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Tegretol
Overview
What is Tegretol?
Tegretol, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg, tablets of 200 mg, XR tablets of 100, 200, and 400 mg, and as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5-dibenz[
]azepine-5-carboxamide, and its structural formula is:
Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27.
Inactive Ingredients
What does Tegretol look like?
What are the available doses of Tegretol?
Sorry No records found.
What should I talk to my health care provider before I take Tegretol?
Sorry No records found
How should I use Tegretol?
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:
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: ½ 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 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:
Maintenance:
Children 6 to 12 years of age-Initial:
Maintenance:
Children under 6 years of age-Initial:
Maintenance:
Combination Therapy:
Trigeminal Neuralgia (SEE INDICATIONS AND USAGE)
Initial:
Maintenance:
*Tablet = Chewable or conventional tablets
†
What interacts with Tegretol?
Sorry No Records found
What are the warnings of Tegretol?
Sorry No Records found
What are the precautions of Tegretol?
Sorry No Records found
What are the side effects of Tegretol?
Sorry No records found
What should I look out for while using Tegretol?
Tegretol should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of Tegretol, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.
Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.
What might happen if I take too much Tegretol?
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 LD 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:
Cardiovascular System:
Nervous System and Muscles:
Gastrointestinal Tract:
Kidneys and Bladder:
Laboratory Findings:
Combined Poisoning:
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:
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:
Measures to Accelerate Elimination:
Dialysis is indicated only in severe poisoning associated with renal failure. Replacement transfusion is indicated in severe poisoning in small children.
Respiratory Depression:
Hypotension, Shock:
Convulsions:
Warning:
not
Surveillance:
Treatment of Blood Count Abnormalities:
Special periodic studies might be helpful as follows: (1) white cell and platelet antibodies, (2) Fe-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 Aand F hemoglobin, and (7) serum folic acid and Blevels.
A fully developed aplastic anemia will require appropriate, intensive monitoring and therapy, for which specialized consultation should be sought.
How should I store and handle Tegretol?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].FOR YOUR PROTECTION:Keep out of reach of children.Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018Chewable Tablets 100 mgBottles of 100………………………………………………………………………………….NDC 0078-0492-05Unit Dose (blister pack)Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35Do not store above 30°C (86°F). Dispense in tight, light-resistant container (USP).Meets USP Dissolution Test 1.Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0509-05Bottles of 60...............................................................................................................................NDC 0078-0509-20Do not store above 30°C (86°F). Dispense in tight container (USP).Meets USP Dissolution Test 2.XR Tablets 100 mg Bottles of 100.............................................................................................................................NDC 0078-0510-05XR Tablets 200 mgBottles of 100.............................................................................................................................NDC 0078-0511-05XR Tablets 400 mg Bottles of 100.............................................................................................................................NDC 0078-0512-05Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) Dispense in tight container (USP).Suspension 100 mg/5 mL (teaspoon) Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83Shake well before using.Do not store above 30°C (86°F). *Thorazine is a registered trademark of GlaxoSmithKline.T2018-27March 2018
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Tegretol has demonstrated anticonvulsant properties in rats and mice with electrically and chemically induced seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. Tegretol greatly reduces or abolishes pain induced by stimulation of the infraorbital nerve in cats and rats. It depresses thalamic potential and bulbar and polysynaptic reflexes, including the linguomandibular reflex in cats. Tegretol is chemically unrelated to other anticonvulsants or other drugs used to control the pain of trigeminal neuralgia. The mechanism of action remains unknown.
The principal metabolite of Tegretol, carbamazepine-10,11-epoxide, has anticonvulsant activity as demonstrated in several in vivo animal models of seizures. Though clinical activity for the epoxide has been postulated, the significance of its activity with respect to the safety and efficacy of Tegretol has not been established.
Non-Clinical Toxicology
Tegretol should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of Tegretol, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated.
Metabolism of a number of medications, including antipsychotics, antidepressants, ß-blockers, and antiarrhythmics, occurs through the cytochrome P450 2D6 isoenzyme (debrisoquine hydroxylase). Approximately 10% of the Caucasian population has reduced activity of this enzyme, so-called "poor" metabolizers. Among other populations the prevalence is not known. Poor metabolizers demonstrate higher plasma concentrations of antipsychotic drugs at usual doses, which may correlate with emergence of side effects. In one study of 45 elderly patients suffering from dementia treated with perphenazine, the 5 patients who were prospectively identified as poor P450 2D6 metabolizers had reported significantly greater side effects during the first 10 days of treatment than the 40 extensive metabolizers, following which the groups tended to converge. Prospective phenotyping of elderly patients prior to antipsychotic treatment may identify those at risk for adverse events.
The concomitant administration of other drugs that inhibit the activity of P450 2D6 may acutely increase plasma concentrations of antipsychotics. Among these are tricyclic antidepressants and selective serotonin reuptake inhibitors, e.g., fluoxetine, sertraline and paroxetine. When prescribing these drugs to patients already receiving antipsychotic therapy, close monitoring is essential and dose reduction may become necessary to avoid toxicity. Lower doses than usually prescribed for either the antipsychotic or the other drug may be required.
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 Stevens-Johnson syndrome 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.
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:
Skin:
Cardiovascular System:
Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.
Liver:
Pancreatic:
Respiratory System:
Genitourinary System:
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:
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:
Eyes:
Musculoskeletal System:
Metabolism:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).