Generic drug of the therapeutic class: Urology nephrology
Active ingredients: Oxybutynin
laboratory: Sanofi-Aventis France
Box of 100
Adults and children over 5 years old:
Urinary incontinence, urinary urgency and pollakiuria in cases of bladder instability that may result from idiopathic bladder hyperactivity or neurogenic bladder injury (detrusor overactivity).
In children over 5 years old:
Nocturnal enuresis associated with detrusor overactivity, in combination with non-drug therapy, in case of failure of another treatment.
Dosage DITROPAN 5 mg scored tablet Box of 100
- Adult :
. The initial dose is 2.5 mg three times daily; it will be increased, if necessary, to the minimum effective dose to obtain a satisfactory clinical response.
. The usual dose is 5 mg two or three times a day and the maximum dose of 5 mg four times a day.
In the elderly, the elimination half-life can be increased; therefore, the initial dose is 2.5 mg twice daily; it can be increased, if necessary, to the minimum effective dose to obtain a satisfactory clinical response.
A usual dose of 10 mg taken twice is usually sufficient, especially in patients of low body size.
- Child (over 5 years old):
The initial dose of 2.5 mg twice daily will be individually increased to the minimum effective dose to achieve a satisfactory clinical response.
The recommended dosage is 0.3 to 0.4 mg / kg body weight per day; the maximum dose is specified in the table below:
Age: Dosage .
. 5-9 years: 2.5 mg, three times daily.
. 9-12 years: 5 mg, twice daily.
. 12 years and older: 5 mg, three times a day.
- Child (under 5 years old):
The use of this medication is not recommended.
- This medicine MUST NEVER be used in case of:
. hypersensitivity to oxybutynin or to any of the excipients,
. risk of urinary retention related to urethroprostatic disorders,
. bowel obstruction,
. toxic megacolon,
. intestinal atony,
. severe ulcerative colitis,
. angle closure glaucoma or shallow anterior chamber.
- Child (under 5 years old): the use of this medicine is not recommended.
- Breast-feeding: In animals, oxybutynin has been found in breast milk. Therefore, this medication should not be administered to women during breastfeeding.
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
Pregnancy: The safety of oxybutynin in pregnancy has not been established. Studies in animals have shown an embryotoxic effect at doses causing maternal toxicity. Therefore, the use of oxybutynin should be considered during pregnancy only if necessary.
Ditropan side effects
The most commonly reported adverse reactions are atropine-like: dry mouth, constipation, blurred vision, mydriasis, tachycardia, nausea, facial erythrosis, agitation, and urination disorders. A reduction in dosage decreases the incidence of these adverse effects.
- Gastrointestinal effects:
Nausea, constipation, dry mouth, abdominal discomfort, diarrhea, gastroesophageal reflux.
- CNS effects and psychiatric effects:
Agitation, headache, dizziness, drowsiness, hallucinations, nightmares, cognitive effects (confusion, anxiety, delirium), seizures.
- Cardiovascular effects:
Tachycardia, cardiac arrhythmias.
- Eye effects:
Blurred vision, mydriasis, intraocular hypertension, onset of angle closure glaucoma, dry eye.
- Kidney and urinary effects:
Micturition disorders, urinary retention.
- Dermatological effects:
Redness of the face (more pronounced in children than in adults), dry skin, allergic reactions such as skin rash, urticaria and angioedema.