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AUGMENTIN (CO-AMOXICLAV)

Posted by Blog Thursday, February 10, 2011

Brief prescribing information (Oral)
Active Ingredient:
Amoxicillin trihydrate and Clavulanic potassium. Indication: Short-term treatment of bacterial infections of upper respiratory tract infections, lower respiratory tract infections, genitourinary tract infections, skin and soft tissue infections, bone and joint infections, dental infections, other infections e.g intra-abdominal sepsis.
Dosage and Administration:
 Adults and Children over 12 years:
 Mild-Moderate infections: 1 tablet 375 mg 3 times a day OR one 625mg tablet twice daily. Severe infections: 1 g tablet twice daily or one 625 mg tablet 3 times a day. Where the 625mg tablet is not available, a dose of two AUGMENTIN 375mg tablets 3 times a day may be taken. Therapy can be started parenterally and continued with an oral preparation.
 Children:
 The usual recommended daily dosage is 25mg/kg/day in divided doses every 8 hours. <1 yr: 25 mg/kg/day. 1-6 yrs (10-18 kg): 5 ml AUGMENTIN 156.25 mg suspension 3 times a day. > 6 yrs (18-40 kg): 5 ml AUGMENTIN 312.5 mg suspension 3 times a day. In more serious infections the dosage may be increased up to 50 mg/kg/day in divided doses every 8 hrs. AUGMENTIN 375mg and 625 mg tablets are not recommended in children of 12 yrs
 In dental infections:
 One 375 mg tablet 3 times a day for 5 days.
 In renal impairment:
See package insert leaflet.
 Contraindications:
 It is contraindicated in patients with a history of hypersensitivity to beta-lactams, eg. penicillins and cephalosporins and with a previous history of AUGMENTM-associated jaundice/hepatic dysfunction.
 Warnings and Precautions:
Before initiating therapy with AUGMENTIN, 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. 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. Adjust dosage in patients with renal impairment. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms. Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving AUGMENTIN and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
Adjustments
in the dose of oral anticoagulants may be necessary io maintain the desired level of anticoagulation. 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 AUGMENTIN suspension contains 12.5 mg aspartame per 5 ml dose, which is a source of phenylalanine, and therefore should be used with caution in patients with phenylketonuria.
 Interactions:
 Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. In common with other antibiotics, AUGMENTIN may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives. In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of AUGMENTIN.
 Pregnancy and Lactation:
 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. Adverse Reactions:
 Common:
 Mucocutaneous candidiasis, diarrhoea, nausea, vomiting. Nausea is more often associated with higher oral doses. Uncommon: Dizziness, headache, indigestion. A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics.
 Rare:
Reversible leucopenia (including neutropenia) and thrombocytopenia.
 Very rare:
 Reversible agranulocytosis and haemolytic anaemia, prolongation of bleeding and prothrombin time, angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis, dizziness, headache, reversible hyperactivity, convulsion. Convulsions may occur in patients with impaired renal function or in those taking high doses. Antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis), black hairy tongue. Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing. Hepatitis, cholestatic jaundice, skin rash, pruritus, urticaria, erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatitis, acute generalized exanthemous pustulosis (AGEP), interstitial nephritis and crystalluria.
Overdose:
 Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Gastrointestinal symptoms may be treated symptomatica!ly with attention to the water electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed. AUGMENTIN can be removed from the circulation by haemodialysis.

Prescribing information (Infant drops)
QUALITATIVE AND QUANTITATIVE COMPOSITION AUGMENTIN
infant drops contain 50 mg amoxicillin (as amoxicillin trihydrate) and 12.5 mg clavulanic acid (as potassium clavulanate) perl ml.
 PHARMACEUTICAL FORM
 Dry powder for reconstitution in water, at time of dispensing, to form an oral sugar-free suspension.
 CLINICAL PARTICULARS Indications
AUGMENTIN infant drops 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. Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia. Genito-urinary 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. Other infections e.g. intra abdominal sepsis. A comprehensive list of susceptible organisms is provided in the Pharmacodynamics section.
 Infections caused by amoxicillin-susceptible organisms are amenable to AUGMENTIN treatment due to its amoxicillin content. Mixed infections caused by amoxicillin-susceptible organisms in conjunction with >WGMEN77N-susceptible -lactamase producing organisms may therefore be treated with AUGMENTIN. Dosage and Administration
 The usual recommended daily dosage is 25 mg/kg/day* in divided doses every eight hours.
 In more serious infections the dosage may be increased up to 50 mg/kg/day in divided doses every eight hours. * Each 25 mg AUGMENTIN provides 20 mg amoxicillin and 5 mg clavulanate. AUGMENTIN infant drops should be administered using the supplied syringe doser. The syringe doser has markings which correspond to the weight of the child.
 For example,
for a child weighing 7 kg, the syringe piston should be withdrawn until the 7 kg marking is level with the top of the body of the syringe. The dose (equivalent to 0.93 ml) should then be orally administered to the child. A similar dose should be administered once every eight hours. For information, the volumes of AUGMENTIN infant drops which correspond to the weight markings are shown below:





Dosage in hepatic impairment
 Dose with caution; monitor hepatic function at regular intervals.
 Administration
 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. Duration of therapy should be appropriate to the indication and should not be extended beyond 14 days without review.
 Contraindications
 AUGMENTIN is contra indicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins. AUGMENTIN is contra indicated in patients with a previous history of AUGME/vT/A/-associated jaundice/hepatic dysfunction.
Warnings and Precautions
Before initiating therapy with AUGMENTIN, 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 Contraindications).
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. Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving AUGMENTIN and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.
Adjustments
in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. Changes in liver function tests have been observed in some patients receiving AUGMENTIN. The clinical significance of these changes is uncertain but AUGMENTIN 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). AUGMENTIN suspensions contain 2.5 mg aspartame per 1 ml, which is a source of phenylalanine, and therefore should be used with caution in patients with phenylketonuria.
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. In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of AUGMENTIN.
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 AUGMENTIN 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.
Adverse Reactions
Data from large clinical trials were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e., those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency. The following convention has been used for the classification of frequency: very common >1/10 common >1/100 and <1/10 uncommon >1/1000 and <1/100 rare >1/10,000 and <1/1000 very rare <1/10,000. 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 time and prothrombin time Immune system disorders Very rare Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis Nervous system disorders Uncommon Dizziness, headache Very rare Reversible hyperactivity and convulsions.
Convulsions
may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders
Common Diarrhoea, nausea, vomiting Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking AUGMENTIN at the start of a meal. Uncommon Indigestion
Very rare Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis). Black hairy tongue Superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing. Hepatobiliary disorders
Uncommon
A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics, but the significance of these findings is unknown Very rare Hepatitis and cholestatic jaundice. These events have been noted with other penicillins and cephalosporins. Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children.
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. These are usually reversible. Hepatic events may be severe and in extremely rare circumstances, deaths have been reported. 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 Very rare Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatitis, acute generalised exanthemous pustulosis (AGEP) If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued.
Renal and urinary disorders
Very rare Interstitial nephritis, crystalluria (see Overdose,)
Overdose
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. Gastrointestinal symptoms may be treated symptomatically with attention to the water electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Warnings and Precautions). AUGMENTIN may be removed from the circulation by haemodialysis.

1 Responses to AUGMENTIN (CO-AMOXICLAV)

  1. John Scott Says:
  2. Nice blog..

    Pharma info source- Amoxicillin Trihydrate suppliers

     

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