Antidepressant, tricyclic (Oral route, parenteral route)

Brand Names:

Anafranil
Asendin
Aventyl
Elavil
Norpramin
Pamelor
Prudoxin
Sinequan
Surmontil
Tofranil
Tofranil-PM
Vanatrip
Vivactil

Dosage Forms:

Tablet
Capsule
Solution

Uses of This Medicine:

Tricyclic antidepressants are used to relieve mental depression.

One form of this medicine (imipramine) is also used to treat enuresis (bedwetting) in children. Another form (clomipramine) is used to treat obsessive-compulsive disorders. Tricyclic antidepressants may be used for other conditions as determined by your doctor.

These medicines are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, tricyclic antidepressants are used in certain patients with the following medical conditions:

Attention deficit hyperactivity disorder (hyperactivity in children) (desipramine, imipramine, and protriptyline)
Bulimia (uncontrolled eating, followed by vomiting) (amitriptyline, clomipramine, desipramine, and imipramine)
Cocaine withdrawal (desipramine and imipramine)
Headache prevention (for certain types of frequent or continuing headaches) (most tricyclic antidepressants)
Itching with hives due to cold temperature exposure (doxepin)
Narcolepsy (extreme tendency to fall asleep suddenly) (clomipramine, desipramine, imipramine, and protriptyline)
Neurogenic pain (a type of continuing pain) (amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, and trimipramine)
Nicotine dependence (as an aid to other smoking cessation therapy) (nortriptyline)
Panic disorder (clomipramine, desipramine, doxepin, nortriptyline, and trimipramine)
Stomach ulcer (amitriptyline, doxepin, and trimipramine)
Urinary incontinence (imipramine)

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Children are especially sensitive to the effects of this medicine. This may increase the chance of side effects during treatment. However, side effects in children taking this medicine for bedwetting usually disappear upon continued use. The most common of these are nervousness, sleeping problems, tiredness, and mild stomach upset. If these side effects continue or are bothersome, check with your doctor.

Antidepressants must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure antidepressants are safe and effective in children

Older adults

Drowsiness, dizziness, confusion, vision problems, dryness of mouth, constipation, and problems in urinating are more likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of tricyclic antidepressants.

Pregnancy

Studies have not been done in pregnant women. However, there have been reports of newborns suffering from muscle spasms and heart, breathing, and urinary problems when their mothers had taken tricyclic antidepressants immediately before delivery. Also, studies in animals have shown that some tricyclic antidepressants may cause unwanted effects in the fetus.

Breast-feeding

Tricyclic antidepressants pass into the breast milk. Doxepin has been reported to cause drowsiness in the nursing baby.

Other medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Bepridil
Cisapride
Clorgyline
Furazolidone
Grepafloxacin
Iproniazid
Isocarboxazid
Levomethadyl
Linezolid
Mesoridazine
Moclobemide
Nialamide
Pargyline
Phenelzine
Pimozide
Procarbazine
Selegiline
Sparfloxacin
Terfenadine
Thioridazine
Toloxatone
Tranylcypromine

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Ajmaline
Amiodarone
Amisulpride
Amprenavir
Aprindine
Arsenic Trioxide
Astemizole
Atazanavir
Azimilide
Bretylium
Chloral Hydrate
Chloroquine
Clarithromycin
Clonidine
Clorgyline
Darifenacin
Disopyramide
Dofetilide
Dolasetron
Droperidol
Enflurane
Entacapone
Epinephrine
Erythromycin
Etilefrine
Flecainide
Fluconazole
Fluoxetine
Fosamprenavir
Foscarnet
Gatifloxacin
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Hydroquinidine
Ibutilide
Iproniazid
Isoflurane
Isradipine
Lidoflazine
Linezolid
Lorcainide
Methoxamine
Midodrine
Moxifloxacin
Nefazodone
Nefopam
Nialamide
Norepinephrine
Octreotide
Olanzapine
Oxilofrine
Pargyline
Pentamidine
Phenelzine
Phenylephrine
Pirmenol
Prajmaline
Procainamide
Procarbazine
Prochlorperazine
Propafenone
Quetiapine
Quinidine
Rasagiline
Risperidone
Selegiline
Sematilide
Sertindole
Sertraline
Sotalol
Spiramycin
Sulfamethoxazole
Sultopride
Tedisamil
Telithromycin
Toloxatone
Tramadol
Trifluoperazine
Trimethoprim
Vasopressin
Venlafaxine
Ziprasidone
Zolmitriptan
Zotepine

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse (or history of) Drinking alcohol may cause increased CNS depressant effects.

Asthma or
Bipolar disorder (manic-depressive illness) or
Blood disorders or
Convulsions (seizures) or
Difficult urination or
Enlarged prostate or
Glaucoma or increased eye pressure or
Heart disease or
High blood pressure (hypertension) or
Schizophrenia Tricyclic antidepressants may make the condition worse.

Kidney disease or
Liver disease Higher blood levels of tricyclic antidepressants may result, increasing the chance of side effects.

Overactive thyroid or
Stomach or intestinal problems Tricyclic antidepressants may cause an increased chance of serious side effects.

Proper Use of This Medicine:

To lessen stomach upset, take this medicine with food, even for a daily bedtime dose, unless your doctor has told you to take it on an empty stomach.

Take this medicine only as directed by your doctor , to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Sometimes this medicine must be taken for several weeks before you begin to feel better. Your doctor should check your progress at regular visits.

To use doxepin oral solution:

This medicine is to be taken by mouth even though it comes in a dropper bottle. The amount you should take should be measured with the dropper provided with your prescription and diluted just before you take each dose. Dilute each dose with about one-half glass (4 ounces) of water, milk, citrus fruit juice, tomato juice, or prune juice. Do not mix this medicine with grape juice or carbonated beverages since these may decrease the medicine's effectiveness.
Doxepin oral solution must be mixed immediately before you take it. Do not prepare it ahead of time.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablet):
- For depression:
  - Adults At first, 25 milligrams (mg) two to four times a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 150 mg a day, unless you are in the hospital. Some hospitalized patients may need higher doses.
  - Teenagers At first, 10 mg three times a day, and 20 mg at bedtime. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 100 mg a day.
  - Children 6 to 12 years of age 10 to 30 mg a day.
  - Children up to 6 years of age Use and dose must be determined by your doctor.
  - Older adults At first, 25 mg at bedtime. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 100 mg a day.
For oral dosage form (syrup):
- For depression:
  - Adults At first, 25 mg two to four times a day. Your doctor may increase your dose gradually as needed.
  - Teenagers At first, 10 mg three times a day, and 20 mg at bedtime. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 100 mg a day.
  - Children 6 to 12 years of age 10 to 30 mg a day.
  - Children up to 6 years of age Use and dose must be determined by your doctor.
  - Older adults At first, 10 mg three times a day, and 20 mg at bedtime. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 100 mg a day.
For injection dosage form:
- For depression:
  - Adults 20 to 30 mg four times a day, injected into a muscle.
  - Children up to 12 years of age Use and dose must be determined by your doctor.

For oral dosage form (tablet):
- For depression:
  - Adults At first, 50 milligrams (mg) two to three times a day. Your doctor may increase your dose gradually as needed.
  - Children up to 16 years of age Use and dose must be determined by your doctor.
  - Older adults At first, 25 mg two to three times a day. Your doctor may increase your dose gradually as needed.

For oral dosage forms (capsules or tablets):
- For obsessive-compulsive disorders:
  - Adults At first, 25 milligrams (mg) once a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 250 mg a day, unless you are in the hospital. Some hospitalized patients may need higher doses.
  - Teenagers and children 10 years of age and over At first, 25 mg once a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 200 mg a day.
  - Children up to 10 years of age Use and dose must be determined by your doctor.
  - Older adults At first, 20 to 30 mg a day. Your doctor may increase your dose gradually as needed.

For oral dosage form (tablet):
- For depression:
  - Adults 100 to 200 milligrams (mg) a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 300 mg a day.
  - Teenagers 25 to 50 mg a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 100 mg a day.
  - Children 6 to 12 years of age 10 to 30 mg a day.
  - Older adults 25 to 50 mg a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 150 mg a day.

For oral dosage forms (capsules or solution):
- For depression:
  - Adults At first, 25 milligrams (mg) three times a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 150 mg a day, unless you are in the hospital. Some hospitalized patients may need higher doses.
  - Children up to 12 years of age Use and dose must be determined by your doctor.
  - Older adults At first, 25 to 50 mg a day. Your doctor may increase your dose gradually as needed.

For oral dosage form (tablets):
- For depression:
  - Adults 25 to 50 milligrams (mg) three to four times a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 200 mg a day, unless you are in the hospital. Some hospitalized patients may need higher doses.
  - Adolescents 25 to 50 mg a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 100 mg a day.
  - Children 6 to 12 years of age 10 to 30 mg a day.
  - Children up to 6 years of age Use and dose must be determined by your doctor.
  - Older adults At first, 25 mg at bedtime. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 100 mg a day.
- For bedwetting:
  - Children 25 mg once a day, taken one hour before bedtime. Your doctor may increase the dose as needed, based on the child's age.
For oral dosage form (capsules):
- For depression:
  - Adults At first, 75 mg a day taken at bedtime. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 200 mg a day, unless you are in the hospital. Some hospitalized patients may need higher doses.
  - Children up to 12 years of age Use and dose must be determined by your doctor.
For injection dosage form:
- For depression:
  - Adults Dose must be determined by your doctor. It is injected into a muscle. The dose is usually not more than 300 mg a day.
  - Children up to 12 years of age Use and dose must be determined by your doctor.

For oral dosage forms (capsules or solution):
- For depression:
  - Adults 25 milligrams (mg) three to four times a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 150 mg a day.
  - Teenagers 25 to 50 mg a day. Your doctor may increase your dose gradually as needed.
  - Children 6 to 12 years of age 10 to 20 mg a day.
  - Older adults 30 to 50 mg a day. Your doctor may increase your dose gradually as needed.

For oral dosage form (tablets):
- For depression:
  - Adults At first, 5 to 10 milligrams (mg) three to four times a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 60 mg a day.
  - Teenagers At first, 5 mg three times a day. Your doctor may increase your dose gradually as needed.
  - Children up to 12 years of age Use and dose must be determined by your doctor.
  - Older adults At first, 5 mg three times a day. Your doctor may increase your dose gradually as needed.

For oral dosage forms (capsules or tablets):
- For depression:
  - Adults At first, 75 milligrams (mg) a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 200 mg a day, unless you are hospitalized. Some hospitalized patients may need higher doses.
  - Children up to 12 years of age Use and dose must be determined by your doctor.
  - Older adults At first, 50 mg a day. Your doctor may increase your dose gradually as needed. However, the dose is usually not more than 100 mg a day.

Missed dose

Call your doctor or pharmacist for instructions.

If you miss a dose of this medicine and your dosing schedule is:

One dose a day at bedtime Do not take the missed dose in the morning since it may cause disturbing side effects during waking hours. Instead, check with your doctor.
More than one dose a day Take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose, and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your doctor.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Keep the liquid form of this medicine from freezing.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to allow dosage adjustments and to help reduce side effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine .

Antidepressants may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

This medicine may cause some people to become drowsy. If this occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Tricyclic antidepressants may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
Wear protective clothing, including a hat. Also, wear sunglasses.
Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of the metyrapone test may be affected by this medicine.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking tricyclic antidepressants together with medicines used during surgery or dental or emergency treatments may increase the risk of side effects.

For diabetic patients:

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, and/or an overall feeling of discomfort.

The effects of this medicine may last for 3 to 7 days after you have stopped taking it. Therefore, all the precautions stated here must be observed during this time.

For patients taking protriptyline:

If taken late in the day, protriptyline may interfere with nighttime sleep.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Reported for amoxapine only: Convulsions (seizures); difficult or fast breathing; fever with increased sweating; high or low (irregular) blood pressure; loss of bladder control; muscle stiffness (severe); pale skin; unusual tiredness or weakness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common: Blurred vision; confusion or delirium; constipation (especially in the elderly); decreased sexual ability (more common with amoxapine and clomipramine); difficulty in speaking or swallowing; eye pain; fainting; fast or irregular heartbeat (pounding, racing, skipping); hallucinations; loss of balance control; mask-like face; nervousness or restlessness; problems in urinating; shakiness or trembling; shuffling walk; slowed movements; stiffness of arms and legs

Less common: Lip smacking or puckering; puffing of cheeks; rapid or worm-like movements of tongue; uncontrolled chewing movements; uncontrolled movements of hands, arms, or legs

Rare: Anxiety; breast enlargement in both males and females; hair loss; inappropriate secretion of milk in females; increased sensitivity to sunlight; irritability; muscle twitching; red or brownish spots on skin; ringing, buzzing, or other unexplained sounds in the ears; seizures (more common with clomipramine); skin rash and itching; sore throat and fever; swelling of face and tongue; swelling of testicles (more common with amoxapine); trouble with teeth or gums (more common with clomipramine); weakness; yellow eyes or skin

Symptoms of acute overdose: Confusion; convulsions (seizures); disturbed concentration; drowsiness (severe); enlarged pupils; fast, slow, or irregular heartbeat; fever; hallucinations (seeing, hearing, or feeling things that are not there); restlessness and agitation; shortness of breath or troubled breathing; unusual tiredness or weakness (severe); vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Dizziness; drowsiness; dryness of mouth; headache; increased appetite (may include craving for sweets); nausea; tiredness or weakness (mild); unpleasant taste; weight gain

Less common: Diarrhea; heartburn; increased sweating; trouble in sleeping (more common with protriptyline, especially when taken late in the day); vomiting

Headache; irritability; nausea, vomiting, or diarrhea; restlessness; trouble in sleeping, with vivid dreams; unusual excitement

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Last Updated: 6/12/2013

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