Ampimax

Ampimax

ampicillin + sulbactam

Manufacturer:

UNILAB, Inc

Distributor:

United Lab
Full Prescribing Info
Contents
Ampicillin sodium, sulbactam sodium.
Action
Pharmacologic Classification: Antibacterial.
Pharmacology: Pharmacokinetics: Bioavailability: Sulbactam is poorly absorbed from the gastrointestinal tract and is given by injection as the sodium salt. Parenteral sulbactam and ampicillin have similar pharmacokinetics.
Peak serum ampicillin and sulbactam concentrations are attained immediately after completion of a 15-minute intravenous (IV) infusion of the combination. After administration of a 1.5 g ampicillin+sulbactam dose, peak serum ampicillin concentrations are approximately 40 to 71 μg/mL while peak serum sulbactam concentrations are 21 to 40 μg/mL.
Ampicillin and sulbactam are rapidly and completely absorbed after intramuscular (IM) injection of the combination. Ampicillin and sulbactam peak serum concentrations are attained within 30 to 40 and 30 to 52 minutes, respectively, after IM injection. In adults with normal renal function, IM administration of a 1.5 g ampicillin+sulbactam dose results in peak serum ampicillin concentrations of 8 to 37 μg/mL and peak serum sulbactam concentrations of 6 to 24 μg/mL.
Both ampicillin and sulbactam are widely distributed throughout the body. Although sulbactam distributes to a greater extent than ampicillin in the blister fluid, peritoneal fluid and intestinal mucosa, sulbactam distribution varies and usually depends on the degree of local inflammation. Ampicillin and sulbactam distribute into the peritoneal fluid, blister fluid, tissue fluid, sputum, middle ear effusion, intestinal mucosa, bronchial wall, alveolar lining fluid, sternum, pericardium, myocardium, endocardium, prostate, gallbladder, bile, myometrium, salpinges, ovaries, and appendix. Ampicillin and sulbactam concentrations at most sites are generally 53 to 100% of the concurrent serum concentrations.
The apparent volume of distribution of ampicillin at steady state is 0.28 to 0.33 L/kg while that of sulbactam is 0.24 to 0.4 L/kg in adults with normal kidney function. In infants and children, the apparent volume of distribution of sulbactam at steady state is 0.31 to 0.38 L/kg.
Ampicillin and sulbactam have poor blood-brain barrier penetration in adults and children. However, cerebrospinal fluid concentrations of both drugs are generally higher during active inflammation.
Ampicillin's protein binding is about 28% while that of sulbactam is about 38%.
Ampicillin and sulbactam readily cross the placenta and concentrations in the umbilical cord blood may be similar to serum concentrations. However, levels in the amniotic fluid do not reach therapeutic concentrations during the first trimester. Small amounts of both drugs may also be distributed into breast milk.
Ampicillin and sulbactam are eliminated from the serum in a biphasic manner. Plasma half-lives of both drugs are similar and are about 1 to 1.8 hours and 1 to 1.3 hours for ampicillin and sulbactam, respectively, in patients with normal renal function. However, plasma half-life may be prolonged in neonates, the elderly and patients with renal impairment. Plasma half-life may be increased up to 7 to 20 hours in patients with severe renal impairment.
Ampicillin and sulbactam are excreted via the kidneys through glomerular filtration and tubular secretion. Approximately 75% to 85% of both drugs are excreted unchanged in the urine within eight hours following IV or IM administration. Ampicillin is also excreted in the bile, but the levels are variable and have a particular tendency to be low in the presence of a non-functional gallbladder. Enterohepatic circulation also occurs at some extent and the drug is inactivated in the liver and excreted in the feces.
Ampicillin and sulbactam are significantly removed by hemodialysis.
Indications/Uses
For the treatment of the following infections caused by susceptible microorganisms: Respiratory tract infections including pneumonia; Urinary tract infections including pyelonephritis; Intraabdominal infections including peritonitis, endometritis and pelvic cellulitis; Bacterial septicemia; Skin and skin structure infections including postoperative wound infections; Bone and joint infections; Gynecological infections including gonococcal infections.
For surgical prophylaxis (including abdominal and pelvic surgical procedures).
Dosage/Direction for Use
For IV administration, the dose may be given by slow bolus IV injection over at least 10 to 15 minutes to avoid the possibility of seizures or may also be delivered, in greater dilutions with 3 mL of a compatible diluent as an intravenous infusion over 15 to 30 minutes.
Recommended Adult Dose: For most infections: Usual Total Daily Dose Range: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 12 g (8 g ampicillin plus 4 g sulbactam) per day to be given in divided doses every 6 or 8 hours.
The dose and duration of treatment is based on the type and severity of infection. (See Table 1.)

Click on icon to see table/diagram/image

For prophylaxis of surgical infections: 1.5 g to 3 g of ampicillin + sulbactam IV or deep IM should be given at the induction of anesthesia; the dose may be repeated every 6 to 8 hours. Treatment is usually stopped 24 hours after in the majority of surgical procedures.
For the treatment of uncomplicated gonorrhea: IV or deep IM, 1.5 g ampicillin + sulbactam as a single dose. Concomitant 1 g oral probenecid should be administered to prolong plasma concentration of ampicillin + sulbactam. (See Table 2.)

Click on icon to see table/diagram/image

Recommended Pediatric Dose: Ampicillin + Sulbactam should be administered by IV infusion in children. Intramuscular administration in children is not recommended since safety and efficacy of ampicillin + sulbactam through this route has not been established.
The duration of treatment is based on the type and severity of infection. However, the duration should not normally exceed 14 days.
Maximum daily dose should not exceed 4 g sulbactam per day.
For children 1 year old and older and/or children weighing less than 40 kg: Usual Total Daily Dose: 150 mg/kg body weight/day (100 mg ampicillin plus 50 mg sulbactam per kg body weight per day) to be given in equally divided doses every 6 to 8 hours by IV infusion.
For neonates (during the first week of life particularly in premature infants): Usual Total Daily Dose: 75 mg/kg body weight/day (50 mg ampicillin plus 25 mg sulbactam per kg body weight per day) to be given in equally divided doses every 12 hours.
Overdosage
Ampimax overdose may manifest as extensions of the drugs' adverse effects. It should be considered that high CSF concentrations of β-lactam antibiotics may cause neurologic effects including seizures.
Since ampicillin and sulbactam are removed by hemodialysis, this procedure should be considered during overdosage in patients with impaired renal function. For overdosage in patients with normal renal function, hemodialysis may not be necessary and only appropriate measures should be taken.
Contraindications
History of allergic reactions to any of the penicillins, cephalosporins or β-lactamase inhibitors, or any of the excipients of Ampimax.
Ampimax should be not be used in patients with infectious mononucleosis due to the high incidence of rash in this group of patients.
Special Precautions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens. A thorough inquiry about the patient's previous hypersensitivity reactions is important. There is clinical and laboratory evidence of partial cross-allergenicity among penicillins and other beta-lactam antibiotics including cephalosporins and cephamycins. The drug should be discontinued at the first sign of rash, unless the physician's judgment dictates otherwise.
Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
Clostridium difficile-associated diarrhea and colitis have been reported with use of nearly all antibacterial agents, including ampicillin + sulbactam, 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.
Overgrowth of nonsusceptible microorganisms, especially Pseudomonas or Candida, has been reported during use of anti-infective agents. Careful monitoring of patients and periodic in vitro susceptibility tests are essential. If superinfection occurs, the drug should be discontinued and appropriate therapy instituted as necessary.
Ampicillin + Sulbactam should be not be used in patients with infectious mononucleosis due to the high incidence of rash in this group of patients.
Adverse Reactions
Ampicillin + sulbactam is generally well tolerated with the frequency of adverse event similar to those reported when ampicillin is given alone.
Body as a whole: anaphylactoid reaction and anaphylactic shock.
Gastrointestinal: diarrhea, nausea, vomiting, flatulence, abdominal discomfort or distention, rectal bleeding and glossitis, gastritis, stomatitis, black or "hairy" tongue, enterocolitis, pseudomembranous colitis.
Nervous: headache, dizziness, confusion, changes in smell or taste perception, rare reports of convulsions.
Renal: urine retention, dysuria, increased blood urea nitrogen (BUN) and creatinine, presence of RBC's and hyaline casts in urine.
Hepatic: bilirubinemia, abnormal hepatic function and jaundice.
Laboratory changes: increased aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and lactate dehydrogenase (LDH); decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes, basophils, eosinophils and platelets; decreased serum albumin and total proteins; agranulocytosis; positive direct Coombs' Tests.
Dermatologic and Sensitivity reactions: rash, itching, other skin reactions, Stevens-Johnson syndrome, epidermal necrolysis, urticaria, pruritus, dry skin, erythema, erythema multiforme, exfoliative dermatitis.
Local reactions: pain at injection site, phlebitis, thrombophlebitis, and inflammation at the injection site.
Other effects: fatigue, malaise, chest pain or tightness, edema, facial swelling, chills, throat tightness, substernal pain, epistaxis and mucosal bleeding, acute hyperpyrexia (oral temperatures of up to 40°C), rapid defervescence after completion of the infusion, candidiasis.
MIMS Class
ATC Classification
J01CR04 - sultamicillin ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 750 mg x 1's. 1.5 g x 1's.
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