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Primaxin IM

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Primaxin IM

INDICATIONS

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 faecalis*; Streptococcus viridans group*; Escherichia coli; Klebsiella pneumoniae*; Pseudomonas aeruginosa*; Bacteroides species including B. fragilis, B. distasonis*, B. intermedius* and B. thetaiotaomicron*; Fusobacterium species; and Peptostreptococcus* 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 pyogenes*; Group D streptococcus including Enterococcus faecalis; Acinetobacter species* including A. calcoaceticus*; Citrobacter species*; Escherichia coli; Enterobacter cloacae; Klebsiella pneumoniae*; Pseudomonas aeruginosa*; and Bacteroides species* including B. fragilis*.
  4. Gynecologic infections, including postpartum endomyometritis, caused by Group D streptococcus including Enterococcus faecalis*; Escherichia coli; Klebsiella pneumoniae*; Bacteroides intermedius*; and Peptostreptococcus species*.

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.

DOSAGE AND ADMINISTRATION

PRIMAXIN I.M. is for intramuscular use only.

The dosage recommendations for PRIMAXIN I.M. represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present.

Patients with lower respiratory tract infections, skin and skin structure infections, and gynecologic infections of mild to moderate severity may be treated with 500 mg or 750 mg administered every 12 hours depending on the severity of the infection.

Intra-abdominal infection may be treated with 750 mg every 12 hours. [See table below.]

DOSAGE GUIDELINES

Type††/Location of Infection Severity Dosage Regimen
Lower respiratory tract Skin and skin structure Gynecologic Mild/Moderate 500 or 750 mg q 12 h depending on the severity of infection
Intra-abdominal Mild/Moderate 750 mg q 12 h
††See INDICATIONS section.

Total daily IM dosages greater than 1500 mg per day are not recommended.

The dosage for any particular patient should be based on the location of and severity of the infection, the susceptibility of the infecting pathogen(s), and renal function.

The duration of therapy depends upon the type and severity of the infection. Generally, PRIMAXIN I.M. should be continued for at least two days after the signs and symptoms of infection have resolved. Safety and efficacy of treatment beyond fourteen days have not been established.

PRIMAXIN I.M. should be administered by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh) with a 21 gauge 2" needle. Aspiration is necessary to avoid inadvertent injection into a blood vessel.

Adults With Impaired Renal Function

The safety and efficacy of PRIMAXIN I.M. have not been studied in patients with creatinine clearance of less than 20 mL/min/1.73 m2. Serum creatinine alone may not be a sufficiently accurate measure of renal function. Creatinine clearance (Tcc) may be estimated from the following equation:

Tcc (Males) = (wt. in kg)(140-age)
(72)(creatinine in mg/dL)

Tcc (Females) = 0.85 above value

Preparation For Administration

PRIMAXIN I.M. should be prepared for use with 1.0% lidocaine HCl solution††† (without epinephrine). PRIMAXIN I.M. 500 should be prepared with 2 mL and PRIMAXIN I.M. 750 with 3 mL of lidocaine HCl. Agitate to form a suspension, then withdraw and inject the entire contents of vial intramuscularly. The suspension of PRIMAXIN I.M. in lidocaine HCl should be used within one hour after preparation. Note: The IM formulation is not for IV use.

Compatibility And Stability

Before reconstitution:

The dry powder should be stored at a temperature below 25°C (77°F).

Suspensions for IM Administration

Suspensions of PRIMAXIN I.M. are white to light tan in color. Variations of color within this range do not affect the potency of the product.

The suspension of PRIMAXIN I.M. in lidocaine HCl should be used within one hour after preparation. PRIMAXIN I.M. should not be mixed with or physically added to other antibiotics. However, PRIMAXIN I.M. may be administered concomitantly but at separate sites with other antibiotics, such as aminoglycosides.

†††Refer to the package circular for lidocaine HCl for detailed information concerning CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

HOW SUPPLIED

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.

MERCK & CO., Whitehouse Station, NJ 08889, USA. Issued December 2007. FDA Rev date: 05/08/08

Last reviewed on RxList: 8/19/2008
This monograph has been modified to include the generic and brand name in many instances.

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