Sibatam

Sibatam

sulbactam

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Full Prescribing Info
Contents
Sulbactam sodium.
Description
Each vial contains Sterile Sulbactam sodium equivalent to Sulbactam 2 g.
Each vial of SIBATAM (2 G FOR INJECTION) contains approximately 8.6 mmol (197 mg) of sodium.
Action
Pharmacology: Pharmacodynamics: Sulbactam, a penicillanic acid sulfone, is a β-lactamases inhibitor with high affinity for and binds to certain β-lactamases leading to the formation of a β-lactamases–Sulbactam complex that irreversibly inhibits the activity of the enzyme and allows synergistic antibacterial effect of the β-lactam antibiotics which is co-administered. Sulbactam also has its intrinsic antimicrobial activity, which is related to its affinity for the penicillin-binding protein. In vitro, Sulbactam concentrations of 0.1-4 mcg/mL inhibit some strains of Acinetobacter spp., Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis. In addition, Sulbactam concentrations of 8-16 mcg/ml inhibit some strains of Bacteroides and Legionella.
Pharmacokinetics: Sulbactam sodium is not absorbed appreciably from the GI tract and must be given parenterally. Sulbactam reportedly distributes into certain tissue and fluids (e.g. bile, blister fluid, peritoneal fluid, intestinal mucosa). Sulbactam distribution may vary and appears to depend on the degree of local inflammation. In adult with normal renal function, the apparent volume of distribution at steady state of Sulbactam is 0.24-0.4 L/kg, and the apparent volume of distribution of Sulbactam at steady state in infants and children is 0.31-0.38 L/kg. In adult and children, CSF concentrations of the drugs generally are higher in patients with inflamed than in those with uninflamed meninges. Sulbactam is approximately 38% bound to serum proteins. Sulbactam crosses the placenta and concentrations in umbilical cord blood may be similar to serum concentrations. Sulbactam is distributed into milk in low concentrations. In lactating women who received 500 mg or 1 g doses of Sulbactam by IV infusion over 20 minutes every 6 hours, concentrations of the drug in milk average 0.52 mcg/ml in samples obtained at random intervals between the first and thirteenth doses. In healthy adults with normal renal function, Sulbactam has a distribution half-life of about 15 minutes and elimination half-life of about 1 hour.
In a study in healthy geriatric adults 65-85 years of age with renal function normal for their age, the elimination half-life of Sulbactam averaged 1.6 hours. In infants and children younger than 12 years of age, Sulbactam has an elimination half-life of 0.92-1.9 hours. The major route of elimination of Sulbactam is glomerular filtration and tubular secretion. Only small amount of the drug are eliminated in feces and bile. About 75-85% of a parenteral dose is excreted unchanged in urine within 8 hours. Serum concentration of Sulbactam is higher and the half-life of the drugs prolonged in patients with renal impairment. In healthy adult with normal renal function, renal clearance of Sulbactam is 169-204 ml/minute.
Indications/Uses
Sulbactam is a β-lactamase inhibitor that is to be used in combination with other parenteral β-lactam antibiotics such as ampicillin as the treatment for moderate to severe bacterial infections.
Dosage/Direction for Use
Mode of administration: Prior to initiation of therapy, appropriate specimens should be obtained for identification of the causative organism(s) and in vitro susceptibility tests.
Preparation for administration: Reconstituted solutions for IM and IV injection must be clear and colorless to slightly yellow solution.
IM injection: Reconstitute SIBATAM (2 G FOR INJECTION) in vial of drug with 8 mL of sterile water for injection (SWFI) to make clear and colorless to slightly yellow solution for IM injection; which should be injected into large muscles and divided into equal doses of injection. High doses should only be administered for intravenous injection and intravenous infusion. Not recommended for intramuscular injection.
IV Injection: Reconstitute SIBATAM (2 G FOR INJECTION) in vial of drug with 8 mL of sterile water for injection (SWFI) to make clear and colorless to slightly yellow solution for IV injection.
IV Infusion: Reconstitute SIBATAM (2 G FOR INJECTION) in vial of drug with 8 mL of sterile water for injection (SWFI) to make clear and colorless to slightly yellow solution. Add one of the following compatible infusion solutions: 0.9% Normal saline solution (NSS), 5% Dextrose in water (D5W) and Lactate Ringer's solution (LRS).
Stability after reconstitution: SIBATAM (2 G FOR INJECTION) should be used immediately after reconstitution in compatible infusion solutions. If not used immediately, the reconstituted solutions are stable as stated in Tables 1 and 2. (See Tables 1 and 2.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Recommended dose: Adult dosage: When administered in combination with other beta-lactam antibiotics, the recommended doses are 0.5-1 g Sulbactam every 6, 8 or 12 hours for adults. The maximum daily dose is 4 g, independent of the dose of the combined antibiotics.
A dosage of 6 g per day in divided doses of Sulbactam alone may be considered in multidrug resistant, life threatening Acinetobacter baumannii infections.
Pediatric dosage: When administered in combination with other beta-lactam antibiotics, the recommended dose is 50 mg/kg/day every 6, 8 or 12 hours for pediatric patients. The maximum daily dose is 80 mg/kg/day.
Since Sulbactam's activity in children under one year of age has not been completely clarified yet. Therefore, Sulbactam should be used in this patient population only after a careful benefit-risk assessment.
Dosage in renal function impairment: In patients with impaired renal function, doses and/or frequency of administration should be modified in response to the degree of renal impairment, severity of infection, and susceptibility of causative organism. In case of the pharmacokinetics of Sulbactam and co-administered beta-lactam antibiotics such as ampicillin, these are affected in patients with renal impairment. Dosage should be adjusted in response to the degree of renal impairment.
Dosage in hepatic function impairment: There is no information of dosage adjustment for the use in patients with hepatic function impairment. However, caution is needed when drug is used in patients with hepatic function impairment.
Dosage in geriatric patients: There is no information of dosage adjustment for the use in geriatric patients. However, caution is needed when drug is used in geriatric patients.
Overdosage
Symptoms: Limited information is available on the acute toxicity of Sulbactam and co-administered beta-lactam antibiotics, ampicillin, in humans. Overdosage of the drug would be expected to produce manifestations that principally are extensions of the adverse reactions reported with the drug. The fact that high CSF concentrations of beta-lactam antibiotics may cause neurologic effects, including seizures, should be considered.
Treatment: Sulbactam is removed from circulation by hemodialysis. This may enhance elimination of the drug from body if overdosage occur in patients with impaired renal function, but may be unnecessary in patients with normal renal function.
Contraindications
Sulbactam is contraindicated in patients with known hypersensitivity situations against Sulbactam or β-lactam antibiotics.
Warnings
Do not use in patient with history of hypersensitivity reactions to Sulbactam.
Sulbactam may cause allergic reactions and fatal hypersensitivity.
If rash, skin irritation, or swelling occurred, the drug should be discontinued and consult the physician.
Special Precautions
Because there is sodium content in the Sulbactam injection, care should be taken regarding the amounts of sodium in patients with electrolyte disorders. It should be considered that Sulbactam 2 g contains approximately 8.6 mM of sodium.
It is advisable to check periodically for organ system dysfunction during extended therapy with Sulbactam; this includes renal, hepatic, and hematopoietic systems.
Use In Pregnancy & Lactation
Pregnant woman: Reproductive studies have revealed no teratological findings. However, there are no adequate and well controlled studies in pregnant woman and the drug diffuses readily into most body tissues and fluids in the human, and cross the placental barrier. There are no adequate and well controlled studies in pregnant woman. Therefore, Sulbactam should be used during pregnancy only if the potential benefits outweigh the potential risk.
Nursing woman: Small amounts of Sulbactam may enter breast milk. The potential risk must be evaluated before use in lactation.
Adverse Reactions
Undesirable effects may be found during treatment with Sulbactam.
Infections and parasitic: fungal infections of the oral mucosa membrane, stomatitis and pseudomembranous colitis.
Blood and lymphatic systems: eosinophilia, thrombocytopenia, leucopenia, increased platelet, leukocytosis, neutropenia, anemia, prolongation of bleeding time and speckled skin or mucosal bleeding (purpura).
Immune system: hypersensitivity reaction and anaphylactic shock.
Nervous system: dizziness, headaches and seizures.
Gastrointestinal: diarrhea, vomiting, stomach upset, gastrointestinal pain, nausea, decreased appetite and bleeding.
Liver and biliary: increase in transaminase levels and bilirubin concentration in the serum.
Skin and sub-skin subcutaneous: Stevens-Johnson syndrome and toxic epidermal necrosis.
Musculoskeletal connective tissue and bone: muscle cramps.
Renal and urinary: increase in creatinine serum and interstitial nephritis.
Other: thrombophlebitis and pain at injection site.
The common adverse reactions reported are eosinophilia, dizziness, diarrhea, increase in transaminase levels and thrombophlebitis.
Drug Interactions
Sulbactam is potentially physically and/or chemically incompatible with aminoglycosides and can inactivate the drugs in vitro.
The serum half-life of Sulbactam may be increased by 18-45% by concomitant oral probenecid.
Storage
Store below 30°C prior to reconstitution.
The reconstituted solutions of SIBATAM (2 G FOR INJECTION) should be used immediately. If not used immediately, the solutions are stable under storage conditions which are mentioned in Stability after reconstitution under Dosage & Administration.
SIBATAM (2 G FOR INJECTION) should be protected from freezing.
MIMS Class
Other Beta-Lactams
ATC Classification
J01CG01 - sulbactam ; Belongs to the class of beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 0.5 g x 1's. 2 g (white or almost white, sterile) x 1's.
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