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 blood, urinary tract, lower respiratory tract, skin, stomach, or female reproductive organs.

Aztreonam may also be used for purposes not listed in this medication guide.

Aztreonam is injected into a muscle, or into a vein through an IV. Aztreonam is usually given in a clinic or hospital setting. The medicine may need to be given for several weeks, depending on how severe your infection is.

You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Aztreonam is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Use only the diluent that your doctor or pharmacist tells you to use.

After mixing the powder and diluent, shake the medicine well. The mixture should appear as a clear to yellow or pink liquid. Do not use aztreonam if it has a different color or has particles in it. Call your pharmacist for new medication.

You may store the mixture for up to 48 hours at room temperature, or up to 7 days in a refrigerator.

Aztreonam is sometimes mixed with other antibiotics in the same solution. You may need to store this type of mixture differently than you would store aztreonam only. Follow all storage directions carefully.

Aztreonam is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Aztreonam will not treat a viral infection such as the flu or a common cold.

Store unmixed aztreonam at room temperature away from moisture and heat.

Aztreonam that is supplied as a frozen solution in a plastic container should be stored in a freezer. If possible, keep the freezer set at 4 degrees below 0 Fahrenheit or colder.

Thaw the medicine either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly.

Aztreonam that is thawed in the refrigerator should be used within 2 weeks. If you have thawed the medicine at room temperature, you must use it within 48 hours.

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

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

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• ringing in your ears;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• mild diarrhea;

• nausea, vomiting;

• mild skin rash;

• vaginal itching or discharge; or

• pain, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Aztreonam may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

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.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: cefoxitin, imipenem.

Although most antibiotics are unlikely to affect hormonal birth control such as pills, patch, or ring, a few antibiotics (such as rifampin, rifabutin) can decrease their effectiveness. This could result in pregnancy. If you use hormonal birth control, ask your doctor or pharmacist for more details.

Aztreonam may cause false positive results with some diabetic urine testing products (cupric sulfate-type). Consult your doctor or pharmacist for recommendations. Make sure laboratory personnel and your doctors know you use this drug.

Applies to aztreonam: inhalation powder for solution

Other dosage forms:

• powder for solution, solution

Along with its needed effects, aztreonam (the active ingredient contained in Azactam) 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 aztreonam:

• Chest discomfort
• cough
• difficulty with breathing or troubled breathing
• fever

• Noisy breathing
• shortness of breath
• tightness in the chest

Some side effects of aztreonam 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:

• Abdominal or stomach pain
• sore throat
• stuffy nose
• vomiting

• Rash

Applies to aztreonam: inhalation powder for reconstitution, injectable powder for injection, intravenous solution

General

Aztreonam (the active ingredient contained in Azactam) for injection was generally well tolerated. The overall incidence of systemic side effects was about 1% to 1.3%.[Ref]

Respiratory

Aztreonam (the active ingredient contained in Azactam) for inhalation:
Very common (10% or more): Cough (54%), nasal congestion (16%), wheezing (16%)
Common (1% to 10%): Bronchospasm (3%)
Postmarketing reports: Dyspnea

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Wheezing, dyspnea, chest pain, sneezing, nasal congestion[Ref]

Other

Aztreonam (the active ingredient contained in Azactam) for inhalation:
Very common (10% or more): Pyrexia (13%), pharyngolaryngeal pain (12%)
Common (1% to 10%): Chest discomfort (8%), abdominal pain (7%)

Aztreonam for injection:
Common (1% to 10%): Superinfection (up to 10%)
Uncommon (0.1% to 1%): Less than 1%: Weakness, fever, malaise, flushing[Ref]

Superinfection has been reported in up to 10% of patients during aztreonam therapy and was usually due to enterococcus or staphylococcus.[Ref]

Gastrointestinal

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.[Ref]

Aztreonam for inhalation:
Common (1% to 10%): Vomiting (6%)

Aztreonam for injection:
Common (1% to 10%): 1% to 1.3%: Nausea, vomiting, diarrhea
Uncommon (0.1% to 1%): Less than 1%: Abdominal cramps, mouth ulcer, altered taste, numb tongue, halitosis
Rare (less than 0.1%): Clostridium difficile associated diarrhea, pseudomembranous colitis, gastrointestinal bleeding[Ref]

Dermatologic

Toxic epidermal necrolysis associated with aztreonam (the active ingredient contained in Azactam) has been reported in very ill patients on many other medications, making implication of aztreonam difficult.[Ref]

Aztreonam for inhalation:
Common (1% to 10%): Rash (2%)

Aztreonam for injection:
Common (1% to 10%): Rash (1% to 1.3%)
Uncommon (0.1% to 1%): Less than 1%: Toxic epidermal necrolysis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis[Ref]

Local

Aztreonam (the active ingredient contained in Azactam) for injection:
Common (1% to 10%): Discomfort/swelling at the injection site after intramuscular administration (2.4%), phlebitis/thrombophlebitis after intravenous administration (1.9%)[Ref]

Hypersensitivity

A 57-year-old male developed a widespread maculopapular eruption two hours after receiving aztreonam (the active ingredient contained in Azactam) Corticosteroids and antihistamines were needed to control the reaction which disappeared after 8 days. The patient also showed cross-reactivity to ceftazidime which shares the same side chain as aztreonam.[Ref]

Aztreonam for inhalation:
Frequency not reported: Allergic reaction (with facial rash, facial swelling, throat tightness)

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Anaphylaxis, angioedema, bronchospasm
Rare (less than 0.1%): Maculopapular eruption (at least 1 case)[Ref]

Hematologic

A case of myelosuppression associated with aztreonam (the active ingredient contained in Azactam) has been reported, but because many other drugs were administered and because the patient was bacteremic, implication of aztreonam as the causative agent was difficult.

In vitro studies have shown that aztreonam may inhibit ADP-induced platelet aggregation at high concentrations. Clinically, therapeutic doses of aztreonam have not been associated with bleeding problems.[Ref]

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis
Frequency not reported: Increased prothrombin time, increased partial thromboplastin time, positive Coombs' test[Ref]

Hepatic

Aztreonam (the active ingredient contained in Azactam) for injection:
Uncommon (0.1% to 1%): Less than 1%: Hepatitis, jaundice, signs or symptoms of hepatobiliary dysfunction
Frequency not reported: Elevated AST, elevated ALT, elevated alkaline phosphatase[Ref]

Cardiovascular

Aztreonam (the active ingredient contained in Azactam) for injection:
Uncommon (0.1% to 1%): Hypotension (less than 1%), transient electrocardiogram changes (ventricular bigeminy, premature ventricular contractions; less than 1%)[Ref]

Nervous system

Aztreonam (the active ingredient contained in Azactam) for injection:
Uncommon (0.1% to 1%): Less than 1%: Seizure, headache, confusion, vertigo, paresthesia, insomnia, dizziness, tinnitus[Ref]

Musculoskeletal

Aztreonam (the active ingredient contained in Azactam) for inhalation:
Postmarketing reports: Arthralgia, joint swelling

Aztreonam for injection:
Uncommon (0.1% to 1%): Muscular aches (less than 1%)[Ref]

Renal

Aztreonam (the active ingredient contained in Azactam) for injection:
Rare (less than 0.1%): Acute interstitial nephritis (at least 1 case)
Frequency not reported: Increased serum creatinine[Ref]

Acute interstitial nephritis associated with aztreonam has been reported in a very ill patient receiving many other medications.[Ref]

Genitourinary

Aztreonam (the active ingredient contained in Azactam) for injection:
Uncommon (0.1% to 1%): Less than 1%: Vaginal candidiasis, vaginitis, breast tenderness[Ref]

Ocular

Aztreonam (the active ingredient contained in Azactam) for injection:
Uncommon (0.1% to 1%): Diplopia (less than 1%)[Ref]

Some side effects of Azactam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Aztreonam has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, or teratogenicity. There are no controlled data from human pregnancy studies. Aztreonam crosses the placenta and enters the fetal circulation. Aztreonam should only be given during pregnancy when need has been clearly established.