Tolterodine

Tell your doctor about all the medicines you take or are planning to take includine prescription and non-prescription medicines, vitamins, and herbal supplements. If you take tolterodine with other medicines, the effects of either could be increased, decreased, or altered. Especially tell your doctor if you take:

• clarithromycin
• cyclosporin
• erythromycin
• itraconazole
• ketoconazole
• miconazole
• vinblastine

This is not a complete list of tolterodine drug interactions. Ask your doctor or pharmacist for more information.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of tolterodine there are no specific foods that you must exclude from your diet when receiving tolterodine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or if you are planning to breastfeed. It is not known if tolterodine is excreted in human breast milk or if it will harm your nursing baby.

In the U.S.

• Detrol
• Detrol LA

Available Dosage Forms:

• Capsule, Extended Release
• Tablet

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Tolterodine

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release 24 Hour, Oral, as tartrate:

Detrol LA: 2 mg, 4 mg

Generic: 2 mg, 4 mg

Tablet, Oral, as tartrate:

Detrol: 1 mg, 2 mg

Generic: 1 mg, 2 mg

Use with caution due to its anticholinergic properties (Beers Criteria [AGS 2015]).

As reported with immediate release tablet, unless otherwise specified.

>10%: Gastrointestinal: Xerostomia (35%; extended release capsules: 23%)

1% to 10%:

Cardiovascular: Chest pain (2%)

Central nervous system: Headache (7%; extended release capsules: 6%), dizziness (5%; extended release capsules: 2%), fatigue (4%; extended release capsules: 2%), drowsiness (immediate and extended release: 3%), anxiety (extended release capsules: 1%)

Dermatologic: Xeroderma (1%)

Endocrine & metabolic: Weight gain (1%)

Gastrointestinal: Constipation (7%; extended release capsules: 6%), abdominal pain (5%; extended release capsules: 4%), diarrhea (4%), dyspepsia (4%; extended release capsules: 3%)

Genitourinary: Dysuria (2%; extended-release capsules: 1%)

Infection: Infection (1%)

Neuromuscular & skeletal: Arthralgia (2%)

Ophthalmic: Xerophthalmia (immediate and extended release: 3%), visual disturbance (2%; extended release capsules: 1%)

Respiratory: Flu-like symptoms (3%), bronchitis (2%), sinusitis (extended release capsules: 2%)

<1% (Limited to important or lfe-threatening): Anaphylaxis, angioedema, confusion, dementia (aggravated), disorientation, hallucination, memory impairment, palpitations, peripheral edema, prolonged Q-T interval on ECG, tachycardia

Teratogenic effects were observed in some animal reproduction studies.

Commonly reported side effects of tolterodine include: xerostomia. Other side effects include: constipation, dyspepsia, and dizziness. See below for a comprehensive list of adverse effects.

Applies to tolterodine: oral capsule extended release, oral tablet

Cardiovascular

Uncommon (0.1% to 1%): Palpitations, arrhythmia, abnormal ECG, hypertension
Very rare (less than 0.01%): Cardiac failure
Postmarketing reports: Tachycardia, peripheral edema, flushing[Ref]

Dermatologic

Common (1% to 10%): Dry skin, acne, rash/erythema
Postmarketing reports: Angioedema[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (35%)
Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, ulcerated stomatitis
Frequency not reported: Gastroesophageal reflux, vomiting[Ref]

General

The most common adverse events reported were dry mouth, headache, constipation, vertigo/dizziness, and abdominal pain. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and xerophthalmia are expected side effects of antimuscarinic agents.[Ref]

Genitourinary

Common (1% to 10%): Dysuria, urinary tract infection, micturition frequent
Uncommon (0.1% to 1%): Urinary retention[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity not otherwise specified
Postmarketing reports: Anaphylaxis[Ref]

Immunologic

Common (1% to 10%): Influenza-like symptoms, infection[Ref]

Metabolic

Common (1% to 10%): Weight gain, abnormal alkaline phosphatase, enzyme abnormality[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, leg pain[Ref]

Nervous system

Common (1% to 10%): Headache, vertigo/dizziness, migraine
Uncommon (0.1% to 1%): Paresthesia, memory impairment
Rare (0.01% to 0.1%): Convulsions[Ref]

Ocular

Common (1% to 10%): Abnormal accommodation, xerophthalmia, vision abnormal[Ref]

Other

Common (1% to 10%): Fatigue, chest pain, malaise, pain, fall[Ref]

Psychiatric

Common (1% to 10%): Somnolence, anxiety
Uncommon (0.1% to 1%): Nervousness
Postmarketing reports: Confusion, disorientation, memory impairment, hallucinations, aggravation of symptoms of dementia (e.g., confusion, disorientation, delusion) after therapy was initiated in patients taking cholinesterase inhibitors for the treatment of dementia[Ref]

Renal

Postmarketing reports: Renal dysfunction[Ref]

Respiratory

Common (1% to 10%): Sinusitis, asthma, bronchitis, coughing, dyspnea[Ref]

Some side effects of tolterodine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Immediate release tablets:
-Initial dose: 2 mg orally 2 times a day
-Maintenance dose: 1 to 2 mg orally 2 times a day, depending on patient response and tolerability

Extended release capsules:
-Initial dose: 4 mg orally once a day
-Maintenance dose: 2 to 4 mg orally once a day, depending on patient response and tolerability

Comments:
-This drug can be taken with or without food.
-The extended release formulation should be swallowed whole.

Use: For the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency