have been reported. [54]
Use of doxycycline or tetracycline should be avoided in children because these drugs are deposited in growing bones and teeth.
G6PD levels should be checked, as primaquine therapy will be necessary to eradicate hypnozoite forms and hemolysis may occur in patients who are deficient in G6PD.
For infections acquired in southeast Asia, quinine treatment should continue for 7 days. For infections acquired elsewhere, quinine treatment should continue for 3 days.
- Primary Options
-
- quinine sulfate : children: 8.3 mg base/kg orally every 8 hours for 3 or 7 days; adults: 542 mg base orally every 8 hours for 3 or 7 days
- -- AND --
- primaquine : children: 0.5 mg base/kg orally once daily for 14 days; adults: 30 mg base orally once daily for 14 days
- -- AND --
- doxycycline : children >8 years of age: 2.2 mg/kg orally every 12 hours for 7 days; adults: 100 mg orally twice daily for 7 days
or
- tetracycline : children >8 years of age: 25 mg/kg/day orally given in four divided doses for 7 days; adults: 250 mg orally four times daily for 7 days
-
- atovaquone/proguanil : children 5-8 kg: (62.5/25 mg tablet) 2 tablets orally once daily for 3 days; children 9-10 kg: (62.5/25 mg tablet) 3 tablets orally once daily for 3 days; children 11-20 kg: (250/100 mg tablet) 1 tablet orally once daily for 3 days; children 21-30 kg: (250/100 mg tablet) 2 tablets orally once daily for 3 days; children 31-40 kg: (250/100 mg tablet) 3 tablets orally once daily for 3 days; children >40 kg and adults: (250/100 mg tablet) 4 tablets orally once daily for 3 days
and
- primaquine : children: 0.5 mg base/kg orally once daily for 14 days; adults: 30 mg base orally once daily for 14 days
- Secondary Options
-
- mefloquine : children: 13.7 mg base/kg orally initially, followed by 9.1 mg base/kg 6-12 hours after initial dose; adults: 684 mg base orally initially, followed by 456 mg base 6-12 hours after initial dose
and
- primaquine : children: 0.5 mg base/kg orally once daily for 14 days; adults: 30 mg base orally once daily for 14 days
|
|
infection originating in chloroquine-resistant region: pregnant
|
1st |
quinine
-
Rarely life-threatening and can usually be managed on an outpatient basis unless comorbidities are present.
There have been reports of chloroquine-resistant P vivax, particularly from Indonesia and Papua New Guinea, and high rates of treatment failure have been reported. [54] For this reason, pregnant patients with P vivax infection from these regions, or from elsewhere who do not respond to standard treatment with chloroquine, should use quinine sulfate alone.
Primaquine should not be used in pregnancy in case of undetected G6PD deficiency in the fetus, which can result in hemolysis. [55]
For infections acquired in southeast Asia, quinine treatment should continue for 7 days. For infections acquired elsewhere, quinine treatment should continue for 3 days.
- Primary Options
-
- quinine sulfate : adults: 542 mg base orally three times daily for 3 or 7 days
|
|
P malariae or P knowlesi: nonpregnant or pregnant
|
1st |
chloroquine
-
Rarely life-threatening and can usually be managed on an outpatient basis unless comorbidities are present.
Infection should be treated with oral chloroquine (preferred) or oral hydroxychloroquine (total of 3 doses).
P knowlesi, which is found in parts of southeast Asia, replicates every 24 hours; therefore, rapid diagnosis and prompt treatment of infection is essential. [53]
- Primary Options
-
- chloroquine phosphate : children: 10 mg base/kg orally as a single dose initially, followed by 5 mg base/kg at 6, 24, and 48 hours, total dose 25 mg base/kg; adults: 600 mg base orally as a single dose initially, followed by 300 mg base at 6, 24, and 48 hours
- Secondary Options
-
- hydroxychloroquine : children: 10 mg base/kg orally as a single dose initially, followed by 5 mg base/kg at 6, 24, and 48 hours, total dose 25 mg base/kg; adults: 620 mg base orally as a single dose, followed by 310 mg base at 6, 24, and 48 hours
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