Branded Medicine

 
DEXYCLAV® dan DEXYCLAV® FORTE

Film-coated caplet

 
:: COMPOSITION ::

Each film-coated caplet contain contains:
Amoxycillin trihydrate equivalent to amoxycillin anhydrous 500 mg
Clavulanate potassium equivalent to clavulanic acid 125 mg

 
:: INDICATIONS ::

DEXYCLAV® is indicated to any kind of infection that caused by bacteria, such as:

  • Upper respiratory infections including sinusitis, tonsillitis, and otitis media.
  • Lower respiratory infections such as acute and chronic bronchitis, emphysema pneumonia, lungs abscess.
  • Soft tissue and skin infections such as: abscess, cellulitis, wound infections.
  • Urogenital infections such as: cystitis, urethritis, abortion caused by sepsis, pelvic infections, gonorrhea.
 
:: CONTRAINDICATIONS ::
  • Patient with hypersensitive to penicillin.
  • Baby born of mothers hypersensitive to penicillin.
 
:: DOSAGE AND ADMINISTRATIONS ::

Adults and children >12 years of age
Mild-moderate infections:
3 times daily 1 caplet 250 mg.
Severe infections:
3 times daily 1 caplet 500 mg.

Patients with renal impairment:
Mild (ClCr >30 ml/minute)
No dosage adjustment

Moderate (ClCr 10-30 ml/minute)
1 caplet 500 mg every 12 hours.

Severe (ClCr < 10 ml/minute)
No more than 1 caplet 250 mg every 12 hours.

Children:
DEXYCLAV® caplet which recommended for children with age less than 12 years of age according to dose 25-50 mg/kg body weight depends on the severity of infections.

Give the appropriate dose decrement. The drug is completely absorbed when administered before meals or at the time of meals. For severe infections, dose can be increased until 2 fold greater than normal. Treatment with DEXYCLAV® is better not more than 14 days.

 
:: WARNING AND PRECAUTIONS ::
  • Patient with moderate and severe renal impairment, the dose adjustment should be needed.
  • It is not recommended to use for women in the first trimester of pregnancy, unless based on the physician’s recommendation.
  • It should be carefully use in patient with severe hepatic impairment.
 
:: ADVERSE REACTIONS ::
  • Diarrhea, gastrointestinal disturbance, nausea, vomiting, and candidiasis have been reported.
  • Urticaria and erythematous rashes can occur, although it is rare.
  • Transient hepatitis, cholestatic jaundice.
 
:: PRESENTATION AND REGISTRATION NUMBER ::

DEXYCLAV® FORTE. Box, 5 strips @ 6 film-coated caplet.

ON MEDICAL PRESCRIPTION ONLY

STORE AT TEMPERATURES BELOW 25°C,

PROTECT FROM LIGHT

Manufactured by:
PT Meprofarm
Bandung-Indonesia

For:
PT Dexa Medica