Generic Medicine Info
May be taken with or without food. Swallow whole, do not chew/crush/divide.
Urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe ulcerative colitis, toxic megacolon. Severe hepatic impairment.
Special Precautions
Patients with autonomic neuropathy, hiatus hernia, controlled or treated narrow-angle glaucoma, pre-existing cardiac diseases, GERD, decreased gastrointestinal motility (e.g. severe constipation, ulcerative colitis), gastrointestinal obstructive disorders (e.g. pyloric stenosis), bladder flow obstruction, prostate enlargement, risk for urinary retention. Caution during hot weather conditions and exercise. Concomitant use with potent CYP2D6 and moderate CYP3A4 inhibitors. Renal and mild to moderate hepatic impairment. Pregnancy and lactation. CYP2D6 poor metabolisers. Patient Counselling This drug may cause dizziness, somnolence, blurred vision or insomnia, if affected, do not drive or operate machinery. Monitoring Parameters Monitor LFTs and for signs or symptoms of anticholinergic effects (e.g. confusion, headache, tremors) and hypersensitivity reactions.
Adverse Reactions
Significant: Acute urinary retention, severe constipation, CNS effects (e.g. headache, confusion, hallucination, somnolence), heat prostration (during hot environment). Eye disorders: Dry eyes, visual disturbance, blurred vision. Gastrointestinal disorders: Dry mouth, constipation, nausea, abdominal pain, dyspepsia, flatulence, diarrhoea, mouth ulceration, altered taste. General disorders and administration site conditions: Asthenia, peripheral/face oedema. Injury, poisoning and procedural complications: Accidental injury. Investigations: Increased AST/ALT, weight gain. Nervous system disorders: Dizziness. Psychiatric disorders: Insomnia, abnormal thinking. Renal and urinary disorders: Urinary tract disorder, bladder pain, UTI. Reproductive system and breast disorders: Erectile dysfunction, vaginitis. Respiratory, thoracic and mediastinal disorders: Nasal dryness, dyspnoea, cough, rhinitis, flu symptoms. Skin and subcutaneous tissue disorders: Rash, dry skin, pruritus, hyperhidrosis. Vascular disorders: Hypertension.
Potentially Fatal: Angioedema of the face, lips, tongue or larynx.
Drug Interactions
May exacerbate oesophagitis with oral bisphosphonates. Increased exposure with potent CYP2D6 inhibitors (e.g. paroxetine, terbinafine, cimetidine, quinidine), and moderate CYP3A4 inhibitors (e.g. erythromycin, clarithromycin, fluconazole). Decreased plasma concentrations with CYP3A4 inducers (e.g. rifampicin, carbamazepine, barbiturates). May increase exposures of midazolam and digoxin. Increased risk of adverse effects with other antimuscarinic agents (e.g. oxybutynin, tolterodine, flavoxate). Increased plasma concentrations of CYP2D6 substrates with narrow therapeutic index (e.g. flecainide, TCAs, thioridazine). Significantly increased exposure with potent CYP3A4 inhibitors (e.g. protease inhibitors, ketoconazole, itraconazole) and potent P-glycoprotein inhibitors (e.g. ciclosporin, verapamil).
ATC Classification
G04BD10 - darifenacin ; Belongs to the class of urinary antispasmodics.
Disclaimer: This information is independently developed by CIMS based on darifenacin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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