DRUGS & SUPPLEMENTS

Lithus

Name: Lithus drug & pharmaceuticals. Lithus available forms, doses, prices
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Published: 2021-11-11T10:10:10+00:00

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WARNING

Lithus toxicity is closely related to serum Lithus levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum Lithus determinations should be available before initiating therapy.

DESCRIPTION

Lithus Carbonate Extended-release Tablets USP contain Lithus carbonate USP, a white granular powder with molecular formula Li₂CO₃ and molecular weight 73.89. Lithus is an element of the alkali-metal group with atomic number 3, atomic weight 6.94 and an emission line at 671 nm on the flame photometer. The tablets meet the requirements of USP Dissolution Test 2 in the USP monograph for Lithus Carbonate Extended-release Tablets USP.

Lithus Carbonate Extended-release Tablets USP are available for oral administration containing 450 mg of Lithus carbonate USP. Each tablet contains the following inactive ingredients: iron oxide (yellow), magnesium stearate, povidone, sodium alginate and sodium starch glycolate.

Lithus Carbonate Extended-release Tablets USP, 450 mg are designed to release a portion of the dose initially and the remainder gradually; the release pattern of the controlled release tablets reduces the variability in Lithus blood levels seen with the immediate release dosage forms.

ACTIONS

Preclinical studies have shown that Lithus alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of Lithus action in mania is unknown.

INDICATIONS

Lithus carbonate is indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.

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. When given to a patient experiencing a manic episode, Lithus carbonate may produce a normalization of symptomatology within 1 to 3 weeks.

WARNINGS

Lithus Toxicity

Lithus toxicity is closely related to serum Lithus levels, and can occur at doses close to therapeutic levels.

Outpatients and their families should be warned that the patient must discontinue Lithus carbonate therapy and contact his physician if such clinical signs of Lithus toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness or muscular weakness occur.

Lithus carbonate may impair mental and/or physical abilities. Caution patients about activities requiring alertness (e.g., operating vehicles or machinery).

Lithus should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, since the risk of Lithus toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, Lithus treatment may be undertaken with extreme caution, including daily serum Lithus determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity.

Unmasking of Brugada Syndrome

There have been postmarketing reports of a possible association between treatment with Lithus and the unmasking of Brugada Syndrome. Brugada Syndrome is a disorder characterized by abnormal electrocardiographic (ECG) findings and a risk of sudden death. Lithus should generally be avoided in patients with Brugada Syndrome or those suspected of having Brugada Syndrome. Consultation with a cardiologist is recommended if: (1) treatment with Lithus is under consideration for patients suspected of having Brugada Syndrome or patients who have risk factors for Brugada Syndrome, e.g., unexplained syncope, a family history of Brugada Syndrome, or a family history of sudden unexplained death before the age of 45 years, (2) patients who develop unexplained syncope or palpitations after starting Lithus therapy.

Renal Effects

Chronic Lithus therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting Lithus retention and toxicity. This condition is usually reversible when Lithus is discontinued.

Morphologic changes with glomerular and interstitial fibrosis and nephron atrophy have been reported in patients on chronic Lithus therapy. Morphologic changes have also been seen in manic-depressive patients never exposed to Lithus. The relationship between renal functional and morphologic changes and their association with Lithus therapy have not been established.

When kidney function is assessed, for baseline data prior to starting Lithus therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function and glomerular function (e.g., serum creatinine or creatinine clearance). During Lithus therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.

Encephalopathic Syndrome

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients treated with Lithus plus a neuroleptic. In some instances, the syndrome was followed by irreversible brain damage. Because of a possible causal relationship between these events and the concomitant administration of Lithus and neuroleptics, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS).

Concomitant Use With Neuromuscular Blocking Agents

Lithus may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving Lithus.

Usage in Pregnancy

Adverse effects on implantation in rats, embryo viability in mice and metabolism in vitro of rat testes and human spermatozoa have been attributed to Lithus, as have teratogenicity in submammalian species and cleft palates in mice.

In humans, Lithus carbonate may cause fetal harm when administered to a pregnant woman. Data from Lithus birth registries suggest an increase in cardiac and other anomalies, especially Ebstein's anomaly. If this drug is used in women of childbearing potential, or during pregnancy, or if a patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Usage in Nursing Mothers

Lithus is excreted in human milk. Nursing should not be undertaken during Lithus therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child.

Usage in Pediatric Patients

Since information regarding the safety and effectiveness of Lithus carbonate in children under 12 years of age is not available, its use in such patients is not recommended.

There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of Lithus carbonate.

Usage in the Elderly

Elderly patients often require lower Lithus dosages to achieve therapeutic serum levels. They may also exhibit adverse reactions at serum levels ordinarily tolerated by younger patients.

PRECAUTIONS

General

The ability to tolerate Lithus is greater during the acute manic phase and decreases when manic symptoms subside.

The distribution space of Lithus approximates that of total body water. Lithus is primarily excreted in urine with insignificant excretion in feces. Renal excretion of Lithus is proportional to its plasma concentration. The half-life of elimination of Lithus is approximately 24 hours. Lithus decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500 to 3000 mL) at least during the initial stabilization period. Decreased tolerance to Lithus has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered under careful medical supervision and Lithus intake reduced or suspended until the condition is resolved.

In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication.

Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to Lithus treatment; where hypothyroidism exists, careful monitoring of thyroid function during Lithus stabilization and maintenance allows for correction of changing thyroid parameters, if any; where hypothyroidism occurs during Lithus stabilization and maintenance, supplemental thyroid treatment may be used.

Information for the Patients

A condition known as Brugada Syndrome may pre-exist and be unmasked by Lithus therapy. Brugada Syndrome is a heart disorder characterized by abnormal electrocardiographic (ECG) findings and risk of sudden death. Patients should be advised to seek immediate emergency assistance if they experience fainting, lightheadedness, abnormal heart beats, or shortness of breath.

Drug Interactions

Caution should be used when Lithus and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of Lithus and increase serum Lithus levels with risk of Lithus toxicity. Patients receiving such combined therapy should have serum Lithus levels monitored and the Lithus dosage adjusted if necessary.

Lithus levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, Lithus toxicity has resulted from interactions between an NSAID and Lithus. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma Lithus concentrations. There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state Lithus plasma levels increased approximately 17% in subjects receiving Lithus 450 mg b.i.d. with celecoxib 200 mg b.i.d. as compared to subjects receiving Lithus alone.

Concurrent use of metronidazole with Lithus may provoke Lithus toxicity due to reduced renal clearance. Patients receiving such combined therapy should be monitored closely.

There is evidence that angiotensin-converting enzyme inhibitors, such as enalapril and captopril, and angiotension II receptor antagonists, such as losartan, may substantially increase steady-state plasma Lithus levels, sometimes resulting in Lithus toxicity. When such combinations are used, Lithus dosage may need to be decreased, and plasma Lithus levels should be measured more often.

Concurrent use of calcium channel blocking agents with Lithus may increase the risk of neurotoxicity in the form of ataxia, tremors, nausea, vomiting, diarrhea and/or tinnitus. Caution is recommended.

The concomitant administration of Lithus with selective serotonin reuptake inhibitors should be undertaken with caution as this combination has been reported to result in symptoms such as diarrhea, confusion, tremor, dizziness and agitation.

The following drugs can lower serum Lithus concentrations by increasing urinary Lithus excretion: acetazolamide, urea, xanthine preparations and alkalinizing agents such as sodium bicarbonate.

The following have also been shown to interact with Lithus: methyldopa, phenytoin and carbamazepine.

ADVERSE REACTIONS

The occurrence and severity of adverse reactions are generally directly related to serum Lithus concentrations as well as to individual patient sensitivity to Lithus, and generally occur more frequently and with greater severity at higher concentrations.

Adverse reactions may be encountered at serum Lithus levels below 1.5 mEq/L. Mild to moderate adverse reactions may occur at levels from 1.5 to 2.5 mEq/L, and moderate to severe reactions may be seen at levels of 2 mEq/L and above.

Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of Lithus administration.

These side effects usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, cessation of Lithus therapy may be required.

Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of Lithus intoxication, and can occur at Lithus levels below 2 mEq/L. At higher levels, ataxia, giddiness, tinnitus, blurred vision and a large output of dilute urine may be seen. Serum Lithus levels above 3 mEq/L may produce a complex clinical picture, involving multiple organs and organ systems. Serum Lithus levels should not be permitted to exceed 2 mEq/L during the acute treatment phase.

The following reactions have been reported and appear to be related to serum Lithus levels, including levels within the therapeutic range:

Neuromuscular/Central Nervous System: tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreo-athetotic 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, myasthenia gravis (rarely).

Cardiovascular: cardiac arrhythmia, hypotension, peripheral circulatory collapse, bradycardia, sinus node dysfunction with severe bradycardia (which may result in syncope), unmasking of Brugada Syndrome (See WARNINGS: Unmasking of Brugada Syndrome and PRECAUTIONS: Information for the Patients ).

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, anesthesia of skin, acne, chronic folliculitis, xerosis cutis, psoriasis or its exacerbation, generalized pruritus with or without rash, cutaneous ulcers, angioedema.

Autonomic: blurred vision, dry mouth, impotence/sexual dysfunction.

Thyroid Abnormalities: euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T₃ and T₄. I¹³¹ uptake may be elevated. Paradoxically, rare cases of hyperthyroidism have been reported.

EEG Changes: diffuse slowing, widening of the frequency spectrum, potentiation and disorganization of background rhythm.

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, 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, dental caries.

Some reports of nephrogenic diabetes insipidus, hyperparathyroidism and hypothyroidism which persist after Lithus discontinuation have been received.

A few reports have been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment with Lithus. The mechanism through which these symptoms (resembling Raynaud's syndrome) developed is not known. Recovery followed discontinuance.

Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with Lithus use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Lithus should be discontinued, if clinically possible, if this syndrome occurs.

OVERDOSAGE

The toxic levels for Lithus are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early toxic symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS.

Treatment

No specific antidote for Lithus poisoning is known. Early symptoms of Lithus toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of Lithus 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 function. Urea, mannitol and aminophylline all produce significant increases in Lithus 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.

DOSAGE AND ADMINISTRATION

Doses of extended-release tablets are usually given b.i.d.. When initiating therapy with immediate-release or extended-release Lithus, dosage must be individualized according to serum levels and clinical response.

When switching a patient from immediate-release capsules to the Lithus carbonate extended-release tablets USP, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily, e.g., Lithus carbonate extended-release tablets, 450 mg b.i.d. When the previous dosage of immediate-release Lithus is not a multiple of 450 mg, e.g., 1500 mg, initiate Lithus extended-release tablet at the multiple of 450 mg nearest to, but below, the original daily dose, i.e., 1350 mg. When the two doses are unequal, give the larger dose in the evening. In the above example, with a total daily dose of 1350 mg, generally 450 mg of Lithus carbonate extended-release tablets should be given in the morning and 900 mg of Lithus carbonate extended-release tablets in the evening. If desired, the total daily dose of 1350 mg can be given in three equal 450 mg doses of Lithus carbonate extended-release tablets. These patients should be monitored at 1- to 2-week intervals, and dosage adjusted if necessary, until stable and satisfactory serum levels and clinical state are achieved.

When patients require closer titration than that available with doses of Lithus carbonate extended-release tablets in increments of 450 mg, immediate-release capsules should be used.

Acute Mania

Optimal patient response to Lithus can usually be established and maintained with 1800 mg per day in divided doses. Such doses will normally produce the desired serum Lithus level ranging between 1 and 1.5 mEq/L.

Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient's clinical state and serum Lithus levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized.

Long-Term Control

The desirable serum Lithus levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 900 mg to 1200 mg per day in divided doses will maintain this level. Serum Lithus levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.

Patients unusually sensitive to Lithus may exhibit toxic signs at serum levels below 1 mEq/L.

N.B.

Blood samples for serum Lithus determinations should be drawn immediately prior to the next dose when Lithus concentrations are relatively stable (i.e., 8 to 12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis.

Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by younger patients.

HOW SUPPLIED

Lithus Carbonate Extended-release Tablets USP

450 mg tablets are supplied as speckled, off-white to yellow, round biconvex tablets with “54 346” debossed on one side and scored on the other side.

NDC 0054-0020-25: Bottle of 100 Tablets

Storage Conditions

Store at 20° to 25°C (68° to 77°F). Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10002294/05

Revised March 2016

fpl-bl-450mg-100tabs-04.jpg

Lithus pharmaceutical active ingredients containing related brand and generic drugs:

Lithium

Lithus available forms, composition, doses:

Tablets; Oral; Lithium 300 mg

Lithus destination | category:

Human:
Antidepressants
Antimanic agents

Lithus Anatomical Therapeutic Chemical codes:

N05AN - Lithium
N05AN01 - Lithium

Lithus pharmaceutical companies:

Taurus Laboratories

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lithus?

Depending on the reaction of the Lithus after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Lithus not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Lithus addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Lithus, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Lithus consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.