hyoscine butylbromide Tablets, film coated 10 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Uruguay
GMP approvals
WHO
Manufacturer #18930
With a history of more than 80 years, they occupy an outstanding place in the market, being one of the main manufacturers of liquid injectables, deferred vehicle powder injectables, and tablets. They have a product line of more than 160 products.

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Hyoscine butylbromide

Hyoscine butylbromide, also called scopolamine butylbromide is a medication used in the treatment of Crampy abdominal pain, bladder & esophageal spasms & renal colic. It especially eases the bloating and the spasm-type pain associated with irritable bowel syndrome and diverticular disease. Its actions relax muscles in gastrointestinal and urinary systems. Hyoscine butylbromide also improves respiratory secretions at the end of life. It is also effective in decreasing the duration of the first stage of labor, while not being associated with any obvious adverse outcomes in mother or newborn. HB improves the quality of pictures during abdominal or pelvic MRI or CT. It can also help bladder cramps and period pain. Its medicine form is manufactured from Hyoscine, which occurs naturally in the plant deadly nightshade. Hyoscine butylbromide is sold under the brand name Buscopan among others. Hyoscine butylbromide has not received approved for sales in the United States, but a similar compound, Methscopolamine is used instead. In Europe, the Manufacturer and Licence Holder is Istituto De Angeli S.r.I, Loc. Prulli in Italy and procured from within the EU. The Licence Holder is LTT Pharma Limited from the UK. Forms and Dosage Hyoscine butylbromide is taken orally or given as an injection into a muscle, or into a vein, as a 20 mg in 1 ml ampoule for Intra Muscular or slow Intra Venous injection. In the treatment of MR enterography, the standard prescribed dose is 0.3 mg/kg IV with a maximum dose capped at 20 mg. in the treatment of Acute spasms, the oral medicine for children in the age group of 6-12 yrs old is 10 mg/dose and for 12-18 yrs old: 20 mg/dose. As an injection for either the muscle or nerves, the recommended dosage for children age 2-6 yrs old is 5 mg per dose with max capped at 15 mg per day. For children aged 6-12 years old it is 5-10 mg per dose with max capped at 30 mg per day and for teenagers, in the age group of 12-18 yrs old, the prescribed dose is 20 mg per dose, with max capped at 80 mg/day. For Adults, the standard recommended dose is 10-20 mg per dose up to 3-5 times a day with the maximum capped at 100 mg per day.

The cost of Hyoscine butylbromide

In the developing countries in India, a 2 weeks supply of tablet costs the consumer as low as USD2.3, whereas the injection cost USD1.5. in Australia, 5 ampoules of 20 mg injections cost AUD23.

How does Hyoscine butylbromide work?

Hyoscine butylbromide quaternary ammonium compound as well as a semisynthetic derivative of Scopolamine. As an Antimuscarinic, it binds to muscarinic acetylcholine receptors, blocking their effect. The attachment of the butyl-bromide moiety minimizes undesirable central nervous system side effects associated with scopolamine/Hyoscine, thereby effectively preventing the movement of this drug across the blood-brain barrier. It decreases the stimulation in smooth muscle contractions and the production of respiratory secretions.

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