RE: Dear Mr. Dziak: This is to advise you that the U. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. In particular, there is some evidence of a stimulating role of citicoline for the release of dopamine neurotransmitters in the brain.
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Dosing Oral dosages of to 2, mg daily have been evaluated in adolescents and adults in clinical trials. Lower doses mg twice daily have been used in short-term trials 6 weeks with combination therapy in patients with major depressive disorder. Contraindications Contraindications have not been identified. Interactions None well documented. Adverse Reactions Citicoline was well tolerated in clinical trials. Adverse effects may include GI disturbances, transient headaches, hypotension, tachycardia, bradycardia, and restlessness.
Toxicology Studies in humans are limited. Source Citicoline is found in all animal and plant cell membranes. It is available commercially in its free-base form or as a sodium salt.
Use of citicoline has been extended to include treatment of chronic conditions, although further research is needed. It is water-soluble and highly bioavailable. Citicoline appears to decrease glutamate levels in the brain and increase adenosine triphosphate, which in turn offers protection against ischemic neurotoxicity.
Increased glucose metabolism in the brain and cerebral blood flow has also been demonstrated, as well as increased availability of the neurotransmitters acetylcholine, norepinephrine, and dopamine. Labeled phospholipid from radioactively labeled citicoline has been shown to cross the blood-brain barrier. Studies in rats with cognitive impairment have been conducted, and improved memory and learning have been demonstrated in older rats and those with induced memory deficits.
Citicoline has also demonstrated enhanced learning ability in dogs. Trials included in the meta-analysis enrolled participants with mild to moderate dementia and Alzheimer disease, as well as those with cerebrovascular disorders. Mini-Mental State Examination scores remained essentially unchanged over time for the treatment arm, while a decline was evident in the control patients. Improved cognitive outcomes were reported for the citicoline-treated group in attention, temporal orientation, and functional outcome measures.
No significant differences were noted in adverse events between groups. Changes in scores were predicted significantly more by a weight-adjusted dose with greater improvements in accuracy, detectability, and commission errors following higher weight-adjusted doses. Similarly, there were no significant differences for adverse events. No significant difference was found in mortality, outcome dependency, effectiveness, or safety between citicoline and controls. The effects of citicoline have been studied in rats during pregnancy for a potential role in the protection of dendrites in the cortex and fetal lung development, as well as in pregnant women in their third trimesters.
However, information is limited on the safety of supplemental citicoline. In dogs given oral citicoline 1. Int J Toxicol. Fioravanti M, Yanagi M. Cytidinediphosphocholine CDP-choline for cognitive and behavioural disturbances associated with chronic cerebral disorders in the elderly.
Cochrane Database Syst Rev. Citicoline preclinical and clinical update Citicoline: pharmacological and clinical review, update. Methods Find Exp Clin Pharmacol. CDP-choline as a biological supplement during neurorecovery: a focused review. Conant R, Schauss AG. Therapeutic applications of citicoline for stroke and cognitive dysfunction in the elderly: a review of the literature. Altern Med Rev.
Citicoline, use in cognitive decline: vascular and degenerative. J Neurol Sci. Fioravanti M, Buckley AE. Citicoline Cognizin in the treatment of cognitive impairment. Clin Interv Aging. Long-term treatment with citicoline may improve poststroke vascular cognitive impairment. Cerebrovasc Dis. Citicoline in vascular cognitive impairment and vascular dementia after stroke. Grieb P, Rejdak R. Pharmacodynamics of citicoline relevant to the treatment of glaucoma.
J Neurosci Res. Evidence of the neuroprotective role of citicoline in glaucoma patients. Prog Brain Res. Saver JL. Citicoline: update on a promising and widely available agent for neuroprotection and neurorepair. Rev Neurol Dis. The protective effects of propofol and citicoline combination in experimental head injury in rats.
Turk Neurosurg. Effect of recombinant human erythropoietin on serum SB protein and interleukin-6 levels after traumatic brain injury in the rat. Neurol Med Chir Tokyo. Poole NA, Agrawal N. Cholinomimetic agents and neurocognitive impairment following head injury: a systematic review. Brain Inj. Neuroprotection and recovery: recent data at the bench on citicoline. Clark WM.
Efficacy of citicoline as an acute stroke treatment. Expert Opin Pharmacother. Citicoline mechanisms and clinical efficacy in cerebral ischemia. Neurochem Res. Overgaard K, Meden P. Citicoline—the first effective neuroprotectant to be combined with thrombolysis in acute ischemic stroke?
Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study ICTUS trial. Brown ES, Gabrielson B. A randomized, double-blind, placebo-controlled trial of citicoline for bipolar and unipolar depression and methamphetamine dependence. J Affect Disord.
Effects of daily treatment with citicoline: a double-blind, placebo-controlled study in cocaine-dependent volunteers. J Addict Med. Citicoline CDP-choline : What role in the treatment of complications of infectious diseases. Int J Biochem Cell Biol. J Pharm Biomed Anal. Cytidinediphosphocholine supplement in early life induces stable increase in dendritic complexity of neurons in the somatosensory cortex of adult rats.
Pregnancy alters choline dynamics: results of a randomized trial using stable isotope methodology in pregnant and nonpregnant women. Am J Clin Nutr. Efficacy and safety of oral citicoline in acute ischemic stroke: drug surveillance study in 4, cases.
Cavun S, Savci V. Fundam Clin Pharmacol. The effect of citicoline supplementation on motor speed and attention in adolescent males [published online ahead of print July 15, ].
J Att Dis. A randomized, double-blind, placebo-controlled trial of citicoline for cocaine dependence in bipolar 1 disorder. Am J Psychiatry. Early application of citicoline in the treatment of acute stroke: a meta-analysis of randomized controlled trials. Citicoline combination therapy for major depressive disorder: a randomized, double-blind, placebo-controlled trial. Clin Neuropharm.
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Citicoline wins EU novel foods approval - in medical foods and food supplements