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EFADERMIN (LITHIUM) INDICATIONS

Efadermin carbonate is indicated for 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. Efadermin is an element of the alkali-metal group. Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines.

EFADERMIN (LITHIUM) INSTRUCTIONS

Use Efadermin Carbonate as directed by your doctor.

  • Take Efadermin Carbonate by mouth after meals or with food or milk to decrease stomach upset.
  • Drinking extra fluids while you are taking Efadermin Carbonate 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 Efadermin Carbonate, 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 Efadermin Carbonate.

EFADERMIN (LITHIUM) STORAGE

Store Efadermin Carbonate at 77 degrees F (25 degrees C) in a tightly closed container. Store away from heat, light, and moisture. Keep Efadermin Carbonate out of the reach of children and away from pets.

Do NOT use Efadermin Carbonate if:

  • you are allergic to any ingredient in Efadermin Carbonate
  • you have moderate to severe kidney, heart, or blood vessel problems
  • you have low blood sodium levels
  • you are severely dehydrated, ill, or weakened
  • you are taking an angiotensin-converting enzyme (ACE) inhibitor (eg, enalapril) or a diuretic (eg, furosemide, hydrochlorothiazide).

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Efadermin Carbonate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have diarrhea, vomiting, excessive sweating, dehydration, fever, infection, or illness, or you are in a weakened state
  • if you have kidney, heart, blood vessel, or thyroid problems
  • if you have brain or nerve problems (eg, organic brain syndrome)
  • if you are on a low-salt diet.

Some medicines may interact with Efadermin Carbonate. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Acetazolamide, urea, urinary alkalinizers (eg, sodium bicarbonate), or xanthines (eg, theophylline) because they may decrease Efadermin Carbonate's effectiveness
  • ACE inhibitors (eg, enalapril), angiotensin II receptor antagonists (eg, losartan), calcium channel blockers (eg, verapamil), carbamazepine, diuretics (eg, furosemide, hydrochlorothiazide), hydantoins (eg, phenytoin), methyldopa, metronidazole, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin, celecoxib), or selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine) because the risk of toxicity of Efadermin Carbonate may be increased
  • Butyrophenones (eg, haloperidol) or other medicines for mental or mood problems because the risk of serious side effects, such as confusion, involuntary muscle movements, fever, and brain damage, may be increased
  • Iodide preparations (eg, potassium iodide) because the risk of low thyroid levels may be increased
  • Nondepolarizing neuromuscular blockers (eg, vecuronium) or succinylcholine because the risk of their side effects may be increased by Efadermin Carbonate.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Efadermin Carbonate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • Efadermin Carbonate may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Efadermin Carbonate with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • It may take 1 to 3 weeks for Efadermin Carbonate to work. Do not stop using Efadermin Carbonate without checking with your doctor.
  • Tell your doctor or dentist that you take Efadermin Carbonate before you receive any medical or dental care, emergency care, or surgery.
  • Fever, infection, vomiting, diarrhea, or excessive sweating may affect the levels of Efadermin Carbonate in your blood. If you experience any of these conditions, contact your doctor. Talk to your doctor about how to replace the salt lost through sweating during exercise.
  • Do not change the amount of salt in your diet unless instructed by your doctor. Check with your doctor before restricting your salt intake. Tell your doctor if you are on a low-salt diet.
  • Lab tests, including blood lithium levels and kidney function tests, may be performed while you use Efadermin Carbonate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Efadermin Carbonate with caution in the elderly; they may be more sensitive to its effects.
  • Efadermin Carbonate should not be used in children younger 12 years; safety and effectiveness in these children have not been confirmed.
  • Pregnancy and breast-feeding: Efadermin Carbonate may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Efadermin Carbonate while you are pregnant. Efadermin Carbonate is found in breast milk. Do not breastfeed while taking Efadermin Carbonate.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Mild hand tremor; mild thirst; temporary, mild nausea and general discomfort at the beginning of treatment.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; diarrhea; drowsiness; excessive weight gain; fainting; giddiness; inability to control the bladder or bowels; increased thirst; increased or decreased urination; involuntary twitching or muscle movements; loss of consciousness; loss of coordination; muscle weakness; persistent headache; persistent or severe nausea; ringing in the ears; seizures; slow or irregular heartbeat; slurred speech; swelling of the ankles or wrists; unsteadiness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.



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