Augmentin
آگمینٹن
QUALITATIVE AND QUANTITATIVE COMPOSITION: AUGMENTIN 375 mg tablets: Each tablet contains 250 mg Amoxycillin (as the Amoxycillin trihydrate U.S.P.) and 125 mg clavulanic acid (as the potassium salt B.P).AUGMENTIN suspension 312.50 mg/5ml: When reconstituted each 5 mL contains 250 mg Amoxycillin (as the Amoxycillin trihydrate U.S.P.) and 62.50 mg clavulanic acid (as the potassium salt B.P.).
CLINICAL PARTICULARS:
AUGMENTIN is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxycillin to embrace a wider range of organisms, including many resistant to other
beta-lactam antibiotics.
AUGMENTIN should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.
AUGMENTIN oral presentations for three times daily dosing, are indicated for short-term treatment of bacterial infections at the following sites: Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media, typically caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis (AECB), (AECOPD), lobar and bronchopneumonia, typically caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis, female genital infections typically caused by Enterobacteriaceae (mainly Escherichia coli), Staphylococcus saprophyticus and Enterococcus species and gonorrhoea caused by Neisseria gonorrhoeae.
Skin and soft tissue infections, e.g. boils, abscesses, cellulitis, wound infections.
Bone and joint infections e.g. osteomyelitis, typically caused by Staphylococcus aureus, where more prolonged therapy may be appropriate.
Dental infections e.g. dentoalveolar abscess
Other infections e.g. intra-abdominal sepsis, septic abortion, puerperal sepsis.
Susceptibility to AUGMENTIN will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.
Dosage and Administration:
To minimise potential gastrointestinal intolerance, administer at the start of a meal. Treatment should not be extended beyond 14 days without review. Therapy can be started parenterally and continued with an oral preparation.
Adults and Children over 12 years: Mild – Moderate infections: One AUGMENTIN 375 mg tablet every 8 hours or One AUGMENTIN 625 mg tablet every 12 hours.
Severe infections: One AUGMENTIN 1 g tablet every 12 hours or One AUGMENTIN 625 mg tablet every 8 hours or Two AUGMENTIN 375 mg tablets every 8 hours.
The usual recommended daily dosage is:
No clinical data are available on doses above 40/10 mg/kg/day in children under 2 years The tables below give dosage guidance for children.
AUGMENTIN is contra-indicated in patients with a previous history of AUGMENTIN-associated jaundice/hepatic dysfunction.
Probenecid decreases the renal tubular secretion of amoxycillin. Concomitant use with AUGMENTIN may result.
Pregnancy and Lactation:
Reproduction studies in animals (mice and rats) with orally and parenterally administered AUGMENTIN have shown no teratogenic effects.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.
Infections and infestations:
Common Mucocutaneous candidiasis
Blood and lymphatic system disorders
Rare
Reversible leucopenia (including neutropenia) and thrombocytopenia.
Very rare
Reversible agranulocytosis and haemolytic anaemia. Prolongation of bleeding lime and prothrombin time
Very Rare Angloneurotic oedema, anaphylaxis (see Warnings and Precautions) serum sicknes-like syndroma, hyperserisitvity vascultis (se abso Skin wind tissue
Uncommon Dizziness, headache
Very rare
Reversible hyperactivity, aseptic meningitis, convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Cardiac disorders:
Very rare Kounis syndrome
Gastrointestinal disorders:
Uncommon Indigestion
Very rare Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis), drug-induced enterocolitis syndrome (see Warnings and Precautions). Black hairy tongue. Good oral hygiene may help to prevent tooth discolouration as it can
Very rare Hepatitis and cholestatic jaundice.
in children These are usually reversible. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.
Skin and subcutaneous tissue disorders:
Uncommon Skin rash, pruritus, urticaria
Rare
Erythema multiforme
Linear IgA disease.
Very rare Interstitial nephritis, crystalluria (see Overdose)
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident.
Special Precautions for Storage:
Do not take after the expiry date shown on the pack. Store in a dry place in the original packaging to protect from moisture.
Refer to pack for storage temperature.
AUGMENTIN tablet packs contain in a form of dessiflex fail.
Not all presentations are available in every country.
Version number: GDS28/IP118 Date of issue: 23 February 2023
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Manufactured by:
GlaxoSmithKline Pakistan Limited
gsk
GlaxoSmithKlin