Description

Composition
Each film-coated tablet contains :
Amoxicillin trihydrate equivalent to amoxicillin (500 mg )
Potassium clavulanate equivalent to clavulanic acid (125 mg)

Pharmacology
Amoxicillin is a semi synthetic penicillin derivative antibiotic, it is a broad spectrum, effective against gram positive and gram
negative. Amoxicillin acts by inhibiting the mycobacterium cell wall synthesis and characterizes bactericidal. Clavulanic acid
blocks beta lactamase enzyme which is produced by certain bacteria. The mechanism of action of clavulanic acid occurs in 2
phases :
As competitive inhibitor because the chemical structure of clavulanic acid resembles with penicillin, therefore clavulanic
acid can replace the active part of beta lactamase enzyme structure without any chemical reaction.
Beta lactamase  carbonyl group   from   clavulanic acid converts penicillinase enzyme to acyl enzyme. The form of acyl
enzyme cannot destroy the beta lactam ring of penicillin.

Indications
Vibranat® is indicated for the treatment of  :
Upper Respiratory Tract Infections : tonsillitis, sinusitis, otitis media.
Lower Respiratory Tract Infections :  acute and chronic bronchitis, lobar and bronchopneumonia.
Genitourinary Tract Infections : urethritis, cystitis, pyelonephritis.
Skin and Soft Tissue Infection : abscess, boils, cellulite, wound infection.
Bond and Joint Infections : Osteomyelitis.
Dental Infections : Dentoalveolar abscess.
Other Infections :  Septic abortion, puerperal sepsis, intra-abdominal sepsis.

Contraindications
Hypersensitivity to penicillin and its derivatives.
Babies born from mother who is hypersensitive to penicillin.
Patients with evidence of cholestatic jaundice (hepatic dysfunction) associated with penicillin or Vibranat® treatment.

Dosage and Administration
Vibranat® should be taken with meal to minimize potential gastrointestinal intolerance. Treatment should not be extended
beyond 14 days without medical review.

Dosage for Infection Treatment
Adults and children > 12 years :
Mild to moderate infections : 1 film-coated tablet 375 mg, 3 times daily.
Severe infections : 1 film-coated tablet 625 mg, 3 times daily.
Dosage for Dental Infection
Adults and children > 12 years : 1 film-coated tablet 375 mg, 3 times daily for 5 days.
Dosage for Patients with Renal Function Impairment
Mild renal impairment (creatinine clearance  > 30 ml / min) : no dosage adjustment required.
Moderate renal impairment ( creatinine clearance 10 – 30 ml / min ) : 1 film-coated tablet 375 mg or 625 mg every 12
hours.
Severe renal impairment ( creatinine clearance < 30 ml / min ) : not more than 1 film-coated tablet 375 mg every 12
hours.

Warnings and Precautions
Caution should be given to patients with severe hepatic dysfunction.
In patients with moderate or severe renal impairment, the dosage should be adjusted as recommended in the Dosage
and Administration.
Administration to pregnant and breastfeeding women is not recommended, unless considered essential by the physician.
High dosage and prolonged use may also result in superinfection (occasionally caused by Enterobacter, Pseudomonas,
S.aureus and Candida) especially in gastrointestinal tract.

Adverse Reactions
Diarrhoea, nausea, vomiting, indigestion, pseudomembranous colitis and candidiasis.
A moderate rise in AST and/or ALT may occur during treatment with semi synthetic penicillins.
Hepatitis and cholestatic jaundice may be more severe and continue for several months, especially in adults or elderly
patients and slightly more frequent in males. The symptoms may occur during treatment but are more frequently
reported after cessation of therapy with a delay of up to 6 weeks. The hepatic events are usually reversible.
Urticaria and erythematous rashes.
Erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis. Treatment
should be discontinued if these adverse reactions occur.
Angioneurotic oedema and anaphylaxis.
Interstitial nephritis might occur rarely.
Transient leucopenia, thrombocytopenia and anemia hemolytic.

Drug Interactions
Vibranat may reduce the efficacy of oral contraceptives.
Prolongation of bleeding time and prothrombine time in patients receiving anticoagulation therapy.

Presentation
Bottle @ 15 film-coated caplets

ON MEDICAL PRESCRIPTION ONLY

Store in a cool (15-25C) and dry place, protected from light.