Licab Tablets (Generic Lithium Carbonate Tablets)

1. Licab Tablets (Generic Lithium Carbonate Tablets) © The Swiss Pharmacy

2. Licab Tablets (Generic Lithium Carbonate Tablets) Licab (Generic Lithium Carbonate Tablets) is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder, treatment of acute manic and mixed episodes in patients 7 years and older and maintenance treatment in patients 7 years and older. © The Swiss Pharmacy

3. Licab Tablets (Generic Lithium Carbonate Tablets) Licab Tablets are manufactured by Torrent Pharmaceuticals Limited, India in the strengths of 300 mg and 400 mg (Extended Release Version). © The Swiss Pharmacy

4. Licab Tablets (Generic Lithium Carbonate Tablets) Chemical Structure © The Swiss Pharmacy

5. Licab Tablets (Generic Lithium Carbonate Tablets) The active ingredient contained in Licab tablets is Lithium Carbonate. Each uncoated Licab tablet contains 300 mg of Lithium Carbonate. Each uncoated prolonged-release Licab tablet contains 400 mg of Lithium Carbonate. © The Swiss Pharmacy

6. Licab Tablets (Generic Lithium Carbonate Tablets) Uses of Licab 300 mg and 400 mg tablets: Licab (Generic Lithium Carbonate Tablets) is indicated in the treatment of manic episodes of Bipolar Disorder (manic-depressive illness). Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate 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 judgment, aggressiveness, and possibly hostility. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

7. Licab Tablets (Generic Lithium Carbonate Tablets) Uses of Licab 300 mg and 400 mg tablets: Manic-depressive patients experience severe mood changes, ranging from an excited or manic state (eg, unusual anger or irritability or a false sense of well-being) to depression or sadness. When given to a patient experiencing a manic episode, Lithium may produce a normalization of symptomatology within 1 to 3 weeks. It is important that you and your family understand all the effects of this medicine. These effects depend on your individual condition and response and the amount of Lithium you use. You must also know when to contact your doctor if there are problems with using the medicine. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

8. Licab Tablets (Generic Lithium Carbonate Tablets) Recommended Dosage The recommended starting dose of Licab Tablets Lithium Carbonate Tablets) is is 300 mg, three times daily. The recommended starting dosage for pediatric patients 20 to 30 kg is 300 mg twice daily. Obtain serum Lithium concentration assay after 3 days, drawn 12 hours after the last oral dose and regularly until patient is stabilized. Licab Tablets (Generic URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

9. Licab Tablets (Generic Lithium Carbonate Tablets) Recommended Dosage Acute Manic or Mixed Episodes (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1.2 mEq/L Maintenance Treatment for Bipolar I Disorder (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1 mEq/L Pre-treatment Screening: Evaluate renal function, vital signs, electrolytes, thyroid function, concurrent medications, and pregnancy status Mild to Moderate Renal Impairment (CLer 30 to 89 mL/min): Start with dosages less than those for patients with normal renal function, titrate slowly with frequent monitoring Severe Renal Impairment (CLer<30mL/min): Avoid use of Lithium Carbonate Tablets (Licab) URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

10. Licab Tablets (Generic Lithium Carbonate Tablets) Contraindications ➔Licab tablets are contraindicated in patients with a known hypersensitivity to Lithium Carbonate or any component of the tablet. ➔Severely impaired renal function. ➔Untreated or untreatable hypothyroidism. ➔Cardiac disease associated with rhythm disorder. ➔Brugada syndrome or family history of Brugada syndrome. ➔Low body sodium levels for example dehydrated patients, those on low sodium diets, or those with Addison's disease. ➔Breast-feeding. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

11. Licab Tablets (Generic Lithium Carbonate Tablets) Storage Instructions Licab Tablets (Generic Lithium Carbonate Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

12. Licab Tablets (Generic Lithium Carbonate Tablets) Warnings Lithium-Induced Polyuria: May develop during initiation of treatment. Increases risk of lithium toxicity. Educate patient to avoid dehydration. Monitor for lithium toxicity and metabolic acidosis. Discontinue Licab (Generic Lithium Carbonate Tablets) or treat with Amiloride as a therapeutic agent Hyponatremia: Symptoms are more severe with faster-onset hyponatremia. Dehydration from protracted sweating, diarrhea, or elevated temperatures from infection increases risk of hyponatremia and lithium toxicity. Educate patients on maintaining a normal diet with salt and staying hydrated. Monitor for and treat hyponatremia and lithium toxicity, which may necessitate a temporary reduction or cessation of lithium and infusion of serum sodium URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

13. Licab Tablets (Generic Lithium Carbonate Tablets) Warnings Lithium-Induced Chronic Kidney Disease: Associated with structural changes in patients on chronic lithium therapy. Monitor kidney function during treatment with lithium Encephalopathic Syndrome: Increased risk in patients treated with lithium and an antipsychotic. Monitor routinely for changes to cognitive function Hypothyroidism and Hyperthyroidism: Monitor thyroid function regularly Hypercalcemia and Hyperparathyroidism: Associated with long-term lithium use. Monitor serum calcium URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

14. Licab Tablets (Generic Lithium Carbonate Tablets) Possible Side Effects Most common Lithium Carbonate (Licab tablets) side effects are given below: Adult Patients: fine hand tremor, polyuria, mild thirst, nausea, general discomfort during initial treatment Pediatric Patients (7-17 years): nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

15. Licab Tablets (Generic Lithium Carbonate Tablets) Possible Side Effects The following side effects have been reported and appear to be related to serum Lithium (Licab tablets) concentrations, including concentrations within the therapeutic range: Central Nervous System: tremor, muscle hyperirritability, hypertonicity, ataxia, choreoathetotic movements, hyperactive deep tendon reflex, extrapyramidal symptoms including acute dystonia, cogwheel rigidity, blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, downbeat nystagmus, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, tongue movements, tics, tinnitus, hallucinations, poor memory, slowed intellectual functioning, startled response, worsening of organic brain syndromes. Cardiovascular: cardiac arrhythmia, hypotension, peripheral circulatory collapse, bradycardia, sinus node dysfunction and severe bradycardia (which may result in syncope), Unmasking of Brugada Syndrome. Gastrointestinal: anorexia, nausea, vomiting, diarrhea, gastritis, salivary gland swelling, abdominal pain, excessive salivation, flatulence, indigestion. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

16. Licab Tablets (Generic Lithium Carbonate Tablets) Possible Side Effects 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, anesthesia of skin, acne, chronic folliculitis, xerosis cutis, psoriasis or its exacerbation, generalized pruritus with or without rash, cutaneous ulcers, angioedema. Autonomic Nervous System: blurred vision, dry mouth, impotence/sexual dysfunction. Thyroid Abnormalities: euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. Iodine uptake may be elevated. Paradoxically, rare cases of hyperthyroidism have been reported. EEG Changes: diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

17. Licab Tablets (Generic Lithium Carbonate Tablets) Possible Side Effects EKG Changes: reversible flattening, isoelectricity or inversion of T- waves. Miscellaneous: fatigue, lethargy, transient scotomata, exophthalmos, dehydration, weight loss, leukocytosis, headache, transient hyperglycemia, hypercalcemia, hyperparathyroidism, albuminuria, excessive weight gain, edematous swelling of ankles or wrists, metallic taste, dysgeusia/taste distortion, salty taste, thirst, swollen lips, tightness in chest, swollen and/or painful joints, fever, polyarthralgia, and dental caries. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

18. Licab Tablets (Generic Lithium Carbonate Tablets) Licab Tablets Overdosage The toxic levels for Lithium Carbonate (Licab tablets) are close to the therapeutic levels. Symptoms of Lithium overdose (Lithium intoxication) can therefore occur due to intercurrent illness, iatrogenic causes, and self-poisoning. Any overdose in a patient who has been taking chronic Lithium therapy should be regarded as potentially serious. It is therefore important that patients and their families be cautioned to watch for early symptoms and to discontinue the medication and inform the physician should they occur. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

19. Licab Tablets (Generic Lithium Carbonate Tablets) Treatment of Licab Tablets Overdosage No specific anti dote for Lithium (Licab tablets) poisoning is known. Early symptoms of Lithium toxicity can usually be treated by reduction of cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of Lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient. Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance and 3) regulation of kidney functioning. Urea, Mannitol, and Aminophylline all produce significant increases in Lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

20. Licab Tablets (Generic Lithium Carbonate Tablets) Licab Tablets During Pregnancy Lithium Carbonate (Licab tablets) has been classified by the US FDA as Pregnancy Category D. Lithium Carbonate (Licab tablets) may cause fetal harm when administered to a pregnant woman. There have been reports of Lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in-vitro of rat testis and human spermatozoa have been attributed to Lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of Lithium-induced teratology. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy

21. Licab Tablets (Generic Lithium Carbonate Tablets) Licab Tablets Licab Tablets (Generic Lithium Carbonate Tablets) are manufactured by Torrent Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9550_Lithium-Carbonate-Tablets.html © The Swiss Pharmacy