SUMMARY
LITHIUM CITRATE SYRUP, USP
Lithium Citrate Syrup, USP is a palatable oral dosage form of lithium ion, with a raspberry flavor. Lithium citrate is prepared in solution from lithium hydroxide and citric acid in a ratio approximating di-lithium citrate. Each 5 mL of Lithium Citrate Syrup, USP contains 8 mEq of lithium ion (Li+), equivalent to the amount of lithium in 300 mg of lithium carbonate and alcohol 0.3% v/v.
Lithium citrate is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM III) is equivalent to Manic Depressive Illness, Manic, in the older DSM-II terminology.
Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur.
Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgement, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
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NEWS HIGHLIGHTSMedia Articles Related to Lithium Citrate (Lithium)
Seeking A Safer Alternative To Lithium For Bipolar Disorder
Source: Bipolar News From Medical News Today [2013.04.01]
Toxicity problems and adverse side effects when taking lithium, the mainstay medication for treating bipolar disorder, are fostering a scientific hunt for insights into exactly how lithium works in the body - with an eye to developing a safer alternative. That's the topic of the cover story in the current edition of Chemical & Engineering News...
Lithium Safe But Of No Benefit To ALS Patients
Source: Clinical Trials / Drug Trials News From Medical News Today [2013.03.21]
A clinical trial concludes that while lithium carbonate appears to be safe, it is ineffective at treating amyotrophic lateral sclerosis (ALS), a type of motor neuron disease (MND) that is also known as Lou Gehrig's Disease...
Lithium Could Be Key To Personalized Treatment For Bipolar Disorder
Source: Bipolar News From Medical News Today [2012.09.25]
Lithium is a 'gold standard' drug for treating bipolar disorder, however not everyone responds in the same way. New research published in BioMed Central's open access journal Biology of Mood & Anxiety Disorders finds that this is true at the levels of gene activation, especially in the activation or repression of genes which alter the level the apoptosis (programmed cell death)...
China battery plant protest gives voice to rising anger over pollution
Source: Yahoo! Health News [2013.05.11]
By Jane Lee and Gabriel Wildau SHANGHAI (Reuters) - Hundreds of protesters gathered in the Chinese financial hub of Shanghai on Saturday to oppose plans for a lithium battery factory, highlighting growing social tension over pollution. Police stoo...
New Study On Post-War Romanian Abortion Policy Demonstrates That Restrictions Result In Maternal Mortality
Source: Abortion News From Medical News Today [2013.01.18]
A unique study published in today's edition of the Journal of Family Planning and Reproductive Health Care1, provides new evidence about the causal links between restrictions to abortion policy and maternal mortality. The study demonstrates that limiting abortion does not prevent women from seeking pregnancy terminations but simply increases the risks they face...
Published Studies Related to Lithium Citrate (Lithium)
Lithium lacks effect on survival in amyotrophic lateral sclerosis: a phase IIb
randomised sequential trial. [2012]
blind, sequential trial... CONCLUSIONS: This trial, designed to detect a modest effect of lithium, did not
Efficacy and safety of lithium carbonate treatment of chronic spinal cord injuries: a double-blind, randomized, placebo-controlled clinical trial. [2011.11.22]
Study design:Lithium has attracted much attention as a neuroregenerative agent for spinal cord injury in animal models. We hypothesized that the lithium can be beneficial to patients with spinal cord injury... No severe adverse event was documented in the study.Conclusion:The lithium treatment did not change the neurological outcomes of patients with chronic spinal cord injury.
Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (trial 144: a randomized controlled study). [2011.11]
CONCLUSIONS: In patients stabilized during acute quetiapine treatment, continuation of quetiapine significantly increased time to recurrence of any mood, manic, or depressive event compared with switching to placebo. Switching to lithium was also more effective than placebo for the prevention of manic and depressive events. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00314184. (c) Copyright 2011 Physicians Postgraduate Press, Inc.
Treatment of suicide attempters with bipolar disorder: a randomized clinical trial comparing lithium and valproate in the prevention of suicidal behavior. [2011.10]
CONCLUSIONS: Despite the high frequency of suicide events during the study, this randomized controlled trial detected no difference between lithium and valproate in time to suicide attempt or suicide event in a sample of suicide attempters with bipolar disorder. However, smaller clinically significant differences between the two drugs were not ruled out.
Dosing strategies for lithium monotherapy in children and adolescents with bipolar I disorder. [2011.06]
OBJECTIVE: The primary goal of this exploratory study was to obtain data that could lead to evidence-based dosing strategies for lithium in children and adolescents suffering from bipolar I disorder... CONCLUSIONS: On the basis of these results, a dosing strategy in which pediatric patients begin lithium at a dose of 300 mg thrice daily (with an additional 300 mg increase during the first week), followed by 300 mg weekly increases until a priori stopping criteria are met, will be used in an upcoming randomized, placebo-controlled trial.
Clinical Trials Related to Lithium Citrate (Lithium)
Safety and Pharmacokinetics Study of Oral Lithium in Patients With Chronic Spinal Cord Injury [Active, not recruiting]
The current study is a phase I open-label clinical trial to examine plasma levels after oral
lithium treatments in 20 subjects with chronic spinal cord injury. The subjects will receive
standard doses of oral lithium used in treatment of manic depression. The goal of the trial
is to show feasibility and safety of maintaining plasma levels of 0. 6 mmol/L to 1. 2 mmol/L
for six weeks in subjects with chronic spinal cord injury.
Lithium in Multiple System Atrophy [Recruiting]
The purpose of this study is to determine safety and tolerability of the treatment with
lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of
life and depressive symptoms, will be considered to further investigate the effect of
lithium therapy.
Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2) [Recruiting]
The purpose of this study is to determine safety and tolerability of the treatment with
lithium in Spinocerebellar Ataxia 2. Moreover, clinical symptoms, neuronal loss, quality of
life and depressive symptoms, will be considered to further investigate the effect of
lithium therapy.
Safety and Efficacy of Lithium Carbonate in Patients With Spinocerebellar Ataxia Type 3 [Recruiting]
Design: Phase II, double-blind, parallel, placebo controlled randomized Clinical trial
Background: Spinocerebellar ataxia type 3 (SCA-3) is an autosomal dominant adult-onset
neurodegenerative disorder for which there is no current treatment. Patients will invariably
become dependent from others and unable to walk during the disease course.
Hypothesis: Lithium Carbonate is safe and effective in treating neurological symptoms and
improving quality of life of patients with SCA3.
Outcomes:
Primary
1. - To assess safety and tolerability of Lithium Carbonate in patients with SCA3
2. - To assess efficacy of Lithium Carbonate in patients with SCA3 through the
Neurological Examination Score for SCA 3 (NESSCA)
Secondary
1. - To assess efficacy on neurological function, ataxic, depressive and quality of life
scores of Lithium Carbonate in patients with SCA3 through the Scale for the Assessment
and Rating of Ataxia (SARA), 9-Hole Peg Board test, 8m walking time, PATA repetition
rate, Click Test, SCA Functional Index (SCAFI), Composite Cerebellar Functional Score
(CCFS), Beck Depression Inventory, Barthel Index and WHOQol
2. - To assess the effect of Lithium Carbonate in peripheral levels and expression of
treatment biomarkers (BDNF, NSE, HDAC, GSK-3Beta)
Study Duration: 12 months - first preliminary analysis at 6 months of study
Location: Hospital de Clínicas de Porto Alegre
Subjects: 60 molecularly diagnosed SCA3 patients from the outpatient unit of the Medical
Genetics Service of Hospital de Clínicas de Porto Alegre
Intervention: Lithium Carbonate tablets of 300mg. Starting dose will be 300mg/day with drug
titration during 49 days or until achieving the defined target lithium serum level of 0,6 to
0,8 mEq/L
Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania. [Recruiting]
Study Design This is the second study of a multiphase, multicenter trial that will
comprehensively examine lithium in the treatment of pediatric participants with bipolar I
disorder. In order to examine the treatment of bipolar disorder with lithium, this study
will include four phases of treatment. The first phase, the Efficacy Phase, will include
participants being randomized to either lithium or placebo for 8 weeks to determine the
efficacy of lithium in the treatment of children and adolescents with bipolar I disorder.
Once participants complete the Efficacy Phase, participants may be eligible to continue in
the Long- Term Effectiveness Phase for a maximum of 24 weeks of lithium treatment.
Subsequently, participants meeting response criteria during the Long-Term Effectiveness
Phase will be eligible to continue in the Discontinuation Phase. During the Discontinuation
Phase, participants will be randomized to either placebo or lithium treatment for up to 28
weeks. Finally, those participants who experience a mood relapse during the Discontinuation
Phase will be enrolled in an Open Label Restabilization Phase and treated with lithium for
up to 8 weeks.
Reports of Suspected Lithium Citrate (Lithium) Side Effects
Rhabdomyolysis (37),
Lactic Acidosis (37),
Fall (37),
Neuroleptic Malignant Syndrome (37),
Humerus Fracture (37),
Organ Failure (33),
Dyspnoea (32),
Renal Failure (28),
Pyrexia (26),
Hypertension (26), more >>
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