Wella^®

Wella^® is a preparation of Amitriptyline and Chlordiazepoxide. Amitriptyline is a dibenzocycloheptadiene tricyclic antidepressant which increases synaptic concentration of serotonin and/or norepinephrine in the CNS by blocking the neuronal reuptake of norepinephrine and serotonin. Chlordiazepoxide is a benzodiazepine which enhances the activity of the inhibitory transmitter GABA in different parts of CNS by increasing neuronal membrane permeability to chloride ions resulting to hyperpolarisation and stabilisation. It has some muscle relaxant and anticonvulsant activity.

Use in children and adolescents

Safety and effectiveness in the pediatric population have not been established. Anyone considering the use of this combination in a child or adolescent must balance the potential risks with the clinical need.

Wella^® 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.

Route of administration: Wella^® should be taken in oral route.
The recommended dose of Wella^® is 3 or 4 tablets daily in divided doses which may be satisfactory in patients who do not tolerate higher doses. 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. In general, lower dosages are recommended for elderly patients.

Pregnancy: Safe use of this combination during pregnancy has not been established. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
Lactation: It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug, since many drugs are excreted in human milk.

Because of the atropine-like action of the amitriptyline component, great care should be used in treating patients with a history of urinary retention or angle-closure glaucoma. Patients with cardiovascular disorders should be watched closely. The use of benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. The continued use of benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, may lead to clinically significant physical dependence. Close supervision is required when chlordiazepoxide and amitriptyline combination 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. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Patients with suicidal ideation should not have easy access to large quantities of the drug.

The most common side effects of this combination are drowsiness, dry mouth, constipation, blurred vision, dizziness, bloating, impotence, tremor, confusion, nasal congestion, anorexia, fatigue, weakness, restlessness and lethargy. Granulocytopenia, jaundice and hepatic dysfunction have also been observed rarely.

This combination is contraindicated in patients with known hypersensitivity to either benzodiazepines or tricyclic antidepressants or any components of this product. This drug is contraindicated during the acute recovery phase following myocardial infarction.

Drug interaction with medication: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. This combination blocks the antihypertensive action of guanethidine or compounds with a similar mechanism of action. Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants and benzodiazepines, thereby delaying elimination and increasing steady-state concentrations of these drugs. This combination should not be given concomitantly with a monoamine oxidase inhibitor.

Drug interaction with food and others: Not applicable.

Deaths may occur from overdosage with this class of drugs. Critical manifestations of overdose includes cardiac dysrhythmias, severe hypotension, convulsions and CNS depression, including coma; therefore, hospital monitoring is required as soon as possible.

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Wella^® tablet: Each coated tablet contains Amitriptyline Hydrochloride BP equivalent to Amitriptyline 12.5 mg and Chlordiazepoxide BP 5 mg.

Wella^® tablet: Carton of 50 tablets in blister pack.