Solifenacin Succiate
Generic Name: solifenacin succiate
Brand Names:
Solifenacin Succinate
11 DESCRIPTION Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder.
Overview
11 DESCRIPTION Solifenacin Succinate Tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder.
Uses
1 INDICATIONS AND USAGE Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin Succinate Tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily. ( 2.1 ) Do not exceed the 5 mg dose of Solifenacin Succinate Tablets in patients with: Severe renal impairment creatinine clearance < 30 mL/min/1.73 m 2 . ( 2.2 , 8.6 ) Moderate hepatic impairment (Child-Pugh B). Solifenacin Succinate Tablets are not recommended in patients with severe hepatic impairment (Child-Pugh C). ( 2.3 , 8.7 ) Concomitant use of strong CYP3A4 inhibitors. ( 2.4 , 7.1 ) 2.1 Dosing Information The recommended oral dose of Solifenacin Succinate Tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin Succinate Tablets should be taken with water and swallowed whole.
Side Effects
6 ADVERSE REACTIONS The most common adverse reactions (> 4% in solifenacin succinate-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AustarPharma LLC at 1-844-375-5410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS CYP3A4 Inhibitors : Do not exceed the 5 mg dose of Solifenacin Succinate Tablets with concomitant use of strong CYP3A4 inhibitors. ( 7.1 ) 7.1 Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology (12.3) ] . The dosage of Solifenacin Succinate Tablets greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration (2.4) ] .
Warnings
5 WARNINGS AND PRECAUTIONS Angioedema and Anaphylactic Reactions : Promptly discontinue Solifenacin Succinate Tablets and provide appropriate therapy. ( 5.1 ) Urinary Retention : Solifenacin Succinate Tablets are not recommended for use in patients with clinically significant bladder outlet obstruction. ( 5.2 ) Gastrointestinal Disorders : Solifenacin Succinate Tablets are not recommended for use in patients with decreased gastrointestinal motility. ( 5.3 ) Central Nervous System Effects: Somnolence has been reported with Solifenacin Succinate Tablets. Advise patients not to drive or operate heavy machinery until they know how Solifenacin Succinate Tablets affect them. 4 CONTRAINDICATIONS Solifenacin Succinate Tablets are contraindicated in patients: With urinary retention [see Warnings and Precautions (5.2) ] , With gastric retention [see Warnings and Precautions (5.3) ] , With uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5) ] , and Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in Solifenacin...
Pregnancy
8.1 Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Solifenacin Succinate Tablets are supplied as round, film-coated tablets, biconvex, available in bottles as follows: Each 5 mg tablet is yellow, debossed with ‘AP28’ on one side and plain on the other side and is available as follows: Bottle of 30 NDC 35561-285-10 Bottle of 90 NDC 35561-285-11 Bottle of 500 NDC 35561-285-13 Each 10 mg tablet is yellow, debossed...
Frequently Asked Questions
What is Solifenacin Succiate used for?▼
1 INDICATIONS AND USAGE Solifenacin Succinate Tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin Succinate Tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.( 1 )
What are the side effects of Solifenacin Succiate?▼
6 ADVERSE REACTIONS The most common adverse reactions (> 4% in solifenacin succinate-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AustarPharma LLC at 1-844-375-5410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Solifenacin Succiate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day.
What are the important warnings for Solifenacin Succiate?▼
5 WARNINGS AND PRECAUTIONS Angioedema and Anaphylactic Reactions : Promptly discontinue Solifenacin Succinate Tablets and provide appropriate therapy. ( 5.1 ) Urinary Retention : Solifenacin Succinate Tablets are not recommended for use in patients with clinically significant bladder outlet obstruction. ( 5.2 ) Gastrointestinal Disorders : Solifenacin Succinate Tablets are not recommended for use in patients with decreased gastrointestinal motility. ( 5.3 ) Central Nervous System Effects: Somnolence has been reported with Solifenacin Succinate Tablets. Advise patients not to drive or operate heavy machinery until they know how Solifenacin Succinate Tablets affect them. 4 CONTRAINDICATIONS Solifenacin Succinate Tablets are contraindicated in patients: With urinary retention [see Warnings and Precautions (5.2) ] , With gastric retention [see Warnings and Precautions (5.3) ] , With uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5) ] , and Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in Solifenacin...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.