12 August

Detruzitol - instructions for use , indications, dosage

Detruzitol - competitive blocker of M-cholinergic receptor, a drug that reduces the tone of smooth muscles of the urinary tract.

release form and composition

  • sustained-release capsules: size №4, hard gelatin, with the body and the lid of blue-green color on the body in white ink applied to the number "2" on the cover - a symbol of a man;contents - microspheres with a diameter of about 1 mm white with a yellowish tint (7 pcs in blister packs in a cardboard unit 1, 4, 7, 12 or 40 blisters.);
  • depot capsules: size №3, hard gelatin, with the housing and the lid is blue and white ink deposited body figure "4" on the cover - as a symbol of man;contents - microspheres with a diameter of about 1 mm white with a yellowish tint (7 pcs in blister packs in a cardboard unit 1, 4, 7, 12 or 40 blisters.);
  • coated tablets:. Round, convex on both sides, white on one side engraved with the letters "TO", above and beneath - the arc (14 pcs in blister packs in a cardboard unit 1, 2 or 4 blisters; 60 pieces in vials,
    in a cardboard bundle one bottle).;
  • coated tablets:. Round, convex on both sides, white on one side engraved with the letters "DT", above and beneath - the arc (14 pcs in blister packs in a cardboard unit 1, 2 or 4 blisters; 60 pieces in vials, in a cardboard bundle one bottle)..

active substance - tolterodine tartrate:

  • 1 capsule size №4 - 2 mg, which corresponds to the content of tolterodine - 1,37 mg;
  • 1 capsule size №3 - 4 mg, which corresponds to the content of tolterodine - 2,74 mg;
  • 1 tablet engraved with "TO" - 1 mg, which corresponds to the content of tolterodine - 0,68 mg;
  • 1 tablet engraved with "DT" - 2 mg, which corresponds to the content of tolterodine - 1.37 mg.

Additional components capsules:

  • Valium Valium, sugar granules (maize starch and sucrose), Surelease E-7-19010 Clear (oleic acid, triglycerides srednetsepochnye, ethyl cellulose);
  • shell composition: indigo, gelatin, titanium dioxide, white ink Opacode White S-1-7085 (titanium dioxide, shellac, simethicone, propylene glycol), and iron oxide yellow dye - capsules №4.

Excipients Tablets: sodium starch glycolate, calcium hydrogen phosphate dihydrate, magnesium stearate, microcrystalline cellulose, stearic acid, hypromellose, titanium dioxide, silica colloidal anhydrous.

Indications

Detruzitol - a drug for the treatment of overactive bladder, manifested frequent urination, and frequent mandatory urination and / or urinary incontinence.

Contraindications

  • and frequent urgency to urinate caused by organic causes;
  • Urinary retention;
  • Severe ulcerative colitis;
  • Myasthenia gravis;
  • Megacolon;
  • delayed gastric emptying;
  • untreatable angle-closure glaucoma;
  • Glucose-galactose malabsorption, a rare inherited disorders of fructose tolerance, sucrase-isomaltase deficiency (capsule);
  • age of 18 years (for capsules);
  • Lactation;
  • hypersensitivity to the drug.

wary Detruzitol prescribed in the following cases:

  • Severe obstruction of the lower urinary tract;
  • risk slowing gastric emptying, including obstructive diseases of the gastrointestinal tract (e.g., pyloric stenosis);
  • Renal or hepatic impairment (daily dose should not exceed 2 mg);
  • hiatal hernia;
  • Neuropathy;
  • congenital or acquired prolongation of the interval QT;
  • Simultaneous administration of antiarrhythmic drugs class IA (procainamide, quinidine) or Class III (sotalol, amiodarone);
  • age of 18 years (for tablets).

During pregnancy, the drug may be appointed only for health reasons, if the anticipated benefits exceed the risks.

Dosage and Administration

Detruzitol taken orally, without reference to the meal.

daily dose is 4 mg: long-acting capsules - 1 mg to 4 times a day, coated tablets - 2 mg 2 times a day.

Depending on tolerability daily dose may be reduced to 2 mg.

recommended daily dose for patients with impaired renal function and / or liver of patients receiving ketoconazole or other CYP3A4 strong inhibitors is 2 mg: capsule - 2 1 mg once a day tablet - 1 mg 2 times a day.

Side effects

classification of adverse effects: often - more than 10% of cases, sometimes - from 1 to 10%, rare - less than 1%:

  • Digestive system: sometimes - abdominal pain, constipation, vomiting, flatulence, dyspepsia;rarely - gastroesophageal reflux disease;
  • central and peripheral nervous system: sometimes - vertigo, drowsiness, headache, blurred vision, nervousness, weakness, fatigue;rarely - hallucinations, confusion;
  • urinary system: rarely - dysuria;
  • Cardiovascular system: rarely - rush of blood to the skin, a feeling of palpitations, tachycardia, peripheral edema;
  • Allergic reactions: seldom - anaphylactic reactions, includingangioedema;
  • Side effects associated with anticholinergic action: often - dry mucous membranes of the oral cavity;sometimes - xerophthalmia (decreased lacrimation), accommodation disturbances;rarely - urinary retention;
  • Side effects caused by administration of the drug in tablets: sometimes - weight gain, dry skin, chest pain, bronchitis;
  • Side effects caused by administration of the drug in capsules: sometimes - sinusitis.

Cautions

Before appointment Detruzitola necessary to conduct examination of the patient to exclude organic causes frequent and urgency to urinate.

The daily dose should be reduced to 2 mg, if necessary simultaneous use of CYP3A4 inhibitors, antibiotics such as macrolides (clarithromycin, erythromycin), antifungals (itraconazole, miconazole, ketoconazole).

Detruzitol not recommended for children, as the safety of its use in this age group of patients has not been studied.

drug can reduce the rate of psychophysical reactions and cause accommodation disturbances, and therefore at the time of treatment should refrain from driving and the performance of potentially hazardous work requiring increased attention and quick reactions.

Women of childbearing age at the time of treatment must use reliable methods of contraception.

Drug Interactions

  • Anticholinergic drugs: enhanced therapeutic effect Detruzitola and its adverse effects;
  • M-cholinomimetics: reduced therapeutic effect of the drug;
  • metoclopramide, cisapride: weakened by their action;
  • Fluoxetine: slight increase in the total concentration of tolterodine and its active metabolite, 5-hydroxymethyl (clinically significant responses are not accompanied).

possible pharmacokinetic interactions with drugs metabolized isoenzymes 2D6 and 3A4 cytochrome P450 or an inducer or inhibitor of these isoenzymes.

patients with CYP2D6 deficiency should avoid simultaneous use Detruzitola with strong inhibitors of CYP3A4, such as antibiotics, macrolides (clarithromycin and erythromycin), antifungals (miconazole, itraconazole, ketoconazole), asTolterodine may increase serum concentrations and increase the risk of overdose.

Tolterodine does not interact with combined oral contraceptives (containing levonorgestrel and ethinyl estradiol) and warfarin.

Terms and conditions of storage

Store at temperatures up to 25 ° C in a place protected from light and the reach of children.

shelf life of the capsules - 2 years, tablets - 3 years.

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