KLAMENTIN 875 125

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KLAMENTIN 875/125

INFORMATION FOR MEDICAL STAFF

COMPOSITION:

Amoxicillin (as amoxicillin trihydrate) ......................... 875 mg

Clavulanic acid (as potassium clavulanate & avicel) ..... 125 mg

Excipients.q.s ........................................................... 1 caplet

(Colloidal silicon dioxide, polyplasdone XL, microcrystalline cellulose M112, magnesium stearate, sepifilm LP914, titanium dioxide, talc).

PHARMACEUTICAL FORM: Film coated caplet.

PHARMACODYNAMIC PROPERTIES:

ATC code: J01CR02

Amoxicillin is a beta-lactam semi-synthetic antibiotic with a broad-spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms due to inhibition of bacterial cell wall synthesis. Amoxicillin is, however, susceptible to degradation by beta-lactamases, and therefore, the spectrum of activity does not include organisms which produce these enzymes.

Clavulanic acid has beta-lactam structure resembling that of penicillin and acts as an inhibitor on beta-lactamases produced by most Gram-negative bacteria and Staphylococcus. Particularly, clavulanic acid potently inhibits the plasmid medicated beta-lactamases, resulting in resistance to penicillins and cephalosporins.

The formulation of clavulanic acid and amoxicillin in Klamentin protects amoxicillin from degradation by beta-lactamases enzymes and effectively extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and microorganisms resistant to other penicillins and cephalosporins.

Spectrum:

Gram-positive bacteria:

Aerobic micro-organisms: Streptococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Staphylococcus aureus, Corynebacterium, Bacillus anthracis, Listeria monocytogenes.

Anaerobic micro-organisms: Species of Clostridium, Peptococcus, Peptostreptococcus.

Gram-negative bacteria:

Aerobic micro-organisms: Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Proteus vulgaris, species of Klebsiella, Salmonella, Shigella, Bordetella, Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, Pasteurella multocida.

Anaerobic micro-organisms: Bacteroides spp. including B. fragilis.

PHARMACOKINETIC PROPERTIES:

Absorption: Amoxicillin and clavulanic acid are well absorbed by oral administration. Peak serum concentrations are generally attained within 1 - 2 hours following oral administration. Presence of food does not affect oral absorption of the drug. However the drug is optimally absorbed when administered orally at the beginning of a standardized meal.

Distribution: After oral administration, both amoxicillin and clavulanic acid are distributed into the lung, pleural fluid and peritoneal fluid and have been shown to cross the placental barrier. Amoxicillin can be detected in breast milk and no data has shown that clavulanic acid is in the milk of lactating mothers. Oral bioavailability of amoxicillin is 90% and that of clavulanic acid is 75%. The serum half-life of amoxicillin is 1 - 2 hours and that of clavulanic acid is about 1 hour. Approximately 55 - 73% and 25 - 45% of the amoxicillin and clavulanic acid doses, respectively, are excreted unchanged in urine.

Metabolism: Amoxicillin is poorly excreted in the body as the penicilloic acid. Clavulanic acid is partly metabolised as the metabolite with low molecular weight.

Elimination: The major route of elimination for amoxicillin and clavulanic acid is via the kidney. Serum concentrations of amoxicillin and of clavulanic acid are higher and the serum half-lives prolonged in patients with renal impairment. In patients with creatinine clearances of 9 ml/minute, the serum half-lives of amoxicillin and clavulanic acid were 7.5 and 4.3 hours, respectively. Amoxicillin and clavulanic acid are both removed by hemodialysis. Clavulanic acid is also removed by peritoneal dialysis. Only minimal amounts of amoxicillin appear to be removed by peritoneal dialysis. Probenecid prolongs the excretion of amoxicillin but does not affect the excretion of clavulanic acid.

PRESENTATION:

Box of 1 pack x 2 blisters x 7 caplets.

THERAPEUTIC INDICATIONS:

For the treatment of adult and children infections, including sinusitis, acute otitis media, acute exacerbation of chronic bronchitis, community-acquired pneumonia, cystitis, pyelonephritis. Skin and soft tissue infections, such as acne, wound infections. Bone and joint infections, such as osteomyelitis.

DOSAGE & ADMINISTRATION:

Dosage generally is expressed in terms of the amoxicillin content. Administration of oral drug before immediately meals reportedly may minimize GI intolerance. The caplets should be swallowed whole and not be chewed. If needed, the caplets can be broken, then swallowing.

Adults and children more than 40 kg: One caplet taken twice a day.

Children less than 40 kg: Not suitable with this content and dosage form.

Dosage in elderly: No adjustment needed.

Dosage in renal impairment:

Creatinine clearances greater than 30 ml/min: No adjustment in dose is required.

Klamentin 875/125 should not be administered in patients with glomerular filtration rates below 30 ml/min.

Hepatic impairment: There are as yet insufficient data. Dose with caution and monitor hepatic function at regular intervals.

The duration of therapy should be 5 to 10 days. Treatment should not be extended beyond 14 days without review.

Or as prescribed by a physician.

CONTRAINDICATIONS:

Hypersensitivity to penicillins, cephalosporins, clavulanic acid or any components of the preparation. A history of jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid.

PRECAUTIONS:

Before initiating therapy with amoxicillin/clavulanic acid, 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.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

Elderly patients and those with a history of jaundice/hepatic dysfunction should be cautious during receiving amoxicillin/clavulanic acid because clavulanic acid causes an increased risk of intrahepatic cholestasis. Signs and symptoms of cholestatic jaundice are though less frequent, may be severe. However, these symptoms are usually reversible and will go away after several weeks of treatment discontinuation.

It should be considered in the differential diagnosis of patients who develop C. difficile-associated diarrhea and pseudomembranous colitis.

Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy.

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin/clavulanic acid and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

In patients with renal impairment, the dose should be adjusted according to the degree of impairment (see Dosage & Administration).

In patients with reduced urine output crystalluria has been observed very rarely, predominantly with parenteral therapy. During 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).

Pregnancy and lactation:

There is no evidence of adverse effects to the fetus; however, the drug should be used during pregnancy only when clearly needed.

A small amount of the drug is found in human milk; the drug should be used with caution during breastfeeding period. Adverse effects on the breastfed infant are unknown. Discontinuation of breastfeeding should be advised during the treatment with drug.

Effect on ability to drive and use machines:

Undesirable effects may occur e.g. dizziness, headache. The drug should be used cautiously in drivers, machine users, workers at height, and other cases.

INTERACTIONS:

The drug may prolong the bleeding and clotting time; so use with caution in patients receiving treatment with anticoagulants (warfarin).

Methotrexate: Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

Oral probenecid administered with amoxicillin slows the rate of renal tubular secretion of the amoxicillin and produces higher serum concentrations of the drug.

Mycophenolate mofetil: In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic acid (MPA) of approximately 50% has been reported following commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not accurately represent changes in overall MPA exposure. Therefore, a change in the dose of mycophenolate mofetil should not normally be necessary in the absence of clinical evidence of graft dysfunction. However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.

The drug may reduce the efficacy of oral contraceptives.

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data with amoxicillin/clavulanic acid and allopurinol administered concurrently.

Amoxicillin has been reported to affect testing for the presence of glucose in urine using copper sulfate method (Clinitest), but not affecting tests using glucose oxidase method (Clinistix).

UNDESIRABLE EFFECTS:

Common, ADR > 1/100:

GI disorders: diarrhoea, nausea, vomiting.

Skin disorders: skin rash, pruritus.

Uncommon, 1/1000 < ADR < 1/100:

Blood disorders: eosinophilia.

Hepatic disorders: hepatitis and cholestatic jaundice, increased transaminases. These symptoms may be severe and last for several months.

Others: candida vaginitis, dizziness, headache, fever, fatigue.

Rare, ADR < 1/1000:

General disorders: anaphylactic reaction, Quincke's edema.

Blood disorders: thrombocytopenia, hypoleukemia, hemolytic anemia.

GI disorders: pseudomembranous colitis.

Skin disorders: Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis.

Biliary disorders: interstitial nephritis.

Treatment of ADRs:

If allergic reactions, including erythema, Quincke’s edema, anaphylactic shock, Stevens-Johnson syndrome occur, therapy with amoxicillin should be discontinued and immediate emergency treatment with adrenaline, oxygen, intravenous and ventilatory corticosteroid therapy, including intubation and never treated with penicillins or cephalosporins.

Pseudomembranous colitis: If it is mild, the drug should be discontinued. If it is severe (likely due to Clostridium difficile), fluid and electrolyte supplementation, use of antibiotics against Clostridium (metronidazole, vancomycin) should be advised.

OVERDOSE:

Symptoms:

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident.

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed.

Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Treatment:

Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance.

Amoxicillin/clavulanic acid can be removed from the circulation by haemodialysis.

Read the direction carefully before use.

For more information, please consult a physician.

The drug is for prescription only.

Note: The drug should be used within 30 days once the aluminium bag was opened.

STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.

SHELF-LIFE: 24 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: April 16, 2018

INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.

Keep out of reach of children.

Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.

The drug is for prescription only.

Note: The drug should be used within 30 days once the aluminium bag was opened.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Amoxicillin (as amoxicillin trihydrate) ......................... 875 mg

Clavulanic acid (as potassium clavulanate & avicel) ..... 125 mg

Excipients.q.s ........................................................... 1 caplet

(Colloidal silicon dioxide, polyplasdone XL, microcrystalline cellulose M112, magnesium stearate, sepifilm LP914, titanium dioxide, talc).

PRODUCT DESCRIPTION:

White to ivory white film coated caplet, a break line on one side, a pattern on the other, intact edges.

PRESENTATION: Box of 1 pack x 2 blisters x 7 caplets.

WHAT THE DRUG IS USED FOR:

For the treatment of adult and children infections, including sinusitis, acute otitis media, acute exacerbation of chronic bronchitis, community-acquired pneumonia, cystitis, pyelonephritis. Skin and soft tissue infections, such as acne, wound infections. Bone and joint infections, such as osteomyelitis.

HOW TO TAKE THIS MEDICINE:

Dosage generally is expressed in terms of the amoxicillin content. Administration of oral drug before immediately meals reportedly may minimize GI intolerance. The caplets should be swallowed whole and not be chewed. If needed, the caplets can be broken, then swallowing.

Adults and children more than 40 kg: One caplet taken twice a day.

Children less than 40 kg: Not suitable with this content and dosage form.

Dosage in elderly: No adjustment needed.

Dosage in renal impairment:

Creatinine clearances greater than 30 ml/min: No adjustment in dose is required.

Klamentin 875/125 should not be administered in patients with glomerular filtration rates below 30 ml/min.

Hepatic impairment: There are as yet insufficient data. Dose with caution and monitor hepatic function at regular intervals.

The duration of therapy should be 5 to 10 days. Treatment should not be extended beyond 14 days without review.

Or as prescribed by a physician.

WHEN SHOULD YOU NOT TAKE THIS MEDICINE:

Hypersensitivity to penicillins and cephalosporins, clavulanic acid or any components of the preparation. A history of jaundice or hepatic dysfunction associated with amoxicillin/clavulanic acid.

UNDESIRABLE EFFECTS:

Common, ADR > 1/100:

GI disorders: diarrhoea, nausea, vomiting.

Skin disorders: skin rash, pruritus.

Uncommon, 1/1000 < ADR < 1/100:

Blood disorders: eosinophilia.

Hepatic disorders: hepatitis and cholestatic jaundice, increased transaminases. These symptoms may be severe and last for several months.

Others: candida vaginitis, dizziness, headache, fever, fatigue.

Rare, ADR < 1/1000:

General disorders: anaphylactic reaction, Quincke's edema.

Blood disorders: thrombocytopenia, hypoleukemia, hemolytic anemia.

GI disorders: pseudomembranous colitis.

Skin disorders: Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis.

Biliary disorders: interstitial nephritis.

Inform your physician about any adverse effects occur during the treatment.

Treatment of ADRs:

If allergic reactions, including erythema, Quincke’s edema, anaphylactic shock, Stevens-Johnson syndrome occur, therapy with amoxicillin should be discontinued and immediate emergency treatment with adrenaline, oxygen, intravenous and ventilatory corticosteroid therapy, including intubation and never treated with penicillins or cephalosporins.

Pseudomembranous colitis: If it is mild, the drug should be discontinued. If it is severe (likely due to Clostridium difficile), fluid and electrolyte supplementation, use of antibiotics against Clostridium (metronidazole, vancomycin) should be advised.

WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:

The drug may prolong the bleeding and clotting time; so use with caution in patients receiving treatment with anticoagulants (warfarin).

Methotrexate: Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

Oral probenecid administered wit

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