Darifenacin is used to treat overactive bladder, helping relieve symptoms such as urgent urinary incontinence, a sudden need to urinate (urgency), and frequent urination.

Darifenacin is a strong, selective, and competitive muscarinic receptor blocker with a higher affinity for M3 receptors. These M3 receptors play an important role in detrusor muscle contraction in the bladder, gastrointestinal smooth muscle activity, saliva secretion, and iris sphincter function. By blocking these receptors, Darifenacin can increase the volume threshold for involuntary bladder contractions, thereby improving bladder capacity.

Darifenacin 7.5 mg once daily; may increase dose to 15 mg once daily if no adequate response after 2 wk of therapy. Darifenacin should be taken with liquid. It can be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.

For patients with moderate hepatic impairment or when co-administered with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of Darifenacin should not exceed 7.5 mg.

Darifenacin is known to interact with CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, and nelfinavir. Using Darifenacin together with other anticholinergic drugs may increase both the frequency and severity of side effects like dry mouth, constipation, blurred vision, and other anticholinergic effects.

This medication is not recommended for patients with urinary retention, gastric (stomach) retention, uncontrolled narrow-angle glaucoma, or for those who are at risk of developing these conditions.

The most frequently reported side effects are dry mouth and constipation. Other, less common side effects may include blurred or abnormal vision, back pain, dry skin, high blood pressure (hypertension), vomiting, peripheral swelling (edema), weight gain, joint pain (arthralgia), bronchitis, pharyngitis, rhinitis, sinusitis, skin rash, itching (pruritus), urinary tract disorders, and vaginitis.

Pregnancy Category C. Darifenacin should be used during pregnancy only if the expected benefit to the mother is greater than the potential risk to the fetus.

Lactation: It is not known whether Darifenacin passes into human breast milk. Therefore, caution is advised when administering this drug to breastfeeding women.

Darifenacin should be used carefully in patients who are at risk of urinary retention or reduced gastrointestinal motility, as well as in those with kidney or liver impairment.

Overdose with antimuscarinic drugs may lead to severe antimuscarinic effects. ECG monitoring is recommended if an overdose occurs. Darifenacin has been studied in clinical trials at doses up to 75 mg (about five times the maximum recommended dose), and the only observed sign of overdose was abnormal vision.

BPH/ Urinary retention/ Urinary incontinence

Store at 25° C. Protect from light.