Limbix 12.5/5 mg Tab

Limbix 12.5/5 mg Tab

DESCRIPTION

LIMBIX 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.

COMPOSITION

Each film-coated tablet contains Amitriptyline Hydrochloride USP equivalent to 12.5 mg Amitriptyline and Chlordiazepoxide USP 5 mg.

INDICATION

LIMBIX is indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.

Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.

DOSAGE AND ADMINISTRATION

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.

LIMBIX Tablets in an initial dosage of 3 or 4 tablets daily in divided doses is satisfactory.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Many symptoms common to the depressive state, such as anorexia, fatigue, weakness, restlessness and lethargy, have been reported as side effects of treatment with LIMBIX.

ADVERSE REACTIONS

Most frequently reported were drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating. Less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion.

CONTRAINDICATIONS

LIMBIX is contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor.

PRECAUTIONS

Use with caution in patients with a history of seizures. Close supervision is required when LIMBIX 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.

DRUG INTERACTIONS

Because of its Amitriptyline component, LIMBIX 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 LIMBIX 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.

SUPPLY

Each box contains 5  10 tablets in blister pack.