Lithium Carbonate (Page 3 of 6)

6 ADVERSE REACTIONS

The following adverse reactions are described in greater detail in other sections:
• Lithium Toxicity [see Warnings and Precautions ( 5.1)]
• Lithium-Induced Polyuria [see Warnings and Precautions ( 5.2)]
• Hyponatremia [see Warnings and Precautions ( 5.3)]
• Lithium-Induced Chronic Kidney Disease [see Warnings and Precautions ( 5.4)]
• Encephalopathic Syndrome [see Warnings and Precautions ( 5.5)]
• Serotonin Syndrome [see Warnings and Precautions ( 5.6)]
• Hypothyroidism or Hyperthyroidism [see Warnings and Precautions ( 5.7)]
• Hypercalcemia and Hyperparathyroidism [see Warnings and Precautions ( 5.8)]
• Unmasking of Brugada Syndrome [see Warnings and Precautions ( 5.9)]
• Pseudotumor Cerebri [see Warnings and Precautions ( 5.10)]
The following adverse reactions have been identified following use of lithium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Central Nervous System: tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreoathetotic movements, hyperactive deep tendon reflexes, extrapyramidal symptoms including acute dystonia, cogwheel rigidity, blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, downbeat nystagmus, incontinence of urine or faeces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, tongue movements, tics, tinnitus, hallucinations, poor memory, slowed intellectual functioning, startled response, worsening of organic brain syndromes, myasthenic syndromes (rarely).
EEG Changes: diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm.
Cardiovascular: conduction disturbance (mostly sinus node dysfunction with possibly severe sinus bradycardia and sinoatrial block), ventricular tachyarrhythmia, peripheral vasculopathy (resembling Raynaud’s Syndrome).
ECG Changes: reversible flattening, isoelectricity or rarely inversion of T-waves, prolongation of the QTc interval.
Gastrointestinal: anorexia, nausea, vomiting, diarrhea, gastritis, salivary gland swelling, abdominal pain, excessive salivation, flatulence, indigestion.
Genitourinary: glycosuria, decreased creatinine clearance, albuminuria, oliguria, and symptoms of nephrogenic diabetes insipidus including polyuria, thirst, and polydipsia.
Dermatologic: drying and thinning of hair, alopecia, anaesthesia of skin, chronic folliculitis, xerosis cutis, psoriasis onset or exacerbation, generalized pruritus with or without rash, cutaneous ulcers, angioedema.
Autonomic Nervous System: blurred vision, dry mouth, impotence/sexual dysfunction. Miscellaneous: fatigue, lethargy, transient scotoma, exopthalmos, dehydration, weight loss, leukocytosis, headache, transient hyperglycemia, hypomagnesemia, excessive weight gain, edematous swelling of ankles or wrists, dysgeusia/taste distortion (e.g., metallic or salty taste), thirst, swollen lips, tightness in chest, swollen and/or painful joints, fever, polyarthralgia, and dental caries.

7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with Lithium

Table 2: Clinically Important Drug Interactions with Lithium

Diuretics
Clinical Impact: Diuretic-induced sodium loss may reduce lithium clearance and increase serum lithium concentrations .
Intervention: More frequent monitoring of serum electrolyte and lithium concentrations. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.6), Warning and Precautions ( 5.3)]
Examples: hydrochlorothiazide, chlorothiazide, furosemide
Non-Steroidal Anti-inflammatory Drugs (NSAID)
Clinical Impact: NSAID decrease renal blood flow, resulting in decreased renal clearance and increased serum lithium concentrations.
Intervention: More frequent serum lithium concentration monitoring. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.6)].
Examples: indomethacin, ibuprofen, naproxen
Renin-Angiotensin System Antagonists
Clinical Impact: Concomitant use increase steady-state serum lithium concentrations.
Intervention: More frequent monitoring of serum lithium concentration. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.6)].
Examples: lisinopril, enalapril, captopril, valsartan
Serotonergic Drugs
Clinical Impact: Concomitant use can precipitate serotonin syndrome.
Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during lithium initiation. If serotonin syndrome occurs, consider discontinuation of lithium and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.6)].
Examples: selective serotonin reuptake inhibitors (SSRI), serotonin and norepinephrine reuptake inhibitors (SNRI), monoamine oxidase inhibitors (MAOI)
Nitroimidazole Antibiotics
Clinical Impact: Concomitant use may cause lithium toxicity due to reduced renal clearance.
Intervention: More frequent monitoring of serum lithium concentration. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.6)].
Examples: metronidazole
Acetazolamide, Urea, Xanthine Preparations, Alkalinizing Agents
Clinical Impact: Concomitant use can lower serum lithium concentrations by increasing urinary lithium excretion.
Intervention: More frequent serum lithium concentration monitoring. Increase lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.6)].
Examples: acetazolamide, theophylline, sodium bicarbonate
Methyldopa, Phenytoin and Carbamazepine
Clinical Impact: Concomitant use may increase risk of toxic effects of these drugs
Intervention: Monitor patients closely for symptoms of toxicity of methyldopa, phenytoin, and carbamazepine.
Iodide Preparations
Clinical Impact: Concomitant use may produce hypothyroidism.
Intervention: Monitor patients for signs or symptoms of hypothyroidism [see Warnings and Precautions ( 5.7)].
Examples: potassium iodide
Calcium Channel Blocking Agents (CCB)
Clinical Impact: Concomitant use may increase the risk of neurologic adverse reactions in the form of ataxia, tremors, nausea, vomiting, diarrhea and/or tinnitus.
Intervention: Monitor for neurologic adverse reactions.
Examples: diltiazem, nifedipine, verapamil
Atypical and Typical Antipsychotic Drugs
Clinical Impact: Reports of neurotoxic reactions in patients treated with both lithium and an antipsychotic, ranging from extrapyramidal symptoms to neuroleptic malignant syndrome, as well as reports of an encephalopathic syndrome in few patients treated with concomitant therapy [see Warnings and Precautions ( 5.5)].
Intervention: Monitor for neurologic adverse reactions.
Examples: risperidone, haloperidol, thioridazine, fluphenazine, chlorpromazine, perphenazine, clozapine
Neuromuscular Blocking Agents
Clinical Impact: Lithium may prolong the effects of neuromuscular blocking agents.
Intervention: Monitor for prolonged paralysis or toxicity.
Examples: succinylcholine, pancuronium

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