Composition
Each capsule : contains: 12.5 mg amitriptyline – 5 mg chlordiazepoxide.

Properties and effects
The two active ingredients of Limbitrol act in a complementary fashion in the treatment of depression with a marked anxiety component, regardless of the aetiology of the depression (endogenous, neurotic, reactive, organic).
Amitriptyline, a tricyclic antidepressant, causes a brightening of the mood and an improvement in other symptoms of depression, though generally only after several days of treatment.
Chlordiazepoxide reduces anxiety, tension and agitation- symptoms which, particularly at the beginning of the treatment, often play a major role in the depressive syndrome.  

Indications
Limbitrol is indicated for the treatment of depressive conditions, especially when there is a marked anxiety component.

Dosage and administration
Standard dosage
The standard dosage for outpatient treatment is up to two capsules three times daily. These dosages comply with general guidelines that should be adapted to the needs of individual patients. Low doses should be administered at the beginning of treatment, increasing stepwise until the optimum effects is achieved.

Special dosage instructions
For hospitalized patients the dosage of Limbitrol may be doubled. In patients with liver or renal failure the usual precautionary measures must be taken. In elderly and frail patients treatment should be limited to the lowest effective dosage

Restrictions on use
Contraindications
Limbitrol should not be given to patients with known hypersensitivity to benzodiazepines or tricyclic antidepressants or to patients with myasthenia gravis, severe respiratory failure, sleep apnea syndrome, severe liver failure, or recent myocardial infarction.

Precautions
Limbitrol should be given under medical supervision to patients with heart failure and arrhythmias, thyroid disorders, prostate hypertrophy, narrow angle glaucoma, epilepsy, liver and kidney failure.
Severe depression is associated with a high suicide risk. Such patients therefore require careful observation and protective measures throughout treatment until the depressive symptoms recede.  As with other antidepressants, the treatment of depressive conditions with Limbitrol can exacerbate schizophrenic symptoms or schizoaffective psychoses. In these patients, therefore, any previous long-term neurologic treatment should be continued, due account being taken of the cumulative anticholinergic effects.
Like all drugs of its type, Limbitrol may influence the patient's reactions (including driving ability and behavior in traffic) depending on the method of administration, dosage and individual susceptibility.

Dependence
The use of benzodiazepines and benzodiazepine-like agents may lead to the development of physical and psychic dependence. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of tremor, restlessness, insomnia, anxiety, headache and poor concentration, though symptoms such as sweating, muscle pain, abdominal pain, impaired perception and in rare cases, delirium and cerebral convulsions may occur. In order to avoid withdrawal phenomena, it is recommended that the dosage be decreased gradually.

Pregnancy, nursing mothers
There is clear evidence of a risk to human foetus, however this can be out-weighed by the therapeutic benefit to the mother.
As both amitriptyline and chlordiazepoxide pass into the breast milk, Limbitrol should not be administered to nursing mothers.

Side effects
Extrapyramidal symptoms, dystonia, dyskinesia, arrhythmias, hypertension, sexual disorders, syndrome of inappropriate ADH secretion.Fatigue, dizziness, muscle weakness, ataxia, visual disturbances, memory disturbances, paradoxical reactions(agitation, aggressiveness, etc.)
Initial side effects such as transient fatigue as well as dose-depend anticholinergic effects (dry mouth, constipation, moderate tachycardia, and accommodation difficulties) generally diminish with continued treatment or dose adjustment. Rarely, treatment with Limbitrol can cause a fall in blood pressure, in particular orthostatic hypotension, reduced muscle tone and skin rashes. Very rare cases of granulocytopenia,, other blood dyscrasias, and impaired liver function have been observed.

Drug interactions
Both animal and clinical trials have shown that amitriptyline can inhibit the effect of adrenergic-neuron-blocking antihypertensives.
The effects of anticholinergic drugs may be potentiated by Limbitrol, there being a risk in particular of hyperthermia and paralytic ileus.
Limbitrol must not be given concurrently with monoamine oxidase inhibitors. Where these have already been used, one to two weeks should be allowed to elapse before Limbitrol is started. As with all psychoactive substances, the effect of Limbitrol is intensified by alcohol and other centrally acting drugs e.g centrally acting analgesics. Combination with anticolinergic or sympathomimetic medications warrants particular caution. Amitriptyline may increase the prothrombin time of patients taking anticoagulants.

Overdosage
Measures recommended for accidental or deliberate overdosage are evacuation of the stomach, administration of activated charcoal and possibly a reversible cholinesterase should be considered, maintenance of airway potency and surveillance of the patient is required .

Stability
This medicine should not be used after the expiry date (EXP) shown on the pack.

Packing
Pack of 30 capsules