Dosing & Uses
Not indicated
Dosage Forms & Strengths
intratracheal suspension
- 35mg phospholipid and 0.7mg protein per mL (3mL, 6mL)
Respiratory Distress Syndrome
3 mL/kg (birth weight) intratracheal q12hr up to 3 doses
Administration
Intratracheally through side-port adapter of ETT in 2 or 4 equal aliquots
Position the infant with either the right or left side after instilling the alliquots
Make administration while ventilation is continued over 20-30 breaths for each aliquot
Store vial in fridge, may swirl to redistribute, warming not necessary
Adverse Effects
>10%
Cyanosis (65%)
Airway obstruction (39%)
Bradycardia (34%)
Reflux into ETT (21%)
Requirement for manual ventilation (16%)
1-10%
Reintubation (3%)
Warnings
Contraindications
None listed by the manufacturer
Cautions
Infant may exhibit bradycardia, reflux, cyanosis, airway obstruction, ETT dislodge, hypoventilation
For endotracheal administration only
Lung oxygenation may improve rapidly, which in turn will require adjustments in oxygen delivery and ventilator settings
Do not chill & thaw more than once; single-use vials; keep 3 mL vial upright
Administer only in a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature infants
Pregnancy & Lactation
Pregnancy Category: Not applicable
Lactation: Not applicable
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Images
Patient Handout
calfactant (in 0.9 % sodium chloride) intratracheal
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.