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Tranxene
Overview
What is Tranxene?
Chemically, TRANXENE is a benzodiazepine. The empirical formula is CHClKNO; the molecular weight is 408.92; 1-1, 4-Benzodiazepine-3-carboxylic acid, 7-chloro-2, 3-dihydro-2-oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1) and the structural formula may be represented as follows:-
The compound occurs as a fine, light yellow, practically odorless powder. It is insoluble in the common organic solvents, but very soluble in water. Aqueous solutions are unstable, clear, light yellow, and alkaline.
TRANXENE T-TAB tablets contain 7.5 mg of clorazepate dipotassium for oral administration.
Inactive ingredients for TRANXENE T-TAB Tablets: Colloidal silicon dioxide, FD&C Yellow No. 6, magnesium oxide, magnesium stearate, microcrystalline cellulose, potassium carbonate, potassium chloride, and talc.
What does Tranxene look like?
What are the available doses of Tranxene?
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What should I talk to my health care provider before I take Tranxene?
Sorry No records found
How should I use Tranxene?
TRANXENE is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
TRANXENE tablets are indicated as adjunctive therapy in the management of partial seizures.
The effectiveness of TRANXENE tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient.
TRANXENE tablets are indicated for the symptomatic relief of acute alcohol withdrawal.
For the symptomatic relief of anxiety:
TRANXENE T-TAB tablets are administered orally in divided doses. The usual daily dose is 30 mg. The dose should be adjusted gradually within the range of 15 to 60 mg daily in accordance with the response of the patient. In elderly or debilitated patients it is advisable to initiate treatment at a daily dose of 7.5 to 15 mg.
TRANXENE tablets may also be administered in a single dose daily at bedtime; the recommended initial dose is 15 mg. After the initial dose, the response of the patient may require adjustment of subsequent dosage. Lower doses may be indicated in the elderly patient. Drowsiness may occur at the initiation of treatment and with dosage increment.
For the symptomatic relief of acute alcohol withdrawal:
The following dosage schedule is recommended:
The maximum recommended total daily dose is 90 mg. Avoid excessive reductions in the total amount of drug administered on successive days.
As an Adjunct to Antiepileptic Drugs:
Adults:
Children (9-12 years):
What interacts with Tranxene?
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What are the warnings of Tranxene?
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What are the precautions of Tranxene?
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What are the side effects of Tranxene?
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What should I look out for while using Tranxene?
TRANXENE tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.
What might happen if I take too much Tranxene?
Overdosage is usually manifested by varying degrees of CNS depression ranging from slight sedation to coma. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
The treatment of overdosage should consist of the general measures employed in the management of overdosage of any CNS depressant. Gastric evacuation either by the induction of emesis, lavage, or both, should be performed immediately. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though rarely reported, may occur with large overdoses. In such cases the use of agents such as norepinephrine bitartrate injection, USP or metaraminol bitartrate injection, USP should be considered.
While reports indicate that individuals have survived overdoses of clorazepate dipotassium as high as 450 to 675 mg, these doses are not necessarily an accurate indication of the amount of drug absorbed since the time interval between ingestion and the institution of treatment was not always known. Sedation in varying degrees was the most common physiological manifestation of clorazepate dipotassium overdosage. Deep coma when it occurred was usually associated with the ingestion of other drugs in addition to clorazepate dipotassium.
Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
How should I store and handle Tranxene?
Storage:[See USP controlled room temperature]Protect from moisture.Storage:[See USP controlled room temperature]Protect from moisture.Storage:[See USP controlled room temperature]Protect from moisture.TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0TRANXENE 7.5 mg scored T-TAB tablets are supplied as peach-colored tablets bearing the letter R, the distinctive T shape and a two-digit designation, 32:Bottles of 100 (NDC 55292-304-01).Recommended storage: Protect from moisture. Keep bottle tightly closed. Store at 20-25°C (68-77°F). See USP controlled room temperature. Dispense in a USP tight, light-resistant container.T-TAB tablet appearance and shape are registered trademarks of Lundbeck LLC.U.S. Design Pat. No. D-300,879Manufactured by: UPM Pharmaceuticals, 510 5th Street, Bristol, TN 37620, U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. TRANXENE is a registered trademark of Recordati Rare Diseases Inc. T-TAB is a registered trademark of Lundbeck LLCThis product label may have been updated. For the most recent prescribing information, please visit .Revised: July 2017 MS-04482 R1.0
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pharmacologically, clorazepate dipotassium has the characteristics of the benzodiazepines. It has depressant effects on the central nervous system. The primary metabolite, nordiazepam, quickly appears in the blood stream. The serum half-life is about 2 days. The drug is metabolized in the liver and excreted primarily in the urine.
Studies in healthy men have shown that clorazepate dipotassium has depressant effects on the central nervous system. Prolonged administration of single daily doses as high as 120 mg was without toxic effects. Abrupt cessation of high doses was followed in some patients by nervousness, insomnia, irritability, diarrhea, muscle aches, or memory impairment.
Since orally administered clorazepate dipotassium is rapidly decarboxylated to form nordiazepam, there is essentially no circulating parent drug. Nordiazepam, the primary metabolite, quickly appears in the blood and is eliminated from the plasma with an apparent half-life of about 40 to 50 hours. Plasma levels of nordiazepam increase proportionally with TRANXENE dose and show moderate accumulation with repeated administration. The protein binding of nordiazepam in plasma is high (97-98%).
Within 10 days after oral administration of a 15 mg (50 μCi) dose of C-TRANXENE to two volunteers, 62-67% of the radioactivity was excreted in the urine and 15-19% was eliminated in the feces. Both subjects were still excreting measurable amounts of radioactivity in the urine (about 1% of the C-dose) on day ten.
Nordiazepam is further metabolized by hydroxylation. The major urinary metabolite is conjugated oxazepam (3-hydroxynordiazepam), and smaller amounts of conjugated p-hydroxynordiazepam and nordiazepam are also found in the urine.
Non-Clinical Toxicology
TRANXENE tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.When protriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.
Hyperpyrexia has been reported when tricyclic antidepressants are administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.
Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side-effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.
Tricyclic antidepressants may enhance the seizure risk in patients taking ULTRAM (tramadol hydrochloride).
Protriptyline may enhance the response to alcohol and the effects of barbiturates and other CNS depressants.
In those patients in which a degree of depression accompanies the anxiety, suicidal tendencies may be present and protective measures may be required. The least amount of drug that is feasible should be available to the patient.
Patients taking TRANXENE tablets for prolonged periods should have blood counts and liver function tests periodically. The usual precautions in treating patients with impaired renal or hepatic function should also be observed.
In elderly or debilitated patients, the initial dose should be small, and increments should be made gradually, in accordance with the response of the patient, to preclude ataxia or excessive sedation.
The side effect most frequently reported was drowsiness. Less commonly reported (in descending order of occurrence) were: dizziness, various gastrointestinal complaints, nervousness, blurred vision, dry mouth, headache, and mental confusion. Other side effects included insomnia, transient skin rashes, fatigue, ataxia, genitourinary complaints, irritability, diplopia, depression, tremor, and slurred speech.
There have been reports of abnormal liver and kidney function tests and of decrease in hematocrit.
Decrease in systolic blood pressure has been observed.
To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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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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Interactions
Interactions
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