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Sunday, August 1, 2010

US FDA Approves glycopyrrolate oral solution brand name Cuvposa for Chronic Drooling in Children

US FDA Approves glycopyrrolate oral solution brand name Cuvposa for Chronic Drooling in Children
The United states FDA has approved approved glycopyrrolate oral solution brand name Cuvposa for treatment of chronic and severe drooling in children’s of age three to sixteen years.
Drooling is a condition where children's are not able to control saliva in mouth , as a result it flows out of mouth .
This is due to in ability to required frequency of swallowing , or it may be because of lac of sensory mechanism which is responsible of making a child aware of presence of saliva in mouth , which could lead to swallowing of excess saliva.drooling is normal in infants as the nervous system is under development
Drooling may occurs in children’s which suffers from neuromuscular dysfunction that is responsible for inability to swallow properly.
Glycopyrrolate oral solution Cuvposa reduces drooling by lowering the secretion and thus volume of saliva produced. Glycopyrrolate oral solution Cuvposa is approved for children's of age group 3 to 16 years ,

Mode of action of Glycopyrrolate:
Glycopyrrolate is a quaternary amine , inhibits acetylcholine a neurotransmitter in parasympathetic nervous system .It blocks action of acetylcholine on Muscarinic acetylcholine receptor, which result in decrease in salivary secretion.

Other Medical uses of Glycopyrrolate:
Glycopyrrolate is also used for treating patients with peptic ulcers and to reduce saliva production and to reduce tracheobronchial, and pharyngeal secretions in patients under going anesthesia.
Glycopyrrolate is used along with neostigmine to counter act bradycardia induced by neostigmine.
(It as a drug interaction which is made use as an advantage)
(bradycardia a condition where cardiac muscles are not able to contract with the required force and frequency to meet body’s demand which results may in congestive cardiac failure due to load on heart,)
US FDA said in their press release that “until now, glycopyrrolate was being used by physicians as off-label basis for treating drooling in children’s suffering from neurological development, but in a different dosage form than the approved product”.
US FDA approved this drug so as to ensure that the children’s suffering from drooling get a product in a more suitable dose form which complies with modern good manufacturing practices requirements and standards for safety, effectiveness, quality and labeling; results for this patient population.
The US FDA is world most efficient and best regulatory authority which takes care while approving a drug , after they are satisfied that the product applied meets standards for safety, effectiveness, quality and labeling and a process that provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product a drug product must standards of expected identity, strength, quality, and purity and safety and efficacy .
Information about clinical trail result for Cuvposa glycopyrrolate oral solution,
In 78 % of the children on the drug reached clinical improvement in drooling compared with 19 percent of those given placebo .
Common adverse reactions reported with glycopyrrolate are dry mouth, constipation, flushing, and urinary retention.
Cuvposa (glycopyrrolate) Oral Solution is marketed by Shionogi Pharma Inc. of Osaka, Japan.a pharmaceutical manufacturing company from Japan
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