STANDACILLIN FOR INJECTION 0.5 G/VIAL [SIN00680P]

Product Info

STANDACILLIN FOR INJECTION 0.5 G/VIAL

[SIN00680P]

4.1 Therapeutic indications
To initiate the therapy of infections caused by sensitive strains identified by a sensitivity test as well as Gram‐positive and Gram‐negative bacteria, or for the treatment of severe infections, especially in patients who cannot take the medication orally (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Infections of the respiratory tract:

• Infections and/or mixed infections of the upper respiratory tract and the ear, nose and throat (ENT) region: acute sinusitis (diagnosed by a professional), acute otitis media

• Infections of the lower respiratory tract: acute exacerbation of chronic bronchitis, community acquired pneumonia

Skin and soft tissues infections:

• Wound infections

• Infections after animal bites

Urogenital infections:

• Acute and chronic pyelonephritis, pyelitis, cystitis, urethritis

Infections of the female genital organs and the pelvis

• febrile abortion, adnexitis, salpingitis, endometritis, parametritis, pelvic peritonitis, puerperal fever

Infections of the gastrointestinal tract:

• salmonellosis, shigellosis, typhus, paratyphus; also treatment of Salmonella carriers

• Infections of the biliary tree (cholangiolitis, cholangitis, cholecystitis)

Acute and latent listeriosis, leptospirosis, possibly together with gentamicin or kanamycin, possibly together with chloramphenicol in patients with meningitis.

Endocarditis (e.g. caused by enterococci, in combination with an aminoglycoside).
Listeria meningitis.

Treatment of bacteraemia‐related or suspected to be related to one of the above infections.

Perioperative infection prophylaxis: during operations on the gastrointestinal or urogenital tracts in combination with another active antibacterial substance, for prophylaxis of endocarditis in persons at risk.

Official recommendations for appropriate use of antibiotics must be taken into consideration.

Standacillin may be used in all age groups.

4.2 Posology and method of administration
Posology
The dose of ampicillin depends on the patient’s age, body weight and renal function, severity and site of the infection, as well as on suspected or proven pathogens.

In general, the following dosage guidelines apply

Listeria meningitides and other severe infections
300 (–400) mg/kg daily or 8–16g daily by short i.v. infusion.

With meningitis, restoring the blood‐brain barrier should be considered after recovery, and the dose should not be reduced accordingly.
Infections with highly sensitive bacteria or infection sites requiring high concentrations of the active substance can be treated with daily doses that are at the lower end of the dosage recommendations.

The daily dose is divided into 2–4 doses. The minimum dose should not be below 1 g/day in adults.

Therapy may be switched to oral aminopenicillins following clinical improvement.

Dosage in patients with impaired kidney function and for premature babies and newborns
With severe kidney insufficiency or in premature babies and newborns, the dose or dosing interval must be adjusted to the reduced kidney excretion. With severe kidney insufficiency, a dose of 1 g of ampicillin per 8 hours should not be exceeded.

The dosing interval increases to 12 – 15 hours in patients with creatinine clearance lower than 10 ml/min.

Method of administration
For intravenous or intramuscular use.
The medicine is administered IV, IM, or as an infusion.
The IV injection should be administered slowly over at least 3 – 5 minutes.
The duration of infusion should be between 15 and 20 minutes.

Instructions for use
Only freshly prepared and clear solutions that are prepared immediately before use should be used.
Complete dissolution must be ensured.
For single use only.

IM solution Method of administration:
The contents of the 500 mg injection bottle are dissolved with 5 ml of solvent (water for injection).

IV infusion Method of administration:
The contents of the 500 mg injection bottle are dissolved with 5 ml of solvent (water for injection).

IV infusion solution:
The contents of the 500 mg injection bottle are dissolved with 5 ml of solvent (water for injection).
The finished solution can be mixed with any amount of blood‐isotonic NaCl 0.9% solution.

Duration of use
Infections of the urogenital tract: at least 4–10 days
Infections with β‐hemolytic streptococci: at least 10 days
Pneumonia: 10–14 days
Typhoid: 14 days
Endocarditis: 4–6 weeks
For other infections, 48 hours after clinical and/or bacterial recovery or 7 days after fever has abated and there is clinical improvement.

4.3 Contraindications
Hypersensitivity to the active substance.
Proven and suspected hypersensitivity to beta‐lactam antibiotics, such as penicillins and cephalosporins.
History of jaundice or impaired liver function due to ampicillin.