URITOS / URITOS OD Tablet Ref.[50721] Active ingredients: Imidafenacin

Source: Web Search  Revision Year: 2017 

3. Indications and Usage

The following symptoms associated with overactive bladder: urinary urgency, urinary frequency, and urge urinary in-continence

Precautions

  1. Prior to use of these products, clinical symptoms of patients should be confirmed with an appropriate interview, and diagnosis by exclusion of some other diseases with similar symptoms, including urinary tract infection, urinary calculus, and lower urinary-tract neoplasm such as bladder cancer and prostate cancer, should be made by performing appropriate examinations such as urinalysis. In addition, special examinations should be considered to conduct, if necessary.
  2. In patients with overactive bladder complicated with lower urinary-tract obstructive disease, including benign prostatic hypertrophy, treatment of the complication should be given priority.

10. Dosage and Administration

The usual oral dosage for adults is 0.1 mg of imidafenacin twice daily, after breakfast and supper. If the efficacy is insufficient, the dosage may be increased up to 0.2 mg twice daily (0.4 mg/day).

Precautions

  1. Increase in dosage should be attempted when 0.1 mg twice daily of imidafenacin provides insufficient efficacy, with maintaining sufficient safety. [Efficacy and safety have not been established for the initial dose of imidafenacin at 0.2 mg twice daily.]
  2. For patients with moderate to severe hepatic dysfunction, dosage of imidafenacin should be kept at 0.1 mg twice daily. (See “Careful Administration” and “PHARMACOKINETICS” 1 (4).)
  3. For patients with severe renal dysfunction, dosage of imidafenacin should be kept at 0.1 mg twice daily. (See “Careful Administration” and “PHARMACOKINETICS” 1 (4).)

9. Overdosage

Symptoms

Urinary retention, mydriasis, excitement, tachycardia, etc.

Countermeasures

After gastric lavage or administration of activated carbon, the measures similar to those for overdosage of atropine should be taken. Appropriate measures should be taken according to individual symptoms, including urethral catheterization for urinary retention and administration of pilocarpine for mydriasis.

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