Kedacillin

KEDACILLIN® for Injection
SODIUM SULBENICILLIN

Composition
KEDACILLIN for Injection is available in 1 g and 2 g vials, each of which contains :
The disodium salt equivalent to Sulbenicillin 1 g and 2 g (potency) respectively.
Sulbenicillin is a antibiotic, chemically 6 (2 - phenyl - 2 - sulphoacetamido) penicillanic acid.

Actions

1. Sulbenicillin is effective against gram-negative bacteria, including Pseudomonas aeruginosa and anaerobic Bacteroides, and is also effective against gram-positive bacteria sensitive to Penicillin - G.
2. Sulbenicillin is excreted into the urine and bile in high concentration.
   Therefore, urinary levels, well above those required to eradicate urinary pathogens, are achieved.

Indications
It is indicated the following infections due to Sulbenicillin susceptible Pseudomonas aeruginosa, Proteus, Retgerella, Klebsiella, Enterobacter, E. coli, Citrobacter cloacae, Pfeiffer's bacilli, Staphylococci, Streptococci, Pneumococcus and Bacteroides.

• Urinary tract infections : pyelonephritis, pyelitis, pyonephrosis, cystitis and urethritis.
• Bile-duct infections : cholecystitis and cholangitis.
• Respiratory tract infections : acute and chronic bronchitis, bronchiectasis, bronchopneumonia, pneumonia and pulmonary suppuration.
• Obstetrics and Gynecology : intrauterine infection, adnexitis, intrapelvic infection and Bartholinitis.
• Otorhinological infections : otitis media, sinusitis, parotitis, submaxillitis, furuncle of the ear and furuncle of the nose.
• Superfacial suppurative diseases : folliculitis, furuncle, carbuncle, abscess, panaris, phlegmon, tonsilitis, peritonsilitis, peritonsillar abscess, erysipelas, ophthalmia, blepharitis, corneal ulcer, dacryocystitis, stye, post-operative wound infection and traumatic and burn infections.
• Peritonitis.
• Septicemia and sub-acute bacterial endocarditis.

Administration and Dosage

• Usually, 2-4 g daily for adults or 40-80 mg/kg body weight daily for children, intravenously, divided into two to four doses.
• For severe and intractable infections caused by Pseudomonas aeruginosa and Proteus, increase the intravenous daily dose up to 20 g for adults or up to 400 mg/kg body weight for children, including new-born infants, according to condition. For septicemia and pneumonia patients, whose defensive power against infections if reduced by leucopenia, increase the intravenous daily dose up to 30 g.
• For intravenous injection, dissolve each 1 g of the product in 20 ml distilled water for injection or glucose solution for injection. If the single dose becomes over 5 g, dissolve in 100 to 500 ml of solution for infusion and administer by intravenous drip over 1 to 2 hours.
• For intramuscular use, KEDACILLIN (1 g in 3 ml) may be given intramuscularly but causes pain similar to other injectable Penicillins. For intramuscular use, a local anaesthetic such as Lidocaine or Mepivacaine must be included.
• The solution may become warm due to heat of dissolution but quality is not affected.

Contraindication
KEDACILLIN must not be administered to patients with known hypersensitivity to Penicillin.

Side effects
Though very rare, side effects such as gastrointestinal disturbance, eruption, eyelid edema, fever, facial pallor and intradermal positive reaction are likely to be observed as with other synthetic Penicillins.

Precautions

1. If the patient or his family has a history of allergic conditions such as bronchial asthma, eruption and urticaria, KEDACILLIN should be given cautiously. Anaphylactic reaction has been reported following administration of antibiotics of the Penicillin series.
2. KEDACILLIN should be administered carefully to patients with severe renal or hepatic damage.
3. As KEDACILLIN contains 4,8 mEq/g (potency) of sodium, KEDACILLIN should be given carefully by measuring electrolyte concentration periodically when the administration of high dosage for long term is required to the patients with cardiac or renal Insufficiency and hypertension.
4. Periodical examination of hepatic or renal function and blood picture is desirable since KEDACILLIN may increase SGOT, SGPT and BUN, and decrease erythrocyte and leucocyte.

Store at room temperature (25-30°C).

Package
Box, 10 vials @ 1 g,
Box, 10 vials @ 2 g,

1 g, Reg.No. DKL7225100444B1.
2 g, Reg. No. DKL8625100444A1.

ON MEDICAL PRESCRIPTION ONLY

Manufactured by PT. Meiji Indonesia, Bangil
For PT. Takeda Indonesia, Bekasi, Indonesia
Licensed by Takeda Pharmaceutical Company Limited, Osaka, Japan

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