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Chemically, TRANXENE is a benzodiazepine. The empirical formula is C16H11ClK2N2O4; the molecular weight is 408.92; 1H-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
Clorazepate is used to treat anxiety, acute alcohol withdrawal, and seizures. This medicationbelongs to a class of drugs called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effects of a certain natural chemical in the body (GABA).
How to use Tranxene T-Tab
Read the Medication Guide provided by your pharmacist before you start taking clorazepate and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor. The dosage is based on your age, medical condition, and response to therapy.
Use this medication exactly as prescribed. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for an extended period of time or for seizure control, do not suddenly stop using this drug without your doctor’s approval. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.
When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
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.
DOSAGE AND ADMINISTRATION
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:
1st 24 hours (Day 1) 30 mg initially; followed by 30 to 60 mg in divided doses
2nd 24 hours (Day 2) 45 to 90 mg in divided doses
3rd 24 hours (Day 3) 22.5 to 45 mg in divided doses
Day 4 15 to 30 mg in divided doses
Thereafter, gradually reduce the daily dose to 7.5 to 15 mg. Discontinue drug therapy as soon as patient’s condition is stable.
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
In order to minimize drowsiness, the recommended initial dosages and dosage increments should not be exceeded.
The maximum recommended initial dose in patients over 12 years old is 7.5 mg three times a day. Dosage should be increased by no more than 7.5 mg every week and should not exceed 90 mg/day
Children (9-12 years)
The maximum recommended initial dose is 7.5 mg two times a day. Dosage should be increased by no more than 7.5 mg every week and should not exceed 60 mg/day.
If TRANXENE is to be combined with other drugs acting on the central nervous system, careful consideration should be given to the pharmacology of the agents to be employed. Animal experience indicates that clorazepate dipotassium prolongs the sleeping time after hexobarbital or after ethyl alcohol, increases the inhibitory effects of chlorpromazine, but does not exhibit monoamine oxidase inhibition. Clinical studies have shown increased sedation with concurrent hypnotic medications. The actions of the benzodiazepines may be potentiated by barbiturates, narcotics, phenothiazines, monoamine oxidase inhibitors or other antidepressants.
If TRANXENE tablets are used to treat anxiety associated with somatic disease states, careful attention must be paid to possible drug interaction with concomitant medication.
In bioavailability studies with normal subjects, the concurrent administration of antacids at therapeutic levels did not significantly influence the bioavailability of TRANXENE tablets.
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Drowsiness, dizziness, fatigue, dry mouth, upset stomach, constipation, blurred vision, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: slurred speech, clumsiness, trouble walking, decreased/increased interest in sex, tremor, trouble urinating, sleep disturbances.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages and list of side effects as well as information on the drug. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.
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