Azactam injection

Name: Azactam injection

Indications

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM 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.

AZACTAM is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms:

Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytoca*, Citrobacter species*, and Serratia marcescens*.

Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens*.

Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis*, Serratia marcescens*, and Enterobacter species.

Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species*.

Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae*, Pseudomonas aeruginosa, Citrobacter species* including C. freundii*, and Serratia species* including S. marcescens*.

Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae*, Enterobacter species* including E. cloacae*, and Proteus mirabilis*.

AZACTAM is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. AZACTAM is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.

Concurrent Therapy

Concurrent initial therapy with other antimicrobial agents and AZACTAM is recommended before the causative organism(s) is known in seriously ill patients who are also at risk of having an infection due to Gram-positive aerobic pathogens. If anaerobic organisms are also suspected as etiologic agents, therapy should be initiated using an anti-anaerobic agent concurrently with AZACTAM (see DOSAGE AND ADMINISTRATION). Certain antibiotics (eg, cefoxitin, imipenem) may induce high levels of beta-lactamase in vitro in some Gram-negative aerobes such as Enterobacter and Pseudomonas species, resulting in antagonism to many beta-lactam antibiotics including aztreonam. These in vitro findings suggest that such beta-lactamase-inducing antibiotics not be used concurrently with aztreonam. Following identification and susceptibility testing of the causative organism(s), appropriate antibiotic therapy should be continued.

Overdose

If necessary, aztreonam may be cleared from the serum by hemodialysis and/or peritoneal dialysis.

What is the most important information I should know about Azactam (aztreonam injection)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my health care provider before using Azactam (aztreonam injection)?

You should not use aztreonam if you are allergic to it.

To make sure aztreonam is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease; or

  • a history of any type of allergy.

Especially tell your doctor if you are allergic to any other drugs, including:

  • similar antibiotics such as ertapenem (Invanz), imipenem (Primaxin), or meropenem (Merrem);

  • cephalosporins such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others; or

  • a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), ticarcillin (Ticar, Timentin), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen).

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Aztreonam can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Aztreonam is not approved for use by anyone younger than 9 months old.

Uses

Aztreonam is used to treat a wide variety of bacterial infections. This medication is an antibiotic that works by stopping the growth of bacteria.

How to use Azactam Vial

This medication is usually given by injection into a vein or a muscle as directed by your doctor. The dosage is based on your medical condition and response to therapy.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day.

Continue to use aztreonam until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection.

Tell your doctor if your condition persists or worsens.

Side Effects

Diarrhea, nausea, vomiting, dizziness, headache, blurred vision, or redness/discomfort/pain/swelling at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, confusion, easy bruising/bleeding, ringing in the ears, seizures, chest pain, yellowing eyes or skin, dark urine, severe stomach/abdominal pain, persistent nausea or vomiting, unusual fatigue, persistent signs of infection (e.g., fever, sore throat).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool..

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection), or a new type of bacterial infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Azactam Vial side effects by likelihood and severity.

What is aztreonam (azactam)?

Aztreonam is an antibiotic that fights severe or life-threatening infection caused by bacteria.

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

Aztreonam may also be used for purposes other than those listed in this medication guide.

What happens if i miss a dose (azactam)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

  • E. coli (0157:H7) (Symptoms, Treatment, Prevention)
  • Urinary Tract Infections (UTIs)
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