Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)
Physicians Total Care, Inc.
AMOXICILLIN
AMOXICILLIN ANHYDROUS 250 mg
ORAL
PRESCRIPTION DRUG
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis. Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treat
Amoxicillin Capsules, USP, for oral administration, contain 250 mg or 500 mg amoxicillin as the trihydrate and are supplied as: 250 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 250 on one side and GG 848 on the other side. 500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side. Amoxicillin Tablets, USP equivalent to 875 mg amoxicillin as the trihydrate and are supplied as: 875 mg: oval-shaped, scored on one side, white to slightly yellowish film-coated tablets embossed GG-962 on one side and 875 on the other side. Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted fruity flavored pink suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. 125 mg/5 mL 200 mg/5 mL 250 mg/5 mL 400mg/5 mL Store capsules, tablets and unreconstituted powder for oral suspension at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in a tight container.
Abbreviated New Drug Application
AMOXICILLIN - AMOXICILLIN CAPSULE AMOXICILLIN - AMOXICILLIN TABLET, FILM COATED AMOXICILLIN - AMOXICILLIN POWDER, FOR SUSPENSION PHYSICIANS TOTAL CARE, INC. ---------- AMOXICILLIN CAPSULES, TABLETS AND POWDER FOR ORAL SUSPENSION, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it is (2_S_,5_R_,6_R_)-6-[(_R_)-(-)-2-amino-2-(_p_-hydroxyphenyl)acetamido]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C H N O S • 3H O, and the molecular weight is 419.45. Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration. CAPS ULES Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. TABLETS Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval- shaped, unscored and white to yellowish. The 500 mg tablet is embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethy Lue koko asiakirja