MEFLOQUINE 250 MG

What is MEFLOQUINE?

MEFLOQUINE 250 MG contains MEFLOQUINE (MEFLOQUINE HYDROCHLORIDE) : 250 MG. It is listed in the Health Canada Drug Product Database under DIN 02244366, held by AA PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 31-May-2011. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MEFLOQUINE 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 strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by P. vivax.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Prophylaxis: The recommended prophylactic dose of MEFLOQUINE is approximately 5 mg/kg once weekly (to a maximum of 250 mg). 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 Treatment: 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). Table 1 - Recommended total therapeutic dosages of MEFLOQUINE tablets relative to body weight and immune status * Non-immune patients | Partially immune patients < 20 kg** | ¼ Tablet per 2.5 - 3 kg of weight | ¼ tablet per 4 kg of weight | 1 tablet per 10 - 12 kg of weight | 1 tablet per 16 kg of weight 20-30 kg | 2-3 tablets | 1½-2 tablets 30-45 kg | 3-4 tablets | 2-3 tablets 45-60 kg | 5 tablets | 3 tablets > 60 kg *** | 6 tablets | 4 tablets 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. To avoid relapse after initial treatment of the acute infection with MEFLOQUINE, patients should subsequently be treated with an 8-aminoquinoline (e.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. 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. 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. 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.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store 15-30°C. Sensitive to moisture. Keep in the blister until consumed.

How is it supplied?

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.

Contraindications

MEFLOQUINE (mefloquine tablets) is contraindicated in: • Patients with known hypersensitivity to mefloquine or related compounds, (e.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 checked 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.

Warnings and precautions

Serious Warnings and Precautions: • MEFLOQUINE should not be prescribed for prophylaxis in patients with major psychiatric disorders. See 2 CONTRAINDICATIONS. • MEFLOQUINE may cause neuropsychiatric adverse reactions that can persist after mefloquine has been discontinued. See 7 WARNINGS AND PRECAUTIONS, 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. 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. • Patients with acute P. vivax malaria treated with MEFLOQUINE are at high risk of relapse because MEFLOQUINE does not eliminate exoerythrocytic (hepatic phase) parasites. To avoid relapse, after initial treatment of the acute infection with MEFLOQUINE, patients should subsequently be treated with an 8-aminoquinoline (e.g., 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. • In a small number of patients it has been reported that neuropsychiatric reactions (e.g., 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. See 8.5 Post-Market Adverse Reactions. Cardiovascular: Caution should be exercised in prescribing MEFLOQUINE to patients suffering from cardiac conduction disorders. In patients with cardiac disease, the benefits of mefloquine therapy should be weighed against the possibility of adverse cardiac effects. Parenteral studies in animals show that mefloquine, a myocardial depressant, possesses 20% of the anti-fibrillatory action of quinidine and produces 50% of the increase in the PR interval reported with quinine. The effect of mefloquine on the compromised cardiovascular system has not been evaluated. However, transitory and clinically silent ECG alterations have been reported during the use of mefloquine; alterations included sinus bradycardia, sinus arrhythmia, first degree AV-block, prolongation of the QTc interval and abnormal T waves. Concomitant administration of MEFLOQUINE and other drugs known to alter cardiac conduction, including quinine, quinidine or chloroquine, may produce electrocardiographic abnormalities or cardiac arrest. If quinine or quinidine are to be used in the initial treatment of severe malaria, mefloquine administration should be delayed for at least 12 hours after the final dose of either of these drugs. See 9.4 Drug-Drug Interactions. Due to the risk of a potentially fatal prolongation of the QTc interval, halofantrine must not be given during MEFLOQUINE therapy for prophylaxis or treatment of malaria, or within 15 weeks after the last dose of MEFLOQUINE. The risk of QTc prolongation may also be expected if ketoconazole is taken during MEFLOQUINE therapy for prophylaxis or treatment of malaria, or within 15 weeks after the last dose of MEFLOQUINE, due to increased plasma concentrations and elimination half-life of mefloquine following co-administration with ketoconazole. See 10.3 Pharmacokinetics. Patients should be advised to consult a healthcare professional if they experience palpitations or any arrhythmia during chemoprophylaxis with MEFLOQUINE. Driving and Operating Machinery: Dizziness or vertigo, a disturbed sense of balance, tinnitus and other disorders of the central or peripheral nervous system have been reported during and after the use of mefloquine tablets. Caution should be exercised with regar

What can be used instead?

Other Canadian products sharing ATC code P01BC02 MEFLOQUINE. 1 of 2 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies MEFLOQUINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. MEFLOQUINE appears in 7 registered pack listings across 4 markets, published on 3 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.