Composition

Each 375-750 mg film-coated tablet contains sultamicillin tosylate dihydrate equivalent to 375-750 mg sultamicillin.

Each 250 mg / 5 mL suspension contains 250 mg sultamicillin.

Each 250-500 mg - 1-2 g vial contains ampicillin sodium equivalent to 250-500 mg- 1- 2 g ampicillin; and sulbactam sodium equivalent to 125-250-500 mg- 1 g sulbactam.

Features

Spectrum of Activity

Gram-positive bacteria:

Gram-negative bacteria:

Indications

Contraindications

Is contraindicated in individuals hypersensitive to penicillins.

Warnings and Precautions

Serious hypersensitivity reactions can be observed during therapy. Patients should therefore be tested for hypersensitivity prior to the start of treatment.

During prolonged treatment periods, vital organ functions including renal, hepatic and hematopoietic system should be monitored.

Ampicillin and sulbactam have no carcinogenic or mutagenic effects; they do not effect fertility.

Safety of administration in pregnant and nursing women has not been determined.

Development of superinfection during administration should be considered and if it does, treatment should be discontinued and necessary measures should be employed.

Ampicillin should not be used in patients with infectious mononucleosis; the drug causes serious skin rashes in these cases.

Adverse Reactions

Local (injection): Pain at injection site and thrombophlebitis in IV administration.

Gastrointestinal system: Stomatitis, tongue discoloration, gastritis, diarrhea, enterocolitis, pseudomembranous colitis.

Skin and soft tissue: Skin rash, itching, urticaria, erythema multiforme and rarely, exfoliative dermatitis and some hypersentivity reactions.

Hematological: Agranulocytosis and decreases in hemoglobin, hematocrit, erythrocyte, leucocyte, lymphocyte and platelet or increases in lymphocyte, monocyte, eosinophilia and platelet; these findings are reversible and return to normal upon discontinuation of therapy.

Laboratory findings: Increases in SGOT, SGPT, LDH, alkaline phosphatase, BUN and serum creatinine and decreases in serum albumin and total protein. Erythrocyte and hyaline casts can be seen in urine.

Drug Interactions

Co-administration of sultamicillin with diarrhea-causing antibacterial agents can aggrevate the symptoms of adverse reactions.Co-administration of ß-lactam antibacterial agents (penicillins and cephalosporins) with aminoglycosides can decrease the effects of both group of drugs. If co-administration is indicated, they should be given separately with at least one hour interval; they should not be mixed in the same IV set. Co-administration of ampicillin with oral contraceptives and estrogen-containing agents can decrease the effects of these drugs. Probenecid delays renal secretions of ampicillin and sulbactam and prolongs half-lives of both of these agents. In treatment of infections where prolonged serum levels are desired, ampicillin/sulbactam-sultamicillin and probenecid can be used concurrently. Administration of ampicillin concomitantly with allopurinol markedly increases skin rashes especially in hyperuricemic patients. However, it is not determined whether this is caused by the presence of hyperuricemia or allopurinol. It delays the absorption of antacids and decreases peak plasma levels.

Dosage and Administration

Tablet and Suspension

The recommended adult dosage is 375-750 mg bid. In children weighing over 30 kg, the adult dosage is used. Therapy should be continued for 5-14 days and after the patient is afebrile and the symptoms disappear, treatment should be continued for a further 2 days. In hemolytic streptococcal infections, treatment should be continued for at least 10 days to prevent complications of acute rheumatic fever and glomerulonephritis. In patients with creatinine clearance >30 mg / min, ampicillin and sulbactam excretion is effected but plasma levels stay the same; in such cases dose intervals should be longer. The recommended dose of the suspension form for treatment of infections in children weighing > 30 kg is 50 mg/kg/day given in 2 equally divided doses. In the treatment of uncomplicated gonorrhea, sultamicillin tablet 2.25 g (3x750 mg) can be given in a single oral dose.

Injection

After reconstitution it can be given by IV or IM route.

Adults

Daily dosage varies between 1.5 g (1 g ampicillin / 0.5 g sulbactam) and 12 g (8 g ampicillin / 4 g sulbactam). Maximum daily sulbactam dose is 4 g. The daily dose should be given with 6-8 hour intervals depending on the severity of the infection. In mild infections this interval can be increased to 12 hours. IV administration should be given very slowly over 10-15 minutes. It can also be given by infusion over 15-30 minutes in a 50-100 mL suitable infusion fluid.Following dilution, the IV dosage form is administered into a deep muscle. If the patient complains of severe pain, 0.5 % anhydrous lidocaine HCI sterile solution for injection can be used. In IV or IM administration the solution should be used within 1 hour following reconstitution. This drug should be used with caution in patients with renal insufficiency and the dosage should be adjusted according to creatinine clearance values.

Storage Conditions

Should be stored out of reach of children, at room temperature (<25ºC) and in its package.

After reconstitution, suspensions can be kept in the refrigerator (2-8ºC) for up to 14 days without loss of activity.

Available Forms

AMPISID 375 mg film-coated tablet, 10-tablet bottles

AMPISID 750 mg film-coated tablet, 10-tablet bottles

AMPISID 250 mg/5 mL suspension, 40 mL bottles

AMPISID 250 mg/5 mL suspension, 70 mL bottles

AMPISID IM/IV for injection 250 mg, 1 vial and 1 diluent ampoule (1 mL)

AMPISID IM for injection 250 mg, 1 vial and 1 diluent ampoule containing lidocaine (1 mL)

AMPISID IM/IV for injection 500 mg, 1 vial and 1 diluent ampoule (1.8 mL)

AMPISID IM for injection 500 mg, 1 vial and 1 diluent ampoule containing lidocaine (1.8 mL)

AMPISID IM/IV for injection 1 g, 1 vial and 1 diluent ampoule (3.5 mL)

AMPISID IM for injection 1 g, 1 vial and 1 diluent ampoule containing lidocaine (3.5 mL)

AMPISID IM/IV for injection 2 g, 1 vial and 1 diluent ampoule (7 mL)