Amoxicillin 500mg bd

Inactive ingredients: Colloidal silicon dioxide, crospovidone, FD&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

Powder for Oral Suspension : Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125-mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium.

Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium. Each 5 mL of the 250-mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium; each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium.

3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum. AMOXIL® is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase–negative) isolates of Streptococcus species. (?-and ?-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae . AMOXIL® is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis .

AMOXIL® is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase–negative) isolates of Streptococcus spp. (?-and ?-hemolytic isolates only), Staphylococcus spp., or E.

AMOXIL® is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase–negative) isolates of Streptococcus spp.

Triple Therapy for Helicobacter Pylori with Clarithromycin and Lansoprazole.

AMOXIL, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H.

pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H.

pylori has been shown to reduce the risk of duodenal ulcer recurrence.

AMOXIL, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert , Microbiology .) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL (amoxicillin) and other antibacterial drugs, AMOXIL should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dosing For Adult And Pediatric Patients > 3 Months Of Age. Treatment should be continued for a minimum of 48 to 72 hours beyond the

time

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.

In some 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.

Table 1: Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months b Ear/Nose/Throat Skin/Skin Structure 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 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 a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b 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. Dosing In Neonates And Infants Aged ? 12 Weeks ( ? 3 Months) Treatment should be

continued

It is recommended that there be at least 10

days

Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of AMOXIL is 30 mg/kg/day divided every 12 hours.

There are currently no dosing recommendations for pediatric patients with impaired renal function. The recommended adult oral dose is 1 gram AMOXIL, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

The recommended adult oral dose is 1 gram AMOXIL and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information.

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, the required amount of suspension should be placed directly on the child's tongue for swallowing.

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 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

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 : 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 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. 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 inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including AMOXIL, 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 produces toxins A and B which contribute to the development of CDAD.

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 antibacterial use.

Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

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 can be used by phenylketonurics. 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).