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| Moxacil Pamphlet |
MOXACIL
Broad-Spectrum Antibiotic
Composition:
Capsules: Each capsule containsAmoxycillln 500 mg (asAmoxycillin trihydrate).
Suspension: Each 5 ml of the suspension, after reconstitution, contains Amoxycillin 125mg or 250mg (asAmoxycilliri trihydrate).
Antibacterial action: Amoxyciliin is bactericidal: it adheres to bacterial penicillin-binding proteins, thus inhibiting bacterial cell wail synthesis. Amoxycilliri’s spectrum of action includes non-penicilinase-producing gram-positive and gram-negative bacteria, Streptococcus group B, Neisseria gonorrheae, Proteus mire bills, Salmonella, and H. influenzae. It is also effective against non-penicillinase producing S. aureus, S. pyogenes, S. bovis, S. pneumoniae, S. viridans, N. meningitidis, E. coil, S. typhi, B. partussis, G vaginalis. Peptococcus, and Peptostreptococcus.
Pharmacokinetics: ____
Absorption:Amoxycillin is approximately 80% absorbed after oral administration; peak serum concentrations occur at 1 to 2.5 hours after an oral dose.
Distribution: Amoxycillin distributes into pleural, peritoneal and synovial fluids, and into the lungs, prostate, muscle, ____ liver, and gallbladder; it also penetrates middle ear, maxillary sinus and bronchial secretions, tonsils, and sputum. Amoxycillin readily crosses the placenta. Amoxycillin is 17% to 20% protein-bound.
Metabolism: Amoxycillin is metabolized only partially.
ExcretIon: Amoxycillin is excreted principally in urine by renal tubular secretion and glomerular filtration; It is also excreted in breast milk. Elimination half-life in adults is I to 1.5 hours; severe renal impairment increases the half-life to 7.5 hours. Amoxycillin can be removed by hemodialysis.
Indications and dosage:
Systemic infections; acute and chronic urina,y or respiratory tract Infections; ear, nose and throat infections; gastrointestinal tract infections; biliary tract infections; orthopedic Infections; skin and soft tissue infections; pelvic Infect ions; endocarditls; meningitis and dental abscess caused by susceptible organisms:
Adults: One capsule (500 mg) orally every 8 hours.
Children: 20 to 40 mg / kg orally per day, divided into doses given every 8 hours.
* Uncomplicated gonorrhea:
Adults: 6 capsules (3 g) orally with 1 g proberiecid given as a single dose.
* Uncomplicated urinary tract infections caused by susceptible organisms:
Adults: 6 capsules (3 g) orally given as a single dose.
Dosage in renal failure:
Patients who require repeated doses may need adjustment of dosing intervaL. If creatinine clearance is 10 to 50 mi/mm, increase interval to every 12 hours; if creatinine clearance is < 10 mI/mm, administer every 12 to 16 hours. Supplemental doses may be necessary after hemodialysis.
Contraindications and precautions:
Amoxycillin is contraindicated in patients with known hypersensitivity to any other penicillin or to cephalosporins. Amoxycillin should not be used in patients with infectious mononucleosis, because many patients develop a rash during therapy.
Amoxycflhin should be used cautiously in patients with renal impairment; decreased dosage is required in moderate to severe renal failure.
Interactions:
Concomitant use with allopurinol appears to increase the incidence of skin rash from both drugs.
Probenecid blocks renal tubular secretion of amoxycillin, raising its serum concentrations.
Large doses of penicillins may interfere wfth renal tubular secretion of methotrexate, thus delaying elimination and prolonging elevated serum concentrations of methotrexate.
Concomitant use with an aminoglycoside antibiotic causes a synergistic bactericidal effect against some strains of Enterococci and group B Streptococci.
Effects on diagnostic tests:
Amoxycillin may alter results of urine glucose tests that use cupric sulfate (Benedict’s reagent). Amoxycillin may falsely decrease serum aminoglycoside concentrations.
Adverse reactions:
Gastrointestinal: nausea, vomiting, diarrhea. pseudomembranous colitis..
Hematological: anemia, thrombocytopenia, ttirombocytopenic purpura, eosinophilia, leukopenia.
Other: The hypersensitivity (erythematous macutopapular rash, urticaria. anaphylaxis), bacterial or fungal superinfection.
Note: The drug should be discontinued if immediate hypersensitivity reactions occur or if bone marrow toxicity or ______ acute interstitial nephritis develops.
— Geriatric use:
Because of diminished renal tubular secretion, the half-life may be prolonged in elderly patients.
Pregnancy and breast-feeding:
______ No teratogenic effects have been shown with amoxycillin In animal studies, It belongs to pregnancy risk category “B”. ______ MOXACIL may be considered appropriate when antibiotic treatment is needed in pregnant women. Amoxycillin is
— distributed into breast milk; alternative feeding method may be recommended during therapy.
______ How supplied:
______ Capsules: Box of 12 capsules, each capsule contains 500 mg amoxycillin.
______ 125 mg 15 ml suspension: Bottles of dry powder to give 60 ml, 80 ml or 100 ml of the suspension after reconstitution. 250 mgi 5 ml suspension: BoWes of dry powderto give 60 ml, 80 ml or 100 ml of the suspension after reconstitution.
Storage:
* The capsules should be stored in a dry place below 25° C.
- Before reconstitution, the bottles should be stored in a dry place at a temperature not exceeding 30° C. Once reconstituted, keep under refrigeration to a maximum of 14 days.
Product of:
Medical Union Pharmaceuticals,
Abu.Sultan, Ismailia, Egypt.
Issue date: 2/112008
Composition:
Capsules: Each capsule containsAmoxycillln 500 mg (asAmoxycillin trihydrate).
Suspension: Each 5 ml of the suspension, after reconstitution, contains Amoxycillin 125mg or 250mg (asAmoxycilliri trihydrate).
Antibacterial action: Amoxyciliin is bactericidal: it adheres to bacterial penicillin-binding proteins, thus inhibiting bacterial cell wail synthesis. Amoxycilliri’s spectrum of action includes non-penicilinase-producing gram-positive and gram-negative bacteria, Streptococcus group B, Neisseria gonorrheae, Proteus mire bills, Salmonella, and H. influenzae. It is also effective against non-penicillinase producing S. aureus, S. pyogenes, S. bovis, S. pneumoniae, S. viridans, N. meningitidis, E. coil, S. typhi, B. partussis, G vaginalis. Peptococcus, and Peptostreptococcus.
Pharmacokinetics: ____
Absorption:Amoxycillin is approximately 80% absorbed after oral administration; peak serum concentrations occur at 1 to 2.5 hours after an oral dose.
Distribution: Amoxycillin distributes into pleural, peritoneal and synovial fluids, and into the lungs, prostate, muscle, ____ liver, and gallbladder; it also penetrates middle ear, maxillary sinus and bronchial secretions, tonsils, and sputum. Amoxycillin readily crosses the placenta. Amoxycillin is 17% to 20% protein-bound.
Metabolism: Amoxycillin is metabolized only partially.
ExcretIon: Amoxycillin is excreted principally in urine by renal tubular secretion and glomerular filtration; It is also excreted in breast milk. Elimination half-life in adults is I to 1.5 hours; severe renal impairment increases the half-life to 7.5 hours. Amoxycillin can be removed by hemodialysis.
Indications and dosage:
Systemic infections; acute and chronic urina,y or respiratory tract Infections; ear, nose and throat infections; gastrointestinal tract infections; biliary tract infections; orthopedic Infections; skin and soft tissue infections; pelvic Infect ions; endocarditls; meningitis and dental abscess caused by susceptible organisms:
Adults: One capsule (500 mg) orally every 8 hours.
Children: 20 to 40 mg / kg orally per day, divided into doses given every 8 hours.
* Uncomplicated gonorrhea:
Adults: 6 capsules (3 g) orally with 1 g proberiecid given as a single dose.
* Uncomplicated urinary tract infections caused by susceptible organisms:
Adults: 6 capsules (3 g) orally given as a single dose.
Dosage in renal failure:
Patients who require repeated doses may need adjustment of dosing intervaL. If creatinine clearance is 10 to 50 mi/mm, increase interval to every 12 hours; if creatinine clearance is < 10 mI/mm, administer every 12 to 16 hours. Supplemental doses may be necessary after hemodialysis.
Contraindications and precautions:
Amoxycillin is contraindicated in patients with known hypersensitivity to any other penicillin or to cephalosporins. Amoxycillin should not be used in patients with infectious mononucleosis, because many patients develop a rash during therapy.
Amoxycflhin should be used cautiously in patients with renal impairment; decreased dosage is required in moderate to severe renal failure.
Interactions:
Concomitant use with allopurinol appears to increase the incidence of skin rash from both drugs.
Probenecid blocks renal tubular secretion of amoxycillin, raising its serum concentrations.
Large doses of penicillins may interfere wfth renal tubular secretion of methotrexate, thus delaying elimination and prolonging elevated serum concentrations of methotrexate.
Concomitant use with an aminoglycoside antibiotic causes a synergistic bactericidal effect against some strains of Enterococci and group B Streptococci.
Effects on diagnostic tests:
Amoxycillin may alter results of urine glucose tests that use cupric sulfate (Benedict’s reagent). Amoxycillin may falsely decrease serum aminoglycoside concentrations.
Adverse reactions:
Gastrointestinal: nausea, vomiting, diarrhea. pseudomembranous colitis..
Hematological: anemia, thrombocytopenia, ttirombocytopenic purpura, eosinophilia, leukopenia.
Other: The hypersensitivity (erythematous macutopapular rash, urticaria. anaphylaxis), bacterial or fungal superinfection.
Note: The drug should be discontinued if immediate hypersensitivity reactions occur or if bone marrow toxicity or ______ acute interstitial nephritis develops.
— Geriatric use:
Because of diminished renal tubular secretion, the half-life may be prolonged in elderly patients.
Pregnancy and breast-feeding:
______ No teratogenic effects have been shown with amoxycillin In animal studies, It belongs to pregnancy risk category “B”. ______ MOXACIL may be considered appropriate when antibiotic treatment is needed in pregnant women. Amoxycillin is
— distributed into breast milk; alternative feeding method may be recommended during therapy.
______ How supplied:
______ Capsules: Box of 12 capsules, each capsule contains 500 mg amoxycillin.
______ 125 mg 15 ml suspension: Bottles of dry powder to give 60 ml, 80 ml or 100 ml of the suspension after reconstitution. 250 mgi 5 ml suspension: BoWes of dry powderto give 60 ml, 80 ml or 100 ml of the suspension after reconstitution.
Storage:
* The capsules should be stored in a dry place below 25° C.
- Before reconstitution, the bottles should be stored in a dry place at a temperature not exceeding 30° C. Once reconstituted, keep under refrigeration to a maximum of 14 days.
Product of:
Medical Union Pharmaceuticals,
Abu.Sultan, Ismailia, Egypt.
Issue date: 2/112008
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