Do I need a prescription for Colfosceril palmitate 67.5mg endotracheal powder vials and diluent?

Colfosceril palmitate 67.5mg endotracheal powder vials and diluent is classified as a Valid as a prescribable product in the UK. However, always consult a pharmacist or doctor before use. (Source: NHS dm+d)

What are the brand names for Colfosceril palmitate 67.5mg endotracheal powder vials and diluent?

Colfosceril palmitate 67.5mg endotracheal powder vials and diluent is the generic name. It is available under brand names including: Exosurf Neonatal 67.5mg endotracheal powder vials and diluent. (Source: NHS dm+d — Actual Medicinal Products)

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Colfosceril palmitate 67.5mg endotracheal powder vials and diluent

Powder

67.5mg

Other

Eye / ear /nose liquids & powders

Active ingredients:

Colfosceril palmitate

ATC classificationBrowse ATC index

International classification by the WHO, grouping medicines by the organ system they act on

ATC R07AA01

Chemical classBrowse classes

Classification based on the molecule's chemical structure and properties

Check interactions for Colfosceril palmitate

No active safety alerts

Official documents, adverse reaction reporting, and safety monitoring

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Submit a Yellow Card report to the MHRA

Official medicine documents

Yellow Card

Report side effects (MHRA)

Drug safety updates

MHRA alerts for Colfosceril palmitate

Source: MHRA Products DatabaseOGL 3.0

Updated 16 Jan 2026

Safety monitoring data

Yellow Card reports

MHRA

The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.

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Submit a Yellow Card report to the MHRA

Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.

EudraVigilance

EMA

The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.

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Learn about EU pharmacovigilance and safety monitoring

EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.

1 branded products available

1 products

Possibly available on the UK marketDiscontinuedAvailability per NHS dm+d

MHRA licensed products

View all licensed products for Colfosceril palmitate on the MHRA register

Exosurf Neonatal 67.5mg endotracheal powder vials and diluent

GlaxoSmithKline UK Ltd

Discontinued

Source: NHS dm+dOGL 3.0

Updated 1 Mar 2026

Daily dose

WHO defined daily dose (DDD)

108 mg

Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.

Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.

Therapeutically similar medicines

Powder

108mg

Same therapeutic group

Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.

NHS prescribing volume and spending trends

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Supply & safety information

Official UK regulator monitoring and safety alerts

MHRA drug safety updates

UK regulator alerts and supply notices

Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).

Codes for healthcare professionals and prescribing systems

These codes are used by healthcare IT systems and prescribers to identify this medicine.

NHS UK identifiers

SNOMED CT

4843511000001100

dm+d ID

4843511000001100

VTM (Virtual Therapeutic Moiety)

13292901000001102

VMP (Virtual Medicinal Product)

4843511000001100

International identifiers

ATC code — Anatomical Therapeutic Chemical (WHO)

R07AA01

Browse tools

dm+d Browser

NHSBSA medicines dictionary lookup

SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).

Active and completed clinical studies from ClinicalTrials.gov

Searching UK clinical trials...

Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.

Academic studies and reviews for this medicine's active substance

Showing the 50 most relevant studies.

Reviews & meta-analyses: 9 · Randomised trials: 6 · 1994–2023

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Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial.

J. Berwaerts, Yanning Liu, S. Gopal, et al.

JAMA psychiatry, 2015

Randomised trial

Cited by 207

A Multicenter, Randomized, Masked, Comparison Trial of Lucinactant, Colfosceril Palmitate, and Beractant for the Prevention of Respiratory Distress Syndrome Among Very Preterm Infants

F. Moya, J. Gadzinowski, E. Bancalari, et al.

Pediatrics, 2005

Randomised trial

Cited by 180

Bronchopulmonary Dysplasia
Respiratory Distress Syndrome, Newborn
Infant, Premature, Diseases

Oxidative stress and calcium dysregulation by palmitate in type 2 diabetes

L. Ly, Shanhua Xu, Seong-Kyung Choi, et al.

Experimental & Molecular Medicine, 2017

Review

Cited by 335

High fat induces acute and chronic inflammation in the hypothalamus: effect of high-fat diet, palmitate and TNF-α on appetite-regulating NPY neurons

Prasad S. Dalvi, J. Chalmers, V. Luo, et al.

International Journal of Obesity, 2017

Cited by 192

Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial.

L. Béghin, X. Marchandise, E. Lien, et al.

Clinical nutrition, 2019

Randomised trial

Cited by 56

Neurodevelopmental Outcomes and Gut Bifidobacteria in Term Infants Fed an Infant Formula Containing High sn-2 Palmitate: A Cluster Randomized Clinical Trial

Wei Wu, A. Zhao, Biao Liu, et al.

Nutrients, 2021

Randomised trial

Cited by 48

A palmitate-rich metastatic niche enables metastasis growth via p65 acetylation resulting in pro-metastatic NF-κB signaling

P. Altea-Manzano, Ginevra Doglioni, Alejandro M. Cuadros, et al.

Nature cancer, 2023

Cited by 132

Walnut shell derived bio-carbon/methyl palmitate as novel composite phase change material with enhanced thermal energy storage properties

G. Hekimoğlu, A. Sari, T. Kar, et al.

Journal of energy storage, 2021

Cited by 166

Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study

A. Savitz, Haiyan Xu, S. Gopal, et al.

International Journal of Neuropsychopharmacology, 2016

Cited by 162

PNPLA3 has retinyl-palmitate lipase activity in human hepatic stellate cells

C. Pirazzi, L. N. Valenti, B. Motta, et al.

Human Molecular Genetics, 2014

Cited by 349

Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.

Pharmacology and chemical data from DrugBank

go.drugbank.com

Key facts

Drug status

Approved

Major interactions

None known

Half-life

20-36 hours

Mechanism

Treatment with colfosceril palmitate aims to reinflate a collapsed area of the l…

Food interactions

None known

Human targets

None mapped

Data: DrugBank · CC BY-NC 4.0

Pharmacokinetics at a glance

Absorption

The absorption is done directly in the alveolus into the lung tissue.
[L1110]
…

Half-life

20-36 hours

The half-life of colfosceril palmitate is registered to be in the range of 20-36 hours.
[L1112]

Protein binding

Colfosceril palmitate stays and gets metabolized in the pulmunar tissue, thus it is not able to bind to plasma proteins.

Volume of distribution

5 days

Colfosceril palmitate is distributed uniformly to all lobes of the lung, distal airways and alveolar spaces.
[L1112]
…

Metabolism

Colfosceril palmitate is catabolized and reutilized for further synthesis and secretion in lung tissues.
[L1110]

Elimination

5 days

After 5 days, most of the administered dose (56%) is distributed throughout the body with renal and fecal excretion being the minor elimination…

Clearance

5 days

After 5 days of drug administration, the lung and liver would contain 10% of the administered dose and the elimination via renal excretion accounts only for 8% of the administered dose.…

Pharmacokinetic data: DrugBank · CC BY-NC 4.0

Status:

Approved

Withdrawn

Small molecule

About this compound

Colfosceril palmitate is a synthetic pulmonary surfactant administered in infants with respiratory distress syndrome.[A31510] It was part of the first generation of commercially available artificial surfactants.[T70] It was developed by Burroughs Wellcome and it was FDA approved on August 6, 1990.[L1109] Nowadays colfosceril palmitate is under the state of canceled post-marketing.

Properties:

solid

Avg. mass: 734.04 Da

DrugBank indication

Colfosceril palmitate is indicated for the treatment of respiratory distress syndrome (RDS) in premature infants. The official label is referred as a intratracheal suspension for prophylactic treatment of infants of less than 1350 grams of birth weight under risk of developing RDS, or in infants with birth weight greater than 1350 grams with pulmonary immaturity, or as rescue treatment of infants that already developed RDS.
[L1109]
The central feature of RDS is a surfactant deficiency due to lung immaturity. This lung condition is more frequently presented due to risk factors like prematurity, delayed lung maturation caused by maternal diabetes or male gender, or surfactant dysfuntion due to perinatal asphyxia, pulmonary infection or delivery without labor.[T70]

Also known as(5)

Colfosceril palmitate

Colfoscerili palmitas

Dipalmitoylphosphatidylcholine

Palmitate de colfosceril

Palmitato de colfoscerilo

Molecular properties(19)

Toxicity & overdose

In clinical trials, there are reports of pulmonary hemorrhage when colfosceril palmitate is administered in infants with a weight of fewer than 700 grams at birth. Another potential risk of the use of colfosceril palmitate is the formation of mucus plugging in the endotracheal tube which can be prevented by performing suction prior to dosing.
[L1109]

How it works

Mechanism of action

Treatment with colfosceril palmitate aims to reinflate a collapsed area of the lung, improve compliance and reduce intrapulmonary shunting.[T73] The actions of colfosceril palmitate are perfomed by replacing the defficient or innefective endogenous lung surfactant and thus, reducing the tension and stabilizing the alveoli from collapsing.[L1110] Colfosceril palmitate will form a very thin film that will cover the surface of the alveolar cells and therefore it will reduce surface tension.[L1111]

Pharmacodynamics

Colfosceril palmitate has shown to significantly reduce the risk of pneumothoraces, pulmonary interstitial emphysema and mortality. Unlike naturals surfactants, colfosceril palmitate reduces the risk of bronchopulmonary dysplasia, intraventricular hemorrhage and patent ductus arteriosus.[T71] In clinical placebo-controlled trials, there was a significant reduction in the number of deaths attributed to hyaline membrane disease, the incidence of pulmonary air leaks, oxygen requirements and mean airway pressure.[T72] Some reports have indicated a lack of therapeutic effect due to the absence of surfactant protein.[T73]

Pharmacokinetics

How the body processes this drug — absorption, distribution, metabolism, and elimination

Absorption

The absorption is done directly in the alveolus into the lung tissue.
[L1110]
As the lung surfactant is distributed in the bronchi, bronchioles and alveoli, its highest concentration is at the alveolar air-fluid interface where it remains as a monolayer.
[A31515]

Half-life

The half-life of colfosceril palmitate is registered to be in the range of 20-36 hours.
[L1112]

Protein binding

Colfosceril palmitate stays and gets metabolized in the pulmunar tissue, thus it is not able to bind to plasma proteins.

Volume of distribution

Colfosceril palmitate is distributed uniformly to all lobes of the lung, distal airways and alveolar spaces.
[L1112]
It will not enter the systemic circulation in healthy lungs, however when the integrity of the tissue is distrupted colfosceril can reach systemic circulation.
[A31515]
Even 5 days after administration, there are traces of colfosceril palmitate retained in the body that represented 72% of the administered dose which by then have entered pathways of lipid metabolism to become tissue associated.
[A31523]

Metabolism

Colfosceril palmitate is catabolized and reutilized for further synthesis and secretion in lung tissues.
[L1110]

Route of elimination

After 5 days, most of the administered dose (56%) is distributed throughout the body with renal and fecal excretion being the minor elimination pathway representing the 4 and 2% of the eliminated dose respectively. The major route of elimination is by expelled air which accounts for 28% of the administered dose.
[A31523]

Clearance

After 5 days of drug administration, the lung and liver would contain 10% of the administered dose and the elimination via renal excretion accounts only for 8% of the administered dose. This proved a very small renal clearance and confirmed that the major elimination route is by expired air.
[A31523]

Scientific references(3)

Bryson H.M., Whittington R.

Colfosceril Palmitate.

PharmacoEconomics

19946(6):563-577. doi: 10.2165/00019053-199406060-00009

PMID: 10155285 DOI: 10.2165/00019053-199406060-00009

Reynolds M.S., Wallander K.A.

Surfactant for neonatal respiratory distress syndrome.

Journal of Pediatric Health Care

19904(4):209-215. doi: 10.1016/0891-5245(90)90009-u

PMID: 2670398 DOI: 10.1016/0891-5245(90)90009-u

DeAngelis R.L., Findlay J.W.

Metabolism of Synthetic Surfactants.

Clinics in Perinatology

199320(4):697-710. doi: 10.1016/s0095-5108(18)30374-9

PMID: 8131363 DOI: 10.1016/s0095-5108(18)30374-9

ATC classification(1 code)

ATC R07AA01

Affected organisms(1)

Humans and other mammals

Experimental properties(4)

Protein Data Bank entries(26)

Chemical identifiers

CAS, UNII, InChI Key and database cross-references

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Linked compound data from DrugBank Open Data (CC BY-NC 4.0)