AMOXICILLIN AND CLAVULANATE POTASSIUM suspension

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

AMOXICILLIN

הרכב:

AMOXICILLIN ANHYDROUS 600 mg in 5 mL

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 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 ≤ 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: • antibiotic exposure for acute otitis media within the preceding 3 months, and either of the following: See ( CLINICAL PHARMACOLOGY, Microbiology) . NOTE: 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 ≥ 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 ≤

leaflet_short:

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL: Each 5 mL of reconstituted suspension contains 600 mg amoxicillin and 42.9 mg clavulanic acid as the potassium salt. NDC 54868-5165-2    75 mL bottle NDC 54868-5165-0    125 mL bottle NDC 54868-5165-1    200 mL bottle Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder for oral suspension at 20º-25°C (68º-77°F) [see USP Controlled Room Temperature]. Dispense in original container. Two clinical studies were conducted in pediatric patients with acute otitis media. A non-comparative, open-label study assessed the bacteriologic and clinical efficacy of Amoxicillin and Clavulanate Potassium for Oral Suspension  USP, 600 mg/42.9 mg per 5 mL (90/6.4 mg/kg/day, divided every 12 hours) for 10 days in 521 pediatric patients (3 to 50 months) with acute otitis media. The primary objective was to assess bacteriological response in children with acute otitis media due to S. pneumoniae with amoxicillin/clavulanic acid MICs of 4 mcg/mL. The study sought the enrollment of patients with the following risk factors: Failure of antibiotic therapy for acute otitis media in the previous 3 months, history of recurrent episodes of acute otitis media, ≤ 2 years, or daycare attendance. Prior to receiving Amoxicillin and Clavulanate Potassium for Oral Suspension  USP, 600 mg/42.9 mg per 5 mL, all patients had tympanocentesis to obtain middle ear fluid for bacteriological evaluation. Patients from whom S. pneumoniae (alone or in combination with other bacteria) was isolated had a second tympanocentesis 4 to 6 days after the start of therapy. Clinical assessments were planned for all patients during treatment (4-6 days after starting therapy), as well as 2-4 days post-treatment and 15-18 days post-treatment. Bacteriological success was defined as the absence of the pretreatment pathogen from the on-therapy tympanocentesis specimen. Clinical success was defined as improvement or resolution of signs and symptoms. Clinical failure was defined as lack of improvement or worsening of signs and/or symptoms at any time following at least 72 hours of Amoxicillin and Clavulanate Potassium for Oral Suspension  USP, 600 mg/5 mL; patients who received an additional systemic antibacterial drug for otitis media after 3 days of therapy were considered clinical failures. Bacteriological eradication on therapy (day 4-6 visit) in the per protocol population is summarized in Table 5 . Table 5. Bacteriologic Eradication Rates in the Per Protocol Population Pathogen Bacteriologic Eradication on Therapy n/N % 95% CI* All S. pneumoniae 121/123 98.4 (94.3, 99.8) S. pneumoniae with penicillin MIC = 2 mcg/mL 19/19 100 (82.4, 100) S. pneumoniae with penicillin MIC = 4 mcg/mL 12/14 85.7 (57.2, 98.2) H. influenzae 75/81 92.6 (84.6, 97.2) M. catarrhalis 11/11 100 (71.5, 100) *CI = confidence intervals; 95% CIs are not adjusted for multiple comparisons. Clinical assessments were made in the per protocol population 2-4 days post-therapy and 15-18 days post-therapy. Patients who responded to therapy 2-4 days post-therapy were followed for 15-18 days post-therapy to assess them for acute otitis media. Nonresponders at 2-4 days post-therapy were considered failures at the latter timepoint. Table 6. Clinical Assessments in the Per Protocol Population (Includes S. pneumoniae Patients With Penicillin MICs = 2 or 4 mcg/mL*) Pathogen 2-4 Days Post-Therapy (Primary Endpoint) n/N % 95% CI†  All S. pneumoniae 122/137 89.1 (82.6, 93.7) S. pneumoniae with penicillin MIC = 2 mcg/mL 17/20 85 (62.1,96.8) S. pneumoniae with penicillin MIC = 4 mcg/mL 11/14 78.6 (49.2, 95.3) H. influenzae 141/162 87  (80.9, 91.8) M. catarrhalis 22/26 84.6 (65.1, 95.6) Pathogen 15-18 Days Post-Therapy‡ (Secondary Endpoint) n/N % 95% CI†  All S. pneumoniae 95/136 69.9 (61.4, 77.4) S. pneumoniae with penicillin MIC = 2 mcg/mL 11/20 55 (31.5, 76.9) S. pneumoniae with penicillin MIC = 4 mcg/mL 5/14 35.7 (12.8, 64.9) H. influenzae 106/156 67.9 (60, 75.2) M. catarrhalis 14/25 56 (34.9, 75.6) *S. pneumoniae strains with penicillin MICs of 2 or 4 mcg/mL are considered resistant to penicillin. †  CI = confidence intervals; 95% CIs are not adjusted for multiple comparisons. ‡ Clinical assessments at 15-18 days post-therapy may have been confounded by viral infections and new episodes of acute otitis media with time elapsed post-treatment. In the intent-to-treat analysis, overall clinical outcomes at 2-4 days and 15-18 days post-treatment in patients with S. pneumoniae with penicillin MIC = 2 mcg/mL and 4 mcg/mL were 29/41 (71%) and 17/41 (41.5%), respectively. In the intent-to-treat population of 521 patients, the most frequently reported adverse events were vomiting (6.9%), fever (6.1%), contact dermatitis (i.e., diaper rash) (6.1%), upper respiratory tract infection (4%), and diarrhea (3.8%). Protocol-defined diarrhea (i.e., 3 or more watery stools in one day or 2 watery stools per day for 2 consecutive days as recorded on diary cards) occurred in 12.9% of patients. A double-blind, randomized, clinical study compared Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL (90/6.4 mg/kg/day, divided every 12 hours) to Amoxicillin and Clavulanate Potassium (45/6.4 mg/kg/day, divided every 12 hours) for 10 days in 450 pediatric patients (3 months to 12 years) with acute otitis media. The primary objective of the study was to compare the safety of Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL to Amoxicillin and Clavulanate Potassium. There was no statistically significant difference between treatments in the proportion of patients with 1 or more adverse events. The most frequently reported adverse events for Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL and the comparator of Amoxicillin and Clavulanate Potassium, were coughing (11.9% versus 6.8%), vomiting (6.5% versus 7.7%), contact dermatitis (i.e., diaper rash, 6% versus 4.8%), fever (5.5% versus 3.9%), and upper respiratory infection (3% versus 9.2%), respectively. The frequencies of protocol-defined diarrhea with Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL (11.1%) and Amoxicillin and Clavulanate Potassium (9.4%) were similar (95% confidence interval on difference: −4.2% to 7.7%). Only 2 patients in the group treated with Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL and 1 patient in the group treated with Amoxicillin and Clavulanate Potassium were withdrawn due to diarrhea. CLINITEST is a registered trademark of Miles, Inc. CLINISTIX is a registered trademark of Bayer Corporation. Manufactured in Slovenia by Lek Pharmaceuticals d.d. for Sandoz Inc., Princeton, NJ 08540 Rev. June 2012 Distributed by: Physicians Total Care, inc. Tulsa, OK     74146

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

AMOXICILLIN AND CLAVULANATE POTASSIUM - AMOXICILLIN AND CLAVULANATE
POTASSIUM SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Amoxicillin and
Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL and
other antibacterial drugs,
Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/ 42.9
mg per 5 mL should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9
mg per 5 mL is an oral
antibacterial combination consisting of the semisynthetic antibiotic
amoxicillin and the β-lactamase
inhibitor, clavulanate potassium (the potassium salt of clavulanic
acid). Amoxicillin is an analog of
ampicillin, derived from the basic penicillin nucleus,
6-aminopenicillanic acid. The amoxicillin
molecular formula is C
H N O S •3H O, and the molecular weight is 419.46. Chemically,
amoxicillin is
_(2S,5R,6R)-_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 and may
be represented structurally as:
Clavulanic acid is produced by the fermentation of _Streptomyces
clavuligerus. _It is a β-lactam structurally
related to the penicillins and possesses the ability to inactivate a
wide variety of β-lactamases by
blocking the active sites of these enzymes. Clavulanic acid is
particularly active against the clinically
important plasmid-mediated β-lactamases frequently responsible for
transferred drug resistance to
penicillins and cephalosporins. The clavulanate potassium molecular
formula is C H KNO and the
molecular weight is 237.25. Chemically, clavulanate potassium is
potassium (_Z_)-(2_R_,5_R_)-3-(2-
hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate
and may be represented
structurally as:
INACTIVE INGREDIENTS: Powder for O