TROPAN XL (Ditropan XL)5 mg – 50 tablet

Oxybutynin Information

Pronunciation

oks i BYOO ti nin

What is this drug used for?

• It is used to treat an overactive bladder.

• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Fatigue

• Headache

• Blurred vision

• Constipation

• Diarrhea

• Nausea

• Loss of strength and energy

• Anxiety

• Trouble sleeping

• Application site redness, irritation, or itching

• Dry mouth

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Urinary tract infection like blood in the urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain.

• Severe dizziness

• Passing out

• Confusion

• Sensing things that seem real but are not

• Agitation

• Mood changes

• Lack of sweat

• Unable to pass urine

• Severe abdominal pain

• Muscle weakness

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Medication Safety Issues

Storage and Stability

Immediate release tablet and syrup: Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Extended release tablet: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture and humidity.

Topical gel: Store at 20°C to 25°C (68°C to 77°F). Protect from moisture and humidity. Keep away from open flame. Do not store outside the sealed pouch or pump dispenser; apply immediately after removal from the protective pouch or once contents expelled from pump dispenser. Discard used sachets such that accidental application or ingestion by children, pets, or others are avoided.

Transdermal patch: Store at 20°C to 25°C (68°F to 77°F). Protect from moisture and humidity. Do not store outside the sealed pouch; apply immediately after removal from the protective pouch. Discard used patches such that accidental application or ingestion by children, pets, or others is avoided.

Adverse Reactions

As reported with oral administration, unless otherwise noted.

Cardiovascular: Decreased blood pressure, edema, flushing, increased blood pressure, palpitations, peripheral edema, sinus arrhythmia

Central nervous system: Confusion, dizziness (more common with oral), drowsiness, falling, fatigue (oral, topical gel), flank pain, headache (more common with oral), insomnia, nervousness, pain

Dermatologic: Macular eruption (transdermal; application site), pruritus (oral, topical gel), xeroderma

Endocrine & metabolic: Fluid retention, increased serum glucose, increased thirst

Gastrointestinal: Abdominal pain, coated tongue, constipation (more common with oral), diarrhea, dysgeusia, dyspepsia, eructation, flatulence, gastroesophageal reflux disease, nausea, upper abdominal pain, viral gastroenteritis (topical gel), vomiting, xerostomia (more common with oral)

Genitourinary: Cystitis, dysuria (oral, transdermal), increased post-void residual urine volume, pollakiuria, urinary hesitancy, urinary retention, urinary tract infection (oral, topical gel)

Infection: Fungal infection

Local: Application site dermatitis (topical gel), application site erythema (transdermal), application site pruritus (more common with transdermal), application site rash (transdermal), application site reaction (topical gel), application site vesicles (transdermal)

Neuromuscular & skeletal: Arthralgia, asthenia, back pain, limb pain

Ophthalmic: Blurred vision, eye irritation, keratoconjunctivitis sicca, visual disturbance (transdermal), xerophthalmia

Respiratory: Asthma, bronchitis, cough, dry nose, dry throat, hoarseness, nasal congestion, nasopharyngitis (oral, topical gel), oropharyngeal pain, paranasal sinus congestion, pharyngolaryngeal pain, sinus headache, upper respiratory tract infection (oral, topical gel)

Rare but important or life-threatening: Abnormal behavior, agitation, anaphylaxis, angioedema, anorexia, cardiac arrhythmia, chest discomfort, confusion, cycloplegia, decreased gastrointestinal motility, delirium, dizziness, drowsiness, dysphagia, facial edema, frequent bowel movements, glaucoma, hallucination, headache, hot flash, hypersensitivity reaction, hypertension, hypohidrosis, impotence, lactation insufficiency, memory impairment, mydriasis, prolonged Q-T interval on ECG, psychotic reaction, seizure, skin rash, tachycardia, urticaria, voice disorder