Lithane

Name: Lithane

Lithane® (lithium carbonate) TABLETS For Control of Manic Episodes in Manic-Depressive Psychosis

Warning

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

Lithane Dosage and Administration

Acute Mania

Optimal patient response to lithium carbonate usually can be established and maintained with 600 mg t.i.d. Such doses will normally produce an effective serum lithium 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 of serum lithium 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 lithium levels are 0.6 to 1.2 mEq./l. Dosage will vary from one individual to another, but usually 300 mg t.i.d. or q.i.d will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.

Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1.0 to 1.5 mEq./l. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients.

N.B.

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

Important information

Do not use lithium 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 lithium 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 this medication. 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.

Lithium 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.

What happens if I overdose?

Stop taking lithium and seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking lithium?

Lithium 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.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. 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.

Do not change the amount of salt you consume in your diet. Changing your salt intake could change the amount of lithium in your blood.

Lithium side effects

Get emergency medical help if you have signs of an allergic reaction to lithium: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • shortness of breath;

  • pounding heartbeats or fluttering in your chest;

  • increased urination;

  • weakness, dizziness or spinning sensation;

  • confusion, memory problems, hallucinations;

  • fever;

  • muscle stiffness, slurred speech;

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

  • loss of bowel or bladder control;

  • a seizure (blackout or convulsions);

  • early signs of lithium toxicity - vomiting, diarrhea, tremors, loss of balance or coordination, drowsiness or muscle weakness;

  • dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or

  • increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common lithium side effects may include:

  • drowsiness;

  • tremors in your hands;

  • dry mouth, increased thirst or urination;

  • nausea, vomiting, loss of appetite, stomach pain;

  • changes in your skin or hair;

  • cold feeling or discoloration in your fingers or toes;

  • feeling uneasy; or

  • impotence, loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect lithium?

Many drugs can interact with lithium. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • carbamazepine;

  • a diuretic or "water pill";

  • fluoxetine (Prozac);

  • metronidazole;

  • potassium iodide thyroid medication;

  • heart or blood pressure medication - benazepril, candesartan, captopril, diltiazem, enalapril, lisinopril, losartan, olmesartan, telmisartan, valsartan, verapamil, and others; or

  • NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs can interact with lithium. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Fine hand tremor, frequent urination and mild thirst commonly occur during lithium initiation. Sometimes these effects may persist throughout treatment.
  • Nausea during initiation is common but usually subsides with continued administration.
  • Diarrhea, vomiting, drowsiness, muscular weakness, loss of appetite and coordination difficulties may be an early sign of lithium toxicity. Dizziness, blurred vision, ringing in the ears and excessive production of dilute urine may occur with higher (toxic) lithium levels. Seek urgent medical advice.
  • Lithium may also cause irregular heartbeat, drying and thinning of hair, alopecia, dry mouth, weight gain, itchiness, and other side effects. Long-term use may lead to hypothyroidism or other thyroid problems.
  • Monitoring is required, particularly during therapy initiation but also long-term.
  • Not suitable for people with significant renal or cardiovascular disease, in those who are frail, dehydrated, taking diuretics or with low levels of sodium. Not recommended for children aged less than 12.
  • Full effects of lithium in pregnancy have not been fully determined so advice is to avoid lithium particularly in the first trimester.
  • May interact with several other medications including diuretics (water pills), NSAIDs and ACE inhibitors.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

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