What happens if I overdose Proaz?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (), or emergency room immediately.
Proper storage of Proaz Inhalation:
Store Proaz Inhalation and the diluent in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Once removed from the refrigerator, Proaz Inhalation and the diluent may be stored at room temperature, below 77 degrees F (25 degrees C), for up to 28 days. Always keep Proaz Inhalation and the diluent together. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Proaz Inhalation out of the reach of children and away from pets.
Overdose of Proaz in details
If necessary, Proaz may be cleared from the serum by hemodialysis and/or peritoneal dialysis.
What should I avoid while taking Proaz?
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Proaz and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Proaz warnings
Both animal and human data suggest that Proaz (Proaz for injection, USP) is rarely cross-reactive with other beta-lactam antibiotics and weakly immunogenic. Treatment with Proaz can result in hypersensitivity reactions in patients with or without prior exposure.
Careful inquiry should be made to determine whether the patient has any history of hypersensitivity reactions to any allergens.
While cross-reactivity of Proaz with other beta-lactam antibiotics is rare, this drug should be administered with caution to any patient with a history of hypersensitivity to beta-lactams (eg, penicillins, cephalosporins, and/or carbapenems). Treatment with Proaz can result in hypersensitivity reactions in patients with or without prior exposure to Proaz. If an allergic reaction to Proaz occurs, discontinue the drug and institute supportive treatment as appropriate (eg, maintenance of ventilation, pressor amines, antihistamines, corticosteroids). Serious hypersensitivity reactions may require epinephrine and other emergency measures.
Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Proaz, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Rare cases of toxic epidermal necrolysis have been reported in association with Proaz in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis.
What should I discuss with my healthcare provider before taking Proaz?
Some medical conditions may interact with Proaz Inhalation. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any penicillin, cephalosporin, or carbapenem antibiotic
- if you have a forced expiratory volume in 1 second (FEV-1) of less than 25% or more than 75% predicted
- if you are colonized with a certain bacteria (Burkholderia cepacia)
Some MEDICINES MAY INTERACT with Proaz Inhalation. However, no specific interactions with Proaz Inhalation are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Proaz Inhalation may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Proaz precautions
General
Prescribing Proaz in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
In patients with impaired hepatic or renal function, appropriate monitoring is recommended during therapy.
If an aminoglycoside is used concurrently with Proaz, especially if high dosages of the former are used or if therapy is prolonged, renal function should be monitored because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics.
The use of antibiotics may promote the overgrowth of nonsusceptible organisms, including Gram-positive organisms (Staphylococcus aureus and Streptococcus faecalis) and fungi. Should superinfection occur during therapy, appropriate measures should be taken.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with Proaz have not been conducted using an intravenous route of administration. A 104-week rat inhalation toxicology study to assess the carcinogenic potential of Proaz demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized Proaz for up to 4 hours per day. Peak plasma levels of Proaz averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level.
Genetic toxicology studies performed with Proaz in vitro (Ames test, mouse lymphoma forward mutation assay, gene conversion assay, chromosome aberration assay in human lymphocytes) and in vivo (mouse bone marrow cytogenetic assay) did not reveal evidence of mutagenic or clastogenic potential.
A two-generation reproduction study in rats at daily doses of 150, 600, or 2400 mg/kg given prior to and during gestation and lactation, revealed no evidence of impaired fertility. Based on body surface area, the high dose is 2.9-fold greater than the maximum recommended human dose (MRHD) for adults of 8 g per day. There was a slightly reduced survival rate during the lactation period in the offspring of rats that received the highest dose, but not in offspring of rats that received lower doses of Proaz.
Pregnancy
Pregnancy Category B
In pregnant women, Proaz crosses the placenta and enters the fetal circulation.
Developmental toxicity studies in pregnant rats and rabbits with daily doses of Proaz up to 1800 and 1200 mg/kg, respectively, revealed no evidence of embryotoxicity or fetotoxicity or teratogenicity. These doses, based on body surface area, are 2.2-and 2.9
What happens if I miss a dose of Proaz?
Use the missed dose as soon as you remember. Then wait at least 4 hours before using your next dose. Even if you miss a dose, you should still try to get all of your scheduled doses for the day, as long as they are spaced at least 4 hours apart. Do not use two doses at one time or use extra medicine to make up a missed dose.
References
- DailyMed. "AZTREONAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "aztreonam". http://www.drugbank.ca/drugs/DB00355 (accessed September 17, 2018).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
