Film-coated caplet
Each caplet contains:
Amoxicillin Trihydrate equivalent to Amoxicillin ........................... 500 mg
Clavulanate Potassium equivalent to Clavulanic Acid .................... 125 mg
PHARMACOLOGY
CAPSINAT® is an oral antibacterial combination consisting of the semi-synthetic antibiotic Amoxicillin and the β - lactamase inhibitor, Clavulanate Potassium (the potassium salt of Clavulanic Acid).
Amoxicillin is a semi-synthetic antibiotic derived from penicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms, the bactericidal effect of Amoxicillin is inhibit the bacterial cell wall synthesis.
As a result the bacterial cell wall is weakened, the plasma cell swells and then ruptures.
Clavulanic Acid is a β - lactamase enzymes inhibitor that produced by certain bacteria. The mechanisms of action of Clavulanic Acid are:
First :
As a competitive inhibitor, structurally related to the penicillins, then Clavulanic Acid replaces the active sites of β-lactamase enzyme structure without the chemical reactions.
Second:
The carbonil β - lactamase of Clavulanic Acid transforms penicillinase enzyme to acyl enzyme. The acyl enzyme, form is not active against penicillin.
INDICATIONS
- Upper respiratory tract infections e.g. tonsillitis, sinusitis, otitis media.
- Lower respiratory tract infections e g. acute and chronic bronchitis, lobar and bronchopneumonia.
- Genito-urinary tract infections e.g. urethritis, cystitis, pyelonephritis.
- Skin and soft tissue infections e.g. abscesses, cellulitis, boils.
- Bone and joint infections e.g. osteomyelitis.
- Dental infections e.g. dentoalveolar abscess.
- Other infections e.g. septic abortion, puerperal sepsis. intraabdominal sepsis.
- Hypersensitivity to penicillin.
- In neonatal whose mother is hypersensitive to penicillins or its derivative.
- History of cholestatic jaundice (hepatic dysfunction).
ADVERSE REACTIONS
- Diarrhoea, nausea, vomiting, indigestion, pseudo-membranous colitis and candidiasis.
- A moderate rise in AST and/or ALT has been noted. in patients with semi-synthetic penicillins,
- Hepatitis and cholestatic jaundice, may be severe and continue for several months, occurring pre-dominantly In adult or elderly patients and slightly more frequently in males. Signs and symptoms mayoccur during treatment but ore more frequently reported after cessation of therapy with a delay of up to 6 weeks. The hepatic events are usually reversible.
- Urticarial and erythematous rashes.
- Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis. Treatment should be discontinued if these reactions occur.
- Angioedema and anophylaxis.
- Interstitial nephritis.
- Transient leucopenia, thrombocytopenia and haemolytic anaemia.
- Cautiously in patients with severe hepatic impairment.
- In patients with moderate or severe renal impairment, dosage should be adjusted as recommended in the DOSAGES section.
- Not recommended to pregnant and nursing mother except on medical recommendation,
- Two tablets of each 375 mg ore not some with one caplet of 625 mg. Therefore one caplet of 625 mg used for severe infections, con not substituted with 2 tablets of each 375 mg.
- In high dose or prolonged administration may induce super-infection (caused by Enterobacter, Pseudomonas, S. aureus, Candida) primarily in gastrointestinal tract.
- May reduce the efficacy of oral contraceptives.
- May prolong bleeding time and prothrombine time in patients on anticoagulation therapy.
To minimize potential gastrointestinal intolerance, administer at the start of a meal.
Treatment should not be extended beyond 14 days without review by a physician.
For the treatment of infection:
Adults and children over 12 years:
- In mild to moderate infections: 1 tablet 375 mg, 3 times daily.
- In severe infections: 1 caplet 625 mg, 3 times daily,
The usual recommended daily dosage is 25 mg/kg/day of body weight in divided doses every 8 hours.
In dental infections:
Adults and children over 12 years: 1 tablet 375 mg, 3 times dally for 5 days,
In renal impairment:
- Mild impairment (creatinine clearance > 30 ml/min): no change in dosage.
- Moderate impairment (creatinine clearance 10-30 ml/min): 1 tablet 375 mg or 1 caplet 625 mg every 12 hours.
- Severe impairment (creatinine clearance <>
PRESENTATIONS
Box of 5 strips @ 6 caplets
Reg. No.: DKL0532400809A1
STORAGE
Keep in a cool place (15°-25° C).
Manufactured by: PT SANBE FARMA
Bandung - Indonesia
For: PT CAPRIFARMINOO LABS.
Bandung - Indonesia
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