MedPath

Caffeine

Generic Name
Caffeine
Brand Names
Anacin, Arthriten Inflammatory Pain, Ascomp, Bc Arthritis, Bc Original Formula, Cafcit, Diurex, Dvorah, Esgic, Exaprin, Excedrin, Excedrin Tension Headache, Fioricet, Fioricet With Codeine, Fiorinal, Goody's Extra Strength, Goody's Headache Relief Shot, Goody's PM, Midol Complete, Midol Cramps & Bodyaches, Migergot, Norgesic, Norgesic Forte, Orbivan, Orphengesic, Pamprin Max Formula, Peyona, Stanback Headache Powder Reformulated Jan 2011, Trezix, Trianal, Trianal C, Triatec, Triatec-8, Vanatol, Vanatol S, Vanquish, Vivarin, Peyona (previously Nymusa), Gencebok
Drug Type
Small Molecule
Chemical Formula
C8H10N4O2
CAS Number
58-08-2
Unique Ingredient Identifier
3G6A5W338E
Background

Caffeine is a drug of the methylxanthine class used for a variety of purposes, including certain respiratory conditions of the premature newborn, pain relief, and to combat drowsiness. Caffeine is similar in chemical structure to Theophylline and Theobromine. It can be sourced from coffee beans, but also occurs naturally in various teas and cacao beans, which are different than coffee beans. Caffeine is also used in a variety of cosmetic products and can be administered topically, orally, by inhalation, or by injection.

The caffeine citrate injection, used for apnea of the premature newborn, was initially approved by the FDA in 1999. According to an article from 2017, more than 15 million babies are born prematurely worldwide. This correlates to about 1 in 10 births. Premature birth can lead to apnea and bronchopulmonary dysplasia, a condition that interferes with lung development and may eventually cause asthma or early onset emphysema in those born prematurely. Caffeine is beneficial in preventing and treating apnea and bronchopulmonary dysplasia in newborns, improving the quality of life of premature infants.

Indication

Caffeine is indicated for the short term treatment of apnea of prematurity in infants and off label for the prevention and treatment of bronchopulmonary dysplasia caused by premature birth. In addition, it is indicated in combination with sodium benzoate to treat respiratory depression resulting from an overdose with CNS depressant drugs. Caffeine has a broad range of over the counter uses, and is found in energy supplements, athletic enhancement products, pain relief products, as well as cosmetic products.

Associated Conditions
Acute Pain, Chronic Lung Disease of Prematurity, Common Cold, Dyspepsia, Fatigue, Fever, Flu caused by Influenza, Headache, Menstrual Pain, Myalgia, Pain, Pain caused by Rheumatism, Primary apnea of premature newborns, Respiratory Depression, Somnolence, Tension Headache, Toothache, Under-eyes Dark Circles, Vascular Headaches, Moderate Pain
Associated Therapies
Analgesia, Antacid therapy, Athletic Performance

KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism

First Posted Date
2024-08-22
Last Posted Date
2024-08-22
Lead Sponsor
Helsinki University Central Hospital
Target Recruit Count
12
Registration Number
NCT06566794
Locations
🇫🇮

Department of Clinical Pharmacology, Helsinki, Finland

A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity

Phase 1
Active, not recruiting
Conditions
Obesity
Overweight
Interventions
First Posted Date
2024-08-21
Last Posted Date
2025-04-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
30
Registration Number
NCT06564441
Locations
🇧🇪

SGS Life Science Services - Clinical Research, Edegem, Belgium

Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population

Phase 1
Recruiting
Conditions
Enhanced Recovery After Surgery in a Pediatric Population
Interventions
Drug: 0.9% Sodium Citrate
First Posted Date
2024-08-06
Last Posted Date
2024-08-21
Lead Sponsor
University of Chicago
Target Recruit Count
100
Registration Number
NCT06538584
Locations
🇺🇸

University of Chicago Medical Center, Chicago, Illinois, United States

Caffeine Citrate in Preterm Infants at Risk of Apnea in Zambia

Phase 4
Not yet recruiting
Conditions
Development, Infant
Premature Infant Disease
Apnea of Prematurity
Interventions
First Posted Date
2024-07-24
Last Posted Date
2025-04-09
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
340
Registration Number
NCT06518603
Locations
🇿🇲

University Teaching Hospital, Lusaka, Lusaka Province, Zambia

PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]

Not Applicable
Not yet recruiting
Conditions
Preterm Birth
Interventions
First Posted Date
2024-06-17
Last Posted Date
2024-06-17
Lead Sponsor
University of Melbourne
Target Recruit Count
100000
Registration Number
NCT06461429

Dose Optimization of Caffeine for HIE

Phase 1
Recruiting
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
First Posted Date
2024-06-07
Last Posted Date
2024-07-29
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
16
Registration Number
NCT06448780
Locations
🇺🇸

The University of North Carolina at Chapel Hill Newborn Critical Care Center, Chapel Hill, North Carolina, United States

Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants

Recruiting
Conditions
Infant,Premature
Caffeine
Interventions
First Posted Date
2024-05-16
Last Posted Date
2024-05-16
Lead Sponsor
University of Oxford
Target Recruit Count
30
Registration Number
NCT06416956
Locations
🇬🇧

Newborn Care Unit, John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom

The Effect of an Additional Pre-extubational Loading Dose of Caffeine-citrate

Phase 4
Recruiting
Conditions
Apnea of Prematurity
Premature Birth
Respiratory Failure
Interventions
First Posted Date
2024-05-06
Last Posted Date
2024-05-06
Lead Sponsor
Semmelweis University
Target Recruit Count
226
Registration Number
NCT06401083
Locations
🇭🇺

Pediatric Center, Semmelweis University, Budapest, Hungary

🇭🇺

Department of Obstetrics and Gynecology, Semmelweis University, Budapest, Hungary

Effect of Caffeine Consumption on Protein Biomarkers and Cardiovascular Disease

Early Phase 1
Not yet recruiting
Conditions
Healthy
Interventions
Drug: Placebo
Device: TASSO+ Device
Device: Finger prick and collection on Whatman Protein 903 Saver Cards
Device: Intravenous Sampling
First Posted Date
2024-04-11
Last Posted Date
2024-04-11
Lead Sponsor
Hamilton Health Sciences Corporation
Target Recruit Count
36
Registration Number
NCT06359197
Locations
🇨🇦

McMaster University, Department of Pathology and Molecular Medicine, Hamilton, Ontario, Canada

🇨🇦

David Braley Research Institute, Hamilton, Ontario, Canada

🇨🇦

Hamilton General Hospital, Hamilton, Ontario, Canada

Caffeine Use in the Management of Preterm Infants

Phase 2
Recruiting
Conditions
Apnea of Prematurity
Interventions
Other: Sterile Water Placebo
First Posted Date
2024-03-25
Last Posted Date
2025-05-13
Lead Sponsor
University of California, Irvine
Target Recruit Count
40
Registration Number
NCT06327152
Locations
🇺🇸

UC Irvine Medical Center, Orange, California, United States

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