Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (), or emergency room immediately.
Proper storage of Aztreonam Vitalis Inhalation:
Store Aztreonam Vitalis 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, Aztreonam Vitalis Inhalation and the diluent may be stored at room temperature, below 77 degrees F (25 degrees C), for up to 28 days. Always keep Aztreonam Vitalis Inhalation and the diluent together. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aztreonam Vitalis Inhalation out of the reach of children and away from pets.
Overdose of Aztreonam Vitalis in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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If necessary, Aztreonam Vitalis may be cleared from the serum by hemodialysis and/or peritoneal dialysis.
What should I avoid while taking Aztreonam Vitalis?
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 Aztreonam Vitalis and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Aztreonam Vitalis warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Both animal and human data suggest that Aztreonam Vitalis (Aztreonam Vitalis for injection, USP) is rarely cross-reactive with other beta-lactam antibiotics and weakly immunogenic. Treatment with Aztreonam Vitalis 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 Aztreonam Vitalis 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 Aztreonam Vitalis can result in hypersensitivity reactions in patients with or without prior exposure to Aztreonam Vitalis. If an allergic reaction to Aztreonam Vitalis 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 Aztreonam Vitalis, 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 Aztreonam Vitalis 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 Aztreonam Vitalis?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Aztreonam Vitalis, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Aztreonam Vitalis or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Aztreonam Vitalis inhalation in children younger than 7 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of Aztreonam Vitalis inhalation have not been performed in the geriatric population.
Pregnancy
Pregnancy Category
Explanation
All Trimesters
B
Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.
Breast Feeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Aztreonam Vitalis. Make sure you tell your doctor if you have any other medical problems, especially:
Allergy to beta-lactams (e.g., amoxicillin, cefdinir, cefuroxime, cephalexin, penicillin, Amoxil®, Augmentin®), history of or
Bronchospasm—Use with caution. May make these conditions worse.
Aztreonam Vitalis precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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General
Prescribing Aztreonam Vitalis 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 Aztreonam Vitalis, 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 Aztreonam Vitalis have not been conducted using an intravenous route of administration. A 104-week rat inhalation toxicology study to assess the carcinogenic potential of Aztreonam Vitalis demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized Aztreonam Vitalis for up to 4 hours per day. Peak plasma levels of Aztreonam Vitalis averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level.
Genetic toxicology studies performed with Aztreonam Vitalis 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 Aztreonam Vitalis.
Pregnancy
Pregnancy Category B
In pregnant women, Aztreonam Vitalis crosses the placenta and enters the fetal circulation.
Developmental toxicity studies in pregnant rats and rabbits with daily doses of Aztreonam Vitalis 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 Aztreonam Vitalis?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
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.
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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).
