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| MALARONE Frequently Asked Questions |
The following Q&A was designed as a quick reference guide to malaria and MALARONE. Each question and answer covers a different aspect of the disease in a clear, concise manner, and should help you find the information you need quickly and easily.
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Q: What is the incubation period for malaria?
A: Symptoms from malaria usually begin from 7 days to 30 days after the bite from an infected mosquito.
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Q: What are the symptoms of malaria?
A: Symptoms of malaria include fever and flu-like illness, including shaking chills, headache, muscle aches, and tiredness. Nausea, vomiting, and diarrhea may also occur. Malaria may cause anemia and jaundice (yellow coloring of the skin and eyes) because of the loss of red blood cells.
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Q: What are the risks associated with malaria?
A: Infection with Plasmodium falciparum, if not promptly treated, may cause kidney failure, seizures, mental confusion, coma, and death. P. falciparum malaria carries a higher risk of death and serious complications in pregnant women than in the general population. Pregnant women anticipating travel to malarious areas should discuss the risks and benefits of such travel with their physicians. [7]
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Q: What is the geographical distribution of malaria?
A: It is mainly transmitted in warmer regions closer to the equator such as Africa (south of the Sahara), Asia, and Latin America.
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Q: How can patients reduce the risk of contracting malaria?
A: Patients who travel regularly to malaria endemic areas should take precautions to prevent getting malaria. Prevention is an important component of malaria control in endemic countries. This can be achieved by using antimalarial drugs prophylactically and taking personal protection measures.
Because of the nocturnal feeding habits of Anopheles mosquitoes, malaria transmission occurs primarily between dusk and dawn. Travelers should be advised to take protective measures to reduce contact with mosquitoes, especially during these hours. Such measures include remaining in well-screened areas, using mosquito nets, and wearing clothes that cover most of the body. Additionally, travelers should be advised to purchase insect repellent for use on exposed skin. The most effective repellent against a wide range of vectors is DEET (N,N-diethylmetatoluamide), an ingredient in many commercially available insect repellents. The actual concentration of DEET varies widely among repellents. DEET formulations as high as 50% are recommended for both adults and children >2 months of age. [3]
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Q: How effective is MALARONE?
A: MALARONE is 98% effective in the prevention of P. falciparum malaria however, no chemoprophylactic regimen is 100% effective. Patients should seek medical attention for any febrile illness that occurs during or after return from a malaria-endemic area; and to inform the health care professional of possible exposure to malaria.
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Q: Are there any adverse reactions associated with MALARONE?
A: For prophylaxis: In adults, the most commonly reported adverse events possibly attributable to MALARONE versus placebo were headache (5% vs. 7%) and abdominal pain (3% vs. 5%); in pediatric patients, headache (14% vs. 14%), abdominal pain (31% vs. 29%), and vomiting (7% vs. 6%).
MALARONE is contraindicated for prevention of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min).
MALARONE is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil HCl or any component of the formulation. Rare cases of anaphylaxis following treatment with MALARONE have been reported.
For complete information on MALARONE, please see the prescribing information.
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Q: Are there any drug interactions when using MALARONE?
A: Concomitant treatment with tetracycline has been associated with approximately 40% reduction in plasma concentration of atovaquone
Concomitant treatment with metoclopramide has been associated with decreased bioavailability of atovaquone
Concomitant administration with rifampin or rifabutin is known to reduce atovaquone levels by approximately 50% and 34% respectively
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Q: What is the dosing regimen for MALARONE?
A: For adults using MALARONE for malaria prevention, the recommended dosage is 1 tablet daily, starting 1 or 2 days prior to entering a malaria-endemic area, 1 tablet a day while in the area and 1 tablet a day for only 7 days after return. For children who weigh 88 pounds or less, a lower-dose pediatric tablet is available. Please see complete prescribing information for pediatric dosing, or see table below.
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Q: How is MALARONE administered?
A: Patients should be instructed:
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- To take MALARONE tablets at the same time each day with food or a milky drink
- To take a repeat dose of MALARONE if vomiting occurs within 1 hour after dosing
- To take a dose as soon as possible if a dose is missed, then return to their normal dosing. If a dose is skipped, the patient should not double the next dose.
- To consult a health care professional regarding alternative forms of prophylaxis if prophylaxis with MALARONE is prematurely discontinued for any reason
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Q: Does MALARONE require special storage or handling?
A: MALARONE should be stored at room temperature of 77° F (25° C). Excursion storage is permitted from 59° F - 86° F (15° C to 30° C).
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Q: How is MALARONE supplied?
A: Prophylaxis dosage for adult and pediatric patients:
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Important Safety Information
For prophylaxis: In adults, the most commonly reported adverse events possibly attributable to MALARONE versus placebo were headache (5% vs 7%) and abdominal pain (3% vs 5%); in pediatric patients, headache (14% vs 14%), abdominal pain (31% vs 29%), and vomiting (7% vs 6%).
In a clinical trial, adverse experiences possibly attributable to prophylactic therapy, which occurred in ≥ 5% of subjects receiving MALARONE versus mefloquine as the comparator drug, are listed as follows: MALARONE: diarrhea (8%), dreams (7%), oral ulcers (6%), and abdominal pain (5%) versus mefloquine: dreams (14%), insomnia (13%), dizziness (9%), nausea (8%), diarrhea (7%), headache (7%), and abdominal pain (5%).
MALARONE is contraindicated for prevention of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min). MALARONE is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil HCl or any component of the formulation. Rare cases of anaphylaxis following treatment with MALARONE have been reported.
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