IMIPRANIME Sugar-coated tablet Ref.[8097] Active ingredients: Imipramine

Posology

Adults

1 × 25mg up to three times daily, increasing stepwise to 150-200mg. This should be reached by the end of the first week and maintained until definite improvement has occurred. The subsequent maintenance dose should be individually determined by gradually reducing the dosage, usually to about 50-100mg daily.

In patients in hospital, i.e. severe cases, the dose may be increased to 100mg three times daily until a distinct improvement is seen. Again the subsequent maintenance dose should be determined individually by reducing the dosage, usually to about 100mg daily.

Elderly

Patients over 60 years may respond to lower doses of imipramine than those recommended above. Treatment should be initiated with 10mg daily, gradually increasing to 30-50mg daily. The optimum dose should be reached after about 10 days and then continued until the end of treatment.

Children (for nocturnal enuresis only)

The tablets should be administered just before bedtime.

Over 11 years (weight 35-54kg or 77-119lbs): 50-75mg daily.
8-11 years (weight 25-35kg or 55-77lbs): 25-50mg daily.
6-7 years (weight 20-25kg or 44-55lbs): 25mg daily.
Under 6 years: Not to be given to children under 6 years of age.

The dose should not exceed 75mg daily. The maximum period of treatment should not exceed three months, and withdrawal should be gradual. If relapse should occur, treatment should not be re-instituted until a full physical examination has been carried out.

Method of Administration

For oral administration.

The signs and symptoms of overdose with imipramine are similar to those reported with other tricyclic antidepressants. Cardiac abnormalities and neurological disturbances are the main complications. In children accidental ingestion of any amount should be regarded as serious and potentially fatal.

Signs and symptoms

Symptoms generally appear within 4 hours of ingestion and reach a maximum severity after 24 hours. Owing to delayed absorption (increased anticholinergic effect due to overdose), long half-life and enterohepatic recycling of the drug, the patient may be at risk for up to 4-6 days. Major symptoms of overdosage include:

• Effects on the central nervous system: drowsiness, stupor, coma, ataxia, restlessness, agitation, enhanced reflexes, muscular rigidity, athetoid and choreiform movements, convulsions.
• Effects on the cardiovascular system include: hypotension, tachycardia, arrhythmia, conduction disorders, heart failure and, in very rare cases, cardiac arrest.
• In addition, respiratory depression, cyanosis, shock, vomiting, fever, hydriasis, sweating and oliguria or anuria may occur.

Treatment

There is no specific antidote to imipramine. Treatment is essentially symptomatic and supportive. Gastric lavage and forced emesis should be employed immediately if the patient is fully conscious to reduce absorption of the drug. If the patient has impaired consciousness, the airway should be secured with a cuffed endotracheal tube before beginning lavage, and vomiting should not be induced. These measures are recommended for up to 12 hours or even longer after the overdose, since the anticholinergic effect of the drug may delay gastric emptying. Administration of activated charcoal may help reduce drug absorption.

Patients presenting with major symptoms of overdosage, particularly children, should be nursed in an intensive care unit for at least 72 hours where full support of vital functions is possible.

Treatment of symptoms is based on modern methods of intensive care with continuous monitoring of cardiac function, blood gases and electrolytes, and if necessary emergency measures such as: anticonvulsive therapy, artificial respiration, insertion of a temporary cardiac pacemaker, plasma expander, dopamine or dobutamine administered by intravenous drip, resuscitation.

Any serious overdosage requires continuous cardiac monitoring for at least 48 hours and dysrhythmias must be treated on an individual basis. Respiratory insufficiency may necessitate intubation and ventilation, and convulsions may be controlled with intravenous diazepam.

Physostigmine should not be used following an overdosage of imipramine as it has been reported that physostigmine may cause severe bradycardia, asystole and seizures. Haemodialysis or peritoneal dialysis is ineffective because of the low plasma concentrations of imipramine.

Shelf life

Shelf-life: Three years from date of manufacture.

Shelf-life after dilution/reconstitution: Not applicable.

Shelf-life after first opening: Not applicable.

Store below 25°C in a dry place.

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene tablet containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass bottles with screw caps and polyfoam wad or cotton wool.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-7g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Not applicable.