Amoxy 500 mg

Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate. Each 5 mL of reconstituted bubble-gumflavored suspension contains 200 mg, 250 mg or 400 mg amoxicillin as the

trihydrate

Capsules: Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500.

NDC 43598-025-01 Bottles of 100 NDC 43598-025-05 Bottles of 500.

NDC 43598-005-01 Bottles of 100 NDC 43598-005-05 Bottles of 500.

Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.

Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively.

NDC 43598-024-01 Bottles of 100 NDC 43598-024-05 Bottles of 500. NDC 43598-019-01 Bottles of 100 NDC 43598-019-14 Bottles of 20. Powder for Oral Suspension: 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 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

NDC 43598-022-80 80-mL bottle NDC 43598-022-52 100-mL bottle NDC 43598-022-53 150-mL bottle.

NDC 43598-023-50 50-mL bottle NDC 43598-023-51 75-mL bottle NDC 43598-023-52 100-mL bottle. NDC 43598-009-80 80-mL bottle NDC 43598-009-52 100-mL bottle NDC 43598-009-53 150-mL bottle. NDC 43598-007-50 50-mL bottle NDC 43598-007-51 75-mL bottle NDC 43598-007-52 100-mL bottle.

Store at or below 20° C (68° F) -250 mg and 500 mg Capsules and 125 mg and 250 mg unreconstituted powder.

Store at or below 25° C (77° F) -500 mg and 875 mg Tablets and 200 mg and 400 mg unreconstituted powder. The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see WARNINGS AND PRECAUTIONS ] CDAD [see WARNINGS AND PRECAUTIONS ] Clinical Trials Experience.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (> 1%) observed in clinical trials of AMOXIL capsules, tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy : The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).

Dual therapy : The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their

package

In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due mox 500 in pregnancy to a combination of their seriousness, frequency of reporting, or potential causal connection to AMOXIL.

Infections and Infestations : Mucocutaneous candidiasis.

Gastrointestinal : Black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see WARNINGS AND PRECAUTIONS ].

Hypersensitivity Reactions : Anaphylaxis [see WARNINGS AND PRECAUTIONS ]. 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. Liver : A moderate rise in AST and/or ALT 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 been reported [see OVERDOSAGE ].

Hemic and Lymphatic Systems : Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. 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 Miscellaneous : Tooth discoloration (brown, yellow, or gray staining) has been reported. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases. Probenecid decreases the renal tubular secretion of amoxicillin.

Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.

Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone.

It is not

known

AMOXIL may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 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.

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 or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. 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 AMOXIL,

careful

directed

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

Prescribing AMOXIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash.

Thus amoxicillin should not be administered to patients with mononucleosis. Amoxil chewable tablets contain aspartame which contains phenylalanine. Each 200 mg chewable tablet contains 1.82 mg phenylalanine; each 400 mg chewable tablet contains 3.64 mg phenylalanine.

The oral suspensions of Amoxil do not contain phenylalanine

and

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 (AUGMENTIN).

AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay.

AUGMENTIN 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.

AUGMENTIN was negative in the mouse micronucleus test and in the dominant

lethal

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 2 times the 3 g human dose based on body surface area).

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. 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 AMOXIL should be modified in pediatric patients 12 weeks or younger ( ? 3 months).

An analysis of

clinical

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.