dicycloverine Tablets 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Philippines
GMP approvals
Philippines
Manufacturer #21232
This pharmaceutical company specializes in manufacturing both generic and branded pharmaceuticals, boasting a 30-year track record of quality production. Their state-of-the-art facilities are strategically located within an industrial zone in Southeast Asia, allowing them to produce a wide range of products across various therapy areas, including prescription medications, over-the-counter drugs, and potentially medical devices or supplements (information on these is limited). While specific product patents and GMP certifications aren't mentioned, their commitment to quality manufacturing is evident. They operate primarily in Southeast Asia, with potential expansion into other regions like North America and the EU based on industry trends.

DICYCLOVERINE

Dicycloverine, also called Dicyclomine, is used to treat spasms in the intestines, that occur in irritable bowel syndrome more specifically hypermotility in adults. In 2016, dicycloverine and other antispasmodics were recommended in the treatment of IBS with diarrhea as a first-line treatment and sometimes for Baby colic but the evidence of efficacy for these two uses is still small and to be verified. Dicycloverine is sold under the brand names Colicon and Cyclopean among others. William S. Merrell Company first synthesized it chemically in the United States in 1945. Dicycloverine was approved by FDA for sales in the United States by 1950..however, since the expiry of its initial patent protection, is made and sold by several companies as a generic medication. With more than 3 million prescriptions in the USA alone, it is one of the most commonly prescribed drugs in the USA.

Dosage and Administration

Dicycloverine is available as a tablet and a syrup and administered orally. For adults, the usual recommended dose is one to two 5ml spoonfuls equal to 10-20mg, taken three times daily before or after meals. For kids Children in the 2-12 year age group, the dose is One 5mlspoonful equal to 10mg, three times daily. For Children between 6 months - 2 years of age the dose is 5-10mg, taken three or four times daily, 15 minutes before feeds, with a daily dose capped at 40mg. this medicine should not be given to children under 6 months. When taking the oral route, the medicine has to be diluted using syrup or use with water.

The Price of Dicycloverine

In the USA, the consumer has to pay an average retail price of $53.17 for a supply of 90 tablets of 20mg, made by a generic drug maker. In the United Kingdom, a supply of 100 tablets of 10mg costs around £215.14.

How does it work?

Dicyclomine acts rapidly, it does this partially by a direct antimuscarinic activity of the M1 and M2 receptors, and antagonism of bradykinin and histamine. Dicyclomine actions inhibit actions of bradykinin and histamine, non-competitively. This results in direct action on the smooth muscle. It also decreases the strength of contractions in spasms of the ileum.

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