Mefloquine Hydrochloride (Mefloquine Hydrochloride)

Trade Name : Mefloquine Hydrochloride

West-Ward Pharmaceuticals Corp.

TABLET

Strength 250 mg/1

MEFLOQUINE HYDROCHLORIDE Antimalarial [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Mefloquine Hydrochloride (Mefloquine Hydrochloride) which is also known as Mefloquine Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 250 mg/1 per ml. Read more

Mefloquine Hydrochloride (Mefloquine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Mefloquine may cause neuropsychiatric adverse reactions that can persist after mefloquine has been discontinued. Mefloquine should not be prescribed for prophylaxis in patients with major psychiatric disorders. During prophylactic use, if psychiatric or neurologic symptoms occur, the drug should be discontinued and an alternative medication should be substituted (see WARNINGS).
  • Mefloquine Hydrochloride Tablets USP is an antimalarial agent available as 250 mg tablets of mefloquine hydrochloride USP (equivalent to 228 mg of the free base) for oral administration.
  • Mefloquine hydrochloride is a 4-quinolinemethanol derivative with the specific chemical name of (R*,S*)-(u00b1)-u03b1-2-piperidinyl-2,8-bis(trifluoromethyl)-4-quinolinemethanol hydrochloride. It is a 2-aryl substituted chemical structural analog of quinine. The drug is a white to almost white crystalline compound, slightly soluble in water.
  • Mefloquine hydrochloride has a calculated molecular weight of 414.8 and the following structural formula:
  • The inactive ingredients are ammonium-calcium alginate blend, colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 331, povidone and pregelatinized starch.
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  • Use of Mefloquine 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 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.
  • In case of life-threatening, serious or overwhelming malaria infections due to , 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 : : ).
  • 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 co-administration (see : : and : ).
  • 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. Neuropsychiatric symptoms can be difficult to identify in children. Therefore, vigilance is required to monitor for the occurrence of these symptoms, especially in non-verbal children.
  • Psychiatric Adverse Reactions
  • Psychiatric symptoms ranging from anxiety, paranoia, and depression to hallucinations and psychotic behavior can occur with mefloquine use. 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 substituted.
  • Neurologic Adverse Reactions
  • Neurologic symptoms such as dizziness or vertigo, tinnitus, and loss of balance have been reported. These adverse reactions may occur early 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. The drug should therefore be prescribed only for curative treatment in such patients and only if there are compelling medical reasons for its use (see ). Concomitant administration of mefloquine and quinine or chloroquine may increase the risk of convulsions.
  • Occular Effects
  • Eye disorders, including but not limited to optic neuropathy and retinal disorders, have been reported during treatment with mefloquine. Any patient presenting with visual symptoms should be referred to the treating physician and an ophthalmologist as certain conditions (such as retinal disorders or optic neuropathy) may require stopping treatment with mefloquine (see , ).
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  • Mefloquine Hydrochloride Tablets USP
  • 250 mg tablet is supplied as a speckled off-white to yellow, round flat faced beveled edge tablet with product identification u201c54 111u201d debossed on one side and scored on the other side. Each tablet contains 250 mg of mefloquine hydrochloride USP.
  • NDC 0054-0025-11: Bottle of 25 Tablets
  • Mefloquine hydrochloride should be stored at 20u02da to 25u00b0C (68u02da to 77u00b0F). [See USP Controlled Room Temperature.]
  • Ocular lesions were observed in rats fed mefloquine daily for 2 years. All surviving rats given 30 mg/kg/day had ocular lesions in both eyes characterized by retinal degeneration, opacity of the lens, and retinal edema. Similar but less severe lesions were observed in 80% of female and 22% of male rats fed 12.5 mg/kg/day for 2 years. At doses of 5 mg/kg/day, only corneal lesions were observed. They occurred in 9% of rats studied.
  • Male Wistar rats orally administered mefloquine daily for 22 days at the equivalent human therapeutic plasma concentration showed CNS penetration of mefloquine, with a 30 to 50 fold greater brain/plasma drug ratio up to 10 days after the final dose administered.n
  • REFERENCES
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10002082/13
  • Revised August 2016
  • Important:
  • Your doctor or pharmacist will give you an Information Wallet Card along with this Medication Guide.
  • What is the most important information I should know about mefloquine?
  • Mefloquine can cause serious side effects, including:
  • 1. Heart Problems.
  • Do not take halofantrine (used to treat malaria) or ketoconazole (used for fungal infections) with mefloquine or within 15 weeks of your last dose of mefloquine. You may get serious heart problems (problems with the electrical system of your heart called QT prolongation) that can lead to death. Do not take quinine (Qualaquin) or quinidine (used to treat malaria or irregular heart beat) with mefloquine. You may get serious heart problems.
  • 2. Mental problems.
  • Some people who take mefloquine think about suicide (putting an end to their life). Some people who were taking mefloquine committed suicide. It is not known if mefloquine was responsible for those suicides.
  • If you have any of these serious mental problems, or you develop other serious side effects or mental problems, you should contact your doctor right away as it may be necessary to stop taking mefloquine and use a different medicine to prevent malaria.
  • 3. Problems with your bodyu2019s nervous system.
  • Dizziness, vertigo, tinnitus, and loss of balance can go on for months or years after mefloquine is stopped or may become permanent in some people.
  • Important:
  • You need to take malaria prevention medicine before you travel to a malaria area, while you are in a malaria area, and after you return from a malaria area.
  • What is mefloquine?
  • Mefloquine is a prescription medicine used to prevent and treat malaria. Malaria can be a life-threatening infection. Mefloquine does not work for all types of malaria.
  • It is not known if mefloquine is safe and effective in children under 6 months old for the treatment of malaria. It is not known how well mefloquine works to prevent malaria in children weighing less than 44 pounds (20 kilograms).
  • Who should not take mefloquine?
  • Do not take mefloquine if you have:
  • Talk to your doctor before you take mefloquine if you have any of the medical conditions listed above.
  • What should I tell my doctor before taking mefloquine?
  • Before taking mefloquine, tell your doctor about all your medical conditions, including if you have:
  • Contact your doctor right away if you have a fever after leaving a malaria area.
  • Tell your doctor about all the medicines you take,
  • How should I take mefloquine?
  • What should I avoid while taking mefloquine?
  • Avoid activities such as driving a car or using heavy machinery or other activities needing alertness and careful movements (fine motor coordination) until you know how mefloquine affects you. You may feel dizzy or lose your balance. This could happen for months or years after you stop taking mefloquine and can be permanent in some cases. See u201c?u201d
  • What are the possible side effects of mefloquine?
  • See u201c?u201d
  • Mefloquine may cause serious side effects, including:
  • Call your healthcare provider right away if you have unexplained symptoms such as nausea or vomiting, stomach pain, fever, weakness, itching, unusual tiredness, loss of appetite, light colored bowel movements, dark colored urine, yellowing of your skin or the white of your eyes.
  • The most common side effects of mefloquine include:
  • The most common side effects in people who take mefloquine for treatment include:
  • Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of mefloquine. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store mefloquine?
  • Keep mefloquine and all medicines out of the reach of children.
  • General information about the safe and effective use of mefloquine.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use mefloquine for a condition for which it was not prescribed. Do not give mefloquine to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about mefloquine. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about mefloquine that is written for health professionals.
  • What are the ingredients in mefloquine?
  • Active ingredients: mefloquine hydrochloride USP
  • Inactive ingredients: ammonium-calcium alginate blend, colloidal silicon dioxide, crospovidone, lactose monohydrate regular, magnesium stearate, microcrystalline cellulose, poloxamer 331, povidone and pregelatinized starch.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10002082/12
  • Revised March 2016
  • It is important that you read the entire Medication Guide for additional information on mefloquine. Carry this wallet card with you when you are taking mefloquine.
  • Important: You need to take malaria prevention medicine before you travel to a malaria area, while you are in a malaria area, and after you return from a malaria area.
  • Mefloquine can cause serious side effects, including:
  • 1. Heart problems.
  • Do not
  • Do not
  • Mefloquine may cause serious problems with the electrical system of your heart, called QT prolongation.
  • 2. Mental problems.
  • If you have any of these serious mental problems you should contact your doctor right away as it may be necessary to stop taking mefloquine and use a different medicine to prevent malaria.
  • 3. Problems with your bodyu2019s nervous system.
  • Do not
  • Symptoms of serious nervous system problems may include dizziness, a feeling that you or things around you are moving or spinning (vertigo), loss of balance, ringing in your ears (tinnitus), convulsions (seizures) in people who already have seizures, or you are unable to sleep (insomnia).
  • These serious mental and nervous system side effects can go on for months or years after mefloquine is stopped or may become permanent in some people.
  • If you are told by a doctor to stop taking mefloquine because of the side effects or for other reasons, you will need to take a different malaria medicine.
  • If you do not have access to a doctor or to a different medicine and have to stop taking mefloquine, leave the malaria area and contact a doctor as soon as possible because leaving the malaria area may not protect you from getting malaria. You will still need to take a malaria prevention medicine for another 4 weeks after you leave the malaria area.
  • Mefloquine may cause serious Symptoms of liver problems include nausea, vomiting, loss of appetite, unusual tiredness, stomach pain, fever, weakness, itching, light-colored bowel movements, dark colored urine, yellowing of your skin or the white of your eyes. The most of mefloquine include nausea, vomiting, diarrhea, abdominal pain and headache.
  • Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of mefloquine. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.
  • What should I avoid while taking mefloquine?
  • Avoid activities such as driving a car or using heavy machinery or other activities needing alertness and careful movements (fine motor coordination) until you know how mefloquine affects you. You may feel dizzy or lose your balance. This could happen for months or years after you stop taking mefloquine and can be permanent in some cases.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10002082/13
  • Revised August 2016
  • No data

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