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AUGMENTIN Powder for suspension / Film coated-tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Neopharma Inc

Λέξεις κλειδιά

72508-004 72508-006 72508-012 72508-018 72508-021

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1. Indications and Usage

To reduce the development of drug‑resistant bacteria and maintain the effectiveness of AUGMENTIN (amoxicillin/clavulanate potassium) and other antibacterial drugs, AUGMENTIN should be used only to treat ...

2. Dosage and Administration

AUGMENTIN may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when AUGMENTIN is administered at the start of a meal. To minimize the potential for gastrointestinal ...

3. Dosage Forms and Strengths

<b>Tablets:</b> <u>250 mg/125 mg Tablets:</u> Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250 mg of amoxicillin and 125 mg clavulanic ...

4. Contraindications

4.1 Serious Hypersensitivity Reactions AUGMENTIN is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate ...

5. Warnings and Precautions

5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including AUGMENTIN. These reactions ...

6. Adverse Reactions

The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions <em>[see Warnings and Precautions (5.1)]</em> Hepatic Dysfunction <em>[see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of AUGMENTIN. Because they are reported voluntarily from a population of unknown ...

7. Drug Interactions

7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with AUGMENTIN may result in increased and prolonged ...

8.1. Pregnancy

Teratogenic Effects Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given AUGMENTIN (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day ...

8.2. Labor and Delivery

Oral ampicillin‑class antibiotics are poorly absorbed during labor. It is not known whether use of amoxicillin/clavulanate potassium in humans during labor or delivery has immediate or delayed adverse ...

8.3. Nursing Mothers

Amoxicillin has been shown to be excreted in human milk. Amoxicillin/clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin/clavulanate ...

8.4. Pediatric Use

The safety and effectiveness of AUGMENTIN Powder for Oral Suspension and Chewable Tablets have been established in pediatric patients. Use of AUGMENTIN in pediatric patients is supported by evidence from ...

8.5. Geriatric Use

Of the 3,119 patients in an analysis of clinical studies of AUGMENTIN, 32% were ≥65 years old, and 14% were ≥75 years old. No overall differences in safety or effectiveness were observed between these ...

8.6. Renal Impairment

Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Patients with Renal Impairment (2.3) for specific ...

10. Overdosage

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that ...

11. Description

AUGMENTIN is an oral antibacterial combination consisting of amoxicillin and the beta‑lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, ...

12.1. Mechanism of Action

AUGMENTIN is an antibacterial drug <em>[see Microbiology 12.4]</em>.

12.3. Pharmacokinetics

Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of AUGMENTIN Tablets are shown in Table 3 and following administration of AUGMENTIN Powder ...

12.4. Microbiology

Amoxicillin is a semisynthetic antibiotic with in vitro bactericidal activity against Gram-positive and Gram-negative bacteria. Amoxicillin is, however, susceptible to degradation by beta-lactamases, and ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long‑term studies in animals have not been performed to evaluate carcinogenic potential. AUGMENTIN (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in the Ames bacterial mutation assay, ...

14. Clinical Studies

14.1 Lower Respiratory Tract and Complicated Urinary Tract Infections Data from 2 pivotal trials in 1,191 patients treated for either lower respiratory tract infections or complicated urinary tract infections ...

15. References

1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66‑67.

16.1. How Supplied

<b>Tablets:</b> <u>250 mg/125 mg Tablets:</u> Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 250/125 on the other side, contains 250<b></b>mg amoxicillin as the trihydrate ...

16.2. Storage and Handling

Store tablets and dry powder at or below 25°C (77°F). Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.

17. Patient Counseling Information

17.1 Information for Patients Patients should be informed that AUGMENTIN may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to ...
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