AMOXICILLIN
AMOXICILLIN
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Clinical information
Indications & Usage
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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. Amoxicillin Capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: Amoxicillin Capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.6 , 1.7 ) 1.1 Infectio ns of the ear, nose, and throat – due to Streptococcus species, (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . 1.2 Infections of the genitourinar y tract – due to Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . 1.3 Infections of the skin and skin structure – due to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . 1.4 Infections of the lower respir atory tract – due to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae . 1.5 Gonorrhea, acute uncomplicated (ano-genital and urethral i nfections in males and females) – due to Neisseria gonorrhoeae . Because of high rates of amoxicillin resistance, Amoxicillin Capsules are not recommended for empiric treatment of gonorrhea. Amoxicillin Capsules use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin. 1.6 Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole Amoxicillin Capsules 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 . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 1.7 Dual therapy for H. pylori with lansoprazole Amoxicillin Capsules 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION In adults, 750-1750 mg/day in divided doses every 8-12 hours. In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.1 , 2.2 , 2.3 ) Treatment of gonorrhea is 3 grams as a single oral dose. ( 2.1 ) The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day divided every 12 hours. ( 2.2 ) Dosing for H. pylori Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.3 ) Reduce the dose in patients with severe renal impairment (GFR 3 Months of Age 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 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 Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children: 50 mg/kg amoxicillin, combined with 25 mg/kg probenecid as a single dose. Note: since probenecid is contraindicated in children under 2 years. Do not use this regimen in children under 2 years of age. 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. 2.2 Dosing in Neonates and Infants Aged ≤ 12 Weeks (≤ 3 Months) 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 Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. 2.3 Dosing for H. pylori Infection Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information. 2.4 Dosing in Renal Impairment 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 < 30 mL/min. should not receive a 875-mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.
Contraindications
4 CONTRAINDICATIONS Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other β-lactam antibiotics (e.g., penicillins and cephalosporins). History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins). ( 4 ).
Safety
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] CDAD [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin capsules were diarrhea, rash, vomiting, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 amoxicillin capsules 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. 6.2 Postmarketing or Other Experience 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 amoxicillin. 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 ( 5.2 )] . Hypersensitivity Reactions: Anaphylaxis [see Warnings and Precautions ( 5.1 )] . 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 ( 10 )] . 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. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Drug Interactions
7 DRUG INTERACTIONS Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin. ( 7.1 ) Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Coadministration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. 7.2 Oral Anticoagulants 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. 7.3 Allopurinol 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. 7.4 Oral Contraceptives Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Other Antibacterials 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. 7.6 Effects on Laboratory Tests 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.
Additional information
Description
11 DESCRIPTION Formulations of Amoxicillin Capsules, USP 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-zabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O and the molecular weight is 419.45. Capsules: Each Amoxicillin Capsule, USP contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule with caramel cap and ivory body is imprinted with West-ward 938, while the 500 mg capsule with ivory cap and ivory body is imprinted with West-ward 939. Inactive ingredients: croscarmellose Sodium, gelatin, magnesium stearate, titanium dioxide and yellow iron oxide. Additionally, the 250 mg capsules contain black iron oxide and red iron oxide. structural formula image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin Capsules, USP 500 mg are available as ivory cap and ivory body. The cap of the 500 mg capsule is imprinted with West-ward and the body with 939. NDC 72789-254-21: Bottle of 21 Capsules NDC 72789-254-60: Bottle of 60 Capsules Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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Frequently Asked Questions
What is amoxicillin used for?+
Amoxicillin is an antibiotic used to treat bacterial infections by stopping the growth of bacteria. It is commonly prescribed for infections such as pneumonia, bronchitis, and infections of the ear, nose, throat, skin, and urinary tract. Consult a doctor to determine if amoxicillin is the right treatment for your specific condition.
How long does it take for amoxicillin to start working?+
Amoxicillin starts working within a few hours of taking the first dose, but it may take a few days to notice an improvement in symptoms. The full effect of the medication may not be seen until the entire course of treatment is completed. Consult a doctor to discuss the expected timeline for your specific condition and treatment plan.
Can I take amoxicillin with other medications?+
Amoxicillin can interact with certain medications, such as blood thinners and certain antibiotics, which may increase the risk of side effects. It is essential to inform your doctor about all medications you are currently taking before starting amoxicillin. Consult a doctor to discuss potential interactions and ensure safe treatment.
What are the common side effects of amoxicillin?+
Common side effects of amoxicillin include nausea, vomiting, diarrhea, and stomach pain. More severe side effects, such as allergic reactions and liver damage, can occur but are rare. Consult a doctor if you experience any side effects, as they can help determine the best course of action and adjust your treatment plan if necessary.
Can I stop taking amoxicillin if I feel better before finishing the prescribed course?+
It is crucial to complete the full course of amoxicillin as prescribed by your doctor, even if you start feeling better before finishing the medication. Stopping the medication too soon can lead to the development of antibiotic-resistant bacteria and reduce the effectiveness of the treatment. Consult a doctor to discuss any concerns or questions you have about your treatment plan.
MEDICAL DISCLAIMER
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