AMOXICILLIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli , Proteus mirabilis , or Enterococcus faecalis . Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . Amoxicillin for oral suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae , Staphylococcus spp., or H. influenzae . Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole: Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1 year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 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 infections that are proven or strongly suspected to be caused by 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 is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin or to other β-lactam antibiotics (e.g., penicillins and cephalosporins). Teratogenic Effects: Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to Amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Amoxicillin should be used during pregnancy only if clearly needed. Oral ampicillin is poorly absorbed during labor. It is not known whether use of Amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when Amoxicillin is administered to a nursing woman. Because of incompletely developed renal function in neonates and young infants, the elimination of Amoxicillin may be delayed. Dosing of Amoxicillin should be modified in pediatric patients 12 weeks or younger (≤ 3 months). [See Dosage and Administration (2.2).] An analysis of clinical studies of Amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Dosing in Renal Impairment (2.4) for specific recommendations in patients with renal impairment.

Product summary:

Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted fruity-flavored suspension contains 125, 250, mg Amoxicillin as the trihydrate. Amoxicillin for Oral Suspension, USP 125 mg/5ml 150-mL bottle - 68788-9019-1 Amoxicillin Powder for Oral Suspension, USP 250 mg/5mL 150-mL bottle - 68788-9017-1 Amoxicillin Powder for Oral Suspension, USP 400 mg/5mL 100-mL bottle - 68788-9018-1 Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Shake well before using. Refrigeration is preferable but not required. Discard suspension after 14 days. Keep container tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN FOR ORAL
SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMOXICILLIN
FOR ORAL SUSPENSION, USP.
AMOXICILLIN FOR ORAL SUSPENSION, USP
DYE FREE
INITIAL U.S. APPROVAL:1974
INDICATIONS AND USAGE
Amoxicillin for Oral Suspension is a penicillin-class antibacterial
indicated for treatment of infections due to
susceptible strains of designated microorganisms.
•
•
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
infections that are proven or strongly
suspected to be caused by bacteria. (1.6)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (>1%) observed in clinical trials of
Amoxicillin for oral suspension
were diarrhea, rash, vomiting, and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT HIKMA PHARMACEUTICALS
USA INC. AT 1-
877-233-2001 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
Infections of the ear, nose, throat, genitourinary tract, skin and
skin structure, and lower respiratory
tract. (1.1 – 1.4)
In combination for treatment of _H. pylori_ infection and duodenal
ulcer disease. (1.5)
In adults, 750-1750 mg/day in divided doses every 8-12 hours. In
Pediatric Patients > 3 Months of
Age, 20-45 mg/kg/day in divided doses every 8-12 hours. Refer to full
prescribing information for
specific dosing regimens. (2.1, 2.2, 2.3)
The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day
divided every 12 hours. (2.2)
Dosing for _H. pylori_ Infection: Triple therapy: 1 gram Amoxicillin,
500 mg clarithromycin, and 30 mg
lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual
the