Mefloquine

Mefloquine

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

  • Aching joints and muscles
  • Anxiety
  • Blistering, loosening, peeling, or redness of the skin
  • Chest pain or discomfort
  • Chills
  • Confusion
  • Convulsions (seizures)
  • Cough or hoarseness
  • Depression
  • Dizziness
  • Fainting
  • Fever
  • Hallucinations (seeing, hearing, or feeling things that are not there)
  • Irregular, pounding, slow, or fast heartbeat or pulse
  • Irritability
  • Lightheadedness
  • Lower back or side pain
  • Mental depression
  • Nervousness
  • Painful or difficult urination
  • Pinpoint red spots on the skin
  • Red or irritated eye
  • Restlessness
  • Sore throat
  • Sores, ulcers, or white spots in the mouth or on the lips
  • Stiff neck
  • Swelling of the ankles, feet, or lower legs
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • Vomiting

Incidence not known

  • Blurred or loss of vision
  • Disturbed color perception
  • Double vision
  • Halos around lights
  • Hearing problems
  • Loss of bladder control
  • Muscle spasm or jerking of all extremities
  • Night blindness
  • Overbright appearance of lights
  • Severe or continuing headache
  • Shortness of breath or wheezing
  • Sudden loss of consciousness
  • Troubled breathing
  • Tunnel vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Continuing ringing or buzzing or other unexplained noise in the ears
  • Diarrhea
  • Emotional problems
  • Hearing loss
  • Loss of balance
  • Nausea
  • Stomach pain

Less common

  • Abnormal dreams
  • Feeling of constant movement of self or surroundings
  • Loss of appetite
  • Sensation of spinning
  • Skin rash
  • Trouble with sleeping

Rare

  • Loss of hair

Incidence not known

  • Acid or sour stomach
  • Belching
  • Flushing, redness of the skin
  • Heartburn
  • Indigestion
  • Skin rash with a general disease
  • Stomach discomfort, upset, or pain
  • Swelling
  • Unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Precautions

It is important that your doctor check your progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects. Blood tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Do not take halofantrine (Halfan®) or ketoconazole (Nizoral®) with mefloquine or within 15 weeks after the last dose of this medicine. This may increase the risk for more serious problems.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Check with your doctor right away if you have flu-like symptoms (such as chills, fever, headache, or muscle pains) again after treatment with this medicine.

Use birth control pills while you are taking this medicine and for 3 months after you stop mefloquine therapy. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions. Call your doctor right away if you have a rash; itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Mefloquine may cause vision problems. It may also cause some people to become dizzy or lightheaded or to have hallucinations (seeing, hearing, or feeling things that are not there). Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well. This is especially important for people whose jobs require fine coordination. If these reactions are especially bothersome, check with your doctor.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

While you are being treated with mefloquine, do not have any immunizations (vaccinations) without your doctor’s approval. Live virus vaccines should be completed 3 days before the first dose of this medicine.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in or will be traveling to an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

  • If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.
  • Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
  • Apply insect repellant, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
  • If possible, sleep in a screened or air-conditioned room or under mosquito netting sprayed with insecticide to avoid being bitten by malaria-carrying mosquitoes.
  • Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

Do not take other medicines unless they have been discussed with your doctor (especially medicines that prolong QT interval). This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a medication guide and an information wallet card. Read and follow the instructions carefully. Talk with your doctor if you have any questions.

Mefloquine is best taken with a full glass (8 ounces) of water and with food, unless otherwise directed by your doctor.

Mefloquine may be crushed and put in water, milk, or juice to make it easier to take.

For patients taking mefloquine to prevent the symptoms of malaria:

  • Your doctor will want you to start taking this medicine one week before you travel to an area where there is a chance of getting malaria.
  • Also, you should keep taking this medicine while you are in the area where malaria is present and for 4 weeks after you leave the area. No medicine will protect you completely from malaria. However, to protect you as completely as possible, it is important that you keep taking this medicine for the full time your doctor ordered. Also, if fever or “flu-like” symptoms develop during your travels or within 2 to 3 months after you leave the area, check with your doctor immediately.
  • This medicine works best when you take it on a regular schedule. For example, if you are to take it once a week, it is best to take it on the same day each week. Do not miss any doses. If you have any questions about this, check with your doctor.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Children may vomit after taking this medicine. Your child may vomit some of the dose of medicine. Contact your child’s doctor if vomiting occurs. The doctor may need for you to give your child more medicine.

The number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on whether you are using mefloquine to prevent or to treat malaria.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For prevention of malaria:
      • Adults and children weighing over 45 kilograms (kg) (99 pounds)—250 milligrams (mg) (1 tablet) one week before traveling to an area where malaria occurs. Then 250 mg once a week on the same day of each week and preferably after your main meal while staying in the area and every week for four weeks after leaving the area.
      • Children and infants above 6 months old—Dose is based on body weight and must be determined by your doctor.
        • Children weighing 5 to 9 kg (11 to 20 pounds): 5 mg per kg of body weight one week before traveling to an area where malaria occurs.
        • Children weighing 10 to 19 kg (21 to 43 pounds): 62.5 mg (¼ tablet) one week before traveling to an area where malaria occurs. Then 62.5 mg once a week while staying in the area where malaria occurs and every week for four weeks after leaving the area.
        • Children weighing 20 to 30 kg (44 to 66 pounds): 125 mg (½ tablet) one week before traveling to an area where malaria occurs. Then 125 mg once a week while staying in the area and every week for four weeks after leaving the area.
        • Children weighing 31 to 45 kg (67 to 99 pounds): 187.5 mg (?? tablet) one week before traveling to an area where malaria occurs. Then 187.5 mg once a week while staying in the area and every week for four weeks after leaving the area.
      • Infants up to 6 months old or weighing less than 5 kilograms (kg)—Use and dose must be determined by your doctor.
    • For treatment of malaria:
      • Adults—1250 milligrams (mg) or five tablets as a single dose.
      • Children and infants above 6 months old—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 25 milligrams (mg) per kilogram (kg) (9 to 11 mg per pound) of body weight as a single dose or two doses (divide the single dose by two) taken 6 to 8 hours apart. Taking two doses may decrease the occurrence of unwanted side effects.
      • Infants up to 6 months old—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mefloquine in children. However, safety and efficacy have not been established in infants up to 6 months old.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mefloquine in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving mefloquine.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aurothioglucose
  • Bepridil
  • Cisapride
  • Dronedarone
  • Isradipine
  • Levomethadyl
  • Mesoridazine
  • Pimozide
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acecainide
  • Ajmaline
  • Amiodarone
  • Amisulpride
  • Aprindine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azimilide
  • Bretylium
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Clarithromycin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Droperidol
  • Enflurane
  • Erythromycin
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Gemifloxacin
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Isoflurane
  • Ketoconazole
  • Lapatinib
  • Lidoflazine
  • Lorcainide
  • Octreotide
  • Pentamidine
  • Pirmenol
  • Prajmaline
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Propafenone
  • Propranolol
  • Quetiapine
  • Quinidine
  • Quinine
  • Risperidone
  • Sematilide
  • Sertindole
  • Sotalol
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Tedisamil
  • Telithromycin
  • Trifluoperazine
  • Trimethoprim
  • Vasopressin
  • Zolmitriptan
  • Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Lumefantrine
  • Rifampin
  • Valproic Acid

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bradycardia (slow heartbeat), severe or
  • Depression, history of or
  • Heart block, severe or
  • Heart disease, severe or
  • Heart rhythm problems (e.g., arrhythmia, prolonged QT interval), history of—Use is not recommended. May make these conditions worse.
  • Emotional or mental problems (e.g. depression, generalized anxiety disorder, psychosis, or schizophrenia) or
  • Seizures, history of—Should not be used in patients with these conditions.
  • Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
  • Malaria, severe or life-threatening—Your doctor may want you to receive an antimalarial injection before taking this medicine.

Description

Mefloquine is used to treat malaria. It is also used to prevent malaria infection in areas or regions where it is known that other medicines (e.g., chloroquine) may not work.

Mefloquine belongs to a group of medicines known as antimalarials. It works by preventing or treating malaria, a red blood cell infection transmitted by the bite of a mosquito.

Malaria transmission occurs in large areas of Central and South America, Hispaniola, sub-Saharan Africa, the Indian subcontinent, Southeast Asia, the Middle East, and Oceania. Country-specific information on malaria can be obtained from the Centers for Disease Control and Prevention (CDC), or from the CDC’s web site at http://www.cdc.gov/travel.

This medicine is available only with your doctor’s prescription.

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