This brand name is authorized in Nigeria.
The drug ZANITIN DUO contains a combination of these active pharmaceutical ingredients (APIs):
1
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UNII
544Y3D6MYH - AMOXICILLIN SODIUM
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Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bactericidal peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. |
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2
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UNII
Q42OMW3AT8 - CLAVULANATE POTASSIUM
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Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. |
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This drug has been approved in Nigeria as follows:
| Identifier | Form | Presentation | Description | Approval |
|---|---|---|---|---|
| B4-1562 | Tablet | ZANITIN DUO 1000 TABLETS TAB 875 mg; 125 mg | 88 CMS-PP-205598 ZANITIN DUO 1000 TABLETS AMOXICILLIN, CLAVULANIC ACID AMOXICILLIN 875MG, CLAVULANIC ACID 125MG (Excipients: Crospovidone BP, Microcrystalline Cellulose PH-112 BP, Silicon Dioxide BP, Colloidal Silicon Dioxide BP, Magnesium stearate BP, Microcrystalline Cellulose BP, Purified Talc BP, Hydroxy Propyl Methyl Cellulose (Any coat-C AN-6) BP, Hydroxy Propyl Methyl Cellulose (Any coat-C AN-15) BP, Ethyl cellulose N-20 BP, Titanium dioxide BP, Dibutyl Phthalate BP, Methylene Dichloride BP, Iso Propyl Alcohol BP) B4-1562 Drugs Imported Products 1x10 Tablets Prescription Only Medicine (POM) 4/8/2021 SHALINA HEALTHCARE NIGERIA LIMITED, 19 Fatai Atere Way, Matori, Mushin 18183973 theophilus.adimoha@shalina.com MEDICEF PHARMA., Plot No. 28, 29 & 48. EPIP, Phase-1, Jharmarjri, Baddi, Distt. Solan, H.P.-173205, India | 21/12/2023 |
| B4-1643 | Suspension | ZANITIN DUO 457 ORAL SUSPENSION SUSP 400 mg/5 mL; 57 mg/5 mL 1X70ml | 35 CMS-PP-206212 ZANITIN DUO 457 ORAL SUSPENSION AMOXCILLIN 400MG AND CLAVULANIC ACID 57MG AMOXICILLIN 400MG, CLAVULANIC ACID 57MG (Excipients: Colloidal Silicon Dioxide, Silicon dioxide, Aspartame, Succinic Acid, Xanthan Gum, Flavor Orange, Flavor Pineapple) B4-1643 Drugs Imported Products 1X70ml Prescription Only Medicine (POM) 4/13/2021 SHALINA HEALTHCARE NIGERIA LIMITED, FATAI ATERE WAY, MATORI MUSHIN LAGOS LAGOS 18183973 theophilus.adimoha@shalina.com MEDICEF PHARMA., Plot No. 28, 29 & 48. EPIP, Phase-1, Jharmarjri, Baddi, Distt. Solan, H.P.-173205, India | 28/02/2024 |
| B4-6725 | Tablet | ZANITIN DUO 625 TABLETS TAB 500 mg; 125 mg 2 X 7 | 89 CMS-PP-206717 ZANITIN DUO 625 TABLETS AMOXICILLIN, CLAVULANIC ACID AMOXCILLIN 500MG, CLAVULANIC ACID 125MG (Excipients: Crospovidone BP, Microcrystalline Cellulose PH-112 BP, Silicon Dioxide BP, Colloidal Silicon Dioxide BP, Magnesium stearate BP, Microcrystalline Cellulose BP, Purified Talc BP, Hydroxy Propyl Methyl Cellulose (Any coat-C AN-6) BP, Hydroxy Propyl Methyl Cellulose (Any coat-C AN-15) BP, Ethyl cellulose N-20 BP, Titanium dioxide BP, Dibutyl Phthalate BP, Methylene Dichloride BP, Iso Propyl Alcohol BP) B4-6725 Drugs Imported Products 27tablets Prescription Only Medicine (POM) 4/19/2021 SHALINA HEALTHCARE NIGERIA LIMITED, 19 Fatai Atere Way, Matori, Mushin 18183973 theophilus.adimoha@shalina.com MEDICEF PHARMA.., 28, Phase-1, Epip, Jhamajiri, Baddi, Dist. Solan (H.P)-173205, India, India | 21/12/2023 |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J01CR02 | Amoxicillin and enzyme inhibitor | J Antiinfectives for systemic use → J01 Antibacterials for systemic use → J01C Beta-lactam antibacterials, penicillins → J01CR Combinations of penicillins, incl. beta-lactamase inhibitors |
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 | B4-1562, B4-1643, B4-6725 |
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