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| Augmentin |
Augmentin 1. gm Tablets Amoxicillin trihydrate - Potassium clavulanate
VGlaxoSmth Kline
COMPOSITION
AUGMENTIN 1 g tablets: Each tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate).
PHARMACEUTICAL FORM
AUGMENTIN 1 g tablets: A white to off-white oval-shaped
film-coated debossed tablet, with a score line on one side and plain on the other side.
Indications
AUGMENTIN is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The 3-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a
wider range of organisms, including many resistant to other 13-lactam antibiotics.
AUGMENTIN 1.0 gm tablet for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites:
Upper respiratoiy tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media.
Lower respiratoiy tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia.
Genito-urinaiy tract infections e.g. cystitis, urethritis,
pyelonephritis.
Skin and soft tissue infections, e.g. boils, abscesses, cellulitis, wound infections.
Bone and joint infections e.g. osteomyelitis.
Dental infections e.g. dentoalveolar abscess
Other infections e,g. septic abortion, puerperal sepsis,
intra-abdominal sepsis.
A comprehensive list of susceptible organisms is provided in the Pharmacodynamics section.
VGlaxoSmth Kline
COMPOSITION
AUGMENTIN 1 g tablets: Each tablet contains 875 mg amoxicillin (as amoxicillin trihydrate) and 125 mg clavulanic acid
(as potassium clavulanate).
PHARMACEUTICAL FORM
AUGMENTIN 1 g tablets: A white to off-white oval-shaped
film-coated debossed tablet, with a score line on one side and plain on the other side.
Indications
AUGMENTIN is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The 3-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a
wider range of organisms, including many resistant to other 13-lactam antibiotics.
AUGMENTIN 1.0 gm tablet for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites:
Upper respiratoiy tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media.
Lower respiratoiy tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia.
Genito-urinaiy tract infections e.g. cystitis, urethritis,
pyelonephritis.
Skin and soft tissue infections, e.g. boils, abscesses, cellulitis, wound infections.
Bone and joint infections e.g. osteomyelitis.
Dental infections e.g. dentoalveolar abscess
Other infections e,g. septic abortion, puerperal sepsis,
intra-abdominal sepsis.
A comprehensive list of susceptible organisms is provided in the Pharmacodynamics section.
Dosage and Administration
Usual dosages for the treatment of infection
Adults and children over 12 years
Severe infections One AUGMENTIN 1 g tablet twice daily
Therapy can be started parenterally and continued with an oral preparation. * AUGMENTIN 1 g tablets are not recommended in children of 12 years and under
Dosage in renal impairment
Adults:
Dosage in hepatic impairment
Dose with caution; monitor hepatic function at regular intervals.
Administration
Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.
To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of AUGMENTIN is optimised when taken at the start of a meal.
Treatment should not be extended beyond 14 days without review.
AUGMEN TIN is also available as AUGMENTIN intravenous for the short-term treatment of bacterial infections and for prophylaxis against infection which may be associated with major surgical procedures. AUGMEN TIN intravenous is described in a separate Pack Insert.
AUGMENTIN is also available as a suspension for three times daily dosing for administration to children under the age of 12 years for the treatment of bacterial infections. AUGMEN TIN suspension three times daily is described in a separate Pack Insert.
Contraindications
AUGMEN TIN is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.
AUGMENTIN is contraindicated in patients with a previous history of AUGMENT!N-associated jaundice/hepatic dysfunction.
Warnings and Precautions
Before initiating therapy with AUGMEN TIN careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity (see Contra-indications).
AUGMENTIN should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Administration
Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.
To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of AUGMENTIN is optimised when taken at the start of a meal.
Treatment should not be extended beyond 14 days without review.
AUGMEN TIN is also available as AUGMENTIN intravenous for the short-term treatment of bacterial infections and for prophylaxis against infection which may be associated with major surgical procedures. AUGMEN TIN intravenous is described in a separate Pack Insert.
AUGMENTIN is also available as a suspension for three times daily dosing for administration to children under the age of 12 years for the treatment of bacterial infections. AUGMEN TIN suspension three times daily is described in a separate Pack Insert.
Contraindications
AUGMEN TIN is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.
AUGMENTIN is contraindicated in patients with a previous history of AUGMENT!N-associated jaundice/hepatic dysfunction.
Warnings and Precautions
Before initiating therapy with AUGMEN TIN careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity (see Contra-indications).
AUGMENTIN should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving AUGMENTIN. AUGMENTIN should be used with care in patients on anti-coagulation therapy.
Changes in liver function tests have been observed in some patients receiving AUGMEN TIN. The clinical significance of these changes is uncertain. AUGMEN TIN should be used with caution in patients with evidence of hepatic dysfunction.
Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to six weeks after treatment has ceased.
In patients with renal impairment AUGMENTIN dosage should be adjusted as recommended in the Dosage and Administration section.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Overdose). Interactions
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with AUGMENTIN may result in increased and prolonged blood levels of amoxicillin but not of clavulanate. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of AUGMENTIN and allopurinol. In common with other antibiotics, AUGMENTIN may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Pregnancy and Lactation
Reproduction studies in animals (mice and rats) with orally and parenterally administered AUGMENTIN have shown no teratogenic effects. In a single study in women with preterm, premature rupture of the foetal membrane (pPROM), it was reported that prophylactic treatment with AUGMEN TIN may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.
AUGMENTIN may be administered during the period of lactation. With the exception of the risk of sensitisation, associated with the excretion of trace quantities in breast milk, there are no detrimental effects for the infant.
Effects on Ability to Drive and Use Machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving AUGMENTIN. AUGMENTIN should be used with care in patients on anti-coagulation therapy.
Changes in liver function tests have been observed in some patients receiving AUGMEN TIN. The clinical significance of these changes is uncertain. AUGMEN TIN should be used with caution in patients with evidence of hepatic dysfunction.
Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to six weeks after treatment has ceased.
In patients with renal impairment AUGMENTIN dosage should be adjusted as recommended in the Dosage and Administration section.
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Overdose). Interactions
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with AUGMENTIN may result in increased and prolonged blood levels of amoxicillin but not of clavulanate. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of AUGMENTIN and allopurinol. In common with other antibiotics, AUGMENTIN may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Pregnancy and Lactation
Reproduction studies in animals (mice and rats) with orally and parenterally administered AUGMENTIN have shown no teratogenic effects. In a single study in women with preterm, premature rupture of the foetal membrane (pPROM), it was reported that prophylactic treatment with AUGMEN TIN may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.
AUGMENTIN may be administered during the period of lactation. With the exception of the risk of sensitisation, associated with the excretion of trace quantities in breast milk, there are no detrimental effects for the infant.
Effects on Ability to Drive and Use Machines
Adverse effects on the ability to drive or operate machinery have not been observed.
The 1 g tablet should not be
one I g tablet twice daily administered.
one I g tablet twice daily administered.
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I’ll’’’’”
The AUGMENTIN 1 g tablet should only be used in patients with a glomerular filtration rate of >30 mI/mm.
Mild impairment Moderate impairment | |
(Creatinine clearance
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(Creatinine clearance
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>30 mI/mm)
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10-30 mI/mm)
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awesome post
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