Novitrothane (Novitropan)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceOxybutyninOxybutynin
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  • Driptan®
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    Laboratories SA Fournier.     France
  • Novitrothane
    pills inwards 
    STS Chemical Industries Co., Ltd.     Israel
    • Dosage form: & nbsppills
    Composition:

    1 the tablet contains:

    active substance: hydroxybutynin hydrochloride 5 mg;

    Excipients: lactose anhydrous, corn starch, povidone, calcium carmellose, magnesium stearate, indigocarmine (FDC, blue No. 2), purified water (removed during production).

    Description:

    Light blue round biconvex tablets with a risk on one side. Presence of marble is admissible.

    Pharmacotherapeutic group:Spasmolytic agent
    ATX: & nbsp

    G.04.B.D   Spasmolytics

    G.04.B.D.04   Oxybutynin

    Pharmacodynamics:

    Spasmolytic agent, eliminates spasms and lowers the tone of smooth muscles: the gastrointestinal tract (GIT), biliary tract, uterus, relaxes detrusor (direct spasmolyolitic and m-cholinoblocking action). Increases the capacity of the bladder, reduces the frequency of detrusor cuts, restrains urge to urinate. Well tolerated for long-term use.

    Pharmacokinetics:

    The time of the maximum concentration (TCmOh) after ingestion - 45 minutes. The concentration is proportional to the applied dose. The half-life (T1/2) - 2 hours, in elderly patients - lengthened.

    Indications:

    Neurogenic bladder (including detrusor hyperreflexia in multiple sclerosis or spina bifida); urinary incontinence (idiopathic nature); nocturnal enuresis (in children older than 5 years).

    Contraindications:

    Hypersensitivity, open and closed angle glaucoma, gastrointestinal obstruction, paralytic intestinal obstruction, intestinal atony, colonic expansion (including toxic, complicated by ulcerative colitis), ulcerative colitis, myasthenia gravis, obstructive uropathy, bleeding, children's age (up to 5 years ), pregnancy, lactation.

    Carefully:

    Renal / hepatic insufficiency, thyrotoxicosis, ischemic heart disease, chronic heart failure, arrhythmias, hypertension, prostatic hyperplasia, diaphragmatic hernia, diarrhea accompanying incomplete intestinal obstruction (especially in patients with ileo- or colostomy), elderly.

    Dosing and Administration:

    Inside, adults - 5 mg 2-3 times (no more than 4 times) a day. The maximum daily dose is 20 mg.

    Children with violations of the bladder neurogenic nature - 5 mg 2 times a day, with night enuresis - 5 mg 2-3 times a day (the last dose taken at night). The maximum daily dose is 15 mg.

    Elderly patients and children may receive an initial dose of 2.5 mg twice a day with a gradual increase to normal.

    Side effects:

    Dyspepsia (nausea, vomiting, constipation, flatulence), dry mouth, upset urination (including urinary retention), decreased motility of the stomach and intestines, drowsiness or insomnia, weakness, dizziness, anxiety, hallucinations, tachycardia, decreased lacrimal production fluid, visual impairment (mydriasis, accommodation paralysis, amblyopia), increased intraocular pressure, decreased sweating, decreased potency, allergic reactions.

    Overdose:

    Symptoms: excitation of the central nervous system (anxiety, tremor, irritability, convulsions, delirium, hallucinations), fever, nausea, vomiting, tachycardia, decreased or increased blood pressure, respiratory failure, paralysis, coma.

    Treatment: gastric lavage, appoint Activated carbon and saline laxative, breathing should be maintained; To reduce the severity of symptoms of anticholinergic intoxication, cholinesterase inhibitors (physostigmine) are used. When hyperpyrexia - cold compresses (including with ice), alcohol wiping.

    Interaction:

    Enhancement of side effects is noted when co-administered with drugs that have anticholinergic effects.

    Ethanol and sedatives increase dizziness and drowsiness.

    Special instructions:

    It must be borne in mind that a high ambient temperature often provokes the occurrence of fever (a decrease in sweating) against the background of taking the drug.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Tablets, 5 mg.

    Packaging:

    For 10 tablets in a blister of PVC / Al.

    For 3 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C in a dry place.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014574 / 01
    Date of registration:10.11.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:STS Chemical Industries Co., Ltd.STS Chemical Industries Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspGENPHA LTD.GENPHA LTD.Russia
    Information update date: & nbsp23.06.2018
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