Doxepin Oral Solution (Concentrate)

Doxepin Hydrochloride (dox’ e pin hye”droe klor’ ide)

Oral Solution USP (Concentrate)

Increased risk of suicidal thoughts and actions. Doxepin hydrochloride and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Doxepin hydrochloride is not for use in children.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

·        Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.

·        Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions.

·        Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency help right away if you or a family member have any of the following symptoms, especially if they are new, worse, or worry you:

o   suicide attempts                                                             o thoughts about suicide or dying

o    acting aggressive, being angry, or violent                o acting on dangerous impulses

o   new or worse depression                                              o new or worse anxiety

o   panic attacks                                                                   o feeling very agitated or restless

o    new or worse irritability                                              o trouble sleeping

o   an extreme increase in activity or talking (mania)         o other unusual changes in behavior or mood

See “What are the possible side effects of doxepin hydrochloride?” for more information about side effects.

Doxepin hydrochloride is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD).

It is not known if doxepin hydrochloride is safe and effective for use in children.

·      are allergic to doxepin, or any of the ingredients in doxepin hydrochloride. See the end of this Medication Guide for a complete list of ingredients in doxepin hydrochloride

·      have glaucoma

·      have or have had trouble urinating

·      are taking, or have stopped taking within the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue

o    Ask your healthcare provider or pharmacist if you are not sure if you are taking an MAOI, including the antibiotic linezolid or intravenous methylene blue

o   Do not start taking an MAOI for at least 14 days after you stop treatment with doxepin hydrochloride

·         have, or have a family history of bipolar disorder, mania, or hypomania

·         have or had depression, suicidal thoughts or behavior

·         have kidney or liver problems

·         have or had seizures or convulsions

·        are pregnant or plan to become pregnant. Taking doxepin hydrochloride during your third trimester of pregnancy may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with doxepin hydrochloride

o   Babies born to mothers who take certain medicines, including doxepin hydrochloride, during the third trimester of pregnancy may have symptoms of sedation, such as breathing problems, sluggishness, low muscle tone, feeding problems, and withdrawal symptoms. Talk to your healthcare provider about the risks to your unborn or newborn baby if you take doxepin hydrochloride during pregnancy

o   There is a pregnancy registry for women who are exposed to doxepin hydrochloride during pregnancy. The purpose of this registry is to collect information about the health of women exposed to doxepin hydrochloride and their babies. If you become pregnant during treatment with doxepin hydrochloride, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/

·        are breastfeeding or plan to breastfeed. Doxepin hydrochloride can pass into your breast milk and harm your baby. Do not breastfeed during treatment with doxepin hydrochloride. Talk to your healthcare provider about the best way to feed your baby during treatment with doxepin hydrochloride

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Doxepin hydrochloride and other medicines may affect each other causing possible serious side effects. Doxepin hydrochloride may affect the way other medicines work and other medicines may affect the way doxepin hydrochloride works.

Especially tell your healthcare provider if you take:

·        medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)

·        medicines to treat migraine headaches known as triptans

·        other tricyclic antidepressants

·        tetracyclic antidepressants

·        opioids

·        lithium

·        tryptophan

·        buspirone

·        St. John’s Wort

·        carbamazepine

·        cimetidine

·        tolazamide

·        medicines that can cause drowsiness

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take doxepin hydrochloride with your other medicines.

Do not start or stop any other medicines during treatment with doxepin hydrochloride without first talking to your healthcare provider.

Know the medicines you take. Keep a list of them to show to your healthcare providers when you start to take a new medicine.

·     Take doxepin hydrochloride exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking doxepin hydrochloride without first talking to your healthcare provider.

·     Your healthcare provider may need to change the dose of doxepin hydrochloride until it is the right dose for you.

·     For people taking doxepin hydrochloride oral solution:

o    Use the calibrated dropper that comes with doxepin hydrochloride oral solution to measure the prescribed dose. The calibrated dropper has markings at 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

o    Mix your prescribed dose with 120 mL (4 ounces) of water, whole or skimmed milk, or orange, grapefruit, tomato, prune, or pineapple juice. Do not mix with other liquids.

o    Take the dose right away after mixing.

·     If you miss a dose of doxepin hydrochloride, take the missed dose as soon as you remember. If it is almost time for the next dose, do not take the missed dose and take your next dose at the regular time. Do not take two doses of doxepin hydrochloride at the same time.

·     If you take too much doxepin hydrochloride, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

·         Do not drive a car or another motor vehicle, operate heavy machinery, or do dangerous activities while taking doxepin hydrochloride. Doxepin hydrochloride can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.

·         Do not drink alcohol during treatment with doxepin hydrochloride. Drinking alcohol during treatment with doxepin hydrochloride can increase your risk of having serious side effects.

Doxepin hydrochloride can cause serious side effects, including:

·         See “What is the most important information I should know about doxepin hydrochloride?”

·         Serotonin syndrome. Taking doxepin hydrochloride can cause a potentially life-threatening problem called serotonin syndrome. The risk of developing serotonin syndrome is increased when doxepin hydrochloride is taken with certain other medicines. See “Do not take doxepin hydrochloride if you:” Stop taking doxepin hydrochloride and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:

o     agitation                                                                 o seeing or hearing things that are not real (hallucinations)

o     confusion                                                               o nausea, vomiting, diarrhea

o     fast heartbeat                                                         o coma

o     dizziness                                                                 o changes in blood pressure

o     flushing                                                                   o sweating

o     shaking (tremors), stiff muscles, or muscle twitching              o high body temperature (hyperthermia)

o      loss of coordination                                             o seizures

·         Eye problems (angle-closure glaucoma). Doxepin hydrochloride may cause a type of eye problem called angle-closure glaucoma in people with certain eye problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.

·         Manic episodes. Manic episodes may happen in people with bipolar disorder who take doxepin hydrochloride. Symptoms may include:

o  greatly increased energy                                             o severe trouble sleeping

o  racing thoughts                                                            o reckless behavior

o  unusually grand ideas                                                 o excessive happiness or irritability

o  talking more or faster than usual

·         Seizures (convulsions)

The most common side effects of doxepin hydrochloride include:

·          feeling overly sleepy                                      ·      constipation

·          dry mouth                                                     ·      tiredness

·          dizziness

These are not all the possible side effects of doxepin hydrochloride.

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