Auget

Auget

amoxicillin + clavulanic acid

Manufacturer:

Getz Pharma

Distributor:

Getz Pharma
Full Prescribing Info
Contents
Co-amoxiclav (amoxicillin, clavulanic acid).
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in the combination preparation of co-amoxiclav anticipates this defense mechanism by blocking the β-lactamase enzymes, thus rendering the organism sensitive to amoxicillin's rapid bactericidal effect at concentrations readily attainable in the body.
Microbiology: Co-amoxiclav has shown to be active against most isolates of the following microorganism, both in vitro and in clinical infections.
Gram-Positive Aerobes: Streptococcus pneumoniae, Streptococcus viridans, Staphylococcus saprophyticus, Corynebacterium spp, Listeria monocytogenes, Peptococcus spp, Streptococcus faecalis, Streptococcus pyogenes, Staphylococcus aureus, Staphylococcus epidermidis, Bacillus anthracis.
Anaerobes: Clostridium spp, Peptostreptococcus.
Gram-Negative Aerobes: Haemophilus influenzae, Proteus mirabilis; Klebsiella spp, Shigella, Brucella spp, Salmonella spp, Neisseria meningitides, Pasteurella septica, Escherichia coli spp, Proteus vulgaris, Bordetella pertusis, Neisseria gonorrheae, Vibrio cholerae, Branhamella catarrhalis.
Anaerobes: Bacteroides spp.
Pharmacokinetics: The pharmacokinetics of both amoxicillin and clavulanate in Auget are closely allied and neither is adversely affected by the presence of food in stomach. After oral administration of Auget, it is well absorbed from the gastrointestinal tract with a peak serum level occurring about 1 hr. Absorption of Auget is optimized at the start of meal. Both amoxicillin and clavulanic acid have low level of serum bindings. Neither components in Auget is highly protein bound, approximately 50-70% of amoxicillin and approximately 25-45% of the clavulanic acid are excreted unchanged in urine during the first 6 hrs. Doubling the dosage of Auget approximately doubles the serum level.
Indications/Uses
Short-term treatment of bacterial infections caused by susceptible strains of the designated organism in the following conditions: Upper Respiratory Tract Infections [including Ears, Nose, Throat (ENT)]: Tonsillitis, sinusitis, otitis media.
Lower Respiratory Tract Infection: Acute exacerbations of chronic bronchitis, lobar and bronchopneumonia.
Genitourinary Tract Infections: Recurrent cystitis or complicated excluding prostatitis, septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis, pyelonephritis, female genital infections.
Skin and Soft Tissue Infections: Boils, abscesses, cellulitis and wound infection.
Bone and Joint Infections: Osteomyelitis.
Dental Infections: Debtoalveolar abscess.
Other Infections: Septic abortion, puerperal sepsis, intra-abdominal sepsis, septicemia, peritonitis.
Mixed infections caused by amoxicillin-susceptible organism in conjunction with Auget, susceptible β-lactamase-producing organism may be treated with Auget.
Dosage/Direction for Use
For the infections caused by amoxicillin-sensitive organisms the dosage is that approved for amoxicillin as the clavulanic acid component does not contribute to the therapeutic effect.
Adults: Tablet: 375 mg: 1-2 tablet every 8 hrs at the start of a meal. 625 mg: Severe Infections and Respiratory Tract Infection: 1 tablet every 8 hrs at the start of the meal or one 1,000 mg tab every 12 hrs at the start of the meal.
Since 375-, 625- and 1000-mg tablets contain the same amount of clavulanic acid (125-mg as the potassium salt), two 375-mg tablets are not equivalent to one 625-mg tablet and are not equivalent to one 1,000-mg tablet. Therefore, two 375-mg tablets should not be substituted for one 625-mg tablet or two 625-mg tablets for one 1000-mg tablet for the treatment of more severe infections.
Amoxicillin Sensitive Organism: Upper and Lower Respiratory Tract, Urinary Tract Infection (UTI), Skin and Soft Tissue Infection: 375 mg: 1-2 tablets every 8 hrs. 625 mg: 1 tablet every 8 hrs. 1,000 mg: 1 tablet every 12 hrs. Amoxicillin Resistant Organism: 375 mg: Upper (Otitis Media) and Lower (Bronchitis) Respiratory Tract Infections caused by H. influenzae and H. parainfluenzae: 2 tablets every 8 hrs. UTI (E. coli, K. pneumoniae), Skin and Soft Tissue infections (S. aureus): 1-2 tablets every 8 hrs. Upper (Otitis Media) and Lower (Bronchitis) Respiratory Tract Infections caused by H. influenzae and H. parainfluenzae, UTI (E. coli, K. pneumoniae), Skin and Soft Tissue infections (S. aureus): 625 mg: 1 tablet every 8 hrs. 1,000 mg: 1 tablet every 12 hrs.
Renal Impairment: Both amoxicillin and clavulanic acid excreted by the kidneys and the serum half-life (t½) of each increases in patients with renal failure. Therefore, the dose may need to be reduced or interval extended. Dosage adjustment are based on the maximum recommended level of amoxicillin.
Mild Impairment [Creatinine Clearance (CrCl) >30 mL/min]: No dosage change.
Moderate Impairment (CrCl 10-30 mL/min): 375 mg or 625 mg tablet once every 12 hrs.
Severe impairment (CrCl <10 mL/min): Not more than one 375 mg tablet every 12 hrs.
625 mg tablets are not recommended.
Children: 25-50 mg/kg/day of the 4 parts amoxicillin, 1 part clavulanic acid preparations (which corresponds to a daily dosage of the equivalent of amoxicillin 40 mg/kg and clavulanic acid 5-10 mg/kg) to be taken in divided doses every 8 hrs at the start of meal. Similar reductions in dosage should be made for children.
Hemodialysis decreases serum concentrations of both amoxicillin and clavulanic acid and additional dose should be administered at the end of dialysis.
Contraindications
Co-amoxiclav combination is contraindicated in patients with a history of allergic reactions to β-lactam antibiotics eg, penicillin and cephalosporins.
Patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with co-amoxiclav combination.
Use in pregnancy: Use should be avoided in pregnancy unless considered essential by the physician.
Special Precautions
General: Periodic assessment of organ system functions, including renal, hepatic and hematopoietic function, advisable during prolonged therapy.
Since Auget contains amoxicillin, an aminopenicillin is not the treatment of choice in patients presenting with sore throat or pharyngitis because of the possibility that the underlying cause is infectious mononucleosis, in the presence of which there is a high incidence of rash if amoxicillin is used.
Co-amoxiclav combination should be given with caution to patients with lymphatic leukemia since they are especially susceptible to amoxicillin induced skin rashes.
The possibility of super infections with mycotic or bacterial pathogens should be kept in mind during therapy. If super infections occur (usually involving Aerobacter, Pseudomonas or Candida), the agent should be discontinued and/ or appropriate therapy should be instituted.
Hepatic Impairment: Changes in liver function test have been observed in some patients receiving co-amoxiclav combination. It should be used with care in patients with evidence of severe hepatic dysfunction.
Renal Impairment: In patients with moderate or severe renal impairment the co-amoxiclav combination dosage should be adjusted.
Use in lactation: Amoxicillin is excreted in breast milk. There is no data on the excretion of clavulanic acid in human milk. Trace quantities of clavulanate can be detected in breast milk. With the exception of the risk of sensitization associated with this excretion, there are no known detrimental effects for the breastfed infant.
Use In Pregnancy & Lactation
Use in pregnancy: Use should be avoided in pregnancy unless considered essential by the physician.
Use in lactation:
Amoxicillin is excreted in breast milk. There is no data on the excretion of clavulanic acid in human milk. Trace quantities of clavulanate can be detected in breast milk. With the exception of the risk of sensitization associated with this excretion, there are no known detrimental effects for the breastfed infant.
Adverse Reactions
Co-amoxiclav potassium combination is generally well-tolerated. Adverse effects are uncommon and mainly of a mild and transitory nature.The most frequently reported adverse effects are diarrhea, nausea, vomiting, indigestion, abdominal pain, skin rashes, urticaria and erythema multiforme, vaginitis, abnormal taste, headache, dizziness, tiredness and hot flushes. The incidence and severity of adverse effects, particularly nausea and diarrhea, increased with the higher recommended dose and can be minimized by administering the agent at the start of a meal.
Hypersensitivity Reactions: Angioneurotic edema, anaphylaxis, serum sickness-like syndrome and hypersensitivity vasculitis have been observed. Skin rashes pruritis and urticaria have been occasionally reported. Erythema multiforme, Stevens-Johnson syndrome and less frequently bullous exfoliative dermatitis, toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP) have been reported.
Gastrointestinal Reactions: Effects include gastritis stomatitis, glossitis, black hairy tongue and enterocolitis. Mucocutaneous candidiasis and antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis) have been reported. If gastrointestinal reactions are evident, they may be reduced by taking Auget at the start of a meal.
Hepatic Effects: Hepatitis and cholestatic jaundice have been reported. Hepatic events have been reported predominantly in males or elderly patients and may be associated with prolonged treatment. Signs and symptoms usually occur during or shortly after treatment, but in some cases may not become apparent until several weeks after treatment has ceased.
Hematologic Effects: Hemolytic anemia, reversible thrombocytopenia, thrombocytopenic purpura, eosinophilia, reversible leukopenia (including neutropenia or agranulocytosis) have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Prolongations of bleeding time and prothrombin time have also been reported less frequently.
Central Nervous System Effects: Central nervous system effects have been seen rarely. These include reversible hyperactivity, dizziness, headache and convulsion. Convulsions may occur with impaired renal function or in those receiving high doses.
Renal and Urinary Tract Disorders:
Crystalluria has been reportedly very rarely.
Miscellaneous: Superficial tooth discoloration has been reported rarely. It usually can be removed by brushing.
Drug Interactions
Probenecid decreases the renal tubular secretion of amoxicillin, but does not affect clavulanic acid excretion. Concomitant use with co-amoxiclav combination may result in increased and prolonged blood levels of amoxicillin but not clavulanic acid.
Prolongation of bleeding time and prothrombin time have been reported in some patients receiving co-amoxiclav combination. Co-amoxiclav combination should be used with care in patients on anticoagulation therapy.
In common with other broad-spectrum antibiotics. Amoxicillin + clavulanate potassium combination may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
The concomitant administration of allopurinol and ampicillin substantially increases the incidence of skin rashes in patients receiving both agents as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in this patients. There are no data on amoxicillin + clavulanate potassium combination and allopurinol administered concomitantly.
Following administration of ampicillin to pregnant woman a transient decreases in plasma concentration of total conjugate estriol, estriolglucuronide, conjugated estrone and estradiol has been noted. This effect may also occur with amoxicillin and therefore amoxicillin + clavulanate potassium combination.
MIMS Class
Penicillins
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 250 mg/125 mg x 100's. 500 mg/125 mg x 100's. 875 mg/125 mg x 10's, 14's. Powd for oral susp 250 mg/62.5 mg/5 mL x 60 mL x 1's. 400 mg/57 mg/5 mL x 70 mL x 1's. Powd for inj 500 mg/100 mg (vial) 20 mL x 1's. 1 g/200 mg (vial) x 1's.
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