Amoxicillin Tablets for Suspension

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets for oral suspension and other antibacterial drugs, amoxicillin tablets for oral suspension should be used only to treat or prevent 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 is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below:
 
Infections of the ear, nose, and throat due to Streptococcus spp. (α- and β-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae
 
Infections of the genitourinary tract due to E. coli, P. mirabilis, or E. faecalis
 
Infections of the skin and skin structure due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli
 
Infections of the lower respiratory tract due to Streptococcus spp. (α- and β-hemolytic strains only), Streptococcus pneumoniae, Staphylococcus spp., or H. influenzae
 
Gonorrhea, acute uncomplicated (ano-genital and urethral infections) due to N. gonorrhoeae (males and females) Therapy may be instituted prior to obtaining results from bacteriological and susceptibility studies to determine the causative organisms and their susceptibility to amoxicillin.
 
Indicated surgical procedures should be performed.

H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple therapy: Amoxicillin/clarithromycin/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 one-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. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.) Dual therapy: Amoxicillin/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 one 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. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

A history of allergic reaction to any of the penicillins is a contraindication.

General

Prescribing amoxicillin tablets for oral suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.

Information for Patients

Patients should be counseled that antibacterial drugs including amoxicillin tablets for oral suspension should only be used to treat bacterial infections.  They do not treat viral infections (e.g., the common cold).  When amoxicillin tablets for oral suspension are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy the medicine should be taken exactly as directed.  Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin tablets for oral suspension or other antibacterial drugs in the future.

A Patient Information Sheet is provided with the drug product.

Phenylketonurics

Each 200 mg amoxicillin tablet for oral suspension contains 3.1 mg phenylalanine; each 400 mg amoxicillin tablet for oral suspension contains 6.2 mg phenylalanine.

Laboratory Tests

As with any potent drug, periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy.
 
All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with amoxicillin should have a follow-up serologic test for syphilis after 3 months.

Drug Interactions

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

Drug/Laboratory Test Interactions

High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest®, Benedict’s Solution or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) be used.

Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with amoxicillin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Mixture of amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Mixture of amoxicillin and potassium clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Mixture of amoxicillin and potassium clavulanate was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micro-nucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m2).

Pregnancy

Teratogenic Effects
Pregnancy Category B.
 
Reproduction studies have been performed in mice and rats at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or 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, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, 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 that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

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.

Pediatric Use

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 - Neonates and infants.)

Geriatric Use

An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects.  Of the 1,811 subjects treated with capsules of amoxicillin, 85% were <60 years old, 15% were ≥61 years old and 7% were ≥71 years old.  This analysis and other reported clinical experience 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.

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.3

Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.

Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients.  In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Fourth Edition; Approved Standard. NCCLS Document M7-A4, Vol. 17, No. 2. NCCLS, Wayne, PA, January 1997. 
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition; Approved Standard. NCCLS Document M2-A6, Vol. 17, No. 1. NCCLS, Wayne, PA, January 1997. 
3. 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.

 

Dispermox™ is a registered trademark of Ranbaxy Pharmaceuticals Inc.

1200 Tablets
 
Batch      :
 
Mfg         :
 
Expiry      :
 
To be repacked within six months from the date of manufacturing
 
NDC 65862-066-12

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Amoxicillin Tablets for Oral Suspension, USP 400 mg

Each tablet for oral suspension contains: Amoxicillin USP (trihydrate)
equivalent to 400 mg anhydrous amoxicillin.

CAUTION: FOR REPACKAGING ONLY

Store at 20° to 25°C (68° to 77°F); excursions permitted to
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072,
India

AMOXICILLIN  amoxicillin tablet, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65862-065 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN) AMOXICILLIN 200 mg

Inactive Ingredients Ingredient Name Strength ASPARTAME   SILICON DIOXIDE   CROSCARMELLOSE SODIUM   FD&C RED NO. 40   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color PINK (Light Pink, Mottled) Score no score Shape ROUND Size 14mm Flavor STRAWBERRY, GUARANA Imprint Code C;31 Contains

Packaging # Item Code Package Description 1 NDC:65862-065-20 20 TABLET, FOR SUSPENSION (20 TABLET) in 1 BOTTLE 2 NDC:65862-065-01 100 TABLET, FOR SUSPENSION (100 TABLET) in 1 BOTTLE 3 NDC:65862-065-05 500 TABLET, FOR SUSPENSION (500 TABLET) in 1 BOTTLE 4 NDC:65862-065-22 2000 TABLET, FOR SUSPENSION (2000 TABLET) in 1 BAG

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065324 01/17/2007

AMOXICILLIN  amoxicillin tablet, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65862-066 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (AMOXICILLIN) AMOXICILLIN 400 mg

Inactive Ingredients Ingredient Name Strength ASPARTAME   SILICON DIOXIDE   CROSCARMELLOSE SODIUM   FD&C RED NO. 40   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color PINK (Light Pink, Mottled) Score no score Shape ROUND Size 18mm Flavor STRAWBERRY, GUARANA Imprint Code C;30 Contains

Packaging # Item Code Package Description 1 NDC:65862-066-20 20 TABLET, FOR SUSPENSION (20 TABLET) in 1 BOTTLE 2 NDC:65862-066-01 100 TABLET, FOR SUSPENSION (100 TABLET) in 1 BOTTLE 3 NDC:65862-066-05 500 TABLET, FOR SUSPENSION (500 TABLET) in 1 BOTTLE 4 NDC:65862-066-12 1200 TABLET, FOR SUSPENSION (1200 TABLET) in 1 BAG

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065324 01/17/2007

Labeler - Aurobindo Pharma Limited (650082092)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		918917683	MANUFACTURE

Revised: 09/2010   Aurobindo Pharma Limited