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APO-AMOXICILLIN is a brand name for Amoxicillin, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-AMOXICILLIN (Amoxicillin Capsules and Amoxicillin Powder for Oral Suspension) may be indicated in the treatment of infections due to susceptible strains of the following micro- organisms: Gram-negative organisms: H. influenzae, P. mirabilis and N. gonorrhoeae. Gram- positive organisms: Streptococci (including…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Periodic assessment of renal, hepatic and hematopoietic functions should be made during prolonged therapy with APO-AMOXICILLIN. 2 Recommended Dose and Dosage Adjustment Usual Dosage Infections of the upper respiratory tract (ear, nose and throat) due to susceptible strains of streptococci (beta-hemolytic and Streptococcus pneumoniae), non penicillinase-producing staphylococci and H.
influenzae. Infections of the urinary tract due to Proteus mirabilis and Streptococcus faecalis. Infections of the skin and soft-tissues due to streptococci and staphylococci (non penicillinase producing). Adults: 250 mg every 8 hours Children < 20 kg: 20 mg/kg/day in divided doses every 8 hours.
This dosage should not exceed the recommended adult dosage. Children weighing 20 kg or more should be dosed according to the adult recommendations. In severe infections or infections associated with organisms where sensitivity determinations require higher blood concentrations: 500 mg every 8 hours for adults, and 40 mg/kg/day in divided doses every 8 hours for children less than 20 kg may be needed.
Infections of the lower respiratory tract, due to susceptible strains of the causative organism and acute otitis media. Adults: 500 mg every 8 hours APO-AMOXICILLIN (Amoxicillin Capsules and Amoxicillin Powder for Oral Suspension) Page 6 of 30 Children < 20 kg: 40 mg/kg/day in divided doses every 8 hours.
This dosage should not exceed the recommended adult dosage. Children weighing 20 kg or more should be dosed according to the adult recommendations. Urethritis due to nonpenicillinase, producing N. 0 %: Adults and children > 45 kg: (3 g as a single oral dose); 1 g of oral probenecid should be administered concomitantly as well as appropriate therapy for presumptive or proven infection with C.
trachomatis. Children <45 kg: a single 50 mg/kg dose (maximum 3 g) given with a single 25 mg/kg (up to 1 g) dose of probenecid. However, probenecid is not recommended in children under 2 years of age. Appropriate therapy of presumptive or proven infection with C.
trachomatis should be included as well. Cases of gonorrhea with a suspected lesion of syphilis should have darkfield examinations before receiving amoxicillin, and monthly serological tests for a minimum of four months. 5 g 6 hours after the initial dose.
). CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile.
In moderate to severe cases, consideration should be APO-AMOXICILLIN (Amoxicillin Capsules and Amoxicillin Powder for Oral Suspension) Page 10 of 30 given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile.
Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe cases. Hematologic Periodic assessment of hematopoietic function should be made during prolonged therapy with APO-AMOXICILLIN.
Hepatic/Biliary/Pancreatic A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted. Periodic assessment of hepatic function should be made during prolonged therapy with APO- AMOXICILLIN. 2 Clinical Trial Adverse Reactions).
Susceptibility/Resistance Development of Drug Resistant Bacteria Prescribing APO-AMOXICILLIN in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug- resistant bacteria.
03/2026 7 WARNINGS AND PRECAUTIONS, Immune 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ...........................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution ....................................................................................................... 4 Administration .......................................................................................................
5 Missed Dose .......................................................................................................... 7 5 OVERDOSAGE...............................................................................................................
APO-AMOXICILLIN is contraindicated in: • patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. APO-AMOXICILLIN (Amoxicillin Capsules and Amoxicillin Powder for Oral Suspension) Page 5 of 30 • patients with a history of a previous hypersensitivity reaction to any of the penicillins or cephalosporins.
• in cases where infectious mononucleosis is either suspected or confirmed.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Children: 50 mg/kg (not to exceed adult dose) orally 1 hour before procedure; then 25 mg/kg 6 hours after the initial dose. It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary.
Smaller doses than those recommended above should not be used. Even higher doses may be needed at times and in stubborn 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.
Except for gonorrhoea, 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 beta- hemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.
Dosage Adjustment Renal Impairment:
Because amoxicillin is excreted mostly by the kidney, the dosage for patients with renal impairment should be reduced in proportion to the degree of loss of renal function. 3 Reconstitution Reconstituted Solution Instructions for Reconstitution: At the time of dispensing, SHAKE BOTTLE to LOOSEN THE POWDER.
To reconstitute, add the following quantities of water:
Regular Suspension Package Size 125 mg / 5 mL 250 mg / 5 mL 75mL 52 51 100 mL 70 68 150 mL 103 101 Shake thoroughly to obtain a uniform suspension. See 11 STORAGE, STABILITY AND DISPOSAL. 4 Administration In order to obtain optimal absorption of drug from APO-AMOXICILLIN capsules they should be administered between meals with a glass of water (250 mL or 8 fl.
). 5 Missed Dose Patients should be instructed to take APO-AMOXICILLIN at the next scheduled dose and not take two doses at the same time if they miss a dose.
Immune Hypersensitivity Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. 5 Post-Market Adverse Reactions). Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients following oral dosing of penicillins.
These reactions are more likely to occur in patients with a history of hypersensitivity to beta-lactams and individuals with a history of sensitivity to multiple allergens. There have been well-documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with cephalosporins.
Before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins and other allergens. If an allergic reaction occurs, administration of APO-AMOXICILLIN (amoxicillin) should be discontinued and appropriate therapy instituted.
Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated. 5 Post-Market Adverse Reaction).
DIES is an allergic reaction with the leading symptom of protracted vomiting (1 to 4 hours after drug intake) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, APO-AMOXICILLIN (Amoxicillin Capsules and Amoxicillin Powder for Oral Suspension) Page 11 of 30 diarrhoea, hypotension or leucocytosis with neutrophilia.
There have been severe cases including progression to shock. Monitoring and Laboratory Tests Periodic assessment of renal, hepatic and hematopoietic functions should be made during prolonged therapy with APO-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 amoxicillin and oral anticoagulants are prescribed concurrently, particularly upon initiation or cessation of concurrent administration. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Renal Because amoxicillin is excreted mostly by the kidney, the dosage for patients with renal impairment should be reduced in proportion to the degree of loss of renal function. Periodic assessment of renal function should be made during prolonged therapy with APO- AMOXICILLIN.
Skin Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with beta-lactam treatment.
When SCAR is suspected, APO-AMOXICILLIN should be discontinued and appropriate therapy and/or measures should be taken. 1 Pregnant Women The safety of amoxicillin trihydrate in the treatment of infections during pregnancy has not been established.
If the administration of APO-AMOXICILLIN to pregnant patients is considered to be necessary, its use requires that the potential benefits be weighed against the possible hazards to the fetus. 3 Pediatrics Pediatrics (<18): A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted, particularly in infants, but the significance of this finding is not known.
4 Geriatrics Use in the Elderly: There are no known specific […]
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations..............................................................................................
1 Pregnant Women ............................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics ........................................................................................................... 11 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ........................................................................... 5 Post-Market Adverse Reactions ..........................................................................
13 APO-AMOXICILLIN (Amoxicillin Capsules and Amoxicillin Powder for Oral Suspension) Page 3 of 30 9 DRUG INTERACTIONS ................................................................................................. 4 Drug-Drug Interactions ........................................................................................
5 Drug-Food Interactions........................................................................................ 6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions.......................................................................
14 10 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 1 Mechanism of Action........................................................................................... 3 Pharmacokinetics ................................................................................................
14 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 15 PART II: SCIENTIFIC INFORMATION ........................................................................................
16 13 PHARMACEUTICAL INFORMATION ............................................................................. 16 14 CLINICAL TRIALS .........................................................................................................
16 15 MICROBIOLOGY ......................................................................................................... 16 16 NON-CLINICAL TOXICOLOGY ......................................................................................
18 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 21 PATIENT MEDICATION INFORMATION ................................................................................... 22 APO-AMOXICILLIN (Amoxicillin Capsules and Amoxicillin Powder for Oral Suspension) Page 4 of 30 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-AMOXICILLIN (Amoxicillin Capsules and Amoxicillin Powder for Oral Suspension) may be indicated in the treatment of infections due to susceptible strains of the following micro- organisms: Gram-negative organisms: H.
influenzae, P. mirabilis and N. gonorrhoeae.
Gram- positive organisms:
Streptococci (including Streptococcus faecalis and Streptococcus pneumoniae). Amoxicillin is not active against Pseudomonas aeruginosa, indole-positive Proteus species, Serratia marcescens, Klebsiella and Enterobacter species. In emergency cases, where the causative organism is not yet identified, therapy may be initiated with amoxicillin on the basis of clinical judgment while awaiting bacteriologic tests to determine its antimicrobial […]