Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Enablex (darifenacin). mg and 15 mg darifenacin (as darifenacin hydrobromide). Muscarinic M3 This leaflet is part III of a three-part Product. Monograph. Enablex (darifenacin) is used to treat symptoms of overactive bladder. Includes Enablex side effects, interactions and indications. See also: Drug Interactions ( in more detail).
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This information is intended for use by health professionals. The information below applies to subjects who have normal CYP2D6 activity extensive metabolisers unless otherwise packwge. For this medicine, the following should be considered:. Do not take other medicines unless they have been discussed with your doctor. The use of agents such as physostigmine can assist in reversing such symptoms. Not all possible interactions are listed in this medication guide.
If your dose is different, do not change it unless your doctor tells you to inserrt so.
Back to top Packge Labs Luxco S. There are no onsert studies in women for determining infant risk when using this medication during breastfeeding. Hepatic insufficiency Darifenacin pharmacokinetics were investigated in subjects with mild Child Pugh A or moderate Child Pugh B impairment of hepatic function given darifenacin 15 mg once daily to steady state. Patients with moderate hepatic impairment Child Pugh B should only be treated if the benefit outweighs the risk, and the dose should be restricted to 7.
Date of first authorisation: The amount of medicine that you take depends on the strength of the medicine. Maximum plasma levels are reached approximately 7 hours after administration of the prolonged-release tablets and steady-state plasma levels are achieved by the sixth day of administration. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below.
Marketing authorisation holder 8. Date of revision of the text. Available for Android and iOS devices. Adverse reactions with Emselex 7. At steady state, peak-to-trough fluctuations in darifenacin concentrations packagr small PTF: Active ingredient darifenacin hydrobromide.
Breast-feeding Darifenacin is excreted in the milk of rats. This is not a complete list of side effects and others may occur. Reporting of suspected adverse reactions.
However the data available do not indicate that darifenacin changes either midazolam clearance or bioavailability. Emselex has been administered in clinical trials at doses up to 75 mg five times maximum therapeutic dose.
As seen in Enavlex 2 below, a pooled analysis of 3 of the studies for the treatment with both Emselex 7. However, there was no association between the enableex of adverse events related to the biliary system in darifenacin-treated patients and increasing age.
Consistent with the pharmacological profile, the most commonly reported packabe reactions were dry mouth Cystometric studies performed with darifenacin in patients with involuntary bladder contractions showed increased bladder capacity, increased volume threshold for unstable contractions and diminished frequency of unstable detrusor contractions.
Warfarin Standard therapeutic prothrombin time monitoring for warfarin should be continued. Therapeutic drug monitoring for digoxin should be performed when initiating and ending darifenacin treatment as well as changing the darifenacin dose.
The dose of this medicine will be different for different patients.
Description and Brand Names Drug information provided by: Darifenacin is used to treat symptoms inxert an overactive bladder, such as incontinence loss of bladder control or a frequent need to urinate. Tell your doctor about all medicines you use, and those you start pacjage stop using during your treatment with Enablex, especially:. The most common adverse reactions seen were dry mouth, constipation, headache, dyspepsia and nasal dryness.
Using this medicine with any of the following medicines is usually not recommended, but pacage be required in some cases. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Medical Information Direct Line. Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
However, caution should be exercised.
FDA alerts for all medications. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Side effects in more detail. To bookmark a medicine you must sign up and log in.
We comply with the HONcode standard for trustworthy health information – verify here. No dose adjustment is required in patients with impaired renal function.
Be careful if you drive or do anything that requires you to be alert and able to see clearly. Skin and subcutaneous tissue disorders. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
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