Doxepin Hydrochloride Oral capsule

What is this medicine?

DOXEPIN (DOX e pin) is used to treat depression and anxiety.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bipolar disorder

• difficulty passing urine

• glaucoma

• heart disease

• if you frequently drink alcohol containing drinks

• liver disease

• lung or breathing disease, like asthma or sleep apnea

• prostate trouble

• schizophrenia

• seizures

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to doxepin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• arsenic trioxide

• certain medicines used to regulate abnormal heartbeat or to treat other heart conditions

• cisapride

• halofantrine

• levomethadyl

• linezolid

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methylene blue

• other medicines for mental depression

• phenothiazines like perphenazine, thioridazine and chlorpromazine

• pimozide

• procarbazine

• sparfloxacin

• St. John's Wort

• ziprasidone

This medicine may also interact with the following medications:

• cimetidine

• tolazamide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. It can take several days before you feel the full effect of this medicine. If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get severe side effects. Ask your doctor or health care professional for advice. Even after you stop taking this medicine it can still affect your body for several days.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• abnormal production of milk in females

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast enlargement in both males and females

• breathing problems

• confusion, hallucinations

• excessive thirst and/or hunger

• fast, irregular or pounding heartbeat

• fever with sweating

• muscle stiffness, or spasms

• passing urine more times in a day

• seizures

• suicidal thoughts or other mood changes

• swelling of the testicles

• tingling, pain, or numbness in the feet or hands

• trouble passing urine or change in the amount of urine

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance

• constipation, or diarrhea

• nausea, vomiting

• weight gain or loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Doxepin Hydrochloride Oral solution

What is this medicine?

DOXEPIN (DOX e pin) is used to treat depression and anxiety.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bipolar disorder

• difficulty passing urine

• glaucoma

• heart disease

• if you frequently drink alcohol containing drinks

• liver disease

• lung or breathing disease, like asthma or sleep apnea

• prostate trouble

• schizophrenia

• seizures

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to doxepin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Measure the correct amount of medicine with the special dropper provided. Just before taking, dilute the solution with half a glass (4 oz.) of water, milk, or orange, grapefruit, tomato, prune or pineapple juice. Do not mix with a carbonated beverage or grape juice, they can stop the medicine from working properly. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• arsenic trioxide

• certain medicines used to regulate abnormal heartbeat or to treat other heart conditions

• cisapride

• halofantrine

• levomethadyl

• linezolid

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methylene blue

• other medicines for mental depression

• phenothiazines like perphenazine, thioridazine and chlorpromazine

• pimozide

• procarbazine

• sparfloxacin

• St. John's Wort

• ziprasidone

This medicine may also interact with the following medications:

• cimetidine

• tolazamide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. It can take several days before you feel the full effect of this medicine.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• abnormal production of milk in females

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breast enlargement in both males and females

• breathing problems

• confusion, hallucinations

• fast, irregular or pounding heartbeat

• fever with sweating

• increased hunger or thirst

• muscle stiffness, or spasms

• passing urine more times in a day

• seizures

• suicidal thoughts or other mood changes

• swelling of the testicles

• tingling, pain, or numbness in the feet or hands

• trouble passing urine or change in the amount of urine

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance

• constipation, or diarrhea

• nausea, vomiting

• weight gain or loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Doxepin Hydrochloride Oral tablet

What is this medicine?

DOXEPIN (DOX e pin) is used to treat insomnia. This medicine helps you sleep through the night.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bipolar disorder

• depression

• difficulty passing urine

• glaucoma

• heart disease

• history of a drug or alcohol abuse problem

• liver disease

• lung or breathing disease, like asthma or sleep apnea

• prostate trouble

• schizophrenia

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to doxepin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, and not within 3 hours of a meal. This medicine should be taken within 30 minutes of going to sleep and only when you are able to get a full night of sleep before you must be active again. Do not take it more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine should only be taken before going to sleep. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• arsenic trioxide

• certain medicines used to regulate abnormal heartbeat or to treat other heart conditions

• cisapride

• halofantrine

• levomethadyl

• linezolid

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methylene blue

• other medicines for mental depression

• phenothiazines like perphenazine, thioridazine and chlorpromazine

• pimozide

• procarbazine

• sparfloxacin

• St. John's Wort

• ziprasidone

This medicine may also interact with the following medications:

• cimetidine

• tolazamide

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. Talk to your doctor if you still have trouble sleeping within 7 to 10 days of using this medicine. This may mean there is another cause for your sleep problems.

Do not take this medicine unless you are able to get a full night of sleep before you must be active again. After taking this medicine, do not drive, use machinery, or do anything that needs mental alertness. Take this medicine only within 30 minutes of going to bed and then confine your activities to those needed to get ready for sleep. You may still feel drowsy the next day after taking this medicine. If this happens, do not drive, use machinery, or do anything that needs mental alertness until you feel fully awake. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you drink alcohol or have taken another medicine for sleep, since your risk of doing these sleep-related activities will be increased.

Patients and their families should watch out for new or worsening thoughts of suicide or depression. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This medicine can cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion, hallucinations

• fast, irregular or pounding heartbeat

• fever or infection

• suicidal thoughts or other mood changes

• trouble passing urine or change in the amount of urine

• unusual activities while asleep like driving, eating, making phone calls

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• daytime drowsiness

• dry mouth

• nausea

• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Doxepin Hydrochloride Topical cream

What is this medicine?

DOXEPIN (DOX e pin) is used on the skin to treat itching caused by certain types of skin disorders.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bipolar disorder

• difficulty passing urine

• glaucoma

• heart disease

• if you frequently drink alcohol containing drinks

• liver disease

• lung or breathing disease, like asthma or sleep apnea

• prostate trouble

• schizophrenia

• seizures

• an unusual or allergic reaction to doxepin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for external use only. Follow the direction on the prescription label. Apply a thin film of cream to the affected area as often as directed. Do not cover the area with a bandage or dressing. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Use your doses at regular intervals. Do not use your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. There should be at least 3 to 4 hours in between each dose. Do not use double or extra doses.

What may interact with this medicine?

• alcohol

• any medicine that makes you drowsy or helps you sleep, such as antihistamines, tranquilizers, barbiturates, seizure medicine, muscle relaxants and others

• cimetidine

• dextromethorphan (included in some cough medicines)

• linezolid

• medicines for correcting heart rhythm problems

• medicines for treating depression, especially MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• methylene blue

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional to check on your progress. Do not use this medicine for more than 8 days.

You may get drowsy or dizzy, especially if you are applying this medicine to large areas. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• burning, tingling feeling on the skin

• changes in vision

• feeling faint or lightheaded, falls

• fast heartbeat

• muscle stiffness or problems with movement

• pain or difficulty passing urine

• seizures

• unusually weak or tired

• worsening of eczema

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in taste

• drowsiness or dizziness

• dry mouth or thirst

• dry, tight skin

• headache

• skin scaling and cracking

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 27 degrees C (80 degrees F). Throw away any unused medicine after the expiration date.