Active ingredients: Oxybutynin
DITROPAN 5 mg tablets
Why is Ditropan used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Urinary antispasmodics.
THERAPEUTIC INDICATIONS
Treatment of voiding disorders resulting from overactivity of the bladder detrusor: unstable bladder, neurological bladder, impaired urination control in elderly patients with neuro-vascular deterioration on an arteriosclerotic basis and in diabetic patients, enuresis, involuntary incontinence with or without urge to urinate, pollakiuria day and night not on an obstructive basis, tenesmus and bladder spasms. Adjuvant in the treatment of cystitis of various kinds, even after radiation treatment, and chronic prostatitis.
Psychosomatic disorders of urination (pollakiuria and cystalgia on a neuro-heretic basis).
Pediatric population
Ditropan is indicated in children over 5 years of age for:
- Urinary incontinence, urgent and frequent need to urinate in unstable bladder conditions due to idiopathic bladder overactivity or neurogenic bladder disorders (detrusor overactivity);
- Nocturnal enuresis associated with detrusor overactivity, in combination with non-drug therapy after failure of other treatments.
Contraindications When Ditropan should not be used
Hypersensitivity to the active substance or to any of the excipients.
Patients with obstructive uropathies which can precipitate urinary retention.
Partial or total obstruction of the gastrointestinal tract, intestinal atony, paralytic ileus.
Mega-colon, toxic mega-colon.
Ulcerative colitis.
Myasthenia gravis.
Narrow-angle glaucoma or low anterior chamber.
Patients in unstable cardiovascular conditions in the presence of acute bleeding.
Precautions for use What you need to know before taking Ditropan
DITROPAN should be used with caution in debilitated elderly and children who may be more sensitive to the effects of the product and in patients with autonomic neuropathy (such as patients with Parkinson's disease), with severe gastrointestinal motility disorders, with hepatic impairment or kidney damage.
Anticholinergics should be used with caution in elderly patients due to the risk of cognitive impairment.
Gastrointestinal Disorders: Anticholinergic drugs may decrease gastrointestinal motility and should be used with caution in patients with problems with gastrointestinal obstruction, intestinal atony and ulcerative colitis.
The administration of DITROPAN to patients with ulcerative colitis can cancel intestinal motility to the point of producing paralytic ileus and triggering or aggravating a toxic megacolon, which is a serious complication of the disease.
DITROPAN can aggravate tachycardia (and thus hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmia, hypertension), cognitive disturbances and symptoms of prostate hypertrophy, so use caution in these cases.
Anticholinergic medicinal products should be given with caution to patients with hiatus hernia / gastroesophageal reflux and / or to those concurrently taking medications (such as bisphosphonates) that can cause or exacerbate esophagitis.
Interactions Which drugs or foods may change the effect of Ditropan
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Care should be taken if other anticholinergic drugs are co-administered with oxybutynin, as the anticholinergic effects may be potentiated.
The anticholinergic activity of oxybutynin increases with concomitant use with other anticholinergics or with medicinal products with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian medicinal products (eg. Biperiden, levodopa), antihistamines, antipsychotics (eg phenothiazines, butyrophenones, clozapine ), quinidine, digitalis, tricyclic antidepressants, atropine and related compounds such as atropine antispasmodics and dipyridamole.
By reducing gastric motility, oxybutynin may affect the absorption of other drugs.
Oxybutynin is metabolised by the cytochrome P450 isoenzyme CYP 3A4. Concomitant administration with a CYP 3A4 inhibitor may inhibit the metabolism of oxybutynin and increase its exposure.
Oxybutynin can antagonize prokinetic therapies.
Concomitant use with cholinesterase inhibitors may result in reduced efficacy of the cholinesterase inhibitor.
In normal subjects, DITROPAN does not modify the metabolism of drugs metabolized by hepatic microsomal enzymes (phenobarbital, phenytoin, warfarin, phenylbutazone, tolbutamide).
Patients should be advised that alcohol may increase drowsiness caused by anticholinergic agents such as oxybutynin (see Special warnings - Effects on ability to drive and use machines).
Warnings It is important to know that:
DITROPAN can cause heat stroke (fever and collapse due to reduced sweating) if administered in the presence of a high ambient temperature.
Diarrhea can be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this case, treatment with DITROPAN would not be appropriate and could be harmful.
Anticholinergic effects on the CNS (eg hallucinations, agitation, confusion, somnolence) have been reported; monitoring is recommended especially in the first months after initiation of therapy or dose increase; Discontinuation of therapy or dose reduction should be considered if anticholinergic effects on the CNS occur.
Since Ditropan can cause narrow-angle glaucoma, patients should be advised that if they become aware of "sudden loss of" visual acuity or eye pain, they should contact a physician immediately.
Ditropan can reduce salivary secretions which can lead to dental caries, periodontal disease or oral candidiasis.
Dependence on oxybutynin has been observed in patients with a history of substance or drug abuse.
Important information about some of the ingredients
The medicine contains lactose so in case of ascertained intolerance to sugars contact your doctor before taking the medicine.
Pediatric population
Ditropan is not recommended for use in children under 5 years of age. It has not been established whether oxybutynin can be safely used in this age group.
There are limited data to support the use of oxybutynin in children with monosymptomatic nocturnal enuresis (unrelated to detrusor overactivity).
In children over 5 years of age, Ditropan should be used with caution as such patients may be more sensitive to the effects of the product, particularly CNS adverse reactions and psychiatric reactions.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There are insufficient data on the use of oxybutynin in pregnant women. Animal studies on the effects on pregnancy, embryonal / fetal development, parturition and postnatal development are insufficient.
The potential risk in pregnant women or women of childbearing age is unknown.
Therefore, DITROPAN should not be administered to pregnant women, unless strictly necessary.
Feeding time
When oxybutynin is used during breastfeeding, a small amount is excreted in breast milk. Therefore, the use of oxybutynin during breastfeeding is not recommended.
Effects on ability to drive and use machines
DITROPAN can cause drowsiness or blurred vision. During therapy with this drug, patients who must perform activities requiring mental alertness, such as driving vehicles, operating machinery and performing hazardous work, should be warned of these possible effects.
Dosage and method of use How to use Ditropan: Dosage
Adults:
the normal dose is 1 tablet of 5 mg two or three times a day. The maximum recommended dose is 1 tablet four times a day.
Children over 5 years:
the normal dose is 1 tablet of 5 mg twice a day. The maximum recommended dose is 1 tablet three times a day.
Overdose What to do if you have taken too much Ditropan
Symptoms of overdosing of DITROPAN range from the intensification of the usual undesirable effects of the S.N.C. (from agitation and excitement to psychotic behavior), to circulatory disturbances (hot flashes, pressure drop, circulatory failure), respiratory failure, paralysis and coma.
The procedure to be implemented includes:
1. immediate gastric lavage
2. slow intravenous injection of physostigmine:
Adults: from 0.5 to 2 mg by slow intravenous route, possibly repeatable up to a maximum of 5 mg
Children: 30 µg / kg by slow intravenous route, possibly repeatable up to a maximum of 2 mg Symptomatic treatment can be used for fever (alcohol sponging, ice packs).
In case of disturbing excitement agitation, diazepam 10 mg intravenously can be administered. Tachycardia can be treated with i.v. propranolol. and urinary retention with bladder catheterization.
In the event that the curare-like effect progresses to paralysis of the respiratory muscles, it is necessary to implement artificial respiration.
In case of accidental ingestion / intake of an excessive dose of Ditropan, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Ditropan, ask your doctor or pharmacist.
Side Effects What are the side effects of Ditropan
Like all medicines, Ditropan can cause side effects, although not everybody gets them.
After the administration of DITROPAN the symptoms that can be found with the use of anticholinergics may arise.
Classification of predicted frequencies: Very common (≥ 1/10), Common (≥ 1/100 e
Infections and infestations
Not known: urinary tract infection
Gastrointestinal disorders
Very common: constipation, nausea, dry mouth,
Common: diarrhea, vomiting,
Uncommon: abdominal discomfort, anorexia, decreased appetite, dysphagia,
Not known: gastroesophageal reflux, bloating, pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility)
Psychiatric disorders
Common: confusional state
Not known: agitation, anxiety, hallucinations, nightmares, paranoia, cognitive impairment in the elderly, symptoms of depression, oxybutynin dependence (in patients with a history of substance or drug abuse)
Nervous system disorders
Very common: dizziness, headache, somnolence
Not known: cognitive disturbances, convulsions, dizziness, insomnia
Cardiac pathologies
Not known: tachycardia, arrhythmia, palpitations Injury, poisoning and procedural complications
Not known: heat stroke
Eye disorders
Common: dry eye,
Not known: blurred vision, pupil dilation, intraocular hypertension, angle-closure glaucoma, cyclopegia
Renal and urinary disorders
Common: problems with urination or urinary retention.
Vascular pathologies
Common: hot flashes
Skin and subcutaneous tissue disorders
Very common: dry skin,
Not known: severe allergic or idiosyncratic reactions to drugs such as hives, rash, angioedema or other skin manifestations, hypohydro
Disorders of the immune system
Not known: hypersensitivity
Diseases of the reproductive system and breast
Not known: Impotence, withdrawal of lactation.
General disorders and administration site conditions
Not known: weakness
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
COMPOSITION
One tablet contains:
Active ingredient: oxybutynin hydrochloride 5 mg
Excipients: anhydrous lactose, microcrystalline cellulose, calcium stearate
PHARMACEUTICAL FORM AND CONTENT
Box of 30 tablets of 5 mg
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DITROPAN 5 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
Active principle: oxybutynin hydrochloride 5 mg.
Excipients: lactose.
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of voiding disorders resulting from overactivity of the bladder detrusor: unstable bladder, neurological bladder, impaired urination control in elderly patients with neuro-vascular deterioration on an arteriosclerotic basis and in diabetic patients, enuresis, involuntary incontinence with or without urge to urinate, pollakiuria day and night not on an obstructive basis, tenesmus and bladder spasms.
Adjuvant in the treatment of cystitis of various kinds, even after radiation treatment and chronic prostatitis.
Psychosomatic disorders of urination (pollakiuria and cystalgia on a neuro-heretic basis).
Pediatric population
Ditropan is indicated in children over 5 years of age for:
- Urinary incontinence, urgent or frequent need to urinate in unstable bladder conditions due to idiopathic bladder overactivity or neurogenic bladder disorders (detrusor overactivity);
- Nocturnal enuresis associated with detrusor overactivity, in combination with non-drug therapy after failure of other treatments.
04.2 Posology and method of administration
Adults:
the normal dose is 1 tablet of 5 mg, two or three times a day.
The maximum recommended dose is 1 tablet of 5 mg, four times a day.
Children over 5 years old:
the normal dose is 1 tablet of 5 mg, twice a day.
The maximum recommended dose is 1 tablet of 5 mg, three times a day.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with obstructive uropathies which can precipitate urinary retention.
Partial or total obstruction of the gastrointestinal tract, intestinal atony, paralytic ileus. Mega-colon, toxic mega-colon.
Ulcerative colitis. Myasthenia gravis.
Narrow-angle glaucoma or low anterior chamber.
Patients in unstable cardiovascular conditions in the presence of acute bleeding.
04.4 Special warnings and appropriate precautions for use
Ditropan can cause heat stroke (fever and collapse due to reduced sweating) when administered in the presence of a high ambient temperature.
Diarrhea can be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this case, treatment with Ditropan would not be appropriate and could be harmful.
Ditropan should be used with caution in debilitated elderly and children who may be more sensitive to the effects of the product and in patients with autonomic neuropathy (such as patients with Parkinson's disease), with severe gastrointestinal motility disorders, with hepatic impairment or kidney damage.
Anticholinergics should be used with caution in elderly patients due to the risk of cognitive impairment.
Gastrointestinal Disorders: Anticholinergic drugs may decrease gastrointestinal motility and should be used with caution in patients with problems with gastrointestinal obstruction, intestinal atony and ulcerative colitis.
The administration of Ditropan to patients with ulcerative colitis can cancel intestinal motility to the point of producing paralytic ileus and triggering or aggravating a toxic megacolon, which is a serious complication of the disease.
Ditropan can aggravate tachycardia (and thus hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmia, hypertension), cognitive disturbances and symptoms of prostate hypertrophy, so use caution in these cases.
Anticholinergic effects on the CNS (eg hallucinations, agitation, confusion, somnolence) have been reported; monitoring is recommended especially in the first months after initiation of therapy or dose increase; Discontinuation of therapy or dose reduction should be considered if anticholinergic effects on the CNS occur.
Since Ditropan can cause narrow-angle glaucoma, patients should be advised that if they become aware of "sudden loss of" visual acuity or eye pain, they should contact a physician immediately.
Ditropan can reduce salivary secretions which can lead to dental caries, periodontal disease or oral candidiasis.
Anticholinergic medicinal products should be given with caution to patients with hiatus hernia / gastroesophageal reflux and / or to those concurrently taking medications (such as bisphosphonates) that can cause or exacerbate esophagitis.
Dependence on oxybutynin has been observed in patients with a history of substance or drug abuse.
Important information about some of the ingredients:
The medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Pediatric population
Ditropan is not recommended for use in children under 5 years of age. It has not been established whether oxybutynin can be safely used in this age group.
There are limited data to support the use of oxybutynin in children with monosymptomatic nocturnal enuresis (unrelated to detrusor overactivity).
In children over 5 years of age, Ditropan should be used with caution as such patients may be more sensitive to the effects of the product, particularly CNS adverse reactions and psychiatric reactions.
04.5 Interactions with other medicinal products and other forms of interaction
Care should be taken if other anticholinergic drugs are co-administered with oxybutynin, as the anticholinergic effects may be potentiated.
The anticholinergic activity of oxybutynin increases with concomitant use with other anticholinergics or with medicinal products with anticholinergic activity, such as amantadine, and other anticholinergic antiparkinsonian medicinal products (eg. Biperiden, levodopa), antihistamines, antipsychotics (eg phenothiazines, butyrophenones, clozapine), quinidine, digitalis, tricyclic antidepressants, atropine and related compounds such as atropine antispasmodics and dipyridamole.
By reducing gastric motility, oxybutynin may affect the absorption of other drugs.
Oxybutynin is metabolised by the cytochrome P450 isoenzyme CYP 3A4. Concomitant administration with a CYP 3A4 inhibitor may inhibit the metabolism of oxybutynin and increase its exposure.
Oxybutynin can antagonize prokinetic therapies.
Concomitant use with cholinesterase inhibitors may result in reduced efficacy of the cholinesterase inhibitor.
In normal subjects, DITROPAN does not modify the metabolism of drugs metabolized by hepatic microsomal enzymes (phenobarbital, phenytoin, warfarin, phenylbutazone, tolbutamide).
Patients should be advised that alcohol may increase drowsiness caused by anticholinergic agents such as oxybutynin (see 4.7).
04.6 Pregnancy and lactation
Pregnancy
There are insufficient data on the use of oxybutynin in pregnant women. Animal studies on the effects on pregnancy, embryonal / fetal development, parturition and postnatal development are insufficient (see section 5.3). The potential risk in pregnant women or women of childbearing age is unknown.
Therefore, DITROPAN should not be administered to pregnant women, unless strictly necessary
Feeding time
When oxybutynin is used during breastfeeding, a small amount is excreted in breast milk. Therefore, the use of oxybutynin during breastfeeding is not recommended.
04.7 Effects on ability to drive and use machines
DITROPAN can cause drowsiness or blurred vision. During therapy with this drug, patients who must perform activities requiring mental alertness, such as driving vehicles, operating machinery and performing hazardous work, should be warned of these possible effects.
04.8 Undesirable effects
After the administration of DITROPAN the symptoms that can be found with the use of anticholinergics may arise.
Classification of expected frequencies:
Very common (≥ 1/10), Common (≥ 1/100 e
Infections and infestations
Not known: urinary tract infection
Gastrointestinal disorders
Very common: constipation, nausea, dry mouth, Common: diarrhea, vomiting,
Uncommon: abdominal discomfort, anorexia, decreased appetite, dysphagia,
Not known: gastroesophageal reflux, bloating, pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility)
Psychiatric disorders
Common: confusional state
Not known: agitation, anxiety, hallucinations, nightmares, paranoia, cognitive impairment in the elderly, symptoms of depression, oxybutynin dependence (in patients with a history of substance or drug abuse)
Nervous system disorders
Very common: dizziness, headache, somnolence
Not known: cognitive disturbances, convulsions, dizziness, insomnia
Cardiac pathologies
Not known: tachycardia, arrhythmia, palpitations
Injury, poisoning and procedural complications
Not known: heat stroke
Eye disorders
Common: dry eye
Not known: blurred vision, mydriasis, intraocular hypertension, closed angle glaucoma, cycloplegia
Renal and urinary disorders
Common: problems with urination or urinary retention
Vascular pathologies
Common: hot flashes
Skin and subcutaneous tissue disorders
Very common: dry skin,
Not known: severe allergic or idiosyncratic reactions to drugs such as hives, rash, angioedema or other skin manifestations, hypohidrosis
Disorders of the immune system
Not known: hypersensitivity
Diseases of the reproductive system and breast
Not known: Impotence, withdrawal of lactation.
General disorders and administration site conditions
Not known: weakness
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
Symptoms of overdosing of DITROPAN range from the intensification of the usual undesirable effects of the S.N.C. (from agitation and excitement to psychotic behavior), to circulatory disturbances (hot flashes, pressure drop, circulatory failure), respiratory failure, paralysis and coma.
The procedure to be implemented includes:
1. immediate gastric lavage
2. slow intravenous injection of physostigmine:
Adults: 0.5 to 2 mg by slow intravenous route, possibly repeatable up to a maximum of 5 mg
Children: 30 mcg / kg by slow intravenous route, possibly repeatable up to a maximum of 2 mg
Symptomatic treatment (alcohol sponging, ice packs) can be used for fever.
In case of worrying agitation or excitement, diazepam 10 mg intravenously can be given. Tachycardia can be treated with i.v. propranolol. and urinary retention with bladder catheterization.
In the event that the curare-like effect progresses to paralysis of the respiratory muscles, it is necessary to implement artificial respiration.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: urinary antispasmodics.
ATC code: G04BD04.
Oxybutynin exerts a direct antispastic action and an antimuscarinic action on smooth muscles.
On the pubo-bladder muscle of the rabbit oxybutynin has only one fifth of the anticholinergic activity of atropine while its antispastic activity is four to ten times higher than that of atropine. Furthermore, it does not cause blocking effects at the level of neuromuscular plaques or ganglia of the autonomic system (antinicotin effects).
05.2 "Pharmacokinetic properties
In rats, the blood peak occurs 2 hours after oral administration, excretion is mainly faecal and only 10% urinary. It is possible the existence of an enterohepatic circle. In the rabbit, 60% of oxybutynin is excreted in the urine and the remainder in the faeces.
In "man," oxybutynin administered by OS is absorbed from the gastrointestinal tract and has a blood peak of about 7mcg / l after 50 "from the oral intake of 5 mg.
05.3 Preclinical safety data
In addition to the information included in the other sections, preclinical data based on conventional studies of general toxicity, genotoxicity and carcinogenicity reveal no particular risk for humans. Embryo-fetal studies in pregnant rats have shown malformed hearts. In addition, higher dosages have been correlated with malformed hearts. presence of additional ribs and increased neonatal toxicity In the absence of exposure data, the validity of these observations cannot be ascertained.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Anhydrous lactose, microcrystalline cellulose, calcium stearate.
06.2 Incompatibility
Not known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Blister packs of suitable shape and size, placed in cartons together with the package leaflet. .
Box of 30 tablets.
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
sanofi-aventis S.p.A.
Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
DITROPAN 5 mg Tablets A.I.C. 025190012
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: 01.06.2010
