Ask your doctor to explain anything you do not understand. If you need an oral vaccine to help prevent you from catching typhoid, you should arrange to receive it at least 3 days before you need to start taking Lariam. Otherwise, Lariam may stop the vaccine from working properly. What you need to know before you take Lariam Pregnancy and breast-feeding Pregnant women should not normally take these tablets. What is in this leaflet 1. What Lariam is and what it is used for 2.

What you need to know before you take Lariam 3. How to take Lariam 4. Possible side effects 5. Clinically significant QTc prolongation has not been found with mefloquine alone. This appears to be the only clinically relevant interaction of this kind with Lariam mefloquine , although theoretically, coadministration of other drugs known to alter cardiac conduction eg, anti-arrhythmic or beta-adrenergic blocking agents, calcium channel blockers , antihistamines or H1-blocking agents, tricyclic antidepressants and phenothiazines might also contribute to a prolongation of the QTc interval.

There are no data that conclusively establish whether the concomitant administration of mefloquine and the above listed agents has an effect on cardiac function. In patients taking an anticonvulsant eg, valproic acid , carbamazepine , phenobarbital or phenytoin , the concomitant use of Lariam mefloquine may reduce seizure control by lowering the plasma levels of the anticonvulsant. When Lariam mefloquine is taken concurrently with oral live typhoid vaccines , attenuation of immunization cannot be excluded.

Vaccinations with attenuated live bacteria should therefore be completed at least 3 days before the first dose of Lariam mefloquine. No other drug interactions are known. Nevertheless, the effects of Lariam mefloquine on travelers receiving comedication, particularly diabetics or patients using anticoagulants, should be checked before departure.

In clinical trials, the concomitant administration of sulfadoxine and pyrimethamine did not alter the adverse reaction profile. Following completion of intravenous treatment, Lariam mefloquine may be given to complete the course of therapy. Data on the use of halofantrine subsequent to administration of Lariam mefloquine suggest a significant, potentially fatal prolongation of the QTc interval of the ECG.

Therefore, halofantrine must not be given simultaneously with or subsequent to Lariam mefloquine. Mefloquine may cause psychiatric symptoms in a number of patients, ranging from anxiety, paranoia, and depression to hallucinations and psychotic behavior.

On occasions, these symptoms have been reported to continue long after mefloquine has been stopped. To minimize the chances of these adverse events, mefloquine should not be taken for prophylaxis in patients with active depression or with a recent history of depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders. Lariam mefloquine should be used with caution in patients with a previous history of depression.

During prophylactic use, if psychiatric symptoms such as acute anxiety, depression, restlessness or confusion occur, these may be considered prodromal to a more serious event. In these cases, the drug must be discontinued and an alternative medication should be substituted. Concomitant administration of Lariam mefloquine and quinine or quinidine may produce electrocardiographic abnormalities. Concomitant administration of Lariam mefloquine and quinine or chloroquine may increase the risk of convulsions.

In patients with epilepsy , Lariam mefloquine may increase the risk of convulsions. Central and Peripheral Nervous System Effects Caution should be exercised with regard to activities requiring alertness and fine motor coordination such as driving, piloting aircraft, operating machinery, and deep-sea diving, as dizziness, a loss of balance, or other disorders of the central or peripheral nervous system have been reported during and following the use of Lariam mefloquine.

These effects may occur after therapy is discontinued due to the long half-life of the drug. Use in Patients with Hepatic Impairment In patients with impaired liver function the elimination of mefloquine may be prolonged, leading to higher plasma levels. Long-Term Use This drug has been administered for longer than 1 year. If the drug is to be administered for a prolonged period, periodic evaluations including liver function tests should be performed. Although retinal abnormalities seen in humans with long-term chloroquine use have not been observed with mefloquine use, long-term feeding of mefloquine to rats resulted in dose-related ocular lesions retinal degeneration, retinal edema and lenticular opacity at Therefore, periodic ophthalmic examinations are recommended.

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. Laboratory Tests Periodic evaluation of hepatic function should be performed during prolonged prophylaxis.

Information for Patients Medication Guide: As required by law, a Lariam mefloquine Medication Guide is supplied to patients when Lariam mefloquine is dispensed. An information wallet card is also supplied to patients when Lariam mefloquine is dispensed. Patients should be instructed to read the Medication Guide when Lariam mefloquine is received and to carry the information wallet card with them when they are taking Lariam. The complete texts of the Medication Guide and information wallet card are reprinted at the end of this document.

Patients should be advised: Although side effects of dizziness and loss of balance are usually mild and do not cause people to stop taking the medication, in a small number of patients it has been reported that these symptoms may continue for months after discontinuation of the drug. No treatment-related increases in tumors of any type were noted.

Mutagenesis The mutagenic potential of mefloquine was studied in a variety of assay systems including: Ames test , a host-mediated assay in mice, fluctuation tests and a mouse micronucleus assay. Several of these assays were performed with and without prior metabolic activation.

In no instance was evidence obtained for the mutagenicity of mefloquine. There are no adequate and well-controlled studies in pregnant women. However, clinical experience with Lariam mefloquine has not revealed an embryotoxic or teratogenic effect. Mefloquine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women of childbearing potential who are traveling to areas where malaria is endemic should be warned against becoming pregnant. Women of childbearing potential should also be advised to practice contraception during malaria prophylaxis with Lariam mefloquine and for up to 3 months thereafter.

However, in the case of unplanned pregnancy, malaria chemoprophylaxis with Lariam mefloquine is not considered an indication for pregnancy termination. Nursing Mothers Mefloquine is excreted in human milk in small amounts, the activity of which is unknown. Because of the potential for serious adverse reactions in nursing infants from mefloquine, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use Use of Lariam mefloquine to treat acute, uncomplicated P. The safety and effectiveness of Lariam mefloquine for the treatment of malaria in pediatric patients below the age of 6 months have not been established. In several studies, the administration of Lariam mefloquine for the treatment of malaria was associated with early vomiting in pediatric patients.

Early vomiting was cited in some reports as a possible cause of treatment failure. Geriatric Use Clinical studies of Lariam mefloquine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Symptoms may occur early in the course of Mefloquine use. In some cases, these symptoms have been reported to continue for months or years after Mefloquine has been stopped. Cases of suicidal ideation and suicide have been reported. Mefloquine should not be prescribed for prophylaxis in patients with active depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders.

Mefloquine should be used with caution in patients with a previous history of depression. During prophylactic use, the occurrence of psychiatric symptoms such as acute anxiety, depression, restlessness or confusion suggest a risk for more serious psychiatric disturbances or neurologic adverse reactions. In these cases, the drug should be discontinued and an alternative medication should be submitted. Neurologic Adverse Reactions Neurologic symptoms such as dizziness or vertigo, tinnitus, and loss of balance have been reported.

These adverse reactions may occur in the course of Mefloquine use and in some cases have been reported to continue for months or years after Mefloquine has been stopped. Dizziness or vertigo, tinnitus, and loss of balance have been reported to be permanent in some cases. During prophylactic use, if neurologic symptoms occur, the drug should be discontinued and an alternative medication should be substituted. Caution should be exercised with regard to activities requiring alertness and fine motor coordination, such as driving, piloting aircraft, operating machinery, and deep-sea diving, while symptoms persist.

Mefloquine may increase the risk of convulsions in patients with epilepsy. Concomitant administration of Mefloquine and quinine or chloroquine may increase the risk of convulsions.

Ocular Effects Eye disorders, including but not limited to optic neuropathy and retinal disorders, have been reported during treatment with Mefloquine. Precautions Hypersensitivity reactions have been reported with Mefloquine use. Use in Patients with Hepatic Impairment In patients with impaired liver function, the elimination of Mefloquine may be prolonged, leading to higher plasma levels and a higher risk of adverse reactions.

Long-Term Use This drug has been administered for longer than one year. The effect of Mefloquine on the compromised cardiovascular system has not been evaluated. The benefits of Mefloquine therapy should be weighed against the possibility of adverse effects in patients with cardiac disease.

For example, resistance of P. Laboratory Tests Periodic evaluation of hepatic function should be performed during prolonged prophylaxis. Information for Patients Medication Guide: As required by law, a Mefloquine Medication Guide is supplied to patients when Mefloquine is dispensed.

An information wallet card is also supplied to patients when Mefloquine is dispensed. Patients should be instructed to read the Medication Guide when Mefloquine is received and to carry the information wallet card with them when they are taking Mefloquine.

The complete text of the Medication Guide and information wallet card is reprinted at the end of this document. Patients should be advised: Drug Interactions Drug-drug interactions with Mefloquine have not been explored in detail.

The effects of Mefloquine on the compromised cardiovascular system have not been evaluated. Other Antimalarial Drugs Concomitant administration of Mefloquine and other related antimalarial compounds e. 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. There are no data that conclusively establish whether the concomitant administration of Mefloquine and the above listed agents has an effect on cardiac function.

Anticonvulsants In patients taking an anticonvulsant e. Vaccines When Mefloquine is taken concurrently with oral live typhoid vaccines, attenuation of immunization cannot be excluded. Vaccinations with attenuated live bacteria should therefore be completed at least 3 days before the first dose of Mefloquine hydrochloride tablets.

Rifampin should be used cautiously in patients taking Mefloquine. Thus, concomitant administration of Mefloquine hydrochloride tablets and substrates of the CYP enzyme system is not expected to result in a drug interaction. Therefore, Mefloquine hydrochloride tablets should be used with caution when administered concomitantly with CYP3A4 inhibitors. Therefore, Mefloquine hydrochloride tablets should also be used with caution when administered concomitantly with CYP3A4 inducers.

Substrates and Inhibitors of P-glycoprotein It has been shown in vitro that Mefloquine is a substrate and an inhibitor of P-glycoprotein. Therefore, drug-drug interactions could also occur with drugs that are substrates or are known to modify the expression of this transporter.

The clinical relevance of these interactions is not known to date. Other Potential Interactions No other drug interactions are known.

Nevertheless, the effects of Mefloquine on travelers receiving concomitant medications, particularly diabetics or patients using anticoagulants, should be checked before departure. In clinical trials, the concomitant administration of sulfadoxine and pyrimethamine did not alter the adverse reaction profile of Mefloquine. No treatment-related increases in tumors of any type were noted.

Mutagenesis The mutagenic potential of Mefloquine was studied in a variety of assay systems including: Due to the seriousness of malaria during pregnancy, it is recommended that you should not travel to an area where you could become infected with malaria if you are pregnant, think that you may be pregnant, or if you are planning to have a baby. Lariam should be avoided by women who are breast-feeding.

If you are pregnant or breast-feeding, think that you may be pregnant, or planning to have a baby, ask your doctor for advice before taking this medicine, as he or she may decide that you should not use this medicine.

Driving and using machines Take special care if you perform activities requiring alertness and coordination accurate small movements and spatial awareness being aware of distances such as driving, piloting an aircraft, operating machinery, cycling, and deep-sea diving as Lariam can cause dizziness, loss of balance and mental problems. If you are in any doubt about whether you can do a particular activity, talk to your doctor. In a small number of patients it has been shown that dizziness, vertigo and loss of balance may persist for months or longer after stopping Lariam.

Lariam contains lactose If you have been told by your doctor that you have an intolerance to some sugars, such as lactose or galactose, you should not take Lariam. Contact your doctor before taking this medicinal product.

How to take Lariam Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The advice you are given will depend on whether you are taking the tablets for prevention or treatment of malaria. Take the tablets with plenty of water, and preferably after a meal. Swallow the tablets whole, do not suck or chew them.

Mefloquine HCL

In pediatric patients, mefloquine 250 mg tablet, the administration of Mefloquine for the treatment of malaria has been associated with early vomiting. Adults and children over 45 kg body weight, dose: In a small number of patients it has been reported mefloquine dizziness or vertigo and loss of balance may continue for months after discontinuation of the drug. During prophylactic administration of Mefloquine to indigenous populations in malaria-endemic areas, the following alterations in laboratory values were observed: As required by law, a Mefloquine Medication Guide is supplied to patients when Mefloquine is dispensed. Data on the use of halofantrine subsequent to administration of Lariam mefloquine suggest a significant, potentially fatal prolongation of the QTc interval of the ECG. Early vomiting was cited in some tablets as 250 possible cause of treatment failure. There may be new information. Treatment Patients should be managed by symptomatic and supportive care following Lariam mefloquine overdose.

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Published data on Mefloquine use during pregnancy include randomized controlled trials, mefloquine 250 mg tablet, intervention trials, prospective and retrospective cohort studies, and case series. Mefloquine tablet need to take a malaria prevention medicine. Drug Resistance Strains of P. Although clearance of Mefloquine may increase in late pregnancy, in general, pregnancy has no clinically relevant effect on the 250 of Mefloquine. Mefloquine Dosage and Administration Malaria Treatment in Adults Treatment of mild to moderate malaria in adults caused by mefloquine-susceptible strains of P. Mefloquine should not be prescribed for prophylaxis in patients with active depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders. Use in Patients with Hepatic Impairment In patients with impaired liver function the elimination of mefloquine may be prolonged, leading to higher plasma levels, mefloquine 250 mg tablet. These alterations were observed in tablets with acute malaria who received treatment doses of the drug and were attributed to the disease itself. Dispense in a tight, light-resistant container as defined in the USP 250 a child-resistant closure, mefloquine 250 mg tablet. Other medicines approved in the United States for malaria prevention include: Microbiology Mechanism of Action Mefloquine is an antimalarial agent which acts as a blood schizonticide. Patients should be advised: What is the most important information I should know about mefloquine?

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