Driptan, tablets 5 mg, 30 pcs.
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Pharmacotherapeutic group: spasmolytic agent.
ATC: G04BD04
Pharmacological properties
Pharmacodynamics
Oxybutynin has an antispasmodic effect on detrusor smooth muscle fibers and an anticholinergic effect by blocking the action of acetylcholine on the m-cholinoreceptors of smooth muscles. These properties contribute to relaxation of the bladder detrusor. In patients with unstable bladder function, the drug increases bladder volume and decreases the frequency of spontaneous detrusor contractions.
Pharmacokinetics
. When administered orally, oxybutynin is rapidly absorbed in the gastrointestinal tract – maximum plasma concentration (Cmax) is reached in less than 1 hour and then decreases biphasically with a half-life of 2-3 hours. The maximum effect is observed within 3-4 hours, the residual effect may persist for more than 10 hours.
Equilibrium concentration is reached after 8 days of oral administration. In elderly patients with an active lifestyle, oxybutynin does not appear to accumulate and its pharmacokinetics does not differ from that of other adult patients. However, Cmax and AUC (area under the concentration-time curve) values are significantly increased in impaired elderly patients. Oxybutynin is extensively metabolized in the liver, primarily by cytochrome P450 system enzymes, in particular CYP3A4, which is found mainly in the liver and intestinal walls; metabolites also have M-cholin-blocking effects. The main route of excretion is through the kidneys. Only 0.3-0.4% of the unchanged drug is detected in the urine of rats after 24 h and 1% in the urine of dogs after 48 h. Consequently, in rats and dogs oxybutynin is almost completely metabolized
Indications
EnuresisAdults
– urinary incontinence, urgent urge to urinate and frequent urination associated with instability of bladder function, resulting either from neurogenic disorders (detrusor hyperreflexia) in diseases such as multiple sclerosis and spina bifida, or due to idiopathic disorders of detrusor function (motor emergency urinary incontinence).
– Bladder hyperactivity following bladder or prostate surgery or concomitant cystitis.
Children over 5 years
. – urinary incontinence, urgent urge to urinate and frequent urination associated with instability of bladder function, resulting either from idiopathic overactive bladder or bladder dysfunction of neurogenic nature (detrusor overactivity);
– nocturnal enuresis associated with detrusor hyperactivity, in combination with non-pharmacological methods if other therapy is ineffective.
Active ingredient
Oxybutynin
Composition
1 tablet contains:
Active substance: oxybutynin hydrochloride – 5.00 mg.
Associates: Microcrystalline cellulose, 17.80 mg; anhydrous lactose, 153.30 mg; calcium stearate, 1.90 mg.
How to take, the dosage
Orally (orally). The tablet may be divided into two equal parts.
Adults
The usual dose of the drug is 5 mg 2-3 times daily. If necessary, it is possible to increase the dose to 5 mg 4 times daily giving a satisfactory clinical result with good tolerability.
Elderly patients
In elderly patients, the elimination half-life may be prolonged, so an initial dose of 2.5 mg 2 times daily is usually sufficient, especially in frail patients. If well tolerated, the dose may be increased to 5 mg 2 times daily.
Children (over 5 years)
In unstable bladder function: the usual dose of the drug is 2.5 mg 2 times daily. To achieve clinical response the dose may be increased to 5 mg 2-3 times a day with good tolerability.
Bedwetting: 2.5 mg 2 times a day. To achieve clinical response, the dose may be increased to 5 mg 2-3 times daily if well tolerated. The last dose should be taken at night.
Children (under 5 years)
Use of Driptan® in children under 5 years is contraindicated (see section “Contraindications”).
Interaction
Caution should be exercised when using Driptan® with other anticholinergic drugs due to possible increase of its anticholinergic effect.
There are reports of rare cases of interaction between anticholinergic agents and phenothiazines, amantadine, neuroleptics (e.g. phenothiazines, butyrophenones, clozapine), other anticholinergic antiparkinsonian drugs (e.g. biperiden, levodopa), antihistamines, quinidine, foxglove drugs, tricyclic antidepressants, atropine, atropine-like antispasmodics and dipyridamole. Caution should be exercised when using Driptan® concomitantly with these drugs.
The drug may affect absorption of other drugs, reducing gastrointestinal motility.
Oxybutynin is metabolized by cytochrome Р450 CYP3A4 isoenzyme. Concomitant use with CYP3A4 inhibitors may inhibit the metabolism of oxybutynin and enhance its effects. Oxybutynin may reduce the effects of prokinetic therapy.
Concomitant administration of oxybutynin with cholinesterase inhibitors may reduce the effectiveness of the latter.
Alcohol may increase sleepiness caused by taking such anticholinergic drugs as oxybutynin.
Special Instructions
Impact on the ability to drive and operate motor vehicles
The drug may cause drowsiness or blurred vision. Patients should refrain from driving or operating machinery unless their physical and mental abilities have not changed.
Synopsis
White round biconvex tablets with a rib on one side.
Contraindications
– hypersensitivity to the active substance or any of the excipients;
– myasthenia;
– closed-angle glaucoma or shallow anterior chamber of the eye;
– patients with hyperthermia or in conditions of high ambient temperature due to the risk of heat stroke;
– children under 5 years of age due to insufficient data on efficacy and safety;
– esophageal dysfunction, including hernia of the esophageal diaphragm;
– functional or organic obstruction of the gastrointestinal tract (GIT), including pylorostenosis, paralytic ileus, intestinal atony;
– Ileostoma, colostomy, toxic dilatation of the colon (megacolon), severe ulcerative colitis;
– Bladder infravesical obstruction, in which urinary retention may be caused by, inter alia, hypertrophy of the prostate.
– period of breast feeding.
Due to the fact that the drug contains lactose, Driptan® is contraindicated in congenital galactosemia, glucose-galactose malabsorption, lactase deficiency, galactose intolerance.
With caution
– elderly persons due to the fact that they may be more sensitive to the action of the drug (a dose reduction may be required, see.
-pathology of vegetative nervous system;
– other severe gastrointestinal diseases, not indicated in the section “Contraindications”;
– hepatic or renal insufficiency;
– cerebrovascular disorders;
– children over 5 years old due to the fact that they can be more sensitive to the action of the drug, especially with regard to the development of side effects from the nervous system and mental disorders;
– pregnancy (see section “Administration during pregnancy and period of
– pregnancy (see section “Administration during pregnancy and breastfeeding”).
Elderly patients should be cautious about taking anticholinergic agents due to the risk of cognitive impairment.
Symptoms of hyperthyroidism, coronary vascular disease, chronic heart failure, arterial hypertension, prostatic hyperplasia, and heart rhythm disorders, tachycardia may increase after administration of oxybutynin.
Nervous system anticholinergic effects (e.g., hallucinations, agitation, mental confusion, drowsiness) have been noted. Monitoring of the condition is recommended, especially in the first few months of treatment after starting therapy or increasing the dose. It is necessary to consider discontinuation of therapy or dose reduction in case of nervous system effects (see section “Interaction with other medicinal products”).
Due to the fact that oxybutynin may cause closed-angle glaucoma, you should immediately consult a physician in case of sudden loss of visual acuity or pain in the eyes.
Caution should be exercised when taking oxybutynin for patients with porphyria because in animal and in vitro tests the drug caused increased synthesis of porphyrinogen.
Prolonged administration of oxybutynin may contribute to dental caries by reducing or suppressing saliva production. Regular follow-up with a dentist is necessary with long-term administration.
Anticholinergic medications should be taken with caution simultaneously with medications (such as bisphosphonates) that may cause or exacerbate esophagitis.
Side effects
very often (≥1/10) | Frequently (≥1/100 to < 1/10) | Infrequent (≥1/1000 to < 1/100) | Frequency em>unknown (cannot estimate frequency based on available data) | ||
Infectious and parasitic diseases | |||||
urinary tract infection | |||||
Gastrointestinal disorders | |||||
constipation, nausea, dry mouth /p> | diarrhea, vomiting | abdominal discomfort, anorexia, decreased appetite, dysphagia | gastroesophageal reflux, pseudo-inflammation in patients at risk (elderly patients or patients with constipation and receiving therapy with other medications that reduce intestinal motility). | ||
Mental disorders | |||||
. | confusion | agitation, anxiety, hallucinations, nightmares, paranoia, cognitive impairment in elderly patients, symptoms of depression, dependence (in patients with a history of drug or addiction), disorientation, delirium/p> | |||
Nervous system disorders | |||||
dizziness, headache, drowsiness | cognitive impairment, seizures /td> | ||||
cardiac disorders | |||||
| tachycardia, arrhythmia | ||||
injuries, intoxications and complications of manipulation | |||||
heat stroke | |||||
Visual disturbances | |||||
dry eyes | closed angle glaucoma, mydriasis, elevated intraocular pressure, blurred vision /p> | ||||
Renal disordersRenal and urinary tract disorders | |||||
urinary retention | disorder of urination | ||||
vascular disorders | |||||
“hot flashes”> | |||||
Dermal and subcutaneous tissue disorders | |||||
dry skin | .td width=”25%”> angioedema, rash, urticaria, hypohidrosis, photosensitization /p> | ||||
Disorders of the immune system | |||||
hypersensitivity |
* more pronounced in children than in adults
Overdose
The symptoms of overdose with oxybutynin gradually increase from the usual CNS side effects (from anxiety and emotional agitation to psychotic behavior), circulatory disorders (“hot flashes” of blood, drop in blood pressure, circulatory failure, etc.) to respiratory failure, paralysis and coma.
The treatment in case of overdose is symptomatic:
1. Immediate gastric lavage.
2. If life-threatening anticholinergic syndrome develops, neostigmine bromide (or physostigmine) may be used in doses according to the instructions for medical use.
Symptomatic treatment in case of fever.
In case of significant agitation or irritability, 10 mg of diazepam should be given intravenously.
If tachycardia develops, intravenous propranololol should be given.
In case of urinary retention, use a catheter.
If respiratory muscle paralysis occurs, artificial lung ventilation is necessary.
Pregnancy use
Pregnancy
The safety of oxybutynin during pregnancy has not been established. Animal studies have shown that the use of the drug in doses that have a toxic effect on the maternal body causes reproductive toxicity. The available animal studies are insufficient to evaluate the effects of the drug on pregnancy, embryonic development, delivery, or postnatal development.
The drug should not be used in pregnant women unless the anticipated benefit to the mother from its use exceeds the potential risk to the fetus.
Breastfeeding period
In animal studies it was found that oxybutynin is detected in breast milk. Accordingly, the drug should not be used during breastfeeding.
.
Weight | 0.020 kg |
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Shelf life | 3 years. Do not use after the expiration date. |
Conditions of storage | Store at a temperature not exceeding 25 ºC. Keep out of reach of children. |
Manufacturer | Resifarm Fontaine, France |
Medication form | pills |
Brand | Resifarm Fontaine |
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