Primaxin IM

Imipenem is an antibiotic that fights serious infections caused by bacteria.

Cilastatin helps imipenem work more effectively by preventing the breakdown of the antibiotic in the kidneys.

Imipenem and cilastatin is used to treat severe infections of the lower respiratory tract, skin, stomach, female reproductive organs, and other body systems.

Imipenem and cilastatin may also be used for other purposes not listed here.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Imipenem and cilastatin combination is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth. This medicine will not work for colds, flu, or other virus infections.

Imipenem and cilastatin combination is used to treat infections in many different parts of the body. It is sometimes given with other antibiotics.

This medicine is available only with your doctor's prescription.

PRIMAXIN I.M. is indicated for the treatment of serious infections (listed below) of mild to moderate severity for which intramuscular therapy is appropriate. PRIMAXIN I.M. is not intended for the therapy of severe or life-threatening infections, including bacterial sepsis or endocarditis, or in instances of major physiological impairments such as shock.

PRIMAXIN I.M. is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

1. Lower respiratory tract infections, including pneumonia and bronchitis as an exacerbation of COPD (chronic obstructive pulmonary disease), caused by Streptococcus pneumoniae and Haemophilus influenzae.
2. Intra-abdominal infections, including acute gangrenous or perforated appendicitis and appendicitis with peritonitis, caused by Group D streptococcus including Enterococcus faecalis2; Streptococcus viridans group2, Escherichia coli; Klebsiella pneumoniae2; Pseudomonas aeruginosa2; Bacteroides species including B. fragilis, B. distasonis2, B. intermedius2 and B. thetaiotaomicron2; Fusobacterium species and Peptostreptococcu 2 species.
3. Skin and skin structure infections, including abscesses, cellulitis, infected skin ulcers and wound infections caused by Staphylococcus aureus including penicillinase-producing strains; Streptococcus pyogenes2; Group D streptococcus including Enterococcus faecalis; Acinetobacter species2 including A. calcoaceticus2; Citrobacter species2; Escherichia coli; Enterobacter cloacae; Klebsiella pneumoniae2; Pseudomonas aeruginosa 2; and Bacteroides species2 including B. fragilis2.
4. Gynecologic infections, including postpartum endomyometritis, caused by Group D streptococcus including Enterococcus faecalis2; Escherichia coli; Klebsiella pneumoniae2; Bacteroides intermedius2; and Peptostreptococcus species2.

As with other beta-lactam antibiotics, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with PRIMAXIN I.M. During therapy of Pseudomonas aeruginosa infections, periodic susceptibility testing should be done when clinically appropriate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN I.M. and other antibacterial drugs, PRIMAXIN I.M. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Efficacy for this organism in this organ system was studied in fewer than 10 infections.

PRIMAXIN I.M.

In 686 patients in multiple dose clinical trials of PRIMAXIN I.M., the following adverse reactions were reported:

The most frequent adverse local clinical reaction that was reported as possibly, probably, or definitely related to therapy with PRIMAXIN I.M. was pain at the injection site (1.2%).

The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.M. were nausea (0.6%), diarrhea (0.6%), vomiting (0.3%) and rash (0.4%).

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:

Hemic: decreased hemoglobin and hematocrit, eosinophilia, increased and decreased WBC, increased and decreased platelets, decreased erythrocytes, and increased prothrombin time.

Hepatic: increased AST, ALT, alkaline phosphatase, and bilirubin.

Renal: increased BUN and creatinine.

Urinalysis: presence of red blood cells, white blood cells, casts, and bacteria in the urine.

Potential ADVERSE EFFECTS:

In addition, a variety of adverse effects, not observed in clinical trials with PRIMAXIN I.M., have been reported with intravenous administration of PRIMAXIN I.V. (Imipenem and Cilastatin for Injection). Those listed below are to serve as alerting information to physicians.

The most frequently reported systemic adverse clinical reactions that were reported as possibly, probably, or definitely related to PRIMAXIN I.V. (Imipenem and Cilastatin for Injection) were fever, hypotension, seizures (see PRECAUTIONS), dizziness, pruritus, urticaria, and somnolence.

Additional adverse systemic clinical reactions reported possibly, probably, or definitely drug related or reported since the drug was marketed are listed within each body system in order of decreasing severity: Gastrointestinal: pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment, see WARNINGS), hemorrhagic colitis, hepatitis (including fulminant hepatitis), hepatic failure, jaundice, gastroenteritis, abdominal pain, glossitis, tongue papillar hypertrophy, staining of the teeth and/or tongue, heartburn, pharyngeal pain, increased salivation; Hematologic: pancytopenia, bone marrow depression, thrombocytopenia, neutropenia, leukopenia, hemolytic anemia; CNS: encephalopathy, tremor, confusion, myoclonus, seizures, paresthesia, vertigo, headache, psychic disturbances including hallucinations; Special Senses: hearing loss, tinnitus, taste perversion; Respiratory: chest discomfort, dyspnea, hyperventilation, thoracic spine pain; Cardiovascular: palpitations, tachycardia; Renal: acute renal failure, oliguria/anuria, polyuria, urine discoloration; Skin: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioneurotic edema, flushing, cyanosis, hyperhidrosis, skin texture changes, candidiasis, pruritus vulvae; Body as a whole: polyarthralgia, asthenia/weakness, drug fever.

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials or reported since the drug was marketed were:

Hepatic: increased LDH; Hemic: positive Coombs test, decreased neutrophils, agranulocytosis, increased monocytes, abnormal prothrombin time, increased lymphocytes, increased basophils; Electrolytes: decreased serum sodium, increased potassium, increased chloride; Urinalysis: presence of urine protein, urine bilirubin, and urine urobilinogen.

Lidocaine HCl Refer to the package circular for lidocaine HCl.

PRIMAXIN I.M. is supplied as a sterile powder mixture in vials for IM administration as follows:

No. 3582 500 mg imipenem equivalent and 500 mg cilastatin equivalent

NDC 0006-3582-75 in trays of 10 vials.

No. 3583 750 mg imipenem equivalent and 750 mg cilastatin equivalent

NDC 0006-3583-76 in trays of 10 vials.

Applies to cilastatin / imipenem: powder for solution

Along with its needed effects, cilastatin / imipenem may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cilastatin / imipenem:

• Confusion
• convulsions (seizures)
• dizziness
• pain at place of injection
• skin rash, hives, itching, fever, or wheezing
• tremors

• Dizziness
• increased sweating
• nausea or vomiting
• unusual tiredness or weakness

• Fever
• severe abdominal or stomach cramps and pain
• watery and severe diarrhea, which may also be bloody (these side effects may also occur up to several weeks after you stop receiving this medicine)

Some side effects of cilastatin / imipenem may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• nausea and vomiting