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Darilax ER (Darifenacin)
Therapeutic Group: Urological » Urinary Incontinence
Presentation

Darifenacin 7.5 ER: Each extended release tablet contains Darifenacin Hydrobromide INN 7.5 mg.

Darifenacin 15 ER: Each extended release tablet contains Darifenacin Hydrobromide INN 15 mg.

Descriptions
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. Darifenacin has greater affinity for the M3 receptor than for the other known muscarinic receptors. M3 receptors are involved in contraction of human bladder and gastrointestinal smooth muscle, saliva production, and iris sphincter function.
Indications
Darilax ER tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Dosage & 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.
Darifenacin extended-release tablets 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.
Side Effects
The most common side effects are dry mouth & constipation. Other less commonly reported side effects include- abnormal vision, back pain, dry skin, hypertension, vomiting, peripheral edema, weight gain, arthralgia, bronchitis, pharyngitis, rhinitis, sinusitis, rash, pruritus, urinary tract disorder and vaginitis.
Precautions
Darifenacin should be used with caution in the patient at risk for urinary retention & decreased gastrointestinal motility, with impaired renal & hepatic impairment.
Contraindications
Darifenacin extended-release tablets are contraindicated in patients with known hypersensitivity to the drug or its ingredients, in patients with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions.
Use in Pregnancy & Lactation
Pregnancy Category C. Darifenacin should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
It is not known whether Darifenacin is excreted into human milk and therefore caution should be exercised before Darifenacin is administered to a nursing woman.
Drug Interaction
Darifenacin has known drug-drug interaction with CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, nelfinavir etc.). The concomitant use of Darifenacin with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects.
Overdose
Overdosage with antimuscarinic agents can result in severe antimuscarinic effects. ECG monitoring is recommended when event of overdosage is occurred. Darifenacin has been administered in clinical trials at doses up to 75 mg (five times the maximum therapeutic dose) and signs of overdose were limited to abnormal vision.
Commercial Packaging
Darifenacin 7.5 ER: Each box contains 3 blister strips of 10 tablets.
Darifenacin 15 ER: Each box contains 3 blister strips of 10 tablets.
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