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

16 HOW SUPPLIED/STORAGE AND HANDLING

Tolterodine Tartrate Extended-Release Capsules are available containing 2 mg or 4 mg of tolterodine tartrate, USP.

The 2 mg capsules are hard-shell gelatin capsules with a green opaque cap and green opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 3402 in black ink on the cap and body. They are available as follows:

NDC 60429-825-30

bottles of 30 capsules

NDC 60429-825-90

bottles of 90 capsules

NDC 60429-825-05

bottles of 500 capsules

The 4 mg capsules are hard-shell gelatin capsules with a powder blue opaque cap and powder blue opaque body filled with white to off-white beads. The capsules are axially printed with MYLAN over 3404 in black ink on the cap and body. They are available as follows:

NDC 60429-826-30

bottles of 30 capsules

NDC 60429-826-90

bottles of 90 capsules

NDC 60429-826-05

bottles of 500 capsules

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling ( Patient Information).

Antimuscarinic Effects: Inform patients that antimuscarinic agents such as tolterodine tartrate extended-release capsules may have side effects including blurred vision, dizziness, or drowsiness. Advise patients not to drive, operate machinery, or do other potentially dangerous activities until they know how tolterodine tartrate extended-release capsules affect them.

Patient Information

Tolterodine Tartrate Extended-Release Capsules
(tol ter′ oh deen tar′ trate)

Read the Patient Information that comes with tolterodine tartrate extended-release capsules before you start using it 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 extended-release capsules is right for you.

What are tolterodine tartrate extended-release capsules?
Tolterodine tartrate extended-release capsules are 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).

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 extended-release capsules?
Do not take tolterodine tartrate extended-release capsules if:

  • You have trouble emptying your bladder (also called “urinary retention”).
  • Your stomach empties slowly (also called “gastric retention”).
  • You have an eye problem called “uncontrolled narrow-angle glaucoma”.
  • You are allergic to tolterodine tartrate extended-release capsules or to any of its ingredients. See the end of this leaflet for a complete list of ingredients.
  • You are allergic to TOVIAZ ® , which contains fesoterodine.

What should I tell my doctor before starting tolterodine tartrate extended-release capsules?
Before starting tolterodine tartrate extended-release capsules, tell your doctor about all of your medical conditions, including if you:

  • Have any stomach or intestinal problems.
  • Have trouble emptying your bladder or you have a weak urine stream.
  • Have an eye problem called narrow-angle glaucoma.
  • Have liver problems.
  • Have kidney problems.
  • Have a condition called myasthenia gravis.
  • Or any family members have a rare heart condition called QT prolongation (long QT syndrome).
  • Are pregnant or trying to become pregnant. It is not known if tolterodine could harm your unborn baby.
  • Are breastfeeding. It is not known if tolterodine passes into your milk and if it can harm your child.

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

  • Certain medicines for fungus or yeast infections such as Nizoral ® (ketoconazole), Sporanox ® (itraconazole), or Monistat ® (miconazole).
  • Certain medicines for bacteria infections such as Biaxin ® (clarithromycin).
  • Certain medicines for treatment of HIV infection such as Norvir ® (ritonavir), Invirase ® (saquinavir), Reyataz ® (atazanavir).
  • Sandimmune ® (cyclosporine) or Velban ® (vinblastine).

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 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 two 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 possible side effects of tolterodine tartrate extended-release capsules?
Tolterodine tartrate extended-release capsules 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 extended-release capsules and get emergency medical help right away.

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

  • Dry mouth
  • Headache
  • Constipation
  • Stomach pain

Medicines like tolterodine tartrate extended-release capsules can cause blurred vision, dizziness, and drowsiness.

Do not drive, operate machinery, or do other dangerous activities until you know how tolterodine tartrate extended-release capsules affect you.

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

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

How do I store tolterodine tartrate extended-release capsules?

  • Store tolterodine tartrate extended-release capsules at room temperature, 20° to 25°C (68° to 77°F). Protect from light. Keep in a dry place.
  • Keep tolterodine tartrate extended-release capsules and all medicines out of the reach of children.

General information about tolterodine tartrate extended-release capsules

Medicines are sometimes prescribed for conditions that are not in the patient information leaflet. Only use tolterodine tartrate extended-release capsules the way your doctor tells you. Do not share it with other people even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about tolterodine tartrate extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about tolterodine tartrate extended-release capsules that is written for health professionals. You can also call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in tolterodine tartrate extended-release capsules?

Active ingredient: tolterodine tartrate

Inactive ingredients: ethylcellulose, FD&C Blue No. 2, gelatin, hypromellose, sodium lauryl sulfate, sugar spheres (corn starch and sucrose), talc and titanium dioxide. The 2 mg capsules also contain yellow iron oxide.

The imprinting ink contains the following: black iron oxide, potassium hydroxide, propylene glycol and shellac.

The brands listed are trademarks of their respective owners.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Marketed/Packaged by:
GSMS, Inc.

Camarillo, CA USA 93012

Revised: 8/2018
TOLTER:R3pt/PL:TOLTER:R3pt

PRINCIPAL DISPLAY PANEL – 2 mg

NDC 60429-825-90

Tolterodine
Tartrate
Extended-Release
Capsules
2 mg

Rx only 90 Capsules

Each extended-release
capsule contains:
Tolterodine tartrate, USP 2 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Dosage: See accompanying prescribing information.

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PRINCIPAL DISPLAY PANEL – 4 mg

NDC 60429-826-90

Tolterodine
Tartrate
Extended-Release
Capsules
4 mg

Rx only 90 Capsules

Each extended-release
capsule contains:
Tolterodine tartrate, USP 4 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Dosage: See accompanying prescribing information.

//rxdruglabels.com/lib/images-rx/tolterodine-tartrate-7/60429-826-90lb-300x231.jpg
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TOLTERODINE TARTRATE tolterodine tartrate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-825(NDC:0378-3402)
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
ETHYLCELLULOSE, UNSPECIFIED
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SUCROSE
STARCH, CORN
Product Characteristics
Color green (green opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;3402
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-825-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:60429-825-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:60429-825-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201486 10/31/2013
TOLTERODINE TARTRATE tolterodine tartrate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-826(NDC:0378-3404)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOLTERODINE TARTRATE (TOLTERODINE) TOLTERODINE TARTRATE 4 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SUCROSE
STARCH, CORN
ETHYLCELLULOSE, UNSPECIFIED
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
Product Characteristics
Color blue (powder blue opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code MYLAN;3404
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-826-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:60429-826-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
3 NDC:60429-826-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201486 10/31/2013
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 repack (60429-825), relabel (60429-825), repack (60429-826), relabel (60429-826)

Revised: 12/2019 Golden State Medical Supply, Inc.

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