Wella®

Amitriptyline + Chlordiazepoxide

Prescribing Details



Description

Wella  & Wella DS contain 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


Uses

No Data


Indications

Wella & Wella DS are 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

Route of administration: Wella & Wella® DS 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.
The recommended dose of Wella® DS is initially 3 or 4 tablets daily in divided doses which may be increased to 6 tablets daily as required. Some patients respond to smaller doses and can be maintained on 2 tablets daily.


Use in pregnancy & lactation

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.

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.


Geriatric use
No Data

Precautions

Caution should be taken in patients with history of urinary retention and seizure, angle closure glaucoma, cardiovascular disorder, impaired hepatic or renal function. Close supervision is required when the combination is given to hyperthyroid patients or those on thyroid medication. All patients should be monitored properly for clinical worsening, suicidality and unusual changes in behavior.


Side effects

The most common side effects of this combination are drowsiness, dry mouth, constipation, blurred vision, dizziness, bloating, anorexia, fatigue, weakness, restlessness and lethargy.


Contraindications

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 interactions

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.


Overdose

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.


Preparation

No Data


Pharmaceutical precautions

No Data


Presentation

Wella Tablet: Each coated tablet contains Amitriptyline 12.5 mg as Amitriptyline Hydrochloride BP and Chlordiazepoxide BP 5 mg.
Wella DS Tablet: Each coated tablet contains Amitriptyline 25 mg as Amitriptyline Hydrochloride BP and Chlordiazepoxide BP 10 mg.


Package quantities

Wella Tablet: Carton of 50 tablets in blister pack.
Wella DS Tablet: Carton of 30 tablets in blister pack.