Lithobid

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• diarrhea
• vomiting
• drowsiness
• muscle weakness
• loss of coordination
• giddiness
• blurred vision
• ringing in the ears
• frequent urination

Lithium is used for the treatment of manic/depressive (bipolar) and depressive disorders. Lithium is a positively charged element or particle that is similar to sodium and potassium. It interferes at several places inside cells and on the cell surface with other positively charged atoms such as sodium, potassium, calcium, and magnesium which are important in many cellular functions.

Lithium interferes with the production and uptake of chemical messengers by which nerves communicate with each other (neurotransmitters). Lithium also affects the concentrations of tryptophan and serotonin in the brain. In addition, lithium increases the production of white blood cells in the bone marrow. Lithium's effects usually begin within 1 week of starting treatment, and the full effect is seen by 2 to 3 weeks.

Lithium has been used since the 1950's. The FDA approved lithium carbonate, the most common lithium preparation in 1970.

The toxic concentrations for lithium ( ≥ 1.5 mEq/L) are close to the therapeutic concentrations (0.6-1.2 mEq/L). 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 lithium poisoning is known. Treatment is supportive. Early symptoms of lithium 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 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. However, patient recovery may be slow.

Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Lithobid, there are no specific foods that you must exclude from your diet when receiving this medication.

However, it is important to follow a proper diet while taking Lithobid. This includes adequate amounts of salt and liquids in your diet. Ask your doctor about the diet that is right for you. Also talk to your doctor about drinking drinks that contain caffeine while taking Lithobid.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended dose of Lithobid for acute episodes of mania is 900 mg 2 times a day.

The recommended dose of Lithobid for long-term control and prevention of episodes of mania is 600 mg 2 or 3 times a day.

Doses of Lithobid should be individualized on the basis of response to therapy and levels of lithium in your blood.

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

Adverse reactions may be encountered at serum lithium concentrations below 1.5 mEq/L. Mild to moderate adverse reactions may occur at concentrations from 1.5-2.5 mEq/L, and moderate to severe reactions may be seen at concentrations from 2.0 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 lithium administration.

These side effects usually subside with continued treatment or with a temporary reduction or cessation of dosage. If persistent, a cessation of lithium therapy may be required. Diarrhea, vomiting, drowsiness, muscular weakness, and lack of coordination may be early signs of lithium intoxication, and can occur at lithium concentrations below 2.0 mEq/L. At higher concentrations, giddiness, ataxia, blurred vision, tinnitus, and a large output of dilute urine may be seen. Serum lithium concentrations above 3.0 mEq/L may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium concentrations should not be permitted to exceed 2.0 mEq/L during the acute treatment phase.

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

Central Nervous System: tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreoathetotic 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. Cases of Pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields, and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically possible, if this syndrome occurs. 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 and PATIENT INFORMATION). 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 Nervous System: blurred vision, dry mouth, impotence/ sexual dysfunction. Thyroid Abnormalities : euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. Iodine uptake may be elevated (see PRECAUTIONS). 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, exophthalmos, dehydration, weight loss, leucocytosis, headache, transient-hyperglycemia, hypercalcemia, hyperparathyroidism, albuminuria, 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, and dental caries.

Some reports of nephrogenic diabetes insipidus, hyperparathyroidism, and hypothyroidism which persist after lithium 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 starting lithium treatment. The mechanism through which these symptoms (resembling Raynaud's Syndrome) developed is not known. Recovery followed discontinuance.

Read the entire FDA prescribing information for Lithobid (Lithium Carbonate Tablets)

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Confusion, poor memory, or lack of awareness
• fainting
• fast or slow heartbeat
• frequent urination
• increased thirst
• irregular pulse
• stiffness of the arms or legs
• troubled breathing (especially during hard work or exercise)
• unusual tiredness or weakness
• weight gain

• Blue color and pain in the fingers and toes
• coldness of the arms and legs
• dizziness
• eye pain
• headache
• noise in the ears
• vision problems

• Dry, rough skin
• fast, irregular, pounding, or racing heartbeat or pulse
• hair loss
• hoarseness
• lightheadedness
• mental depression
• sensitivity to cold
• shortness of breath
• swelling of the feet or lower legs
• swelling of the neck
• unusual excitement

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• clumsiness or unsteadiness
• convulsions (seizures)
• diarrhea
• drowsiness
• increase in the amount of urine
• lack of coordination
• loss of appetite
• muscle weakness
• nausea or vomiting
• ringing in the ears
• slurred speech
• trembling (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne or skin rash
• bloated feeling or pressure in the stomach
• muscle twitching (slight)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Lithobid affects you.
• If you start on a low-salt diet, tell your doctor. It will change the way your body handles the lithium.
• Talk with your doctor before you drink alcohol.
• Fever, infection, throwing up, loose stools (diarrhea), or sweating a lot may change how much of this medicine is in your blood. If any of these happen, talk with the doctor.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• A certain heart problem (Brugada Syndrome) has shown up in some people taking Lithobid. These people had this problem but did not know it at the time. People with Brugada Syndrome have a heartbeat that is not normal and are at risk for sudden death. Talk with the doctor.
• Brain problems have rarely happened in people taking this medicine with certain other drugs like haloperidol. Sometimes, these brain problems have led to long-lasting brain damage. Talk with the doctor.
• If you are 65 or older, use Lithobid with care. You could have more side effects.
• This medicine is not approved for use in children younger than 12 years old. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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

Applies to lithium: oral capsule, oral solution, oral syrup, oral tablet, oral tablet extended release

Along with its needed effects, lithium (the active ingredient contained in Lithobid) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lithium:

• Confusion, poor memory, or lack of awareness
• fainting
• fast or slow heartbeat
• frequent urination
• increased thirst
• irregular pulse
• stiffness of the arms or legs
• troubled breathing (especially during hard work or exercise)
• unusual tiredness or weakness
• weight gain

• Blue color and pain in the fingers and toes
• coldness of the arms and legs
• dizziness
• eye pain
• headache
• noise in the ears
• vision problems

• Dry, rough skin
• fast, irregular, pounding, or racing heartbeat or pulse
• hair loss
• hoarseness
• lightheadedness
• mental depression
• sensitivity to cold
• shortness of breath
• swelling of the feet or lower legs
• swelling of the neck
• unusual excitement

Get emergency help immediately if any of the following symptoms of overdose occur while taking lithium:

• Blurred vision
• clumsiness or unsteadiness
• convulsions (seizures)
• diarrhea
• drowsiness
• increase in the amount of urine
• lack of coordination
• loss of appetite
• muscle weakness
• nausea or vomiting
• ringing in the ears
• slurred speech
• trembling (severe)

Some side effects of lithium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne or skin rash
• bloated feeling or pressure in the stomach
• muscle twitching (slight)

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Taking Lithobid can make it easier for you to become dehydrated, especially if you have any vomiting or diarrhea, if you are outdoors in the sun, or if you exercise vigorously or sweat more than usual. Dehydration can increase some of the side effects of this medicine.

Call your doctor if you have are sick with a fever and vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Lithobid, which may affect your dose needs. Do not change your dose or medication schedule without your doctor's advice.

Drink extra fluids each day to prevent dehydration.

It may take up to 3 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not begin to improve after 1 week of treatment.

If you need surgery, tell the surgeon ahead of time that you are using Lithobid.

While using Lithobid, you may need frequent blood tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.