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

Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed

Phase 2
Completed
Conditions
Pain, Postoperative
Interventions
First Posted Date
2019-10-18
Last Posted Date
2021-09-01
Lead Sponsor
Bayer
Target Recruit Count
193
Registration Number
NCT04132336
Locations
🇺🇸

JBR Clinical Research, Salt Lake City, Utah, United States

Caffeine Treatment in in the Delivery Room

Not Applicable
Completed
Conditions
Respiratory Distress Syndrome
Interventions
First Posted Date
2019-08-05
Last Posted Date
2023-03-10
Lead Sponsor
University of Florence
Target Recruit Count
42
Registration Number
NCT04044976
Locations
🇮🇹

Division of Neonatology, Careggi University Hospital, Florence, Italy

Effect of Early Use of Caffeine Citrate in Preterm Neonates

Phase 3
Completed
Conditions
Preterm Birth
Interventions
First Posted Date
2019-06-28
Last Posted Date
2019-07-02
Lead Sponsor
Ain Shams University
Target Recruit Count
54
Registration Number
NCT04001712
Locations
🇪🇬

Ain Shams University Hospitals, Cairo, Al Qahirah, Egypt

A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or Rosuvastatin

Phase 1
Completed
Conditions
Parkinson's Disease
Interventions
First Posted Date
2019-06-03
Last Posted Date
2019-11-29
Lead Sponsor
Kyowa Kirin Co., Ltd.
Target Recruit Count
50
Registration Number
NCT03970798
Locations
🇯🇵

Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan

Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

Phase 1
Completed
Conditions
Food-drug Interaction
Interventions
First Posted Date
2019-05-13
Last Posted Date
2023-05-06
Lead Sponsor
University of Illinois at Chicago
Target Recruit Count
19
Registration Number
NCT03948243
Locations
🇺🇸

University of Illinois at Chicago, Chicago, Illinois, United States

The Effects of a Combination of TeaCrine®, Dynamine, and Caffeine in Law Enforcement

Early Phase 1
Completed
Conditions
Caffeine, Teacrine, and Dynamine: Effects on Performance
Interventions
Drug: Placebo
Drug: Caffeine+TeaCrine+Dynamine
First Posted Date
2019-05-06
Last Posted Date
2021-09-30
Lead Sponsor
University of South Carolina
Target Recruit Count
49
Registration Number
NCT03937687
Locations
🇺🇸

University of South Carolina Sport Science Lab, Columbia, South Carolina, United States

🇺🇸

Rutgers University Center for Health and Human Performance, New Brunswick, New Jersey, United States

Caffeine for Hypoxic-Ischemic Encephalopathy

Phase 1
Completed
Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
First Posted Date
2019-04-12
Last Posted Date
2025-03-27
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
17
Registration Number
NCT03913221
Locations
🇺🇸

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

Pregabalin Versus Hydrocortisone for Postdural Puncture Headache After Spinal for Cesarean

Phase 4
Completed
Conditions
Post-Dural Puncture Headache
Interventions
First Posted Date
2019-04-10
Last Posted Date
2019-11-12
Lead Sponsor
Cairo University
Target Recruit Count
30
Registration Number
NCT03910088
Locations
🇪🇬

Cairo University, Cairo, Zamalek, Egypt

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

First Posted Date
2019-03-06
Last Posted Date
2023-06-08
Lead Sponsor
Pfizer
Target Recruit Count
56
Registration Number
NCT03864042
Locations
🇨🇦

Sir Mortimer B Davis Jewish General Hospital, Montreal, Quebec, Canada

🇺🇸

UC Irvine Health, Orange, California, United States

🇺🇸

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP), Aurora, Colorado, United States

and more 26 locations

Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy

Phase 2
Active, not recruiting
Conditions
Carcinoma Breast
Interventions
First Posted Date
2018-12-07
Last Posted Date
2023-10-25
Lead Sponsor
NYU Langone Health
Target Recruit Count
60
Registration Number
NCT03768492
Locations
🇺🇸

New York University Medical Center, New York, New York, United States

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