This brand name is authorized in Nigeria.
The drug SIVOOFLOXACIN contains one active pharmaceutical ingredient (API):
1
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UNII
A4P49JAZ9H - OFLOXACIN
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Ofloxacin is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both Gram-negative and Gram-positive organisms. The primary mode of action of the quinolones is the specific inhibition of bacterial DNA gyrase. This enzyme is required for DNA replication, transcription, repair and recombination. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-0688 | Tablet | Sivoromycin 500 mg Tablets TAB 500 mg 3 x 10's (in Alu-Alu blisters) | Tablet Yellow, caplet shaped, film coated tablets having a break line on one side of the tablets. Note: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. SIVOROMYCIN 500mg TABLETS AZITHROMYCIN USP 500MG AZITHROMYCIN--500mg Maize Starch--120mg Dibasic Calcium Phosphate--80mg Microcrystalline Cellulose (Plain)--40mg Ethyl Cellulose (20 CPS)--14mg Colloidal Silicon Dioxide ( Light)--20mg Croscarmellose Sodium--14mg Magnesium Stearate--20mg Purified Talc--12mg HyLake of Tartrazine-1mg promellose--7mg Purified Talc--1mg Isopropyl Alcohol-1mg B4-0688 Drugs Imported Products 3x10 Prescription Only Medicine (POM) 13/06/2019 ADPHARM PHARMACETICAL INDUSTRIES LIMITED, NO. 60, AJAO ROAD, SURULERE, LAGOS STATE, NIGERIA. 9082437677 adpharmaltd@yahoo.com GLOBELA PHARM PVT LTD, 357 GIDC Sachin Surat Gujarat State, India | 26/04/2023 |
| B4-1792 | Tablet | Sivoofloxacin 400 mg Tablets TAB 400 mg 1 x 10's (in PVC-Alu blister) | Tablet A white colored, caplet shaped, film coated tablet having a break line on one side and the other side plain SIVOOFLOXACIN 400MG TABLETS OFLOXACIN USP 400MG OFLOXACIN--400MG Dibasic Calcium Phosphate--40MG • Maize Starch--81.890MG • Gelatine--2.0MG • Methyl paraben--0.100MG • Propyl paraben--0.010MG • Colloidal Anhydrous silica--6.0MG • Magnesium Stearate--8.0MG • Purified Talc--6.00MG • Titanium Dioxide--1.0MG • Hypromellose (H.P.M.C. E 5)--7.00MG • Macrogol (PEG 6000)--0.500MG B3-1792 Drugs Imported Products 1X10 Prescription Only Medicine (POM) 13/06/2019 ADPHARM PHARMACETICAL INDUSTRIES LIMITED, NO. 60, AJAO ROAD, SURULERE, LAGOS STATE, NIGERIA. 9082437677 adpharmaltd@yahoo.com GLOBELA PHARM PVT LTD, 357 GIDC Sachin Surat Gujarat State, India | 26/04/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J01FA10 | Azithromycin | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01F Macrolides, lincosamides and streptogramins → J01FA Macrolides |
| J01MA01 | Ofloxacin | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01M Quinolone antibacterials → J01MA Fluoroquinolones |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| NG | Registered Drug Product Database | B4-0688, B4-1792 |
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