What is Litholite (DIG)?
Litholite (DIG) is used to treat mania that is part of bipolar disorder (manic-depressive illness). It is also used on a daily basis to reduce the frequency and severity of manic episodes. Manic-depressive patients experience severe mood changes, ranging from an excited or manic state (e.g., unusual anger or irritability or a false sense of well-being) to depression or sadness.
It is not known how Litholite (DIG) works to stabilize a person's mood. However, it does act on the central nervous system. It helps you to have more control over your emotions and helps you cope better with the problems of living.
It is important that you and your family understand all the effects of Litholite (DIG). These effects depend on your individual condition and response and the amount of Litholite (DIG) you use. You also must know when to contact your doctor if there are problems with using the medicine.
Litholite (DIG) is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Litholite (DIG) is used in certain patients with the following medical conditions:
- Cluster headaches.
- Mental depression.
- Neutropenia (a blood condition where there is a decreased number of a certain type of white blood cells).
Litholite (DIG) indications
Oral
Bipolar disorder, Mania, Recurrent unipolar depression
Adult: Dose depends on the preparation used. Doses should be adjusted to produce a serum-Litholite (DIG) concentration of 0.4-1 mmol/l. Camcolit® tablets: Treatment: Initiate at 1-1.5 g daily; Prevention: Initiate at 300-400 mg daily. Priadel® tablets: Treatment and prevention: Initially, 400-1,200 mg daily in 1-2 divided doses. Priadel® syrup: Treatment and prevention: Initially, 1.04-3.12 g daily in 2 divided doses. Liskonum® tablets: Treatment: Initially, 450-675 mg bid; Prevention: Initially, 450 mg bid. Doses should be divided throughout the day during the initial period; once-daily dosing may be used when serum-Litholite (DIG) concentrations have stabilised. Adjust initial dose 4-7 days after starting based on results of serum-Litholite (DIG) concentrations. Monitor serum-Litholite (DIG) concentrations once wkly until dosage has remained constant for 4 wk, after which monitoring may be reduced to once every 3 mth.
Child: ≥12 yr: Acute phase: Serum concentrations of 1-1.2 mEq/l. Max dose: 1.5 mEq/l. Initially, 1.8 g Litholite (DIG) carbonate daily as conventional capsules/tablets in 3-4 divided doses, or 30 ml (approx 48 mEq) Litholite (DIG) citrate oral solution daily in 3-4 divided doses. Alternatively, initially 1.8 g Litholite (DIG) carbonate daily as extended-release tablets in 2-3 divided doses.
Maintenance: Not established.
Elderly: ≤900 mg Litholite (DIG) carbonate daily. Titrate dose slowly to achieve therapeutic serum concentrations.
Maintenance: Maintain serum concentrations at the lower end of 0.6-1.2 mEq/l.
How should I use Litholite (DIG)?
Use Litholite (DIG) controlled-release and extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Litholite (DIG) controlled-release and extended-release tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Swallow Litholite (DIG) controlled-release and extended-release tablets whole. Do not break, crush, or chew before swallowing.
- Drinking extra fluids while you are taking Litholite (DIG) controlled-release and extended-release tablets is recommended. Check with your doctor for instructions.
- Do not change your diet, including the amount of salt in your diet, unless instructed by your doctor.
- If you miss a dose of Litholite (DIG) controlled-release and extended-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Litholite (DIG) controlled-release and extended-release tablets.
Uses of Litholite (DIG) in details
Use: Labeled Indications
Bipolar disorder:
Immediate release: Treatment of manic and mixed episodes and maintenance treatment in patients ≥7 years of age with a diagnosis of bipolar disorder.
Extended release: Treatment of manic episodes and maintenance treatment in patients ≥12 years of age with a diagnosis of bipolar disorder.
Off Label Uses
Bipolar disorder, hypomania
Data from a limited number of patients studied suggest that Litholite (DIG) may be beneficial in the treatment of hypomania.
Litholite (DIG) description
Litholite (DIG) was used during the 19th century to treat gout. Litholite (DIG) salts such as Litholite (DIG) carbonate (Li2CO3), Litholite (DIG) citrate, and Litholite (DIG) orotate are mood stabilizers. They are used in the treatment of bipolar disorder, since unlike most other mood altering drugs, they counteract both mania and depression. Litholite (DIG) can also be used to augment other antidepressant drugs. It is also sometimes prescribed as a preventive treatment for migraine disease and cluster headaches. The active principle in these salts is the Litholite (DIG) ion Li+, which having a smaller diameter, can easily displace K+ and Na+ and even Ca+2, in spite of its greater charge, occupying their sites in several critical neuronal enzymes and neurotransmitter receptors.
Litholite (DIG) dosage
Immediate-release capsules are usually given t.i.d. or q.i.d. Doses of controlled-release tablets are usually given b.i.d. (approximately 12-hour intervals). When initiating therapy with immediate-release or controlled-release Litholite (DIG), dosage must be individualized according to serum levels and clinical response.
When switching a patient from immediate-release capsules to Litholite (DIG) (Litholite (DIG) carbonate) CR Controlled-Release Tablets, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily, e.g., Litholite (DIG) (Litholite (DIG) carbonate) CR 450 mg b.i.d. When the previous dosage of immediate-release Litholite (DIG) is not a multiple of 450 mg, e.g., 1,500 mg, initiate Litholite (DIG) (Litholite (DIG) carbonate) CR at the multiple of 450 mg nearest to, but below, the original daily dose, i.e., 1,350 mg. When the 2 doses are unequal, give the larger dose in the evening. In the above example, with a total daily dose of 1,350 mg, generally 450 mg of Litholite (DIG) (Litholite (DIG) carbonate) CR should be given in the morning and 900 mg of Litholite (DIG) (Litholite (DIG) carbonate) CR in the evening. If desired, the total daily dose of 1,350 mg can be given in 3 equal 450-mg doses of Litholite (DIG) (Litholite (DIG) carbonate) CR. 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 Litholite (DIG) (Litholite (DIG) carbonate) CR in increments of 450 mg, immediate-release capsules should be used.
Acute Mania: Optimal patient response to Litholite (DIG) (Litholite (DIG) carbonate) can usually be established and maintained with 1,800 mg per day in divided doses. Such doses will normally produce the desired serum Litholite (DIG) level ranging between 1.0 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 Litholite (DIG) 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 Litholite (DIG) levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 900 mg to 1,200 mg per day in divided doses will maintain this level. Serum Litholite (DIG) levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.
Patients unusually sensitive to Litholite (DIG) may exhibit toxic signs at serum levels below 1.0 mEq/L.
N.B.: Blood samples for serum Litholite (DIG) determinations should be drawn immediately prior to the next dose when Litholite (DIG) 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
Litholite (DIG) (Litholite (DIG) carbonate) Capsules 300 mg are gray and yellow capsules imprinted with "Litholite (DIG) (Litholite (DIG) carbonate) " and "SB" on one side of each half of the capsule, in bottles of 100 (NDC 0007-4007-20).
Litholite (DIG) (Litholite (DIG) carbonate) CR Tablets 450 mg are round, yellow, biconvex, controlled-release tablets, debossed with "SKF" and "J10" on one side and scored on the other side, in bottles of 100 (NDC 0007-4010-20).
STORAGE CONDITIONS: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Manufactured by: Cardinal Health., Winchester, KY 40391 for GlaxoSmithKline., Research Triangle Park, NC 27709. September 2003
FDA rev date: 03/11/2004
Litholite (DIG) interactions
See also:
What other drugs will affect Litholite (DIG)?
Caution should be used when Litholite (DIG) and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of Litholite (DIG) and increase serum Litholite (DIG) levels with risk of Litholite (DIG) toxicity. Patients receiving such combined therapy should have serum Litholite (DIG) levels monitored closely and the Litholite (DIG) dosage adjusted if necessary.
Litholite (DIG) levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, Litholite (DIG) toxicity has resulted from interactions between an NSAID and Litholite (DIG). Indomethacin and piroxicam have been reported to increase significantly steady-state plasma Litholite (DIG) 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 Litholite (DIG) plasma levels increased approximately 17% in subjects receiving Litholite (DIG) 450 mg b.i.d. with celecoxib 200 mg b.i.d. as compared to subjects receiving Litholite (DIG) alone.
Concurrent use of metronidazole with Litholite (DIG) may provoke Litholite (DIG) 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 Litholite (DIG) levels, sometimes resulting in Litholite (DIG) toxicity. When such combinations are used, Litholite (DIG) dosage may need to be decreased, and plasma Litholite (DIG) levels should be measured more often.
Concurrent use of calcium channel blocking agents with Litholite (DIG) 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 Litholite (DIG) 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 Litholite (DIG) concentrations by increasing urinary Litholite (DIG) excretion: acetazolamide, urea, xanthine preparations, and alkalinizing agents such as sodium bicarbonate.
The following have also been shown to interact with Litholite (DIG): methyldopa, phenytoin, and carbamazepine.
Litholite (DIG) side effects
See also:
What are the possible side effects of Litholite (DIG)?
Litholite (DIG) Toxicity
The likelihood of toxicity increases with increasing serum Litholite (DIG) levels. Serum Litholite (DIG) levels greater than 1.5 mEq/L carry a greater risk than lower levels. However, patients sensitive to Litholite (DIG) may exhibit toxic signs at serum levels below 1.5 mEq/L.
Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of Litholite (DIG) toxicity, and can occur at Litholite (DIG) levels below 2.0 mEq/L. At higher levels, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum Litholite (DIG) levels above 3.0 mEq/L may produce a complex clinical picture involving multiple organs and organ systems. Serum Litholite (DIG) levels should not be permitted to exceed 2.0 mEq/L during the acute treatment phase.
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 Litholite (DIG) administration.
These side effects are an inconvenience rather than a disabling condition, and usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, a cessation of dosage is indicated.
The following adverse reactions have been reported and do not appear to be directly related to serum Litholite (DIG) levels.
Neuromuscular: Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), ataxia, choreoathetotic movements, hyperactive deep tendon reflexes.
Central Nervous System: Blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, acute dystonia, downbeat nystagmus.
Cardiovascular: Cardiac arrhythmia, hypotension, peripheral circulatory collapse, sinus node dysfunction with severe bradycardia (which may result in syncope).
Neurological: Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with Litholite (DIG) use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Litholite (DIG) should be discontinued, if clinically possible, if this syndrome occurs.
Gastrointestinal: Anorexia, nausea, vomiting, diarrhea.
Genitourinary: Albuminuria, oliguria, polyuria, glycosuria.
Dermatologic: Drying and thinning of hair, anesthesia of skin, chronic folliculitis, xerosis cutis, alopecia and exacerbation of psoriasis.
Autonomic Nervous System: Blurred vision, dry mouth.
Thyroid Abnormalities: Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. Iodine 131 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.
EKG Changes: Reversible flattening, isoelectricity or inversion of T-waves.
Miscellaneous: Fatigue, lethargy, transient scotomata, dehydration, weight loss, tendency to sleep.
Miscellaneous reactions unrelated to dosage are: Transient electroencephalographic and electrocardiographic changes, leukocytosis, headache, diffuse nontoxic goiter with or without hypothyroidism, transient hyperglycemia, generalized pruritis with or without rash, cutaneous ulcers, albuminuria, worsening of or-ganic brain syndromes, excessive weight gain, edematous swelling of ankles or wrists, and thirst or polyuria, sometimes resembling diabetes insipidus, and metallic taste.
A single report has 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 of Litholite (DIG). The mechanism through which these symptoms (resembling Raynaud's Syndrome) developed is not known. Recovery followed discontinuance.
Litholite (DIG) contraindications
See also:
What is the most important information I should know about Litholite (DIG)?
Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.
Call your doctor at once if you have any early signs of Litholite (DIG) toxicity, such as nausea, vomiting, diarrhea, drowsiness, muscle weakness, tremor, lack of coordination, blurred vision, or ringing in your ears.
Do not crush, chew, or break an extended-release tablet. Swallow the pill whole.
Drink extra fluids to keep from getting dehydrated while you are taking Litholite (DIG). Tell your doctor if you have been sweating excessively, or if you are sick with fever, vomiting, or diarrhea.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.
Litholite (DIG) can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Active ingredient matches for Litholite (DIG):
| Unit description / dosage (Manufacturer) | Price, USD |
| LITHOLITE 300MG TABLET 1 strip / 10 tablets each (Digmedi Pvt Ltd) | $ 0.14 |
List of Litholite (DIG) substitutes (brand and generic names): | |
| LITHOLENT | |
| Litholent 400mg Tablet SR (Talent India ) | $ 0.05 |
| LITHON | |
| LITHON 300MG TABLET 1 strip / 10 tablets each (RKG Pharma) | $ 0.12 |
| LITHON SR 450MG TABLET 1 strip / 10 tablets each (RKG Pharma) | $ 0.28 |
| Lithon 450mg Tablet SR (RKG Pharma) | $ 0.03 |
| Lithonate | |
| LITHONEX | |
| LITHONEX 300MG TABLET 1 strip / 10 tablets each (Theo Pharma Pvt Ltd) | $ 0.17 |
| LITHONEX SR TABLET 1 strip / 10 tablets each (Theo Pharma Pvt Ltd) | $ 0.23 |
| LITHONEX XL 450MG TABLET 1 strip / 10 tablets each (Theo Pharma Pvt Ltd) | $ 0.43 |
| Lithonex 400mg Tablet SR (Theo Pharma Pvt Ltd) | $ 0.02 |
| Lithonex 450mg Tablet XL (Theo Pharma Pvt Ltd) | $ 0.04 |
| LITHORIL (India) | |
| 300 mg x 10's (Reliance) | $ 0.11 |
| 400 mg x 10's (Reliance) | $ 0.17 |
| Lithoril 300mg TAB / 10 (Reliance) | $ 0.11 |
| Lithoril 400mg SR-TAB / 10 (Reliance) | $ 0.17 |
| LITHORIL 300 MG TABLET 1 strip / 10 tablets each (Reliance) | $ 0.17 |
| LITHORIL 400 MG TABLET SR 1 strip / 10 tablet srs each (Reliance) | $ 0.31 |
| LITHORIL tab 300 mg x 10's (Reliance) | $ 0.11 |
| LITHORIL SR tab 400 mg x 10's (Reliance) | $ 0.17 |
| Lithoril 300mg TAB / 10 (Reliance) | $ 0.11 |
| Lithoril 400mg SR-TAB / 10 (Reliance) | $ 0.17 |
| Lithoril 300mg Tablet (Reliance) | $ 0.02 |
| Lithoril 400mg Tablet SR (Reliance) | $ 0.03 |
| LITHOSAN 400MG TABLET SR | |
| LITHOSAN 400MG TABLET SR 1 strip / 10 tablets each (Sun Pharmaceutical Industries Ltd) | $ 0.41 |
| Lithosun (India) | |
| Lithosun 250mg TAB / 10 (Sun) | $ 0.11 |
| Lithosun 300mg TAB / 10 (Sun) | $ 0.28 |
| Lithosun 400mg SR-TAB / 10 (Sun) | $ 0.35 |
| 250 mg x 10's (Sun) | $ 0.11 |
| 300 mg x 10's (Sun) | $ 0.28 |
| 400 mg x 10's (Sun) | $ 0.35 |
| Tablets; Oral; Lithium Carbonate 250 mg (Sun) | |
| Tablets; Oral; Lithium Carbonate 300 mg (Sun) | |
| Tablets, Sustained Release; Oral; Lithium Carbonate 400 mg (Sun) | |
| LITHOSUN 250 MG TABLET 1 strip / 10 tablets each (Sun) | $ 1.74 |
| LITHOSUN 300 MG TABLET 1 strip / 10 tablets each (Sun) | $ 0.17 |
| LITHOSUN 400 MG TABLET SR 1 strip / 10 tablet srs each (Sun) | $ 0.49 |
| LITHOSUN tab 250 mg x 10's (Sun) | $ 0.11 |
| LITHOSUN tab 300 mg x 10's (Sun) | $ 0.34 |
| LITHOSUN SR tab 400 mg x 10's (Sun) | $ 0.41 |
| Lithosun 250mg Tablet (Sun) | $ 0.17 |
| Lithosun 300mg Tablet (Sun) | $ 0.02 |
| Lithosun-SR (Bangladesh) | |
| LithoTab | |
| Lithotabs | |
| Tablet; Oral; Lithium Carbonate 300 mg (Solvay) | |
See 479 substitutes for Litholite (DIG) | |
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
