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: C_₈H_₁₀N_₄O_₂

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

Clinical Trials

Caffeine in Amblyopia Study

Phase 1

Withdrawn

Conditions: Amblyopia

Interventions: Drug: Caffeine

First Posted Date: 2015-11-03

Last Posted Date: 2017-03-07

Lead Sponsor: Johns Hopkins University

Registration Number: NCT02594358

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

A Study to Determine if Caffeine Accelerates Emergence From Anesthesia

Phase 4

Completed

Conditions: Anesthesia

Interventions: Drug: Placebo Control
Drug: Caffeine

First Posted Date: 2015-10-05

Last Posted Date: 2018-08-16

Lead Sponsor: University of Chicago

Target Recruit Count: 8

Registration Number: NCT02567968

Locations: 🇺🇸
The University of Chicago, Chicago, Illinois, United States

Early Versus Late Caffeine for ELBW Newborns

Not Applicable

Terminated

Conditions: Apnea of Prematurity
Bronchopulmonary Dysplasia

Interventions: Drug: Placebo (dextrose)
Drug: Caffeine

First Posted Date: 2015-08-14

Last Posted Date: 2022-05-02

Lead Sponsor: Wayne State University

Target Recruit Count: 110

Registration Number: NCT02524249

Locations: 🇺🇸
Hutzel Women's Hospital, Detroit, Michigan, United States

A DDI Study to Assess the Effect of INC280 on the PK of Midazolam and Caffeine in Patients With cMET-dysregulated Advanced Solid Tumors

Phase 1

Completed

Conditions: cMET-dysregulated Advanced Solid Tumors

Interventions: Drug: INC280
Drug: Midazolam
Drug: Caffeine

First Posted Date: 2015-08-13

Last Posted Date: 2020-12-10

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 37

Registration Number: NCT02520752

Locations: 🇬🇧
Novartis Investigative Site, Manchester, United Kingdom
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Emory University School of Medicine/Winship Cancer Institute SC-2, Atlanta, Georgia, United States