SOLITEN
Manufacturer Details
SUN PHARMA
Compositions:
Solifenacin 5mg/10mg tablets,
|
Strength
|
Rate
|
Packing Style
|
|
5mg
|
260.00
|
10s tablets
|
|
10mg
|
370.00
|
10s tablets
|
List of Related Indications:
- Frequency
- Incontinence
- Urgency
List Of Drugs:
- Solifenacin @ Urinary anti-spasmodics-(July 2006)
Indication Type Description:
Drug Interaction:
Inducers or inhibitors of CYP3A4 may alter solifenacin pharmacokinetics
Recommended not to exceed 5mg daily dose when administered with therapeutic dose of ketoconazole or ther CYP4A4 inhibitors
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 75
Name of the Drug- Solifenacin Succinate Tablet (5mg/10mg) Pharmacological Classification- For Overactive Bladder with urge urinary
incontience urgency & urinary frequency
Date of Approval- 06-07-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Solifenacin succinate tablet 5mg/10mg 06-07-2006
For overactive Bladder with urge, urinary frequency, urinary
incontinence urgency
Treatment of overactive bladder with symptoms of urinary incontinence , urgency and frequency
Adverse Reaction:
ADVERSE REACTIONS-
CNS - Dizziness 2%
GI - Abdoninal pain 1 % Constipation 3 % Dry mouth 4 %
Dyspepsia 1 % Nausea 2 % Vomiting 1 %
GU Urinary retention 1% Urinary tract infn 3 % Psychiatric depn 1%
RESPIRATORY - Cough rare
SPECIAL SENSES - Dry eyes 1% Vision blurred 2%
Contra-Indications:
Urinary or gastric retention,
Uncontrolled narrow-angle glaucoma in patients who are at risk these conditions
Special precautions-
Bladder outflow obstruction- caution patients with clinically significant bladder outflow obstruction
GI obstructive disorders and decreased GI motility - administer with caution to patients with GI obstructive disorders because of risk of gastric retention
Controlled narrow angle glaucoma - use with caution.Solifenacin is contraindicated for use in these conditions
Patients with congenital or acquired QT prolongation- solifenacin is known to prolong QT interval. Observe caution.
Renal function impairment- use with caution
Hepatic function impairment- observe cautioni
Pregnancy-
Administer during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
Lactation-
Use caution before administering to breast feeding women
Children-
Safety and efficacy not established in children
Dosages/ Overdosage Etc:
Indications-
Treatment of overactive bladder with symptoms of urinary incontinence , urgency and frequency
Dosage-
5mg once daily is well tolerated. Dose may be increased to 10mg once daily
Patient Information:
Take with liquids .
Administer with or without food
Contact physician if you experience sever abdominal pain, or become constipated for 3 or days.
Can cause blurred vision. Observe caution before undertaking hazardous tasks.
Heat prostration ( caused by decreased sweating ) can occur , especially when used in hot weather. Observe caution
Interaction with Food:
Administer with or without food
Pregnancy and lactation:
Pregnancy-
Administer during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.
Lactation-
Use caution before administering to breast feeding women
Children-
Safety and efficacy not established in children
