1. Name Of The Medicinal Product
Ditropan elixir 2.5mg/5ml
2. Qualitative And Quantitative Composition
Ditropan elixir contains 2.5mg oxybutynin hydrochloride per 5ml.
3. Pharmaceutical Form
Ditropan elixir is a clear and colourless elixir.
4. Clinical Particulars
4.1 Therapeutic Indications
For use in 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).
Children over 5 years of age: In addition to neurogenic bladder disorders, Ditropan may also be used in nocturnal enuresis in conjunction with non-drug therapy where this alone, or in conjunction with other drug treatment, has failed.
4.2 Posology And Method Of Administration
Dosage and administration:
Adults: The usual dose is 5mg (10ml) 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: The elimination half-life is increased in the elderly, therefore, a dose of 2.5mg (5ml) 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 tolerated.
Children (under 5 years of age): Not recommended.
Children (over 5 years of age): Neurogenic bladder: the usual dose is 2.5mg (5ml) twice a day. This dose may be titrated upwards to 5mg (10ml) two or three times a day to obtain a clinical response provided that the side effects are tolerated. Nocturnal enuresis: the usual dose is 2.5mg (5ml) twice a day. This dose may be titrated upwards to 5mg (10ml) two or three times a day to obtain a clinical response provided that the side effects are tolerated. The last dose should be given before bedtime.
4.3 Contraindications
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.
4.4 Special Warnings And Precautions For Use
Oxybutynin should be used with caution in the frail elderly and 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.
The use of oxybutynin in children under 5 years of age is not recommended; it has not been established whether oxybutynin can be safely used in this age group.
Special care should be taken in patients with hiatus hernia associated with reflux oesophagitis, as anticholinergic drugs can aggravate this condition.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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.
4.6 Pregnancy And Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
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.
4.8 Undesirable Effects
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.
4.9 Overdose
The symptoms of overdosage with oxybutynin progress from an intensification of the usual side effects of CNS disturbances (from restlessness and excitement to psychotic behaviour), circulatory 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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Oxybutynin hydrochloride 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.
5.2 Pharmacokinetic Properties
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.
5.3 Preclinical Safety Data
No data of therapeutic relevance.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Ditropan elixir contains citric acid, sodium citrate, sucrose (1.3g per 5ml dose), sorbitol, glycerol, sodium methyl-p-hydroxybenzoate (E219), purified water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
Ditropan Elixir 2.5mg/5ml has a 30 month shelf life.
6.4 Special Precautions For Storage
Ditropan Elixir 2.5mg/5ml: Store below 25oC. Protect from light
Discard any medicine remaining 28 days after opening the bottle
6.5 Nature And Contents Of Container
Ditropan Elixir 2.5mg/5ml: 30ml (sample size) and 150ml amber glass bottle with a child resistant screw cap.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
sanofi-aventis
One Onslow Street
Guildford
Surrey GU1 4YS
8. Marketing Authorisation Number(S)
PL 04425/0286
9. Date Of First Authorisation/Renewal Of The Authorisation
6 February 2009
10. Date Of Revision Of The Text
1 October 2009
Legal Category: POM
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