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Tropan Xl 5 Mg Tablet

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10 TABLETProduct code 252724

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Product information

Manufacturer
Sun Pharma Laboratories Ltd.
Category
Allopathy
Composition
Not provided
Packaging
10 TABLET
Box / case pack
1 / —
Description

TROPAN XL 5 MG TABLET

Name: TROPAN XL 5 MG TABLET (Brand Name)

Composition: TROPAN XL 5 MG TABLET contains Oxybutynin (5 mg) as its active ingredient. This medication belongs to the class of anticholinergics and antispasmodic agents.

Uses: TROPAN XL 5 MG TABLET is primarily used to manage symptoms associated with an overactive bladder (OAB). These symptoms include:

  • Urinary urgency (a sudden, compelling need to urinate).
  • Urinary frequency (needing to urinate more often than usual).
  • Urge incontinence (involuntary leakage of urine accompanied by an urgent need to urinate).
  • Increased night-time urination (nocturia).
  • Dysuria (painful or difficult urination).

Additionally, it may be used to treat night-time bed-wetting in children above 5 years when other treatments have not been effective. It works by relaxing the bladder muscles, which helps to reduce involuntary contractions and increases the bladder's capacity to hold urine.

Dosage and Administration: TROPAN XL 5 MG TABLET should be taken as directed by your doctor. It is generally swallowed whole with a glass of water and should not be chewed, divided, or crushed. While it can be taken with or without food, some sources suggest taking it on an empty stomach, at least an hour before a meal. The dosage can vary based on the individual's health condition and response to the medicine. For extended-release formulations, the typical starting dose is 5 mg once daily, which can be increased by 5 mg weekly if necessary, up to a maximum of 30 mg daily. For children over 6 years with bladder overactivity, an initial dose of 5 mg/day may be increased weekly, not exceeding 20 mg/day.

Side Effects: Common side effects may include:

  • Dry mouth.
  • Constipation.
  • Blurred vision.
  • Drowsiness, dizziness, or sleepiness.
  • Headache.
  • Nausea.
  • Dry skin or facial flushing.
  • Urinary retention.
  • Diarrhea, cough, nasal discomfort, or indigestion.

Serious but less common side effects can include hallucinations, confusion, rapid heartbeat, severe allergic reactions (e.g., angioedema with swelling of the face, tongue, or throat), difficulty urinating, and heatstroke (due to decreased sweating). Consult your doctor if any side effects persist or worsen.

Precautions:

  • Alcohol: Avoid consuming alcohol as it can increase drowsiness and other side effects.
  • Driving/Machinery: This medicine may cause dizziness, drowsiness, or blurred vision. Do not drive or operate heavy machinery until you know how it affects you.
  • Pregnancy and Breastfeeding: Consult your doctor if you are pregnant or breastfeeding. It will only be prescribed if the benefits outweigh the risks.
  • Children: Not recommended for children below 5 years of age.
  • Medical Conditions: Inform your doctor if you have uncontrolled narrow-angle glaucoma, urinary retention, gastric retention, severe gastrointestinal motility issues (e.g., paralytic ileus), muscle weakness (myasthenia gravis), significant bladder outflow obstruction, inflammatory bowel disease, an overactive thyroid, high blood pressure, irregular heartbeats, enlarged prostate, liver or kidney problems, autonomic neuropathy, or CNS disorders like Parkinson's disease.
  • Heat Exposure: This medicine can reduce sweating, increasing the risk of heatstroke. Drink adequate fluids and limit strenuous activity in hot weather.
  • Drug Interactions: Inform your doctor about all other medications you are taking, including herbal products. It may interact with other anticholinergics, antifungals (e.g., ketoconazole), CNS depressants, and antihistamines, potentially increasing side effects.
  • Oral Hygiene: Due to dry mouth, maintain good oral hygiene to prevent tooth decay or fungal infections.

Storage: Store TROPAN XL 5 MG TABLET below 30°C in a cool, dry place, away from direct sunlight. Keep out of sight and reach of children.

Frequently asked questions

What is TROPAN XL 5 MG TABLET used for?

TROPAN XL 5 MG TABLET, which contains the active ingredient oxybutynin, is primarily used to treat symptoms of an overactive bladder (OAB). These symptoms include frequent urination, an urgent need to urinate, and urinary incontinence (loss of bladder control). It can also be prescribed for nighttime bed-wetting in children over 5 years old when other treatments have not been successful.

How does TROPAN XL 5 MG TABLET work?

TROPAN XL 5 MG TABLET belongs to a class of medications known as anticholinergics or antispasmodics. Oxybutynin works by blocking specific muscarinic receptors, particularly M3 receptors, in the bladder muscles. This action causes the bladder muscles to relax, reduces involuntary contractions, and increases the bladder's capacity to hold urine. Consequently, it helps in delaying the urge to urinate and decreases the frequency and urgency of urination. Being an extended-release formulation, the medication is released slowly and consistently over approximately 24 hours, ensuring prolonged relief of symptoms.

What is the usual dosage for TROPAN XL 5 MG TABLET?

For adults, the typical starting dose of extended-release oxybutynin is 5 mg or 10 mg once daily, preferably taken at the same time each day. The dosage can be adjusted in 5 mg increments based on efficacy and tolerability, up to a maximum daily dose of 30 mg. For children aged 6 years and older, the recommended starting dose is 5 mg once daily, with a maximum daily dose not exceeding 20 mg. The tablets must be swallowed whole and should not be chewed, crushed, or divided.

What are the possible side effects of TROPAN XL 5 MG TABLET?

Common side effects of TROPAN XL 5 MG TABLET include dry mouth, constipation, dizziness, drowsiness, headache, and blurred vision. Other possible side effects can include confusion, stomach pain, diarrhea, and dry eyes. Extended-release formulations may be associated with a lower incidence of some side effects compared to immediate-release forms. Patients should also be aware that this medication can reduce sweating, increasing the risk of heat prostration or heat stroke, especially in hot environments.

Is TROPAN XL 5 MG TABLET safe during pregnancy or breastfeeding?

Pregnancy: TROPAN XL 5 MG TABLET should only be used during pregnancy if explicitly prescribed by a doctor, and only when the potential benefits to the mother are considered to outweigh the potential risks to the unborn baby. While animal studies have not provided conclusive evidence of harm, comprehensive safety data for human pregnancy are still being established. Breastfeeding: It is not known whether oxybutynin passes into breast milk. If the medication is used while breastfeeding, it is advisable to monitor the infant for any signs of reduced milk intake or other adverse effects. Consulting a doctor before breastfeeding is recommended.

Can TROPAN XL 5 MG TABLET be taken with other medications?

TROPAN XL 5 MG TABLET can interact with various medications. Taking it alongside other anticholinergic drugs (such as certain antidepressants, antihistamines, or Parkinson's medications) can heighten side effects like dry mouth, constipation, drowsiness, and blurred vision. Medications that inhibit the CYP3A4 enzyme system (e.g., ketoconazole, itraconazole, or macrolide antibiotics like erythromycin) may increase the levels of oxybutynin in the body, potentially leading to increased side effects. It may also reduce the effectiveness of prokinetic agents (e.g., metoclopramide). Always inform your doctor or pharmacist about all prescription, over-the-counter, and herbal medicines you are currently taking to avoid potential interactions.

What precautions should be taken while using TROPAN XL 5 MG TABLET?

Patients with certain conditions, such as glaucoma, myasthenia gravis, severe gastrointestinal narrowing or obstruction, ulcerative colitis, autonomic neuropathy, liver or kidney disease, or an enlarged prostate gland, should use this medication with caution. TROPAN XL 5 MG TABLET can cause dizziness, drowsiness, or blurred vision, so it is important to avoid driving or operating heavy machinery until you understand how it affects you. Alcohol can intensify these sedative effects, and should be avoided. Due to its effect on sweating, it is important to avoid extreme heat to prevent heat prostration or heat stroke. Monitoring for central nervous system effects, such as confusion or agitation, is also advised.

What happens if a dose of TROPAN XL 5 MG TABLET is missed?

If a dose of TROPAN XL 5 MG TABLET is missed, take it as soon as you remember. However, if it is almost time for your next scheduled dose, you should skip the missed dose and resume your regular dosing schedule. Do not take a double dose to compensate for a missed one.

How should TROPAN XL 5 MG TABLET be stored?

TROPAN XL 5 MG TABLET should be stored at room temperature, typically between 15°C and 30°C (59°F and 86°F). Keep the medication in its original closed container, protected from heat, moisture, and direct light, and ensure it is not exposed to freezing temperatures. Always keep it out of the reach of children. Any unused medication should be discarded after its expiration date.