Ditropan tablets 2.5mg

Ditropan tablets 5mg

Each tablet contains 2.5mg or 5mg oxybutynin hydrochloride as the active ingredient.

Ditropan tablets 2.5mg are pale blue oval bi-convex tablets 8 mm x 5.5 mm, marked OXB2.5 on one side.

Ditropan tablets 5mg are pale blue circular tablets with a 8.0mm nominal diameter, with a centre breakline on one side, and marked OXB5 on the reverse.

Urinary incontinence, urgency and frequency in the unstable bladder, whether due to neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida, or to idiopathic detrusor instability (motor urge incontinence).

Paediatric population

Oxybutynin hydrochloride is indicated in children over 5 years of age for:

- Urinary incontinence, urgency and frequency in unstable bladder conditions due to idiopathic overactive bladder or neurogenic bladder disorders (detrusor overactivity).

- Nocturnal enuresis associated with detrusor overactivity, in conjunction with non-drug therapy, when other treatment has failed.

Dosage and administration:

Adults: The usual dose is 5mg two or three times a day. This may be increased to a maximum of 5 mg four times a day to obtain a clinical response provided that the side effects are tolerated.

Elderly (including frail elderly): The elimination half-life is increased in the elderly. Therefore, a dose of 2.5mg twice a day, particularly if the patient is frail, is likely to be adequate. This dose may be titrated upwards to 5mg two times a day to obtain a clinical response provided the side effects are well tolerated.

Children (under 5 years of age): Not recommended

Children (over 5 years of age): Neurogenic bladder instability: the usual dose is 2.5mg twice a day. This dose may be titrated upwards to 5mg two or three times a day to obtain a clinical response provided the side effects are well tolerated. Nocturnal enuresis: the usual dose is 2.5mg twice a day. This dose may be titrated upwards to 5mg two or three times a day to obtain a clinical response provided the side effects are tolerated. The last dose should be given before bedtime.

Hypersensitivity to oxybutynin or any component.

Myasthenia gravis.

Narrow-angle glaucoma or shallow anterior chamber.

Gastrointestinal obstruction including paralytic ileus, intestinal atony.

Patients with toxic megacolon, severe ulcerative colitis.

Patients with bladder outflow obstruction where urinary retention may be precipitated.

Oxybutynin should be used with caution in the frail elderly and in children who may be more sensitive to the effects of the product and in patients with autonomic neuropathy, hepatic or renal impairment and severe gastro-intestinal motility disorders (also see section 4.3).

Oxybutynin may aggravate the symptoms of hyperthyroidism, congestive heart failure, coronary heart disease, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy.

Oxybutynin can cause decreased sweating; in high environmental temperatures this can lead to heat prostration.

Special care should be taken in patients with hiatus hernia associated with reflux oesophagitis, as anticholinergic drugs can aggravate this condition.

Paediatric population

Oxybutynin hydrochloride is not recommended for use in children below age 5 years due to insufficient data on safety and efficacy.

There is limited evidence supporting the use of Oxybutynin in children with monosymptomatic nocturnal enuresis (not related to detrusor overactivity).

In children over 5 years of age, Oxybutynin hydrochloride should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.

Care should be taken if other anticholinergic agents are administered together with Ditropan, as potentiation of anticholinergic effects could occur.

Occasional cases of interaction between anticholinergics and clozapine, phenothiazines, amantidine, butyrophenones, L-dopa, digitalis and tricyclic antidepressants have been reported and care should be taken if Ditropan is administered concurrently with such drugs.

By reducing gastric motility, oxybutynin may affect the absorption of other drugs.

Pregnancy

There is no evidence as to the safety of Ditropan in human pregnancy nor is there evidence from animal work that it is totally free from hazard. Avoid in pregnancy unless there is no safer alternative.

Lactation

Small amounts of oxybutynin have been found in mother's milk of lactating animals. Breast feeding while using oxybutynin is therefore not recommended.

As Ditropan may produce drowsiness or blurred vision, the patient should be cautioned regarding activities requiring mental alertness such as driving, operating machinery or performing hazardous work while taking this drug.

Gastro-intestinal disorders

Nausea, diarrhoea, constipation, dry mouth, abdominal discomfort, anorexia, vomiting, gastroesophageal reflux.

CNS and psychiatric disorders

Agitation, headache, dizziness, drowsiness, disorientation, hallucinations, nightmares, convulsions.

Cardiovascular disorders

Tachycardia, cardiac arrythmia.

Vision disorders

Blurred vision, mydriasis, intraocular hypertension, onset of narrow-angle glaucoma, dry eyes.

Renal and urinary disorders

Urinary retention, difficulty in micturition.

Skin and appendages

Facial flushing which may be more marked in children, dry skin, allergic reactions such as rash, urticaria, angioedema, photosensitivity.

The symptoms of overdose with oxybutynin progress from an intensification of the usual side effects of CNS disturbances (from restlessness and excitement to psychotic behaviour), circulation changes (flushing, fall in blood pressure, circulatory failure etc), respiratory failure, paralysis and coma.

Measures to be taken are:

1) Immediate gastric lavage

2) physostigmine by slow intravenous injection

Adults: 0.5 to 2.0 mg of physostigmine by slow intravenous administration. Repeat after 5 minutes, if necessary up to a maximum total dose of 5mg.

Children: 30 micrograms/kg of physostigmine by slow intravenous administration. Repeat after 5 minutes, if necessary up to a maximum total dose of 2mg.

Fever should be treated symptomatically with tepid sponging or ice packs.

In pronounced restlessness or excitation, diazepam 10mg may be given by intravenous injection, tachycardia may be treated by intravenous injection of propranolol and urinary retention can be managed by catheterisation.

In the event of progression of the curare- like effect to the paralysis of the respiratory muscles, mechanical ventilation will be required.

Oxybutynin has both direct antispasmodic action on the smooth muscle of the bladder detrusor muscle as well as an anticholinergic action in blocking the muscarinic effects of acetylcholine on smooth muscle. These properties cause relaxation of the detrusor muscle of the bladder in patients with an unstable bladder. Ditropan increases bladder capacity and reduces the incidence of spontaneous contractions of the detrusor muscle.

Oxybutynin is poorly absorbed from the gastrointestinal tract. It is highly bound to plasma proteins, the peak plasma level is reached between 0.5 to 1 hour after administration. The half life is biexponential, the first phase being about 40 minutes and the second about 2-3 hours. The elimination half life may be increased in the elderly, particularly if they are frail.

Oxybutynin and its metabolites are excreted in the faeces and urine. There is no evidence of accumulation.

No data of therapeutic relevance.

Ditropan tablets contain lactose, cellulose, calcium stearate and indigo carmine (E132).

None known.

4 years

Store at or below 30°C.

Cartons containing 84 tablets in blister strips.

No special requirements.

sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

26 March 2009

17 December 2010

POM