Tolterodine

What is Tolterodine?

Tolterodine

• Tolterodine (Detrol; Detrol LA) is an antimuscarinic used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

What are the uses of this medicine?

Tolterodine (Detrol; Detrol LA) is a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

• Having a strong need to urinate with leaking or wetting accidents (urge urinary incontinence).
• Having a strong need to urinate right away (urgency).
• Having to urinate often (frequency).

Overactive bladder:

• Overactive bladder happens when you cannot control your bladder muscle.
• When the muscle contracts too often or cannot be controlled, you get symptoms of overactive bladder, which are leakage of urine (urge urinary incontinence), needing to urinate right away (urgency), and needing to urinate often (frequency).

How does this medicine work?

• Tolterodine (tol ter' oh deen) is a synthetic anticholinergic and antispasmotic agent that inhibits muscarinic actions of acetylcholine on autonomic nerve endings, decreasing secretions and inhibiting gastrointestinal and bladder motility.
• Tolterodine increases bladder capacity and decreases bladder contractions and the urgency of urination.

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"
• Are allergic to tolterodine tartrate tablets or to any of its ingredients.
• Are allergic to Toviaz (fesoterodine fumarate) which contains fesoterodine.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• amiodarone (Nexterone, Pacerone)
• antihistamines
• atazanavir (Reyataz, in Evotaz)
• clarithromycin
• cyclosporine (Gengraf, Neoral, Sandimmune)
• donepezil (Aricept, in Namzaric)
• erythromycin (E.E.S., Ery-Tab, others)
• galantamine (Razadyne)
• itraconazole (Onmel, Sporanox. Tolsura)
• medications for irritable bowel disease, motion sickness, or Parkinson's disease
• ketoconazole
• procainamide
• quinidine (in Nuedexta)
• ritonavir (Norvir, in Kaletra, Technivie, Viekira)
• rivastigmine (Exelon)
• saquinavir (Invirase)
• sotalol (Betapace, Sorine, Sotylize)
• vinblastine

Is this medicine FDA approved?

Tolterodine2DCSD

• Tolterodine was approved for use in the United States in 1998 and indications include urge incontinence and overactive bladder syndrome, including symptoms of urinary urgency and frequency.

How should this medicine be used?

Recommended dosage: Tolterodine tartrate tablets:

• The initial recommended dose of tolterodine tartrate tablets is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on individual response and tolerability.
• For patients with significantly reduced hepatic or renal function or who are currently taking drugs that are potent inhibitors of CYP3A4, the recommended dose of tolterodine tartrate is 1 mg twice daily.

Tolterodine tartrate extended-release capsules:

• The recommended dose of tolterodine tartrate extended-release capsules is 4 mg once daily with water and swallowed whole.
• The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for tolterodine tartrate extended-release capsules 2 mg.

2 mg capsules taken orally once daily with water and swallowed whole in the presence of:

• mild to moderate hepatic impairment.
• severe renal impairment [Creatinine Clearance (CCr) 10-30 mL/min].
• drugs that are potent CYP3A4 inhibitors.

Administration:

• Tolterodine comes as a tablet and an extended-release capsule to take by mouth.

Tolterodine tartrate tablets:

• Take tolterodine tartrate tablets exactly as your doctor tells you to take them.
• Your doctor will tell you how many tolterodine tartrate tablets to take and when to take them.
• Do not change your dose unless told to do so by your doctor.
• You can take tolterodine tartrate tablets with or without food.
• Take tolterodine tartrate tablets at the same times each day.
• If you miss a dose of tolterodine tartrate tablets, just take your next regular dose at your next regular time. Do not try to make up for your missed dose.
• If you take too many tolterodine tartrate tablets, call your doctor, or go to the hospital emergency room right away.

Tolterodine tartrate extended-release capsules:

• Take tolterodine tartrate extended-release capsules exactly as prescribed. Your doctor will prescribe the dose that is right for you.
• Do not change your dose unless told to do so by your doctor.
• Take tolterodine tartrate extended-release capsules once a day with liquid.
• Swallow the whole capsule.
• Tell your doctor if you cannot swallow a capsule.
• Tolterodine tartrate extended-release capsules can be taken with or without food.
• Take tolterodine tartrate extended-release capsules the same time each day.
• If you miss a dose of tolterodine tartrate extended-release capsules, begin taking tolterodine tartrate extended-release capsules again the next day. Do not take 2 doses of tolterodine tartrate extended-release capsules in the same day.
• If you took more than your prescribed dose of tolterodine tartrate extended-release capsules, call your doctor or poison control center, or go to the hospital emergency room.

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

This medicine is available in fallowing doasage form:

• As a tablet and an extended-release capsule

This medicine is available in fallowing brand namesː

• Detrol; Detrol LA

What side effects can this medication cause?

The most common side effects with tolterodine tartrate tablets are:

• Dry mouth
• Dizziness
• Headache
• Stomach pain
• Constipation

The most common side effects with tolterodine tartrate extended-release capsules are:

• Dry mouth
• Constipation
• Headache
• Stomach pain

• Anticholinergic agents can precipitate acute narrow angle glaucoma and acute urinary retention.

What special precautions should I follow?

• Tolterodine tartrate can cause blurred vision, dizziness, and drowsiness. Do not drive, operate machinery, or do other dangerous activities until you know how tolterodine tartrate tablets affect you.
• Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of tolterodine tartrate.
• Tolterodine should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention and to patients with gastrointestinal obstructive disorders, such as pyloric stenosis, because of the risk of gastric retention.
• Tolterodine, like other antimuscarinic drugs, should be used with caution in patients with decreased gastrointestinal motility.
• Tolterodine should be used with caution in patients being treated for narrow-angle glaucoma.
• Tolterodine tablets are associated with anticholinergic central nervous system (CNS) effects including dizziness and somnolence. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.
• Tolterodine should be used with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.
• Consider observations from the thorough QT study in clinical decisions to prescribe tolterodine tartrate extended-release capsules to patients with a known history of QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications.
• It is not known if tolterodine tartrate tablets pass into your breast milk or if they can harm your baby. Talk to your doctor about the best way to feed your baby if you take tolterodine tartrate tablets.
• Tolterodine has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• anticholinergic effects
• confusion
• dry mouth

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• ECG monitoring is recommended in the event of overdosage.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no studies of tolterodine in pregnant women.
• Therefore, tolterodine should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus.

Can this medicine be used in children?

• Efficacy in the pediatric population has not been demonstrated.

What are the active and inactive ingredients in this medicine?

Tolterodine tartrate tablets:

• Active ingredients: tolterodine tartrate
• Inactive ingredients: corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium stearyl fumarate, and titanium dioxide.

Tolterodine tartrate extended-release capsules:

• Active ingredients: tolterodine tartrate USP
• Inactive ingredients: colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, FD & C Blue no.2, gelatin, hypromellose, hypromellose phthalate, sucrose, talc and titanium dioxide. 2 mg capsule also contains iron oxide yellow. Capsules have pharmaceutical grade printing ink that contains ammonium hydroxide, iron oxide black, shellac, potassium hydroxide, propylene glycol and titanium dioxide.

Who manufactures and distributes this medicine?

Tolterodine tartrate extended-release capsules: Manufactured By:

• Inventia Healthcare Limited,
• F1-F1/1-F75/1, Additional Ambernath MIDC,
• Ambernath (East)
• Dist.-Thane, Maharashtra, INDIA.

Distributed by:

• ANI Pharmaceuticals, Inc.
• Baudette, MN

Tolterodine tartrate tablets: Manufactured In India By:

• Cipla Ltd.
• Goa, India

Manufactured For:

• TEVA PHARMACEUTICALS USA, INC.
• North Wales, PA

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

• Store tolterodine tartrate tablets at 20º to 25ºC (68º to 77ºF).
• Keep them in a dry place.

• Store tolterodine tartrate extended-release capsules at room temperature, 68° - 77°F (20° - 25°C); brief periods permitted between 59° - 86°F (15° - 30°C).
• Protect from light.
• Keep in a dry place.
• Keep tolterodine tartrate extended-release capsules and all medicines out of the reach of children.

Urologic agents

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

• Dailymed label info on Tolterodine
• FDA Tolterodine

Tolterodine Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

Tolterodine Resources
Latest articles Most recent articles Ongoing trials	Wikipedia