Utrobin 5 mg

Weight 0.15 g

৳ 20.00

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  • Type: Tablet
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Description

Indications

Utrobin is used for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency, conditions commonly seen in patients with overactive bladder syndrome.
Take this medication only as prescribed by a registered healthcare professional.

Pharmacology

Solifenacin, the active ingredient in Utrobin, is a competitive antagonist of muscarinic receptors. It predominantly binds to the M3, M1, and M2 muscarinic receptors, with the M2 receptor being the most prevalent in the bladder (80%), followed by the M3 receptor (20%). The antagonism of the M3 receptor prevents detrusor muscle contraction, while M2 receptor antagonism may reduce smooth muscle contraction in the bladder. This mechanism helps to relieve symptoms associated with overactive bladder.

Dosage and Administration

  • Adults and Elderly: The recommended starting dose is 5 mg of Solifenacin Succinate once daily. If necessary, the dose may be increased to 10 mg once daily.
  • Use in Children: Safety and efficacy have not been established in pediatric patients. Therefore, Utrobin should not be used in children.
    Always follow the advice of a registered healthcare professional regarding the dosage.

Drug Interactions

  • Other Anticholinergic Medications: Concomitant use with other anticholinergics may result in more pronounced effects and possible adverse reactions. It is advised to wait at least one week after stopping Utrobin before starting another anticholinergic therapy.

  • Cholinergic Receptor Agonists: The therapeutic effect of Utrobin may be reduced if used alongside cholinergic receptor agonists.

  • Drugs that Stimulate Gastrointestinal Motility: Utrobin may diminish the effectiveness of medications like Metoclopramide and Cisapride.

  • CYP Enzyme Interactions: Utrobin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 at therapeutic concentrations, so it is unlikely to affect drugs metabolized by these enzymes. However, when taken with potent CYP3A4 inhibitors (e.g., Ketoconazole), the dose of Utrobin should be limited to 5 mg daily.

  • CYP3A4 Inhibitors: Care should be taken when Utrobin is used with potent CYP3A4 inhibitors like Ketoconazole, Ritonavir, or Itraconazole, especially in patients with severe renal or moderate hepatic impairment.

  • Effect of Utrobin on Other Drugs:

    • Oral Contraceptives: Utrobin does not interfere with the pharmacokinetics of combined oral contraceptives.
    • Warfarin: Utrobin does not alter the pharmacokinetics or effect of Warfarin on prothrombin time.
    • Digoxin: Utrobin has no significant effect on Digoxin levels or its pharmacokinetics.

Contraindications

Solifenacin is contraindicated in individuals who are hypersensitive to Solifenacin or any of its excipients. Additionally, it should not be used in patients with:

  • Myasthenia gravis
  • Urinary retention
  • Uncontrolled narrow-angle glaucoma
  • Severe gastrointestinal conditions (e.g., toxic megacolon)
  • Severe renal or hepatic impairment
  • Those undergoing hemodialysis
  • Patients on strong CYP3A4 inhibitors such as Ketoconazole

Side Effects

The most commonly observed side effect of Utrobin is dry mouth, which occurs more frequently with higher doses. Other potential side effects include:

  • Gastrointestinal Issues:

    • Very common: Dry mouth
    • Common: Constipation, nausea, dyspepsia, abdominal pain
    • Uncommon: Gastroesophageal reflux, dry throat
    • Rare: Colonic obstruction, fecal impaction
    • Very rare: Vomiting
  • Infections:

    • Uncommon: Urinary tract infections, cystitis
  • Nervous System Disorders:

    • Uncommon: Somnolence, dysgeusia
    • Very rare: Dizziness, headache
  • Psychiatric Disorders:

    • Very rare: Hallucinations
  • Eye Disorders:

    • Common: Blurred vision
    • Uncommon: Dry eyes
  • General Conditions:

    • Uncommon: Fatigue, peripheral edema
  • Respiratory Disorders:

    • Uncommon: Nasal dryness
  • Skin Issues:

    • Uncommon: Dry skin
    • Very rare: Pruritus, rash, urticaria
  • Urinary Issues:

    • Uncommon: Difficulty urinating
    • Rare: Urinary retention

Pregnancy and Lactation

There is no clinical data available for the use of Solifenacin during pregnancy. Animal studies have not shown direct harmful effects on fertility or fetal development, but the potential risk to humans remains unknown. Caution is advised when prescribing Utrobin to pregnant women.
Solifenacin is excreted in the milk of mice and may cause neonatal harm. Therefore, its use should be avoided while breastfeeding.

Precautions and Warnings

Before starting treatment with Utrobin, it is important to rule out other causes of frequent urination (such as heart failure or renal disease). If a urinary tract infection is present, appropriate antibacterial therapy should be initiated.
Utrobin should be used cautiously in patients with:

  • Bladder outflow obstruction or at risk of urinary retention
  • Gastrointestinal obstructive disorders
  • Severe renal impairment (creatinine clearance <30 ml/min)
  • Moderate hepatic impairment (Child-Pugh score 7-9)

In these patients, the daily dose should not exceed 5 mg. Caution is also needed when used alongside medications that can cause or exacerbate gastroesophageal reflux or esophagitis. Safety and efficacy have not been established in patients with neurogenic bladder conditions.

Use in Special Populations

  • Renal Impairment: No dosage adjustment is necessary for patients with mild to moderate renal impairment. For severe renal impairment, the dose should not exceed 5 mg daily.
  • Hepatic Impairment: No dose adjustment is required for mild hepatic impairment. For moderate hepatic impairment, the dose should not exceed 5 mg daily.
  • CYP3A4 Inhibitors: When used with potent CYP3A4 inhibitors, such as Ketoconazole, the maximum daily dose of Utrobin should be limited to 5 mg.

Overdose

Overdose with Utrobin can lead to severe anticholinergic symptoms. The highest reported accidental dose was 280 mg in a 5-hour period, which caused mental status changes but did not require hospitalization. Overdose treatment includes:

  • Severe central effects (hallucinations, excitation): Treated with physostigmine or carbachol.
  • Convulsions or severe excitation: Managed with benzodiazepines.
  • Respiratory insufficiency: Treated with artificial respiration.
  • Tachycardia: Treated with beta-blockers.
  • Urinary retention: Managed with catheterization.
  • Mydriasis: Treated with pilocarpine eye drops.

Therapeutic Class

Utrobin belongs to the class of Anticholinergics/Antimuscarinics, used for treating conditions such as Benign Prostatic Hyperplasia (BPH), urinary retention, and urinary incontinence.

Storage Conditions

Store in a cool, dry place, away from direct light.

Additional information

Weight 0.15 g

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