Amoxil

Amoxil capsules, tablets and powder for oral suspension are intended for oral administration.

Capsules: Each Amoxil capsule, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body, contains 250 mg capsule is imprinted with the product name AMOXIL and 250; 500 mg-AMOXIL and 500. Inactive ingredients: D&C Red No, FD&C Red No. 40, gelatin, magnesium stearate and titanium dioxide.

Tablets: Each oval, pink, cherry-banana-peppermint-flavored tablet contains 125 mg or 250 mg amoxicillin as the trihydrate. The tablets are imprinted with the product name AMOXIL on one side and 125 or 250 on the other side. Inactive ingredients: citric acid, corn starch, FD&C Red No.40, flavorings, glycine, mannitol, magnesium sterate, saccharin sodium, silica gel and sucrose.

Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg or 250 mg amoxicillin as the trihydrate.

Pediatric Drops for Oral Suspension: Each mL of reconstituted suspension contains 125 mg or 250 mg amoxicillin as the trihydrate.

Pediatric Drops for Oral Suspension: Each mL of reconstituted suspension contains 50 mg amoxicillin a the trihydrate.

Amoxicillin trihydrate for oral suspension 125 mg/5 mL (reconstituted) is a strawberry-flavored pink suspension; the 250 mg/5 mL or 50 mg/mL is a bubble-gum-flavored pink suspension. Inactive ingredients: FD&C Red No. 3, flavorings, silca gel, sodium benzoate, sodium citrate, sucrose and xanthan gum.

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Orally administered doses of 250 mg and 500 mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5.0 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL respectively.

Orally administered doses of amoxicillin suspension 125 mg/5 mL and 250 mg/5 mL result in average peak blood levels 1 to 2 hours after administration in the range of 1.5 mcg/mL to 3.0 mcg/mL and 3.5 mcg/mL to 5.0 mcg/mL, respectively. Amoxicillin chewable tablets, 125 mg and 250 mg, produced blood levels similar to those achieved with the corresponding doses of amoxicillin oral suspensions.

Detectable serum levels are observed up to 8 hours after an orally administered dose of amoxicillin. Following a 1 gram dose and utilizing a special skin window technique to determine levels of the antibiotic, it was noted that therapeutic levels were found in the interstitial fluid. Approximately 60 % of an orally administered dose of amoxicillin is excreted in the urine within 6 to 8 hours.

MICROBIOLOGY
Amoxil (amoxicillin) is similar to ampicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. In vitro studies have demonstrated the susceptibility of most strains of the following gram-positive bacteria: alpha-and beta-hemolytic streptococci, Diploccoccus pneumoniae, nonpenicillinase-producuing staphylococci and Streptococcus faecalis. It is active in vitro against many strains of Haemophilus influenza. Neisseria gonorrhoeae, Escherichia coli and Proteus mirabilis. Because it does not resist destruction by penicillinase, it is not effective against penicillnase-producing bacteria, particularly resistant staphylococci. All strains of Pseudomonas and most strains of Klebsiella and Enterobacter are resistant.

DISK SUSCEPTIBILITY TESTS:
Quantitative methods that require measurement of zone diameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommended for use with disks for testing susceptibility of ampicillin-class antibiotics. Interpretations correlate diameters of the disk test with MIC values for amoxiciillin. With this procedure, a report from the laboratory of “susceptible” indicates that the infecting organism is likely to respond to therapy. A report of “resistant” indicates that the infecting organism is not likely to respond to therapy. A report of “intermediate susceptibility” suggests that the organism would be susceptible if high dosage is used, or if the infection is confined to tissues and fluids (e.g, urine), in which high antibiotic levels are attained.

^*Bauer, A.W, Kirb,. W.M.M., Sherris, J. C., and Turck, M

Antibiotic Testing by a Standardized Single Disc Method, Am. J. Clin. Pathol. 45:493,

1966. Standardized Disc Susceptibility Test, Federal Register 37:20527-29, 1972.

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INDICATIONS
Amoxil (amoxicillin) is indicated in the treatment of infections due to susceptible strains of the following:

Gram-negative organisms – H. influenzae, E. Coli,

P.mirabilis and N. gonorrhoeae.

Gram-positive organisms – Streptococci (including Streptococcus faecalist), D. Pneumoniae and nonpenicillinase-producing staphylococci.

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.

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

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WARNINGS
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (anaphylactic) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. BEFORE INITIATING THERAPY WITH AMOXIL, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PERVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS AMOXIL SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE OXYGEN, INTRAVENOUS STEROIDS AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated colitis.”

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.

USAGE IN PREGNANCY

Safety for use in pregnancy has not been established.

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PRECAUTIONS
As with any potent drug, periodic assessment of rental, hepatic and hematopoietic function should be made during prolonged therapy. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Enterobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.

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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 and diarrhea.

Hypersensitivity Reactions: Erythematous maculopapular rashes erythema multiforme, Stevens- Johnson Syndrome, toxic epidermal necrolysis and uticaria 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 serum glutamic oxaloacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown.

Hemic and Lymphatic Systems: 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, behavioral changes and or dizziness have been reported rarely.

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DOSAGE AND ADMINISTRATION
Infections of the ear, nose and throat due to steptococci, pneumococci, nonpenicillinase- producing staphylococci and H. influenzae.

Infections of the genitourinary tract due to E. Coli, proteus mirabilis and Streptococcus faecalis:

Infections of the skin and soft-tissues due to steptococci, susceptible staphylococci and E. Coli:

USUAL DOSAGE:

Adults: 250 mg every 8 hours

children:20 mg/kg/day in divided doses every 8 hours.

children weighing 20 kg or more should be dosed according to the adult recommendations.

In severe infections or those caused by less susceptible organisms:

500 mg every 8 hours for adults and 40 mg/kg/day in divided doses every 8 hours for children may be needed.

Infections of the lower respiratory tract due to steptococci, pneumococci, nonpenicillinase- producing staphylococci and H. influenzae.

USUAL DOSAGE:

Adults: 500 mg every 8 hours.

Children: 40 mg/kg/day in divided doses every 8 hours.

children weighing 20 kg or more should be dosed according to the adult recommendations.

Gonorrhea, acute uncomplicated ano-genital and urethral infetions due to N. gonorrhoeae (males and females):

USUAL DOSAGE:

Adults: 3 grams as a single oral dose

Prepubertal children: 50 mg/kg amoxicillin combined with 25

mg/kg probencid as a single dose.

NOTE: SINCE PROBENECID IS CONTRAINDICATED IN CHILDREN UNDER 2 YEARS, THIS REGIMEN SHOULD NOT BE USED IN THESE CASES.

Cases of gonorrhea with a suspected lesion of syphilis should have dark-field examinations before receiving amoxicillin, and monthly serological tests for a minimum of 4 months.

Larger doses may be required for stubborn or severe infections.

The children’s dosage is intended for individuals whose weight will not cause a dosage to be calculated greater than that recommended for adults.

It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses that 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 hemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.

DOSAGE AND ADMINISTRATION OF PEDIATRIC DROPS
Usual dosage for all indications except infections of the lower respiratory tract:

Under 6 kg (13 lbs:) 0.75 mL every 8 hours.

6 to 7 kg (13 to 15 lbs): 1.75 mL every 8 hours.

8 kg (16 to 18 lbs): 2.25 mL every 8 hours.

Children weighing more than 8 kg (18 pounds should receive the appropriate dose of the Oral Suspension 125 mg or 250 mg/5 mL.

After reconstitution, the required amount of suspension should be placed directly on the child’s tounge for swallowing. Alternate means of administration are to add the required amound of suspension to formula, milk, fruit juice, water, ginger ale or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

DIRECTIONS FOR MIXING ORAL SUSPENSION
Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

                  125 mg/5 mL                                                                 Amount of Water   Bottle Size            Required for Reconstitution      80 mL        62 mL     100 mL        78 mL     150 mL       116 mL    Each teaspoonful (5 mL) will contain 125 mg amoxicillin.     125 mg unit dose        5 mL                 250 mg/5 mL       100 mL         74 mL     150 mL        111 mL    Each teaspoonful (5 mL) will contain 250 mg amoxicillin.       250 mg unit dose                   5 mL    

DIRECTIONS FOR MIXING PEDIATRIC DROPS
Prepare pediatric drops at time of dispensing as follows: Add the required amount of water (see table below) to the bottle and shake vigorously. Each mL of suspension will then contain amoxicillin trihydrate equivalent to 50 mg amoxicillin.

                                      Amount of Water  Bottle Size               Required for Reconstitution     15 mL     12 mL     30 mL     23 mL    

NOTE: SHAKE BOTH ORAL SUSPENSION AND PEDIATRIC DROPS WELL BEFORE USING. Keep bottle tightly closed. Any portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required.

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HOW SUPPLIED
Amoxil (amoxicillin) capsules. Each capsule contains 250 mg or 500 mg amoxicillin as the trihydrate.

               250 mg Capsule    NDC 0029-6006-30.................................bottles of 100  NDC 0029-6006-32.................................bottles of 500                 500 mg Capsule    NDC 0029-6007-30................................ bottles of 100  NDC 0029-6007-32................................ bottles of 500  

Amoxil (amoxicillin) Chewable Tablets. Each cherry-bananna-peppermint-flavored tablet contains 125 mg amoxicillin as the trihydrate.

               125 mg Tablet    NDC 0029-6004-39.................................bottles of 30                        250 mg Tablet    NDC 0029-6005-13.................................bottles of 30  NDC 0029-6005-30................................bottles of 100  

Amoxil(amoxicillin) for Oral Suspension.

                 125 mg/5 mL    NDC 0029-6008-21...............................80 mL bottle  NDC 0029-6008-23...............................100 mL bottle  NDC 0029-6008-22...............................150 mL bottle                   250 mg/5 mL    NDC 0029-6009-21................................80 mL bottle  NDC 0029-6009-23..............................100 mL bottle  NDC 0029-6009-22..............................150 mL bottle  

Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate.

Each 5 mL of reconstituted bubble-gum-flavored suspension contains 250 mg amoxicillin as the trihydrate.

NDC 0029-6008-18…………………………………………………………………125 mg unit dose bottle NDC 0029-6009-18…………………………………………………………………250 mg unit dose bottle

Amoxil (amoxicillin) Pediatric Drops for Oral Suspension. Each mL of bubble-gum-flavored reconstitued suspension contains 50 mg amoxicillin as the trihydrate.

NDC 0029-6035-20……………………………………………………………………………..15 mL bottle NDC 0029-6038-39……………………………………………………………………………. 30 mL bottle

DATE OF ISSUANCE MAY 1995
SmithKline Beecham, 1995
SmithKline Beecham Pharmaceuticals
Philadelphia, PA 19101
9416648
AM:L 10B
Printed in U.S.A

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