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Country of origin : Jordan

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solifenacin

Tablets, film coated 5 mg, 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Jordan
GMP approvals
Jordan
Manufacturer #20799
It is one of the most technologically advanced manufacturing companies of high-quality drugs. It was launched in the 2010s. Professional employees and management, well-equipped technical departments up to international current Good Manufacturing Practice (cGMP), state-of-the-art manufacturing site, and a proactive, customer-oriented company on a quest to perfection. This will be the base for the mission to create value in all dimensions of health care to serve patients, medical professionals, and the communities where they operate.

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SOLIFENACIN

Solifenacin is an antimuscarinic medication. It treats overactive bladder, a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination. Solifenacin is also used to treat neurogenic detrusor overactivity, a condition in which a bladder control condition caused by a brain, spinal cord or nerve problem in children 2 years of age and older. Solifenacin is called an antimuscarinic, they work by relaxing the bladder muscles.
Solifenacin is sold under the brand name Vesicare among others. Yamanouchi Pharma America, Inc studied the compound using animal models in the early 2000s. Solifenacin was first approved for sale in the United States in 2004 with an indication to treat overactive bladder in adults older than 18 years. In May 2020, FDA to treat neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older, approved Solifenacin.

Forms and dosage:

The Usual Adult Dose recommended for treating Urinary Incontinence is an initial dose of 5 mg, orally, once daily. This is followed by a maintenance dose of 5 to 10 mg, taken orally, once a day. For treating overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, the usual adult dose starts with 5 mg, followed by a maintenance dose of 5 to 10 mg, taken orally, once daily.

The cost of Solifenacin

As of 2019, consumers in the United Kingdom paid about £27.62 for a month's supply. However, this is significantly higher in the United States, with the cost of the same supply is about US$370.

How does it work?

Its action improves the ability of the patient to control urination by relaxing the muscles in the bladder. It also reduces leaking of urine, urges to urinate urgently and reduces the frequency of trips to the washroom. To elaborate, it works as a competitive cholinergic receptor antagonist, selective for the M3 receptor subtype. When acetylcholine binds to these receptors, particularly M3, it makes contraction of smooth muscle possible. This medicine prevents the binding of acetylcholine to these receptors, thus reducing the smooth muscle tone in the bladder. The overall effects of the activity increase the bladder’s ability to retain larger volumes of urine and reducing the number of micturition, urgency and incontinence episodes.

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