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Ampisid
Ampisid film-coated tablet 375-750 mg, 10 film-coated tablets
Ampisid suspension 250 mg/5 mL, 40-70 mL
Ampisid IM/IV for injection 250-500 mg – 1 g, 1 vial + 1 diluent ampoule
Ampisid IM for injection 250-500 mg – 1 g, 1 vial +
1 diluent ampoule containing lidocaine
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.
PHARMACOLOGICAL PROPERTIES: Has a wide spectrum of activity. Exerts bactericidal effect by
inhibiting bacterial wall mucopeptide biosynthesis mediated by the ampicillin in its formula. Provides irreversible beta-lactamase inhibition by the sulbactam in its formula. Provides high serum
concentrations following IM and IV administration.
INDICATIONS:
Skin and soft-tissue infections
Intra-abdominal infections
Gynecological infections
Respiratory tract infections
Urinary tract infections
Bacterial septicemia, bone and joint infections and gonococcal infections
Prophylaxis following abortion and cesarean section to decrease the risk of sepsis.
CONTRAINDICATIONS: Is contraindicated in individuals hypersensitive to penicillins. Lidocaine
used as diluent in the IM formulation should not be used in individuals hypersensitive to amide
group of products and in patients with heart block.
WARNINGS AND PRECAUTIONS: Serious hypersensitivity reactions can be observed during therapy. Patients should therefore be tested for hypersensitivity prior to the start of treatment.
SIDE EFFECTS / ADVERSE EFFECTS: 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.
Ampisid
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. 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.
Infants and children: The recommended total daily dose is 150 mg/kg administered with 6-8 hour
intervals. In premature and newborn infants, the recommended dosage for the first week of life
is 150 mg/kg/day administered with 12 hour intervals.
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 375-750 mg film-coated tablet, 10-tablets
AMPISID 250 mg/5 mL suspension, 40-70 mL bottles
AMPISID IM/IV for injection 250-500 mg - 1 g, 1 vial and 1 diluent ampoule (1 mL)
AMPISID IM for injection 250-500 mg – 1 g, 1 vial and 1 diluent ampoule containing lidocaine (1 mL)
NAME AND ADDRESS OF THE AUTHORISATION HOLDER: Mustafa Nevzat Ilac Sanayii A.Ş. Prof.
Dr. Bülent Tarcan Sok., Pak Iş Merkezi No: 5/1 34349 Gayrettepe/Istanbul.
NAME AND ADDRESS OF THE MANUFACTURING COMPANY:Mustafa Nevzat Ilac Sanayii A.Ş.
Çobançeşme Mah.Sanayi Cad. No.13 Yenibosna-Istanbul.