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Protriptyline (Oral route)

Pronunciation:

proe-TRIP-ti-leen

Brand Names:

  • Vivactil

Dosage Forms:

  • Tablet

Warnings:

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 .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Antidepressant, Tricyclic

Uses of This Medicine:

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

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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—

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 .

Older adults—

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.

Other 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 this medicine, 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 this medicine 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 this medicine 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
  • Dasatinib
  • Desipramine
  • Desvenlafaxine
  • Dextromethorphan
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Enflurane
  • Epinephrine
  • Erythromycin
  • Etilefrine
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Frovatriptan
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Indacaterol
  • Iobenguane I 123
  • Iproniazid
  • Isoflurane
  • Isradipine
  • Ivabradine
  • Lapatinib
  • Levalbuterol
  • Levofloxacin
  • Levothyroxine
  • Lopinavir
  • Lorcainide
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Methoxamine
  • Midodrine
  • Mifepristone
  • Moricizine
  • Moxifloxacin
  • Naratriptan
  • Nefopam
  • Nilotinib
  • Norepinephrine
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxilofrine
  • Paliperidone
  • Pargyline
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Phenylephrine
  • Posaconazole
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Quetiapine
  • Quinidine
  • Quinine
  • Rasagiline
  • Risperidone
  • Salmeterol
  • Saquinavir
  • Sertindole
  • Sertraline
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sultopride
  • Sunitinib
  • Tapentadol
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vortioxetine
  • Ziprasidone
  • Zolmitriptan
  • Zotepine

Using this medicine 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

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 this medicine. 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 This Medicine:

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 .

This medicine 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 this medicine 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 this medicine. 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 this medicine, 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 This Medicine:

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 this medicine together with cisapride (Propulsid®), may increase the chance of having serious side effects .

Do not stop taking this medicine 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 .

This medicine 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 this medicine. Check with your doctor before taking any of the above while you are using this medicine.

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

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 .

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

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.

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.


Last Updated: 4/4/2014

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