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- Mefloquine: Side Effects
Mefloquine: Side Effects
Mefloquine, a fluorinated derivative of 4-quinoline methanol, is a product of the US Army’s antimalarial research program. It is active against chloroquine-resistant Plasmodium falciparum, and has an excellent schizonticidal effect in the blood in experimentally induced Plasmodium vivax infections in volunteers. It is not gametocidal. P. vivax infections can persist after successful treatment of the falciparum infection with other drugs; the fact that mefloquine is effective against both organisms is thus of practical importance.
Mefloquine is readily absorbed after oral administration; absorption is influenced by the formulation and is more rapid from an aqueous solution. Maximum serum concentrations occur after hours. Absorption is reduced by diarrhea. The half-life varies considerably and has been variously reported to be 7-23 days, 15-30 days, and 8-18 days,. Plasma protein binding is high. Sick patients have a prolonged fmax.
Mefloquine has a high cure rate after a single dose of 750-1000 mg. The use of combinations of mefloquine with other antimalarial drugs has been advocated in order to reduce the development of resistance. Mefloquine is effective as a prophylactic. Using a weekly dosage schedule, a dose of 250 mg is appropriate in adults. Because early reports also suggested that the drug was without serious adverse effects, mefloquine became widely advocated by various advisory bodies for prophylactic use, starting a week before travel to an endemic area where chloroquine resistance is common, and continuing for 4 weeks after departure from the area. Regrettably, but as might have been expected, it has also been used for prophylaxis in areas where its use is unnecessary.
Mefloquine remains useful in the treatment of uncomplicated malaria in areas of chloroquine resistance, but recommendations for mefloquine as prophylaxis in travellers are under constant review. In visitors to the Kruger National Park (South Africa), adverse effects were reported in 325 (25%) of 1300 subjects taking mefloquine; gastrointestinal and neuropsychia-tric effects were dominant. Four subjects required hospital attention for particularly severe neuropsychiatric reactions and 53 changed from mefloquine prophylaxis because of adverse effects. However in the same study chloroquine + proguanil prophylaxis led to reported adverse effects in 720 (29%) of 2488 subjects: one had a convulsion and 69 altered their prophylaxis because of adverse events or the dosing schedule. In this population mefloquine was as well tolerated as chloroquine + proguanil prophylaxis in general terms. This is in contrast to previous studies, in which the use of mefloquine led to higher rates of intolerance and severe adverse effects.
Malaria prevention measures taken by 5626 returning North American and European travellers departing from Kenyan airports have been examined in a cross-sectional questionnaire study. Mefloquine (74%) and chloroquine and proguanil (15%) were the most common drugs used. There were adverse events in 20% of the travellers who took mefloquine and 16% of those who took chloroquine and proguanil. Neuropsychological adverse events were reported by 7.8% of those taking mefloquine and 1.9% of those taking chloroquine. Despite adverse events, adherence was better in the mefloquine group (95 versus 81%; OR = 0, which may have been due to a lower dosing frequency.
Atovaquone + proguanil (250/100 mg/day) and mefloquine (250 mg/week) have been compared in non-immune subjects attending travel clinics in North America, Europe, and South Africa in a randomized, double-blind study. Adverse events were reported by an equivalent proportion of subjects who had taken either drug (71 versus 67%; difference 4.1%, 95% CI = 1.7). Those who took atovaquone + proguanil had significantly fewer treatment-related neuropsychiatric adverse events (14 versus 29%), fewer adverse events of moderate or severe intensity (10 versus 19%), and fewer adverse events that caused prophylaxis to be withdrawn (1.2 versus 5%), compared with those who took mefloquine. Adherence was better in the atovaquone + proguanil group, which may have been due to the shorter duration of post-travel dosing (1 week versus 4 weeks for mefloquine). There were no confirmed cases of malaria.
Mefloquine (125 or 250 mg/week) has been compared with proguanil (100 or 200 mg/day) for short-term (6 months) malaria chemoprophylaxis in Nigerians with sickle cell anemia in a non-blinded, randomized study. Efficacy was similar (89% for mefloquine and 82% for proguanil). Adverse events were reported by 32% of those who took proguanil and 20% of those who took mefloquine. Surprisingly, only 3.6% of the mefloquine group reported neuropsychiatric adverse events.
Single-dose pyrimethamine + sulfadoxine (25 mg/kg) has been compared with mefloquine (15 mg/kg) in the treatment of uncomplicated P. falciparum malaria in an unblinded, randomized study in 102 Malawi children. Immediate vomiting was more common in those who took mefloquine (eight cases) than in those who took pyrimethamine + sulfadoxine (one case), with comparable parasite failure rates at 14 days (20 and 22% respectively).
General adverse effects
Although mefloquine is generally well tolerated, particularly when used prophylactically, the list of adverse effects has grown with accumulated experience. With therapeutic doses (for example 750-1500 mg in adults; 20 mg/kg in children) adverse effects are usually mild, but with occasional severe neuropsychiatric derangement. The overall incidence of adverse effects is about the same as with chloroquine, about 40-50%. Events most commonly reported include nausea, diarrhea, abdominal pain, dizziness, strange dreams, and insomnia. Adverse effects are dose-related, with an increase in dizziness and gastrointestinal complaints and fatigue at higher doses. Extensive acute, subacute, and chronic studies of mefloquine in animals have shown that it is not phototoxic, like some of the quinolone-methanols studied, nor was it mutagenic, teratogenic, or carcinogenic in these studies.
The adverse effects of mefloquine have been extensively reviewed both for prophylaxis (when rare neuropsychiatric adverse effects make its use controversial) and in treatment doses, when it has been linked to an increased incidence of the postmalaria neurological syndrome. A retrospective review of 5120 Italian soldiers showed an overall chemoprophylaxis curtailment rate of less than 1%, which was not significantly different from the combination of chloroquine and proguanil. A semi-systematic review also suggested no significant difference in tolerability compared with other antimalarial drugs.
The frequency and spectrum of adverse events associated with mefloquine (750 and 500 mg 6 hours apart) has been assessed in 22 healthy volunteers who were monitored for 21 days after drug administration. More women than men reported severe adverse reactions. The most commonly reported adverse effects were vertigo (96%), nausea (82%), and headache (73%). The vertigo was severe (grade in 73% and required bed rest and specific medication for 1-4 days. In most cases (17/1) the symptoms resolved within 3 weeks after drug administration. Biochemical and hematological measures stayed within the reference ranges, but there were significant rises in serum sodium, chloride, calcium, bilirubin, gammaglutamyl transpeptidase, and lactate dehydrogenase.
Mefloquine: Organs and Systems
Instances of mefloquine resistance were reported in Tanzania in 1983, in Thailand in 1989, and in Africa (Malawi) in 1991. Resistance to combinations of mefloquine with sulfadoxine and pyrimethamine was reported in 1985 (40). The possibility of cross-resistance between mefloquine and halofantrine was raised in 1990. Currently there are extensive areas, including Thailand, Cambodia, Laos, Papua New Guinea, and Myanmar, where P. falciparum is resistant to mefloquine. High-dose mefloquine has been tried in areas with mefloquine-resistant P. falciparum; and a dose of 25 mg/kg is effective, even in a multidrug-resistant area.
Early laboratory studies suggested cross-resistance between mefloquine and halofantrine, but in a later rodent model cross-resistance was not absolute.
Mefloquine: Second-Generation Effects
A study of the pharmacokinetics of oral mefloquine in 12 healthy adults (6 men, 6 women) over 10 weeks has given insights into sex differences in mefloquine pharmacokinetics. Five weekly doses of mefloquine 250 mg were given to healthy volunteers. After this, half the subjects took 5 weekly doses of mefloquine 125 mg and half continued to have 250 mg per week. By the second week, all the subjects had plasma mefloquine concentrations over 1.5 µmol/l (the effective prophylactic threshold), but it was only after the fourth dose that the trough concentrations reached this threshold. The women had significantly higher values of Coax and Cmin ss than the men. Although the dose of mefloquine was reduced to 125 mg, the plasma mefloquine concentration was maintained above 1.5 µmol/l in all subjects. In this small study, the most commonly reported adverse events were headache, insomnia, and vertigo, with most adverse events occurring between weeks 5 and 8, when plasma mefloquine concentrations were highest. Women had significantly more adverse events (number of days with adverse events/total number of days exposed 149/1) than men (43/1).
These results may explain why earlier studies in male military personnel failed to detect a higher proportion of neuropsychiatric problems with mefloquine compared with other prophylactic regimens.
Neuropsychiatric events have been extensively reviewed, but little is known about the sex-related incidence. Of 179 travellers (mean age 39 years) who took mefloquine for a 3-week prophylactic period before travelling, the women reported adverse events significantly more often than the men. There was an increase in fatigue exclusively in the women, especially in first-time users of mefloquine.
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Synonyms of Mefloquine *:
Mefloquine HCL, Mefloquinone
* Official titles and synonyms used in the British, European, and US Pharmacopoeias. INNs in the other main official languages (French, Latin, and Spanish) have also been included in the list of synonyms where these differ from the English INN.
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