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MEFLOQUINE is a brand name for Mefloquine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MEFLOQUINE (mefloquine tablets) is indicated for: • Prophylaxis: Prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum. • Treatment of Acute Malaria Infections: Treatment of mild to moderate acute malaria caused by mefloquine-susceptible…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Prophylaxis The recommended prophylactic dose of MEFLOQUINE is approximately 5 mg/kg once weekly (to a maximum of 250 mg). MEFLOQUINE (Mefloquine T ablets) Page 6 of 40 Unclassified / Non classifié 1.
Adults and children weighing over 45 kg In persons over 45 kg, the prophylactic dose is 250 mg of mefloquine (one MEFLOQUINE tablet) once weekly. 2. Children and adults weighing less than 45 kg The weekly dose decreases in proportion to bodyweight.
Weight (kg) Dose > 30-45 kg ¾ tablet > 20-30 kg ½ tablet 5 to 20 kg ¼ tablet Experience with mefloquine in infants less than 3 months old or weighing less than 5 kg is limited. Children weighing between 5 to 10 kg will receive a higher prophylactic dose of mefloquine than the recommended 5 mg/kg; however the tablet cannot be accurately subdivided into less than ¼ tablet.
The first dose should be taken at least one week before arrival in an endemic area. Weekly doses should always be taken on the same day of the week. To reduce the risk of malaria after leaving an endemic area, prophylaxis must be continued for 4 additional weeks.
Consideration may also be given to initiating mefloquine prophylaxis 2 to 3 weeks prior to departure in order to determine tolerance to MEFLOQUINE and allow time to substitute other antimalarials if required.
Unexpected Travel - Loading Dose:
If it is not possible to initiate therapy one week before arrival in an endemic area, data from the literature indicate that a loading dose of mefloquine can be given in order to rapidly achieve effective blood levels of the drug; in adults weighing over 45 kg this is one MEFLOQUINE tablet (250 mg mefloquine) daily for 3 days, followed thereafter by standard weekly dosing during exposure and for 4 weeks after leaving an endemic area.
Day 1 1st Dose Day 2 2nd Dose Day 3 3rd Dose Thereafter Regular weekly doses The use of a loading dose may also permit an assessment of drug tolerance before travel and allows a change to a suitable alternative if required. The use of a loading dose may be associated with an increased incidence of adverse events.
See 8 ADVERSE REACTIONS. When prophylaxis with MEFLOQUINE fails, physicians should carefully evaluate which antimalarial to use for malaria treatment. Regarding the use of halofantrine, See 7 WARNINGS AND PRECAUTIONS, Cardiovascular.
When prophylaxis with MEFLOQUINE fails, physicians should carefully evaluate which antimalarial to use for malaria treatment. Regarding the use of halofantrine, See 7 WARNINGS AND PRECAUTIONS, Cardiovascular. Treatment MEFLOQUINE (Mefloquine T ablets) Page 7 of 40 Unclassified / Non classifié The recommended total therapeutic dose of mefloquine for non-immune patients is 20 to 25 mg/kg.
A lower total dose of 15 mg/kg may suffice for partially immune individuals. Thus, non-immunes weighing over 45 kg should receive a total of 1250 to 1500 mg mefloquine (5 to 6 MEFLOQUINE tablets) while partially immune patients of the same weight should receive 750 to 1000 mg (3 to 4 MEFLOQUINE tablets).
g. 3 + 1, 3 + 2, 3 + 2 + 1 tablets) taken 6 to 8 hours apart may reduce the occurrence or severity of adverse effects. See 8 ADVERSE REACTIONS. ** Experience with mefloquine in infants less than 3 months old or weighing less than 5 kg is limited.
*** There is no specific experience with total dosages of more than 6 tablets in very heavy patients . A second full dose should be given to patients who vomit less than 30 minutes after receiving the drug. If vomiting occurs 30 to 60 minutes after a dose, an additional half-dose should be given.
Patients with acute P. vivax malaria treated with MEFLOQUINE are at high risk of relapse because MEFLOQUINE does not eliminate exoerythrocytic (hepatic phase) parasites. g. primaquine) in order to eliminate liver forms. If a full treatment course with MEFLOQUINE does not lead to improvement within 48 to 72 hours, alternative treatments should be considered.
When break through malaria occurs during MEFLOQUINE prophylaxis, physicians should carefully evaluate which antimalarial to use for therapy. Regarding the use of halofantrine, See 7 WARNINGS AND PRECAUTIONS, Cardiovascular. MEFLOQUINE can be given for severe acute malaria after an initial course of intravenous quinine lasting at least 2 to 3 days.
, Psychiatric. • During prophylactic use, if psychiatric or neurologic symptoms occur, MEFLOQUINE should be discontinued and an alternative medication should be substituted. See 7 WARNINGS AND PRECAUTIONS, Neurologic and Psychiatric.
2 Recommended Dose and Dosage Adjustment Prophylaxis The recommended prophylactic dose of MEFLOQUINE is approximately 5 mg/kg once weekly (to a maximum of 250 mg). MEFLOQUINE (Mefloquine T ablets) Page 6 of 40 Unclassified / Non classifié 1.
Adults and children weighing over 45 kg In persons over 45 kg, the prophylactic dose is 250 mg of mefloquine (one MEFLOQUINE tablet) once weekly. 2. Children and adults weighing less than 45 kg The weekly dose decreases in proportion to bodyweight.
Weight (kg) Dose > 30-45 kg ¾ tablet > 20-30 kg ½ tablet 5 to 20 kg ¼ tablet Experience with mefloquine in infants less than 3 months old or weighing less than 5 kg is limited. Children weighing between 5 to 10 kg will receive a higher prophylactic dose of mefloquine than the recommended 5 mg/kg; however the tablet cannot be accurately subdivided into less than ¼ tablet.
The first dose should be taken at least one week before arrival in an endemic area. Weekly doses should always be taken on the same day of the week. To reduce the risk of malaria after leaving an endemic area, prophylaxis must be continued for 4 additional weeks.
Consideration may also be given to initiating mefloquine prophylaxis 2 to 3 weeks prior to departure in order to determine tolerance to MEFLOQUINE and allow time to substitute other antimalarials if required.
Unexpected Travel - Loading Dose:
If it is not possible to initiate therapy one week before arrival in an endemic area, data from the literature indicate that a loading dose of mefloquine can be given in order to rapidly achieve effective blood levels of the drug; in adults weighing over 45 kg this is one MEFLOQUINE tablet (250 mg mefloquine) daily for 3 days, followed thereafter by standard weekly dosing during exposure and for 4 weeks after leaving an endemic area.
g. quinine, quinidine, chloroquine) or to any components contained in the formulation including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with active depression or a history of psychiatric disturbances (including depression, generalized anxiety disorder, psychosis, schizophrenia or other major psychiatric disorders) or a history of convulsions should not be prescribed MEFLOQUINE prophylactically since MEFLOQUINE may precipitate these conditions.
Checklist for the Prescription of MEFLOQUINE Chemoprophylaxis:
The following checklist provides a brief guide to conditions that are contraindications to MEFLOQUINE chemoprophylaxis. The checklist is designed to assist in determining the patient’s eligibility for MEFLOQUINE chemoprophylaxis. All items should be checke d in the presence of the patient or his/her caregiver.
If one of the checklist questions 1 to 4 is answered with “Yes” then the patient is ineligible for MEFLOQUINE chemoprophylaxis. MEFLOQUINE (Mefloquine T ablets) Page 5 of 40 Unclassified / Non classifié No. Question YES NO 1. g. quinine, quinidine, chloroquine) or to any excipients of the tablet formulation?
2. Does the patient suffer from active depression or have a history of depression, generalized anxiety disorder, psychosis, schizophrenia or other psychiatric disorders? 3. Does the patient have a history of convulsions of any origin?
4. Does the patient have a history of self-endangering behaviour, suicide attempts or suicidal ideations? ca. Patient should be advised to consult a healthcare professional if any neurological and / or psychiatric symptoms occur during the prophylactic use of mefloquine as healthcare professionals may have to discontinue MEFLOQUINE and prescribe an alternative medicine for the prevention of malaria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment MEFLOQUINE (Mefloquine T ablets) Page 7 of 40 Unclassified / Non classifié The recommended total therapeutic dose of mefloquine for non-immune patients is 20 to 25 mg/kg. A lower total dose of 15 mg/kg may suffice for partially immune individuals.
Thus, non-immunes weighing over 45 kg should receive a total of 1250 to 1500 mg mefloquine (5 to 6 MEFLOQUINE tablets) while partially immune patients of the same weight should receive 750 to 1000 mg (3 to 4 MEFLOQUINE tablets). g. 3 + 1, 3 + 2, 3 + 2 + 1 tablets) taken 6 to 8 hours apart may reduce the occurrence or severity of adverse effects.
See 8 ADVERSE REACTIONS. ** Experience with mefloquine in infants less than 3 months old or weighing less than 5 kg is limited. *** There is no specific experience with total dosages of more than 6 tablets in very heavy patients . A second full dose should be given to patients who vomit less than 30 minutes after receiving the drug.
If vomiting occurs 30 to 60 minutes after a dose, an additional half-dose should be given. Patients with acute P. vivax malaria treated with MEFLOQUINE are at high risk of relapse because MEFLOQUINE does not eliminate exoerythrocytic (hepatic phase) parasites.
g. primaquine) in order to eliminate liver forms. If a full treatment course with MEFLOQUINE does not lead to improvement within 48 to 72 hours, alternative treatments should be considered. When break through malaria occurs during MEFLOQUINE prophylaxis, physicians should carefully evaluate which antimalarial to use for therapy.
Regarding the use of halofantrine, See 7 WARNINGS AND PRECAUTIONS, Cardiovascular. MEFLOQUINE can be given for severe acute malaria after an initial course of intravenous quinine lasting at least 2 to 3 days. Interactions leading to adverse events can largely be prevented by allowing an interval of at least 12 hours after the last dose of quinine.
4 Administration MEFLOQUINE (mefloquine tablets) should be taken with food, and with at least 8 oz (240 mL) of liquid. All dosage instructions relate to the mefloquine base. The tablets may be crushed and suspended in a small amount of water, milk or other beverage for administration to small children and other persons unable to swallow them whole.
5 Missed Dose If the patient misses a dose, inform the patient to skip the missed dose and take the next dose at the regular dosing schedule.
Interactions leading to adverse events can largely be prevented by allowing an interval of at least 12 hours after the last dose of quinine. 4 Administration MEFLOQUINE (mefloquine tablets) should be taken with food, and with at least 8 oz (240 mL) of liquid.
All dosage instructions relate to the mefloquine base. The tablets may be crushed and suspended in a small amount of water, milk or other beverage for administration to small children and other persons unable to swallow them whole. 5 Missed Dose If the patient misses a dose, inform the patient to skip the missed dose and take the next dose at the regular dosing schedule.
5 OVERDOSAGE Symptoms and signs In cases of overdosage with MEFLOQUINE (mefloquine tablets), the symptoms mentioned under 8 ADVERSE REACTIONS may be more pronounced. Treatment Patients should be managed by symptomatic and supportive care following MEFLOQUINE overdose, particularly for cardiovascular disturbances.
There are no specific antidotes. The use of activated charcoal to limit mefloquine absorption may be considered within one hour of ingestion of an overdose. Monitor cardiac function (if possible by ECG) and neuropsychiatric status for at least 24 hours.
Provide symptomatic and intensive supportive treatment as required. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 - Dosage Forms, Strengths, Composition and Packaging MEFLOQUINE 250 mg: Each white, round, flat-faced, bevelled-edged tablet, cross-scored on one side, other side plain, contains 250 mg mefloquine (base) as mefloquine hydrochloride.
Available in blister packs of 8 tablets. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General • In case of life-threatening, serious or overwhelming malaria infections due to P. falciparum, patients should be treated with an intravenous antimalarial drug.
Following completion of initial intravenous treatment, MEFLOQUINE may be given orally to complete the course of therapy. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 250 mg of mefloquine hydrochloride Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.
MEFLOQUINE (Mefloquine T ablets) Page 9 of 40 Unclassified / Non classifié • Patients with acute P. vivax malaria treated with MEFLOQUINE are at high risk of relapse because MEFLOQUINE does not eliminate exoerythrocytic (hepatic phase) parasites.
, primaquine). • There are insufficient clinical data to document the effect of MEFLOQUINE in malaria caused by P. ovale or P. malariae. • MEFLOQUINE has a long half-life; adverse reactions to MEFLOQUINE may occur or persist up to several weeks or months after discontinuation of the drug.
, depression, tinnitus, dizziness, vertigo or loss of balance) may continue for months or years after discontinuation of MEFLOQUINE, and permanent vestibular damage has been seen in some cases. 5 Post-Market Adverse Reactions. […]
Day 1 1st Dose Day 2 2nd Dose Day 3 3rd Dose Thereafter Regular weekly doses The use of a loading dose may also permit an assessment of drug tolerance before travel and allows a change to a suitable alternative if required. The use of a loading dose may be associated with an increased incidence of adverse events.
See