Name Novitropan tabl. The main active ingredient Oxybutynin Release form Tablets Dosage 5 mg Pharmacological action Antispasmodic, relieves spasms and lowers the tone of the smooth muscles of the gastrointestinal tract, biliary tract, uterus, relaxes the detrusor (direct antispasmodic and m-anticholinergic action). Increases the capacity of the bladder, reduces the frequency of detrusor contractions, inhibits the urge to urinate. Indications for use Novitropan is used for urinary incontinence associated with instability of the bladder function, impaired as a result of disorders of a neurogenic nature (detrusor hyperreflex (muscle that contracts the bladder)), for example, with widespread sclerosis or spina bifida, or with idiopathic disorders of the detrusor function (motor incontinence). In addition, in children older than 5 years, oxybutynin can be used for nocturnal enuresis in combination with non-drug therapy or in combination with other drugs when previous therapy has failed. Dosage and administration Inside, before meals. Adults: The usual dose is 5 mg two or three times a day. This dose may be increased to a maximum dosage of 5 mg four times a day (20 mg) to obtain a clinical response provided there are no side effects. Elderly patients: The half-life in the elderly may be prolonged, so dosage should be titrated individually, starting at 2.5 mg twice daily. The final dosage will depend on the response and tolerability of the side effects. Children (under 5 years old): not recommended. Children (over 5 years): Neurogenic bladder disorders: The usual dose is 2.5 mg twice daily. This dose may be increased to 5 mg two or three times a day to achieve a therapeutic effect, provided there are no side effects. Nocturnal enuresis: The usual dose is 2.5 mg twice daily. This dose may be increased to 5mg twice or thrice daily to obtain a clinical response, side effects are tolerated. The last dose should be given at bedtime. The tablet of the drug Novitropan is not divisible and is not intended for titration. If it is necessary to use Novitropan at a dose of less than 5 mg, it is recommended to use a drug from another manufacturer that provides the possibility of such a dosage. If you forget to take a medicine, do not take a double dose to make up for the missed one! Do not stop taking Novitropan without first consulting with your doctor! Use during pregnancy and lactation If you are pregnant or breastfeeding, if you think you are pregnant or do not rule out the possibility of pregnancy, tell your doctor. Use during pregnancy and lactation is contraindicated. Impact on the ability to drive vehicles and other potentially dangerous mechanisms During the period of treatment, it is not recommended to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. PrecautionsOxybutynin should be used with caution in the frail elderly and children, who may be more sensitive to the drug, and in patients with autonomic neuropathy (eg, Parkinson’s disease), severe gastrointestinal motility disorders, hepatic or renal insufficiency. Anticholinergics should be used with caution in elderly patients due to the risk of cognitive impairment. Diseases of the gastrointestinal tract: Anticholinergic drugs can impair gastrointestinal motility, which should be considered in the treatment of patients with gastrointestinal obstructive disorders, intestinal atony and ulcerative colitis. Oxybutynin may increase tachycardia (caution should be exercised in case of hyperthyroidism, congestive heart failure, cardiac arrhythmia, coronary heart disease, hypertension), cognitive impairment and symptoms of prostatic hypertrophy. CNS adverse reactions (eg, hallucinations, agitation, confusion, drowsiness) have been reported with anticholinergic drugs. In the first few months after the start of therapy or when increasing the dose, it is recommended to monitor the condition of patients. If such complications develop, consideration should be given to discontinuing therapy or reducing the dose. Taking oxybutynin can lead to angle-closure glaucoma. Patients should be advised to seek immediate medical attention in case of sudden loss of visual acuity or eye pain. Oxybutynin may reduce salivary gland secretion, which may contribute to the development of caries, periodontal disease, or oral candidiasis. Anticholinergic drugs should be used with caution in patients with hiatal hernia, gastroesophageal reflux, and/or who are concomitantly taking drugs (eg, bisphosphonates) that may cause or exacerbate esophagitis. The use of oxybutynin in conditions of high ambient temperatures can lead to the development of fever due to a decrease in sweating. Children: The use of oxybutynin in children under 5 years of age is not recommended. There is limited evidence to support the use of oxybutynin in children with monosymptomatic nocturnal enuresis (not associated with detrusor overactivity). In children older than 5 years, oxybutynin should be used with caution, as they may be more sensitive to the effects of the drug (for example, adverse reactions from the central nervous system). The composition of the drug includes lactose, and therefore it is not recommended for use in patients with rare congenital galactose intolerance, the Lapp lactase deficiency and glucose-galactose malabsorption. Interaction with other drugs If you are currently or have recently taken other drugs, tell your doctor. The anticholinergic effects of oxybutynin are increased when used concomitantly with other anticholinergic drugs or with anticholinergic drugs (eg, amantadine and other antiparkinsonian drugs: biperiden, levodopa), antihistamines, neuroleptics (eg, phenothiazines and butyrophenones), quinidine, digitalis preparations, tricyclic antidepressants, atropine and atropine-like antispasmodics, dipyridamole. With a decrease in the motor function of the stomach, oxybutynin may affect the absorption of other drugs. Oxybutynin is metabolized by cytochrome P450 (CYP3A4 isoenzyme). Simultaneous use with inhibitors of CYP3A4 can slow down the metabolism of oxybutynin and increase the concentration of oxybutynin in plasma. Simultaneous use with cholinesterase inhibitors may lead to a decrease in the effectiveness of the cholinesterase inhibitor. Patients should be informed that alcohol may increase drowsiness caused by anticholinergic drugs such as oxybutynin. During treatment with Novitropan, the use of alcohol should be excluded. Contraindications Hypersensitivity, open- and closed-angle glaucoma, obstruction of the gastrointestinal tract, paralytic ileus, intestinal atony, expansion of the colon (including toxic, complicated by ulcerative colitis), ulcerative colitis, myasthenia gravis, obstructive uropathy, bleeding, children’s age ( up to 5 years), pregnancy, lactation. Carefully. Renal / liver failure, thyrotoxicosis, coronary heart disease, chronic heart failure, arrhythmias, arterial hypertension, prostatic hyperplasia, hiatal hernia, diarrhea accompanying incomplete intestinal obstruction (especially in patients with ileo- or colostomy), advanced age. Composition Each tablet contains: active substance: oxybutynin chloride – 5.0 mg; auxiliary components: lactose monohydrate, corn starch, povidone, magnesium stearate, calcium carboxymethylcellulose, indigo carmine (E 132). Overdose Symptoms: excitation of the central nervous system (anxiety, tremor, irritability, convulsions, delirium, hallucinations), fever, nausea, vomiting, tachycardia, decrease or increase in blood pressure, respiratory failure, paralysis, coma. Treatment: immediately seek medical attention, gastric lavage, prescribe activated charcoal and saline laxative drug, breathing should be supported; to reduce the severity of symptoms of anticholinergic intoxication, anticholinesterase drugs (physostigmine) are used. With hyperpyrexia – cold compresses (including with ice), alcohol rubdowns. Side effect The assessment of undesirable side reactions is based on the following data on the frequency of occurrence: very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1,000); very rarely (< 1/10000); unknown (cannot be estimated from available data). Infections and infestations: unknown: urinary tract infections. From the gastrointestinal tract: very often: constipation, nausea, dry mouth, often: diarrhea, vomiting, infrequently: abdominal discomfort, anorexia, loss of appetite, dysphagia, unknown: gastroesophageal reflux disease, pseudo-obstruction in patients with potential risk (elderly, patients with constipation, treatment with other drugs that reduce intestinal motility). Psychiatric disorders: often: confusion, not known: agitation, anxiety, hallucinations, nightmares, paranoia, cognitive impairment in the elderly, symptoms of depression, dependence on oxybutynin (in patients with a history of drug or substance abuse). From the nervous system: very often: dizziness, headache, drowsiness; unknown: cognitive disorders, convulsions, drowsiness, disorientation. From the side of the cardiovascular system: unknown: tachycardia, arrhythmia. General disorders: unknown: heat stroke. From the sensory organs: very often - visual disturbances, often - decreased production of lacrimal fluid, unknown - angle-closure glaucoma, increased intraocular pressure. From the urinary system: often: urinary retention; unknown: difficulty urinating. On the part of the skin: very often: dry skin; unknown: Quincke's edema, rash, urticaria, anhidrosis, photosensitivity. From the immune system: unknown: hypersensitivity. From the reproductive system: unknown: decreased potency, suppression of lactation. If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not described in this package insert. Storage conditions In a place protected from moisture at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Novitropan tabl.
INN | OXYBUTYNIN |
---|---|
The code | 14 431 |
Barcode | 4 810 133 001 678 |
Dosage | 5mg |
Active substance | oxybutynin |
Manufacturer | Belmedpreparaty RUE, Belarus |
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