DESCRIPTION
id: eb517e9f-aa95-4ac1-917f-5c1dea41e664
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Formulations of amoxicillin 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. It may be represented structurally as:
The amoxicillin molecular formula is C16H19N3O5S • 3H2O, and the molecular weight is 419.45.
Capsules, tablets and powder for oral suspension of amoxicillin are intended for oral administration.
CLINICAL PHARMACOLOGY
id: cfbe86c1-91cd-48c3-8479-071b794e4eb9
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. The effect of food on the absorption of amoxicillin from the tablets and suspension has been partially investigated. The 400 mg and 875 mg formulations have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. The half-life of amoxicillin is 61.3 minutes. Most of the amoxicillin is excreted unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid. In blood serum, amoxicillin is approximately 20% protein-bound.
Orally administered doses of 250 mg and 500 mg of amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.
Mean amoxicillin pharmacokinetic parameters from an open, two-part, single-dose crossover bioequivalence study in 27 adults comparing 875 mg of Amoxicillin tablets with 875 mg of amoxicillin and clavulanate potassium showed that the 875 mg tablet of amoxicillin produces an AUC0-∞ of 35.4 ± 8.1 mcg∙hr/mL and a Cmax of 13.8 ± 4.1 mcg/mL. Dosing was at the start of a light meal following an overnight fast.
Oral administration of single doses of amoxicillin 400 mg chewable tablets and 400 mg/5 mL suspension to 24 adult volunteers yielded the following pharmacokinetic data:
| Dose
|
AUC0-∞ (mcg.hr./mL) |
Cmax (mcg/mL)
|
| Amoxicillin |
amoxicillin
(±S.D.) |
amoxicillin
(±S.D.) |
| 400 mg (5 mL of suspension) |
17.1 (3.1) |
5.92 (1.62) |
| 400 mg (chewable tablet) |
17.9 (2.4) |
5.18 (1.64) |
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 mcg/mL and 3.5 mcg/mL to 5 mcg/ mL, respectively.
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.
INDICATIONS AND USAGE
id: 09f23a96-0ebd-4b8d-bd65-dd75f85bd7b7
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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), S. 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), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N. gonorrhoeae (males and females).
H. pylori eradication to reduce the risk of duodenal ulcer recurrence
CONTRAINDICATIONS
id: f26d6e56-5047-4a3e-aa4e-447632d97a6b
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
A history of allergic reaction to any of the penicillins is a contraindication.
WARNINGS
id: cc47c3eb-613e-470f-bdc6-556f52b594c3
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH AMOXICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN 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.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin capsules, amoxicillin for oral suspension, or amoxicillin tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
ADVERSE REACTIONS
id: c28d08ed-859d-4cbd-b8a8-21b77d98ceb1
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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:
Infections and Infestations: Mucocutaneous candidiasis.
Gastrointestinal: Nausea, vomiting, diarrhea, black hairy tongue, and hemorrhagic/pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See
WARNINGS.)
Hypersensitivity Reactions: Anaphylaxis (See
WARNINGS
), 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.
OVERDOSAGE
id: 9a1af7e1-2fdf-42c4-af9f-9609694a392c
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
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.
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.
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.
DOSAGE AND ADMINISTRATION
id: 1d4d8dc2-fe04-415d-b310-4ed248db2457
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Capsules, tablets and oral suspensions of amoxicillin may be given without regard to meals. The 400 mg suspension and the 875 mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200 mg and 500 mg formulations.
HOW SUPPLIED
id: ada6566f-2ce9-4106-8bad-913a0f44de3a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Amoxicillin Capsules, USP, for oral administration, contain 250 mg or 500 mg amoxicillin as the trihydrate and are supplied as:
250 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 250 on one side and GG 848 on the other side.
| Bottles of 15
|
NDC 54868-3107-9
|
| Bottles of 20
|
NDC 54868-3107-7
|
| Bottles of 21
|
NDC 54868-3107-6
|
| Bottle sof 30
|
NDC 54868-3107-1
|
| Bottles of 40
|
NDC 54868-3107-3
|
| Bottles of 500
|
NDC 54868-3107-2
|
500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side.
| Bottles of 09
|
NDC 54868-3109-6
|
| Bottles of 15
|
NDC 54868-3109-8
|
| Bottles of 20
|
NDC 54868-3109-7
|
| Bottles of 21
|
NDC 54868-3109-3
|
| Bottles of 30
|
NDC 54868-3109-1
|
| Bottles of 40
|
NDC 54868-3109-9
|
| Bottles of 60
|
NDC 54868-3109-5
|
| Bottles of 100
|
NDC 54868-3109-2
|
| Bottles of 500
|
NDC 54868-3109-0
|
Amoxicillin Tablets, USP equivalent to 875 mg amoxicillin as the trihydrate and are supplied as:
875 mg: oval-shaped, scored on one side, white to slightly yellowish film-coated tablets embossed GG-962 on one side and 875 on the other side.
| Bottles of 10
|
NDC 54868-4543-3
|
| Bottles of 14
|
NDC 54868-4543-1
|
| Bottles of 20
|
NDC 54868-4543-0
|
| Bottles of 30
|
NDC 54868-4543-2
|
Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted fruity flavored pink suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.
125 mg/5 mL
| 100 mL Bottles
|
NDC 54868-4150-2
|
| 150 mL Bottles
|
NDC 54868-4150-1
|
200 mg/5 mL
| 100 mL Bottles
|
NDC 54868-4468-0
|
250 mg/5 mL
| 80 mL Bottles
|
NDC 54868-4155-0
|
| 100 mL Bottles
|
NDC 54868-4155-2
|
| 150 mL Bottles
|
NDC 54868-4155-1
|
| 200 mL Bottles
|
NDC 54868-4155-3
|
| 300 mL Bottles
|
NDC 54868-4155-4
|
400mg/5 mL
| 50 mL Bottles
|
NDC 54868-5101-1
|
| 75 mL Bottles
|
NDC 54868-5101-2
|
| 100 mL Bottles
|
NDC 54868-5101-0
|
| 200 mL Bottles
|
NDC 54868-5101-3
|
REFERENCES
id: c4fdcc5a-29a7-48c0-b548-2fe4c49ddecb
displayName: REFERENCES SECTION
FDA Article Code: 34093-5
- 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.
- 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.
- 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.
250 mg Capsule Label
id: 37e4e490-0ae8-4ad1-9acb-02fd78d69c16
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amoxicillin
Capsules,
USP
250 mg
Rx only
500 mg Capsule Label
id: f088ced2-55eb-4152-b396-cc8cc3d8c617
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amoxicillin
Capsules,
USP
500 mg
Rx only
875 mg Tablet Label
id: 59b803d4-23d1-4ab3-ab52-d4127fee057f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amoxicillin
Tablets, USP
875 mg
Rx only
125 mg/5 mL Oral Suspension Label
id: 5867f605-0ea3-44e5-a3bb-601cd8b931ab
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amoxicillin
for Oral
Suspension, USP
125 mg/5 mL
When reconstituted, each 5 mL
(1 teaspoonful) will contain
amoxicillin trihydrate equivalent
to 125 mg amoxicillin.
Rx only
200 mg/5 mL Oral Suspension Label
id: f703e8d8-da08-4b01-88f8-1e011b712872
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amoxicillin
for Oral
Suspension, USP
200 mg/5 mL
When reconstituted, each 5 mL
(1 teaspoonful) will contain
amoxicillin trihydrate equivalent
to 200 mg amoxicillin.
Rx only
250 mg/5 mL Oral Suspension Label
id: 40dc5cfe-9054-429c-9147-2fe43c11aa49
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amoxicillin
for Oral
Suspension, USP
250 mg/5 mL
When reconstituted, each 5 mL
(1 teaspoonful) will contain
amoxicillin trihydrate equivalent
to 250 mg amoxicillin.
Rx only
400 mg/5 mL Oral Suspension Label
id: dada3914-449a-4902-9635-bcee0738bfe7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Amoxicillin
for Oral
Suspension, USP
400 mg/5 mL
When reconstituted, each 5 mL
(1 teaspoonful) will contain
amoxicillin trihydrate equivalent
to 400 mg amoxicillin.
Rx only
