Methadose Concentrate

Pronunciation: METH-a-done
Generic Name: Methadone
Brand Name: Methadose

Methadose Concentrate may cause severe and sometimes fatal heart and breathing problems. These problems may occur some time after you take a dose. Tell your doctor right away if you develop any new or worsening symptoms such as slowed or shallow breathing or irregular heartbeat. Your doctor will perform heart and lung function tests to check for side effects while you take Methadose Concentrate. Keep all doctor and laboratory appointments. Talk with your doctor and be sure you understand the risks and benefits of using Methadose Concentrate.

Do not take more than the recommended dose or take Methadose Concentrate more often than prescribed. This can lead to overdose and possible death.

Methadose Concentrate is used for:

Treating a narcotic addiction as part of a treatment program. It may also be used for other conditions as determined by your doctor.

Methadose Concentrate is a narcotic analgesic. It works by acting on opiate pain receptors in the brain and on smooth muscle to provide pain relief.

Do NOT use Methadose Concentrate if:

• you are allergic to any ingredient in Methadose Concentrate


• you have slowed breathing or severe asthma, or if you are having an asthma attack


• you have a stomach or bowel blockage or certain severe bowel problems (eg, paralytic ileus)


• you have diarrhea caused by food poisoning or antibiotic use


• you are taking sodium oxybate (GHB)


• if you have taken a monamine oxidase inhibitor type B (MAOI-B) (eg, rasagiline, selegiline) within the last 14 days

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

Before using Methadose Concentrate:

Some medical conditions may interact with Methadose Concentrate. 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 lung or breathing problems (eg, asthma), chronic obstructive pulmonary disease (COPD), sleep apnea, stomach or bowel problems (eg, bowel inflammation), stomach pain or constipation, liver or kidney problems, thyroid problems, or Addison disease


• if you have an abnormal curvature of the spine; narrowing of the urethra, trouble urinating, or an enlarged prostate; low blood volume, blood pressure, or blood oxygen levels; low potassium or magnesium blood levels; increased pressure, tumors, or lesions in your head; a recent head injury; or seizures


• if you have a history of heart problems (eg, enlarged heart) or irregular heartbeat


• if you or a family member have a history of mental or mood problems (eg, anxiety, depression), suicidal thoughts or attempts, or alcohol or substance abuse


• if you are elderly, very ill, or very overweight, or if you have recently had stomach or intestine surgery

Some MEDICINES MAY INTERACT with Methadose Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, midazolam), cimetidine, MAOI-B (eg, rasagiline, selegiline), other narcotic analgesics (eg, morphine), phenothiazines (eg, promethazine), or sodium oxybate (GHB) because side effects such as sedation and slowed breathing may occur


• Antiarrhythmics (eg, amiodarone, dofetilide, flecainide, propafenone), antipsychotics (eg, haloperidol, paliperidone, ziprasidone), calcium channel blockers (eg, nifedipine), certain antiemetics (eg, dolasetron, droperidol), chloroquine, cisapride, diuretics (eg, furosemide), H₁ antagonists (eg, astemizole), kinase inhibitors (eg, lapatinib, nilotinib), lithium, macrolide antibiotics (eg, clarithromycin), phenothiazines (eg, chlorpromazine), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin), tacrolimus, or tricyclic antidepressants (eg, desipramine) because the risk of QT prolongation may be increased


• Azole antifungals (eg, fluconazole, ketoconazole, voriconazole) or certain selective serotonin reuptake inhibitors (SSRIs) (eg, fluvoxamine, sertraline) because they may increase the risk of Methadose Concentrate's side effects


• Abacavir, carbamazepine, efavirenz, HIV protease inhibitors (eg, amprenavir, lopinavir, nelfinavir, ritonavir), narcotic agonists/antagonists (eg, butorphanol, nalbuphine, pentazocine), narcotic antagonists (eg, naloxone, naltrexone), nevirapine, phenobarbital, phenytoin, rifampin, or St. John's wort because they may decrease Methadose Concentrate's effectiveness


• Zidovudine because the risk of its side effects may be increased by Methadose Concentrate


• Nucleoside reverse transcriptase inhibitors (NRTIs) (eg, abacavir, didanosine, stavudine) because their effectiveness may be decreased by Methadose Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methadose Concentrate 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.

How to use Methadose Concentrate:

Use Methadose Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Methadose Concentrate by mouth with or without food. Methadose Concentrate is for oral use only and must not be injected.


• Methadose Concentrate must be administered under close medical supervision.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Methadose Concentrate must be mixed with water or other liquid before you use it. Follow your doctor's instructions on how to mix Methadose Concentrate.


• Take Methadose Concentrate on a regular schedule to get the most benefit from it.


• If Methadose Concentrate is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Methadose Concentrate properly.


• Always keep Methadose Concentrate in a secure place to protect from theft.


• If you miss a dose of Methadose Concentrate and you are using it regularly, 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. If you miss your doses of Methadose Concentrate for more than 2 days, contact your doctor before you start taking Methadose Concentrate again.

Ask your health care provider any questions you may have about how to use Methadose Concentrate.

Important safety information:

• Methadose Concentrate may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Methadose Concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Methadose Concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Methadose Concentrate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Breathing problems may occur some time after you take a dose of Methadose Concentrate. Tell your doctor or seek medical care immediately if you notice trouble breathing (eg, slowed or shallow breathing) while you take Methadose Concentrate.


• Methadose Concentrate may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.


• The risk of Methadose Concentrate becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use Methadose Concentrate for longer than prescribed without talking with your doctor.


• Tell your doctor or dentist that you take Methadose Concentrate before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, lung function, and heart function, may be performed while you use Methadose Concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Methadose Concentrate with caution in the ELDERLY; they may be more sensitive to its effects.


• Methadose Concentrate should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Methadose Concentrate may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Methadose Concentrate while you are pregnant. Methadose Concentrate is found in breast milk. If you are or will be breast-feeding while you use Methadose Concentrate, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Methadose Concentrate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Methadose Concentrate stops working well. Do not take more than prescribed.

Some people who use Methadose Concentrate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Methadose Concentrate suddenly, you may have WITHDRAWAL symptoms. These may include convulsions, tremor, stomach and muscle cramps, vomiting, and sweating. Do not stop therapy suddenly or change the dosage without asking your doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Methadose Concentrate:

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:

Constipation; dizziness; drowsiness; dry mouth; headache; increased sweating; itching; lightheadedness; nausea; vomiting; weakness.

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); confusion; decreased sexual desire or ability; excessive drowsiness; fainting; fast, slow, or irregular heartbeat; hallucinations; loss of appetite; menstrual changes; mental or mood changes (eg, agitation, disorientation, exaggerated sense of well-being); seizures; severe or persistent dizziness or lightheadedness; shortness of breath; slow or shallow breathing; swelling of the arms, feet, or legs; trouble sleeping; trouble urinating; unusual bruising or bleeding.

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. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Methadose side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold and clammy skin; coma; fainting; fast, slow, or irregular heartbeat; muscle weakness; pinpoint pupils; severe dizziness, drowsiness, or lightheadedness; slow, shallow, or difficult breathing.

Proper storage of Methadose Concentrate:

Store Methadose Concentrate at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methadose Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Methadose Concentrate, please talk with your doctor, pharmacist, or other health care provider.


• Methadose Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Methadose Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Methadose resources

• Methadose Side Effects (in more detail)
• Methadose Use in Pregnancy & Breastfeeding
• Drug Images
• Methadose Drug Interactions
• Methadose Support Group
• 21 Reviews for Methadose - Add your own review/rating

Compare Methadose with other medications

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Imipramine Capsules

Pronunciation: im-IP-ra-meen
Generic Name: Imipramine
Brand Name: Tofranil-PM

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Imipramine Capsules outweigh the risks.

Family and caregivers must closely watch patients who take Imipramine Capsules. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.

Imipramine Capsules is used for:

Treating depression. It may also be used for other conditions as determined by your doctor.

Imipramine Capsules is a tricyclic antidepressant. It works by increasing the activity of certain chemicals in the brain that help elevate mood.

Do NOT use Imipramine Capsules if:

• you are allergic to any ingredient in Imipramine Capsules or to similar medicines


• you have taken furazolidone, linezolid, methylene blue, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days, or you are taking astemizole, droperidol, or terfenadine


• you are recovering from a recent heart attack

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

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Imipramine Capsules:

Some medical conditions may interact with Imipramine Capsules. 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 drink alcohol-containing beverages daily or you have a history of alcohol abuse


• if you take thyroid medicine or you have a history of overactive thyroid, glaucoma, heart problems, kidney or liver problems, diabetes, seizures, the blood disease porphyria, or difficulty urinating


• if you have a history of suicidal thoughts or behavior, bipolar disorder, or any other mental disorders; you are undergoing electroshock therapy; or you are scheduled to have any surgery

Some MEDICINES MAY INTERACT with Imipramine Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, fluconazole), cimetidine, duloxetine, flecainide, methylphenidate, mibefradil, phenothiazines (eg, chlorpromazine), propafenone, quinidine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or terbinafine because they may increase the risk of Imipramine Capsules's side effects


• Arsenic, astemizole, droperidol, furazolidone, linezolid, MAOIs (eg, phenelzine), methylene blue, pimozide, streptogramins (eg, dalfopristin), terfenadine, or tramadol because the risk of high blood pressure, serious heart problems (eg, irregular heartbeat), or seizures may be increased


• Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Imipramine Capsules's effectiveness


• Anticholinergics (eg, benztropine), carbamazepine, or sympathomimetics (eg, phenylephrine) because the risk of their side effects may be increased by Imipramine Capsules


• Clonidine, guanethidine, or guanfacine because their effectiveness may be decreased by Imipramine Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Imipramine Capsules 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.

How to use Imipramine Capsules:

Use Imipramine Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Imipramine Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Imipramine Capsules refilled.


• Take Imipramine Capsules by mouth with or without food.


• Taking Imipramine Capsules at bedtime may help reduce side effects (eg, daytime drowsiness). Discuss this possibility with your doctor.


• It may take 1 to 3 weeks before you notice the effect of Imipramine Capsules. Continue to use Imipramine Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Imipramine Capsules, 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. If you take 1 dose daily at bedtime, do not take the missed dose the next morning.

Ask your health care provider any questions you may have about how to use Imipramine Capsules.

Important safety information:

• Imipramine Capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Imipramine Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Imipramine Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Imipramine Capsules may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Children, teenagers, and young adults who take Imipramine Capsules may be at increased risk for suicidal thoughts or actions. Watch all patients who take Imipramine Capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Imipramine Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Imipramine Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tell your doctor or dentist that you take Imipramine Capsules before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including blood counts, may be performed while you use Imipramine Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Imipramine Capsules with caution in the ELDERLY (especially those with cardiac disease); they may be more sensitive to its effects.


• Imipramine Capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Imipramine Capsules can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Imipramine Capsules while you are pregnant. It is not known if Imipramine Capsules is found in breast milk. Do not breast-feed while taking Imipramine Capsules.

If you suddenly stop taking Imipramine Capsules, you may experience WITHDRAWAL symptoms, including headache, nausea, and tiredness.

Possible side effects of Imipramine Capsules:

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:

Dizziness; drowsiness; dry mouth; excitement; headache; impotence; nausea; nightmares; pupil dilation; sensitivity to sunlight; sweating; tiredness; upset stomach; vomiting; weakness; weight loss or gain.

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 or other vision changes; changes in sex drive; chest pain; confusion; constipation; fainting; fast, slow, or irregular heartbeat; fever; frequent or difficult urination; hallucinations; impulsive behavior or other unusual changes in behavior; jaw, neck, or muscle spasms; mental or mood changes (eg, increased anxiety, mood swings, agitation, irritability, nervousness, restlessness); panic attacks; ringing in the ears; seizures; severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinking or behavior; swelling of the testicles; tremor; trouble sleeping; trouble walking or keeping your balance; twitching of the face or tongue; uncontrolled movements of arms and legs or stiffness; unusual bleeding or bruising; worsening of depression; yellowing of the skin or eyes.

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. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Imipramine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; bluish skin or mucous membranes; breathing problems; chest pain; coma; confusion; dry mouth; enlarged pupils; excess sweating; fainting; fast or irregular heartbeat; flushing; incoordination; involuntary movements; loss of consciousness; restlessness; rigid muscles; seizures; severe drowsiness; shock; stupor; vomiting.

Proper storage of Imipramine Capsules:

Store Imipramine Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly sealed container. Stored away from heat, moisture, and light. Do not store in the bathroom. Keep Imipramine Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Imipramine Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Imipramine Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Imipramine Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Imipramine resources

• Imipramine Side Effects (in more detail)
• Imipramine Dosage
• Imipramine Use in Pregnancy & Breastfeeding
• Drug Images
• Imipramine Drug Interactions
• Imipramine Support Group
• 13 Reviews for Imipramine - Add your own review/rating

Compare Imipramine with other medications

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• Night Terrors
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• Panic Disorder
• Primary Nocturnal Enuresis

Lithobid

lithium carbonate

Dosage Form: tablet, film coated, extended release
Lithobid® (Lithium Carbonate, USP)

Extended-Release Tablets 300 mg

Rev 10/2011

Rx only

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 (see DOSAGE AND ADMINISTRATION).

Lithobid Description

Lithobid® tablets contain lithium carbonate, a white odorless alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Each peach-colored, film-coated, extended-release tablet contains 300 mg of lithium carbonate. This slowly dissolving film-coated tablet is designed to give lower serum lithium peak concentrations than obtained with conventional oral lithium dosage forms. Inactive ingredients consist of calcium stearate, carnauba wax, cellulose compounds, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, povidone, propylene glycol, sodium chloride, sodium lauryl sulfate, sodium starch glycolate, sorbitol, and titanium dioxide. Product meets USP Drug Release Test 1.

ACTIONS

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.

INDICATIONS

Lithobid® (lithium carbonate) is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithobid® is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur.


Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.

Warnings

Lithium Toxicity


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


Outpatients and their families should be warned that the patient must discontinue lithium therapy and contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness, or muscular weakness occur.

Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation, dehydration, sodium depletion, and to patients receiving diuretics, or angiotensin converting enzyme (ACE) inhibitors, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity.

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.


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 manic-depressive patients never exposed to lithium. The relationship between renal function and morphologic changes and their association with lithium therapy have not been established.


Kidney function should be assessed prior to and during lithium therapy. 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.


Encephalopathic Syndrome


An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and FBS) has occurred in a few patients treated with lithium plus a neuroleptic, most notably haloperidol. In some instances, the syndrome was followed by irreversible brain damage. Because of possible causal relationship between these events and the concomitant administration of lithium and neuroleptic drugs, patients receiving such combined therapy or patients with organic brain syndrome or other CNS impairment should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as Neuroleptic Malignant Syndrome (NMS).


Concomitant Use with Neuromuscular Blocking Agents


Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium.

Usage in Pregnancy

Adverse effects on nidationin 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 palate in mice.


In humans, lithium may cause fetal harm when administered to a pregnant woman. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein's anomaly. If this drug is used in women of childbearing potential, or during pregnancy, or if a patient becomes pregnant while taking this drug, the patient should be apprised by their physician of the potential hazard to the fetus.

Usage in Nursing Mothers

Lithium is excreted in human milk. Nursing should not be undertaken during lithium therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazard to the infant or neonate. Signs and symptoms of lithium toxicity such as hypertonia, hypothermia, cyanosis, and ECG changes have been reported in some infants and neonates.

Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been determined; its use in these patients is not recommended.

There has been a report of transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg pediatric patient who ingested 300 mg of lithium carbonate.

Precautions

The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside (see DOSAGE AND ADMINISTRATION).


The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma concentration. The elimination half-life of lithium is approximately 24 hours. Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500-3500 mL) at least during the initial stabilization period. Decreased tolerance to lithium has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered under careful medical supervision and lithium intake reduced or suspended until the condition is resolved.


In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication.


Previously existing thyroid disorders do not necessarily constitute a contraindication to lithium treatment. Where hypothyroidism preexists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters and/or adjustment of lithium doses, if any. If hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used. In general, the concomitant use of diuretics or angiotensin converting enzyme (ACE) inhibitors with lithium carbonate should be avoided. In those cases where concomitant use is necessary, extreme caution is advised since sodium loss from these drugs may reduce the renal clearance of lithium resulting in increased serum lithium concentrations with the risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium serum concentrations is recommended. See WARNINGS for additional caution information.


Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.


The following drugs can lower serum lithium concentrations by increasing urinary lithium excretion: acetazolamide, urea, xanthine preparations, and alkalinizing agents such as sodium bicarbonate.


Concomitant extended use of iodide preparations, especially potassium iodide, with lithium may produce hypothyroidism.


Concurrent use of calcium channel blocking agents with lithium may increase the risk of neurotoxicity in the form of ataxia, tremors, nausea, vomiting, diarrhea, and/or tinnitus.


Concurrent use of metronidazole with lithium may provoke lithium toxicity due to reduced renal clearance. Patients receiving such combined therapy should be monitored closely.


Concurrent use of fluoxetine with lithium has resulted in both increased and decreased serum lithium concentrations. Patients receiving such combined therapy should be monitored closely.


Nonsteroidal anti-inflammatory drugs (NSAIDs): Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between a NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium 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 lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone.


Lithium may impair mental and/or physical abilities. Patients should be cautioned about activities requiring alertness (e.g., operating vehicles or machinery).

Usage in Pregnancy

Pregnancy Category D. (See WARNINGS).

Usage in Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants and neonates from lithium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS).

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established (see WARNINGS).

Geriatric Use

Clinical studies of Lithobid® tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other therapy.


This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

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 COUNSELING 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. 131Iodine 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.

DOSAGE AND ADMINISTRATION

Acute Mania

Optimal patient response can usually be established with 1800 mg/day in the following dosages:

Acute Mania

1Can also be administered on 600 mg TID recommended dosing interval.
	Morning	Afternoon	Nighttime
Lithobid®	3 tabs		3 tabs
Extended-Release Tablets1	(900 mg)		(900 mg)

Such doses will normally produce an effective serum lithium concentration ranging between 1.0 and 1.5 mEq/L. Dosage must be individualized according to serum concentrations and clinical response. Regular monitoring of the patient's clinical state and of serum lithium concentrations is necessary. Serum concentrations should be determined twice per week during the acute phase, and until the serum concentrations and clinical condition of the patient have been stabilized.

Long-Term Control

Desirable serum lithium concentrations are 0.6 to 1.2 mEq/L which can usually be achieved with 900-1200 mg/day. Dosage will vary from one individual to another, but generally the following dosages will maintain this concentration:

Long-Term Control

1Can be administered on TID recommended dosing interval up to 1200 mg/day.
	Morning	Afternoon	Nighttime
Lithobid®	2 tabs		2 tabs
Extended-Release Tablets1	(600 mg)		(600 mg)

Serum lithium concentrations 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 concentrations of 1.0 to 1.5 mEq/L. Geriatric patients often respond to reduced dosage, and may exhibit signs of toxicity at serum concentrations ordinarily tolerated by other patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Important Considerations

• 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 previous dose). Total reliance must not be placed on serum concentrations alone. Accurate patient evaluation requires both clinical and laboratory analysis.


• Lithobid® Extended-Release Tablets must be swallowed whole and never chewed or crushed.

Overdosage

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.

Patient Counseling Information

Information for Patients: A condition known as Brugada Syndrome may pre-exist and be unmasked by lithium therapy.  Brugada Syndrome is a heart disorder characterized by abnormal electrocardiographic (ECG) findings and risk of sudden death.  Patients should be advised to seek immediate emergency assistance if they experience fainting, lightheadedness, abnormal heart beats, or shortness of breath because they may have a potentially life-threatening heart disorder known as Brugada Syndrome.

How is Lithobid Supplied

Lithobid® (Lithium Carbonate, USP)

Extended-Release Tablets, 300 mg, peach-colored imprinted “Lithobid 300”

NDC 68968-4492-1

(Bottle of 100)

Storage Conditions

Store between 59°-86°F (15°-30°C). Protect from moisture. Dispense in tight, child-resistant container (USP).


Lithobid®

(Lithium Carbonate, USP)

Extended-Release Tablets, 300 mg


Manufactured By:

ANI Pharmaceuticals, Inc.

Baltimore, Maryland 21244


For:

Noven Therapeutics, LLC

Miami, FL 33186

Print Date: MM/YYYY

© 2011 Noven Therapeutics, LLC

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 300 MG LABEL

NDC 68968-4492-1

100 TABLETS

Lithobid®

(lithium carbonate)

TABLET, FILM COATED, EXTENDED RELEASE

300 mg

Rx ONLY

NOVEN THERAPEUTICS, LLC

Lithobid  lithium carbonate  tablet, film coated, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68968-4492 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength lithium carbonate (Lithium cation) lithium carbonate 300 mg

Inactive Ingredients Ingredient Name Strength calcium stearate   carnauba wax   Hypromellose 2910 (50 MPA.S)   FD&C Blue No. 2   FD&C Red No. 40   FD&C Yellow No. 6   povidone   propylene glycol   sodium chloride   sodium lauryl sulfate   sodium starch glycolate type a potato   sorbitol   titanium dioxide

Product Characteristics Color pink (PINK) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code Lithobid;300 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68968-4492-1 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA018027	04/27/1979

Labeler - NOVEN THERAPEUTICS, LLC (166888268)

Establishment
Name	Address	ID/FEI	Operations
ANI Pharmaceuticals, Inc.		148515737	MANUFACTURE, ANALYSIS

Revised: 10/2011NOVEN THERAPEUTICS, LLC

More Lithobid resources

• Lithobid Side Effects (in more detail)
• Lithobid Dosage
• Lithobid Use in Pregnancy & Breastfeeding
• Drug Images
• Lithobid Drug Interactions
• Lithobid Support Group
• 12 Reviews for Lithobid - Add your own review/rating

• Lithobid Concise Consumer Information (Cerner Multum)


• Lithobid Advanced Consumer (Micromedex) - Includes Dosage Information


• Lithobid Controlled-Release and Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Lithium Professional Patient Advice (Wolters Kluwer)


• Eskalith MedFacts Consumer Leaflet (Wolters Kluwer)


• Lithium Salts Monograph (AHFS DI)

Compare Lithobid with other medications

• Bipolar Disorder
• Cluster Headaches
• Mania
• Schizoaffective Disorder

pregabalin

Generic Name: pregabalin (pre GAB a lin)

Brand Names: Lyrica

What is pregabalin?

Pregabalin is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.

Pregabalin is used to control seizures and to treat fibromyalgia. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy) or herpes zoster (post-herpetic neuralgia).

Pregabalin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about pregabalin?

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

If you are taking pregabalin to prevent seizures, keep taking the medication even if you feel fine. Do not stop using pregabalin without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using pregabalin.

Do not change your dose of pregabalin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Wear a medical alert tag or carry an ID card stating that you take pregabalin. Any medical care provider who treats you should know that you take seizure medication.

What should I discuss with my healthcare provider before taking pregabalin?

You should not use this medication if you are allergic to pregabalin.

To make sure you can safely take pregabalin, tell your doctor if you have any of these other conditions:

• 
  

  congestive heart failure;

  
  


• 
  

  diabetes (unless you are taking pregabalin to treat diabetic neuropathy);

  
  


• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  a bleeding disorder;

  
  


• 
  

  low levels of platelets in your blood;

  
  


• 
  

  a history of depression or suicidal thoughts;

  
  


• 
  

  a history of drug or alcohol addiction; or

  
  


• 
  

  if you have ever had a severe allergic reaction.

  
  

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether pregabalin will harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant while taking pregabalin for seizures. Do not start or stop taking pregabalin during pregnancy without your doctor's advice.

If you become pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of pregabalin on the baby.

It is not known whether pregabalin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using pregabalin.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment.

Do not give this medication to a child younger than 18 years old.

How should I take pregabalin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take pregabalin with or without food.

Do not change your dose of pregabalin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Call your doctor if you have any problems with your vision while taking pregabalin. If you are taking pregabalin to prevent seizures, keep taking it even if you feel fine. You may have an increase in seizures if you stop taking pregabalin. Follow your doctor's instructions. Do not stop using pregabalin without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using pregabalin. Wear a medical alert tag or carry an ID card stating that you take pregabalin. Any medical care provider who treats you should know that you take seizure medication. Store at room temperature away from moisture, light, and heat.

See also: Pregabalin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pregabalin?

Drinking alcohol can increase certain side effects of pregabalin. Pregabalin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Pregabalin side effects

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• 
  

  muscle pain, weakness, or tenderness (especially if you also have a fever and feel tired);

  
  


• 
  

  vision problems;

  
  


• 
  

  easy bruising or bleeding; or

  
  


• 
  

  swelling in your hands or feet, rapid weight gain.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  loss of balance or coordination;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  breast swelling;

  
  


• 
  

  tremors; or

  
  


• 
  

  dry mouth, constipation.

  
  

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.

Pregabalin Dosing Information

Usual Adult Dose for Diabetic Neuropathy:

Initial dose: 50 mg 3 times a day

The maximum recommended dose is 100 mg 3 times a day in patients with a creatinine clearance of at least 60 mL/min.

The dose may be increased to 100 mg 3 times a day within 1 week based on efficacy and tolerability.

Usual Adult Dose for Postherpetic Neuralgia:

Initial dose: 75 mg 2 times a day or 50 mg 3 times a day in patients with a creatinine clearance of at least 60 mL/min

The dose may be increased to 100 mg 3 times a day within 1 week based on efficacy and tolerability.

Maximum dose: Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate pregabalin, may be treated with up to 300 mg 2 times a day or 200 mg 3 times a day. Due to the dose-dependent adverse effects and the higher rate of treatment discontinuation due to adverse events, dosing above 300 mg/day should be reserved only for those patients who have ongoing pain and are tolerating 300 mg daily.

Usual Adult Dose for Epilepsy:

Initial dose: 75 mg 2 times a day or 50 mg 3 times a day

Doses of 150 mg to 600 mg/day have been shown to be effective as adjunctive therapy in the treatment of partial onset seizures. The total daily dose should be divided and given either 2 or 3 times a day.

Maximum dose: Based on individual patient response and tolerability, the dose may be increased to a maximum of 600 mg/day.

The efficacy of add-on pregabalin in patients taking gabapentin has not been evaluated in controlled trials. Therefore, dosing recommendations for the use of pregabalin with gabapentin cannot be offered.

Usual Adult Dose for Fibromyalgia:

Initial dose: 75 mg two times a day (150 mg/day)
The dose may be increased to 150 mg two times a day (300 mg/day) within one week based on efficacy and tolerability.

Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).

Recommended dose: 300 to 450 mg/day

Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated. In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended.

What other drugs will affect pregabalin?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to dizziness or sleepiness caused by pregabalin. Tell your doctor if you regularly use any of these medicines, or any other seizure medication.

Tell your doctor about all other medicines you use, especially:

• 
  

  rosiglitazone (Avandia, Avandamet, Avandaryl); or

  
  


• 
  

  heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

  
  

This list is not complete and other drugs may interact with pregabalin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More pregabalin resources

• Pregabalin Side Effects (in more detail)
• Pregabalin Dosage
• Pregabalin Use in Pregnancy & Breastfeeding
• Pregabalin Drug Interactions
• Pregabalin Support Group
• 332 Reviews for Pregabalin - Add your own review/rating

• pregabalin Advanced Consumer (Micromedex) - Includes Dosage Information


• Pregabalin Professional Patient Advice (Wolters Kluwer)


• Pregabalin MedFacts Consumer Leaflet (Wolters Kluwer)


• Pregabalin Monograph (AHFS DI)


• Lyrica Prescribing Information (FDA)


• Lyrica Consumer Overview

Compare pregabalin with other medications

• Diabetic Nerve Damage
• Epilepsy
• Fibromyalgia
• Generalized Anxiety Disorder
• Migraine Prevention
• Neuralgia
• Pain
• Peripheral Neuropathy
• Persisting Pain, Shingles
• Reflex Sympathetic Dystrophy Syndrome
• Restless Legs Syndrome
• Spondylolisthesis
• Syringomyelia

Where can I get more information?

• Your pharmacist can provide more information about pregabalin.

See also: pregabalin side effects (in more detail)

Neo-Terramycin 100/50

Dosage Form: FOR ANIMAL USE ONLY
Neo-Terramycin® 100/50

(neomycin-oxytetracycline)

(Antibiotic Premix)

Active Drug Ingredients:

Oxytetracycline (from oxytetracycline quaternary salt) equivalent to

oxytetracycline hydrochloride (Terramycin®) . . . . . . . . . . . . . . . . . . . . . . . . .50 g/lb

Neomycin sulfate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100 g/lb

(providing 70 g neomycin base per lb)

CAUTION:

For use in manufacturing medicated animal feeds only.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.

STORE IN A DRY, COOL PLACE

Mixing Directions

Thoroughly mix the amount of this premix according to the tables in the DIRECTIONS FOR USE with nonmedicated feed.

Directions for Use

Indications for use	g/ton Terramycin	g/ton Neomycin Base	lb of Neo-Terramycin 100/50/ton
CHICKENS
Prevention of diseases from oxytetracycline-susceptible organisms during periods of stress As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50	70	1
Prevention of early chick mortality due to oxytetracycline-susceptible organisms As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50–100 (first 2 weeks)	70–140	1–2
To extend period of high egg production, to improve feed efficiency, to improve fertility, to improve egg production and feed efficiency in presence of disease and at times of stress; as an aid in maintaining and improving hatchability where birds are suffering stress from moving, vaccination, culling, extreme temperature changes and worming; to improve livability of progeny when losses are due to oxytetracycline-susceptible organisms, to improve egg shell quality, prevention of bluecomb (mud fever or transmissible enteritis) As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50–100	70–140	1–2
Prevention of complicated chronic respiratory disease (air-sac infection) and control of complicated CRD by lowering mortality and severity during outbreaks As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	100	140	2
SPECIAL CONSIDERATIONS: Oxytetracycline in low calcium feeds (0.18–0.55% dietary calcium) should not be fed for more than five days and should not be fed to laying hens.
WARNING: This combination requires withdrawal from feed 5 days before slaughter of broilers and 14 days before slaughter of laying hens.
TURKEYS
As an aid in the prevention of disease from oxytetracycline-susceptible organisms during periods of stress As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50	70	1
To extend period of high egg production, to improve egg production, to improve feed efficiency, to improve fertility, to improve egg production and feed efficiency in presence of disease and at time of stress; as an aid in maintaining and improving hatchability where birds are suffering from stress from exposure, moving, vaccination, culling, extreme losses due to oxytetracycline-susceptible organisms, and to improve egg shell quality; prevention of hexamitiasis As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50–100	70–140	1–2
As an aid in the prevention of early poultry mortality due to oxytetracycline-susceptible organisms As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	50–100 (first 4 weeks)	70–140	1–2
Control of bluecomb (mud fever or transmissible enteritis), infectious sinusitis and hexamitiasis; prevention of infectious synovitis As an aid in the prevention of bacterial enteritis and in the control of neomycin-sensitive organisms associated with bluecomb (mud fever or transmissible enteritis)	100	140	2
SWINE (baby pigs, growing-finishing pigs and sows)
As an aid in the prevention of bacterial enteritis (scours), baby pig diarrhea (in baby pigs only), vibrionic dysentery, bloody dysentery and salmonellosis (necro or necrotic enteritis)	50	70	1
As an aid in the treatment of bacterial enteritis (scours), baby pig diarrhea (in baby pigs only), vibrionic dysentery, bloody dysentery and salmonellosis (necro or necrotic enteritis)	50–100	70–140	1–2
(When used in sows: to be fed during the gestation and lactation periods) As an aid in the maintenance of weight gains and feed consumption in the presence of atrophic rhinitis As an aid in the treatment of bacterial enteritis	50–100	70–140	1–2
WARNING: Withdraw from feed 10 days before slaughter when neomycin base level is 140 g/ton and 5 days before slaughter when the neomycin base level is below 140g/ton.
CALVES (starter feeds)
Aid in the prevention of bacterial enteritis (scours)	50	70	1
Aid in the treatment of bacterial enteritis (scours)	100	140	2
WARNING: This combination, when fed at the level of 1.4 grams neomycin base plus 2 grams oxytetracycline per head daily, requires withdrawal from feed 7 days before slaughter. No withdrawal is required at lower levels. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

FOR USE IN DRY FEEDS ONLY. NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

Neo-Terramycin is a registered trademark of Pfizer, Inc., licensed to

Phibro Animal Health, for Neomycin-Oxytetracycline combination products.

SEE BACK PANEL FOR COMPLETE MIXING DIRECTIONS

USE DIRECTIONS AND WARNINGS

Net Weight 50 lb (22.6 kg)

NADA #94-975, Approved by FDA

7931000

101-9014-02

Neo-Terramycin 100/50  neomycin-oxytetracycline  powder

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 66104-8850 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYTETRACYCLINE HYDROCHLORIDE (OXYTETRACYCLINE) OXYTETRACYCLINE HYDROCHLORIDE 50 g  in 0.45 kg NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 100 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength MINERAL OIL   SODIUM ALUMINIUM SILICATE   RICE BRAN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66104-8850-1 22.6 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA94975	01/11/1999

Labeler - Phibro Animal Health (006989008)

Revised: 04/2010Phibro Animal Health