Prescription Drug Information: Tolterodine Tartrate (Page 5 of 5)

Postmarketing Surveillance

The following events have been reported in association with tolterodine use in worldwide postmarketing experience: General: anaphylaxis and angioedema; Cardiovascular: tachycardia, palpitations, peripheral edema; Central/Peripheral Nervous: confusion, disorientation, memory impairment, hallucinations.

Reports of aggravation of symptoms of dementia (e.g., confusion, disorientation, delusion) have been reported after tolterodine therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia.

Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of tolterodine in their causation cannot be reliably determined.

OVERDOSAGE

A 27 month-old child who ingested 5 to 7 tolterodine tablets 2 mg was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered.

Management of Overdosage

Overdosage with tolterodine can potentially result in severe central anticholinergic effects and should be treated accordingly.

ECG monitoring is recommended in the event of overdosage. In dogs, changes in the QT interval (slight prolongation of 10% to 20%) were observed at a suprapharmacologic dose of 4.5 mg/kg, which is about 68 times higher than the recommended human dose. In clinical trials of normal volunteers and patients, QT interval prolongation was observed with tolterodine immediate-release at doses up to 8 mg (4 mg BID) and higher doses were not evaluated (see PRECAUTIONS , Patients With Congenital or Acquired QT Prolongation).

DOSAGE AND ADMINISTRATION

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 (see PRECAUTIONS , General; PRECAUTIONS , Reduced Hepatic and Renal Function, and PRECAUTIONS, Drug Interactions).

HOW SUPPLIED

Tolterodine Tartrate Tablets, 1 mg, are available as white, round, unscored, biconvex, film-coated tablets, debossed with “93” on one side and “0010” on the other side containing 1 mg tolterodine tartrate, packaged in bottles of 60 (NDC 0093-0010-06) and 500 (NDC 0093-0010-05) tablets.

Tolterodine Tartrate Tablets, 2 mg, are available as white, round, unscored, biconvex, film-coated tablets, debossed “93” on one side and “18” on the other side containing 2 mg tolterodine tartrate, packaged in bottles of 60 (NDC 0093-0018-06) and 500 (NDC 0093-0018-05) tablets.

PHARMACIST: Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured In India By:

Cipla Ltd.

Goa, India

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. D 4/2015

TOLTERODINE TARTRATE TABLETS

PATIENT INFORMATION

TOLTERODINE (Tol-TER-oh-deen) TARTRATE (TAHR-trat) TABLETS

Read the Patient Information that comes with tolterodine tartrate tablets before you start using them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or your treatment. Only your doctor can determine if treatment with tolterodine tartrate tablets is right for you.

What are tolterodine tartrate tablets?

Tolterodine tartrate tablets are 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

Tolterodine tartrate extended-release capsules did not help the symptoms of overactive bladder when studied in children.

What is 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).

Who should not take tolterodine tartrate tablets?

Do not take tolterodine tartrate tablets if you:

  • 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. See the end of this leaflet for a complete list of ingredients
  • Are allergic to Toviaz® (fesoterodine fumarate) which contains fesoterodine

What should I tell my doctor before starting tolterodine tartrate tablets?

Before starting tolterodine tartrate tablets, tell your doctor about all of your medical and other conditions that may affect the use of tolterodine tartrate tablets, including:

  • Stomach or intestinal problems or problems with constipation
  • Problems emptying your bladder or if you have a weak urine stream
  • Treatment for an eye problem called narrow-angle glaucoma
  • Liver problems
  • Kidney problems
  • A condition called myasthenia gravis
  • If you or any family members have a rare heart condition called QT prolongation (long QT syndrome)
  • If you are pregnant or trying to become pregnant. It is not known if tolterodine tartrate tablets could harm your unborn baby.
  • If you are breastfeeding. 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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Other medicines can affect how your body handles tolterodine tartrate tablets. Your doctor may use a lower dose of tolterodine tartrate tablets if you are taking:

  • Certain medicines for fungus or yeast infections
  • Certain medicines for bacterial infections
  • Sandimmune® (cyclosporine) or Velban® (vinblastine)

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them with you to show your doctor or pharmacist each time you get a new medicine.

How should I take 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.

What should I avoid while taking tolterodine tartrate tablets?

Medicines like tolterodine tartrate tablets 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.

What are possible side effects of tolterodine tartrate tablets?

Tolterodine tartrate tablets may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat or tongue. If you experience these symptoms, you should stop taking tolterodine tartrate tablets and get emergency medical help right away.

The most common side effects with tolterodine tartrate tablets are:

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

Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all the side effects with tolterodine tartrate tablets. For a complete list, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How do I store tolterodine tartrate tablets?

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

Keep tolterodine tartrate tablets and all medicines out of the reach of children.

General information about tolterodine tartrate tablets

Medicines are sometimes prescribed for conditions that are not mentioned in the Patient Information leaflet. Only use tolterodine tartrate tablets the way your doctor tells you. Do not give tolterodine tartrate tablets to other people even if they have the same symptoms you have. They may harm them.

This leaflet summarizes the most important information about tolterodine tartrate tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about tolterodine tartrate tablets that is written for health professionals. For more information about tolterodine tartrate tablets, call Teva Pharmaceuticals Medical Affairs at 1-888-838-2872.

What are the ingredients in 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.

Manufactured In India By:

Cipla Ltd.

Goa, India

Manufactured For:

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. B 4/2015

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

Package/Label Display Panel

NDC 0093-0010 -06

Tolterodine Tartrate Tablets, 1 mg

PHARMACIST: PLEASE DISPENSE
WITH ATTACHED PATIENT
INFORMATION LEAFLET

Rx only

60 TABLETS

TEVA

1
(click image for full-size original)

Package/Label Display Panel

NDC 0093-0018 -06

Tolterodine Tartrate Tablets, 2 mg

PHARMACIST: PLEASE DISPENSE
WITH ATTACHED PATIENT
INFORMATION LEAFLET

Rx only

60 TABLETS

TEVA

2
(click image for full-size original)

TOLTERODINE TARTRATE
tolterodine tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLTERODINE TARTRATE (TOLTERODINE) TOLTERODINE TARTRATE 1 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 6000
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 93;0010
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0010-06 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0093-0010-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077006 11/01/2015
TOLTERODINE TARTRATE
tolterodine tartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0018
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLTERODINE TARTRATE (TOLTERODINE) TOLTERODINE TARTRATE 2 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (15 MPA.S)
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 6000
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 93;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0018-06 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0093-0018-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077006 11/01/2015
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 10/2022 Teva Pharmaceuticals USA, Inc.

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