UROCALM 5: Each Film-Coated Tablet Contains: Solifenacin Succinate BP 5 mg.
UROCALM 10: Each Film-Coated Tablet Contains: Solifenacin Succinate BP 10 mg.
Pharmacology: Mechanism of Action: Solifenacin is a competitive, specific cholinergic-receptor antagonist.
Muscarinic receptors (M3) play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion. Solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine and reducing the number of incontinence episodes.
Other special populations: Elderly: No dosage adjustment based on patient age is required.
Paediatric: The pharmacokinetics of solifenacin has not been established in Paediatric children and adolescents.
Gender: The pharmacokinetics of solifenacin are not influenced by gender.
Race: The pharmacokinetics of solifenacin are not influenced by race.
Renal impairment: The AUC and Cmax of solifenacin in mild and moderate renally impaired patients, was not significantly different from that found in healthy volunteers.
Pharmacokinetics in patients undergoing haemodialysis have not been studied.
Hepatic impairment: In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) the Cmax is not affected, AUC increased with 60% and t½ doubled. Pharmacokinetics of solifenacin in patients with severe hepatic impairment have not been studied.
UROCALM is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of unintentional loss of urine (urinary incontinence) urgency, and urinary frequency.
Adults, including the elderly: The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily.
Do not exceed 5 mg tablet once daily in patients with: Severe Renal Impairment [Creatinine Clearance] (Clcr < 30 mL/min).
Moderate Hepatic Impairment (Child-Pugh B).
Concomitant Use Of Potent CYP3A4 Inhibitors.
Use of UROCALM is not recommended in patients with severe hepatic impairment (Child-Pugh C).
Method of administration: Solifenacin succinate should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.
Overdosage: Overdosage with solifenacin succinate can potentially result in severe anticholinergic effects.
Treatment: In the event of overdose with solifenacin succinate the patient should consult healthcare.
Solifenacin is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma in patients who have demonstrated hypersensitivity to the drug.
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Solifenacin should be used with caution in patients with: Angioedema and anaphylactic reactions: Reports of angioedema of the face, lips and/or larynx, in some cases occurring after the first dose, have been described. Anaphylactic reactions have been reported rarely.
Urinary Retention: Administer with caution to patients with clinically significant bladder outflow obstruction.
Gastrointestinal Disorders: Use with caution in patients with decreased gastrointestinal motility.
Central Nervous System Effects: Advise patients not to drive or operate heavy machinery until they know how UROCALM affects them.
Controlled Narrow-Angle Glaucoma: Use with caution in patients being treated for narrow-angle glaucoma.
QT Prolongation: Use with caution in patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval.
Dose should not exceed 5mg for the patients with severe renal impairment (creatinine clearance ≤ 30 mL/min) moderate hepatic impairment (Child-Pugh score of 7 to 9).
Autonomic neuropathy.
Pregnancy: Category C.
The potential risk for humans is unknown. Caution should be exercised when prescribing to pregnant women.
Lactation: The use of Solifenacin should be avoided during breast-feeding.
Blurred vision, Dry mouth, constipation, Nausea, Dyspepsia and Abdominal pain, Urinary tract infection, Cystitis, Somnolence, Dysgeusia, Dizziness, Headache, Dry eyes, Nasal dryness, Gastroesophageal reflux diseases, Dry throat, Colonic obstruction, Faecal impaction, Vomiting, Dry skin, Pruritus, Rash, Difficulty in micturition, Urinary retention, Fatigue, Peripheral oedema. This is not a complete list of ADR and others may occur.
Drug Interactions: Inhibitors of CYP3A4 may increase the concentration of UROCALM.
Inducers of CYP3A4 may decrease the concentration of UROCALM.
Drugs Metabolized by Cytochrome P450: At therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes.
Pharmacological interactions: The therapeutic effect of Solifenacin may be reduced by concomitant administration of cholinergic receptor agonists.
An interval of approximately one week should be allowed after stopping treatment with Solifenacin, before commencing other anticholinergic therapy.
Solifenacin can reduce the effect of medicinal products that stimulate the motility of the gastro-intestinal tract, such as metoclopramide and cisapride.
Effect of other medicinal products on the pharmacokinetics of solifenacin: Solifenacin is metabolised by CYP3A4. Simultaneous administration of ketoconazole (200 mg/day), a potent CYP3A4 inhibitors resulted in two fold increase of the AUC of Solifenacin. Therefore, the maximum dose of Solifenacin should be restricted to 5 mg, when used simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole).
Simultaneous treatment of solifenacin and a potent CYP3A4 inhibitor is contra−indicated in patients with severe renal impairment or moderate hepatic impairment.
Effect of solifenacin on the pharmacokinetics of other medicinal products: Oral Contraceptives: Intake of Solifenacin showed no pharmacokinetic interaction of solifenacin on combined oral contraceptives (ethinylestradiol/levonorgestrel).
Warfarin: Intake of Solifenacin did not alter the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time.
Digoxin: Intake of Solifenacin showed no effect on the pharmacokinetics of digoxin.
Store below 30°C. Protect from light and moisture.
G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.
FC tab 5 mg (yellow coloured, circular, biconvex, plain on both sides) x 10 x 10's. 10 mg (pink coloured, circular, biconvex, plain on both sides) x 10 x 10's.
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