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CLORPROMAZIN Thorazine (chlorpromazine) is 10-(3-dimethylaminopropyl)-2-chlorphenothiazine, a dimethylamine derivative of phenothiazine.

It is present in oral and injectable forms as the hydrochloride salt, and in the suppositories as the base.

Tablets Each round, orange, coated tablet contains chlorpromazine hydrochloride as follows: 10 mg imprinted SKF and T73; 25 mg imprinted SKF and T74; 50 mg imprinted SKF and T76; 100 mg imprinted SKF and T77; 200 mg imprinted SKF and T79. Inactive ingredients consist of benzoic acid, croscarmellose sodium, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Yellow No. 6, gelatin, hydroxypropyl methylcellulose, lactose, magnesium stearate, methylparaben, polyethylene glycol, propylparaben, talc, titanium dioxide and trace amounts of other inactive ingredients. Spansule sustained release capsules Each Thorazine (chlorpromazine) Spansule capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with opaque orange cap and natural body, contains chlorpromazine hydrochloride as follows: 30 mg imprinted SKF and T63; 75 mg imprinted SKF and T64; 150 mg imprinted SKF and T66. Inactive ingredients consist of benzyl alcohol, calcium sulfate, cetylpyridinium chloride, FD&C Yellow No. 6, gelatin, glyceryl distearate, glyceryl monostearate, iron oxide, povidone, silicon dioxide, sodium lauryl sulfate, starch, sucrose, titanium dioxide, wax and trace amounts of other inactive ingredients. Ampuls Each mL contains, in aqueous solution, chlorpromazine hydrochloride, 25 mg; ascorbic acid, 2 mg; sodium bisulfite, 1 mg; sodium chloride, 6 mg; sodium sulfite, 1 mg. Multi-Dose Vials Each mL contains, in aqueous solution, chlorpromazine hydrochloride, 25 mg; ascorbic acid, 2 mg; sodium bisulfite, 1 mg; sodium chloride, 1 mg; sodium sulfite, 1 mg; benzyl alcohol, 2%, as a preservative. Syrup Each 5 mL (1 teaspoonful) of clear, orange-custard flavored liquid contains chlorpromazine hydrochloride, 10 mg. Inactive ingredients consist of citric acid, flavors, sodium benzoate, sodium citrate, sucrose and water. Suppositories Each suppository contains chlorpromazine, 25 or 100 mg, glycerin, glyceryl monopalmitate, glyceryl monostearate, hydrogenated coconut oil fatty acidsand hydrogenated palm kernel oil fatty acids. WHAT ARE THE POSSIBLE SIDE EFFECTS OF CHLORPROMAZINE (THORAZINE)? 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. Stop taking chlorpromazine and call your doctor at once if you have a serious side effect such as: twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs; tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking; feeling restless, jittery, or agitated;

feeling... What is chlorpromazine (Thorazine)? Chlorpromazine is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-azeens). It works by changing the actions of chemicals in your brain. Chlorpromazine is used to treat psychotic disorders such as schizophrenia or manic-depression, and severe behavioral problems in children. It is also used to treat nausea and vomiting, anxiety before surgery, chronic hiccups, acute intermittent porphyria, and symptoms of tetanus. Chlorpromazine may also be used for other purposes not listed in this medication guide. Chlorpromazine 10 mg-GG

ORANGE What are the possible side effects of chlorpromazine (Thorazine)? 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. Stop taking chlorpromazine and call your doctor at once if you have a serious side effect such as: twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs; tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking; feeling restless, jittery, or agitated; feeling like you might pass out; seizure (black-out or convulsions); nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes); pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms; high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing; unusual thoughts or behavior; decreased night vision, tunnel vision, watery eyes, increased sensitivity to light; urinating less than usual or not at all; joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include: dizziness, drowsiness, anxiety, sleep problems (insomnia); breast swelling or discharge; changes in menstrual periods; weight gain, swelling in your hands or feet; dry mouth or stuffy nose, blurred vision; constipation; or impotence, trouble having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about chlorpromazine (Thorazine)? Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Chlorpromazine is not for use in psychotic conditions related to dementia. Chlorpromazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use chlorpromazine if you have brain damage, bone marrow depression, or are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to chlorpromazine or other phenothiazines. Before you take chlorpromazine, tell your doctor if you have liver or kidney disease, heart disease or high blood pressure, glaucoma, severe breathing problems, past or present breast cancer, low levels of calcium in your blood, adrenal gland tumor, enlarged prostate or urination problems, a history of seizures, Parkinson's disease, or if you have ever had a serious side effect while using chlorpromazine or similar medicines. Chlorpromazine is an antipsychotic drug. It is a member of the phenothiazine family of compounds and is used to alleviate the symptoms and signs of psychosis . Psychosis is a form of severe mental illness, which is characterized by loss of contact with reality, hallucinations , delusions , agitation, and unusual behavior. In the United States, chlorpromazine is also sold under the brand name Thorazine. Purpose Chlorpromazine is principally used to reduce the signs and symptoms of psychosis. For this purpose, the drug is used in schizophrenia and the manic phase of bipolar (formerly manic-depressive) disorder. The drug is also used in the management of severe behavioral disorders with aggression, combativeness, or excessive excitability. Chlorpromazine may sometimes be used as a sedative in non-psychotic patients with excessive anxiety and agitation. In addition, the drug has been used to relieve nausea, vomiting, and persistent hiccups. Description Chlorpromazine was the first antipsychotic drug. It is not an exaggeration to say that the development of this medication began a revolution in the treatment of severe mental illness, which continues to this day. Patients with schizophrenia and other psychoses, who once would have been considered hopelessly untreatable and relegated to the back wards of state institutions, are often able today, as a result of treatment with chlorpromazine or similar medications, to live in the community and lead fuller lives. The discovery of chlorpromazine resulted from efforts of pharmaceutical researchers in the first half of the twentieth century to develop sedative medications. Several drugs of a chemical class known as phenothiazines were investigated and shown to be effective sedatives, but they had little effect on agitated patients with psychosis. A new

phenothiazine drug, chlorpromazine, was synthesized in France in 1950 and was tested on such patients. In 1952, two French psychiatrists, Delay and Deniker, announced that the drug exerted a specific effect in diminishing the symptoms and signs of psychosis in patients with severe mental illnesses. The mechanism of action of chlorpromazine is not completely understood. Its antipsychotic effects are believed to be related to its action in selectively blocking the transmission of nerve impulses from cell to cell in a region of the brain called the limbic system. This part of the brain is involved with emotions and motivation. Chlorpromazine, when sold under the name Thorazine, is available in many forms: tablets of 10, 25, 50, 100, and 200 mg; spansules (sustained release capsules) of 30, 75, and 150 mg; ampules for injection of 25 and 50 mg; multidose vial of 10 mL of 25 mg/mL; syrup 10mg/5mL, 4 fl oz.; suppositories of 25 and 100 mg. Generic chlorpromazine manufacturers may supply a somewhat different set of dosages and products. Recommended dosage For acutely disturbed adult patients suffering from a psychosis, such as schizophrenia or mania, the usual daily dosage ranges from 100 mg to 1000 mg per day. Some patients may require a higher dosage. There is great variation in individual dosage requirements for chlorpromazine and for other antipsychotic medications. It is usually advisable to begin with a lower dosage, and increase the dosage until sufficient reduction of symptoms is achieved. Maximum reduction of symptoms may take many weeks of continued treatment. Because of the possibility of side effects, which may be severe, lower dosages should be used in outpatients, children, the elderly, and patients with serious health problems. For non-psychotic patients with excessive anxiety or agitation, amounts used are generally less than 200 mg per day, divided among two or three doses. For nausea and vomiting in adults, the usual dosage is 1025 mg every four to six hours as needed, given by injection. Alternatively, doses of 50100 mg may be given rectally. Persistent hiccups may be treated with 2550 mg three or four times per day, orally or by injection. Precautions Elderly patients (those over age 65), especially women, and patients receiving long-term antipsychotic treatment are prone to develop tardive dyskinesia . This syndrome consists of involuntary, uncoordinated movements that may not disappear or may only partially improve after the drug is stopped. Tardive dyskinesia involves involuntary movements of the tongue, jaw, mouth or face or other groups of skeletal muscles. Tardive dyskinesia may also appear after chlorpromazine use has stopped. There is no known effective treatment for tardive dyskinesia, although

gradual (but rarely complete) improvement may occur over a long period. The need for long-term antipsychotic medication should be weighed against the risk of tardive dyskinesia, which increases with duration of treatment. Neuroleptic malignant syndrome (NMS), a dangerous condition with high fever, muscular rigidity, rapid pulse, sweating, and altered mental state, may occur with antipsychotic medication. NMS requires immediate medical treatment. Phenothiazine drugs, such as chlorpromazine, may cause sedation and may interfere with driving and other tasks requiring alertness. They may increase the effects of alcohol and sedatives. The adverse effects of chlorpromazine may be increased in people with diseases of the heart, liver, or kidney, or other debilitating illnesses. Phenothiazines may lower the seizure threshold, making it more likely that a seizure will occur in people who have a history of seizures . People with epilepsy may require adjustment of their anti-seizure medications. Chlorpromazine may cause acute muscle spasms, particularly of the head and neck, and sudden decreases of blood pressure. Patients may need to be hospitalized during the initial phase of treatment, particularly when receiving high doses or treatment by injection. Chlorpromazine reduces the body's ability to sweat, thus interfering with the regulation of body temperature. This may be a problem for some people in very hot weather. The problem most commonly occurs in elderly people in hot buildings without air conditioning. Body temperature may reach fatal levels. People taking chlorpromazine should be aware of the possibility of developing hyperthermia (high body temperature) in very hot weather. They should seek cool places in very hot weather. Children may especially susceptible to neurologic reactions to phenothiazines, such as muscle spasms. Elderly patients may be particularly sensitive to sedation, low blood pressure, and other side effects. These patients should start with lower doses and increase their dosage gradually under physician supervision. Chlorpromazine may decrease salivation in older patients, predisposing to tooth decay, gum disease and mouth infections. Candy and other sugary foods should be limited, and oral hygiene should be maintained. Chlorpromazine, like all phenothiazines, should not be taken by pregnant women because they harm the developing fetus. Breast-feeding is not recommended while taking the drug. Phenothiazines are secreted in breast milk and may cause harm to nursing infants.

Side effects Chlorpromazine and other phenothiazines may cause many side effects. The following more common side effects are grouped by the body system affected: Cardiovascular: decreases of blood pressure, especially on arising, which may cause dizziness or fainting; rapid heart rate, changes in heart rhythm and electrocardiogram. Nervous system: sedation, muscle spasms of the head and neck, muscle rigidity, restlessness, tremors, slowed movement, shuffling gait, increased seizure tendency. Digestive system: dry mouth, nausea, constipation, abnormal liver tests. Autonomic: blurred vision, nasal congestion, reduced sweating, difficulty urinating, problems with ejaculation, impotence. Hormonal: lactation, breast enlargement. Skin: rashes, sensitivity to sunlight. Body as a whole: weight gain.

Interactions Chlorpromazine interacts with a long list of other medications. Anyone starting this drug should review the other medications they are taking with their physician and pharmacist for possible interactions. Chlorpromazine and other phenothiazines may intensify the effects of drugs causing sedation, including alcohol, barbiturates , narcotic pain medications, minor tranquilizers, and antihistamines. Similarly, chlorpromazine may cause excessive reductions of blood pressure in patients taking other medicines that lower blood pressure. Chlorpromazine may also intensify side effects of drugs that also cause blurred vision, dry mouth, diminished sweating in hot weather, and constipation. Many other antipsychotics and antidepressants cause such effects. Chlorpromazine may enhance the effects of medications that lower the seizure threshold, such as steroid drugs, the asthma medication theophylline, and many other psychiatric drugs. Patients with epilepsy may require dosage adjustments of their anti-seizure medications. The effectiveness of medications for Parkinson's disease may be reduced by chlorpromazine and other antipsychotics. The likelihood of changes in heart rhythm may be increased when the drug is taken with other medications that have the same effect, including other antipsychotic drugs, antidepressants, certain heart medicines, and erythromycin.

Certain drugs that are eliminated by the liver may interfere with the elimination of chlorpromazine from the body, causing higher blood levels and increased side effects. Chlorpromazine may retard the elimination of other medicines, including many antidepressants, antipsychotic drugs, and heart medications, resulting in higher levels of these other medications and possibly increased side effects.

Read more: Chlorpromazine - children, effects, adults, drug, people, used, medication, brain http://www.minddisorders.com/Br-Del/Chlorpromazine.html#b#ixzz1r4uBOccl PROPANOLOL Definition Propranolol is classified as a beta blocker. It is sold in the United States under the brand name Inderal. When combined with the diuretic, hydrochlorothiazide, it is sold under the brand name Inderide. Propranolol also is produced as a generic product by a number of generic manufacturers. Propranolol is approved by the Food and Drug Administration (FDA) for the treatment of hypertension (high blood pressure), angina, certain types of cardiac arrhythmias, certain types of cardiac output diseases, a sympathetic nervous system disorder known as pheochromocytoma, hyperthyroid conditions, migraine, heart attack, and tremors of a variety of origins. It is also used on occasion for the treatment of medication-induced movement disorders caused by antipsychotic drugs and certain anxiety states in people suffering from a specific form of social phobia . Beta blockers , such as propanolol, are not useful for people with general social phobia who are anxious in most social situations; instead, propanolol may be useful for people who are anxious about specific performance situations, such as presenting a speech before an audience. Description Propranolol falls into the broad pharmacologic category known as beta blockers. Beta blockers block specific sites in the central nervous system known as beta-adrenergic receptor sites. When these sites are blocked, heart rate and blood pressure are reduced and patients become less anxious. Because of this, propranolol is useful in treating chest pain, high blood pressure, and excessive nervousness. Unfortunately, propranolol often makes breathing disorders, such as asthma, worse because it tends to constrict breathing passages and sometimes causes fluid to build up in the lungs if it excessively depresses the heart.

In the treatment of anxiety, propranolol is usually not administered on a chronic basis but, rather, prior to stressful events such as public speaking or acting. In the treatment of certain types of tremors, especially tremors secondary to a drug, and movement disorders secondary to antipsychotic therapy, propranolol is administered throughout the day in divided doses. Propranolol is available in 10-, 20-, 40-, 60-, and 80-mg tablets; in long-acting capsules; and an injectable form containing 1 mg per mL. It is also combined with the diuretic hydrochlorothiazide in tablets and extended-release capsules. Recommended dosage For the treatment of performance anxiety or stage fright, a single dose of 1040 mg may be administered 2030 minutes before the event. For the treatment of tremors, especially tremors secondary to lithium, doses range from 20 to 160 mg per day administered in two or three divided doses. For the treatment of movement disorders secondary to antipsychotic drug therapy, doses range from 10 to 30 mg three times daily. Precautions Precautions should be taken when administering propranolol in the following situations: liver or renal (kidney) failure prior to screening tests for glaucoma a history of immediate allergic reaction (known as anaphylaxis) to a beta blocker of any kind

Side effects The following side effects have been observed with propranolol. Most have been mild and transient (temporary) and rarely require the withdrawal of therapy: Cardiovascular: bradycardia, congestive heart failure, hypotension, Raynaud's syndrome. Central nervous system: light-headedness, mental depression, insomnia , vivid dreams, disorientation, memory loss. Gastrointestinal: nausea, vomiting, abdominal pain, cramping, diarrhea, constipation, bowel ischemia. Allergic: fever, rash, laryngospasm, thrombocytopenia. Respiratory: bronchospasm. Hematologic: bone marrow suppression, bleeding under the skin.

Interactions When drugs that deplete the body of epinephrine and norepinephrine (such as reserpine and guanethidine) are taken with propranolol, interactions have been reported. Some of these interactions include: fainting, hypotension, dizziness, and slow heart rate. Drugs known as calcium channel blockers may decrease the pumping ability of the heart and lead to the development of cardiac arrhythmias. Nonsteroidal anti-inflammatory agents (i.e., ibuprofen and naproxen) may blunt the blood pressurelowering effects of propranolol. Aluminum hydroxide antacids greatly reduce the rate of intestinal absorption of propranolol. Alcohol slows the rate of propranolol absorption. Interactions have also been reported with phenytoin, rifampin, phenobarbital, chlorpromazine , lidocaine, thyroxin, cimetidine, and theophylline.

MERLOPAN Usual Adult Dose for Epilepsy Initial dose: 200 mg orally twice a day (immediate and extended release) or 100 mg orally 4 times a day (suspension). Increase dose at weekly intervals in 200 mg/day increments using a twice daily regimen of extended release or a three times a day or four times a day regimen of the other formulations. Maintenance dose: 800 to 1200 mg/day. Dosage generally should not exceed 1200 mg/day. However, doses up to 1600 mg/day have been used in rare instances. Usual Adult Dose for Trigeminal Neuralgia Initial dose: 100 mg orally twice a day (immediate or extended release) or 50 mg orally 4 times a day (suspension). May increase by up to 200 mg/day using increments of 100 mg every 12 hours (immediate or extended release), or 50 mg four times a day. (suspension), only as needed to achieve freedom from pain. Do not exceed 1200 mg/ day. Maintenance dose: 400 to 800 mg/day. Some patients may be maintained on as little as 200 mg/day while others may require as much as 1200 mg/day. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or to discontinue the drug.

Usual Adult Dose for Bipolar Disorder Initial dose: 200 mg orally in tablet or capsule form every 12 hours or 100 mg of oral solution 4 times a day. Tablets and solution: Following autoinduction, higher doses will be necessary to maintain drug levels within the therapeutic range of 6 to 12 mcg/mL. The daily dose should be increased in 100 to 200 mg increments at 1 to 2 week intervals. Maintenance dose: up to 1200 mg daily in 3 or 4 divided doses may be necessary to maintain plasma levels in the therapeutic range. Extended release capsules: The dose should be adjusted in 200 mg daily increments (increase by 100 mg twice daily) to achieve optimal clinical response. Doses higher than 1600 mg per day have not been studied. Usual Adult Dose for Diabetic Neuropathy Initial dose: 100 mg orally in tablet form every 12 hours or 50 mg of oral solution 4 times a day. The daily dose should be increased in 100 mg increments at 1 to 2 week intervals. Maintenance dose: 600 to 1200 mg daily in 3 or 4 divided doses may be necessary to maintain plasma levels in the therapeutic range. Usual Pediatric Dose for Epilepsy <6 years: Initial dose: 10 to 20 mg/kg/day orally in 2 to 3 divided doses (tablets) or 4 divided doses (suspension) . Increase dose at weekly intervals to achieve optimal clinical response. Maximum dose: 35 mg/kg/day. If satisfactory response not achieved, measure levels to determine if in therapeutic range. 6 to 12 years: Initial dose: 100 mg orally twice a day (immediate or extended release tablets) or 50 mg orally 4 times a day (suspension). Increase dose at weekly intervals in 100 mg/day increments using a twice daily regimen of extended release or a three times a day or four times a day regimen of the other formulations. Maintenance dose: 400 to 800 mg/day. Maximum dose: 1000 mg/day. >12 years: Initial dose: 200 mg orally twice a day (immediate and extended release) or 100 mg orally 4 times a day

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(suspension). Increase dose at weekly intervals in 200 mg/day increments using a twice a day regimen of extended release or a three times daily to four times daily regimen of the other formulations. Maintenance dose: 800 to 1200 mg/day. Dosage generally should not exceed 1000 mg in children 12 to 15 years and 1200 mg/day in patients >15 years. Doses up to 1600 mg/day have been used in rare instances. Renal Dose Adjustments Data not available Liver Dose Adjustments Data not available Dose Adjustments 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. Precautions When added to existing anticonvulsant therapy, carbamazepine should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased. Dialysis Carbamazepine is slightly dialyzed by hemodialysis. The dialysis clearance averages 54 mL/min. Using a Cobe Century II hollow tube dialyzer with a cuprophane membrane, 10% of a dose is removed during 4 hour of hemodialysis. Hemoperfusion has been reported to be useful in the removal of carbamazepine during acute overdose.

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INDICATIONS AND USAGE Epilepsy Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. 2. 3. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. Generalized tonic-clonic seizures (grand mal). Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Tegretol (see PRECAUTIONS, General).

Trigeminal Neuralgia Tegretol is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.

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DOSAGE AND ADMINISTRATION (SEE TABLE BELOW) 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 6-12 years: 1/2 teaspoon q.i.d.) 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., b.i.d. tablets to t.i.d. 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 b.i.d. for tablets and XR tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day). Increase at weekly intervals by adding up to 200 mg/day using a b.i.d. regimen of Tegretol-XR or a t.i.d. or q.i.d. regimen of the other formulations until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12-15 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 800-1200 mg daily. Children 6 -12 years of age - Initial: Either 100 mg b.i.d. for tablets or XR tablets, or 1/2 teaspoon q.i.d. for suspension (200 mg/day). Increase at weekly intervals by adding up to 100 mg/day using a b.i.d. regimen of Tegretol-XR or a t.i.d. or q.i.d. 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 400-800 mg daily. Children under 6 years of age - Initial: 10-20 mg/kg/day b.i.d. or t.i.d. as tablets, or q.i.d. as suspension. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. 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 Category D). Trigeminal Neuralgia (SEE INDICATIONS AND USAGE)

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HOW SUPPLIED 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 30C (86F). 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

Do not store above 30C (86F). 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 controlled room temperature 15C-30C (59F-86F). 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

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