Mefloquine Hydrochloride 250 mg/1
Mefloquine Hydrochloride · TABLET · A-S Medication Solutions
Mefloquine Hydrochloride is a tablet containing mefloquine hydrochloride at 250 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Mefloquine Hydrochloride
- Generic Name
- Mefloquine Hydrochloride
- NDC Code (Product)
50090-2396- Manufacturer
- A-S Medication Solutions
- Strength
- 250 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA076392
- Marketing Start
- 01/06/2004
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Treatment of Acute Malaria Infections Mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum (both chloroquine-susceptible and resistant strains) or by Plasmodium vivax. There are insufficient clinical data to document the effect of mefloquine in malaria caused by P. ovale or P. malariae. Note: 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 derivative (e.g., primaquine). Prevention of Malaria Mefloquine hydrochloride tablets are indicated for the prophylaxis of P. falciparum and P. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of P. falciparum.
Dosage & Administration
DOSAGE AND ADMINISTRATION Malaria Treatment in Adults Treatment of mild to moderate malaria in adults caused by mefloquine-susceptible strains of P. falciparum or by P. vivax: Dosage: Five tablets (1250 mg) mefloquine hydrochloride to be given as a single oral dose. The drug should not be taken on an empty stomach and should be administered with at least 8 oz (240 mL) of water. If a full-treatment course with mefloquine does not lead to improvement within 48 to 72 hours, mefloquine should not be used for retreatment. An alternative therapy should be used. Similarly, if previous prophylaxis with mefloquine failed, mefloquine should not be used for curative treatment (see INDICATIONS AND USAGE ). Note: 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 derivative (e.g., primaquine). Malaria Prophylaxis in Adults Dosage: One 250 mg mefloquine hydrochloride tablet once weekly. Prophylactic drug administration should begin 1…
Warnings
WARNINGS 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 intravenous treatment, mefloquine may be given to complete the course of therapy. QTc Interval Prolongation and Drug Interactions Halofantrine should not be administered with mefloquine or within 15 weeks of the last dose of mefloquine due to the risk of a potentially fatal prolongation of the QTc interval (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elimination ). Ketoconazole should not be administered with mefloquine or within 15 weeks of the last dose of mefloquine due to the risk of a potentially fatal prolongation of the QTc interval. Ketoconazole increases plasma concentrations and elimination half-life of mefloquine following coadministration (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elimination and PRECAUTIONS, Drug Interactions ). Concomitant administration of mefloquine and quinine or quinidine may produce electrocardiographic abnormalities. Psychiatric and Neurologic Adverse Reactions Mefloquine may cause neuropsychiatric adverse reactions in adults and children. Neuropsychia…
Contraindications
CONTRAINDICATIONS Use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (e.g., quinine and quinidine) or to any of the excipients contained in the formulation. Mefloquine hydrochloride tablets should not be prescribed for prophylaxis in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, schizophrenia or other major psychiatric disorders, or with a history of convulsions.
Drug Interactions
Drug Interactions Drug-drug interactions with mefloquine have not been explored in detail. There is one report of cardiopulmonary arrest, with full recovery, in a patient who was taking a beta blocker (propranolol) (see PRECAUTIONS, Cardiac Effects ). The effects of mefloquine on the compromised cardiovascular system have not been evaluated. The benefits of mefloquine therapy should be weighed against the possibility of adverse effects in patients with cardiac disease. Halofantrine Halofantrine should not be administered with mefloquine or within 15 weeks of the last dose of mefloquine due to the risk of a potentially fatal prolongation of the QTc interval (see WARNINGS ). Other Antimalarial Drugs Concomitant administration of mefloquine and other related antimalarial compounds (e.g., quinine, quinidine and chloroquine) may produce electrocardiographic abnormalities and increase the risk of convulsions (see WARNINGS ). If these drugs are to be used in the initial treatment of severe malaria, mefloquine administration should be delayed at least 12 hours after the last dose. Clinically significant QTc prolongation has not been found with mefloquine alone. Ketoconazole (Potent Inhibit…
Adverse Reactions
ADVERSE REACTIONS Clinical At the doses used for treatment of acute malaria infections, the symptoms possibly attributable to drug administration cannot be distinguished from those symptoms usually attributable to the disease itself. Among subjects who received mefloquine for prophylaxis of malaria, the most frequently observed adverse experience was vomiting (3%). Dizziness, syncope, extrasystoles and other complaints affecting less than 1% were also reported. Two serious adverse reactions were cardiopulmonary arrest in one patient shortly after ingesting a single prophylactic dose of mefloquine while concomitantly using propranolol (see PRECAUTIONS, Drug Interactions ), and encephalopathy of unknown etiology during prophylactic mefloquine administration. The relationship of encephalopathy to drug administration could not be clearly established. Among subjects who received mefloquine for treatment, the most frequently observed adverse experiences included: dizziness, myalgia, nausea, fever, headache, vomiting, chills, diarrhea, skin rash, abdominal pain, fatigue, loss of appetite, and tinnitus. Those side effects occurring in less than 1% included bradycardia, hair loss, emotional…
Frequently Asked Questions
What is Mefloquine Hydrochloride used for?
Mefloquine Hydrochloride contains Mefloquine Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Mefloquine Hydrochloride a controlled substance?
Mefloquine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Mefloquine Hydrochloride?
The generic name for Mefloquine Hydrochloride is Mefloquine Hydrochloride. There are no other listed brand versions of Mefloquine Hydrochloride.
What is the NDC code for Mefloquine Hydrochloride 250 mg/1?
The NDC (National Drug Code) for Mefloquine Hydrochloride 250 mg/1 is 50090-2396, listed by A-S Medication Solutions.
Other Mefloquine Hydrochloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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