Lariam

Generic Name: Mefloquine Hydrochloride
Class: Antimalarials
VA Class: AP101
Chemical Name: (R*,S*)-(±)-α-2-Piperidinyl-2,8-bis(trifluoromethyl)-4-quinolinemethanol
Molecular Formula: C₁₇H₁₆F₆N₂O
CAS Number: 53230-10-7

REMS:

FDA approved a REMS for mefloquine to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antimalarial; 4-quinolinemethanol derivative; quinine analog.^{1 2 3 7}

Uses for Lariam

Malaria

Prevention (prophylaxis) of malaria caused by Plasmodium vivax or P. falciparum, including chloroquine-resistant P. falciparum;^{1 2 3 11 17 50 51 54 55 56 57 58 59 60 61 62 63 64 113 130 134} designated an orphan drug by FDA for this use.⁵⁶ A drug of choice for prophylaxis in those traveling to areas where chloroquine-resistant P. falciparum has been reported^{17 134} and an alternative for prophylaxis in those traveling to areas where chloroquine-resistant P. falciparum malaria has not been reported.¹⁷

Treatment of uncomplicated malaria caused by mefloquine-susceptible P. falciparum, including chloroquine-susceptible and -resistant P. falciparum;^{1 2 3 11 134 143} designated an orphan drug by FDA for this use.⁵⁶ CDC and others consider mefloquine an alternative that should be used only when the regimens of choice cannot be used.^{134 143 144}

One of several regimens recommended by CDC for treatment of uncomplicated chloroquine-resistant P. vivax malaria.¹⁴⁴

Active only against the asexual erythrocytic forms of Plasmodium and cannot prevent delayed primary attacks or relapse of P. ovale or P. vivax malaria or provide a radical cure;^{1 2 3 11 17 34} primaquine usually also indicated to eradicate hypnozoites and prevent relapse in patients exposed to or being treated for P. ovale or P. vivax malaria.^{1 2 3 11 17 34 58 64 143 144}

Detailed recommendations regarding prevention of malaria available from CDC 24 hours a day from the voice information service (877-394-8747) or at .¹⁷

Assistance with diagnosis or treatment of malaria available from CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time or CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays.^{143 144}

Lariam Dosage and Administration

General

• 
  

  A mefloquine medication guide and information wallet card is available from the manufacturer to help individuals understand the risks of malaria, risks and benefits of taking mefloquine to prevent malaria, and the rare but potentially serious psychiatric adverse effects associated with the drug.^{1 142}

  
  


• 
  

  As required by law, a copy of the mefloquine medication guide must be supplied to patients each time mefloquine is dispensed for prevention of malaria.^{1 142}

  
  


• 
  

  The mefloquine medication guide is intended only for individuals taking mefloquine to preventmalaria; information in the guide may not apply to patients receiving the drug for the treatmentof malaria.¹⁴²

  
  

Administration

Oral Administration

Administer orally with ample water (at least 8 oz [240 mL] of water for an adult).¹

Do not administer on an empty stomach;¹ administration on a full stomach minimizes nausea and vomiting.¹⁷

If patient receiving mefloquine for treatment of malaria vomits within 30 minutes after receiving a dose, give a full dose as replacement; if vomiting occurred within 30–60 minutes of the dose, give 50% of the dose as replacement.^{1 115 129} If vomiting recurs, monitor patient closely and consider alternative malaria treatment if improvement is not observed within a reasonable period of time.¹

For administration in children and others who are unable to swallow tablets, mefloquine tablets may be crushed and mixed with a small amount of liquid (e.g., water, milk, other beverage)^{1 17 22 129} or food (e.g., applesauce, chocolate syrup, jelly) or enclosed in gelatin capsules to mask the bitter taste.¹⁷

Gelatin capsules containing the calculated pediatric dosage may be prepared extemporaneously in advance (preferably by a pharmacist) and each dose administered by mixing the contents of the opened capsule with a sweet-tasting food (e.g., applesauce, chocolate syrup, or jelly).¹⁷

Dosage

Available as mefloquine hydrochloride; dosage usually expressed in terms of the salt.¹ In the US, each 250 mg of mefloquine hydrochloride is equivalent to 228 mg of mefloquine base.¹

Dosage in children is based on body weight.¹

Pediatric Patients

Malaria

Prevention of P. vivax or P. falciparum Malaria

Oral

Children weighing ≤45 kg: Approximately 5 mg/kg once weekly on the same day each week.¹ (See Table.) Experience in infants <3 months of age or weighing <5 kg is limited.^{1 134}

Children weighing >45 kg: 250 mg once weekly on the same day each week.^{1 134}

Dosage for Prevention of Malaria in Children Weighing ≤45 kg1134

Weight (kg)	Dosage Once Weekly
30–45	187.5 mg (¾ of a 250-mg tablet)
20–30	125 mg (½ of a 250-mg tablet)
10–20	62.5 mg (¼ of 250-mg tablet)
5–10	31.25 mg (1/8 of a 250-mg tablet)

Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.^{1 17 57 58 60 113 134} If there are concerns about tolerance or drug interactions, it may be advisable to initiate prophylaxis 3–4 weeks prior to travel in individuals receiving other drugs to ensure that the combination of drugs is well tolerated and to allow ample time if a switch to another antimalarial is required.^{1 17}

Terminal prophylaxis with primaquine may be indicated during the final 2 weeks of mefloquine prophylaxis if exposure occurred in areas where P. ovale or P. vivax are endemic.^{17 134}

Treatment of Uncomplicated P. vivax or P. falciparum Malaria

Oral

Children ≥6 months of age: 20–25 mg/kg; dividing the dosage into 2 doses given 6–8 hours apart may reduce incidence and severity of adverse effects.¹ Alternatively, CDC and some clinicians recommend that children weighing <45 kg may receive an initial dose of 15 mg/kg followed by a single dose of 10 mg/kg 6–12 hours later.^{134 143 144}

If a response is not attained within 48–72 hours, an alternative antimalarial agent should be given; mefloquine should not be used for retreatment.¹

For those with P. vivax malaria, a 14-day regimen of oral primaquine also may be indicated to provide a radical cure and prevent delayed attacks or relapse.^{134 143 144}

Adults

Malaria

Prevention of P. vivax or P. falciparum Malaria

Oral

250 mg once weekly on the same day each week.^{1 2 17 57 60 113 134}

Initiate prophylaxis 1–2 weeks prior to entering a malarious area and continue for 4 weeks after leaving the area.^{1 17 57 58 60 113 134} If there are concerns about tolerance or drug interactions, it may be advisable to initiate prophylaxis 3–4 weeks prior to travel in individuals receiving other drugs to ensure that the combination of drugs is well tolerated and to allow ample time if a switch to another antimalarial is required.^{1 17}

Terminal prophylaxis with primaquine may be indicated during the final 2 weeks of mefloquine prophylaxis if exposure occurred in areas where P. ovale or P. vivax are endemic.^{17 134}

Treatment of Uncomplicated P. vivax or P. falciparum Malaria

Oral

A single dose of 1250 mg.¹ Alternatively, CDC and others recommend an initial dose of 750 mg followed by 500 mg given 6–12 hours later (total dose of 1250 mg).^{115 134 143 144}

If a response is not attained within 48–72 hours, an alternative antimalarial agent should be given; mefloquine should not be used for retreatment.¹

For those with P. vivax malaria, a 14-day regimen of oral primaquine also may be indicated to provide a radical cure and prevent delayed attacks or relapse.^{134 143}

Prescribing Limits

Pediatric Patients

Malaria

Prevention of P. vivax or P. falciparum Malaria

Oral

Maximum 1250 mg daily.¹⁴³

Special Populations

Hepatic Impairment

No specific recommendations available regarding need for dosage adjustment in individuals with hepatic impairment.¹ Increased mefloquine plasma concentrations may occur because of decreased elimination.¹

Renal Impairment

No specific recommendations available regarding need for dosage adjustment in individuals with renal impairment.¹

When used for prevention of malaria, limited data indicate that dosage adjustment is not necessary in patients undergoing hemodialysis.^{1 49}

Cautions for Lariam

Contraindications

• 
  

  Hypersensitivity to mefloquine, structurally related agents (e.g., quinine, quinidine), or any ingredient in the formulation.^{1 17 57}

  
  


• 
  

  Malaria prevention in patients with active depression, recent history of depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders.¹

  
  


• 
  

  History of seizures.¹

  
  

Warnings/Precautions

Warnings

Severe Malaria

Not recommended for treatment of life-threatening, serious or overwhelming malaria caused by P. falciparum.¹ These infections should be treated with an IV antimalarial; mefloquine may be used as follow-up after completion of the IV regimen.¹

Neuropsychiatric Effects

Severe neuropsychiatric disorders have been reported occasionally with mefloquine,^{1 63 78 86} including sensory and motor neuropathies (paresthesia, tremor, ataxia), seizures,^{1 18 62 64 74 78 84 85 88 113} agitation or restlessness, anxiety, depression, mood changes, panic attacks, forgetfulness, confusion, hallucinations, aggression, psychotic or paranoid reactions, and encephalopathy.¹ In some patients, these symptoms have been reported to continue long after mefloquine was discontinued.¹

Although a causal relationship has not been established, there have been rare cases of suicidal ideation and suicide in patients receiving mefloquine.¹

To minimize risk of psychiatric symptoms, use of mefloquine for prevention of malaria is contraindicated in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, or schizophrenia or other major psychiatric disorders.¹ In addition, use with caution in individuals with a previous history of depression.¹

In patients receiving mefloquine for prevention of malaria, if neuropsychiatric manifestations (e.g., acute anxiety, depression, restlessness, confusion) occur, they may be considered prodromal for a serious psychiatric event and mefloquine should be discontinued and an alternative drug substituted.¹

Interactions

Concomitant use with certain other antimalarials not recommended (chloroquine, quinine, quinidine) because of possible increased risk of ECG abnormalities and seizures.¹ In addition, concomitant or sequential use with halofantrine not recommended because of possible increased risk of prolongation of QT interval.¹ (See Interactions.)

Sensitivity Reactions

Hypersensitivity Reactions

Serious cutaneous reactions, including Stevens-Johnson syndrome,^{1 2 93 99} erythema multiforme,^{1 2} and cutaneous vasculitis,⁹⁷ have been reported rarely.^{1 2} Reactions ranging from mild cutaneous events to anaphylaxis cannot be predicted.¹

General Precautions

Epilepsy Patients

Increased risk of seizures in epilepsy patients.¹ Do not use for prevention of malaria in epilepsy patients; may be used for treatment of malaria only if there are compelling reasons for its use.¹

Cardiac Effects

Mefloquine is a myocardial depressant, and mefloquine-induced changes in several cardiac parameters have been described.^{1 2} Bradycardia,^{1 2 76 94} extrasystoles,^{1 2} reversible sinus arrhythmia,^{2 94 100} aberrant cardiac conduction,⁹⁸ first degree AV-block,¹ hypotension,¹ hypertension,¹ flushing,¹ and syncope¹ have been reported.

Substantial changes in PR or QRS intervals have not been reported,^{2 94} but the drug has been associated with prolongation of the QT_c interval and abnormal T waves.^{1 117}

The benefits of mefloquine should be weighed against the possibility of adverse effects in patients with cardiac disease.¹ Some experts state the drug should not be used in patients with cardiac conduction abnormalities.¹³⁴

Ocular Effects

Visual disturbances have been reported infrequently.^{1 50 63 64 77 103} Dose-related ocular lesions (retinal degeneration, retinal edema, lenticular opacity) reported in long-term animal studies.¹

Periodic ophthalmic examinations recommended.¹

Laboratory Monitoring

If used for prolonged periods (e.g., for malaria prophylaxis), evaluate liver function periodically.¹

Specific Populations

Pregnancy

Category C.¹

Women of childbearing potential should use effective contraceptive measures while receiving mefloquine prophylaxis and for up to 3 months following the last mefloquine dose.¹ In the event of an unplanned pregnancy, use of mefloquine for prevention of malaria is not considered an indication for pregnancy termination.¹

Because of the potential risk of stillbirth associated with mefloquine exposure, CDC and other clinicians state that the drug should not be used for treatment of malaria during pregnancy unless no other treatment option exists and benefits outweigh risks.^{134 136 143}

Lactation

Distributed into milk.^{1 2 102 107} Discontinue nursing or the drug.¹

Pediatric Use

Only limited experience for prevention of malaria in infants <3 months of age or weighing <5 kg.¹

Safety and efficacy not established for treatment of malaria in children <6 months of age.¹

Use in children for treatment of acute uncomplicated malaria caused by P. falciparum is supported by evidence from adequate and well-controlled studies in adults and from published open-label and comparative studies in children <16 years of age.^{1 100 101 102} Experience is limited regarding use of mefloquine for treatment of malaria in children <3 months of age or weighing <5 kg.¹

Children of any age can contract malaria, and the indications for prophylaxis and treatment of malaria are the same for children as for adults.^{22 57 58 100 101 102 113 115 129}

Children ≤6 years of age being treated for malaria have experienced early vomiting (within 1 hour of drug administration) more frequently than individuals 7–50 years of age;^{18 68 70 76} early vomiting has been cited as a possible cause of treatment failure in some children.¹ If a second dose is not tolerated, the child should be closely monitored, and alternative antimalarial treatment considered if the child does not improve within a reasonable period of time.¹

Geriatric Use

Response in patients ≥65 years of age does not appear to differ from that in younger adults.¹

Because mefloquine therapy is associated with ECG abnormalities, the greater frequency of cardiac disease observed in the elderly should be considered and the benefit of mefloquine therapy in geriatric individuals should be weighed against the possibility of adverse cardiac effects.¹

Hepatic Impairment

Mefloquine elimination may be prolonged resulting in higher plasma concentrations.¹

Common Adverse Effects

GI effects (nausea, vomiting, loose stools or diarrhea, abdominal pain); CNS effects (dizziness, vertigo); neuropsychiatric events (headache, somnolence, sleep disorders); rash; pruritus.^{1 2 50 51 61 63 76 113 138}

Interactions for Lariam

Drugs Affecting QT Interval

Possibility of prolongation of QT interval if used concomitantly with other drugs that alter cardiac conduction, including antiarrhythmic agents, β-adrenergic blocking agents, calcium channel blocking agents, antihistamines, tricyclic antidepressants, and phenothiazines.¹ Some experts state that mefloquine may be used concomitantly with β-adrenergic blocking agents in patients without an underlying arrhythmia.^{58 134}

Specific Drugs

Drug	Interaction	Comments
Anticonvulsants (carbamazepine, phenobarbital, phenytoin, valproic acid)	Possible decreased concentrations of the anticonvulsant and loss of seizure control1 2 74	Mefloquine generally contraindicated in patients with history of seizures;57 if used in an individual receiving an anticonvulsant agent, monitor concentrations of the anticonvulsant and adjust dosage as necessary1
Antimalarial agents	Possibility of ECG abnormalities and increased risk of seizures with quinine, quinidine, or chloroquine1 Use of halofantrine after mefloquine has resulted in potentially fatal prolongation of the QTc interval; data not available regarding use of mefloquine after halofantrine1	If quinine, quinidine, or chloroquine is used in initial treatment of severe malaria, mefloquine should not be administered until ≥12 hours after the last dose of any of these drugs1 2 If mefloquine administered in the 12 hours preceding initiation of parenteral therapy for severe malaria, a loading dose of quinidine gluconate should not be administered143 Concomitant or sequential use with halofantrine not recommended1 17 57 112
Typhoid Vaccine	Possibility of interference with immune response to typhoid vaccine live oral since mefloquine has in vitro activity against Salmonella typhi108 109 110	Vaccination with typhoid vaccine live oral should be delayed for 24 hours after mefloquine dose;58 108 complete typhoid vaccination ≥3 days before initiating mefloquine prophylaxis1 2 57

Lariam Pharmacokinetics

Absorption

Bioavailability

Mefloquine is a racemic mixture of 2 erythro enantiomers whose rates of release, absorption, transport, action, degradation, and elimination may differ.^{1 2 4 30 41 42 43 44}

Slowly absorbed from GI tract; peak concentrations in blood or plasma are attained within 6–24 hours and appear to be proportional to dose.^{2 30 31 35 36 37 38 39 40 45}

Food

Limited evidence indicates that bioavailability is greater when administered with food than when administered in the fasting state.^{2 3 49}

Special Populations

Some evidence that peak blood or plasma concentrations of mefloquine are substantially higher in Asians than in other ethnic groups.^{2 30 37 38} The reason for this ethnic variation has not been determined, but may involve differences in the volume of distribution secondary to the relatively lower body fat in Asians or differences in the enterohepatic circulation of mefloquine in Asians.^{2 40}

Distribution

Extent

Widely distributed into body tissues and fluids.^{1 2 30 31 37 38 39 45 46 107}

Concentrates in erythrocytes to a greater extent than in plasma.^{1 2 7 8 30 31 33 41 44 122 123}

Distributed into CNS.^{74 83} Because GI absorption may be incomplete and erratic in patients with severe malaria, oral mefloquine therapy should not be relied on for CNS infections.^{1 115}

Distributed into milk in low concentrations.^{1 2 102 107}

Plasma Protein Binding

98% bound to plasma proteins.^{1 2 3 30 31 33 44 45}

Elimination

Metabolism

Metabolized in the liver, but metabolic fate has not been fully determined.^{1 2 3} Plasma concentrations of the principal metabolite, the 4-carboxylic acid derivative, exceed those of mefloquine.^{1 3 31 44}

Elimination Route

Mefloquine and its metabolites are excreted in feces, with only small amounts (<13% combined) eliminated in urine.^{1 2 3 42 48}

Undergoes biliary excretion and extensive enterohepatic circulation;³⁰ some evidence suggests that enterohepatic circulation and fecal elimination may be increased in patients with malaria compared with those in healthy adults.³⁰

Mefloquine and its 4-carboxylic acid metabolite are not removed by hemodialysis.⁴⁹

Half-life

Terminal elimination half-life shows considerable interindividual variation, ranging from 13–33 days (mean: 21 days) in healthy adults and about 10–15 days in patients with uncomplicated malaria.^{1 2 30 31 35 37 38 39 41 42 45 47}

Faster elimination in patients with uncomplicated malaria relative to healthy individuals may result from decreased enterohepatic recirculation and increased fecal elimination.³⁰

In Thai children with uncomplicated malaria, a terminal elimination half-life of 9.8–10.7 days was reported in those 6–24 months of age and 5–12 years of age.^{120 121}

Special Populations

Mefloquine elimination may be prolonged in patients with hepatic impairment, resulting in higher plasma concentrations.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Actions and Spectrum

• 
  

  A blood schizonticidal agent^{1 2 11} active against asexual erythrocytic forms of most strains of Plasmodium falciparum, P. malariae, P. ovale, and P. vivax, including chloroquine-resistant and pyrimethamine-sulfadoxine-resistant strains of P. falciparum.^{2 11 113} Not active against mature gametocytes or against intrahepatic stages of plasmodial development.^{2 11}

  
  


• 
  

  Also active in vitro against Entamoeba histolytica,¹³ Giardia lamblia,¹⁵ and against the larval and adult stages of Brugia patei and B. malayi.¹⁴

  
  


• 
  

  Mefloquine-resistant Plasmodium has been reported in geographic areas where mefloquine has been used.^{2 3 7 17 18 19 20 21 22 113 114} In addition, P. falciparum strains with in vitro resistance to mefloquine have been identified in areas before introduction of the drug (i.e., intrinsic resistance).^{2 7 23 25 26}

  
  


• 
  

  P. falciparum resistant to mefloquine also may be resistant to halofantrine.^{2 24} Cross-resistance between mefloquine and quinine has been reported in some areas.¹

  
  

Advice to Patients

• 
  

  Importance of reading the medication guide supplied with mefloquine.¹ Advise patients to carry the information wallet card with them when they are taking mefloquine.¹

  
  


• 
  

  For prevention of malaria, necessity of starting mefloquine prophylaxis ≥1 week before arriving in an area with malaria.¹

  
  


• 
  

  Necessity of taking protective measures to reduce contact with mosquitoes (protective clothing, insect repellents, mosquito nets, remaining in air-conditioned or well-screened areas).^{1 17 57 60 113}

  
  


• 
  

  Possibility of contracting malaria during travel, regardless of prophylactic regimen used.^{1 17 57 60 113}

  
  


• 
  

  Advise travelers who plan presumptive self-treatment in the event of a possible malarial infection to keep an amount of mefloquine sufficient for self-treatment in their possession during travel and to take it promptly in the event of a febrile illness during or after their travel if professional medical care is not readily available.¹³⁴

  
  


• 
  

  Advise travelers that presumptive self-treatment of malaria is an interim measure and that they should seek medical evaluation as soon as possible.¹³⁴

  
  


• 
  

  Importance of seeking medical attention as soon as possible if febrile illness develops during or after return from a malaria-endemic area and of informing clinician of possible malaria exposure, including instances when such illness was self-treated as malaria during travel.^{1 17 57 60 113 134}

  
  


• 
  

  Advise patients that a small percentage of people are unable to take mefloquine because of adverse effects and that it may be necessary to change medications if this occurs.¹

  
  


• 
  

  Potential for mefloquine to cause dizziness, loss of balance, or other disorders of the CNS or peripheral nervous system; use caution with regard to activities requiring alertness and fine motor coordination (driving, piloting aircraft, operating machinery, deep-sea diving).¹

  
  


• 
  

  Advise patients that psychiatric symptoms (e.g., acute anxiety, depression, restlessness, confusion) may be considered prodromal to more serious events.¹ If these effects occur, the drug should be discontinued and an alternative substituted.¹

  
  


• 
  

  Warn women of childbearing potential against becoming pregnant if they will be traveling to areas where malaria is endemic.¹ Advise women of childbearing potential to practice contraception during mefloquine prophylaxis and for up to 3 months after the drug is discontinued.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, and any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Mefloquine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	250 mg	Lariam (scored)	Roche

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Mefloquine HCl 250MG Tablets (ROXANE): 25/$251.50 or 75/$675.09

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Roche. Lariam (mefloquine hydrochloride) tablets prescribing information. Nutley, NJ; 2004 May.

2. Palmer KJ, Holliday SM, Brogden RN. Mefloquine: a review of its antimalarial activity, pharmacokinetic properties and therapeutic efficacy. Drugs. 1993; 45:430-75. [PubMed 7682911]

3. Tracy JW, Webster LT Jr. Drugs used in the chemotherapy of protozoal infections: malaria. In: Hardman JG, Limbird LE, Molinoff PB et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 9th ed. New York: McGraw-Hill; 1995:978-98..

4. Gimenez F, Pennie RA, Koren G et al. Stereoselective pharmacokinetics of mefloquine in healthy Caucasians after multiple doses. J Pharm Sci. 1994; 83:824-7. [IDIS 330679] [PubMed 9120814]

5. Reber-Liske R. Note on the stability of mefloquine hydrochloride in aqueous solution. Bull World Health Organ. 1983; 61:525-7. [PubMed 6349842]

6. Basco LK, Gillotin C, Gimenez F et al. In vitro activity of the enantiomers of mefloquine, halofantrine and enpiroline against Plasmodium falciparum. Br J Clin Pharmacol. 1992; 33:517-20. [IDIS 297355] [PubMed 1524966]

7. Foley M, Tilley L. Quinoline antimalarials: mechanisms of action and resistance. Int J Parasitol. 1997; 27:231-40. [PubMed 9088993]

8. Desneves J, Thorn G, Berman A et al. Photoaffinity labelling of mefloquine-binding proteins in human serum, uninfected erythrocytes and Plasmodium falciparum-infected erythrocytes. Mol Biochem Parasitol. 1996; 82:181-94. [PubMed 8946384]

9. Berman A, Shearing LN, Ng KF et al. Photoeffinity labeling of Plasmodium falciparum proteins involved in phospholipid transport. Mol Biochem Parasitol. 1994:67:235-43.

10. Geary TG, Divo AA, Jensen JB. Stage specific actions of antimalarial drugs on Plasmodium falciparum in culture. Am J Trop Med Hyg. 1989; 40:240-4. [PubMed 2648881]

11. Krogstad DJ. Plasmodium species (malaria). In: Mandell GL, Bennett JE, Dolin R eds. Mandell, Douglas and Bennett’s principles and practice of infectious diseases. 4th ed. New York: Churchill Livingstone; 1995:2415-26.

12. Basco LK, Gillotin C, Gimenez F et al. Absence of antimalarial activity or interaction with mefloquine enantiomers in vitro of the main human metabolite of mefloquine. Trans R Soc Trop Med Hyg. 1991; 85:208-9. [PubMed 1887471]

13. Osisanya JOS. Comparative in vitro activity of mefloquine, diloxanide furoate and other conventionally used amoebicides against entamoeba histolytica. E Afr Med J. 1986; 63:263-8.

14. Walter RD, Wittich RM, Kuhlow F. Filaricidal effect of mefloquine on adults and microfilariae of Brugia patei and Brugia malayi. Trop Med Parsitol. 1987; 38:55-6.

15. Crouch AA, Seow WK, Thong YH. Effect of twenty-three chemotherapeutic agents on the adherence and growth of Giardia lamblia in vitro. Trans R Soc Trop Med Hyg. 1986; 80:893-6. [PubMed 3603639]

16. Karle JM, Karle IL. Crystal structure and molecular structure of mefloquine methylsulfonate monohydrate: implications for a malaria receptor. Antimicrob Agents Chemother. 1991; 35:2238-45. [PubMed 1803997]

17. Centers for Disease Control and Prevention. Health information for international travel, 2010. Atlanta, GA: US Department of Health and Human Services; 2010. Updates available from CDC website ().

18. Nosten F, ter Kuile F, Chongsuphajaisiddhi T et al. Mefloquine-resistant falciparum malaria on the Thai-Burmese border. Lancet. 1991; 337:1140-3. [IDIS 280801] [PubMed 1674024]

19. Sowunmi A, Oduola AMJ, Salako LA et al. The relationship between the response of Plasmodium falciparum malaria to mefloquine in African children and its sensitivity in vitro. Trans R Soc Trop Med Hyg. 1992; 86:368-71. [PubMed 1440804]

20. Lambros C, Notsch JD. Plasmodium falciparum: mefloquine resistance produced in vitro. Bull World Health Organ. 1984; 62:433-7. [IDIS 260490] [PubMed 6380785]

21. Oduola AMJ, Milhous WK, Weatherly NF et al. Plasmodium falciparum: induction of resistance to mefloquine in cloned strains by continuous drug exposure in vitro. Exp Parasitol. 1988; 67:354-60. [PubMed 3056740]

22. Nosten F, ter Kuile F, Chongsuphajaisiddhi T et al. Mefloquine pharmacokinetics and resistance in children with acute falciparum malaria. Br J Clin Pharmacol. 1991; 31:556-9. [IDIS 282555] [PubMed 1888626]

23. White NJ. Mefloquine: in the prophylaxis and treatment of falciparum malaria. BMJ. 1994; 308:286-7. [IDIS 325041] [PubMed 8124114]

Phoslyra

Generic Name: calcium acetate (KAL see um AH seh tate)

Brand Names: Eliphos, PhosLo Gelcap, Phoslyra

What is Phoslyra (calcium acetate)?

Calcium is a mineral that is needed for many functions of the body, especially bone formation and maintenance. Calcium can also bind to other minerals such as phosphate, and aid in their removal from the body.

Calcium acetate is used to control phosphate levels to keep them from getting too high in people with kidney failure.

Calcium acetate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Phoslyra (calcium acetate)?

Do not use this medication if you have high levels of calcium in your blood, or if you are also taking digoxin (digitalis, Lanoxin, Lanoxicaps). Do not take additional calcium supplements unless your doctor has told you to.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium and you could be getting too much of this mineral if you take a calcium antacid with calcium acetate.

What should I discuss with my healthcare provider before taking Phoslyra (calcium acetate)?

Do not use this medication if you have high levels of calcium in your blood, or if you are also taking digoxin (digitalis, Lanoxin, Lanoxicaps).

Before taking this medication, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether calcium acetate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether calcium acetate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Phoslyra (calcium acetate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take this medication with each meal, unless your doctor tells you otherwise.

You may need to keep a food diary to measure how much calcium you are getting in your diet.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. You may also need x-rays to check for calcium deposits around your joints or other soft tissues. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, loss of appetite, dry mouth, increased thirst or urination, constipation, confusion, fainting, or coma.

What should I avoid while taking Phoslyra (calcium acetate)?

Do not take additional calcium supplements unless your doctor has told you to.

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium and you could be getting too much of this mineral if you take a calcium antacid with calcium acetate.

Phoslyra (calcium acetate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely to occur, such as:

• 
  

  nausea, vomiting, loss of appetite;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth or increased thirst; or

  
  


• 
  

  urinating more than usual.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Phoslyra (calcium acetate)?

Tell your doctor about all other medicines you use, especially an antibiotic such as:

• 
  

  ciprofloxacin (Cipro);

  
  


• 
  

  demeclocycline (Declomycin);

  
  


• 
  

  doxycycline (Doryx, Oracea, Periostat, Vibramycin);

  
  


• 
  

  gemifloxacin (Factive);

  
  


• 
  

  levofloxacin (Levaquin);

  
  


• 
  

  minocycline (Dynacin, Minocin, Solodyn);

  
  


• 
  

  moxifloxacin (Avelox);

  
  


• 
  

  norfloxacin (Noroxin);

  
  


• 
  

  ofloxacin (Floxin); or

  
  


• 
  

  tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with calcium acetate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Phoslyra resources

• Phoslyra Side Effects (in more detail)
• Phoslyra Use in Pregnancy & Breastfeeding
• Phoslyra Drug Interactions
• Phoslyra Support Group
• 0 Reviews for Phoslyra - Add your own review/rating

• Phoslyra Prescribing Information (FDA)


• Phoslyra Advanced Consumer (Micromedex) - Includes Dosage Information


• Phoslyra Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Calcium Acetate MedFacts Consumer Leaflet (Wolters Kluwer)


• Eliphos Prescribing Information (FDA)


• Phoslo Prescribing Information (FDA)

Compare Phoslyra with other medications

• Hyperphosphatemia

Where can I get more information?

• Your pharmacist can provide more information about calcium acetate.

See also: Phoslyra side effects (in more detail)

Meggezones

1. Name Of The Medicinal Product

Meggezones

2. Qualitative And Quantitative Composition

Each pastille contains menthol 16.0mg BP

3. Pharmaceutical Form

Pastille.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of sore throats, coughs, colds, catarrh and nasal congestion.

4.2 Posology And Method Of Administration

Allow one pastille to dissolve slowly in the mouth as required.

Maximum daily dose : Adults - 15 pastilles; children aged 6 to 12 years - 10 pastilles; children aged under 6 years - 5 pastilles.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Hypersensitivity to the product is a possible side effect. Contact dermatitis may occur with menthol products.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety in pregnancy and lactation has not been established. However menthol-containing products have been used for many years with no ill effect.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Systemic effects due to overdosage are most unlikely.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Menthol in pastille formulation relieves catarrh and other symptoms associated with colds.

5.2 Pharmacokinetic Properties

Menthol is excreted in the urine and bile as a glucuronide.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Modified starch, antifoam 1510, sucrose, liquorice extract powder, liquid glucose (80%) solid (1963); peppermint oil; benzoin; water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Once opened keep in a cool dry place.

6.5 Nature And Contents Of Container

PVC blister packs with aluminium seal in a cardboard box. Packs contain 3, 8, 24, 36 or 48 pastilles.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Schering-Plough Ltd

Shire Park

Welwyn Garden City

Hertfordshire

AL7 1TW

UK

8. Marketing Authorisation Number(S)

PL 0201/0104

9. Date Of First Authorisation/Renewal Of The Authorisation

5 May 1988 / 5 May 1993

10. Date Of Revision Of The Text

November 1998

11. Legal Status

GSL

Meggezones/UK/02-10/1

Lamisil AT for Women

Generic Name: terbinafine hydrochloride

Dosage Form: cream
Drug Facts

Active ingredient

Terbinafine hydrochloride

Purpose

Antifungal

Uses

• cures most athlete’s foot (tinea pedis)


• cures most jock itch (tinea cruris) and ringworm (tinea corporis)


• relieves itching, burning, cracking and scaling which accompany these conditions

Warnings

For external use only

Do Not Use

• on nails or scalp


• in or near the mouth or eyes


• for vaginal yeast infections

When using this product

do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use and ask doctor

if too much irritation occurs or gets worse

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.

Directions

• adults and children 12 years and over:
  
  • use the tip of the cap to break the seal and open the tube
  
  
  • wash the affected skin with soap and water and dry completely before applying
  
  
  • for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
    
    • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
    
    
  
  
  • 
    

    1 week between the toes

    
    
    
    
    • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
    
    
    • 
      

      2 weeks on the bottom or sides of the foot

      
      
      
      
    
    
  
  
  • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
  
  
  • wash hands after each use
  
  


• children under 12 years: ask a doctor

Other information

• do not use if seal on tube is broken or is not visible


• store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Questions

call 1-800-452-0051

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008

Principal Display

LAMISIL  AT FOR WOMEN terbinafine hydrochloride  cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-6171 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TERBINAFINE HYDROCHLORIDE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL   CETYL ALCOHOL   CETYL PALMITATE   ISOPROPYL MYRISTATE   POLYSORBATE 60   WATER   SODIUM HYDROXIDE   SORBITAN MONOSTEARATE   STEARYL ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0067-6171-85 1 TUBE In 1 CARTON contains a TUBE 1 24 g In 1 TUBE This package is contained within the CARTON (0067-6171-85)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020980	08/10/2005

Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 01/2010Novartis Consumer Health, Inc.

More Lamisil AT for Women resources

• Lamisil AT for Women Use in Pregnancy & Breastfeeding
• Lamisil AT for Women Support Group
• 5 Reviews for Lamisil AT for Women - Add your own review/rating

Compare Lamisil AT for Women with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Thyrolar-3

Generic Name: liotrix (LYE oh trix)

Brand Names: Thyrolar-1, Thyrolar-1/2, Thyrolar-1/4, Thyrolar-2, Thyrolar-3

What is Thyrolar-3 (liotrix)?

Liotrix is a man-made form of a hormone that is normally produced by your thyroid gland to regulate the body's energy and metabolism. Liotrix is given when the thyroid does not produce enough of this hormone on its own.

Liotrix treats hypothyroidism (low thyroid hormone). Liotrix is also used to treat or prevent goiter (enlarged thyroid gland), and is also given as part of a medical tests for thyroid disorders.

Liotrix should not be used to treat obesity or weight problems.

Liotrix may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Thyrolar-3 (liotrix)?

Since thyroid hormone occurs naturally in the body, almost anyone can take liotrix. However, you may not be able to use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

Before taking liotrix, tell your doctor if you have heart disease, angina (chest pain), coronary artery disease, congestive heart failure, diabetes, or problems with your pituitary or adrenal glands.

Tell your doctor if you are pregnant or breast-feeding.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Keep using this medicine as directed, even if you feel well. You may need to take thyroid medication for the rest of your life.

Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual.

What should I discuss with my healthcare provider before taking Thyrolar-3 (liotrix)?

Since thyroid hormone occurs naturally in the body, almost anyone can take liotrix. However, you may not be able to use this medication if you have a thyroid disorder called thyrotoxicosis, or an adrenal gland problem that is not controlled by treatment.

To make sure you can safely take liotrix, tell your doctor if you have any of these other conditions:

• 
  

  heart disease, angina (chest pain);

  
  


• 
  

  coronary artery disease;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  any type of diabetes; or

  
  


• 
  

  problems with your pituitary or adrenal gland.

  
  

FDA pregnancy category A. Liotrix is not expected to harm an unborn baby. However, tell your doctor if you become pregnant, since your dose needs may be different during pregnancy. Small amounts of liotrix can pass into breast milk, but this is not expected to harm a nursing baby. However, do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Thyrolar-3 (liotrix)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Keep using this medicine as directed, even if you feel well. You may need to take thyroid medication for the rest of your life.

Call your doctor if you notice any signs of thyroid toxicity, such as chest pain, fast or pounding heartbeats, feeling hot or nervous, or sweating more than usual. If you need surgery, tell the surgeon ahead of time that you are using liotrix. You may need to stop using the medicine for a short time. Store liotrix tablets in a tightly closed container in the refrigerator. Protect the medicine from light and do not allow it to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, sweating, diarrhea, irregular menstrual periods, confusion, weakness, swelling in your hands or feet, fast heart rate, chest pain, feeling short of breath, fainting, or feeling nervous, restless, or irritable.

What should I avoid while taking Thyrolar-3 (liotrix)?

Do not change brands or change to a generic drug product without first asking your doctor. Different brands of liotrix may not work the same. If you get a prescription refill and your new pills look different, talk with your pharmacist or doctor.

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking these medications within 4 hours before or after you take liotrix.

Thyrolar-3 (liotrix) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  nausea;

  
  


• 
  

  depression, anxiety, feeling weak or tired;

  
  


• 
  

  weight gain;

  
  


• 
  

  dry or itchy skin;

  
  


• 
  

  joint or muscle pain; or

  
  


• 
  

  temporary hair loss (especially in children).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Thyrolar-3 (liotrix)?

Tell your doctor about all other medicines you use, especially:

• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  epinephrine (EpiPen) or norepinephrine (Levophed);

  
  


• 
  

  insulin or oral diabetes medication;

  
  


• 
  

  medications that contain iodine (such as I-131);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

  
  


• 
  

  salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;

  
  


• 
  

  steroids such as prednisone and others.

  
  

This list is not complete and other drugs may interact with liotrix. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Thyrolar-3 resources

• Thyrolar-3 Use in Pregnancy & Breastfeeding
• Thyrolar-3 Drug Interactions
• Thyrolar-3 Support Group
• 0 Reviews for Thyrolar-3 - Add your own review/rating

• Liotrix Professional Patient Advice (Wolters Kluwer)


• Liotrix Monograph (AHFS DI)


• liotrix Advanced Consumer (Micromedex) - Includes Dosage Information


• Liotrix MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Thyrolar-3 with other medications

• Underactive Thyroid

Where can I get more information?

• Your pharmacist can provide more information about liotrix.

Carbamazepine Chewable Tablets

Pronunciation: KAR-ba-MAZ-e-peen
Generic Name: Carbamazepine
Brand Name: Tegretol

Carbamazepine Chewable Tablets may rarely cause severe blood problems (eg, aplastic anemia, agranulocytosis). Contact your doctor right away if you develop fever, chills, or sore throat; rash; ulcers or sores in the mouth; unusual bruising or bleeding; unusual tiredness; or swollen lymph nodes. Lab tests, including complete blood cell counts, will be performed before and during treatment with Carbamazepine Chewable Tablets. These tests will be used to check for side effects.

Carbamazepine Chewable Tablets may rarely cause serious and sometimes fatal skin reactions. Contact your doctor at once if you develop red, swollen, blistered, or peeling skin with or without fever. The risk of this reaction may be greater in Asian patients. Asian patients may need to have a blood test before they start Carbamazepine Chewable Tablets to determine whether they have a greater risk of developing a severe skin reaction.

Carbamazepine Chewable Tablets are used for:

Treating certain types of seizures. It is also used to treat severe pain of the jaw or cheek caused by a facial nerve problem (trigeminal neuralgia). It may also be used for other conditions as determined by your doctor.

Carbamazepine Chewable Tablets are an anticonvulsant. It works to control seizures by blocking certain nerve impulses in the brain. It works to treat trigeminal neuralgia by altering nerve impulses in certain facial nerves, which relieves pain.

Do NOT use Carbamazepine Chewable Tablets if:

• you are allergic to any ingredient in Carbamazepine Chewable Tablets


• you are allergic to tricyclic antidepressants (eg, amitriptyline), cyclobenzaprine, or similar medicines


• you have a history of bone marrow depression, the blood disorder porphyria, or other serious blood disorders


• you are taking nefazodone


• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or you have taken an MAOI within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Video: Treatment for Depression

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Before using Carbamazepine Chewable Tablets:

Some medical conditions may interact with Carbamazepine Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are allergic to other seizure medicines (eg, phenytoin, phenobarbital)


• if you have a history of other types of seizures (eg, absence, atonic), increased pressure in the eye (eg, glaucoma), liver or kidney problems, mood or mental problems, suicidal thoughts or actions, or multiple sclerosis


• if you have a history of heart problems (eg, heart failure, heart block, irregular heartbeat), an abnormal electrocardiogram (ECG), high blood pressure, or high blood cholesterol


• if you have a history of blood problems, including blood problems caused by other medicines


• if you have been tested and know whether or not you have a gene type called HLA-B*1502


• if you have previously taken Carbamazepine Chewable Tablets

Some MEDICINES MAY INTERACT with Carbamazepine Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, phenelzine) because a severe reaction, including severe high blood pressure and high fever, may occur


• Nefazodone because its effectiveness may be decreased by Carbamazepine Chewable Tablets


• Many other prescription and nonprescription medicines (eg, used for allergies, asthma, blood thinning, cancer, diabetes, infections, inflammation, aches and pains, heartburn or reflux disease, high blood pressure, heart problems, high cholesterol, birth control, hormone replacement, immune system suppression, mental or mood problems, sleep, seizures), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may also interact with Carbamazepine Chewable Tablets. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with Carbamazepine Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbamazepine Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Carbamazepine Chewable Tablets:

Use Carbamazepine Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Carbamazepine Chewable Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Carbamazepine Chewable Tablets refilled.


• Take Carbamazepine Chewable Tablets by mouth with food.


• Chew Carbamazepine Chewable Tablets well before you swallow it.


• Eating grapefruit or drinking grapefruit juice may increase the risk of Carbamazepine Chewable Tablets's side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.


• Do not suddenly stop taking Carbamazepine Chewable Tablets. You may have an increased risk of seizures. If you need to stop Carbamazepine Chewable Tablets or add a new medicine, your doctor will gradually lower your dose.


• Taking Carbamazepine Chewable Tablets at the same time each day will help you remember to take it.


• Take Carbamazepine Chewable Tablets on a regular schedule to get the most benefit from it.


• Continue to take Carbamazepine Chewable Tablets even if you feel well. Do not miss any doses.


• If you miss a dose of Carbamazepine Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Carbamazepine Chewable Tablets.

Important safety information:

• Carbamazepine Chewable Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Carbamazepine Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Carbamazepine Chewable Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do NOT take more than the recommended dose without checking with your doctor.


• Patients who take Carbamazepine Chewable Tablets may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Carbamazepine Chewable Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Carbamazepine Chewable Tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Carbamazepine Chewable Tablets may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Carbamazepine Chewable Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Carbamazepine Chewable Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Carbamazepine Chewable Tablets. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Tell your doctor or dentist that you take Carbamazepine Chewable Tablets before you receive any medical or dental care, emergency care, or surgery.


• Patients who have a certain gene type called HLA-B*1502 may have an increased risk of serious skin reactions from Carbamazepine Chewable Tablets. This gene type is found most commonly in Asian patients. Tell your doctor if you have been tested and know whether or not you have the HLA-B*1502 gene type. Discuss any questions or concerns with your doctor.


• Do not switch from the tablets form of Carbamazepine Chewable Tablets to the suspension form without checking with your doctor. The same dose may not have the same effects.


• Carbamazepine Chewable Tablets may interfere with certain lab tests, including thyroid function tests. Be sure your doctor and lab personnel know you are using Carbamazepine Chewable Tablets.


• Lab tests, including complete blood cell counts, liver and kidney function, eye exams, and carbamazepine blood levels, may be performed while you use Carbamazepine Chewable Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Carbamazepine Chewable Tablets may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have questions or concerns about your pregnancy test results.


• Use Carbamazepine Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially agitation or confusion.


• PREGNANCY and BREAST-FEEDING: Carbamazepine Chewable Tablets has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Carbamazepine Chewable Tablets while you are pregnant. Carbamazepine Chewable Tablets are found in breast milk. Do not breast-feed while taking Carbamazepine Chewable Tablets.

Possible side effects of Carbamazepine Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth; nausea; unsteadiness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; calf pain, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; dark urine; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; joint pain; light-headedness; loss of appetite; menstrual changes; new or worsening mental or mood changes (eg, aggression, agitation, anger, anxiety, depression, irritability, restlessness); pain, tenderness, or unusual swelling in the neck, groin, or under the arms; red or purple spots on your body; red, swollen, blistered, or peeling skin; severe or persistent dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; speech problems; stomach pain; sudden, unusual weight gain; suicidal thoughts or actions; swelling of the hands, ankles, or feet; swollen lymph nodes; ulcers or sores in the mouth; trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding (eg, bleeding gums, nosebleeds); unusual tiredness or weakness; vision or eye problems; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Carbamazepine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; fainting; fast or irregular heartbeat; loss of consciousness; muscle twitching or tremor; seizures; severe dizziness, headache, or drowsiness; severe nausea or vomiting; slow, shallow, or irregular breathing.

Proper storage of Carbamazepine Chewable Tablets:

Store Carbamazepine Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Carbamazepine Chewable Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Carbamazepine Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Carbamazepine Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Carbamazepine Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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