AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Disponible depuis:

Clinical Solutions Wholesale

DCI (Dénomination commune internationale):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 200 mg in 5 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and Clavulanate Potassium is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis

Descriptif du produit:

Tablets: Amoxicillin and Clavulanate Potassium 250 mg/125 mg Tablets (Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250 mg amoxicillin/125 mg clavulanic acid):  NDC 43598-218-30 bottles of 30 NDC 43598-218-78 100 Unit Dose tablets   Amoxicillin and Clavulanate Potassium 500 mg/125 mg Tablets (Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500   mg amoxicillin and 125   mg clavulanic acid):  NDC 43598-206-14 bottles of 20 NDC 43598-206-78 100 Unit Dose tablets   Amoxicillin and Clavulanate Potassium 875 mg/125 mg Tablets (Each scored white capsule‑shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875   mg amoxicillin and 125   mg clavulanic acid):  NDC 43598-221-14 bottles of 20 NDC 43598-221-78 100 Unit Dose tablets Powder for Oral Suspension : k Amoxicillin and Clavulanate Potassium 125 mg/31.25 mg per 5 mL for OralSuspension: Each 5 mL of reconstituted banana-flavored suspension contains 125 mg amoxicillin and 31.25 mg clavulanic acid as the potassium salt.  NDC 43598-212-51 ..............75 mL bottle NDC 43598-212-52 ..............100 mL bottle NDC 43598-212-53 ............. 150 mL bottle  Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg per 5 mL for OralSuspension: Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt.  NDC 43598-213-50 ..............50 mL bottle NDC 43598-213-51 ..............75 mL bottle NDC 43598-213-52 ............. 100 mL bottle  Amoxicillin and Clavulanate Potassium 250 mg/62.5 mg per 5 mL for OralSuspension: Each 5 mL of reconstituted orange-flavored suspension contains 250 mgamoxicillin and 62.5 mg clavulanic acid as the potassium salt.  NDC 43598-204-51 ..............75 mL bottle NDC 43598-204-52 ..............100 mL bottle NDC 43598-204-53 ............. 150 mL bottle   Amoxicillin and Clavulanate Potassium 400 mg/57 mg per 5 mL for OralSuspension: Each 5 mL of reconstituted orange-flavored suspension contains 400 mgamoxicillin and 57 mg clavulanic acid as the potassium salt.  NDC 43598-208-50 ..............50 mL bottle NDC 43598-208-51 ..............75 mL bottle NDC 43598-208-52 ............. 100 mL bottle Chewable Tablets : Amoxicillin and Clavulanate Potassium 125 mg/31.25 mg Chewable Tablets: Each mottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 189, contains125 mg amoxicillin as the trihydrate and 31.25 mg clavulanic acid as the potassium salt.  NDC 43598-214-31 carton of 30 tablets   Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg Chewable Tablets: Eachmottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with PL over C20 contains 200 mg amoxicillinas the trihydrate and 28.5 mg clavulanic acid as the potassium salt.  NDC 43598-215-14 carton of 20 tablets   Amoxicillin and Clavulanate Potassium 250 mg/62.5 mg Chewable Tablets: Eachmottled yellow, round, lemon-lime-flavored tablet, debossed with BMP 190, contains250 mg amoxicillin as the trihydrate and 62.5 mg clavulanic acid as the potassium salt.  NDC 43598-216-31 carton of 30 tablets   Amoxicillin and Clavulanate Potassium 400 mg/57 mg Chewable Tablets: Eachmottled pink, round, biconvex, cherry-banana-flavored tablet, debossed with PL over C40  contains 400 mg amoxicillinas the trihydrate and 57.0 mg clavulanic acid as the potassium salt.  NDC 43598-217-14 carton of 20 tablets Store tablets and dry powder at or below 25°C (77°F). Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. CLINITEST is a registered trademark of Miles, Inc. Distributed by: Dr. Reddy’s Laboratories Inc. Bridgewater, NJ 08807 Issued: XXXX

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
CLINICAL SOLUTIONS WHOLESALE
REFERENCE LABEL SET ID: 07B15552-879D-4B04-B0E3-634ADD4632C8
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND CLAVULANATE POTASSIUM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN AND CLAVULANATE POTASSIUM.
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, POWDER FOR ORAL
SUSPENSION AND CHEWABLE TABLETS
INITIAL U.S. APPROVAL: 1984
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF AMOXICILLIN AND
CLAVULANATE POTASSIUM AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN AND
CLAVULANATE POTASSIUM SHOULD BE USED
ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE
CAUSED BY BACTERIA.
INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium is a combination
penicillin-class antibacterial and beta lactamase inhibitor indicated
for treatment of the following:
Lower respiratory tract infections (1.1)
Acute bacterial otitis media (1.2)
Sinusitis (1.3)
Skin and skin structure infections (1.4)
Urinary tract infections (1.5)
DOSAGE AND ADMINISTRATION
1. Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hours
or 250 or 500 mg every 8 hours. ( 2.1, 2.2)
2. _RefPediatric patients aged 12 weeks (3 months) and older: 25 to 45
mg/kg/day every 12 hours or 20 to 40 mg/kg/day
every 8 hours, up to the adult dose. (2.2)
3. Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every
12 hours, based on the amoxicillin component.
Use of the 125 mg/5 mL oral suspension is recommended. (2.2)
DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin/clavulanate content are:
Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg
tablets are scored. (3)
Powder for Oral Suspension: 125 mg/31.25 mg per 5 mL, 200 mg/28.5 mg
per 5 mL, 250 mg/62.5 mg per 5 mL, 400
mg/57 mg per 5 mL (3)
Chewable Tablets: 125 mg/31.25 mg, 200 mg/28.5 mg, 250 mg/6