APIS
|
Active Pharmaceutical Ingredient |
CAS NO. |
Molecular Formula |
Defination |
Structural Formula |
|
Amoxicillin Film-coated Tablets |
34642-77-8 |
C16H18N3NaO5S |
[2S-[2a,5a,6b[S*]]]-6-[[Amino[4-hydroxyphenyl]acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Monosodium Salt |
|
Product Specifications
|
Products |
Specification |
Vomume of vials |
Packing form |
|
Amoxicillin Film-coated Tablets 500mg; 1000mg |
USP latest version |
White film-coated tablets |
10tabs/blister, 10blisters/box |
Details
- Genitourinary tract infections caused by Escherichia coli, Proteus mirabilis and Enterococcus faecalis.
- Acute uncomplicated anogenital and urethral gonorrhoea in males and females, caused by Neisseria gonorrhoeae.
- Infections of the nose, ear and throat caused by Streptococci, Pneumococci, non penicillinase producing Staphylococci and Haemophilus influenzae.
Skin and soft tissue infections caused by Streptococci, non penicillinase producing Staphylococci, E. coli and Proteus mirabilis.
In the therapy of duodenal ulcer associated with Helicobacter pylori, amoxicillin used in conjunction with another appropriate antibiotic and a proton pump inhibitor may be useful.
Pharmacological Action
Amoxicillin is a semi-synthetic penicillinase susceptible penicillin, inhibiting bacterial cell wall synthesis. It has a broad spectrum of in-vitro bactericidal activity against both gram positive and gram negative organisms. In vitro sensitivity does not necessarily imply in vivo efficacy.
Amoxicillin is acid stable and is rapidly and completely absorbed from the gastro-intestinal tract (75-90%). Peak plasma concentrations of about 5 mcg per mL are achieved 1 to 2 hours after a 250 mg dose. Presence of food does not affect the total absorption of the medicine. Amoxicillin is widely distributed in body tissues and fluids. It crosses the placenta and appears in the breast milk. Distribution into the cerebrospinal fluid is low in subjects with non inflamed meninges. Amoxicillin is about 20% protein bound and has a half life of 1 to 1,5 hours.
Amoxicillin is metabolised to a limited extent and about 60% is excreted in urine in six hours by glomerular filtration and tubular secretion. High concentrations may be reached in bile and some amount may be excreted in the faeces.
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