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Clavulin (Amoxicillin Trihydrate Clavulanate Potassium)
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Pharmacology
Amoxicillin exerts a bactericidal action against sensitive organisms during the stage of active multiplication, through the inhibition of the biosynthesis of bacterial cell wall mucopeptides. Clavulanic acid inhibits specific b-lactamases of some microorganisms and allows amoxicillin to inhibit amoxicillin (ampicillin)-resistant organisms which produce clavulanic acid sensitive b-lactamases.
Amoxicillin exerts a bactericidal action against sensitive organisms during the stage of active multiplication, through the inhibition of the biosynthesis of bacterial cell wall mucopeptides. Clavulanic acid inhibits specific b-lactamases of some microorganisms and allows amoxicillin to inhibit amoxicillin (ampicillin)-resistant organisms which produce clavulanic acid sensitive b-lactamases.
Indications
Amoxicillin Exerts A Bactericidal Action Against Sensitive Organisms During The Stage Of Active Multiplication, Through The Inhibition Of The Biosynthesis Of Bacterial Cell Wall Mucopeptides. Clavulanic Acid Inhibits Specific B-lactamases Of Some Microorganisms And Allows Amoxicillin To Inhibit Amoxicillin (ampicillin)-resistant Organisms Which Produce Clavulanic Acid Sensitive B-lactamases.
Amoxicillin Exerts A Bactericidal Action Against Sensitive Organisms During The Stage Of Active Multiplication, Through The Inhibition Of The Biosynthesis Of Bacterial Cell Wall Mucopeptides. Clavulanic Acid Inhibits Specific B-lactamases Of Some Microorganisms And Allows Amoxicillin To Inhibit Amoxicillin (ampicillin)-resistant Organisms Which Produce Clavulanic Acid Sensitive B-lactamases.
Contraindications
In patients with a history of hypersensitivity to the penicillin, or cephalosporin group of b-lactams.
In patients where infectious mononucleosis is either suspected or confirmed.
In patients with a previous history of Clavulin-associated jaundice/hepatic dysfunction.
In patients with a history of hypersensitivity to the penicillin, or cephalosporin group of b-lactams.
In patients where infectious mononucleosis is either suspected or confirmed.
In patients with a previous history of Clavulin-associated jaundice/hepatic dysfunction.
Safety Information / Warning
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients on penicillin therapy, including Clavulin. Although these reactions are more frequent following parenteral therapy, they have occurred in patients receiving penicillins orally. These reactions are more apt to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of cephalosporin hypersensitivity who have experienced severe reactions when treated with penicillins. Before initiating therapy with Clavulin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
If an allergic reaction occurs, the administration of Clavulin should be discontinued and appropriate therapy should be instituted. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, i.v. steroids, and airway management, including intubation, should also be used as indicated.
Clavulin should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of Clavulin is usually reversible. On rare occasions, deaths have been reported (less than 1death reported per estimated 4million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications (see Contraindications and Adverse Effects, Liver).
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis and angioedema) have been reported in patients on penicillin therapy, including Clavulin. Although these reactions are more frequent following parenteral therapy, they have occurred in patients receiving penicillins orally. These reactions are more apt to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of cephalosporin hypersensitivity who have experienced severe reactions when treated with penicillins. Before initiating therapy with Clavulin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
If an allergic reaction occurs, the administration of Clavulin should be discontinued and appropriate therapy should be instituted. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, i.v. steroids, and airway management, including intubation, should also be used as indicated.
Clavulin should be used with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of Clavulin is usually reversible. On rare occasions, deaths have been reported (less than 1death reported per estimated 4million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications (see Contraindications and Adverse Effects, Liver).
Precautions
General: Periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy with Clavulin.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy with Clavulin. If superinfection should occur (usually involving Aerobacter, Pseudomonas, or Candida), the administration of Clavulin should be discontinued and appropriate therapy instituted.
The occurrence of a morbilliform rash following the use of ampicillin in patients with infectious mononucleosis is well documented. This reaction has also been reported following the use of amoxicillin. A similar reaction would also be expected with Clavulin.
Clavulin suspensions, which contain aspartame, should be used with caution in patients with phenylketonuria.
Renal: Clavulin is excreted mostly by the kidney. There are insufficient data to make specific dosage recommendations for patients with renal dysfunction. However, either a reduction in dose level or an extension in dose interval in proportion to the degree of loss of renal function will be needed.
Pregnancy: The safety of Clavulin in the treatment of infections during human pregnancy is unknown. As with all medicines, use should be avoided during pregnancy, especially during the first trimester, unless the anticipated benefit justifies the potential risk to the fetus.
Lactation: Penicillins (including ampicillin) have been shown to be excreted in human breast milk. It is not known whether clavulanic acid is excreted in breast milk. Caution should be exercised if Clavulin is to be administered to a nursing mother.
Drug Interactions : In common with other broad-spectrum antibiotics, Clavulin may reduce the efficacy of oral contraceptives and patients should therefore be advised accordingly.
Concomitant use of probenecid is not recommended, and may result in increased and prolonged blood levels of amoxicillin, but not of clavulanic acid.
Children: Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of Clavulin should be modified in pediatric patients younger than 12 weeks (3 months) (see Dosage, Children).
In infants 12 weeks (3 months) of age or older and in children, b.i.d. use of the Clavulin 200 and 400 mg formulations is recommended because of a significantly reduced incidence of diarrhea with the b.i.d. regimen.
General: Periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy with Clavulin.
The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy with Clavulin. If superinfection should occur (usually involving Aerobacter, Pseudomonas, or Candida), the administration of Clavulin should be discontinued and appropriate therapy instituted.
The occurrence of a morbilliform rash following the use of ampicillin in patients with infectious mononucleosis is well documented. This reaction has also been reported following the use of amoxicillin. A similar reaction would also be expected with Clavulin.
Clavulin suspensions, which contain aspartame, should be used with caution in patients with phenylketonuria.
Renal: Clavulin is excreted mostly by the kidney. There are insufficient data to make specific dosage recommendations for patients with renal dysfunction. However, either a reduction in dose level or an extension in dose interval in proportion to the degree of loss of renal function will be needed.
Pregnancy: The safety of Clavulin in the treatment of infections during human pregnancy is unknown. As with all medicines, use should be avoided during pregnancy, especially during the first trimester, unless the anticipated benefit justifies the potential risk to the fetus.
Lactation: Penicillins (including ampicillin) have been shown to be excreted in human breast milk. It is not known whether clavulanic acid is excreted in breast milk. Caution should be exercised if Clavulin is to be administered to a nursing mother.
Drug Interactions : In common with other broad-spectrum antibiotics, Clavulin may reduce the efficacy of oral contraceptives and patients should therefore be advised accordingly.
Concomitant use of probenecid is not recommended, and may result in increased and prolonged blood levels of amoxicillin, but not of clavulanic acid.
Children: Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of Clavulin should be modified in pediatric patients younger than 12 weeks (3 months) (see Dosage, Children).
In infants 12 weeks (3 months) of age or older and in children, b.i.d. use of the Clavulin 200 and 400 mg formulations is recommended because of a significantly reduced incidence of diarrhea with the b.i.d. regimen.
Side Effects / Adverse Effects
The following adverse reactions have been observed during therapy with Clavulin.
Gastrointestinal: nausea, vomiting, diarrhea, abdominal cramps, flatulence, constipation, anorexia, colic pain, acid stomach, mucocutaneous candidiasis, intestinal candidiasis, antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis) have been reported rarely. If gastrointestinal reactions are evident, they may be reduced by taking Clavulin at the start of the meal. The incidence of gastrointestinal side effects tends to be proportional to dose and tends to be greater in children than in adults.
A US-Canadian clinical trial compared a 10-day Clavulin b.i.d. regimen (45/6.4 mg/kg/day q12h) with a 10-day Clavulin t.i.d. regimen (40/10 mg/kg/day q8h) in 575 patients with acute otitis media, aged 2 months to 12 years. The incidence of diarrhea was significantly lower in patients who received the b.i.d. regimen compared to patients who received the t.i.d. regimen (9.6% vs 26.7%; p<0.001). Significantly fewer patients who received the b.i.d. regimen withdrew due to diarrhea compared to patients receiving the t.i.d. regimen (2.8% vs 7.6%; p=0.009). The incidence of related/possibly related diaper rash was also lower in patients who received the b.i.d. regimen compared to patients who received the t.i.d. regimen (3.1% vs 6.6%; p=0.054).
Data from 2 pivotal studies in 1191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875 mg Clavulin tablets every 12 hours with 500 mg Clavulin tablets dosed every 8 hours.
The most frequently reported adverse event was diarrhea; incidence rates were similar (14.9% and 14.3% respectively) for the 875 mg every 12 hours and 500 mg every 8 hours dosing regimens. However, there was a statistically significant difference in rates of moderate/severe diarrhea between the regimens: 3.4% for 875 mg every 12 hours dosing vs 5.9% for the 500 mg every 8 hours dosing.
Hypersensitivity: erythematous maculopapular rash, urticaria, anaphylaxis, hypersensitivity vasculitis and pruritus. A morbilliform rash in patients with mononucleosis. Rarely erythema multiforme and Stevens-Johnson syndrome have been reported. Other reactions, including angioedema, toxic epidermal necrolysis and exfoliative dermatitis, and acute generalized exanthematous pustulosis (AGEP) as in the case of other b-lactam antibiotics, have been seen rarely. Interstitial nephritis can occur rarely.
Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and if necessary systemic corticosteroids. Whenever such reactions occur, Clavulin should be discontinued, unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to Clavulin therapy.
Liver: Transient hepatitis and cholestatic jaundice have been reported rarely. These events have been noted with other penicillins and cephalosporins. The hepatic events associated with Clavulin may be severe, and occur predominantly in adult and elderly patients. 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. The hepatic events are usually reversible. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Moderate rises in AST, alkaline phosphatase, lactic dehydrogenase, and/or ALT have been noted in patients treated with ampicillin class antibiotics. The significance of these findings is unknown.
Hemic and Lymphatic Systems: As with other b-lactams, anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, lymphocytopenia, basophilia, slight increase in platelets, neutropenia and agranulocytosis have been reported rarely during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Prolongation of bleeding time and prothrombin time have also been reported rarely.
CNS Effects: Convulsions may occur with impaired renal function or in those receiving high doses.
Other: vaginitis, headache, bad taste, dizziness, malaise, glossitis, black hairy tongue and stomatitis. Tooth discoloration has been reported very rarely in children and less frequently in adults. Good oral hygiene may help to prevent tooth discoloration as it can often be removed by brushing.
The following adverse reactions have been observed during therapy with Clavulin.
Gastrointestinal: nausea, vomiting, diarrhea, abdominal cramps, flatulence, constipation, anorexia, colic pain, acid stomach, mucocutaneous candidiasis, intestinal candidiasis, antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis) have been reported rarely. If gastrointestinal reactions are evident, they may be reduced by taking Clavulin at the start of the meal. The incidence of gastrointestinal side effects tends to be proportional to dose and tends to be greater in children than in adults.
A US-Canadian clinical trial compared a 10-day Clavulin b.i.d. regimen (45/6.4 mg/kg/day q12h) with a 10-day Clavulin t.i.d. regimen (40/10 mg/kg/day q8h) in 575 patients with acute otitis media, aged 2 months to 12 years. The incidence of diarrhea was significantly lower in patients who received the b.i.d. regimen compared to patients who received the t.i.d. regimen (9.6% vs 26.7%; p<0.001). Significantly fewer patients who received the b.i.d. regimen withdrew due to diarrhea compared to patients receiving the t.i.d. regimen (2.8% vs 7.6%; p=0.009). The incidence of related/possibly related diaper rash was also lower in patients who received the b.i.d. regimen compared to patients who received the t.i.d. regimen (3.1% vs 6.6%; p=0.054).
Data from 2 pivotal studies in 1191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875 mg Clavulin tablets every 12 hours with 500 mg Clavulin tablets dosed every 8 hours.
The most frequently reported adverse event was diarrhea; incidence rates were similar (14.9% and 14.3% respectively) for the 875 mg every 12 hours and 500 mg every 8 hours dosing regimens. However, there was a statistically significant difference in rates of moderate/severe diarrhea between the regimens: 3.4% for 875 mg every 12 hours dosing vs 5.9% for the 500 mg every 8 hours dosing.
Hypersensitivity: erythematous maculopapular rash, urticaria, anaphylaxis, hypersensitivity vasculitis and pruritus. A morbilliform rash in patients with mononucleosis. Rarely erythema multiforme and Stevens-Johnson syndrome have been reported. Other reactions, including angioedema, toxic epidermal necrolysis and exfoliative dermatitis, and acute generalized exanthematous pustulosis (AGEP) as in the case of other b-lactam antibiotics, have been seen rarely. Interstitial nephritis can occur rarely.
Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and if necessary systemic corticosteroids. Whenever such reactions occur, Clavulin should be discontinued, unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to Clavulin therapy.
Liver: Transient hepatitis and cholestatic jaundice have been reported rarely. These events have been noted with other penicillins and cephalosporins. The hepatic events associated with Clavulin may be severe, and occur predominantly in adult and elderly patients. 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. The hepatic events are usually reversible. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Moderate rises in AST, alkaline phosphatase, lactic dehydrogenase, and/or ALT have been noted in patients treated with ampicillin class antibiotics. The significance of these findings is unknown.
Hemic and Lymphatic Systems: As with other b-lactams, anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, lymphocytopenia, basophilia, slight increase in platelets, neutropenia and agranulocytosis have been reported rarely during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Prolongation of bleeding time and prothrombin time have also been reported rarely.
CNS Effects: Convulsions may occur with impaired renal function or in those receiving high doses.
Other: vaginitis, headache, bad taste, dizziness, malaise, glossitis, black hairy tongue and stomatitis. Tooth discoloration has been reported very rarely in children and less frequently in adults. Good oral hygiene may help to prevent tooth discoloration as it can often be removed by brushing.
Overdose
Symptoms and Treatment: Many patients have been asymptomatic following overdosage or have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients.
In the case of overdosage, discontinue Clavulin, treat symptomatically, and institute supportive measures as required. If gastrointestinal symptoms and disturbance of the fluid and electrolyte balances are evident, they may be treated symptomatically. Clavulin can be removed from the circulation by hemodialysis. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison centre suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.
Symptoms and Treatment: Many patients have been asymptomatic following overdosage or have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients.
In the case of overdosage, discontinue Clavulin, treat symptomatically, and institute supportive measures as required. If gastrointestinal symptoms and disturbance of the fluid and electrolyte balances are evident, they may be treated symptomatically. Clavulin can be removed from the circulation by hemodialysis. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison centre suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.
Recommended Dosage
While Clavulin can be given without regard to meals, absorption of clavulanic acid when taken with food is greater relative to the fasted state. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. The safety and efficacy of Clavulin have been established in clinical trials where Clavulin was taken without regard to meals.
Adults: Note: Since both the Clavulin-250 and Clavulin-500F tablets contain the same amount of clavulanic acid (125 mg as the potassium salt), 2 Clavulin-250 tablets are not equivalent to 1 Clavulin-500F tablet. Therefore, 2 Clavulin-250 tablets should not be substituted for 1 Clavulin-500F tablet.
The usual adult dose is 1 Clavulin 500 mg tablet every 12 hours or 1 Clavulin 250 mg tablet every 8 hours. For more severe infections and infections of the lower respiratory tract, the dose should be 1 Clavulin 875 mg tablet every 12 hours or 1 Clavulin 500mg tablet every 8 hours.
Children: Based on the amoxicillin component, Clavulin should be dosed as in Table I in patients aged 12 weeks (3 months) and older.
The normal duration of treatment was 7 to 10 days. However, in general, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days treatment for any infection caused by b-hemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.
Neonates and children aged <12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of Clavulin is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/5 mL formulation in this age group is limited and, thus, use of the 125 mg/5 mL oral suspension is recommended.
The children's dosage should not exceed that recommended for adults. Children weighing more than 38 kg should be dosed according to the adult recommendations.
A calibrated dropper should be used to measure the appropriate volume for dosing.
Reconstitution: Reconstitute powder for oral suspension with purified water: Clavulin-125F Powder for Oral Suspension: The approximate average concentration after reconstitution is 125mg of amoxicillin (as the trihydrate) and 31.25mg of clavulanic acid (as the potassium salt) per 5mL.
F Powder for Oral Suspension: The approximate average concentration after reconstitution is 250mg of amoxicillin (as the trihydrate) and 62.5mg of clavulanic acid (as the potassium salt) per 5mL. See TableVI.
Shake vigorously.
Stability and Storage: Oral Suspensions: Store powder in a dry place at room temperature (15 to 25°C). Use the powder only if its appearance is white to off-white.
The reconstituted Clavulin-125F and Clavulin-250F oral suspension should be stored under refrigeration and should be used within 10 days.
The reconstituted Clavulin-200 and Clavulin-400 oral suspension should be stored under refrigeration and should be used within 7 days.
Keep bottle tightly closed at all times.
Tablets: Store in a dry place at room temperature (15 to 25°C).
While Clavulin can be given without regard to meals, absorption of clavulanic acid when taken with food is greater relative to the fasted state. Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of amoxicillin. The safety and efficacy of Clavulin have been established in clinical trials where Clavulin was taken without regard to meals.
Adults: Note: Since both the Clavulin-250 and Clavulin-500F tablets contain the same amount of clavulanic acid (125 mg as the potassium salt), 2 Clavulin-250 tablets are not equivalent to 1 Clavulin-500F tablet. Therefore, 2 Clavulin-250 tablets should not be substituted for 1 Clavulin-500F tablet.
The usual adult dose is 1 Clavulin 500 mg tablet every 12 hours or 1 Clavulin 250 mg tablet every 8 hours. For more severe infections and infections of the lower respiratory tract, the dose should be 1 Clavulin 875 mg tablet every 12 hours or 1 Clavulin 500mg tablet every 8 hours.
Children: Based on the amoxicillin component, Clavulin should be dosed as in Table I in patients aged 12 weeks (3 months) and older.
The normal duration of treatment was 7 to 10 days. However, in general, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days treatment for any infection caused by b-hemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.
Neonates and children aged <12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of Clavulin is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/5 mL formulation in this age group is limited and, thus, use of the 125 mg/5 mL oral suspension is recommended.
The children's dosage should not exceed that recommended for adults. Children weighing more than 38 kg should be dosed according to the adult recommendations.
A calibrated dropper should be used to measure the appropriate volume for dosing.
Reconstitution: Reconstitute powder for oral suspension with purified water: Clavulin-125F Powder for Oral Suspension: The approximate average concentration after reconstitution is 125mg of amoxicillin (as the trihydrate) and 31.25mg of clavulanic acid (as the potassium salt) per 5mL.
F Powder for Oral Suspension: The approximate average concentration after reconstitution is 250mg of amoxicillin (as the trihydrate) and 62.5mg of clavulanic acid (as the potassium salt) per 5mL. See TableVI.
Shake vigorously.
Stability and Storage: Oral Suspensions: Store powder in a dry place at room temperature (15 to 25°C). Use the powder only if its appearance is white to off-white.
The reconstituted Clavulin-125F and Clavulin-250F oral suspension should be stored under refrigeration and should be used within 10 days.
The reconstituted Clavulin-200 and Clavulin-400 oral suspension should be stored under refrigeration and should be used within 7 days.
Keep bottle tightly closed at all times.
Tablets: Store in a dry place at room temperature (15 to 25°C).
Supplied / Packaging
Suspension: Clavulin-125F: Each 5mL of reconstituted suspension contains: amoxicillin 125mg as the trihydrate and clavulanic acid 31.25mg as the potassium salt (in a ratio of4:1). Nonmedicinal ingredients: aspartame, colloidal silica, flavors (golden syrup dry, orange dry1, orange dry2, raspberry dry), hydroxypropyl methylcellulose, silicon dioxide, succinic acid and xanthan gum. Bottles of100and150mL.
Clavulin-200: Each 5mL of reconstituted suspension contains amoxicillin 200mg as the trihydrate and clavulanic acid 28.5mg as the potassium salt (in a ratio of 7:1). Nonmedicinal ingredients: aspartame, colloidal silica, flavors (golden syrup dry, orange dry1, orange dry2, raspberry dry), hydroxypropyl methylcellulose, silicon dioxide, succinic acid and xanthan gum. Bottles of 70mL.
Clavulin-250F: Each 5mL of reconstituted suspension contains: amoxicillin 250mg as the trihydrate and clavulanic acid 62.5mg as the potassium salt (in a ratio of4:1). Nonmedicinal ingredients: aspartame, colloidal silica, flavors (golden syrup dry, orange dry1, orange dry2, raspberry dry), hydroxypropyl methylcellulose, silicon dioxide, succinic acid and xanthan gum. Bottles of100and150mL.
Clavulin-400: Each 5mL of reconstituted suspension contains: amoxicillin 400mg as the trihydrate and clavulanic acid 57mg as the potassium salt (in a ratio of 7:1). Nonmedicinal ingredients: aspartame, colloidal silica, flavors (golden syrup dry, orange dry1, orange dry2, raspberry dry), hydroxypropyl methylcellulose, silicon dioxide, succinic acid and xanthan gum. Bottles of 70mL.
Tablets: Clavulin-250: Each white oval film-coated tablet contains: amoxicillin 250mg as the trihydrate and clavulanic acid 125mg as the potassium salt (in a ratio of2:1). Nonmedicinal ingredients: colloidal silica, dimethicone500, hydroxypropyl methylcellulose (methocel E5), hydroxypropyl methylcellulose (methocel E15), magnesium stearate, microcrystalline cellulose, polyethylene glycol4000, polyethylene glycol6000, sodium starch glycolate and titanium dioxide. Bottles of100.
Clavulin-500F: Each white oval film-coated tablet contains: amoxicillin 500mg as the trihydrate and clavulanic acid 125mg as the potassium salt (in a ratio of4:1). Nonmedicinal ingredients: colloidal silica, dimethicone500, hydroxypropyl methylcellulose (methocel E5), hydroxypropyl methylcellulose (methocel E15), magnesium stearate, microcrystalline cellulose, polyethylene glycol4000, polyethylene glycol6000, sodium starch glycolate and titanium dioxide. Bottles of 100.
Clavulin-875: Each white, capsule-shaped tablet contains: amoxicillin 875mg as the trihydrate and clavulanic acid 125mg as the potassium salt (in a ratio of 7:1). Nonmedicinal ingredients: colloidalsilica, dimethicone 500, hydroxypropyl methylcellulose (methocelE5), hydroxypropyl methylcellulose (methocelE15), magnesium stearate, microcrystalline cellulose, polyethylene glycol4000, polyethylene glycol6000, sodium starch glycolate and titanium dioxide. Bottles of 60.Clavulin®
GlaxoSmithKline
Amoxicillin Trihydrate--Clavulanate Potassium
Antibiotic--B-Lactamase Inhibitor
Suspension: Clavulin-125F: Each 5mL of reconstituted suspension contains: amoxicillin 125mg as the trihydrate and clavulanic acid 31.25mg as the potassium salt (in a ratio of4:1). Nonmedicinal ingredients: aspartame, colloidal silica, flavors (golden syrup dry, orange dry1, orange dry2, raspberry dry), hydroxypropyl methylcellulose, silicon dioxide, succinic acid and xanthan gum. Bottles of100and150mL.
Clavulin-200: Each 5mL of reconstituted suspension contains amoxicillin 200mg as the trihydrate and clavulanic acid 28.5mg as the potassium salt (in a ratio of 7:1). Nonmedicinal ingredients: aspartame, colloidal silica, flavors (golden syrup dry, orange dry1, orange dry2, raspberry dry), hydroxypropyl methylcellulose, silicon dioxide, succinic acid and xanthan gum. Bottles of 70mL.
Clavulin-250F: Each 5mL of reconstituted suspension contains: amoxicillin 250mg as the trihydrate and clavulanic acid 62.5mg as the potassium salt (in a ratio of4:1). Nonmedicinal ingredients: aspartame, colloidal silica, flavors (golden syrup dry, orange dry1, orange dry2, raspberry dry), hydroxypropyl methylcellulose, silicon dioxide, succinic acid and xanthan gum. Bottles of100and150mL.
Clavulin-400: Each 5mL of reconstituted suspension contains: amoxicillin 400mg as the trihydrate and clavulanic acid 57mg as the potassium salt (in a ratio of 7:1). Nonmedicinal ingredients: aspartame, colloidal silica, flavors (golden syrup dry, orange dry1, orange dry2, raspberry dry), hydroxypropyl methylcellulose, silicon dioxide, succinic acid and xanthan gum. Bottles of 70mL.
Tablets: Clavulin-250: Each white oval film-coated tablet contains: amoxicillin 250mg as the trihydrate and clavulanic acid 125mg as the potassium salt (in a ratio of2:1). Nonmedicinal ingredients: colloidal silica, dimethicone500, hydroxypropyl methylcellulose (methocel E5), hydroxypropyl methylcellulose (methocel E15), magnesium stearate, microcrystalline cellulose, polyethylene glycol4000, polyethylene glycol6000, sodium starch glycolate and titanium dioxide. Bottles of100.
Clavulin-500F: Each white oval film-coated tablet contains: amoxicillin 500mg as the trihydrate and clavulanic acid 125mg as the potassium salt (in a ratio of4:1). Nonmedicinal ingredients: colloidal silica, dimethicone500, hydroxypropyl methylcellulose (methocel E5), hydroxypropyl methylcellulose (methocel E15), magnesium stearate, microcrystalline cellulose, polyethylene glycol4000, polyethylene glycol6000, sodium starch glycolate and titanium dioxide. Bottles of 100.
Clavulin-875: Each white, capsule-shaped tablet contains: amoxicillin 875mg as the trihydrate and clavulanic acid 125mg as the potassium salt (in a ratio of 7:1). Nonmedicinal ingredients: colloidalsilica, dimethicone 500, hydroxypropyl methylcellulose (methocelE5), hydroxypropyl methylcellulose (methocelE15), magnesium stearate, microcrystalline cellulose, polyethylene glycol4000, polyethylene glycol6000, sodium starch glycolate and titanium dioxide. Bottles of 60.Clavulin®
GlaxoSmithKline
Amoxicillin Trihydrate--Clavulanate Potassium
Antibiotic--B-Lactamase Inhibitor
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Brand Name
Clavulin
Clavulin
Generic Name
Amoxicillin Trihydrate Clavulanate Potassium
Amoxicillin Trihydrate Clavulanate Potassium
General Indications
Antibiotic B-Lactamase Inhibitor
Antibiotic B-Lactamase Inhibitor
