Amoxicillin chewable tablets

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 Strength Bottle Size Amount of Water Reauired for Reconstitution Oral Suspension 125 mg/5 mL 80 mL 62 mL 100 mL 78 mL 150 mL 116 mL Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL Oral Suspension 250 mg/5 mL 80 mL 59 mL 100 mL 74 mL 150 mL 111 mL Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL.

After

reconstitution

placed

child

Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks.

These preparations should then be taken immediately. Any unused portion of the reconstituted suspension must be discarded after 14 days.

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. 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.

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

250

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

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

AND

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 inserts.

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 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

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

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 whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. AMOXIL may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.