Roliten OD Capsules (Generic Tolterodine Tartrate Capsules)

1. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) © Clearsky Pharmacy ( www.clearskypharmacy.biz )

2. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Roliten OD (Generic Tolterodine Tartrate Capsules) is an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. This medication is used to treat an overactive bladder. By relaxing the muscles in the bladder, Tolterodine improves your ability to control your urination. It helps to reduce leaking of urine, feelings of needing to urinate right away, and frequent trips to the bathroom. This medication belongs to the class of drugs known as antispasmodics. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

3. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Active Ingredient The active ingredient present in Roliten OD capsules is Tolterodine Tartrate. Each Roliten OD capsule contains 2 mg or 4 mg of Tolterodine Tartrate (as extended-release pellets). © Clearsky Pharmacy ( www.clearskypharmacy.biz )

4. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Chemical Structure The structure of Tolterodine Tartrate is given below: © Clearsky Pharmacy ( www.clearskypharmacy.biz )

5. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Roliten OD Capsules are manufactured by Sun Pharmaceutical Industries Limited, India in the strengths of of 2 mg and 4 mg. ( Website: Website: https://sunpharma.com/ https://sunpharma.com/ ) URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

6. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Tolterodine Tartrate Capsules – Brand Names Tolterodine Tartrate Capsules are available under various drug trade names that include Detrol LA, Blerone XL, Neditol XL, Terol, Terol- LA, Urolax, Cgtol, Torq SR, Tolu, Tolter, Detrusitol, Uridin, Roliflo OD, Roliten, Urotel and Urotel-XL. © Clearsky Pharmacy ( www.clearskypharmacy.biz )

7. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Uses of Roliten OD Capsules Roliten OD Capsules (Tolterodine Tartrate Capsules) is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate. Tolterodine belongs to the group of medicines called antispasmodics. It helps decrease muscle spasms of the bladder and the frequent urge to urinate caused by these spasms. The symptoms of urinary frequency and urgency may improve with drug treatment. Tolterodine is a competitive antagonist at muscarinic receptors. This action reduces bladder contraction. Improvements in urodynamic function can be detected after two weeks of treatment. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

8. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Roliten OD Capsules Dosage The dosage of Roliten OD capsules Roliten OD capsules (Tolterodine Tartrate capsules) is given below: The recommended dose of Roliten OD Capsules is 4 mg once daily with water and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for Roliten OD 2 mg. For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) or severe renal impairment (CCr 10-30 mL/min), the recommended dose of Roliten OD is 2 mg once daily. Roliten OD is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Patients with CCr<10 mL/min have not been studied and use of Roliten OD in this population is not recommended. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

9. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Contraindications Roliten OD Capsules are contraindicated in persons with a hypersensitivity (allergy) to Tolterodine Tartrate or any of the other ingredients of this medicine. This medicine is also contraindicated in patients with a hypersensitivity to Fesoterodine Fumarate extended-release tablets which, like Roliten OD, are metabolized to 5- Hydroxymethyl Tolterodine. Roliten OD Capsules are contraindicated in patients with urinary retention, gastric retention, Myasthenia gravis, Severe ulcerative colitis, Toxic megacolon or uncontrolled narrow- angle glaucoma. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

10. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Storage Instructions Roliten OD capsules (Tolterodine Tartrate capsules) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

11. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Warnings Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of Generic Tolterodine. Urinary Retention: use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. Gastrointestinal Disorders: use caution in patients with gastrointestinal obstructive disorders or decreased gastrointestinal motility because of the risk of gastric retention. Controlled Narrow-Angle Glaucoma: use caution in patients being treated for narrow-angle glaucoma. Central Nervous System Effects: Somnolence has been reported with Roliten OD. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

12. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Warnings Central Nervous System Effects: Patients must be advised not to drive or operate heavy machinery until they know how Generic Tolterodine (Roliten OD Capsules) affects them. Patients must not drive, use machinery, or do anything that needs alertness or clear vision until they are sure that they can do it safely. Limit alcoholic beverages. Myasthenia Gravis: use caution in patients with myasthenia gravis. QT Prolongation: consider observations from the thorough QT study in clinical decisions to prescribe Roliten OD to patients with a known history of QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

13. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Side Effects The most common Side effects reported by patients receiving Tolterodine extended-release capsules (Roliten OD capsules) during clinical trials were dry mouth, headache, constipation and abdominal pain. Dry mouth was the most frequently reported adverse event for patients treated with Tolterodine extended-release, occurring in 23.4% of patients treated with Tolterodine extended release as against 7.7% of placebo- treated patients. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention and dry eyes are expected side effects of antimuscarinic agents. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

14. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Side Effects The following events have been reported in association with Tolterodine use in worldwide postmarketing experience: General: Anaphylaxis and angioedema Cardiovascular: Tachycardia, palpitations, peripheral oedema Gastrointestinal: Diarrhoea 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. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

15. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Overdose Overdosage with Roliten OD capsules can potentially result in severe central anticholinergic effects and should be treated accordingly. Electrocardiographic (ECG) monitoring is recommended in the event of overdosage. 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 twice a day); higher doses were not evaluated. A 27-month-old child who ingested 5 to 7 Tolterodine Tartrate immediate-release 2 mg tablets was treated with a suspension of activated charcoal and was hospitalized overnight with symptoms of dry mouth. The child fully recovered. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

16. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Roliten OD Capsules During Pregnancy Tolterodine Tartrate Capsules (Roliten OD capsules) is classified by the US FDA as Pregnancy Category C. In animal reproduction studies, oral administration of Tolterodine and its 5-HMT metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20 mg/kg/day; however, higher doses produced adverse developmental outcomes. At 14 to 18 times the clinical exposure (doses of 30 to 40 mg/kg/day) in mice, Tolterodine has been shown to be embryolethal and reduce fetal weight, and increase the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra-abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification). URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

17. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) Roliten OD Capsules During Breastfeeding It is not known whether Tolterodine (Roliten OD capsules) is excreted in human milk. A decision should be made to discontinue breastfeeding or discontinue Roliten OD capsules, taking into account the importance of the drug to the mother. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )

18. Roliten OD Capsules (Generic Tolterodine Tartrate Capsules) For more details on Roliten OD capsules click here Roliten OD capsules click here Roliten OD (Tolterodine Tartrate Capsules) by Sun Pharmaceutical Industries Limited, India. URL: URL: https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html https://www.clearskypharmacy.biz/tolterodine-tartrate-capsules.html © Clearsky Pharmacy ( www.clearskypharmacy.biz )