Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Fluoxetine may also be used for purposes other than those listed in this medication guide.

Important information about Fluoxetine

Do not take fluoxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor.

Before taking Fluoxetine

Do not use fluoxetine if you are using any of the following drugs:

• pimozide (Orap);
• thioridazine (Mellaril); or
• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

Serious and sometimes fatal reactions can occur when these medicines are taken with fluoxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine (Mellaril) or an MAOI.

Before taking fluoxetine, tell your doctor if you are allergic to any drugs, or if you have:

• cirrhosis of the liver;
• kidney disease;
• diabetes;
• seizures or epilepsy;
• bipolar disorder (manic depression); or
• a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may not be able to use fluoxetine, or you may need a dosage adjustment or special tests.

You may have thoughts about suicide while taking an antidepressant, such as fluoxetine, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks 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 for at least the first 12 weeks of treatment.

FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor. Fluoxetine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give fluoxetine to anyone younger than 18 years old without a doctor’s advice. Fluoxetine is the only antidepressant that is FDA-approved for use in children with depression.

How should I take Fluoxetine?

Take fluoxetine exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from fluoxetine.

Do not break, chew, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

Measure the liquid form of fluoxetine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

It may take 4 weeks or longer before you start feeling better. Do not stop using fluoxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.

To treat premenstrual dysphoric disorder, the usual dose of fluoxetine is once daily while you are having your period, or 14 days before you expect your period to start. Follow your doctor’s instructions.

Store fluoxetine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

If you miss a dose of Prozac Weekly, take the missed dose as soon as you remember and take the next dose 7 days later. However, if it is almost time for the next regularly scheduled weekly dose, skip the missed dose and take the next one as directed.Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medication. Overdose may cause nausea, vomiting, fever, sleepiness, rapid or uneven heartbeat, confusion, fainting, seizures, or coma.

Fluoxetine side effects

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

Call your doctor at once if you have any new or worsening symptoms 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 experience any of these serious side effects from using fluoxetine :

• severe blistering, peeling, and red skin rash;
• very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;
• nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
• headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious fluoxetine side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• drowsiness, dizziness, feeling nervous;
• mild nausea, upset stomach, constipation;
• increased appetite, weight changes;
• sleep problems (insomnia);
• decreased sex drive, impotence, or difficulty having an orgasm; or
• dry mouth.

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

What other drugs will affect Fluoxetine?

Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with fluoxetine may cause you to bruise or bleed easily.

Before taking fluoxetine, tell your doctor if you are using any of the following medicines:

• alprazolam (Xanax);
• clozapine (Clozaril, Fazaclo);
• digitoxin (Crystodigin);
• flecainide (Tambocor);
• haloperidol (Haldol);
• seizure medication such as phenytoin (Dilantin) or carbamazepine (Tegretol);
• tryptophan (also called L-tryptophan);
• vinblastine (Velban);
• a blood thinner such as warfarin (Coumadin);
• almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
• any other antidepressants such as amitriptyline (Elavil), escitalopram (Lexapro), imipramine (Tofranil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with fluoxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Trazodone is a tetracyclic antidepressant medication. It is thought to increase the activity of one of the brain chemicals (serotonin) which may become unbalanced and cause depression. It may also be used for relief of anxiety disorders (eg, sleeplessness, tension) and chronic pain.

Trazodone is used to treat depression.

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

Important information about Trazodone

Before taking trazodone, tell your doctor if you are allergic to any drugs, or if you have bipolar disorder (manic depression), schizophrenia or other psychiatric illness, a history of drug abuse or suicidal thoughts, or if you have recently had a heart attack.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Trazodone works best if you take it after a meal or a snack. Call your doctor at once if you have any new or worsening symptoms 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. Trazodone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not drink alcohol while you are taking trazodone. Alcohol can increase drowsiness and dizziness caused by trazodone. Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 4 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

Before taking Trazodone

Do not use this medication if you are allergic to trazodone.

Before using trazodone, tell your doctor if you are allergic to any drugs, or if you have:

• bipolar disorder (manic depression);
• schizophrenia, or other psychiatric illness;
• a history of drug abuse or suicidal thoughts; or
• if you have recently had a heart attack.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take trazodone.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks 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 for at least the first 12 weeks of treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Trazodone may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give trazodone to anyone younger than 18 years old without the advice of a doctor.

How should I take Trazodone?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Trazodone works best if you take it after a meal or a snack.

You may need to take this medicine at bedtime, because trazodone can cause drowsiness. Follow your doctor’s instructions.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using trazodone. You may need to stop using the medicine for a short time. It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 weeks of treatment. You may need to take trazodone for several weeks or months to control your depression symptoms.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Store trazodone at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of trazodone can be fatal when it is taken with alcohol, barbiturates such as phenobarbital, or sedatives such as diazepam (Valium).

Overdose symptoms may include drowsiness, vomiting, penis erection that is painful or prolonged, uneven heart rate, seizure (black-out or convulsions), or breathing that slows or stops.

Trazodone side effects

Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 4 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery. 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.

Call your doctor at once if you have any new or worsening symptoms 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:

• feeling light-headed, fainting;
• fever, chills, body aches, flu symptoms; or
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
• problems with urination.

Less serious trazodone side effects may be more likely to occur, such as:

• dizziness or drowsiness;
• headache;
• sleep problems (insomnia);
• dry mouth, stuffy nose;
• nausea, vomiting, loss of appetite;
• diarrhea or constipation;
• muscle pain;
• loss of coordination; or
• blurred vision.

This is not a complete list of trazodone side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trazodone?

Before taking trazodone, tell your doctor if you are using any of the following drugs:

• an HIV medicine such as indinavir (Crixivan) or ritonavir (Norvir);
• an antibiotic such as ketoconazole (Nizoral) or itraconazole (Sporanox);
• digoxin (Lanoxin, Lanoxicaps);
• seizure medicine such as carbamazepine (Carbatrol, Tegretol) or phenytoin (Dilantin);
• warfarin (Coumadin); or
• if you have taken an MAO inhibitor within the past 14 days, such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and there may be other drugs that can interact with trazodone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Haloperidol is an antipsychotic medication. It works by changing the actions of chemicals in your brain.

Haloperidol is used to treat schizophrenia. It is also used to control motor and speech tics in people with Tourette’s syndrome.

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

What is the most important information I should know about Haldol (Haloperidol)?

Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Haloperidol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase drowsiness or dizziness caused by haloperidol.

What should I discuss with my healthcare provider before taking Haldol (Haloperidol)?

Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to haloperidol, or have certain conditions. Be sure your doctor knows if you have Parkinson’s disease.

Before taking haloperidol, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• kidney disease;
• heart disease, angina (chest pain);
• a thyroid disorder;
• epilepsy or other seizure disorder;
• a personal or family history of “Long QT syndrome”;
• an electrolyte imbalance such as low potassium or magnesium levels in your blood.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take haloperidol.

It is not known whether haloperidol is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Haloperidol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Haldol (Haloperidol)?

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Taking too much of this medication can cause a serious heart rhythm disorder or sudden death. Never take more than your prescribed dose. Take haloperidol with a full glass of water.

Haloperidol can be taken with or without food.

It may take several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Do not stop using haloperidol suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store haloperidol at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of haloperidol can be fatal.

Overdose symptoms may include extreme drowsiness, feeling like you might pass out, tremors, and uncontrolled muscle movements in your eyes, tongue, jaw, or neck.

Haldol (Haloperidol) 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. Call your doctor at once if you have any of these serious side effects:

• dizziness, fainting, fast or pounding heartbeat;
• restless muscle movements in your eyes, tongue, jaw, or neck;
• tremor (uncontrolled shaking);
• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
• stabbing chest pain, feeling short of breath, cough with yellow or green mucus;
• sudden mood changes;
• confusion, agitation, hallucinations, unusual thoughts or behavior; or
• jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

• headache, dizziness, drowsiness;
• sleep problems (insomnia);
• feeling restless or anxious;
• mild skin rash or itching;
• breast enlargement, irregular menstrual periods, loss of interest in sex; or
• dry mouth, blurred vision, urinating less than usual.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Haldol (Haloperidol) Dosing Information

Usual Adult Dose for ICU Agitation:

Haloperidol lactate:
IV, intermittent: 0.03 to 0.15 mg/kg IV (2 to 10 mg) every 30 minutes to 6 hours.
IV, infusion: 3 to 25 mg/hour by continuous IV infusion, has been used for ventilator patients with agitation and delirium.

Usual Adult Dose for Dementia:

For non-psychotic behavioral problems related to dementia:
Initial dose: 0.5 mg orally 2 to 3 times daily.
Maintenance dose: 0.5 to 3 mg orally 2 times a day.

Usual Adult Dose for Mania:

Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day
Maintenance dose: 1 to 30 mg/day in 2 or 3 divided doses. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:
Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Usual Adult Dose for Nausea/Vomiting:

Oral:
1 to 5 mg orally every 4 to 6 hours as needed.

Parenteral:
Haloperidol lactate:
1 to 5 mg IM or IV every 4 to 6 hours as needed.

Usual Adult Dose for Psychosis:

Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:
Haloperidol lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Haloperidol decanoate:
Initial dose: 10 to 15 times the previous oral daily dose intramuscularly every 3 to 4 weeks. The initial dose should not exceed 100 mg and the balance should be given in 3 to 7 days. There is limited experience with doses greater than 450 mg/month. Do not give IV.

Usual Adult Dose for Tourette’s Syndrome:

Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.
Maintenance dose: May increase every 5 to 7 days to 3 to 5 mg 2 to 3 times daily for more severe or resistant cases.

Usual Geriatric Dose for not applicable:

Delirium: 0.25 to 0.5 mg orally or IM every 4 hours.

Usual Geriatric Dose for Psychosis:

Oral:
Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses. The lowest possible effective dose should be used since geriatric patients are more sensitive to the adverse effects of haloperidol (e.g., tardive dyskinesia).

Parenteral:
Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Usual Pediatric Dose for Psychosis:

Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.
Maintenance dose: The daily dose may be increased every 5 to 7 days in 0.25 to 0.5 mg increments. The usual range is 0.05 to 0.15 mg/kg/day in 2 to 3 divided doses. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
13 to 18 years and greater than 40 kg:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:
Haloperidol lactate:
5 years younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.

Haloperidol decanoate:
17 year or younger: Safety and efficacy have not been established.

Usual Pediatric Dose for Tourette’s Syndrome:

2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.
Maintenance dose: The daily dose may be increased weekly in 0.25 to 0.5 mg increments up to 0.05 to 0.075 mg/kg/day. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
13 to 18 years and greater than 40 kg: 1 to 2 mg orally 2 to 3 times a day.

Usual Pediatric Dose for not applicable:

Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Agitation/Hyperkinesia: 0.01 to 0.03 mg/kg/day, up to a maximum of 0.15 mg/kg/day.
Autism: 0.5 to 4 mg/day.
13 to 18 years and greater than 40 kg: 0.5 to 5 mg orally 2 to 3 times a day.

Intramuscular:
Haloperidol lactate:
5 years or younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.

What other drugs will affect Haldol (Haloperidol)?

Before using haloperidol, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by haloperidol.

The following drugs can interact with haloperidol. Tell your doctor if you are using any of these:

• lithium (Eskalith, Lithobid, others);
• a blood thinner such as warfarin (Coumadin); or
• rifampin (Rifadin, Rifamate, Rimactane).

This list is not complete and there may be other drugs that can interact with haloperidol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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5- HTP provides the quickest, most effective, and most consistent overall results in treating insomnia. 5-HTP (5-Hydroxy-l-tryptophan) is an amino acid that converts into two chemicals called Serotonin and Melatonin. Melatonin is a sleep-inducing hormone, produced by the body, and Serotonin is a calming neurotransmitter. Both help aid in sleep, reliving worries, and allowing you to clear your mind.

Benefits:

• Enhanced Sleep;
• Relieved Anxiety;
• Relieve symptoms of SAD (Seasonal Affective Disorder).

How Taken

Take 1 to 3 mg, thirty to forty-five minutes before retiring. Start with the lower dose for at least three days, and then consider increasing the dose if results are not what you expected.

Drug Class and Mechanism

5-HTP improves the quality of sleep. More importantly, clinical studies show that 5- HTP is also useful in the treatment of sleep disorders other than insomnia.

5-HTP increases REM sleep significantly (typically by about 25 percent) while simultaneously increasing deep sleep stages 3 and 4 without increasing total sleep time. 5- HTP accomplishes this by shortening the amount of time you spend in sleep stages 1 and 2, which in certain ways are the least important stages of the cycle. The higher the dose, the more time spent in REM.

By shifting the balance of the sleep cycle, 5-HTP makes sleep more restful and rejuvenating. Instead of waking feeling tired, worn out, people taking 5- HTP feel vibrant, well rested, and ready to take on the challenges of the day. When we sleep more deeply and dream more efficiently, we wake in the morning with our physical and psychological batteries fully charged.

Missed Dose

If you miss a dose of 5-HTP, 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.

Storage

Store 5-HTP at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep 5-HTP out of the reach of children and away from pets.

Warnings/Precautions

5-HTP should not be taken with other antidepressants, MAO inhibitors, weight loss products, St.John’s wort, or by pregnant women, unless recommended by a health practitioner. Vitamin B6 should not be taken at the same time, although it is helpful if taken about 6 hours earlier than the 5-HTP.

Possible Side Effects

Aside from the risk of consuming impure 5HTP, the supplement can cause side effects, though most are generally mild. 5 HTP side effects include:

• nausea;
• constipation;
• headaches.

More Information

5-HTP may prove to be better than melatonin. Several clinical studies have shown 5-HTP to produce good results in promoting and maintaining sleep in normal subjects as well as those experiencing insomnia (11-14). One of the key benefits with 5-HTP in the treatment of insomnia is its ability to increase sleep quality.

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Vitamin B1 is a supplement used to treat Vitamin B1 deficiency, a condition caused by not having enough Vitamin B1 in the body. Vitamin B1 may also be used to improve memory, such as in Alzheimer’s disease. A heart problem called congestive heart failure may be treated with Vitamin B1. A person who is trying to stop drinking alcohol may be helped with Vitamin B1. Beriberi (bear-ee-bear-ee), a nerve disease caused by Vitamin B1 deficiency, may be treated with Vitamin B1. Other uses for Vitamin B1 include the treatment of nerve problems caused by diabetes. Vitamin B1 may be used to treat Wernicke’s encephalopathy (en-cef-uh-LOP-uh-thee), a brain disease. In children, maple syrup urine disease may be treated with Vitamin B1.

Other names for Vitamin B1 include: thiamine or Aneurine hydrochloride.

Ask your doctor, nurse, or pharmacist if you need more information about this medicine or if any information in this leaflet concerns you.

Before Using:

Tell your doctor if you

• are taking medicine or are allergic to any medicine (prescription or over-the-counter (OTC) or dietary supplement)
• are pregnant or plan to become pregnant while using this medicine
• are breastfeeding
• have other health problems, such as high blood pressure or heart or blood vessel disease

Dosage:

Talk with your doctor, pharmacist, or nurse about how much Vitamin B1 you should take. The amount depends on the strength of the medicine and the reason you are taking Vitamin B1. If you are using this medicine without instructions from your caregiver, follow the directions on the label. Do not take more Vitamin B1 or take it more often than what is written on the directions.

To store this medicine:

Keep all medicine locked up and away from children. Store medicine away from heat and direct light. Do not store your medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down and not work the way it should work. Throw away medicine that is out of date or that you do not need. Never share your medicine with others.

Drug and Food Interactions:

Do not take Vitamin B1 without talking to your doctor first.

Warnings:

• Before taking Vitamin B1, tell your doctor if you are pregnant or breastfeeding

Side Effects:

Stop taking your medicine right away and talk to your doctor if you have any of the following side effects.

• Allergic reaction: Itching or hives, swelling in your face or hand, swelling or tingling in your mouth or throat, chest tightness, trouble breathing, or rash.

Other Side Effects:

You may have the following side effects, but this medicine may also cause other side effects. Tell your doctor if you have side effects that you think are caused by this medicine.

• Pain in the area of your arm where you received Vitamin B1 intravenously (through a needle into a vein).

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Why is Lithium carbonate prescribed?

Eskalith is used to treat the manic episodes of manic-depressive illness, a condition in which a person’s mood swings from depression to excessive excitement. A manic episode may involve some or all of the following symptoms:
Aggressiveness
Elation
Fast, urgent talking
Frenetic physical activity
Grandiose, unrealistic ideas
Hostility
Little need for sleep
Poor judgment

Once the mania subsides, Eskalith treatment may be continued over the long term, at a somewhat lower dosage, to prevent or reduce the intensity of future manic episodes.

Some doctors also prescribe lithium for premenstrual tension, eating disorders such as bulimia, certain movement disorders, and sexual addictions.

Most important fact about Lithium Carbonate

If the Eskalith dosage is too low, you will derive no benefit; if it is too high, you could suffer lithium poisoning. You and your doctor will need to work together to find the correct dosage. Initially, this means frequent blood tests to find out how much of the drug is actually circulating in your bloodstream. As long as you take Eskalith, you will need to watch for side effects. Signs of lithium poisoning include vomiting, unsteady walking, diarrhea, drowsiness, tremor, and weakness. Stop taking the drug and call your doctor if you have any of these symptoms.

How should you take Lithium Carbonate?

To avoid stomach upset, take Eskalith immediately after meals or with food or milk.

Do not change from one brand of lithium to another without consulting your doctor or pharmacist. Take the drug exactly as prescribed.

While taking Eskalith, you should drink 10 to 12 glasses of water or fluid a day. To minimize the risk of harmful side effects, eat a balanced diet that includes some salt and lots of liquids. If you have been sweating a great deal or have had diarrhea, make sure you get extra liquids and salt.

If you develop an infection with a fever, you may need to cut back on your Eskalith dosage or even quit taking it temporarily. While you are ill, keep in close touch with your doctor.

Long-acting forms of lithium, such as Eskalith CR or Lithobid, should be swallowed whole. Do not chew, crush, or break.

• If you miss a dose…
  Ask your doctor what to do; requirements vary for each individual. Do not take 2 doses at once.

• Storage instructions…
  Store at room temperature.

What side effects may occur?

The possibility of side effects varies with the level of lithium in your bloodstream. If you experience unfamiliar symptoms of any kind, inform your doctor as soon as possible.

• Side effects that may occur when you start taking lithium include:
  Discomfort, frequent urination, hand tremor, mild thirst, nausea

• Other side effects may include:
  Diarrhea, drowsiness, lack of coordination, muscle weakness, vomiting

Why should Lithium Carbonate not be prescribed?

Although your doctor will be cautious under certain conditions, lithium may be prescribed for anyone.

Special warnings about Lithium Carbonate

Eskalith may affect your judgment or coordination. Do not drive, climb, or perform hazardous tasks until you find out how Lithium carbonate affects you.

Your doctor will prescribe Eskalith with extra caution if you have a heart or kidney problem, brain or spinal cord disease, or a weak, run-down, or dehydrated condition.

Also make sure your doctor is aware of any medical problems you may have, including diabetes, epilepsy, thyroid problems, Parkinson’s disease, and difficulty urinating.

You should be careful in hot weather to avoid activities that cause you to sweat heavily. Also avoid drinking large amounts of coffee, tea, or cola, which can cause dehydration through increased urination. Do not make a major change in your eating habits or go on a weight loss diet without consulting your doctor. The loss of water and salt from your body could lead to lithium poisoning.

Possible food and drug interactions when taking Lithium Carbonate

If Eskalith is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Eskalith with the following:
ACE-inhibitor blood pressure drugs such as captopril or enalapril
Acetazolamide
Amphetamines such as dextroamphetamine
Antidepressant drugs that boost serotonin levels, including fluoxetine, paroxetine, and sertraline
Antipsychotic drugs such as chlorpromazine and haloperidol
Bicarbonate of soda
Caffeine
Calcium-blocking blood pressure drugs such as verapamil and diltiazem
Carbamazepine
Diuretics such as furosemide or hydrochlorothiazide
Fluoxetine
Iodine-containing preparations such as potassium iodide
Methyldopa
Metronidazole
Nonsteroidal anti-inflammatory drugs such as celecoxib, ibuprofen, indomethacin, and piroxicam
Phenytoin
Sodium bicarbonate
Tetracyclines
Theophylline

Special information if you are pregnant or breastfeeding

The use of Eskalith during pregnancy can harm the developing baby. If you are pregnant or plan to become pregnant, inform your doctor immediately.

Eskalith appears in breast milk and is considered potentially harmful to a nursing infant. If Lithium carbonate is essential to your health, your doctor may advise you to discontinue breastfeeding while you are taking it.

Recommended dosage for Lithium Carbonate

ADULTS

Acute Episodes

The usual dosage is a total of 1,800 milligrams per day. Immediate-release forms are taken in 3 or 4 doses per day; long-acting forms are taken twice a day.

Your doctor will individualize your dosage according to the levels of the drug in your blood. Your blood levels will be checked at least twice a week when the drug is first prescribed and on a regular basis thereafter.

Long-term Control

Dosage will vary from one individual to another, but a total of 900 milligrams to 1,200 milligrams per day is typical. Immediate-release forms are taken in 3 or 4 doses per day; long-acting forms are taken twice a day.

Blood levels in most cases should be checked every 2 months.

CHILDREN

Safety and effectiveness of Eskalith in children under 12 years of age have not been established.

OLDER ADULTS

Older people often need less Eskalith and may show signs of overdose at a dosage younger people can handle well.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect symptoms of an overdose of Eskalith, seek medical attention immediately.

The harmful levels are close to those that will treat your condition. Watch for early signs of overdose, such as diarrhea, drowsiness, lack of coordination, vomiting, and weakness. If you develop any of these signs, stop taking the drug and call your doctor.

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Amitriptyline is in a group of drugs called tricyclic antidepressants. Amitriptyline affects chemicals in the brain that may become unbalanced.

Amitriptyline is used to treat symptoms of depression.

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

What is the most important information I should know about Endep (Amitriptyline)?

Do not use this medication if you are allergic to amitriptyline, or if you have recently had a heart attack. Do not use amitriptyline if you have taken cisapride (Propulsid) or used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

What should I discuss with my healthcare provider before taking Endep (Amitriptyline)?

Do not use this medication if you are allergic to amitriptyline, or if you have recently had a heart attack. Do not use amitriptyline if you have taken cisapride (Propulsid) or used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take amitriptyline before the MAO inhibitor has cleared from your body.

Before taking amitriptyline, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease;
• a history of heart attack, stroke, or seizures;
• bipolar disorder (manic-depression);
• schizophrenia or other mental illness;
• diabetes (amitriptyline may raise or lower blood sugar);
• overactive thyroid;
• glaucoma; or
• problems with urination.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take amitriptyline.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks 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 for at least the first 12 weeks of treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Amitriptyline can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take Endep (Amitriptyline)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking amitriptyline. You may need to stop using the medicine for a short time.

Do not stop using amitriptyline without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Store amitriptyline at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of amitriptyline can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, blurred vision, feeling hot or cold, sweating, muscle stiffness, feeling light-headed, fainting, seizure (convulsions), or coma.

Endep (Amitriptyline) 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.

Call your doctor at once if you have any new or worsening symptoms 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:

• fast, pounding, or uneven heart rate, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• hallucinations, or seizures (convulsions), feeling light-headed, fainting;
• restless muscle movements in your eyes, tongue, jaw, or neck, uncontrollable shaking or tremor;
• skin rash, severe tingling, numbness, pain, muscle weakness;
• easy bruising or bleeding;
• extreme thirst with headache, nausea, vomiting, and weakness; or
• urinating less than usual or not at all.

Less serious side effects may include:

• nausea, vomiting, constipation, diarrhea, loss of appetite;
• dry mouth, unpleasant taste;
• feeling dizzy, drowsy, or tired;
• trouble concentrating;
• nightmares;
• blurred vision, headache, ringing in your ears;
• breast swelling (in men or women); or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Endep (Amitriptyline)?

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants).

Before taking amitriptyline, tell your doctor if you have used an “SSRI” antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking amitriptyline, tell your doctor if you are currently using any of the following drugs:

• cimetidine (Tagamet);
• guanethidine (Ismelin);
• disulfiram (Antabuse); or
• heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

This list is not complete and there are many other medicines that can interact with amitriptyline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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Elavil is in a group of drugs called tricyclic antidepressants. Elavil affects chemicals in the brain that may become unbalanced.

Elavil is used to treat symptoms of depression.

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

What is the most important information I should know about Elavil (Amitriptyline)?

Do not use Elavil if you are allergic to amitriptyline, or if you have recently had a heart attack. Do not use Elavil if you have taken cisapride (Propulsid) or used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

What should I discuss with my healthcare provider before taking Elavil (Amitriptyline)?

Do not use Elavil if you are allergic to amitriptyline, or if you have recently had a heart attack. Do not use Elavil if you have taken cisapride (Propulsid) or used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Elavil before the MAO inhibitor has cleared from your body.

Before taking Elavil, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease;
• a history of heart attack, stroke, or seizures;
• bipolar disorder (manic-depression);
• schizophrenia or other mental illness;
• diabetes (Elavil may raise or lower blood sugar);
• overactive thyroid;
• glaucoma; or
• problems with urination.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Elavil.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks 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 for at least the first 12 weeks of treatment.

FDA pregnancy category C. Elavil may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Elavil can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give Elavil to anyone under 18 years old without the advice of a doctor.

How should I take Elavil?

Take Elavil exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Elavil. You may need to stop using the medicine for a short time.

Do not stop using Elavil without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Store Elavil at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Elavil can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, blurred vision, feeling hot or cold, sweating, muscle stiffness, feeling light-headed, fainting, seizure (convulsions), or coma.

Elavil (Amitriptyline) 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.

Call your doctor at once if you have any new or worsening symptoms 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:

• fast, pounding, or uneven heart rate, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• hallucinations, or seizures (convulsions), feeling light-headed, fainting;
• restless muscle movements in your eyes, tongue, jaw, or neck, uncontrollable shaking or tremor;
• skin rash, severe tingling, numbness, pain, muscle weakness;
• easy bruising or bleeding;
• extreme thirst with headache, nausea, vomiting, and weakness; or
• urinating less than usual or not at all.

Less serious side effects may include:

• nausea, vomiting, constipation, diarrhea, loss of appetite;
• dry mouth, unpleasant taste;
• feeling dizzy, drowsy, or tired;
• trouble concentrating;
• nightmares;
• blurred vision, headache, ringing in your ears;
• breast swelling (in men or women); or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Elavil (Amitriptyline)?

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants).

Before taking Elavil, tell your doctor if you have used an “SSRI” antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking Elavil, tell your doctor if you are currently using any of the following drugs:

• cimetidine (Tagamet);
• guanethidine (Ismelin);
• disulfiram (Antabuse); or
• heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

This list is not complete and there are many other medicines that can interact with Elavil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

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Mirtazapine is an antidepressant. Mirtazapine affects chemicals in the brain that may become unbalanced and cause depression.

Mirtazapine is used to treat major depressive disorder.

Mirtazapine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Remeron (Mirtazapine)?

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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. Do not use mirtazapine if you have used an MAO inhibitor within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.

Before taking mirtazapine, tell your doctor if you have bipolar disorder, liver or kidney disease, seizures, heart disease, a history of heart attack or stroke, or a history of drug abuse or suicidal thoughts.

It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Avoid drinking alcohol. It can increase some of the side effects of mirtazapine. Mirtazapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking Remeron (Mirtazapine)?

You should not take this medication if you are allergic to mirtazapine.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks 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 for at least the first 12 weeks of treatment.

Do not use mirtazapine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take mirtazapine before the MAO inhibitor has cleared from your body.

Before taking mirtazapine, tell your doctor if you are allergic to any drugs, or if you have:

• liver or kidney disease;
• bipolar disorder (manic depression);
• seizures or epilepsy;
• heart disease, including angina (chest pain);
• a history of heart attack or stroke; or
• a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may not be able to use mirtazapine, or you may need a dosage adjustment or special tests during treatment.

Mirtazapine is in the FDA pregnancy category C. This means that it is not known whether mirtazapine will harm an unborn baby. Do not take mirtazapine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether mirtazapine passes into breast milk. Do not take mirtazapine without first talking to your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the side effects of this medication.

The orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of mirtazapine if you have phenylketonuria (PKU).

How should I take Remeron (Mirtazapine)?

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

Take the regular tablet form of mirtazapine with water.

To take mirtazapine orally disintegrating tablets (Remeron SolTab):

• Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may break the tablet.
• Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
• Swallow several times as the tablet dissolves. No water is needed.

Mirtazapine is usually taken once a day at bedtime. Follow your doctor’s instructions.

It may take up to several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Store mirtazapine at room temperature, away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, memory problems, drowsiness, and fast heart rate.

Remeron (Mirtazapine) side effects

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

Call your doctor at once if you have any new or worsening symptoms 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:

• fever, chills, body aches, flu symptoms;
• white patches or sores inside your mouth or on your lips; or
• feeling like you might pass out.

Less serious side effects include:

• drowsiness, dizziness, weakness;
• nausea, stomach pain;
• constipation;
• increased appetite, weight gain;
• dry mouth; or
• thirst.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Remeron (Mirtazapine)?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by mirtazapine. Tell your doctor if you need to use any of these other medicines while you are taking mirtazapine.

There may be other drugs that can interact with mirtazapine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Bupropion is an antidepressant medication.

Bupropion is used to treat major depressive disorder and seasonal affective disorder. At least one brand (Zyban) is used to help people stop smoking by reducing cravings and other withdrawal effects.

Bupropion may also be used for purposes other than those listed in this medication guide.

Important information about Bupropion

Do not take bupropion if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl), or tranylcypromine (Parnate) in the last 14 days. You should not take bupropion if you have seizures, an eating disorder, if you are using a second form of bupropion, or if you have suddenly stopped using alcohol or sedatives.

Bupropion may cause seizures, especially in people with certain medical conditions or when using certain drugs. Tell your doctor about all of your medical conditions and the drugs you use.

You may have thoughts about suicide when you first start taking an antidepressant, such as bupropion, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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. Do not smoke at any time if you are using a nicotine product along with Zyban. Too much nicotine can cause serious side effects. Avoid drinking alcohol while taking bupropion. Alcohol may increase your risk of a seizure while you are taking bupropion.

Before taking Bupropion

Do not take bupropion if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl), or tranylcypromine (Parnate) in the last 14 days. You should not take bupropion if you have:

• epilepsy or a seizure disorder;
• an eating disorder such as anorexia or bulimia;
• if you are using a second form of bupropion; or
• if you have suddenly stopped using alcohol or sedatives (such as Valium).

Bupropion may cause seizures, especially in people with certain medical conditions or when using certain drugs. Tell your doctor about all of your medical conditions and the drugs you use.

If you have certain conditions, may need a dose adjustment or special tests to safely take this medication. Before taking bupropion, tell your doctor if you have:

• heart disease, high blood pressure, history of heart attack;
• a history of head injury, seizures, or brain or spinal cord tumor;
• kidney disease;
• liver disease (especially cirrhosis);
• bipolar disorder (manic depression);

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks 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 for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking bupropion, tell your doctor if you are pregnant or plan to become pregnant during treatment. Bupropion passes into breast milk and could be harmful to a nursing baby. Do not take this medicine without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone younger than 18 years old without the advice of a doctor.

How should I take Bupropion?

Take bupropion exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Bupropion can be taken with or without food.

Do not crush, chew, or break the extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

If you take Zyban (bupropion) to help you stop smoking, you may continue to smoke for about 1 week after you start the medicine. Set a date to quit smoking during the second week of Zyban treatment. By that time you will have enough of the medicine in your blood stream to help you quit smoking. Talk to your doctor if you are having trouble quitting after you have used Zyban for at least 7 weeks.

Your doctor may prescribe nicotine patches or gum to help support your smoking cessation treatment. Be sure you read all directions and safety information for the nicotine product. Using nicotine with Zyban may raise your blood pressure and your doctor may want to check your blood pressure regularly. Do not smoke at any time if you are using a nicotine product along with Zyban. Too much nicotine can cause serious side effects.

Do not stop taking bupropion without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.

If you use the bupropion extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.

Store bupropion at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include seizures, muscle stiffness, hallucinations, fainting, fast or uneven heartbeat, or shallow breathing.

Bupropion side effects

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

Call your doctor at once if you have any new or worsening symptoms 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 a serious side effect such as:

• seizure (convulsions);
• severe blistering, peeling, and red skin rash;
• fever, swollen glands, rash or itching, joint pain, or general ill feeling;
• confusion, trouble concentrating; or
• hallucinations, unusual thoughts or behavior.

Less serious side bupropion effects may include:

• headache or migraine;
• sleep problems (insomnia);
• nausea, vomiting, constipation, dry mouth;
• dizziness, tremors (shaking);
• appetite changes, weight loss or gain;
• mild itching or skin rash, increased sweating; or
• loss of interest in sex.

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

Bupropion Dosing Information

Usual Adult Dose for Depression:

Immediate release tablets:
Initial dose: 100 mg orally twice a day.
Maintenance dose: The dosage may be increased in 75 to 100 mg/day increments not more often than every 3 days up to the usual maintenance dose of 100 mg orally 3 times a day. The maximum dose is 450 mg/day, given in 4 divided doses; bupropion should be discontinued if there is not an adequate response to this dose. Single doses should not exceed 150 mg.

Sustained release tablets:
Initial dose: 150 mg orally once a day in the morning.
Maintenance dose: After at least 4 days, the dose may be increased to 100 to 150 mg twice a day. If there is not adequate improvement after several week, the dose may be increased to a maximum of 200 mg twice a day.

Extended release tablets:
Initial dose: 150 mg bupropion orally once a day in the morning.
Maintenance dose: After at least 4 days, the dose may be increased to 300 mg once a day. If there is not adequate improvement after several week, the dose may be increased to a maximum of 450 mg once a day in the morning.

Usual Adult Dose for Smoking Cessation:

Initial Dose: 150 mg orally once a day.
Maintenance: Based on clinical response, this dosage may be increased to 300 mg/day, given as 150 mg twice a day, no sooner than 3 days after beginning therapy.

Usual Adult Dose for Seasonal Affective Disorder:

Extended-release:
Initial: 150 mg orally once a day in the morning
Titration: If tolerated, after 7 days dose may be increased to maximum dose of 400 mg once a day administered in the morning. Patients who are unable to tolerate this increase in dose should be reduced back to 150 mg orally once a day.

Usual Geriatric Dose for Depression:

Initial dose: 75 mg bupropion orally twice a day.
Maintenance dose: 75 mg orally 3 times a day.
Maximum doses:
Immediate Release: 150 mg orally 3 times a day.
Sustained Release: 400 mg given as 200 mg twice a day.

Usual Pediatric Dose for Attention Deficit Disorder:

Immediate release tablets:
6 to 18 years:
20 to 30 kg: 50 to 150 mg/day in 2 divided doses (investigational).
31 to 40 kg: 75 to 200 mg/day in 2 divided doses (investigational).
>40 kg: 100 to 250 mg/day in 2 divided doses (investigational).

Extended release tablets:
<11 years: Safety and effectiveness have not been established.
11 to 18 years: 150 to 300 mg/day in 2 divided doses (investigational).

What other drugs will affect Bupropion?

Many drugs can interact with bupropion. Below is just a partial list. Tell your doctor if you are using:

• cancer medicine such as cyclophosphamide (Cytoxan, Neosar) or thiotepa (Thioplex);
• heart rhythm medication such as flecainide (Tambocor), propafenone (Rythmol), and others; or
• heart or blood pressure medication such as atenolol (Tenormin), metoprolol (Lopressor, Toprol), propranolol (Inderal), and others.

This list is not complete and there are many other medicines that can interact with bupropion. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you. You may have a higher risk of seizures if you use certain medications together with bupropion. Tell your doctor about all other medications you use, especially:

• any other antidepressant, or a medicine to treat a psychiatric disorder;
• antihistamines that make you sleepy;
• asthma medications or bronchodilators;
• birth control pills or hormone replacement estrogens;
• bladder or urinary medications such as oxybutynin (Ditropan, Urotrol);
• certain antibiotics such as cefdinir (Omnicef), cephalexin (Keflex), ciprofloxacin (Cipro), amoxicillin (Amoxil, Augmentin), penicillin, and others;
• diet pills, a stimulant, or ADHD medication such as Adderall or Ritalin;
• insulin or diabetes medications you take by mouth;
• medication for nausea, vomiting, or motion sickness;
• medications to treat or prevent malaria;
• medicines to treat Parkinson’s disease, restless leg syndrome, or pituitary gland tumor (prolactinoma);
• medicines used to prevent organ transplant rejection;
• narcotic pain medication;
• a sedative such as diazepam (Valium), and others;
• a steroid such as prednisone, and others;
• street drugs such as “speed” or cocaine;
• theophylline (Theo-Dur, Slo-Bid, Bronkodyl Theolair, Respbid); or
• ulcer or irritable bowel medications.

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