protriptyline (Oral route)

proe-TRIP-ti-leen

Oral route(Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

  • Vivactil

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

Uses For protriptyline

Protriptyline is used to treat the symptoms of mental depression. protriptyline is a tricyclic antidepressant (TCA) .

Slideshow: Depression, the Risk of Suicide, and Treatment Options

protriptyline is available only with your doctor's prescription .

Before Using protriptyline

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For protriptyline, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to protriptyline 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of protriptyline in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of protriptyline in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require an adjustment in the dose for patients receiving protriptyline .

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking protriptyline, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

  • Amifampridine
  • Bepridil
  • Cisapride
  • Clorgyline
  • Dronedarone
  • Grepafloxacin
  • Isocarboxazid
  • Levomethadyl
  • Linezolid
  • Mesoridazine
  • Methylene Blue
  • Metoclopramide
  • Moclobemide
  • Phenelzine
  • Pimozide
  • Piperaquine
  • Ranolazine
  • Selegiline
  • Sparfloxacin
  • Thioridazine
  • Tranylcypromine

Using protriptyline 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.

  • Alfuzosin
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Amprenavir
  • Apomorphine
  • Aprindine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azithromycin
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clonidine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Desvenlafaxine
  • Dextromethorphan
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Enflurane
  • Epinephrine
  • Erythromycin
  • Escitalopram
  • Etilefrine
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Frovatriptan
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indacaterol
  • Iobenguane I 123
  • Iproniazid
  • Isoflurane
  • Isradipine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levalbuterol
  • Levofloxacin
  • Levothyroxine
  • Lopinavir
  • Lorcainide
  • Lumefantrine
  • Mefloquine
  • Meperidine
  • Methadone
  • Methoxamine
  • Midodrine
  • Mifepristone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Naratriptan
  • Nefopam
  • Nilotinib
  • Norepinephrine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxilofrine
  • Oxymorphone
  • Paliperidone
  • Pargyline
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Phenylephrine
  • Posaconazole
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Quetiapine
  • Quinidine
  • Quinine
  • Rasagiline
  • Risperidone
  • Salmeterol
  • Saquinavir
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sultopride
  • Sunitinib
  • Tapentadol
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Umeclidinium
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vortioxetine
  • Ziprasidone
  • Zolmitriptan
  • Zotepine

Using protriptyline with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Arbutamine
  • Atomoxetine
  • Cannabis
  • Carbamazepine
  • Dicumarol
  • Flecainide
  • Paroxetine
  • Phenprocoumon
  • S-Adenosylmethionine

Interactions with Food/Tobacco/Alcohol

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 protriptyline. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or
  • Heart attack, recent—Should not be used in patients with these conditions .
  • Diabetes or
  • Glaucoma or
  • Heart disease or
  • Overactive thyroid or
  • Schizophrenia or
  • Seizures, history of or
  • Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse .

Proper Use of protriptyline

Take protriptyline 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 .

protriptyline comes with a medication guide. Read and follow the instructions in the guide carefully. Ask your doctor if you have any questions .

Dosing

The dose of protriptyline 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 protriptyline. 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 (tablets):
    • For depression:
      • Adults—At first, 15 to 40 milligrams (mg) a day divided into three or four doses. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Teenagers and Older Adults—At first, 5 milligrams (mg) three times a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of protriptyline, take it 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using protriptyline

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects .

Protriptyline 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 .

Do not take protriptyline if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking a MAO inhibitor within 5 days of stopping protriptyline. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions .

Do not take other medicines unless they have been discussed with your doctor. Using protriptyline together with cisapride (Propulsid®), may increase the chance of having serious side effects .

Do not stop taking protriptyline without first checking with your doctor. Your doctor may want you to gradually reduce 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, or a general feeling of discomfort or illness .

protriptyline will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). 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. This effect may last for a few days after you stop taking protriptyline. Check with your doctor before taking any of the above while you are using protriptyline.

Before having any kind of surgery, tell the medical doctor in charge that you are using protriptyline. Taking protriptyline together with medicines used during surgery may increase the risk of side effects .

protriptyline 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 .

protriptyline may cause some people to become drowsy. Make sure you know how you react to protriptyline before you drive, use medicines, or do anything else that could be dangerous if you are drowsy or not alert.

protriptyline Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Abdominal or stomach pain
  • actions that are out of control
  • agitation
  • anxiety
  • black, tarry stools
  • bleeding and bruising
  • bleeding gums
  • blood in urine or stools
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • clay-colored stools
  • cold sweats
  • coma
  • confusion about identity, place, and time
  • continuing ringing, buzzing, or other unexplained noise in ears
  • convulsions
  • cool, pale skin
  • cough or hoarseness
  • dark urine
  • decrease in frequency of urination
  • decrease in urine volume
  • decreased urine output
  • depression
  • difficulty in passing urine (dribbling)
  • difficulty in speaking
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • double vision
  • drooling
  • dry mouth
  • false beliefs that cannot be changed by facts
  • fast, pounding, or irregular heartbeat or pulse
  • fear or nervousness
  • feeling of warmth
  • feeling, seeing, or hearing things that are not there
  • feeling that others can hear your thoughts
  • feeling that others are watching you or controlling your behavior
  • fever with or without chills
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of tiredness or weakness
  • headache
  • hearing loss
  • hostility
  • hyperventilation
  • inability to move arms, legs, or facial muscles
  • inability to speak
  • increased hunger
  • increased need to urinate
  • increased thirst
  • increased urination
  • irritability
  • itching
  • lack of coordination
  • lethargy
  • loss of appetite
  • loss of balance control
  • lower back or side pain
  • mood or mental changes
  • muscle spasm or jerking of all extremities
  • muscle trembling or twitching
  • nausea
  • nightmares
  • pain or discomfort in arms, jaw, back, or neck
  • painful or difficult urination
  • panic
  • passing urine more often
  • perspiration
  • pinpoint red or purple spots on skin
  • pounding in the ears
  • rapid weight gain
  • rash
  • redness of the face, neck, arms, and occasionally, upper chest
  • restlessness
  • seizures
  • shakiness and unsteady walk
  • shortness of breath
  • shuffling walk
  • sleeplessness
  • slow speech
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • stiffness of limbs
  • stupor
  • sudden loss of consciousness
  • sweating
  • swelling of face, ankles, or hands
  • swollen glands
  • talking, feeling, and acting with excitement
  • trouble in holding or releasing urine
  • trouble sleeping
  • twisting movements of body uncontrolled movements, especially of face, neck, and back
  • unable to sleep
  • unpleasant breath odor
  • unsteadiness or awkwardness
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual behavior
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • weakness in arms, hands, legs, or feet
  • weight gain or loss
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of Overdose
  • Change in consciousness
  • clumsiness
  • decreased awareness or responsiveness
  • difficulty sleeping
  • disorientation
  • disturbed concentration
  • drowsiness to profound coma
  • enlarged pupils
  • increased or excessive unconscious or jerking movements
  • loss of consciousness
  • low body temperature
  • muscle aches
  • muscle tightness
  • muscle weakness
  • shivering
  • severe sleepiness
  • trouble breathing
  • weak or feeble pulse

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:

Incidence not known
  • Abdominal cramps
  • bigger, dilated, or enlarged pupils (black part of eye)
  • black tongue
  • bloating
  • decreased interest in sexual intercourse
  • diarrhea
  • difficulty having a bowel movement (stool)
  • disturbance of accommodation
  • enlargement of the breasts
  • hair loss, thinning of hair
  • heartburn
  • hives or welts
  • inability to have or keep an erection
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • increased sensitivity of eyes to light
  • increased sensitivity of skin to sunlight
  • increased urge to urinate during the night
  • loss in sexual ability, desire, drive, or performance
  • pain or discomfort in chest, upper stomach, or throat
  • peculiar taste
  • redness or other discoloration of skin
  • severe sunburn
  • small red or purple spots on skin
  • swelling of testicles
  • swelling of the breasts or breast soreness in both females and males
  • swelling or inflammation of the mouth
  • swollen, painful, or tender lymph glands on side of face or neck
  • unexpected or excess milk flow from breasts
  • waking to urinate at night

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

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

See also: Side effects (in more detail)

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