Urispas

Generic name: flavoxate hydrochloride

Drug class: Urinary antispasmodics

Dosage form: Tablets

Root of administration: Oral

Dose: Adults and children over 12 years of age: 100 mg to 200 mg, 3 to 4 times daily. With improvement of symptoms, the dose may be reduced. Safety and efficacy in children under 12 years have not been established.

Mechanism of action: Flavoxate hydrochloride acts as a direct antagonist at muscarinic acetylcholine receptors in cholinergically innervated organs. Its anticholinergic-parasympatholytic action reduces the tonus of smooth muscle in the bladder, effectively reducing the number of required voids, facilitating increased volume per void.

Drug usage cases:

• Symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency, and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis, and urethrotrigonitis.
• Relief of vesico-urethral spasms due to catheterization, cystoscopy, or indwelling catheters; prior to cystoscopy or catheterization; sequelae of surgical intervention of the lower urinary tract.

Drug contraindications:

• Hypersensitivity to flavoxate hydrochloride or any of the excipients.
• Gastrointestinal obstructive conditions or ileus.
• Gastrointestinal hemorrhage.
• Achalasia.
• Urinary retention.
• Glaucoma.

Side effects:

• Gastrointestinal: Nausea, vomiting, dry mouth.
• CNS: Vertigo, headache, mental confusion (especially in the elderly), drowsiness, nervousness.
• Cardiovascular: Tachycardia, palpitations.
• Allergic: Urticaria, other dermatoses, eosinophilia, hyperpyrexia.
• Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation.
• Hematologic: Leukopenia (reversible upon discontinuation of the drug).

Warnings:

• Use cautiously in patients with suspected glaucoma.
• May cause drowsiness and blurred vision; patients should avoid operating vehicles or machinery until they know how the drug affects them.
• Not approved for use in children under 12 years of age.
• Not indicated for the definitive treatment of urinary tract infections; infections must be treated with appropriate antibiotics.

Use during pregnancy or breastfeeding: Flavoxate is classified as Pregnancy Category B, indicating no proven risk in humans. Reproduction studies in rats and rabbits at doses up to 34 times the human dose revealed no evidence of impaired fertility or harm to the fetus. However, there are no well-controlled studies in pregnant women. Therefore, this drug should be used during pregnancy only if clearly needed. It is not known whether flavoxate is excreted in human milk. Caution should be exercised when administering to nursing women.