AMOXICILLIN AND CLAVULANATE POTASSIUM suspension

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Hikma Pharmaceuticals USA Inc.

INN (Mezinárodní Name):

AMOXICILLIN

Složení:

AMOXICILLIN 600 mg in 5 mL

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with - Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: -Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4)] . Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Therapy may be instituted prior to obtaining the results from bacteriological studies when t

Přehled produktů:

How Supplied   Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL: Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin trihydrate and 42.9 mg clavulanic acid as the potassium salt (equivalent to 51.1 mg of clavulanate potassium). NDC 0143-9853-75                                         75 mL bottle NDC 0143-9853-16                                         125 mL bottle NDC 0143-9853-24                                         200 mL bottle Storage Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature. Dispense in original container].

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM SUSPENSION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP, 600 MG/42.9 MG PER 5 ML
SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND
CLAVULANATE
POTASSIUM FOR ORAL SUSPENSION USP, 600 MG/42.9 MG PER 5 ML.
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION 600 MG/42.9
MG PER 5
ML.
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions (5) 6/2022
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9
mg per 5 mL is a combination of
amoxicillin, a penicillin-class antibacterial and clavulanate
potassium, a beta-lactamase inhibitor, indicated
for the treatment of pediatric patients with
Recurrent or persistent acute otitis media due to _S. pneumoniae_
(penicillin MICs less than or equal to 2
mcg/mL), _H. influenzae_ (including β-lactamase-producing strains),
or _M. catarrhalis_ (including β-
lactamase-producing strains) characterized by the following risk
factors (1):
- Antibacterial exposure for acute otitis media within the preceding 3
months, and either of the following:
1) age 2 years, or younger or 2) daycare attendance
Limitations of Use
Acute otitis media due to _S. pneumoniae_ alone can be treated with
amoxicillin. Amoxicillin and clavulanate
potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not
indicated for the treatment of acute otitis
media due to _S. pneumoniae_ with penicillin MIC greater than or equal
to 4 mcg/mL. Therapy may be
instituted prior to obtaining the results from bacteriological studies
when there is reason to believe the
infection may involve both _S. pneumoniae_ (penicillin MIC less than
or equal to 2 mcg/mL) and the β-
lactamase-producing organisms listed above. (1)
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness