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Sultamicillin

Drug Nomenclature

International Nonproprietary Names (INNs) in main languages (French, Latin, Russian, and Spanish):

Synonyms: CP-49952; Sultamicilin; Sultamicilina; Sultamicillin; Sultamicillinum; Sultamisilliini
BAN: Sultamicillin
USAN: Sultamicillin
INN: Sultamicillin [rINN (en)]
INN: Sultamicilina [rINN (es)]
INN: Sultamicilline [rINN (fr)]
INN: Sultamicillinum [rINN (la)]
INN: Сультамициллин [rINN (ru)]
Chemical name: Penicillanoyloxymethyl (6R)-6-(d-2-phenylglycylamino)penicillanate S´,S´-dioxide
Molecular formula: C25H30N4O9S2 =594.7
CAS: 76497-13-7
ATC code: J01CR04

Sultamicillin

Pharmacopoeias

In Europe

European Pharmacopoeia, 6th ed., 2008 and Supplements 6.1 and 6.2 (Sultamicillin). A semi-synthetic product derived from a fermentation product. A white or almost white, slightly hygroscopic, crystalline powder. Practically insoluble in water and in alcohol; very slightly soluble in methyl alcohol. Store in airtight containers.

Sultamicillin Tosilate

Drug Nomenclature INNs in main languages (French, Latin, Russian, and Spanish):

Synonyms: Sultamicilin-tosylát; Sultamicilina, tosilato de; Sultamicillin Tosylate; Sultamicillini Tosilas; Sultamicillintosilat; Sultamisilliinitosilaatti
BAN: Sultamicillin Tosilate [BANM]
INN: Sultamicillin Tosilate [rINNM (en)]
INN: Tosilato de sultamicilina [rINNM (es)]
INN: Sultamicilline, Tosilate de [rINNM (fr)]
INN: Sultamicillini Tosilas [rINNM (la)]
INN: Сультамициллина Тосилат [rINNM (ru)]
Chemical name: Sultamicillin toluene-4-sulphonate
Molecular formula: C25H30N4O9S2,C7H8O3S =766.9
CAS: 83105-70-8

Pharmacopoeias

In China Europe and Japan include the dihydrate.

European Pharmacopoeia, 6th ed., 2008 and Supplements 6.1 and 6.2 (Sultamicillin Tosilate Dihydrate; Sultamicillini Tosilas Dihydricus). A white or almost white, crystalline powder. Practically insoluble in water; sparingly soluble in alcohol. Store in airtight containers. Profile Sultamicillin is a prodrug of ampicillin and of the beta-lactamase inhibitor sulbactam; it consists of the two compounds linked as a double ester. During absorption from the gastrointestinal tract it is hydrolysed, releasing equimolar quantities of ampicillin and sulbactam. Sultamicillin is given orally as tablets containing sultamicillin tosilate or as oral suspension containing sultamicillin. It is used in the treatment of infections where beta-lactamase-producing organisms might occur, including uncomplicated gonorrhoea, otitis media, and respiratory-tract and urinary-tract infections. The usual dose is 375 to 750 mg of sultamicillin (equivalent to 147 to 294 mg of sulbactam and 220 to 440 mg of ampicillin) twice daily. A single dose of sultamicillin 2.25 g with probenecid 1 g may be used for uncomplicated gonorrhoea. When parenteral therapy is necessary a combined preparation of ampicillin with sulbactam is given.

Single-ingredient Preparations

Argentina: Ampigen SB; Unasyna; Unsayna; Austria: Dynapen; Unasyn; Unasyn; Brazil: Unasyn; Chile: Unasyna; France: Unacim; Germany: Unacid PD; Greece: Begalin; Hong Kong: Unasyn; Hungary: Unasyn; India: Sulbacin; Italy: Bethacil; Unasyn; Unasyn; Malaysia: Unasyn; Mexico: Pentrexyl-S12-H; Unasyna; Singapore: Unasyn; Spain: Bacimex; Unasyn; Switzerland: Unacide; Thailand: Combicid; Unasyn; United Kingdom: Unasyn; Venezuela: Fipexiam; Sinif; Sulamp; Sultamicina; Sultamilan; Unasyn

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