Description
Trade name:
Sofenacin
Compound:
Each tablet contains:
Solifenacin succinate 5 mg, equivalent to 3.8 mg solifenacin.
Auxiliary components:
Lactose monohydrate, corn starch, HPMC E5, BHA, magnesium stearate, opadryl AMB yellow.
Properties:
Antispasmodic. Solifenacin is a specific competitive inhibitor of m-cholinergic receptors, primarily the M3 subtype. Solifenacin has also been shown to have low or no affinity for various other receptors and ion channels.
The effectiveness of solifenacin when used in doses of 5 mg and 10 mg in overactive bladder syndrome is observed already during the first week of treatment and stabilizes over the next 12 weeks of treatment. The maximum effect can be observed after 4 weeks. The effectiveness is maintained during long-term use (at least 12 months).
Indications:
Treatment of urgent (imperative) urinary incontinence, frequent urination and urgent (imperative) urge to urinate, typical for patients with overactive bladder syndrome.
Method of administration and dosage:
Taken orally.
Adults over 18 years of age, including elderly patients – 5 mg once a day. If necessary, the dose can be increased to 10 mg once a day.
Contraindications:
Urinary retention; severe gastrointestinal disease (including toxic megacolon); myasthenia gravis; angle-closure glaucoma; severe liver failure; severe renal failure or moderate liver failure with concomitant treatment with CYP3A4 inhibitors (eg, ketoconazole); hemodialysis; childhood; hypersensitivity to solifenacin.
Precautions:
With caution: clinically significant bladder outlet obstruction with risk of urinary retention; pregnancy and lactation; gastrointestinal obstructive diseases (including food stagnation in the stomach); risk of decreased gastrointestinal motility; severe renal insufficiency (CC <30 ml / min), moderate hepatic insufficiency (7-9 points on the Child-Pugh scale) insufficiency (doses for these patients should not exceed 5 mg); concomitant use of strong inhibitors of the CYP3A4 isoenzyme, such as ketoconazole; esophageal hernia, gastroesophageal reflux, concomitant use with drugs (eg, bisphosphonates) that can cause or worsen esophagitis; peripheral neuropathy; with risk factors such as long QT syndrome and hypokalemia (prolongation of the QT interval and torsades de pointes have been observed).
Before initiating treatment with solifenacin, it should be established whether there are other causes of urinary dysfunction (heart failure or kidney disease). If a urinary tract infection is detected, appropriate antimicrobial treatment should be initiated.
Side effects:
From the digestive system: often – constipation, nausea, dyspepsia, abdominal pain; uncommon – gastroesophageal reflux disease, dry throat; rare – intestinal obstruction, coprostasis; very rare – vomiting, decreased appetite.
From the urinary system: uncommon – urinary tract infections, difficulty urinating; rare – urinary retention; very rare – renal failure.
From the central nervous system: uncommon – drowsiness, dysgeusia (taste disturbance); very rare – dizziness, headache.
From the organ of vision: often – blurred vision (accommodation disorder); uncommon – dry eyes.
From the respiratory system: uncommon – dry nasal cavity.
From the skin and subcutaneous tissue: uncommon – dry skin; very rare – erythema multiforme, itching, rash, urticaria, angioedema, exfoliative dermatitis.
Others: uncommon – fatigue, swelling of the lower extremities; prolongation of the QT interval and heart rhythm disturbances of the “pirouette” type, liver dysfunction with increased activity of ALT, AST, GGT, cases of hyperkalemia, allergic reactions cannot be excluded.
Storage method:
Store at a temperature not exceeding 30 degrees in a dry place.
Package:
The cardboard pack contains 3 blisters of 10 tablets and paper instructions.
