Amoxicillin Tablets for Suspension

Name: Amoxicillin Tablets for Suspension

Amoxicillin Tablets for Oral Suspension, USP


To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets for oral suspension and other antimicrobial 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 bacteria.

Amoxicillin Tablets for Suspension Description


Amoxicillin tablets for oral suspension contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically it 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. The structural formula is:

The amoxicillin molecular formula is C16H19N3O5S • 3H2O, and the molecular weight is 419.45.

Amoxicillin tablets for oral suspension are intended for oral administration.
 
Each amoxicillin tablet for oral suspension contains amoxicillin trihydrate equivalent to amoxicillin anhydrous 200 mg or 400 mg.  Inactive ingredients:  aspartame•, colloidal silicon dioxide, croscarmellose sodium, FD&C Red no. 40 aluminium lake, magnesium stearate, microcrystalline cellulose and strawberry guarana flavor.
 
  • See PRECAUTIONS

Adverse Reactions


As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:

Gastrointestinal:  nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis.
 
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)

Hypersensitivity Reactions:  Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.

NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.

Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis, and acute cytolytic hepatitis have been reported.

Renal:  Crystalluria has also been reported (see OVERDOSAGE).

Hemic and Lymphatic Systems:  Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Central Nervous System:  Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.
 
Miscellaneous:  Tooth discoloration (brown, yellow, or gray staining) has been rarely reported.  Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Combination therapy with clarithromycin and lansoprazole


In clinical trials using combination therapy with amoxicillin plus clarithromycin and lansoprazole, and amoxicillin plus lansoprazole, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with amoxicillin, clarithromycin, or lansoprazole.

Triple therapy: amoxicillin/clarithromycin/lansoprazole


The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual therapy: amoxicillin/lansoprazole


The most frequently reported adverse events for patients who received amoxicillin t.i.d.  plus lansoprazole t.i.d. dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with amoxicillin t.i.d. plus lansoprazole t.i.d. dual therapy than with lansoprazole alone.

For more information on adverse reactions with clarithromycin or lansoprazole, refer to their package inserts, ADVERSE REACTIONS.

Amoxicillin Tablets for Suspension Dosage and Administration


Amoxicillin may be given without regard to meals.

Direction for Amoxicillin Tablets for Oral Suspension


Mix one tablet in a small amount of water [approximately 2 teaspoonfuls]. Drink the entire mixture.  Rinse the container with an additional small amount of water and drink the contents to assure the whole dose is taken. Do not chew or swallow the tablets. The tablets will not rapidly dissolve in your mouth.

The tablet is not recommended to be mixed with any liquid other than water, as studies have only been conducted using water.

ALL RECOMMENDED DOSAGES FOR AMOXICILLIN ARE INCLUDED IN THIS SECTION FOR INFORMATIONAL PURPOSES ONLY. THE 200 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 200 mg DOSE AND THE 400 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 400 mg DOSE.

Neonates and infants aged ≤ 12 weeks (≤ 3 months)


Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided q12h.

Adults and pediatric patients > 3 months




   Infection    Severity‡    Usual Adult Dose    Usual Dose for Children >3
   Months§
‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.
§The children’s dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.
   Ear/nose/throat
   Mild/Moderate
   500 mg every 12 hours
   or 250 mg every 8 hours   
   25 mg/kg/day in divided
   doses every 12 hours
   or
   20 mg/kg/day in divided
   doses every 8 hours
   Severe
   875 mg every 12 hours
   or 500 mg every 8 hours   
   45 mg/kg/day in divided
   doses every 12 hours
   or
   40 mg/kg/day in divided
   doses every 8 hours
   Lower respiratory tract    
   Mild/Moderate or Severe    
   875 mg every 12 hours
   or 500 mg every 8 hours
   45 mg/kg/day in divided
   doses every 12 hours
   or
   40 mg/kg/day in divided
   doses every 8 hours
   Skin/skin structure
   Mild/Moderate
   500 mg every 12 hours
   or 250 mg every 8 hours
   25 mg/kg/day in divided
   doses every 12 hours
   or
   20 mg/kg/day in divided
   doses every 8 hours
   Severe
   875 mg every 12 hours
   or 500 mg every 8 hours
   45 mg/kg/day in divided
   doses every 12 hours
   or
   40 mg/kg/day in divided
   doses every 8 hours
   Genitourinary tract
   Mild/Moderate
   500 mg every 12 hours
   or 250 mg every 8 hours
   25 mg/kg/day in divided
   doses every 12 hours
   or
   20 mg/kg/day in divided
   doses every 8 hours
   Severe
   875 mg every 12 hours
   or 500 mg every 8 hours
   45 mg/kg/day in divided
   doses every 12 hours
   or
   40 mg/kg/day in divided
   doses every 8 hours
   Gonorrhea Acute,
   uncomplicated
   ano-genital and
   urethral infections
   in males and
   females
 
   3 grams as single oral
   dose    
   Prepubertal children:   50
   mg/kg amoxicillin,
   combined with 25 mg/kg
   probenecid as a single dose.
   NOTE: SINCE
   PROBENECID IS
   CONTRAINDICATED
   IN CHILDREN UNDER
   2 YEARS, DO NOT USE    
   THIS REGIMEN IN
   THESE CASES.

All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS - Laboratory Tests.)

Larger doses may be required for stubborn or severe infections.

General


It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.  Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. H. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple therapy: Amoxicillin/clarithromycin/lansoprazole


The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

Dual therapy: Amoxicillin/lansoprazole


The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)
 
Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

Dosing recommendations for adults with impaired renal function:


Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of < 30 mL/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
 
There are currently no dosing recommendations for pediatric patients with impaired renal function.

How is Amoxicillin Tablets for Suspension Supplied


Amoxicillin Tablets for Oral Suspension, USP

200 mg Tablets for Oral Suspension are light pink colored, circular mottled tablets debossed with ‘C’ on one side and ‘31’on the other side.

                     Bottles of 20                             NDC 65862-065-20
                     Bottles of 100                           NDC 65862-065-01
                     Bottles of 500                           NDC 65862-065-05

400 mg Tablets for Oral Suspension are light pink colored, circular mottled tablets debossed with ‘C’ on one side and ‘30’on the other side.

                     Bottles of 20                             NDC 65862-066-20
                     Bottles of 100                           NDC 65862-066-01
                     Bottles of 500                           NDC 65862-066-05

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].
 
Dispense in a tight container.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg Bulk Tablet Label


2000 Tablets
 
Batch      :
 
Mfg         :
 
Expiry      :
 
To be repacked within six months from the date of manufacturing
 
NDC 65862-065-22

BULK SHIPMENT
PLEASE HANDLE CAREFULLY

Rx only

Amoxicillin Tablets for Oral Suspension, USP 200 mg

Each tablet for oral suspension contains: Amoxicillin USP (trihydrate)
equivalent to 200 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
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