CAYSTON- aztreonam kit

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

aztreonam (UNII: G2B4VE5GH8) (aztreonam - UNII:G2B4VE5GH8)

זמין מ:

Gilead Sciences, Inc.

INN (שם בינלאומי):

aztreonam

הרכב:

aztreonam 75 mg in 1 mL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

CAYSTON® 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 CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pseudomonas aeruginosa in the lungs. CAYSTON is contraindicated in patients with a known allergy to aztreonam. Risk Summary Available data on CAYSTON use in pregnant women is insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; however, systemic absorption of aztreonam following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3)]. There are risks to the mother associated with cystic fi

leaflet_short:

Each kit for a 28-day course of CAYSTON contains 84 sterile vials of CAYSTON 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. CAYSTON 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, CAYSTON and diluent may be stored at room temperature (up to 25 °C/77 °F) for up to 28 days. Do not separate the CAYSTON vials from the diluent ampules. CAYSTON should be protected from light. Do not use CAYSTON if it has been stored at room temperature for more than 28 days. Do not use CAYSTON beyond the expiration date stamped on the vial. Do not use diluent beyond the expiration date embossed on the ampule. CAYSTON should be used immediately upon reconstitution. Do not reconstitute more than one dose at a time. Do not use diluent or reconstituted CAYSTON if it is cloudy or if there are particles in the solution.

מצב אישור:

New Drug Application

מאפייני מוצר

CAYSTON- AZTREONAM
GILEAD SCIENCES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CAYSTON SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CAYSTON.
CAYSTON (AZTREONAM FOR INHALATION SOLUTION), FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 1986
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of CAYSTON and
other antibacterial drugs, CAYSTON should be used only to treat
patients with cystic fibrosis (CF) known to
have _Pseudomonas aeruginosa_ in the lungs. (1)
INDICATIONS AND USAGE
CAYSTON 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 FEV <25% or >75%
predicted, or patients colonized with
_Burkholderia cepacia_. (1)
DOSAGE AND ADMINISTRATION
Administer one dose (one single use vial and one ampule of diluent) 3
times a day for 28 days. (2.1)
Use dose immediately after reconstitution. (2.2)
Administer only with the Altera Nebulizer System. Do not administer
with any other type of nebulizer.
(2.3)
DOSAGE FORMS AND STRENGTHS
Lyophilized aztreonam (75 mg/vial) (3)
Diluent (0.17% sodium chloride): 1 mL/ampule (3)
CONTRAINDICATIONS
Contraindicated in patients with a known allergy to aztreonam. (4)
WARNINGS AND PRECAUTIONS
Allergic reaction to CAYSTON was seen in clinical trials. Stop
treatment if an allergic reaction occurs.
Use caution when CAYSTON is administered to patients with a known
allergic reaction to beta-lactams.
(5.1)
Bronchospasm has been reported with CAYSTON. Stop treatment if chest
tightness develops during
nebulizer use. (5.2)
ADVERSE REACTIONS
Common adverse reactions (more than 5%) occurring more frequently in
CAYSTON patients are cough,
nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest
discomfort, abdominal pain and
vomiting. (6.1)
TO REPORT SUSPECTED ADVERSE REACTI