Azactam Injection

DRUG DESCRIPTION

AZACTAM® (aztreonam for injection, USP) contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum. It is a synthetic bactericidal antibiotic.

The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (eg, penicillins, cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side chain in the 3-position and a methyl group in the 4-position confer the specific antibacterial spectrum and beta-lactamase stability.

Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid.

Structural formula:

AZACTAM®
  (aztreonam) Structural Formula Illustration

AZACTAM is a sterile, nonpyrogenic, sodium-free, white powder containing approximately 780 mg arginine per gram of aztreonam. Following constitution, the product is for intramuscular or intravenous use. Aqueous solutions of the product have a pH in the range of 4.5 to 7.5.

What are the possible side effects of aztreonam (Azactam)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • confusion, seizure (convulsions);
  • feeling light-headed, fainting;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • ...

Read All Potential Side Effects and See Pictures of Azactam Injection »

What are the precautions when taking aztreonam injection (Azactam Injection)?

Before using aztreonam, tell your doctor or pharmacist if you are allergic to it; or to penicillins, cephalosporins, or certain other antibiotics (e.g., imipenem, meropenem); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

This drug may rarely make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and...

Read All Potential Precautions of Azactam Injection »


Azactam Injection Consumer (continued)

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 immediately 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.

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

PRECAUTIONS: Before using aztreonam, tell your doctor or pharmacist if you are allergic to it; or to penicillins, cephalosporins, or certain other antibiotics (e.g., imipenem, meropenem); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

This drug may rarely make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk in small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Azactam Injection Patient Information Including Side Effects

Brand Names: Azactam

Generic Name: aztreonam (Pronunciation: AZ tree oh nam)

  • What is aztreonam (Azactam Injection)?
  • What are the possible side effects of aztreonam (Azactam Injection)?
  • What is the most important information I should know about aztreonam (Azactam Injection)?
  • What should I discuss with my health care provider before using aztreonam (Azactam Injection)?
  • How should I use aztreonam (Azactam Injection)?
  • What happens if I miss a dose (Azactam Injection)?
  • What happens if I overdose (Azactam Injection)?
  • What should I avoid while using aztreonam (Azactam Injection)?
  • What other drugs will affect aztreonam (Azactam Injection)?
  • Where can I get more information?

What is aztreonam (Azactam Injection)?

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 are the possible side effects of aztreonam (Azactam Injection)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • confusion, seizure (convulsions);
  • feeling light-headed, fainting;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may be more likely to occur, such as:

  • mild stomach discomfort;
  • warmth, redness, or tingly feeling under your skin;
  • dizziness;
  • numbness, tingling, or burning pain;
  • mild skin rash or itching;
  • vaginal itching or discharge; or
  • pain, swelling, or irritation where the IV needle is placed.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

You should not use this medication if you are allergic to aztreonam or to a penicillin antibiotic such as amoxicillin (Amoxil), ampicillin (Omnipen, Principen), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.

Before using aztreonam, tell your doctor if you are allergic to cephalosporins such as Ceclor, Ceftin, Duricef, Keflex, and others, or if you have liver or kidney disease, or a history of any type of allergy.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Aztreonam will not treat a viral infection such as the common cold or flu.

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 any medicine to stop the diarrhea unless your doctor has told you to.

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