TRANXENE T-TAB- clorazepate dipotassium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLORAZEPATE DIPOTASSIUM (UNII: 63FN7G03XY) (CLORAZEPIC ACID - UNII:D51WO0G0L4)

Available from:

Recordati Rare Diseases, Inc.

INN (International Name):

CLORAZEPATE DIPOTASSIUM

Composition:

CLORAZEPATE DIPOTASSIUM 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. TRANXENE tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.

Product summary:

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-300,879 Manufactured 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 LLC This product label may have been updated. For the most recent prescribing information, please visit www.recordatirarediseases.com. Revised: May 2018 MS-04482 R2.0

Authorization status:

New Drug Application

Patient Information leaflet

Recordati Rare Diseases, Inc.
----------
MEDICATION GUIDE
TRANXENE ® (TRAN-zeen) T-Tab ®
(clorazepate dipotassium) Tablets,
What is the most important information I should know about TRANXENE?
•
Do not stop taking TRANXENE without first talking to your healthcare
provider.
Stopping TRANXENE suddenly can cause serious side effects.
•
TRANXENE is a benzodiazepine medicine. Taking benzodiazepines with
opioid medicines, alcohol,
or other central nervous system depressants (including street drugs)
can cause severe drowsiness,
breathing problems (respiratory depression), coma and death.
•
TRANXENE can make you sleepy or dizzy and can slow your thinking and
motor skills.
•
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
TRANXENE affects you.
•
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
TRANXENE without first talking to your healthcare provider. When taken
with alcohol or
drugs that cause sleepiness or dizziness, TRANXENE may make your
sleepiness or dizziness
much worse.
•
TRANXENE can cause abuse and dependence.
•
Do not stop taking TRANXENE all of a sudden. Stopping TRANXENE
suddenly can cause
seizures that do not stop (status epilepticus), hearing or seeing
things that are not there
(hallucinations), shaking, nervousness, and stomach and muscle cramps.
•
Talk to your healthcare provider about slowly stopping TRANXENE to
avoid withdrawal
symptoms.
•
Physical dependence is not the same as drug addiction. Your healthcare
provider can tell you
more about the differences between physical dependence and drug
addiction.
•
TRANXENE is a federally controlled substance (C-IV) because it can be
abused or lead to
dependence. Keep TRANXENE in a safe place to prevent misuse and abuse.
Selling or giving away
TRANXENE may harm others, and is against the law. Tell your healthcare
provider if you have ever
abused or been dependent on alcohol, prescription medicines or street
drugs.
•
TRANXENE may harm your unborn or developin

Summary of Product characteristics

TRANXENE T-TAB- CLORAZEPATE DIPOTASSIUM TABLET
RECORDATI RARE DISEASES, INC.
----------
TRANXENE® T-TAB® TABLETS
(clorazepate dipotassium tablets, USP)
RX ONLY
Each tablet contains 7.5 mg of Clorazepate Dipotassium, USP equivalent
to 5.8 mg of
Clorazepate.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death (see WARNINGS, DRUG
INTERACTIONS).
Reserve concomitant prescribing of these drugs for use in patients for
whom
alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
DESCRIPTION
Chemically, TRANXENE is a benzodiazepine. The empirical formula is C
H
ClK
N
O
;
the molecular weight is 408.92; 1 _H_-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.
Each tablet contains 7.5 mg of Clorazepate Dipotassium, USP equivalent
to 5.8 mg of
Clorazepate.
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.
16
11
2
2
4
CLINICAL 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.