AMPIMAX Film-coated tablet Ref.[10830] Active ingredients: Sultamicillin

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including sultamicillin. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity to multiple allergens. Careful inquiry should be made concerning previous hypersensitivity to penicillins, cephalosporins or other drugs before initiating therapy with sultamicillin. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.

Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, IV steroids, and airway management, including intubation, should be administered as indicated.

• Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with the use of nearly all antibacterial agents, including sultamicillin, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
• The renal, hepatic, and hematologic status of patients undergoing prolonged treatment with aminopenicillins should be evaluated periodically, particularly when administered to patients with liver or renal impairment.
• Prescribing sultamicillin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of antibiotic resistance.
• As with other antibacterial agents, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.

Sultamicillin is generally well-tolerated. Most adverse effects (AEs) are mild to moderate in severity and are normally tolerated with continued treatment.

Body as a Whole: Fatigue/malaise and headache have been rarely observed

Dermatologic/Hypersensitivity reactions: Rash, itching, pemphigus vulgaris, angioedema, dermatitis, urticaria; allergic reaction, anaphylaxis/anaphylactic shock, anaphylactoid reaction, superinfections, adult respiratory distress syndrome

Gastrointestinal (Gl): Vomiting, nausea, diarrhea, loose stools, epigastric distress, melena, abdominal pain/cramps

Nervous system: Taste disturbances, ototoxicity, dizziness, drowsiness/sedation

Renal: Kidney function disorder

Respiratory: Dyspnea

The following AEs have also been reported for aminopenicillin-class antibiotics including ampicillin and/or parenteral ampicillin/sulbactam:

Dermatologic/Hypersensitivity reactions: Pruritus, dry skin, erythema; rare reports of exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, and Stevens- Johnson syndrome; serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever); systemic allergic reactions (characterized by neck tightness, difficulty and pain when breathing, generalized weakness, and hypertension); facial swelling; positive direct antiglobulin (Coombs' test)

Gl: Anorexia, gastritis, black hairy tongue, glossitis, stomatitis, CDAD and colitis; acute, transient enterocolitis with severe abdominal pain and bloody diarrhea, but without evidence of CDAD and colitis; acute pancreatitis; flatulence, abdominal discomfort or distension, rectal bleeding

Nervous system: Headache, confusion; rare reports of convulsions/myoclonic seizures; generalized seizures

Hematologic: Anemia, hemolytic anemia, hypothrombinemia, eosinophilia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, abnormal platelet aggregation, prolongation of bleeding time, and prolongation of activated partial thromboplastin time (APTT); decreased hemoglobin concentration, hematocrit, erythrocyte, lymphocyte, and platelet counts; increased lymphocyte, monocyte, basophil, eosinophil, and platelet counts

Hepatobiliary: Transient elevations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, lactate dehydrogenase (LDH), creatine kinase (CK), bilirubin, and y-glutamyltransferase (y-glutamyltranspeptidase, GT, GGTP); bilirubinemia, abnormal hepatic function, and jaundice

Renal: Rare reports of acute interstitial nephritis; glomerulonephritis; increased blood urea nitrogen (BUN) and serum creatinine concentrations; presence of red blood cells and hyaline casts in urine, urine retention, dysuria, hematuria, crystalluria

Other Adverse Effects

Decreased concentrations of serum albumin and total protein; chest pain or tightness, edema, chills, throat tightness, substernal pain, epistaxis, mucosal bleeding; changes in smell perception.

For suspected adverse drug reaction, seek medical attention immediately and report to the FDA at www.fda.aov.Dh AND Unilab at (+632) 858-1000 or Droductsafetv@unilab.com.Dh. By reporting undesirable effects, you can help provide more information on the safety of this medicine.

Allopurinol: An increased incidence of rash reportedly occurs in patients with hyperuricemia who are receiving allopurinol and concomitant ampicillin compared with those receiving ampicillin or allopurinol alone.

Aminoglycosides: Both ampicillin and sulbactam are potentially physically and/or chemically incompatible with aminoglycosides and can inactivate the drugs in vitro.

Anticoagulants: Alterations in platelet aggregation and coagulation tests have been reported with penicillin use. Increased anticoagulant activity may also be expected.

Bacteriostatic Drugs (e.g., erythromycin, sulfonamides and tetracyclines): These drugs may interfere with the bactericidal effect of penicillins; therefore, concurrent therapy is not recommended.

Chloramphenicol: In vitro evidence of antagonism with ampicillin has been observed.

Chloroquine: The absorption of ampicillin has been reduced in patients taking chloroquine.

Methotrexate: Concomitant use of penicillins may result in decreased renal clearance of methotrexate and subsequent increase in methotrexate toxicity.

Estrogen-containing Oral Contraceptives: Possible decreased efficacy of estrogen-containing oral contraceptives and increased incidence of breakthrough bleeding have been reported with ampicillin.

Probenecid: Oral probenecid administered shortly before or concomitantly with ampicillin and sulbactam competitively inhibits renal tubular secretion of both ampicillin and sulbactam and produces higher and prolonged serum concentrations of the drugs.

Others: Variable in vitro effects from additive or indifferent to antagonistic effects have been demonstrated when ampicillin is used in conjunction with rifampicin or acetohydroxamic acid.

Interference with Laboratory Tests

Ampicillin reportedly interferes with urinary glucose determinations using cupric sulfate (e.g., Benedict’s solution, Clinitest) but does not affect glucose oxidase methods (Clinistix, Tes-Tape).

Reproduction studies of sultamicillin in animals have revealed no evidence of impaired fertility or harm to fetus. Although ampicillin alone has been administered to pregnant women without evidence of adverse effect to the fetus, the safety of sultamicillin use during pregnancy has not been definitely established.

Use with caution in breastfeeding women. Low concentrations of ampicillin and sulbactam are excreted in human milk. This should be considered as the neonate may be exposed, particularly since renal function is not fully developed in neonates.

Although serum half-lives of ampicillin and sulbactam are slightly longer in elderly patients than in younger adults, dosage of sultamicillin does not need to be modified in elderly patients with normal renal function. Flowever, since these patients have increased risk of renal impairment, renal function monitoring may be necessary.

In patients with severe renal impairment (creatinine clearance <30 mL/min), the elimination kinetics of ampicillin and sulbactam are similarly affected and hence the plasma ratio of one to the other will remain constant. The dose of sultamicillin in such patients should be administered less frequently in accordance with usual practice for ampicillin.