Darifenacin

What is Darifenacin?

• Darifenacin (Enablex) is a muscarinic antagonist, used to treat an overactive bladder.

Darifenacin

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What are the uses of this medicine?

• Darifenacin (Enablex) is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:
• Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
• Urgency: a strong need to urinate right away
• Frequency: urinating often

How does this medicine work?

• Darifenacin (dar" i fen' a sin) is anticholinergic agent with a degree of selectivity for the M3 subtype of muscarinic acetylcholine receptors which is found predominantly in the smooth muscle of the bladder.
• Darifenacin increases bladder capacity and decreases bladder contractions and the urgency of urination.
• Darifenacin has greater affinity for the M 3 receptor than for the other known muscarinic receptors (9- and 12-fold greater affinity for M 3 compared to M 1 and M 5, respectively, and 59-fold greater affinity for M 3 compared to both M 2 and M 4).
• M 3 receptors are involved in contraction of human bladder.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are not able to empty your bladder ("urinary retention")
• have delayed or slow emptying of your stomach ("gastric retention")
• have an eye problem called "uncontrolled narrow-angle glaucoma"

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• antifungal medicine ketoconazole (Nizoral®) or itraconazole (Sporanox®)
• antibiotic medicine clarithromycin (Biaxin®)
• anti-HIV medicine ritonavir (Norvir®) or nelfinavir (Viracept®)
• medicine to treat depression nefazadone (Serzone®)
• medicine to treat an abnormal heartbeat flecainide (TambocorTM)
• antipsychotic medicine thioridazine (Mellaril®)
• medicine to treat depression called a tricyclic antidepressant

Is this medicine FDA approved?

• Darifenacin was approved for use in the United States in 2004 and indications include urinary urge incontinence and overactive bladder syndrome.

How should this medicine be used?

Recommended dosage:

• 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.

In Patients with moderate hepatic impairment (Child-Pugh B) :

• The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg.

In Patients taking potent CYP3A4 inhibitors:

• The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg.

• Darifenacin extended-release tablets is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).

Administration:

• Darifenacin comes as an extended-release tablet to take by mouth.
• Take darifenacin extended-release tablets exactly as prescribed. Your doctor will prescribe the dose that is right for you. Take darifenacin extended-release tablets 1 time daily with water.
• Darifenacin extended-release tablets should be swallowed whole. Do not chew, cut or crush darifenacin extended-release tablets.
• Darifenacin extended-release tablets may be taken with or without food.
• If you take too much darifenacin extended-release tablets call your doctor or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As extended-release tablets 7.5 mg and 15 mg.

This medicine is available in fallowing brand namesː

• Enablex

What side effects can this medication cause?

The most common side effects of this medicine may include:

• constipation
• dry mouth
• headache
• heartburn
• nausea
• urinary tract infection
• blurred vision
• heat exhaustion or heat-stroke. This can happen when darifenacin extended-release tablets are used in hot environments. Symptoms of heat exhaustion may include:
• decreased sweating
• dizziness
• tiredness
• nausea
• increase body temperature

Darifenacin extended-release tablets may cause serious side effects including:

• Serious allergic reaction
• hives, skin rash or swelling
• severe itching
• swelling of your face, mouth or tongue
• trouble breathing

What special precautions should I follow?

• Darifenacin extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
• Darifenacin extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
• Darifenacin extended-release tablets should be used with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks.
• Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin. Darifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
• Darifenacin extended-release tablets are associated with anticholinergic central nervous system (CNS) effects. Advise patients not to drive or operate heavy machinery until they know how darifenacin extended-release tablets affect them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.
• The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg for patients with moderate hepatic impairment.
• There are no data on the presence of darifenacin in human milk, the effects on the breastfed infant, or the effects of darifenacin on milk production.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• severe antimuscarinic effects

Management of overdosage:

• Treatment should be symptomatic and supportive.
• In the event of overdosage, ECG monitoring is recommended.
• Darifenacin extended-release tablets has been administered in clinical trials at doses up to 75 mg and signs of overdose were limited to abnormal vision.

Can this medicine be used in pregnancy?

• There are no available data on darifenacin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• It is not known if darifenacin extended-release tablets can harm your unborn baby.

Can this medicine be used in children?

• The safety and effectiveness of darifenacin extended-release tablets in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: darifenacin

• Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, magnesium stearate, hypromellose (E15 LV), titanium dioxide, polyethylene glycol 400 and hypromellose (methocel K4M CR).

• The 15 mg tablet also contains ferric oxide red and ferric oxide yellow.

Who manufactures and distributes this medicine?

Manufactured by:

• TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for:

• TORRENT PHARMA INC., Basking Ridge, NJ

What should I know about storage and disposal of this medication?

• Store darifenacin extended-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
• Protect from light.

Urologic agents

• Overactive bladder syndrome agents - darifenacin, fesoterodine, flavoxate, hyoscyamine, mirabegron, oxybutynin, solifenacin, tolterodine, trospium

• Dailymed label info on Darifenacin
• FDA Darifenacin

Darifenacin Resources
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