Sulvacil

Sulvacil

ampicillin + sulbactam

Manufacturer:

Shin Poong

Distributor:

Elin
Full Prescribing Info
Contents
Ampicillin sodium, sulbactam sodium.
Description
750 mg: Each vial contains Ampicillin (as sodium) 500 mg and Sulbactam (as Sodium) 250 mg.
1.5 g: Each vial contains Ampicillin (as sodium) 1 g and Sulbactam (as Sodium) 500 mg.
Action
Pharmacology: Pharmacokinetics: The pharmacokinetics of ampicillin and sulbactam are broadly similar and neither appears to affect the other to any great extent.
Microbiology: Spectrum of activity: *Staphylococcus aureus, *Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus faecalis, Staphylococcus saprophyticus, Streptococcus pyogenes, Streptococcus viridans, *Hemophilus influenzae, Moraxella catarrhalis, *Escherichia coli, *Klebsiella species, *Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Morganella morgnii, Neisseria gonorrhoeae, Clostridium species, Peptococcus species, Peptostreptococcus species, *Bacteroides species.
(*: including β-lactamase producing strains).
Indications/Uses
Use for the treatment of infections due to beta-lactamase-producing H. influenza, including those of the respiratory tract, bones, joints and soft tissues; for polymicrobial infections with mixed aerobic and anaerobic such as diabetic foot, gynecologic infections, and intra-abdominal infections; and for urinary tract infections due to susceptible organism.
Upper and lower respiratory tract infection (including otitis media, laryngitis, sinusitis), Bacterial pneumonia, Urinary tract infection and pyelonephritis, Intra-abdominal infections (including peritonitis, cholecystitis, endometritis, pelvic infection), Bacterial sepsis, Skin and skin structure infections, Bon e and joint infections, Gonorrhea, Prevention after operation.
Dosage/Direction for Use
If beta-lactamase-producing organisms are present, ampicillin can be given with a Beta-lactamase inhibitor such as sulbactam.
The sodium salts of ampicillin and sulbactam may be given intramuscularly (I.M.) or intravenously (I.V.) in the treatment of infections due to beta-lactamase-producing organisms. The usual dose is ampicillin 1 g with sulbactam 500 mg every 6 hours; doses may be doubled in severe infections.
Adults: 0.5 to 3 g (potency) of ampicillin sodium and sulbactam sodium (SULVACIL) is administered by I.V. or I.M. injection in 3 to 4 divided doses a day. Do not exceed 4 g (potency)/day as sulbactam. (See Table 1.)

Click on icon to see table/diagram/image

Infant and Children: 150 mg (potency)/kg/day of ampicillin sodium and sulbactam sodium (SULVACIL) is administered 3 ~ 4 divided doses a day.
For neonate or prematurely born baby, administer 2 divided doses a day for a week after birth.
Impaired renal function: In patient with impairment of renal function (less than 30 mL/min of Creatinine Clearance rate) should be administered less frequently.
In case of prevention of infection in surgical, this drug is administered 1.5 ~ 3 g (potency) by I.V. or I.M injection when put under an anesthetic and it can be used 3 ~ 4 times more.
To Prepare Admixture: For I.V. or I.M. administration, it should be dissolved with sterile water for injection, dextrose injection or physiological salt solution. It should be slowly administered at least over 3 minutes. (See Table 2.)

Click on icon to see table/diagram/image
Contraindications
Patients with penicillin hypersensitivity.
Patients with infectious mononucleosis.
Patients with a previous history of cholestatic jaundice or hepatic dysfunction.
Special Precautions
Ampicillin should be stopped if a skin rash occurs. It should preferably not be given to patients with infectious mononucleosis since they are especially susceptible to ampicillin-induced skin rashes; patients with lymphatic leukemia or possibly HIV infection may also be at increased risk of developing skin rashes.
Careful administration: Patients with severe liver disorder.
Patients with moderate or severe renal disorder. (It should be administered at regular intervals because the blood concentration last.)
Patients with a history of hypersensitivity to penicillin or cephalosporins (cross tolerance).
Patients who or whose family have a predisposition to develop allergic reactions such as bronchial asthma, rash and urticaria.
Patients with poor oral intake or receiving parenteral nutrition or aged patients. (As vitamin K deficiency symptoms may appear, close observation should be made.)
Use In Pregnancy & Lactation
Reproduction studies in animals revealed no evidence of impaired fertility or harm to the fetus due to this drug. The safety during pregnancy has not been established therefore the drug should not be administered to pregnant patients or women suspected of being pregnant. Therefore use this drug only if the expected therapeutic benefit is thought to outweigh any possible risk.
Low concentration of ampicillin and sulbactam are excreted in the milk. Therefore, caution should be exercised when this drug is administered to a nursing woman.
Adverse Reactions
Skin rashes are among the most common adverse effects and are generally either urticarial or maculopapular; the urticarial reactions are typical of penicillin hypersensitivity, while the erythematous maculopapular eruptions are characteristic of ampicillin and amoxicillin and often appear more than 7 days after commencing treatment. Such rashes may be due to hypersensitivity to the beta-lactam moiety or to the amino group in the side-chain, or to a toxic reaction. The occurrence of a maculopapular rash during ampicillin use does not necessarily preclude the subsequent use of other penicillins.
However, since it may be difficult in practice to distinguish between hypersensitive and toxic responses, skin testing for hypersensitivity may be advisable before penicillin is used in patients who have had ampicillin rashes. Most patients with infectious mononucleosis develop a maculopapular rash when treated with ampicillin, and patients with other lymphoid disorders such as lymphatic leukemia, and possibly those with HIV infection, also appear to be at higher risk. More serious skin reactions may occur and erythema multiforme associated with ampicillin has occasionally been reported.
Gastrointestinal adverse effects, particularly diarrhea and nausea and vomiting, occur quite often, usually after oral use. Pseudomembranous colitis has also been reported.
Drug Interactions
The possibility of a prolonged bleeding time after oral treatment with a broad-spectrum drug like ampicillin should be borne in mind in patients receiving anticoagulants.
Hormonal contraceptives: A variety of broad-spectrum antibacterial have also been reported to decrease oral contraceptive efficacy. It is recommended that additional contraceptive precautions should be used while taking, and for 7 days after stopping, a short course of any broad-spectrum antibacterial. If these 7 days run into the last 7 days of the cycle, then the tablet-free interval (or the 7 inert tablets) should be omitted and the next cycle of tablets started immediately. If the course of antibacterial exceeds 3 weeks the intestinal flora develops resistance and additional precautions become unnecessary.
Methotrexate: Various penicillins have been reported to markedly decrease the clearance of methotrexate given intravenously for treatment of neoplasms. There have also been a few reports of penicillins possibly exacerbating the toxicity of low-dose methotrexate in patients being treated for psoriasis or rheumatoid arthritis, but a small study found that although flucloxacillin decreased methotrexate clearance slightly, this was not clinically significant.
Allopurinol: An increased frequency of skin rashes has been reported in patients receiving ampicillin or amoxicillin, with allopurinol.
Chloroquine: The absorption of ampicillin has been reduced in healthy subjects taking chloroquine.
Probenecid: Decreases the renal tubular secretion of ampicillin and sulbactam. This may result in increased blood level.
Caution For Usage
For I.M. administration, it should be used within 1 hour after reconstitution.
Don't combine with blood preparations or amino acid solution.
When concomitant therapy with aminoglycosides is indicated, ampicillin and aminoglycosides should be reconstituted and administered separately, due to inactivation of aminoglycosides by any of the aminopenicillins.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01CR01 - ampicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
500 mg/250 mg powd for inj (vial) 10's. 1 g/500 mg powd for inj (vial) 10's.
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