Lariam

Lariam is a prescription medication used to prevent and treat malaria. Lariam belongs to a group of drugs called antimalarials, which work by killing the parasite that causes malaria.

This medication comes in tablet form and is taken once a day with food and with one cup (8 ounces) of water.

Common side effects of Lariam include nausea, vomiting, and stomach pain. Lariam can also cause dizziness. Do not drive or operate heavy machinery until you know how Lariam affects you.

Lariam is a prescription medication used to prevent and treat malaria.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Roche Pharmaceuticals

Serious side effects have been reported with Lariam. See the “Drug Precautions” section.

Common side effects of Lariam include the following:

• nausea
• vomiting
• diarrhea
• stomach pain
• headache
• muscle pain
• fever
• chills
• skin rash
• fatigue
• loss of appetite
• irregular heart beat

This is not a complete list of Lariam side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• medications that block the p-glycoprotein transporter such as amiodarone (Cordarone, Pacerone), azithromycin (Zithromax, Zmax), captopril (Capoten), carvedilol (Coreg), clarithromycin (Biaxin), conivaptan (Vaprisol), cyclosporine (Neoral, Sandimmune, Gengraf), diltiazem (Cardizem), dronedarone (Multaq), erythromycin (EES, Ery-Tab), felodipine (Plendil), itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), lopinavir and ritonavir (Kaletra), quinidine (Cardioquine, Duraquin), ranolazine (Ranexa), verapamil (Calan, Isoptin, Covera, Verelan)
• medications that use the p-glycoprotein transporter such as digoxin (Lanoxin), loperamide (Imodium), quinidine (Cardioquine, Duraquin), vinblastine (Velban), fexofenadine (Allegra), indinavir (Crixivan), colchicine (Colcrys), topotecan (Hycamtin), and paclitaxel (Abraxane, Onxol, Taxol)
• beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), and propranolol (Inderal)
• calcium channel blockers such as nifedipine (Adalat, Nifedical, Procardia), amlodipine (Norvasc), verapamil (Calan, Isoptin, Covera, Verelan), and diltiazem (Cardizem)
• anti-arrhythmia medications such as procainamide (Procanbid, Procan), disopyramide (Norpace, Rythmodan), lidocaine (Xylocaine, Lidoderm), phenytoin (Dilantin), mexiletine (Mexitil), flecainide (Tambocor), propafenone (Rythmol), amiodarone (Cordarone, Pacerone), sotalol (Betapace), dofetilide (Tikosyn), dronedarone (Multaq), digoxin (Lanoxin), and adenosine (Adenocard)
• valproic acid (Depakene, Depakote, Stavzor)
• halofantrine (Halfan)
• chloroquine (Aralen)

This is not a complete list of Lariam drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Lariam including the following:

• heart problems. Do not take halofantrine (Halfan) or ketoconazole (Nizoral) with Lariam or within 15 weeks of your last dose of Lariam. 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 (Cardioquine, Quinact, Duraquin) with Lariam. You may get serious heart problems.
• mental problems. Symptoms of serious mental problems may include:
  • severe anxiety
  • paranoia (feelings of mistrust towards others)
  • hallucinations (seeing or hearing things that are not there)
  • depression
  • feeling restless
  • unusual behavior
  • feeling confused

Some people who take Lariam think about suicide (putting an end to their life). Some people who were taking Lariam committed suicide. It is not known if Lariam 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 Lariam and use a different medicine to prevent malaria.

• problems with your body’s nervous system. 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 sound in your ears (tinnitus)
  • convulsions (seizures) in people who already have seizures (epilepsy)
  • convulsions (seizures) in people who take quinine (Qualaquin) or chloroquine (Aralen) with Lariam. Do not take quinine or chloroquine with Lariam.
  • unable to sleep (insomnia)

Dizziness, vertigo, tinnitus, and loss of balance can go on for months or years after Lariam is stopped or may become permanent in some people. Do not drive or operate heavy machinery until you know how Lariam affects you.

Do not take Lariam if you:

• are allergic to Lariam or to any of its ingredients
• have or have had depression recently
• had recent mental problems, including anxiety disorder, schizophrenia, or psychosis (losing touch with reality)

• seizures or had seizures (epilepsy or convulsions)
• an allergy to quinine (Qualaquin) or quinidine (Cardioquine, Duraquin)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Lariam, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Lariam, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Lariam or to any of its ingredients
• have heart disease

• have liver problems
• have a history of seizures or epilepsy
• have diabetes

• have blood clotting problems or take blood thinner medicines such as warfarin (Coumadin, Jantoven)
• have mental problems

• are pregnant or plan to become pregnant. It is not known if Lariam will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. You should use birth control while you take Lariam and for 3 months after you stop Lariam. If you have an unplanned pregnancy, talk to your doctor right away.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Lariam falls into category B. It is not known if Lariam will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

You should use birth control while you take Lariam and for 3 months after you stop Lariam. If you have an unplanned pregnancy, talk to your doctor right away.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Lariam has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Lariam, a choice should be made whether to stop nursing or to stop use of Lariam. The importance of the drug to the mother should be considered.

• Take Lariam exactly as prescribed.
• This medication comes in tablet form and is taken once a day. Take just after the largest meal of the day and with one cup (8 ounces) of water.
• Do not take Lariam on an empty stomach.
• If you vomit after taking Lariam, contact your doctor to see if you should take another dose.
• Continue taking Lariam for 4 weeks after returning from a malaria area.
• Tablets may be crushed and mixed with a small amount of water, milk or other beverage for children or other people unable to swallow Lariam whole. Your doctor will tell you the correct dose for your child based on your child’s weight.
• If you take Lariam for a year or longer, your doctor should check your:
  • eyes (especially if you have trouble seeing while you take Lariam)
  • liver function (to see if there has been damage to your liver)
• Use protective clothing, insect repellents, and bed nets to protect you from being bitten by mosquitoes. Medicine alone does not always stop you from catching malaria from mosquito bites.
• It is not known if Lariam is safe and effective in children under 6 months old for the treatment of malaria. It is not known how well Lariam works to prevent malaria in children weighing less than 44 pounds (20 kilograms).
• 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.
• If you are told by a doctor to stop taking Lariam because of the side effects or for other reasons, you will need to take different malaria medicine.
• If you do not have access to a doctor or to another medicine and have to stop taking Lariam , 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 malaria prevention medicine for another 4 weeks after you leave the malaria area.
• Lariam does not work for all types of malaria.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Lariam at the same time.

Take Lariam exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Lariam dose your doctor recommends will be based on the following:

• the condition being treated
• your age

The recommended dose for Lariam in adults for the prevention of malaria is one tablet (250 mg) once weekly.

The recommended dose for Lariam in adults for the treatment of malaria is 5 tablets (1250 mg) to be given as a single dose.

The recommended dose range for Lariam in children (weighing 20 kg or greater) for the prevention of malaria is based on the child’s body weight.

• Over 45 kg: take one whole tablet (250 mg)
• 30 to 45 kg: take 3/4 of a tablet (187.5 mg)
• 20 to 30 kg: take 1/2 of a tablet (125 mg)

The recommended dose range for Lariam in children (weighing 20 kg or greater) for the treatment of malaria is 20 to 25 mg/kg. Splitting the total dose into 2 doses taken 6 to 8 hours apart may reduce the occurrence or severity of adverse effects. This dose should not exceed the adult dose.

If you take too much Lariam, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Lariam  at room temperature between 20˚-25˚ C (68˚-77˚F).

Keep this and all medicines out of the reach of children.

Lariam may cause neuropsychiatric adverse reactions that can persist after Lariam has been discontinued.

Lariam 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.