PAMECIL Hard capsule Ref.[28315] Active ingredients: Ampicillin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

Ampicillin is a broad spectrum penicillin, used for the treatment of bacterial infections caused by susceptible microorganisms.

These include:

  • Infections of the Genitourinary Tract (including Gonorrhea) caused by E. Coli, P. Mirabilis, enterococci, Shigella, S. Typhosa and other Salmonella, and non-penicillinase-producing N. Gonorrhoeae.
  • Infections of the Respiratory Tract caused by Non-penicillinase-producing H. Influenzae and staphylococci, and streptococci including Streptococcus Pneumoniae.
  • Infections of the Gastrointestinal Tract caused by Shigella, S. Typhosa and other Salmonella, E. Coli, P. Mirabilis, and enterococci.
  • Meningitis caused by N. Meningitidis.

4.2. Posology and method of administration

Posology

Dosage for Adults and Elderly patients

  • Ear, Nose, Throat infections: 250 mg four times daily
  • Bronchitis: For routine therapy 250 mg four times daily are administered. For severe infections dosage may be increased up to 1000 mg four times daily.
  • Pneumonia: 500 mg four times daily
  • Urinary tract infections: 500 mg 4 times daily
  • Gastrointestinal infections: 500 to 750 mg three to four times daily Enteric infections: For acute infections 1g to 2g four times daily for a period of two weeks. In carries therapy should continue for a period of four to twelve weeks.
  • Gonorrhoea: 2 g orally with 1 g of probenecid as a single dose. Repeated doses are recommended for the females.

Paediatric population

Children less than 10 years old: Half adult routine dosage is recommended. For this group of patients the use of oral suspension is recommended.

Renal Impairment

In the presence of severe renal impairment (creatinine clearance less than 10 ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure.

Method of administration

Pamecil capsules are administered orally.

Oral doses of ampicillin should be taken half to one hour before meals. In all the above mentioned infections when oral administration is not possible, the drug may be administered parenterally.

4.9. Overdose

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not by peritoneal dialysis.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C in the original package, in order to protect from light and moisture.

6.5. Nature and contents of container

PVC-Al blisters.

Cartons of 16, 20 and 100 capsules are available.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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