Darifen ER 15 mg Tab

Darifen ER

DESCRIPTION

Darifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of the urinary bladder smooth muscle and stimulation of salivary secretion.

COMPOSITION

Each Extended Release Tablet contains Darifenacin Hydrobromide INN equivalent to Darifenacin 7.5 mg.

INDICATION

This product is indicated in the treatment of overactive bladder with symptoms of urinary frequency, urgency and incontinence.

DOSAGE AND ADMINISTRATION

The recommended starting dose of Darifenacin Extended-Release Tablets is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECT

Nausea, vomiting, abdominal pain, back pain, dry skin may occur.

CONTRAINDICATION

Darifenacin is contraindicated in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these condition. Darifenacin is also contraindicated in patients with known hypersensitivity to the drug or its ingredients.

PRECAUTION

Darifenacin should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

USE IN PREGNANCY AND LACTATION

Pregnancy category of Darifenacin is C. Caution should be exercised during lactation.

USE IN CHILDREN

Safety and effectiveness in children have not been established.

DRUG INTERACTION

The daily dose of Darifenacin should not exceed 7.5 mg when coadministered with potent CYP3A4 inhibitors e.g., ketoconazole, itraconazole, ritonavir, clarithromycin and nefazadone. The concomitant use of Darifenacin with other anticholinergic agents may increase the frequency and /or severity of dry mouth, constipation.