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otilonium bromide + simethicone Tablets, film coated 40 mg + 80 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
PICS
Manufacturer #2371

This company is a pharmaceutical manufacturer with a long history dating back to 1939. It produces a range of prescription medications, over-the-counter drugs, and medical devices. Key therapy areas include cardiovascular diseases, infectious diseases (particularly upper respiratory infections), liver disease, and digestive disorders. The company has manufacturing facilities in Turkey and exports its products internationally. They emphasize research and development, particularly in the synthesis of active pharmaceutical ingredients and botanical extracts for use in their formulations. The company is also involved in sterile production processes.

OTILONIUM BROMIDE

Otilonium bromide is a calcium channel blocker and an antimuscarinic medication. it is prescribed to relieve spasmodic pain of the gut, especially for those suffering from irritable bowel syndrome. Otilonium bromide belong to a class of synthetic anticholinergics called the quaternary ammonium compounds which are primarily used in the treatment of functional bowel disorders, as it exerts an intense antispasmodic action on the digestive tract’s smooth muscles. It is always sold in combination with SIMETHICONE and its actions have not yet been full elucidated. Otilonium bromide is sold under the brand name Spasmoctyl 40, Doralin among others. Menarini Sas developed and filed for patent in Italy for using it for topical application in the gastro-intestinal tract and related appropriate uses in 1986. Santa Farma Ilac Sanayi AS is the current patent assignee for Oral compositions combining simethicone with bulk density and with improved characteristics for dissolution. This medicine is not approved for sale in the USA.

DOSAGE AND ADMINISTRATION

Otilonium bromide is sold in Europe and the rest of the world as tablets commonly I 40mg prescription strength. It has to be take on an empty stomach, precisely as suggested by the doctor. The patient must take care not to take antacids within two hours of taking Otilonium Bromide and the course should continue until the doctor feesl the needs. The usual recommended dose for adults is 120 mg daily, maximum. If a dose is missed, it should be taken at the earliest but not too close to the next dose or two doses combined for make up for the lost dose.

The price of Otilonium bromide

In India, each 40 mg tablets of Otilonium bromide cost around USD 0.20, taking the cost of a monthly supply to USD 15. In the European market, the cost of 10 tablets of 40mg is around USD 19 for a branded version of Otilonium bromide and USD 1.56 for a generic version of the tablet.

How does it work?

Otilonium bromide actions block Ca2+ entry through L-type Ca2+ channels. It interferes with intracytoplasmatic Ca2+ mobilization necessary for SMC contraction. The result is the prevention of excessive bowel contractions and abdominal cramps. It also blocks T-type Ca2+ channels while interfering with the muscarinic responses. It also interacts with the tachykinin receptors on SMC and primary afferent neurons. The combined effect results in the reduction of motility and abdominal pain.

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