TEGRETOL XR 400 MG TABLET | BROWN ROUND T 400 MG NOVARTIS 0078051205

SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH TEGRETOL. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH TEGRETOL. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH TEGRETOL UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE WARNINGS AND PRECAUTIONS, LABORATORY TESTS). APLASTIC ANEMIA AND AGRANULOCYTOSIS APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF TEGRETOL. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5 TO 8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA. ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF TEGRETOL, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS. BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON TEGRETOL ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY. DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT BONE MARROW DEPRESSION DEVELOPS.

In clinical studies, Tegretol suspension, conventional tablets, and XR tablets delivered equivalent amounts of drug to the systemic circulation. However, the suspension was absorbed somewhat faster, and the XR tablet slightly slower, than the conventional tablet. The bioavailability of the XR tablet was 89% compared to suspension. Following a twice a day dosage regimen, the suspension provides higher peak levels and lower trough levels than those obtained from the conventional tablet for the same dosage regimen. On the other hand, following a three times a day dosage regimen, Tegretol suspension affords steady-state plasma levels comparable to Tegretol tablets given twice a day when administered at the same total mg daily dose. Following a twice a day dosage regimen, Tegretol-XR tablets afford steady-state plasma levels comparable to conventional Tegretol tablets given four times a day, when administered at the same total mg daily dose. Tegretol in blood is 76% bound to plasma proteins. Plasma levels of Tegretol are variable and may range from 0.5 to 25 mcg/mL, with no apparent relationship to the daily intake of the drug. Usual adult therapeutic levels are between 4 and 12 mcg/mL. In polytherapy, the concentration of Tegretol and concomitant drugs may be increased or decreased during therapy, and drug effects may be altered (see PRECAUTIONS, Drug Interactions). Following chronic oral administration of suspension, plasma levels peak at approximately 1.5 hours compared to 4 to 5 hours after administration of conventional Tegretol tablets, and 3 to 12 hours after administration of Tegretol-XR tablets. The CSF/serum ratio is 0.22, similar to the 24% unbound Tegretol in serum. Because Tegretol induces its own metabolism, the half-life is also variable. Autoinduction is completed after 3 to 5 weeks of a fixed dosing regimen. Initial half-life values range from 25 to 65 hours, decreasing to 12 to 17 hours on repeated doses. Tegretol is metabolized in the liver. Cytochrome P450 3A4 was identified as the major isoform responsible for the formation of carbamazepine-10,11-epoxide from Tegretol. Human microsomal epoxide hydrolase has been identified as the enzyme responsible for the formation of the 10,11-transdiol derivative from carbamazepine-10,11 epoxide. After oral administration of 14C-carbamazepine, 72% of the administered radioactivity was found in the urine and 28% in the feces. This urinary radioactivity was composed largely of hydroxylated and conjugated metabolites, with only 3% of unchanged Tegretol. The pharmacokinetic parameters of Tegretol disposition are similar in children and in adults. However, there is a poor correlation between plasma concentrations of carbamazepine and Tegretol dose in children. Carbamazepine is more rapidly metabolized to carbamazepine-10,11-epoxide (a metabolite shown to be equipotent to carbamazepine as an anticonvulsant in animal screens) in the younger age groups than in adults. In children below the age of 15, there is an inverse relationship between CBZ-E/CBZ ratio and increasing age (in one report from 0.44 in children below the age of 1 year to 0.18 in children between 10 to 15 years of age). The effects of race and gender on carbamazepine pharmacokinetics have not been systematically evaluated.

Before initiating therapy, a detailed history and physical examination should be made. Tegretol should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients Tegretol has been associated with increased frequency of generalized convulsions (see INDICATIONS AND USAGE). Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac conduction disturbance, including second- and third-degree AV heart block; cardiac, hepatic, or renal damage; adverse hematologic or hypersensitivity reaction to other drugs, including reactions to other anticonvulsants; or interrupted courses of therapy with Tegretol. AV heart block, including second- and third-degree block, have been reported following Tegretol treatment. This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances. Hepatic effects, ranging from slight elevations in liver enzymes to rare cases of hepatic failure have been reported (see ADVERSE REACTIONS and PRECAUTIONS, Laboratory Tests). In some cases, hepatic effects may progress despite discontinuation of the drug. In addition, rare instances of vanishing bile duct syndrome have been reported. This syndrome consists of a cholestatic process with a variable clinical course ranging from fulminant to indolent, involving the destruction and disappearance of the intrahepatic bile ducts. Some, but not all, cases are associated with features that overlap with other immunoallergenic syndromes, such as multiorgan hypersensitivity (DRESS syndrome) and serious dermatologic reactions. As an example, there has been a report of vanishing bile duct syndrome associated with SJS and in another case an association with fever and eosinophilia. Since a given dose of Tegretol suspension will produce higher peak levels than the same dose given as the tablet, it is recommended that patients given the suspension be started on lower doses and increased slowly to avoid unwanted side effects (see DOSAGE AND ADMINISTRATION). Tegretol suspension contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance.

Patients should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide before taking Tegretol. Patients should be made aware of the early toxic signs and symptoms of a potential hematologic problem, as well as dermatologic, hypersensitivity or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. The patient should be advised that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician. In addition, the patient should be advised that these signs and symptoms should be reported even if mild or when occurring after extended use. Patients should be advised that serious skin reactions have been reported in association with Tegretol. In the event a skin reaction should occur while taking Tegretol, patients should consult with their physician immediately (see WARNINGS). Patients should be advised that anaphylactic reactions and angioedema may occur during treatment with Tegretol (see WARNINGS). Advise patients to immediately report signs and symptoms suggesting angioedema (swelling of the face, eyes, lips, or tongue, or difficulty in swallowing or breathing) and to stop taking the drug until they have consulted with their healthcare provider. Patients, their caregivers, and families should be counseled that AEDs, including Tegretol, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers. Tegretol may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or nonprescription medications or herbal products. Caution should be exercised if alcohol is taken in combination with Tegretol therapy, due to a possible additive sedative effect. Since dizziness and drowsiness may occur, patients should be cautioned about the hazards of operating machinery or automobiles or engaging in other potentially dangerous tasks. Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 (see WARNINGS, Usage in Pregnancy subsection).

If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING), the liver, and the cardiovascular system. The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. The following additional adverse reactions have been reported: Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda. Skin: TEN and SJS (see BOXED WARNING), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, onychomadesis and hirsutism. In certain cases, discontinuation of therapy may be necessary. Cardiovascular System: Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism (e.g., pulmonary embolism), and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds. Liver: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of hepatic failure. Pancreatic: Pancreatitis. Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia. Genitourinary System: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported. There have been rare reports of impaired male fertility and/or abnormal spermatogenesis. Testicular atrophy occurred in rats receiving Tegretol orally from 4 to 52 weeks at dosage levels of 50 to 400 mg/kg/day. Additionally, rats receiving Tegretol in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and higher. Relevance of these findings to humans is unknown. Nervous System: Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, hyperacusis, neuroleptic malignant syndrome. There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established. Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomitant use of psychotropic drugs. Digestive System: Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis. Eyes: Scattered punctate cortical lens opacities, increased intraocular pressure (see WARNINGS, General) as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes. Musculoskeletal System: Aching joints and muscles, and leg cramps. Metabolism: Fever and chills. Hyponatremia (see WARNINGS, General). Decreased levels of plasma calcium have been reported. Osteoporosis has been reported. Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants. A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Acute Toxicity Lowest known lethal dose: adults, 3.2 g (a 24-year-old woman died of a cardiac arrest and a 24-year-old man died of pneumonia and hypoxic encephalopathy); children, 4 g (a 14-year-old girl died of a cardiac arrest), 1.6 g (a 3-year-old girl died of aspiration pneumonia). Oral LD50 in animals (mg/kg): mice, 1100 to 3750; rats, 3850 to 4025; rabbits, 1500 to 2680; guinea pigs, 920. Signs and Symptoms The first signs and symptoms appear after 1 to 3 hours. Neuromuscular disturbances are the most prominent. Cardiovascular disorders are generally milder, and severe cardiac complications occur only when very high doses (greater than 60 g) have been ingested. Respiration: Irregular breathing, respiratory depression. Cardiovascular System: Tachycardia, hypotension or hypertension, shock, conduction disorders. Nervous System and Muscles: Impairment of consciousness ranging in severity to deep coma. Convulsions, especially in small children. Motor restlessness, muscular twitching, tremor, athetoid movements, opisthotonos, ataxia, drowsiness, dizziness, mydriasis, nystagmus, adiadochokinesia, ballism, psychomotor disturbances, dysmetria. Initial hyperreflexia, followed by hyporeflexia. Gastrointestinal Tract: Nausea, vomiting. Kidneys and Bladder: Anuria or oliguria, urinary retention. Laboratory Findings: Isolated instances of overdosage have included leukocytosis, reduced leukocyte count, glycosuria, and acetonuria. EEG may show dysrhythmias. Combined Poisoning: When alcohol, tricyclic antidepressants, barbiturates, or hydantoins are taken at the same time, the signs and symptoms of acute poisoning with Tegretol may be aggravated or modified. Treatment The prognosis in cases of severe poisoning is critically dependent upon prompt elimination of the drug, which may be achieved by inducing vomiting, irrigating the stomach, and by taking appropriate steps to diminish absorption. If these measures cannot be implemented without risk on the spot, the patient should be transferred at once to a hospital, while ensuring that vital functions are safeguarded. There is no specific antidote. Elimination of the Drug: Induction of vomiting. Gastric lavage. Even when more than 4 hours have elapsed following ingestion of the drug, the stomach should be repeatedly irrigated, especially if the patient has also consumed alcohol. Measures to Reduce Absorption: Activated charcoal, laxatives. Measures to Accelerate Elimination: Forced diuresis. Dialysis is indicated only in severe poisoning associated with renal failure. Replacement transfusion is indicated in severe poisoning in small children. Respiratory Depression: Keep the airways free; resort, if necessary, to endotracheal intubation, artificial respiration, and administration of oxygen. Hypotension, Shock: Keep the patient s legs raised and administer a plasma expander. If blood pressure fails to rise despite measures taken to increase plasma volume, use of vasoactive substances should be considered. Convulsions: Diazepam or barbiturates. Warning: Diazepam or barbiturates may aggravate respiratory depression (especially in children), hypotension, and coma. However, barbiturates should not be used if drugs that inhibit monoamine oxidase have also been taken by the patient either in overdosage or in recent therapy (within 1 week). Surveillance: Respiration, cardiac function (ECG monitoring), blood pressure, body temperature, pupillary reflexes, and kidney and bladder function should be monitored for several days. Treatment of Blood Count Abnormalities: If evidence of significant bone marrow depression develops, the following recommendations are suggested: (1) stop the drug, (2) perform daily CBC, platelet, and reticulocyte counts, (3) do a bone marrow aspiration and trephine biopsy immediately and repeat with sufficient frequency to monitor recovery. Special periodic studies might be helpful as follows: (1) white cell and platelet antibodies, (2) 59Fe-ferrokinetic studies, (3) peripheral blood cell typing, (4) cytogenetic studies on marrow and peripheral blood, (5) bone marrow culture studies for colony-forming units, (6) hemoglobin electrophoresis for A2 and F hemoglobin, and (7) serum folic acid and B12 levels. A fully developed aplastic anemia will require appropriate, intensive monitoring and therapy, for which specialized consultation should be sought.

Tegretol suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange rubbery precipitate in the stool following coadministration of the two drugs (see PRECAUTIONS, Drug Interactions). Because the extent to which this occurs with other liquid medications is not known, Tegretol suspension should not be administered simultaneously with other liquid medications or diluents. Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals. Since a given dose of Tegretol suspension will produce higher peak levels than the same dose given as the tablet, it is recommended to start with low doses (children 6 to 12 years: teaspoon four times a day and to increase slowly to avoid unwanted side effects. Conversion of patients from oral Tegretol tablets to Tegretol suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., twice a day tablets to three times a day suspension). Tegretol-XR is an extended-release formulation for twice a day administration. When converting patients from Tegretol conventional tablets to Tegretol-XR, the same total daily mg dose of Tegretol-XR should be administered. Tegretol -XR tablets must be swallowed whole and never crushed or chewed. Tegretol-XR tablets should be inspected for chips or cracks. Damaged tablets, or tablets without a release portal, should not be consumed. Tegretol-XR tablet coating is not absorbed and is excreted in the feces; these coatings may be noticeable in the stool. Epilepsy (see INDICATIONS AND USAGE) Adults and children over 12 years of age-Initial: Either 200 mg twice a day for tablets and XR tablets, or 1 teaspoon four times a day for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a twice a day regimen of Tegretol-XR or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily. Children 6 to 12 years of age-Initial: Either 100 mg twice a day for tablets or XR tablets, or teaspoon four times a day for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a twice a day regimen of Tegretol-XR or a three times a day or four times a day regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily. Children under 6 years of age-Initial: 10 to 20 mg/kg/day twice a day or three times a day as tablets, or four times a day as suspension. Increase weekly to achieve optimal clinical response administered three times a day or four times a day. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made. Combination Therapy: Tegretol may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions, and Pregnancy). Trigeminal Neuralgia (see INDICATIONS AND USAGE) Initial: On the first day, either 100 mg twice a day for tablets or XR tablets, or teaspoon four times a day for suspension, for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours for tablets or XR tablets, or 50 mg ( teaspoon) four times a day for suspension, only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug. Dosage Information Initial Dose Subsequent Dose Maximum Daily Dose Indication Tablet* XR Suspension Tablet* XR Suspension Tablet* XR Suspension Epilepsy Under 6 yr 10-20 mg/kg/daytwice a day or 3 times a day 10-20 mg/kg/day4 times a day Increase weekly to achieve optimal clinical response, 3 times a day or 4 times a day Increase weekly to achieve optimal clinical response, 3 times a day or 4 times a day 35 mg/kg/24 hr (see Dosage and Administration section above) 35 mg/kg/24 hr (see Dosage and Administration section above) 6-12 yr 100 mg twice a day (200 mg/day) 100 mg twice a day (200 mg/day) tsp 4 times a day(200 mg/day) Add up to 100 mg/day at weekly intervals, 3 times a day or 4 times a day Add 100 mg/day at weekly intervals, twice a day Add up to 1 tsp (100 mg)/day at weekly intervals, 3 times a day or 4 times a day 1000 mg/24 hr Over 12 yr 200 mg twice a day (400 mg/day) 200 mg twice a day (400 mg/day) 1 tsp 4 times a day(400 mg/day) Add up to 200 mg/day at weekly intervals, 3 times a day or 4 times a day Add up to 200 mg/day at weekly intervals, twice a day Add up to 2 tsp (200 mg)/day at weekly intervals, 3 times a day or 4 times a day 1000 mg/24 hr (12-15 yr)1200 mg/24 hr (> 15 yr)1600 mg/24 hr (adults, in rare instances) Trigeminal Neuralgia 100 mg twice a day (200 mg/day) 100 mg twice a day (200 mg/day) tsp 4 times a day(200 mg/day) Add up to 200 mg/day in increments of 100 mg every 12 hr Add up to 200 mg/day in increments of 100 mg every 12 hr Add up to 2 tsp (200 mg)/day in increments of 50 mg ( tsp) 4 times a day 1200 mg/24 hr *Tablet = Chewable or conventional tablets. XR = Tegretol-XR extended-release tablets.

Chewable Tablets 100 mg - round, red-speckled, pink, single-scored (imprinted Tegretol on one side and 52 twice on the scored side) Bottles of 100 .NDC 0078-0492-05 Unit Dose (blister pack) Box of 100 (strips of 10) ....NDC 0078-0492-35 Do not store above 30 C (86 F). Protect from light and moisture. Dispense in tight, light-resistant container (USP). Meets USP Dissolution Test 1. Tablets 200 mg - capsule-shaped, pink, single-scored (imprinted Tegretol on one side and 27 twice on the partially scored side) Bottles of 100.............................................................................................................................NDC 0078-0509-05 Bottles of 60...............................................................................................................................NDC 0078-0509-20 Store at 20 C to 25 C (68 F to 77 F), excursions permitted between 15 C and 30 C (59 F and 86 F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Meets USP Dissolution Test 2. XR Tablets 100 mg - round, yellow, coated (imprinted T on one side and 100 mg on the other), release portal on one side Bottles of 100.............................................................................................................................NDC 0078-0510-05 XR Tablets 200 mg - round, pink, coated (imprinted T on one side and 200 mg on the other), release portal on one side Bottles of 100.............................................................................................................................NDC 0078-0511-05 XR Tablets 400 mg - round, brown, coated (imprinted T on one side and 400 mg on the other), release portal on one side Bottles of 100.............................................................................................................................NDC 0078-0512-05 Store at 20 C to 25 C (68 F to 77 F), excursions permitted between 15 C and 30 C (59 F and 86 F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Suspension 100 mg/5 mL (teaspoon) yellow-orange, citrus-vanilla flavored Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83 Shake well before using. Do not store above 30 C (86 F). Dispense in tight, light -resistant container (USP). *Thorazine is a registered trademark of GlaxoSmithKline. T2023-61September 2023

TEGRETOL and TEGRETOL -XR (Teg-ret-ol)(carbamazepine)Tablets, Suspension, Chewable Tablets, Extended-Release Tablets Read this Medication Guide before you start taking Tegretol or Tegretol XR (TEGRETOL) and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about TEGRETOL? Do not stop taking TEGRETOL without first talking to your healthcare provider. Stopping TEGRETOL suddenly can cause serious problems. TEGRETOL can cause serious side effects, including: TEGRETOL may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking TEGRETOL within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take TEGRETOL to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include: skin rash hives sores in your mouth blistering or peeling of the skin TEGRETOL may cause rare but serious blood problems. Symptoms may include: fever, sore throat, or other infections that come and go or do not go away easy bruising red or purple spots on your body bleeding gums or nose bleeds severe fatigue or weakness TEGRETOL may cause allergic reactions or serious problems, which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of the following: swelling of your face, eyes, lips, or tongue a skin rash painful sores in the mouth or around your eyes unusual bruising or bleeding frequent infections or infections that do not go away fever, swollen glands, or sore throat that do not go away or come and go trouble swallowing or breathing hives yellowing of your skin or eyes severe fatigue or weakness severe muscle pain Like other antiepileptic drugs, TEGRETOL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not stop TEGRETOL without first talking to a healthcare provider. Stopping TEGRETOL suddenly can cause serious problems. You should talk to your healthcare provider before stopping. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. What is TEGRETOL ? TEGRETOL is a prescription medicine used to treat: certain types of seizures (partial, tonic-clonic, mixed) certain types of nerve pain (trigeminal and glossopharyngeal neuralgia) TEGRETOL is not a regular pain medicine and should not be used for aches or pains. Who should not take TEGRETOL? Do not take TEGRETOL if you: have a history of bone marrow depression. are allergic to carbamazepine or any of the ingredients in TEGRETOL. See the end of this Medication Guide for a complete list of ingredients in TEGRETOL. take nefazodone. are allergic to medicines called tricyclic antidepressants (TCAs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. have taken a medicine called a Monoamine Oxidase Inhibitor (MAOI) in the last 14 days. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. What should I tell my healthcare provider before taking TEGRETOL? Before you take TEGRETOL, tell your healthcare provider if you: have or have had suicidal thoughts or actions, depression, or mood problems have or ever had heart problems have or ever had blood problems have or ever had liver problems have or ever had kidney problems have or ever had allergic reactions to medicines have or ever had increased pressure in your eye have any other medical conditions drink grapefruit juice or eat grapefruit use birth control. TEGRETOL may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and TEGRETOL. are pregnant or plan to become pregnant. TEGRETOL may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking TEGRETOL. You and your healthcare provider should decide if you should take TEGRETOL while you are pregnant. If you become pregnant while taking TEGRETOL, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334. are breastfeeding or plan to breastfeed. TEGRETOL passes into breast milk. You and your healthcare provider should discuss whether you should take TEGRETOL or breastfeed; you should not do both. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking TEGRETOL with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take TEGRETOL? Do not stop taking TEGRETOL without first talking to your healthcare provider. Stopping TEGRETOL suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus). Take TEGRETOL exactly as prescribed. Your healthcare provider will tell you how much TEGRETOL to take. Your healthcare provider may change your dose. Do not change your dose of TEGRETOL without talking to your healthcare provider. Take TEGRETOL with food. TEGRETOL-XR Tablets: Do not crush, chew, or break TEGRETOL-XR tablets. Tell your healthcare provider if you cannot swallow TEGRETOL-XR whole. TEGRETOL Suspension: Shake the bottle well each time before use. Do not take TEGRETOL suspension at the same time you take other liquid medicines. If you take too much TEGRETOL, call your healthcare provider or local Poison Control Center right away. What should I avoid while taking TEGRETOL? Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking TEGRETOL until you talk to your healthcare provider. TEGRETOL taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not drive, operate heavy machinery, or do other dangerous activities until you know how TEGRETOL affects you. TEGRETOL may slow your thinking and motor skills. What are the possible side effects of TEGRETOL? See What is the most important information I should know about TEGRETOL? TEGRETOL may cause other serious side effects. These include: Irregular heartbeat - symptoms include: Fast, slow, or pounding heartbeat Shortness of breath Feeling lightheaded Fainting Liver problems - symptoms include: yellowing of your skin or the whites of your eyes dark urine pain on the right side of your stomach area (abdominal pain) easy bruising loss of appetite nausea or vomiting Get medical help right away if you have any of the symptoms listed above or listed in What is the most important information I should know about TEGRETOL? The most common side effects of TEGRETOL include: dizziness drowsiness problems with walking and coordination (unsteadiness) nausea vomiting These are not all the possible side effects of TEGRETOL. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store TEGRETOL? Store TEGRETOL Tablets at 20 C to 25 C (68 F to 77 F), excursions permitted between 15 C and 30 C (59 F and 86 F). Keep TEGRETOL Tablets dry. Do not store TEGRETOL Chewable Tablets above 30 C (86 F). Keep TEGRETOL Chewable Tablets out of the light. Keep TEGRETOL Chewable Tablets dry. Store TEGRETOL-XR Tablets at 20 C to 25 C (68 F to 77 F); excursions permitted between 15 C and 30 C (59 F and 86 F). Keep TEGRETOL-XR Tablets dry. Do not store TEGRETOL Suspension above 30 C (86 F). Shake well before using. Keep TEGRETOL Suspension in a tight, light-resistant container. Keep TEGRETOL and all medicines out of the reach of children. General Information about TEGRETOL. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TEGRETOL for a condition for which it was not prescribed. Do not give TEGRETOL to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about TEGRETOL. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about TEGRETOL that is written for health professionals. For more information, go to www.novartis.us or call 1-888-669-6682. What are the ingredients in TEGRETOL? Active ingredient: carbamazepine Inactive ingredients: TEGRETOL Tablets: colloidal silicon dioxide, D&C Red No. 30 Aluminum Lake (chewable tablets only), FD&C Red No. 40 (200 mg tablets only), flavoring (chewable tablets only), gelatin, glycerin, magnesium stearate, sodium starch glycolate (chewable tablets only), starch, stearic acid, and sucrose (chewable tablets only). TEGRETOL Suspension: citric acid, FD&C Yellow No. 6, flavoring, polymer, potassium sorbate, propylene glycol, purified water, sorbitol, sucrose, and xanthan gum. TEGRETOL-XR Tablets: cellulose compounds, dextrates, iron oxides, magnesium stearate, mannitol, polyethylene glycol, sodium lauryl sulfate, titanium dioxide (200 mg tablets only). This Medication Guide has been approved by the U.S. Food and Drug Administration. Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936 Novartis T2023-62September 2023

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