Clamentin

Clamentin

amoxicillin + clavulanic acid

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Full Prescribing Info
Contents
Amoxicillin, Clavulanic acid.
Description
Clamentin Film Coated Tablet: Each 375- and 1,000-mg film-coated tablet contains Amoxicillin (as Trihydrate) 250 mg and 875 mg, respectively, and Clavulanic Acid (as Potassium Salt) 125 mg.
Each 625 mg film-coated tablet contains Amoxicillin 500 mg and Clavulanic Acid (as Potassium Salt) 125 mg.
Clamentin Powder for Oral Suspension: Each 31.25 mg/mL powder for oral suspension contains Amoxicillin (as Trihydrate) 25 mg and Clavulanic Acid (as Potassium Salt) 6.25 mg.
Clamentin Powder for Injection: Each 1.2-g vial contains Amoxicillin (as Amoxicillin Sodium) 1 gm and Clavulanic Acid (as Potassium Clavulanate) and 0.2 gm.
Appearance of reconstituted solution : (See Table 1.)

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Action
Pharmacology: Pharmacodynamics: Clamentin Film Coated Tablet: Bacterial enzymes that destroy the antibiotic before it can act on the pathogen cause resistance to many antibiotics. The clavulanate in Clamentin anticipates this defense mechanism by blocking the beta-lactamase enzymes, thus rendering the organisms sensitive to amoxicillin's rapid bactericidal effect at concentrations readily attainable in the body.
Clavulanate by itself has little antibacterial activity; however, in association with amoxicillin as Clamentin, it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.
Clamentin is bactericidal to a wide range of organisms including: Gram-positive: Aerobes: Enterococcus faecalis*, Enterococcus faecium*, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Staphylococcus aureus*, Coagulase negative staphylococci* (including Staphylococcus epidermis*), Corynebacterium species, Bacillus anthracis*, Listeria monocytogenes.
Anaerobes: Clostridium species, Peptococcus species, Peptostreptococcus.
Gram-negative: Aerobes: Haemophilus influenzae*, Moraxella catarrhalis* (Branhamella catarrhalis), Escherichia coli*, Proteus mirabilis*, Proteus vulgaris*, Klebsiella species*, Salmonella species*, Shigella species*, Bordetella pertusis, Brucella species, Neisseria gonorrhoeae*, Neisseria meningitidis*, Vibrio cholerae, Pasteurella multocida.
Anaerobes: Bacteroides species* including B. fragilis.
*Some members of these species of bacteria produce beta-lactamase, rendering them insensitive to amoxicillin alone.
Pharmacokinetics: The pharmacokinetics of the two components of Clamentin is closely matched. Peak serum levels of both occur about one hour after oral administration. Absorption of Clamentin is optimized at the start of a meal. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.
Doubling the dosage of Clamentin approximately doubles the serum levels achieved.
Clamentin Powder for Injection: Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in Clamentin anticipates this defense mechanism by blocking the β-lactamase enzymes, thus rendering the organisms sensitive to Amoxicillin’s rapid bactericidal effect at concentrations readily attainable in the body.
Clamentin is bactericidal to a wide range of organisms including: Gram-positive: Aerobes: *Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, *Staphylococcus aureus, *Coagulase-negative staphylococci (including Staphylococcus epidermidis), Corynebacterium sp, *Bacillus anthracis, Listeria monocytogenes, Enterococcus faecium, Streptococcus agalactiae, Streptococcus sp.
Anaerobes: Clostridium, Peptococcus spp, Peptostreptococcus.
Gram-negative: Aerobes: *Haemophilus influenzae, *Escherichia coli, *Proteus mirabilis, *Proteus vulgaris, *Klebsiella sp, *Moraxella catarrhalis (Branhamella catharralis), *Salmonella sp, *Shigella sp, Bordetella pertussis, Brucella sp, *Neisseria gonorrhoeae, *Neisseria meningitidis, Vibrio cholerae, *Yersinia enterocolitica, Pasteurella multocida, Gardnerella vaginalis, Helicobacter pylori, Legionella sp.
Anaerobes: *Bacteroides sp (including Bacteroides fragilis), *Fusobacterium sp.
*Including β-lactamase producing strains resistant to ampicillin and Amoxicillin.
Amoxicillin and clavulanate potassium are well absorbed from the gastrointestinal tract after oral administration.
Dosing in the fasted or fed state has minimal effect on the pharmacokinetics of Amoxicillin. While Clamentin can be given without regard to meals, absorption of clavulanate acid when taken with food is greater relative to the fasted state.
Amoxicillin serum concentrations achieved with Clamentin are similar to those produced by the oral administration of equivalent doses of amoxicillin alone. The half-life of amoxicillin after oral administration is 1.3 hours and that of clavulanic acid is 1.0 hour.
Concurrent administration of probenecid delays Amoxicillin excretion but does not delay renal excretion of clavulanic acid.
Clavulanic acid has been found to be approximately 25% bound to human serum and Amoxicillin approximately 18% bound.
Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like Amoxicillin, is well distributed in body tissues.
Indications/Uses
Clamentin Film Coated Tablet: Clamentin 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 amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics.
Clementin should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. Clementin oral presentations for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites: Upper respiratory tract infections (inclunding ENT) e.g. 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. Dental infections e.g. dentoalveolar abscess. Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis. Susceptibility to Clamentin will vary with geography and time (see Pharmacology: Pharmacodynamics under Actions). Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.
Clamentin Powder for Injection: Clamentin Intravenous is indicated for short-term treatment of bacterial infections at the following sites when amoxicillin-resistant β-lactamase-producing strains are suspected as the cause: Upper Respiratory Tract Infections (Including ENT) in particular sinusitis, otitis media, recurrent tonsillitis. These infections are often caused by Streptococcus pneumoniae, Haemophilus influenzae*, Moraxella catarrhalis* and Streptococcus pyogenes.
Lower Respiratory Tract Infections in particular acute exacerbations of chronic bronchitis (especially if considered severe), bronchopneumonia. These infections are often caused by Streptococcus pneumoniae, Haemophilus influenzae* and Moraxella catarrhalis*.
Genito-urinary Tract and Abdominal Infections in particular cystitis (especially when recurrent or complicated - excluding prostatitis), septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis. These infections are often caused by Enterobacteriaceae* (mainly Escherichia coli*), Staphylococcus saprophyticus, Enterococcus species*.
Skin and Soft Tissue Infections in particular cellulitis, animal bites and severe dental abscess with spreading cellutitis. These infections are often caused by Staphylococcus aureus*, Streptococcus pyogenes and Bacteroides species*.
Prophylaxis of wound infection associated with surgical procedures in particular gastrointestinal, pelvic, major head and neck surgery and after limb amputation for infection.
*Some member of these species of bacteria produces β-lactamase, rendering them insensitive to amoxicillin alone.
Dosage/Direction for Use
Tab: Adults and children over 12 years: Mild to Moderate Infections: 625 mg twice daily.
Severe Infections: One Clamentin Film Coated Tablet 1,000 mg twice daily.
Therapy can be started parentally and continued with an oral preparation.
Dental Infections: 625 mg twice daily for 5 days.
Dosage in Renal Impairment: The Clamentin Film Coated Tablet 1,000 mg should only be used in patients with a glomerular filtration rate of >30 ml/min (see Table 2).

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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 Clamentin is optimized when taken at the start of a meal.
Treatment should not be extended beyond 14 days without review.
Powd for Oral Susp: Children 7-12 years: 10 mL 3 times daily, 2-7 years: 5 mL 3 times daily, 9 months to 2 years: 25 mg/kg/day in 3 divided doses. Severe infections: Increase frequency to 6 hourly intervals.
Powd for Inj: Adults: By intravenous injection over 3-4 minutes or by intravenous infusion, 1.2 g every 8 hours. Increased to 1.2 g every 6 hours in more serious infections.
Children 3 months-12 years: 30 mg/kg every 8 hours, increased to 30 mg/kg every 6 hours in more serious infections.
Children 0-3 months: 30 mg/kg every 12 hours during the perinatal period and in premature infants, increasing to every 8 hours thereafter.
Surgical Prophylaxis: 1.2 g at induction; for high risk procedures (e.g. colorectal surgery) a further 2-3 doses may be given every 8 hours in a 24-hour period. Continue for several days if the procedure has a significantly increased risk of infection.
Renal Impairment: Adults: Mild impairment (creatinine clearance >30 mL/min) - no change in dosage.
Moderate impairment (creatinine clearance 10-30 mL/min) - 1.2g IV stat, followed by 600 mg IV 12 hourly.
Severe impairment (creatinine clearance <10 mL/min) - 1.2g IV stat, followed by 600 mg IV 24 hourly. An additional 600 mg IV dose may need to be given during dialysis and at the end of dialysis.
Children: Similar reductions in dosage should be made.
Preparation for injection: Clamentin intravenous may be administered either by intravenous injection or by intermittent infusion. It is not suitable for intramuscular administration.
1.2 g vial: To reconstitute dissolve contents in 20 ml of Water For Injection BP.
Intravenous injection: Administer slowly, over a period of 3-4 minutes. Clamentin may be injected directly into a vein or via a drip tube. Intravenous Injections of Clamentin must be administered within 10 minutes.
Intravenous infusion: Add 1.2 g reconstituted solution to 100 ml infusion fluid. The infusion should be given over 30-40 minutes. Solution should be made up to full infusion volume immediately after reconstitution.
Any residual antibiotic solutions should be discarded.
Overdosage
Cases of overdosage with Amoxicillin-clavulanic acid are usually asymptomatic. If encountered, gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. They may be treated symptomatically with attention to the water electrolyte balance. Clamentin can be removed from the circulation by haemodialysis.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed.
Contraindications
Clamentin is contraindicated in patients with a history of hypersensitivity to beta-lactams e.g. penicillin and cephalosporins.
Clamentin is contraindicated in patients with a previous history of Clamentin or penicillin-associated jaundice/hepatic dysfunction.
Special Precautions
Changes in liver function tests have been observed in some patients receiving Clamentin. The clinical significance of these changes is uncertain but Clamentin 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 several weeks after treatment has ceased.
In patients with renal impairment, dosage should be adjusted according to the degree of impairment.
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. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
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.
Erythematous rashes have been associated with glandular fever in patients following the use of Amoxicillin. Clamentin should be avoided if glandular fever is suspected.
Use In Pregnancy & Lactation
Use in Pregnancy: The prophylactic treatment with Clamentin 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.
Use in Lactation: Clamentin 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 breast-fed infant.
Adverse Reactions
Clamentin Film Coated Tablet: 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 my occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders: Adults: Very common: Diarrhoea.
Common: Nausea, vomiting.
Children: Common: Diarrhoea, nausea, vomiting.
All populations: Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking Clamentin Film Coated Tablet 1,000 mg at the start of a meal.
Uncommon: Indigestion. Very rare: Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis). Black hairy tongue.
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 muliforme. 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.
Clamentin Powder for Injection: Side effects, as with Amoxicillin, are uncommon and mainly of a mild and transitory nature.
Gastrointestinal reactions: Diarrhea, indigestion, nausea, vomiting, candidiasis and antibiotic-associated colitis have been reported rarely. Nausea, although uncommon, is more often associated with higher oral dosages.
Hepatic effects: A moderate rise in AST and/or ALT has been noted in patients with beta-lactam class antibiotics, but the significance of these findings is unknown. Hepatitis and cholestatic jaundice have been reported rarely. They may, however, be severe and continue for several months. They are reported as occurring predominantly in adult or elderly patients and slightly more frequently in males. Signs and symptoms may occur during treatment but are more frequently reported after cessation of therapy with a delay of up to six weeks. The hepatic events are usually reversible. However, in extremely rare circumstances, deaths have been reported.
Hypersensitivity reactions: Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis have been reported. Treatment should be discontinued if one of these types of rash appears. In common with other β-lactam antibiotics, angioedema, oedema, anaphylaxis, serum sickness-like syndrome and hypersensitivity vasculitis have been reported.
Interstitial nephritis can occur rarely.
Haematological effects: As with other β-lactams, reversible leucopenia, reversible thrombocytopenia and haemolytic anemia have been reported rarely.
CNS effects: Hyperactivity, dizziness, and headache are rare. Convulsions may occur with impaired renal functions or in those receiving high doses.
Local effects: Thrombophlebitis at the site of injection.
Drug Interactions
Prolongation of bleeding time and prothrombin time may be possible. Clamentin should be used with care in patients on anti-coagulation therapy.
In common with other broad-spectrum antibiotics, Clamentin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
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 Clamentin and allopurinol.
Concomitant use of Probenecid is not recommended. Probenecid decreases the renal tubular secretion of Amoxicillin. Concomitant use with Clamentin may result in increased and prolonged blood levels of Amoxicillin but not of clavulanic acid.
Caution For Usage
Clamentin Powder for Injection: Stability and compatibility: Satisfactory antibiotic concentrations are retained at 5°C and at room temperature (25°C) in the recommended volumes of the following infusion fluids. If reconstituted and maintained at room temperature, infusions should be completed within the times stated as Table 3. (See Table 3).

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Reconstituted solutions should not be frozen.
Clamentin is less stable in infusions containing glucose, dextran or bicarbonate.
Reconstituted solutions should therefore not be added to such infusions but may be injected into the drip tubing over a period of 3-4 min.
If Clamentin IV is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, IV fluid container or given set because loss of activity of the aminoglycoside can occur under these conditions.
For storage at 5°C, the reconstituted solution should be added to pre-refrigerated infusion bags which can be stored for up to 8 hrs. Thereafter, the infusion should be administered immediately after reaching room temperature.
Storage
Clamentin Film Coated Tablet: Store below 30°C in dry place, protect from light.
Clamentin Powder for Injection: Store at temperature below 30°C. Protect from light and moisture.
Shelf-Life: Clamentin Film Coated Tablet: 24 months.
Clamentin Powder for Injection: 2 years.
MIMS Class
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 625 mg x 10 x 10's. 1,000 mg (white, oblong, biconvex, plain on both sides) x 10's, 5 x 10's. Powd for oral susp 12 g. Powd for inj (white to off-white powd in vial) 1.2 g x 10's.
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