UNASYN

This brand name is authorized in Nigeria. It is also authorized in Austria, Cyprus, Ecuador, Estonia, Hong Kong SAR China, Japan, Lithuania, Poland, Romania, Singapore, United States.

Active ingredients

The drug UNASYN contains one active pharmaceutical ingredient (API):

1	Sultamicillin UNII 2M66QX49ZZ - SULTAMICILLIN TOSYLATE DIHYDRATE
	Sultamicillin is the tosylate salt of the double ester of sulbactam plus ampicillin. Sulbactam is a semisynthetic beta-lactamase inhibitor which, in combination with ampicillin, extends the antibacterial activity of the latter to include some beta-lactamase-producing strains of bacteria that would otherwise be resistant.
	Read more about Sultamicillin

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
04-0554	Powder for injection	Unasyn Powder for Injection INJ_PWD 1.5 g 1.5 g x 1's (in glass vial)	Ampicillin sodium/Sulbactam sodium parenteral combination is available as a white to off-white dry powder for reconstitution in clear, colourless glass vial. UNASYN dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same.	20/12/2019

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
UNASYN Powder for solution for injection	MPI, US: SPL/Old	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
J01CR04	Sultamicillin	J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01C Beta-lactam antibacterials, penicillins → J01CR Combinations of penicillins, incl. beta-lactamase inhibitors
Discover more medicines within J01CR04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	29567-01-11, 360490612, 360870612
EE	Ravimiamet	1018482, 1018493, 1018886, 1018897, 1814161, 1827660, 1828021, 1848449
HK	Department of Health Drug Office	29807
JP	医薬品医療機器総合機構	6131008C1033, 6131008F1030
LT	Valstybinė vaistų kontrolės tarnyba	1003199, 1003200, 1003987, 1060295
NG	Registered Drug Product Database	04-0554
PL	Rejestru Produktów Leczniczych	100068940
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65045001, W65046001
SG	Health Sciences Authority	01948P, 01949P, 01950P, 04892P, 06985P
US	FDA, National Drug Code	0049-0013, 0049-0014, 0049-0024