ERTAPENEM PACKAGE INSERT PDF

For Package Inserts, please click on the NDC#. Presentation(s):1g; Reference Listed Drug:Invanz®; Therapeutic Class: Antibacterial, carbapenem type. INVANZ 1 g powder for concentrate for solution for infusion. 2. . This medicinal product contains approximately mEq (approximately mg) of sodium per g dose which should Package Leaflet: information for the user. INVANZ 1 . Product Availability · Contact Us · Make An Inquiry. () Product Summary. Ertapenem Sodium Injection. Therapeutic Class: Carbapenem Antibiotic.

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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. IV or IM broad-spectrum carbapenem antibiotic stable against beta-lactamases Used to treat UTI, skin, pelvic, intraabdominal infections and community-acquired pneumonia; used for colorectal surgical prophylaxis Once-daily dosing may be advantageous, but no P.

Consider transitioning to an appropriate oral therapy after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated. Ertapenem, in combination with an agent for atypical pathogens, is considered an acceptable alternative beta-lactam alternative for hospitalized patients with risk factors for infection with gram-negative pathogens other than Pseudomonas aeruginosa.

Guidelines recommend ertapenem for 4 to 7 days for mild-to-moderate community-acquired infections, including perforated or abscessed appendicitis. Guidelines recommend ertapenem for 4 to 7 days for community-acquired infections. Guidelines recommend ertapenem for mixed necrotizing infections. Surgical intervention is the primary therapeutic intervention. Antibiotic therapy should be administered until further debridement is not necessary, the patient has improved clinically, and fever has been absent for 48 to 72 hours.

Ertapenem is also recommended for incisional insrrt site infections of the intestinal or genitourinary tract. In setting of a cat or dog bite, preemptive antimicrobial therapy is pac,age for 3 to 5 days for patients who are immunocompromised, asplenic, have advanced liver disease, have edema of the bite area, have moderate to severe injuries, particularly of the hand or face, or have penetrating injuries to the periosteum or joint capsule.

Ertapenem is suggested as an option for moderate to severe diabetic wound infections. Ertapeneem patients with skin and soft tissue infections do well with 1 to 2 weeks of therapy. No intraoperative redosing and duration of prophylaxis less than 24 hours are suggested by clinical practice guidelines.

Safety and efficacy have not been established.

No data are available regarding use in pediatric patients with renal impairment. FDA-approved dosage in renal failure for adults: No dosage adjustment needed. Other dosage adjustment guidelines for adults: If ertapenem is given 6 hours or more prior to hemodialysis, no supplemental dosing packaye required. If ertapenem is given within 6 hours of packag, a supplementary dose of mg is recommended following the hemodialysis session.

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Ertapenem solution is colorless to pale yellow; variations of color within this range do not affect the potency of the product. Reconstitute each 1 g vial with 10 mL of 0. Use with a needless IV system is not recommended. Shake well to dissolve. Further dilution is necessary for IV infusion.

Immediately transfer the appropriate amount of the reconstituted vial to diluent. For 1 g dose: Dilute the entire contents of the reconstituted vial in 50 mL of 0. For less than 1 g dose: Dilute the nisert volume of the reconstituted solution based on body weight in 0. Use within 6 hours if stored at room temperature 25 degrees C. The diluted solution may be refrigerated erta;enem up to 24 hours 5 degrees C and used within 4 hours after removal from refrigeration. Complete the infusion within 6 ertpenem of reconstitution.

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Infuse IV over 30 minutes. Do not co-infuse with other medications.

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Reconstitute the 1 g vial with 3. Agitate well to form a solution. Use within 1 hour after preparation. The IM reconstituted formulation is not for IV use. May consider IM administration as an alternative to IV administration in the treatment of infections where Packxge therapy is appropriate; however, only administer via IM injection for 7 days. Immediately withdraw the appropriate dose and inject deeply into a large muscle i.

This drug is not an effective treatment for a viral infection e. Prescribing ertapenem in the absence of a proven or strongly suspected bacterial infection or for a prophylactic indication is unlikely to provide benefit to inseet patient and increases the risk of the development of drug-resistant bacteria. Patients should be told eratpenem complete the full course of treatment, even if they feel better earlier. Lidocaine is the diluent for IM administration of ertapenem.

IM use is contraindicated in patients with an amide local anesthetic hypersensitivity. Ertapenem is contraindicated ertpenem any patient who has exhibited hypersensitivity to ertapenem, other drugs in the same class e. Prior to initiating ertapenem therapy, the patient should be carefully questioned about previous penicillin hypersensitivity, cephalosporin hypersensitivity, allergic reactions to other beta-lactams e. Patients who have experienced anaphylactic reactions to penicillins or cephalosporins should not receive ertapenem.

Ertapenem is structurally similar to the penicillins and cephalosporins and these patients may be more susceptible to hypersensitivity reactions. If an allergic reaction occurs, discontinue the drug and initiate appropriate emergency treatment with epinephrine, oxygen, IV steroids, intubation or other therapy as indicated. A supplemental dose may or may not be required following dialysis. During clinical studies, seizures occurred in 0.

Patients at greater risk for seizures may include: Anticonvulsive therapy should be continued in patients with a known seizure disorder. If focal tremor or myoclonic seizures occur, patients should be evaluated neurologically. Anticonvulsant therapy should be initiated if indicated and the dose of ertapenem should be re-evaluated based on the patient’s renal function.

Almost all antibacterial agents have been associated with pseudomembranous colitis antibiotic-associated colitis which pacjage range in severity from mild to life-threatening. In the colon, overgrowth of Clostridia may exist when normal flora is altered subsequent to antibacterial administration. The toxin produced by Clostridium difficile is a primary cause of pseudomembranous colitis.

It is known that systemic use of antibiotics predisposes patients to development of pseudomembranous colitis. Consideration should be given to the diagnosis of pseudomembranous colitis packaeg patients presenting with diarrhea following antibacterial administration. Ertapenem should be prescribed with caution to patients with inflammatory bowel disease such as ulcerative colitis or other GI disease. If diarrhea develops during therapy, the drug should be discontinued.

Following diagnosis of packaeg colitis, therapeutic measures should be instituted. In milder cases, the colitis may respond to discontinuation of the offending agent. In moderate to severe cases, fluids and electrolytes, protein supplementation, and treatment with an antibacterial effective against Clostridium difficile may be warranted. Products inhibiting peristalsis are contraindicated in this clinical situation.

Practitioners should be aware that antibiotic-associated colitis has been observed to occur over two months ertapene, more following discontinuation of systemic pacjage therapy; a careful medical history should be taken. Available data from a small number of postmarketing cases with ertapenem use in pregnancy are insufficient to inform any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal studies evaluating doses 1. Ertapenem is excreted in human breast milk.

Invanz (ertapenem) dose, indications, adverse effects, interactions from

The concentration in breast milk 24 hours after a 1 g dose ranged from less than 0. By day 5 after discontinuation, the concentration in breast milk was undetectable. There are no data on the effects of ertapenem on the breast-fed infant or on milk production.

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In general, unless the infant is allergic to ertapenem, breast-feeding is likely safe during maternal carbapenem therapy; observe the infant for potential effects. Consider the benefits of breast-feeding along with the mother’s clinical need for ertapenem and any potential adverse effects on the breast-fed infant from ertapenem or the underlying maternal condition.

Clinical trial data and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out.

Ertapenem is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Ertapenem for Injection

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. According to OBRA, use of antibiotics should be limited edtapenem confirmed or suspected bacterial infections.

Antibiotics are non-selective insret may result in the eradication of beneficial microorganisms while promoting the emergence of undesired ones, causing secondary infections such as oral thrush, colitis, or vaginitis. Any antibiotic may cause diarrhea, nausea, vomiting, anorexia, and hypersensitivity reactions. Moderate It would be prudent to recommend alternative or additional contraception when oral contraceptives OCs are used in conjunction with antibiotics.

It was previously thought that antibiotics may decrease ertapene effectiveness of OCs containing estrogens due to stimulation packags metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported.

It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs.

Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives.

These authors concluded that because females most at risk for OC failure or noncompliance may ertapene, be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, inxert recommending an additional method of contraception during short-term antibiotic use may be justified.

During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries e.

Packae Probenecid inhibits the renal excretion of ertapenem by competing with them for active tubular secretion.

In some instances, this effect is used therapeutically to increase availability of the antimicrobial agent. However, the elimination half-life of ertapenem is increased only from 4 to 4. Concurrent administration of ertapenem with probenecid is not recommended.