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

Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

Phase 1
Completed
Conditions
NASH
Interventions
First Posted Date
2017-06-15
Last Posted Date
2017-08-21
Lead Sponsor
Enanta Pharmaceuticals, Inc
Target Recruit Count
24
Registration Number
NCT03187496
Locations
🇺🇸

Pharmaceutical Research Associates, Inc.,, Lenexa, Kansas, United States

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

First Posted Date
2017-04-27
Last Posted Date
2017-12-15
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
26
Registration Number
NCT03131973
Locations
🇺🇸

PPD Development, LP, Austin, Texas, United States

Does Caffeine Enhance Bowel Recovery After Colorectal Surgery?

Phase 2
Completed
Conditions
Postoperative Ileus
Interventions
First Posted Date
2017-03-31
Last Posted Date
2020-02-11
Lead Sponsor
Hadassah Medical Organization
Target Recruit Count
70
Registration Number
NCT03097900
Locations
🇮🇱

Hadassah Medical Organization, Jerusalem Region, Israel

Early Caffeine in Preterm Neonates

Phase 4
Conditions
Intubation
BPD - Bronchopulmonary Dysplasia
Apnea of Prematurity
Hemodynamic Instability
Interventions
Drug: Placebo (Normal Saline)
First Posted Date
2017-03-22
Last Posted Date
2021-08-03
Lead Sponsor
Jennifer Shepherd
Target Recruit Count
24
Registration Number
NCT03086473
Locations
🇺🇸

LAC+USC Medical Center, Los Angeles, California, United States

🇺🇸

Hollywood Presbyterian Medical Center, Los Angeles, California, United States

The Effects of Caffeine Withdrawal on Migraine

Phase 2
Terminated
Conditions
Migraine
Caffeine Withdrawal
Interventions
First Posted Date
2017-01-18
Last Posted Date
2019-07-23
Lead Sponsor
Nordlandssykehuset HF
Target Recruit Count
10
Registration Number
NCT03022838
Locations
🇳🇴

Departement of Neurology, Tromsø, Norway

🇳🇴

Departement of Neurology, NLSH HF, Bodø, Norway

🇳🇴

Nordland Hospital, Bodø, Norway

Ibuprofen/Caffeine Lower Back or Neck Pain Study

Phase 3
Completed
Conditions
Back Pain
Neck Pain
Interventions
First Posted Date
2016-12-26
Last Posted Date
2019-06-07
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
635
Registration Number
NCT03003000
Locations
🇩🇪

Praxis Dr. Steinebach, Essen, Essen, Germany

🇩🇪

Praxis Dr. Pabst, Gilching, Gilching, Germany

🇩🇪

Praxis Dr. Klein, Künzing, Künzing, Germany

and more 15 locations

To Evaluate the Superiority of Fixed Combination (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to Voltaren® (Diclofenac Sodium 50mg) in the Treatment of Acute Postural Low Back Pain.

Phase 3
Conditions
Postural Low Back Pain
Mechanical Low Back Pain
Interventions
Drug: Placebo (for experimental drug)
Drug: Placebo (for Voltaren)
First Posted Date
2016-12-07
Last Posted Date
2020-09-03
Lead Sponsor
Ache Laboratorios Farmaceuticos S.A.
Target Recruit Count
110
Registration Number
NCT02985671

Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise

Not Applicable
Conditions
Autonomic Nervous System
Cardiorespiratory Parameters
Interventions
Drug: Placebo
Other: Cardiopulmonary test
Other: Treadmill aerobic exercise
First Posted Date
2016-09-28
Last Posted Date
2016-09-30
Lead Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Target Recruit Count
35
Registration Number
NCT02917889
Locations
🇧🇷

Universidade Estadual Paulista, Presidente Prudente, São Paulo, Brazil

The Effect of Caffeine on the Narcoleptic Patients

Phase 1
Completed
Conditions
Narcolepsy
Interventions
Drug: Fiber
First Posted Date
2016-07-14
Last Posted Date
2019-03-01
Lead Sponsor
King Saud University
Target Recruit Count
16
Registration Number
NCT02832336
Locations
🇸🇦

King Khalid University Hospital:King Saud Medical City, Riyadh, Saudi Arabia

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