Each film-coated tablet contains Amitriptyline Hydrochloride USP equivalent to 12.5 mg Amitriptyline and Chlordiazepoxide USP 5 mg.
Limbixâ„¢ combines Amitriptyline, a tricyclic antidepressant and Chlordiazepoxide, an anxiolytic. Amitriptyline inhibits the reuptake of norepinephrine and serotonin in brain. This interference with the reuptake is responsible for antidepressant activity of Amitriptyline. Chlordiazepoxide works by enhancing GABA-mediated chloride influx through GABA receptor channels, causing membrane hyperpolarization. The net neuro-inhibitory effects result in the observed sedative and anxiolytic effect.
Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient.
Limbixâ„¢ Tablets in an initial dosage of 3 or 4 tablets daily in divided doses is satisfactory.
OR AS DIRECTED BY THE PHYSICIAN.
Because of its Amitriptyline component, Limbixâ„¢ may block the antihypertensive action of guanethidine or compounds with a similar mechanism of action.
Use in Special Population:In Pregnancy and Lactation: Safe use of Limbixâ„¢ during pregnancy and lactation has not been established.
Pediatric Use: Safety and effectiveness in the pediatric population have not been established. Anyone considering the use of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets in a child or adolescent must balance the potential risks with the clinical need.
Geriatric Use: In elderly and debilitated patients it is recommended that dosage be limited to the smallest effective amount to preclude the development of ataxia, over sedation, confusion or anticholinergic effects.
Use with caution in patients with a history of seizures. Close supervision is required when Limbixâ„¢ is given to hyperthyroid patients or those on thyroid medication. The usual precautions should be observed when treating patients with impaired renal or hepatic function.
All pediatric patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior.
Drug Abuse and Dependence:
Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of Chlordiazepoxide.
Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Withdrawal symptoms (e.g., nausea, headache and malaise) have also been reported in association with abrupt Amitriptyline discontinuation.
Overdosage:
Deaths may occur from overdosage with this class of drugs. Critical manifestations of Amitriptyline overdose include cardiac dysrhythmias, severe hypotension, convulsions and CNS depression, including coma.
Manifestations of benzodiazepine overdosage include somnolence, confusion, coma and diminished reflexes.
Store in a cool and dry place, protected from light. Keep all medicines out of reach of the children.