Aztreotic

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Aztreotic uses


1 INDICATIONS AND USAGE

Aztreotic® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ].

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aztreotic and other antibacterial drugs, Aztreotic should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs.

Aztreotic is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia. (1)

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended dose of Aztreotic for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of Aztreotic) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off Aztreotic therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart.

Aztreotic is administered by inhalation using an Altera® Nebulizer System. Patients should use a bronchodilator before administration of Aztreotic.

2.2 Instructions for Aztreotic Reconstitution

Aztreotic should be administered immediately after reconstitution. Do not reconstitute Aztreotic until ready to administer a dose.

Take one amber glass vial containing Aztreotic and one diluent ampule from the carton. To open the glass vial, carefully remove the metal ring by lifting or pulling the tab and remove the gray rubber stopper. Twist the tip off the diluent ampule and squeeze the liquid into the glass vial. Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved.

The empty vial, stopper, and diluent ampule should be disposed of properly upon completion of dosing.

2.3 Instructions for Aztreotic Administration

Aztreotic is administered by inhalation using an Altera Nebulizer System. Aztreotic should not be administered with any other nebulizer. Aztreotic should not be mixed with any other drugs in the Altera Nebulizer Handset.

Aztreotic is not for intravenous or intramuscular administration.

Patients should use a bronchodilator before administration of Aztreotic. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of Aztreotic. Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of Aztreotic. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and lastly, Aztreotic.

To administer Aztreotic, pour the reconstituted solution into the handset of the nebulizer system. Turn the unit on. Place the mouthpiece of the handset in your mouth and breathe normally only through your mouth. Administration typically takes between 2 and 3 minutes. Further patient instructions on how to administer Aztreotic are provided in the FDA-approved patient labeling. Instructions on testing nebulizer functionality and cleaning the handset are provided in the Instructions for Use included with the nebulizer system.

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3 DOSAGE FORMS AND STRENGTHS

A dose of Aztreotic consists of a single-use vial of sterile, lyophilized Aztreotic (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted Aztreotic is administered by inhalation.

4 CONTRAINDICATIONS

Aztreotic is contraindicated in patients with a known allergy to Aztreotic.

5 WARNINGS AND PRECAUTIONS

5.1 Allergic Reactions

Severe allergic reactions have been reported following administration of Aztreotic for injection to patients with no known history of exposure to Aztreotic. In addition, allergic reaction with facial rash, facial swelling, and throat tightness was reported with Aztreotic in clinical trials. If an allergic reaction to Aztreotic occurs, stop administration of Aztreotic and initiate treatment as appropriate.

Caution is advised when administering Aztreotic to patients if they have a history of beta-lactam allergy, although patients with a known beta-lactam allergy have received Aztreotic in clinical trials and no severe allergic reactions were reported. A history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems, may be a risk factor, since cross-reactivity may occur.

5.2 Bronchospasm

Bronchospasm is a complication associated with nebulized therapies, including Aztreotic. Reduction of 15% or more in forced expiratory volume in 1 second immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3% of patients treated with Aztreotic.

5.3 Decreases in FEV1 After 28-Day Treatment Cycle

In clinical trials, patients with increases in FEV1 during a 28-day course of Aztreotic were sometimes treated for pulmonary exacerbations when FEV1 declined after the treatment period. Healthcare providers should consider a patient's baseline FEV1 measured prior to Aztreotic therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV1 are caused by a pulmonary exacerbation.

5.4 Development of Drug-Resistant Bacteria

Prescribing Aztreotic in the absence of known Pseudomonas aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.

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6 ADVERSE REACTIONS



To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD5, option 3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Aztreotic was evaluated in 344 patients from two placebo-controlled trials and one open-label follow-on trial. In controlled trials, 146 patients with CF received 75 mg Aztreotic 3 times a day for 28 days.

Table 1 displays adverse reactions reported in more than 5% of patients treated with Aztreotic 3 times a day in placebo-controlled trials. The listed adverse reactions occurred more frequently in CAYSTON-treated patients than in placebo-treated patients.

Event (Preferred Term) Placebo

(N=160)

n (%)

Aztreotic

75 mg 3 times a day

(N=146)

n (%)

Cough 82 (51%) 79 (54%)
Nasal congestion 19 (12%) 23 (16%)
Wheezing 16 (10%) 23 (16%)
Pharyngolaryngeal pain 17 (11%) 18 (12%)
Pyrexia 9 (6%) 19 (13%)
Chest discomfort 10 (6%) 11 (8%)
Abdominal Pain 8 (5%) 10 (7%)
Vomiting 7 (4%) 9 (6%)

Adverse reactions that occurred in less than 5% of patients treated with Aztreotic were bronchospasm (3%) [see Warnings and Precautions (5.2) ] and rash (2%).

6.2 Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following possible adverse reactions have been identified during post-approval use of Aztreotic. Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Arthralgia, joint swelling

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7 DRUG INTERACTIONS

No formal clinical studies of drug interactions with Aztreotic have been conducted.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B

No reproductive toxicology studies have been conducted with Aztreotic. However, studies were conducted with Aztreotic for injection. Aztreotic has been shown to cross the placenta and enter fetal circulation. No evidence of embryo or fetotoxicity or teratogenicity has been shown in studies with pregnant rats and rabbits. In rats receiving Aztreotic for injection during late gestation and lactation, no drug induced changes in maternal, fetal or neonatal parameters were observed. These animal reproduction and developmental toxicity studies used parenteral routes of administration that would provide systemic exposures far in excess of the average peak plasma levels measured in humans following Aztreotic therapy.

No adequate and well-controlled studies of Aztreotic for injection or Aztreotic in pregnant women have been conducted. Because animal reproduction studies are not always predictive of human response, Aztreotic should be used during pregnancy only if clearly needed.

8.3 Nursing Mothers

Following administration of Aztreotic for injection, Aztreotic is excreted in human milk at concentrations that are less than one percent of those determined in simultaneously obtained maternal serum. Peak plasma concentrations of Aztreotic following administration of Aztreotic are approximately 1% of peak concentrations observed following IV Aztreotic (500 mg). Therefore, use of Aztreotic during breastfeeding is unlikely to pose a risk to infants.

8.4 Pediatric Use

Patients 7 years and older were included in clinical trials with Aztreotic. Fifty-five patients under 18 years of age received Aztreotic in placebo-controlled trials. No dose adjustments were made for pediatric patients. Pyrexia was more commonly reported in pediatric patients than in adult patients. Safety and effectiveness in pediatric patients below the age of 7 years have not been established.

8.5 Geriatric Use

Clinical trials of Aztreotic did not include CAYSTON-treated patients aged 65 years of age and older to determine whether they respond differently from younger patients.

8.6 Use in Patients with Renal Impairment

Aztreotic is known to be excreted by the kidney. Placebo-controlled clinical trials with Aztreotic excluded patients with abnormal baseline renal function (defined as serum creatinine greater than 2 times the upper limit of normal range). Given the low systemic exposure of Aztreotic following administration of Aztreotic, clinically relevant accumulation of Aztreotic is unlikely to occur in patients with renal impairment. Therefore, Aztreotic may be administered to patients with mild, moderate and severe renal impairment with no dosage adjustment.

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10 OVERDOSAGE

No overdoses have been reported with Aztreotic in clinical trials to date. In clinical trials, 225 mg doses of Aztreotic via inhalation were associated with higher rates of drug-related respiratory adverse reactions, particularly cough. Since the peak plasma concentration of Aztreotic following administration of Aztreotic (75 mg) is approximately 0.6 mcg/mL, compared to a serum concentration of 54 mcg/mL following administration of Aztreotic for injection (500 mg), no systemic safety issues associated with Aztreotic overdose are anticipated.

11 DESCRIPTION

A dose of Aztreotic consists of a 2 mL amber glass vial containing lyophilized Aztreotic (75 mg) and lysine (46.7 mg), and a low-density polyethylene ampule containing 1 mL sterile diluent (0.17% sodium chloride). The reconstituted solution is for inhalation. The formulation contains no preservatives or arginine.

The active ingredient in Aztreotic is Aztreotic, a monobactam antibacterial. The monobactams are structurally different from beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems) due to a monocyclic nucleus. This nucleus contains several side chains; sulfonic acid in the 1-position activates the nucleus, an aminothiazolyl oxime side chain in the 3-position confers specificity for aerobic Gram-negative bacteria including Pseudomonas spp., and a methyl group in the 4-position enhances beta-lactamase stability.

Aztreotic 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. The structural formula is presented below:

Aztreotic is a white to off-white powder. Aztreotic is sterile, hygroscopic, and light sensitive. Once reconstituted with the supplied diluent, the pH range is 4.5 to 6.0.

Chemical Structure Figure 1

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Aztreotic is an antibacterial drug [see Clinical Pharmacology ].

12.3 Pharmacokinetics

Sputum Concentrations

Sputum Aztreotic concentrations exhibited considerable variability between patients receiving Aztreotic (75 mg) in clinical trials. The mean sputum concentration 10 minutes following the first dose of Aztreotic (n = 195 patients with CF) was 726 mcg/g. Mean sputum concentrations of Aztreotic in patients receiving Aztreotic 3 times a day for 28 days were 984 mcg/g, 793 mcg/g, and 715 mcg/g 10 minutes after dose administration on Days 0, 14, and 28, respectively, indicating no accumulation of Aztreotic in sputum.

Plasma Concentrations

Plasma Aztreotic concentrations exhibited considerable variability between patients receiving Aztreotic (75 mg) in the clinical trials. The mean plasma concentration one hour following the first dose of Aztreotic (at approximately the peak plasma concentration) was 0.59 mcg/mL. Mean peak plasma concentrations in patients receiving Aztreotic 3 times a day for 28 days were 0.55 mcg/mL, 0.67 mcg/mL, and 0.65 mcg/mL on Days 0, 14, and 28, respectively, indicating no systemic accumulation of Aztreotic. In contrast, the serum concentration of Aztreotic following administration of Aztreotic for injection (500 mg) is approximately 54 mcg/mL.

Absorption

Evaluation of plasma and urine Aztreotic concentrations following administration of Aztreotic indicates low systemic absorption of Aztreotic. Approximately 10% of the total Aztreotic dose is excreted in the urine as unchanged drug, as compared to 60–65% following intravenous administration of Aztreotic for injection.

Distribution

The protein binding of Aztreotic in serum is approximately 56% and is independent of dose.

Metabolism

Following intramuscular administration of Aztreotic for injection 500 mg every 8 hours for 7 days, approximately 6% of the dose was excreted as a microbiologically inactive open β-lactam ring hydrolysis product in an 8-hour urine collection on the last day of multiple dosing.

Excretion

The elimination half-life of Aztreotic from plasma is approximately 2.1 hours following administration of Aztreotic to adult patients with CF, similar to what has been reported for Aztreotic for injection. Approximately 10% of the total Aztreotic dose is excreted in the urine as unchanged drug. Systemically absorbed Aztreotic is eliminated about equally by active tubular secretion and glomerular filtration. Following administration of a single intravenous dose of radiolabeled Aztreotic for injection, about 12% of the dose was recovered in the feces.

12.4 Microbiology

Mechanism of Action

Aztreotic exhibits activity in vitro against Gram-negative aerobic pathogens including P. aeruginosa. Aztreotic binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition of bacterial cell wall synthesis and death of the cell. Aztreotic activity is not decreased in the presence of CF lung secretions.

Susceptibility Testing

A single sputum sample from a patient with CF may contain multiple morphotypes of P. aeruginosa and each morphotype may have a different level of in vitro susceptibility to Aztreotic. There are no in vitro susceptibility test interpretive criteria for isolates of P. aeruginosa obtained from the sputum of CF patients.1

Development of Resistance

No changes in the susceptibility of P. aeruginosa to Aztreotic were observed following a 28-day course of Aztreotic in the placebo-controlled trials.

Cross-Resistance

No cross-resistance to other classes of antibiotics, including aminoglycosides, quinolones, and beta-lactams, was observed following a 28-day course of Aztreotic in the Phase 3 placebo-controlled trials or in an open-label follow-on trial of up to nine 28-day courses of 75 mg Aztreotic 3 times a day.

Other

No trends in the treatment-emergent isolation of other bacterial respiratory pathogens (Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans, and Staphylococcus aureus) were observed in clinical trials. There was a slight increase in the isolation of Candida spp. following up to nine 28-day courses of Aztreotic therapy.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

A 104-week rat inhalation toxicology study to assess the carcinogenic potential of Aztreotic demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to Aztreotic for up to 4 hours per day. Peak plasma levels of Aztreotic averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level. This is approximately 12-fold higher than the average peak plasma level measured in humans following Aztreotic therapy.

Genetic toxicology studies performed in vitro demonstrated that Aztreotic did not induce structural chromosome aberrations in CHO cells and did not induce mutations at the TK locus in mouse lymphoma L5178Y TK+/- cells. Likewise, genetic toxicology studies performed in vivo did not reveal evidence of mutagenic potential.

Aztreotic did not impair the fertility of rats when administered at doses that would provide systemic exposures far in excess of peak plasma levels measured in humans following Aztreotic therapy.

14 CLINICAL STUDIES

Aztreotic was evaluated over a period of 28 days of treatment in a randomized, double-blind, placebo-controlled, multicenter trial that enrolled patients with CF and P. aeruginosa. This trial was designed to evaluate improvement in respiratory symptoms. Patients 7 years of age and older and with FEV1 of 25% to 75% predicted were enrolled. All patients received Aztreotic or placebo on an outpatient basis administered with the Altera Nebulizer System. All patients were required to take a dose of an inhaled bronchodilator (beta-agonist) prior to taking a dose of Aztreotic or placebo. Patients were receiving standard care for CF, including drugs for obstructive airway diseases.

The trial enrolled 164 patients with CF and P. aeruginosa. The mean age was 30 years, and the mean baseline FEV1 % predicted was 55%; 43% were females and 96% were Caucasian. These patients were randomized in a 1:1 ratio to receive either Aztreotic (75 mg) or volume-matched placebo administered by inhalation 3 times a day for 28 days. Patients were required to have been off antibiotics for at least 28 days before treatment with study drug. The primary efficacy endpoint was improvement in respiratory symptoms on the last day of treatment with Aztreotic or placebo. Respiratory symptoms were also assessed two weeks after the completion of treatment with Aztreotic or placebo. Changes in respiratory symptoms were assessed using a questionnaire that asks patients to report on symptoms like cough, wheezing, and sputum production.

Improvement in respiratory symptoms was noted for CAYSTON-treated patients relative to placebo-treated patients on the last day of drug treatment. Statistically significant improvements were seen in both adult and pediatric patients, but were substantially smaller in adult patients. Two weeks after completion of treatment, a difference in respiratory symptoms between treatment groups was still present, though the difference was smaller.

Pulmonary function, as measured by FEV1 (L), increased from baseline in patients treated with Aztreotic. The treatment difference at Day 28 between CAYSTON-treated and placebo-treated patients for percent change in FEV1 (L) was statistically significant at 10% (95% CI: 6%, 14%). Improvements in FEV1 were comparable between adult and pediatric patients. Two weeks after completion of drug treatment, the difference in FEV1 between Aztreotic and placebo groups had decreased to 6% (95% CI: 2%, 9%).

Figure 1 Adjusted Mean Percent Change in FEV1 from Baseline to Study End (Days 0–42)

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

Each kit for a 28-day course of Aztreotic contains 84 sterile vials of Aztreotic and 88 ampules of sterile diluent packed in 2 cartons, each carton containing a 14-day supply. The four additional diluent ampules are provided in case of spillage.

Package Configuration Dosage Strength NDC
28-Day Kit 75 mg 61958-0901-1

Aztreotic vials and diluent ampules should be stored in the refrigerator at 2 °C to 8 °C (36 °F to 46 °F) until needed. Once removed from the refrigerator, Aztreotic and diluent may be stored at room temperature (up to 25 °C / 77 °F) for up to 28 days. Do not separate the Aztreotic vials from the diluent ampules. Aztreotic should be protected from light.

Do not use Aztreotic if it has been stored at room temperature for more than 28 days. Do not use Aztreotic beyond the expiration date stamped on the vial. Do not use diluent beyond the expiration date embossed on the ampule.

Aztreotic should be used immediately upon reconstitution. Do not reconstitute more than one dose at a time.

Do not use diluent or reconstituted Aztreotic if it is cloudy or if there are particles in the solution.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

Patients should be advised that Aztreotic is for inhalation use only and that Aztreotic should only be administered using the Altera Nebulizer System. Patients should be instructed only to reconstitute Aztreotic with the provided diluent and not mix other drugs with Aztreotic in the Altera Nebulizer System.

Patients should be advised to complete the full 28-day course of Aztreotic even if they are feeling better. Inform the patient that if they miss a dose, they should take all 3 daily doses as long as the doses are at least 4 hours apart.

Patients should be advised to use a bronchodilator prior to administration of Aztreotic. Patients taking several inhaled medications should be advised to use the medications in the following order of administration: bronchodilator, mucolytics, and lastly, Aztreotic.

Patients should be advised to tell their doctor if they have new or worsening symptoms. Patients who believe they are experiencing an allergic reaction to Aztreotic should be advised to contact their doctor immediately.

Patients should be counseled that antibacterial drugs including Aztreotic should only be used to treat bacterial infections. They do not treat viral infection (e.g., the common cold). When Aztreotic is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Aztreotic or other antibacterial drugs in the future.

Figure 1 Figure 2, 3, 4, 5 Figure 6 Figure 7, 8 Figure 9

Manufactured by: Gilead Sciences, Inc., Foster City, CA 94404

Aztreotic is a trademark of Gilead Sciences, Inc. All other trademarks referenced herein are the property of their respective owners.

© 2014 Gilead Sciences, Inc. All rights reserved.

50-814-GS-002

FDA-Approved Patient Labeling

PATIENT INFORMATION

Aztreotic® (kay-stun)

(aztreonam for inhalation solution)

Read this Patient Information before you start taking Aztreotic and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is Aztreotic?

Aztreotic is a prescription inhaled antibiotic. Aztreotic is used to improve breathing symptoms in people with cystic fibrosis (CF) who have Pseudomonas aeruginosa (P. aeruginosa) in their lungs.

Aztreotic is only for infections caused by bacteria. It is not for infections caused by viruses, such as the common cold.

Aztreotic is used only with the Altera® Nebulizer System.

It is not known if Aztreotic is safe and effective in children under the age of 7.

Who should not take Aztreotic?

Do not take Aztreotic if you are allergic to Aztreotic (AZACTAM®).

What should I tell my doctor before taking Aztreotic?

Before taking Aztreotic, tell your doctor if you:


Tell your doctor about all the medicine you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Aztreotic?


What are the possible side effects of Aztreotic?

Aztreotic can cause serious side effects, including:


Common side effects of Aztreotic include:


Other possible side effects of Aztreotic include:


Tell your doctor if you have any new or worsening symptoms while taking Aztreotic. Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Aztreotic. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Aztreotic?


Keep Aztreotic and all medicines out of the reach of children.

General information about Aztreotic

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Aztreotic for a condition for which it was not prescribed. Do not give Aztreotic to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Aztreotic. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Aztreotic that is written for health professionals.

For more information, call 1-877-7CAYSTON (1-877-722-9786).

What are the ingredients in Aztreotic?

Active ingredient: Aztreotic

Inactive ingredient: lysine, sodium chloride (diluent)


PATIENT INSTRUCTIONS FOR USE

Aztreotic®

(aztreonam for inhalation solution)

Be sure that you read, understand and follow the Patient Instructions for Use below for the right way to take Aztreotic. If you have any questions, ask your doctor or pharmacist.

You will need the following supplies (Figure 1):


Check to make sure that your Altera Nebulizer System works properly before starting your treatment with Aztreotic. See the manufacturer's instructions for use that comes with your Altera Nebulizer System. This should have complete information about how to put together (assemble), prepare, use, and care for your Altera Nebulizer System.

Step 1 Preparing your Aztreotic for inhalation


Step 2 Taking your Aztreotic treatment

See the manufacturer's instructions for use that comes with your Altera Nebulizer System for complete instructions on taking a treatment, and how to clean and disinfect your Altera Nebulizer Handset.


Manufactured by: Gilead Sciences, Inc., Foster City, CA 94404

Aztreotic is a trademark of Gilead Sciences, Inc. All other trademarks referenced herein are the property of their respective owners.

© 2014 Gilead Sciences, Inc. All rights reserved.

50-814-GS-002

Principal Display Panel - Aztreotic 28 Day Carton - Representative Label

NDC 61958-0901-1

GILEAD

Aztreotic ®

(aztreonam for

inhalation solution)

75 mg/vial

For Oral Inhalation Only

Store Refrigerated, 2 °C to 8 °C (36 °F to 46 °F)

Contains:

84 Single-Use Vials of Aztreotic for Inhalation Solution

88 Diluent Ampules of Sodium Chloride 0.17%, 1 mL

(4 extra ampules provided in case of spillage)

For use only with the Altera® Nebulizer System

28-Day Supply

Rx only

Aztreotic pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Aztreotic available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Aztreotic destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Aztreotic Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Aztreotic pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CAYSTON (AZTREONAM) KIT [GILEAD SCIENCES, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. 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/dailym... (accessed August 28, 2018).
  3. "aztreonam". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Aztreotic?

Depending on the reaction of the Aztreotic after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Aztreotic not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Aztreotic addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Aztreotic, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Aztreotic consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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