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    Active Ingredient *
    Ampicillin (as sodium|) 1000 mg, 2000 mg
    Sulbactam (as sodium|) 500 mg, 1000 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 x 1.5 g

    not in the basket chart 2899 21059

    Vial

    1 x 3 g

    not in the basket chart

    Dosage

    May be administered by either the IV or the IM routes.
    For IV administration, the dose can be given by slow intravenous injection over at least 10–15 minutes or can also be delivered in greater dilutions with 50–100 mL of a compatible diluent as an intravenous infusion over 15–30 minutes.
    May be administered by deep intramuscular injection.
    The recommended adult dosage is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.
    Pediatric Patients 1 Year of Age or Older: The recommended daily dose in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days.
    Impaired Renal Function: In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose in such patients should be administered less frequently in accordance with the usual practice for ampicillin.
    For full details see prescribing information.


    Indications

    Indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the following conditions:
    Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*
    Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), cteroides spp. (including B. fragilis), and Enterobacter spp.*
    Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*).
    * Efficacy for this organism in this organ system was studied in fewer than 10 infections.
    While the product is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to the product should not require the addition of another antibacterial.


    Contra-Indications

    Contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
    Contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with the product.


    Special Precautions

    General: A high percentage of patients with mononucleosis who receive ampicillin develop a skin rash. Thus, ampicillin class antibacterial should not be administered to patients with mononucleosis. In patients treated with this product the possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
    Prescribing this product in the absence of proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
    Hypersensitivity: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, this product should be discontinued and the appropriate therapy instituted.
    Hepatotoxicity: Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of this product. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.
    Severe Cutaneous Adverse Reactions: this product may cause severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), dermatitis exfoliative, erythema multiforme, and Acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash they should be monitored closely and this product discontinued if lesions progress.
    Clostridium difficile-Associated Diarrhea: Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including this product, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
    For full details see prescribing information.


    Side Effects

    Adult Patients: generally well tolerated. The following adverse reactions have been reported in clinical trials.
    Local Adverse Reactions: Pain at IM injection site – 16%, Pain at IV injection site – 3%, Thrombophlebitis – 3%, Phlebitis – 1.2%.
    Systemic Adverse Reactions: The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients. Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting, candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain, epistaxis and mucosal bleeding.
    Pediatric Patients: Available safety data for pediatric patients treated with this product demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient.
    Adverse Laboratory Changes: Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:
    Hepatic: Increased AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH.
    Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes, basophils, eosinophils, and platelets.
    Blood Chemistry: Decreased serum albumin and total proteins.
    Renal: Increased BUN and creatinine.
    Urinalysis: Presence of RBC’s and hyaline casts in urine.
    Postmarketing Experience: In addition to adverse reactions reported from clinical trials, the following have been identified during post-marketing use of ampicillin sodium/sulbactam sodium or other products containing ampicillin. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency, or potential causal connection to ampicillin sodium/sulbactam sodium.
    Blood and Lymphatic System Disorders: Hemolytic anemia, thrombocytopenic purpura and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some individuals have developed positive direct Coombs Tests during treatment, as with other beta-lactam antibacterials.
    Gastrointestinal Disorders: Abdominal pain, cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice, abnormal hepatic function, melena, gastritis, stomatitis, dyspepsia, black “hairy” tongue and Clostridium difficile associated diarrhea.
    General Disorders and Administration Site Conditions: Fatigue, malaise, and injection site reaction.
    Immune System Disorders: Serious and fatal hypersensitivity (anaphylactic) reactions, anaphylactic shock.
    Nervous System Disorders: Headache, convulsion, dizziness, somnolence, and sedation.
    Renal and Urinary Disorders: Tubulointerstitial nephritis.
    Respiratory, Thoracic and Mediastinal Disorders: Dyspnea.
    Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, Acute generalized exanthematous pustulosis (AGEP), erythema multiforme, exfoliative dermatitis, urticaria, and dermatitis.


    Drug interactions

    Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with the product may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with this product and allopurinol administered concurrently. This product and aminoglycosides should not be reconstituted together due to the in vitro inactivation of aminoglycosides by the ampicillin component of the product.


    Pregnancy and Lactation

    Pregnancy: Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
    Labor and Delivery: Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions, and duration of contractions. However, it is not known whether the use of this product in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
    Nursing Mothers: Low concentrations of ampicillin and sulbactam are excreted in the milk; therefore, caution should be exercised when administered to a nursing woman.


    Overdose

    Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular weight, degree of protein binding and pharmacokinetics profile of sulbactam suggest that this compound may also be removed by hemodialysis.


    Important notes

    Storage: Stored below 25°C prior to reconstitution.


    Manufacturer
    Haupt Pharma Latina S.r.l, Italy
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