Data from FDA - Curated by EPG Health - Last updated 06 July 2018
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Advisory information
6
(6.1) To report SUSPECTED
6.1 Clinical Trials Experience Because clinical trials are conducted under widely
The
In
Table 1 displays
CAYSTON 3 times a day in placebo-controlled trials.
The listed
Table 1
6.2 Postmarketing Experience In addition to
Because these events have been reported voluntarily from a population of unknown size, estimates of frequency can not be made.
MUSCULOSKELETAL AND CONNECTIVE TISSUE
Usage information
2 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) 2.1 Dosing Information The
Dosage is not based on weight or
Doses should be taken at least 4 hours apart.
CAYSTON is administered by inhalation using an Altera® Nebulizer System.
Patients should use a bronchodilator before administration of CAYSTON. 2.2 Instructions for CAYSTON Reconstitution CAYSTON should be administered immediately after reconstitution.
Do not reconstitute CAYSTON until ready to administer a dose.
Take one amber glass vial containing CAYSTON and one diluent ampule from the carton.
To open the glass vial,
Twist the tip off the diluent ampule and squeeze the liquid into the glass vial.
Replace the rubber stopper, then
The empty vial, stopper, and diluent ampule should be disposed of
2.3 Instructions for CAYSTON Administration CAYSTON is administered by inhalation using an Altera Nebulizer System.
CAYSTON should not be administered with any other nebulizer.
CAYSTON should not be mixed with any other drugs in the Altera Nebulizer Handset.
CAYSTON is not for intravenous or intramuscular administration.
Patients should use a bronchodilator before administration of CAYSTON. Short-acting bronchodilators can be taken between 15
Alternatively, long-acting bronchodilators can be taken between 30
For patients taking multiple inhaled therapies, the
bronchodilator, mucolytics, and lastly, CAYSTON.
To administer CAYSTON, 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
Further patient instructions on how to administer
Instructions on testing nebulizer functionality and
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B
However, studies were conducted with aztreonam for injection.
Aztreonam has been shown to cross the placenta and enter fetal circulation.
In
These animal reproduction and developmental toxicity studies used parenteral routes of administration that would provide systemic exposures far in excess of the
Because animal reproduction studies are not always predictive of human response, CAYSTON should be used during pregnancy only if clearly needed.
8.3 Nursing Mothers Following administration of aztreonam for injection, aztreonam 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 aztreonam following administration of CAYSTON (75 mg) are approximately 1 % of peak concentrations observed following IV aztreonam (500 mg).
Therefore, use of CAYSTON during breastfeeding is
8.4 Pediatric Use Patients 7 years and older were included in clinical trials with CAYSTON. Fifty-five patients under 18 years of age received CAYSTON in placebo-controlled trials.
Pyrexia was more commonly reported in pediatric patients than in adult patients.
8.5 Geriatric Use Clinical trials of CAYSTON did not include CAYSTON-treated patients aged 65 years of age and older to determine whether they respond differently from younger patients.
Placebo-controlled clinical trials with CAYSTON excluded
Given the
Therefore, CAYSTON may be administered to
8.3 Nursing Mothers Following administration of aztreonam for injection, aztreonam 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 aztreonam following administration of CAYSTON (75 mg) are approximately 1 % of peak concentrations observed following IV aztreonam (500 mg).
Therefore, use of CAYSTON during breastfeeding is
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More information
| Category | Value |
|---|---|
| Authorisation number | NDA050814 |
| Orphan designation | No |
| Product NDC | 61958-0901 |
| Date Last Revised | 29-05-2014 |
| Type | HUMAN PRESCRIPTION DRUG |
| RXCUI | 901614 |
| Storage and handling | CAYSTON vials and diluent ampules should be stored in the refrigerator at 2 °C to 8 °C (36 °F to 46 °F) until 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. Do not Do not CAYSTON should be used immediately upon reconstitution. Do not reconstitute more than one dose at a time. |
| Marketing authorisation holder | Gilead Sciences, Inc. |