Pediamox

Pediamox

amoxicillin

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Amoxicillin trihydrate.
Description
Each mL suspension (oral drops) contains: Amoxicillin (as trihydrate) 100 mg.
Each 5 mL (1 teaspoon) suspension contains: Amoxicillin (as trihydrate) 250 mg.
Action
Pharmacology: Pharmacodynamics: Amoxicillin, a semi-synthetic aminopenicillin, kills bacteria by interfering with the synthesis of the bacterial cell wall. It binds to penicillin-binding proteins on the bacterial cell wall and blocks peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that gives cell wall its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycine bridge linking to the fourth residue of the pentapeptide. The transpeptidase that performs this step is inhibited by penicillins. The bacterial cell wall, thus weakened, leads to swelling and rupture of the microorganisms.
Pharmacokinetics: Amoxicillin is generally stable in the presence of acidic gastric secretions and well-absorbed after oral administration. Oral absorption of amoxicillin is 90% and peak serum level is 10 mg/L after a 500 mg oral dose. Peak levels are attained after 1-2 hours. Food has no significant influence on amoxicillin absorption.
Amoxicillin is widely distributed after absorption from the GI tract. The drug is generally distributed into ascitic, synovial and pleural fluids. Amoxicillin is distributed into middle ear effusions, bronchial secretions, sputum, maxillary sinus secretions, and tonsils. It is also distributed into liver, lungs, gallbladder, prostate, and muscle. Only minimal concentration of aminopenicillins including amoxicillin, are attained in the cerebrospinal fluid. Amoxicillin is 17-20 % bound to serum protein. It readily crosses the placenta; amoxicillin concentrations in cord blood are reportedly 25-33% of concurrent maternal serum concentrations.
Approximately 19-33% of a single oral dose of amoxicillin is excreted in urine as penicilloic acids. Like other penicillins, amoxicillin is excreted by renal tubular secretion and to a lesser extent by glomerular filtration. Small amounts of the drug are also excreted in feces and bile. Serum clearance of amoxicillin is reportedly 283 mL/minute. Serum half-life is generally inversely proportional to birthweight, gestational age and chronological age. The serum half-life of amoxicillin is reportedly 3.7 hours in full-term neonates and 0.9-1.9 hours in infants and children.
Amoxicillin is removed by hemodialysis; a 4 - 6 hour period of hemodialysis generally removes 30-40% of a single oral dose of the drug into the dialysate when the dose is given immediately prior to dialysis. Only minimal amounts of amoxicillin appear to be removed by peritoneal dialysis.
Microbiology: Antimicrobial Spectrum of Activity: Amoxicillin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections: (See Table 1.)

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Indications/Uses
For the treatment of the following infections caused by susceptible microorganisms: Ear, nose, throat, genitourinary tract infections; Uncomplicated skin and skin structure infections; Acute otitis media; Lower respiratory tract infections.
Dosage/Direction for Use
Recommended Oral Dosing Regimen: Neonates and infants <3 months: 20-30 mg/kg body weight/day in divided doses every 12 hours.
Infants >3 months and Children < 40 kg: 25-50 mg/kg body weight/day in divided doses every 8 hours or every 12 hours.
Usual Duration of Treatment: 5 to 14 days depending on severity and type of infection.
Or, as prescribed by a physician.
Oral Dosing Regimen for Specific Infections: (See Table 2.)

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Directions for Reconstitution of Powder Suspension and Storage Stability: (See Table 3.)

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Overdosage
Amoxicillin is of low toxicity, although nausea, vomiting, diarrhea, and allergic manifestations may occur. Symptomatic treatment is required for almost all patients. Problems are unlikely if adequate fluid intake and urinary output are maintained; however, crystalluria and hemorrhagic cystitis are possible.
Contraindications
Hypersensitivity to penicillins and to any ingredient in the products.
Patients with infectious mononucleosis due to possible development of rash during therapy.
Special Precautions
A thorough inquiry about the patient's previous hypersensitivity history should be made. Amoxicillin, like other penicillins, cephalosporins and other drugs, may cause serious hypersensitivity reactions and should be used with caution in any patient who has demonstrated some allergy to any drug. There is clinical and laboratory evidence of partial cross-allergenicity among penicillins and other beta-lactam antibiotics including cephalosporins and cephamycins.
Use in Renal Failure: The dose of amoxicillin may have to be reduced due to prolonged plasma half-life.
Use in Pregnancy & Lactation: Amoxicillin has been administered to pregnant women without evidence of adverse effects to the fetus. The use of amoxicillin is currently included in the US Center for Disease Control and Prevention (CDC) recommendations for the treatment of chlamydial infections during pregnancy and for the treatment of cutaneous anthrax or for post-exposure prophylaxis after exposure to Bacillus anthracis spores.
Use with caution in breastfeeding mothers because amoxicillin is distributed into milk and may lead to sensitization of infants.
Use in Elderly:
No special precautions have to be taken when prescribing for the elderly.
Use In Pregnancy & Lactation
Pregnancy and Lactation: Amoxicillin has been administered to pregnant women without evidence of adverse effects to the fetus. The use of amoxicillin is currently included in the US Center for Disease Control and Prevention (CDC) recommendations for the treatment of chlamydial infections during pregnancy and for the treatment of cutaneous anthrax or for post-exposure prophylaxis after exposure to Bacillus anthracis spores.
Use with caution in breastfeeding mothers because amoxicillin is distributed into milk and may lead to sensitization of infants.
Adverse Reactions
Hypersensitivity reactions: Erythematous maculopapular rashes have been reported fairly frequently. Urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis. Rarely, anaphylaxis.
Gastrointestinal effects: Most common symptoms include glossitis, stomatitis, nausea, vomiting, enterocolitis, and diarrhea. Few cases of pseudomembranous colitis have been reported.
Hepatic: Rarely, moderate rise in aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) have been noted.
Hematologic and Lymphatic Systems: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported but are usually reversible on discontinuation of therapy.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioral changes, and/or dizziness have been reported rarely.
Drug Interactions
Concomitant use of penicillins may decrease renal clearance of methotrexate by inhibiting renal tubular secretion amoxicillin. Carefully monitor patients receiving methotrexate and penicillins concomitantly.
Oral probenecid administered shortly before or simultaneously with aminopenicillins slows the rate of renal tubular secretions of penicillins and produces higher and prolonged serum concentrations of the drugs.
Allopurinol may increase the possibility of skin rash, particularly in hyperuricemic patients.
Concomitant use of penicillins with oral contraceptives may cause breakthrough bleeding.
Storage
Store in a dry place at temperatures not exceeding 30°C.
Protect from light.
MIMS Class
ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Presentation/Packing
Oral susp 250 mg/5 mL (off-white to yellow powd for reconstitution into orange, sweet, fruit-flavored) x 60 mL, 105 mL. Oral drops 100 mg/mL (off-white to yellow powd for reconstitution into orange, sweet, fruit-flavored) x 10 mL.
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