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Doxepin Hydrochloride Oral solution

It is used to treat depression and anxiety.

Generic Name: doxepin  |  Brand Name: Silenor

Brand Names: Silenor, Doxepin Hydrochloride, Adapin, Sinequan

There is an FDA Alert for this drug. Click here to view it.

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Doxepin is not approved for use in pediatric patients <12 years of age. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on doxepin therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk and Pediatric Use under Cautions.)

REMS:

FDA approved a REMS for doxepin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of doxepin and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

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

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.

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

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.


Last Updated: May 03, 2013
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