Lithium Oral Solution

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (see DOSAGE AND ADMINISTRATION).

Unmasking of Brugada Syndrome

There have been postmarketing reports of a possible association between treatment with lithium and the unmasking of Brugada Syndrome. Brugada Syndrome is a disorder characterized by abnormal electrocardiographic (ECG) findings and a risk of sudden death. Lithium 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 lithium 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 lithium therapy.

Pregnancy

Lithium 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. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein's anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother.

Lithium-Induced Renal Effects

Chronic lithium 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 lithium retention and toxicity. This condition is usually reversible when lithium is discontinued.

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

When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.

The toxic levels for lithium are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early 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 lithium 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.

Lithium Oral Solution USP, 8 mEq per 5 mL.

NDC 68094-757-62
5 mL per unit dose cup
Thirty (30) cups per shipper

Store and Dispense

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP/NF.

Manufactured By:
Roxane Laboratories, Inc.
Columbus, OH 43216

Packaged By:
Precision Dose, Inc.
South Beloit, IL 61080

LI849 Rev. 06/13

NDC 68094-757-59
PrecisionDose™

LITHIUM
Oral Solution USP
8 mEq per 5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• blurred vision
• breathing problems
• clumsiness or loss of balance
• confusion
• difficulty speaking or swallowing
• dizziness
• feeling faint or lightheaded, falls
• increased thirst
• increased urination
• loss of appetite
• muscle weakness
• nausea, vomiting
• pain, coldness, or blue coloration of fingers or toes
• sensitivity to cold
• seizures
• slow, fast, or irregular heartbeat (palpitations)
• slurred speech
• swelling in the neck
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• acne
• diarrhea
• mild tremor
• stomach pain
• weight gain

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or container to measure your medicine. Ask your pharmacist if you do not have one. Household spoons are not accurate. Mix the syrup with fruit juice or other flavored drink before taking to improve the taste. Take after a meal or snack to avoid stomach upset. Take your doses at regular intervals. Do not take your medicine more often than directed. The amount of this medicine you take is very important. Taking more than the prescribed dose can cause serious side effects. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

They need to know if you have any of these conditions:

• Brugada Syndrome
• dehydration (diarrhea or sweating)
• heart or blood vessel disease
• kidney disease
• low level of salt in the blood, or on a low salt diet
• an unusual or allergic reaction to lithium, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Visit your doctor or health care professional for regular checks on your progress. It can take several weeks of treatment before you start to get better.

The amount of salt (sodium) in your body influences the effects of this medicine, and this medicine can increase salt loss from the body. Eat a normal diet that includes salt. Do not change to salt substitutes. Avoid changes involving diet, or medications that include large amounts of sodium like sodium bicarbonate. Ask your doctor or health care professional for advice if you are not sure.

Drink plenty of fluids while you are taking this medicine. Avoid drinks that contain caffeine, such as coffee, tea and colas. You will need extra fluids if you have diarrhea or sweat a lot. This will help prevent toxic effects from this medicine. Be careful not to get overheated during exercise, saunas, hot baths, and hot weather. Consult your doctor or health care professional if you have a high fever or persistent diarrhea.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.