Vivactil

Name: Vivactil

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What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Vivactil Overview

Vivactil is a prescription medication used to treat the symptoms of depression in people who are under close medical supervision. Vivactil is in a class of medications called tricyclic antidepressants (TCAs). It works by increasing the levels of certain natural substances in the brain that play a part in mental balance.

Vivactil is available as an oral (by mouth) tablet and is usually taken 3 or 4 times a day.

Common side effects of Vivactil include nausea, vomiting, and dry mouth. Vivactil can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Vivactil affects you.

Vivactil FDA Warning

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of protriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed 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. Protriptyline hydrochloride is not approved for use in pediatric patients.

How should I take Vivactil (protriptyline)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

If you need surgery, tell the surgeon ahead of time that you are using protriptyline. You may need to stop using the medicine for a short time.

Do not stop using protriptyline suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using protriptyline.

It may take a few weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

Cautions for Vivactil

Contraindications

Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.a c (See Specific Drugs under Interactions.)
Concurrent therapy with cisapride.a c (See Specific Drugs under Interactions.)
During the acute recovery phase following MI.a
Known hypersensitivity to protriptyline.a

Warnings/Precautions

Warnings

Shares the toxic potentials of other TCAs; observe the usual precautions of TCA therapy.a b c

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.101 102 103 104 d However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.101 102 103

Appropriately monitor and closely observe patients receiving protriptyline for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.101 102 103 d (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.102 103 Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.101 102 103 (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.102 a d

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder [OCD]) or nonpsychiatric disorders.102 a c

Bipolar Disorder

May unmask bipolar disorder.102 a c (See Activation of Mania or Hypomania under Cautions.) Protriptyline is not approved for use in treating bipolar depression.a

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.102 a c d

Cardiovascular Effects

Tachycardia and postural hypotension may occur more frequently with protriptyline than with other TCAs.a Possible arrhythmias, prolongation of the conduction time, MI, and stroke.a c

Patients with preexisting or prior history of cardiac disease,a c geriatric patients,a and patients with disturbed eating behaviors (e.g., purging) that result in inadequate hydration and/or compromised cardiac status most at risk.c Use with caution and monitor closely (e.g., perform ECG at baseline and as appropriate during therapy).a c

Interactions

May block hypotensive actions of guanethidine and similar compounds.a c (See Specific Drugs under Interactions.)

May enhance CNS depressant effects of alcohol.a c Use with caution in patients with a history of excessive alcohol consumption.a (See Specific Drugs under Interactions.)

Seizures

Lowers seizure threshold; use with caution in patients with a history of seizures.a c

Anticholinergic Effects

Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased IOP, angle-closure glaucoma, prostatic hypertrophy).a c

Thyroid Disorders

Possible cardiovascular toxicity (e.g., arrhythmias); use with caution in hyperthyroid patients or patients receiving thyroid agents.a c

Sensitivity Reactions

Photosensitivity

Photosensitivity reported with TCAs; patients demonstrating photosensitivity should avoid excessive exposure to sunlight.a c

General Precautions

Activation of Mania or Hypomania

Possible activation of mania and hypomania, particularly in patients with bipolar disorder; decrease dosage or administer an antipsychotic agent concomitantly.a c (See Bipolar Disorder under Cautions.)

Psychosis

Possible exacerbation of psychosis in patients with schizophrenia; decrease dosage or administer an antipsychotic agent concomitantly.a c

Anxiety or Agitation

Increased anxiety and agitation may occur, particularly when administered to overactive or agitated patients.a

Electroconvulsive Therapy (ECT)

Possible increased ECT risks; limit to patients for whom concomitant use is essential.a

Elective Surgery

Discontinue therapy several days prior to surgery whenever possible.a c

Blood Glucose Effects

Possible alterations in blood glucose concentrations.a

Withdrawal of Therapy

Possibly withdrawal reactions; avoid abrupt discontinuance of therapy and taper dosage gradually.a c

Specific Populations

Pregnancy

Category C.e

Lactation

Possibly distributed into milk.e Caution if used in nursing women; carefully assess potential benefits and risks.a

Pediatric Use

Safety and efficacy of protriptyline in pediatric patients have not been established.a b

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).102 a d However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.104 No suicides occurred in these pediatric trials.102 104 a d

Carefully consider these findings when assessing potential benefits and risks of protriptyline in a child or adolescent for any clinical use.101 102 103 104 a (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

Insufficient experience from clinical trials in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.a Other reported clinical experience has not revealed differences in clinical responses between geriatric and younger adult patients.a

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.101 102 (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Possible increased sensitivity to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, and orthostatic hypotension effects of TCAs.a c

Use with caution; titrate dosage carefully.a (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Exacerbation of anxiety/agitation, CNS stimulation, dizziness, drowsiness, weakness, fatigue, cardiovascular reactions (e.g., tachycardia, orthostatic hypotension), anticholinergic effects (e.g., dry mouth, constipation, blurred vision).a c k l

Interactions for Vivactil

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP2D6: potential pharmacokinetic interaction (increased plasma protriptyline concentrations) with concomitant use; use with caution.a c Consider protriptyline dosage adjustment whenever a CYP2D6 inhibitor is added or discontinued.a c

Specific Drugs

Drug	Interaction	Comments
Alcohol	Potentiates the effects of alcohola c	Increased risks if overdose or suicide attempt occursa
Antiarrhythmics: class 1C (e.g., flecainide, propafenone); quinidine	Potential for decreased protriptyline metabolisma c	Dosage adjustment may be neededa c
Anticholinergic agents	Possible addictive anticholinergic effects; hyperthermia, particularly during hot weather; and paralytic ileusa c	Use with caution; dosage adjustment may be neededa c
Antipsychotics (e.g., phenothiazines)	Potential for decreased protriptyline metabolisma c	Dosage adjustment may be neededa c
Cimetidine	Possible increased plasma protriptyline concentrationsa c Potential for TCA toxicity, particularly adverse anticholinergic effectsa c	Monitor for TCA toxicity; dosage adjustment may be neededa c
Cisapride	Increased risk of QT interval prolongation and arrhythmiasa c	Concomitant use contraindicateda c
CNS depressants (e.g., analgesics, antihistamines, barbiturates, general anesthetics, opiates)	Potentiates the effects of CNS depressantsa c
Guanethidine and related compounds	Possible antagonism of the antihypertensive effects of guanethidine and related compoundsa c
Levodopa	May interfere with levodopa absorptionc	Monitor levodopa dosage carefullyc
MAO inhibitors	Potentially life-threatening serotonin syndrome a c	Concomitant use contraindicateda c Allow at least 2 weeks to elapse when switching to or from these drugsa c
Methylphenidate	Potential for decreased metabolism and increased therapeutic efficacy and toxicity of TCAsc
SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)	Potential for decreased protriptyline metabolism and increased plasma concentrationsa c	Use with caution; dosage adjustment may be neededa c Allow at least 5 weeks to elapse when switching from fluoxetinea c
Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine)	Increased vasopressor, cardiac effectsa c	Use with caution; dosage adjustment may be requireda c
Thyroid agents	Possible cardiac arrhythmiasa c	Use with caution a c
Tramadol	Possible increased risk of seizuresa c

Uses For Vivactil

Protriptyline is used to treat depression. It is thought to work by increasing the activity of serotonin in the brain. This medicine is a tricyclic antidepressant (TCA).

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

Before Using Vivactil

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.

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 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
Bromopride
Cisapride
Clorgyline
Dronedarone
Grepafloxacin
Isocarboxazid
Levomethadyl
Linezolid
Mesoridazine
Methylene Blue
Metoclopramide
Moclobemide
Phenelzine
Pimozide
Piperaquine
Ranolazine
Safinamide
Selegiline
Sparfloxacin
Terfenadine
Thioridazine
Tranylcypromine
Ziprasidone

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.

Aceclofenac
Acemetacin
Albuterol
Alfentanil
Alfuzosin
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Amphetamine
Amtolmetin Guacil
Anagrelide
Apomorphine
Aprindine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Aspirin
Astemizole
Azithromycin
Benzphetamine
Bromfenac
Bufexamac
Buprenorphine
Bupropion
Buserelin
Butorphanol
Celecoxib
Chloroquine
Chlorpromazine
Choline Salicylate
Ciprofloxacin
Citalopram
Clarithromycin
Clomipramine
Clonidine
Clonixin
Clozapine
Codeine
Crizotinib
Cyclobenzaprine
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desmopressin
Desvenlafaxine
Deutetrabenazine
Dexibuprofen
Dexketoprofen
Dextroamphetamine
Dextromethorphan
Diclofenac
Diflunisal
Dihydrocodeine
Dipyrone
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Droperidol
Droxicam
Efavirenz
Enflurane
Epinephrine
Erythromycin
Escitalopram
Etilefrine
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fingolimod
Flecainide
Floctafenine
Fluconazole
Flufenamic Acid
Fluoxetine
Flurbiprofen
Foscarnet
Frovatriptan
Gatifloxacin
Gemifloxacin
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Halothane
Histrelin
Hydrocodone
Hydromorphone
Hydroxychloroquine
Hydroxyzine
Ibuprofen
Ibutilide
Iloperidone
Imipramine
Indomethacin
Iobenguane I 123
Iproniazid
Isoflurane
Isradipine
Ivabradine
Ketoconazole
Ketoprofen
Ketorolac
Lapatinib
Leuprolide
Levalbuterol
Levofloxacin
Levorphanol
Levothyroxine
Lisdexamfetamine
Lopinavir
Lorcainide
Lornoxicam
Loxoprofen
Lumefantrine
Lumiracoxib
Meclofenamate
Mefenamic Acid
Mefloquine
Meloxicam
Meperidine
Methadone
Methamphetamine
Methoxamine
Metronidazole
Midodrine
Mifepristone
Mirtazapine
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nabumetone
Nafarelin
Nalbuphine
Naproxen
Naratriptan
Nefopam
Nepafenac
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Norepinephrine
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Ondansetron
Oxaprozin
Oxilofrine
Oxycodone
Oxymetazoline
Oxymorphone
Oxyphenbutazone
Paliperidone
Palonosetron
Panobinostat
Parecoxib
Pargyline
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Phenylbutazone
Phenylephrine
Piketoprofen
Pimavanserin
Piroxicam
Pitolisant
Posaconazole
Pranoprofen
Procainamide
Procarbazine
Prochlorperazine
Proglumetacin
Promethazine
Propafenone
Propyphenazone
Proquazone
Quetiapine
Quinidine
Quinine
Rasagiline
Remifentanil
Ribociclib
Risperidone
Rofecoxib
Salicylic Acid
Salsalate
Sertindole
Sertraline
Sevoflurane
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Sodium Salicylate
Solifenacin
Sorafenib
Sotalol
Sufentanil
Sulindac
Sulpiride
Sultopride
Sumatriptan
Sunitinib
Tacrolimus
Tapentadol
Telavancin
Telithromycin
Tenoxicam
Tetrabenazine
Tiaprofenic Acid
Tiotropium
Tolfenamic Acid
Tolmetin
Toremifene
Tramadol
Trazodone
Trifluoperazine
Trimipramine
Triptorelin
Valdecoxib
Vandetanib
Vardenafil
Vasopressin
Vemurafenib
Venlafaxine
Vilanterol
Vilazodone
Vinflunine
Voriconazole
Vortioxetine
Zolmitriptan
Zotepine
Zuclopenthixol

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
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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Very bad dizziness or passing out.
Feeling confused.
A heartbeat that does not feel normal.
Not able to pass urine.
Feeling very tired or weak.
Fever or chills.
Seizures.
Mood changes.
Chest pain or pressure or a fast heartbeat.
Hallucinations (seeing or hearing things that are not there).
Change in balance.
Trouble controlling body movements.
Any unexplained bruising or bleeding.
Yellow skin or eyes.
Behavioral problems.
Sweating a lot.
Ringing in ears.
Change in sex ability.

What are some other side effects of Vivactil?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Dry mouth.
Dizziness.
Upset stomach or throwing up.
Bad dreams.
Feeling sleepy.
Restlessness.
Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Vivactil?

Store at room temperature.
Protect from light.
Store in a dry place. Do not store in a bathroom.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Check with your pharmacist about how to throw out unused drugs.

Medication Guide

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

• all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults when the medicine is first started. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. 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, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is first started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

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

• thoughts about suicide or dying • new or worse irritability • attempts to commit suicide • acting aggressive, being angry, or violent • new or worse depression • acting on dangerous impulses • new or worse anxiety • an extreme increase in activity and talking (mania) • feeling very agitated or restless • other unusual changes in behavior or mood • panic attacks • visual problems: eye pain, changes in vision,
swelling or redness in or around the eye • trouble sleeping (insomnia)

What else do I need to know about antidepressant medicines?

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. • Visual problems: Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information. If you would like more information, call 1-888-838-2872. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Teva Select Brands, Horsham, PA 19044

Division of Teva Pharmaceuticals USA, Inc.

Iss. 5/2014

For the Consumer

Applies to protriptyline: oral tablet

Along with its needed effects, protriptyline (the active ingredient contained in Vivactil) 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 while taking protriptyline:

Incidence not known

Abdominal or stomach pain
agitation or irritability
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
change in urination
chest pain or discomfort
clay-colored stools
cold sweats
confusion about identity, place, and time
continuing ringing, buzzing, or other unexplained noise in the ears
convulsions
cool, pale skin
difficulty with speaking
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
double vision
drooling
false beliefs that cannot be changed by facts
fast, pounding, or irregular heartbeat or pulse
feeling of warmth
feeling, seeing, or hearing things that are not there
feeling that others are watching you or controlling your behavior
feeling that others can hear your thoughts
fever with or without chills
hearing loss
hostility
hyperventilation
inability to move the arms, legs, or facial muscles
lack of coordination
lower back or side pain
mood or mental changes
muscle spasm or jerking of all extremities
muscle trembling or twitching
nightmares
pain or discomfort in the arms, jaw, back, or neck
panic
pinpoint red or purple spots on the skin
pounding in the ears
redness of the face, neck, arms, and occasionally, upper chest
shakiness and unsteady walk
slurred speech
sore throat
sores, ulcers, or white spots on the lips or in the mouth
stiffness of the limbs
stupor
sweating
swelling of face, ankles, or hands
swollen glands
talking, feeling, and acting with excitement
trouble sleeping
twisting movements of body uncontrolled movements, especially of the face, neck, and back
unusual behavior
unusual bleeding or bruising
unusual tiredness or weakness
weakness in the 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 while taking protriptyline:

Symptoms of overdose

Change in consciousness
clumsiness
disorientation
disturbed concentration
drowsiness to profound coma
enlarged pupils
increased or excessive unconscious or jerking movements
low body temperature
muscle aches or tightness
muscle weakness
severe sleepiness
shivering
trouble breathing
weak or feeble pulse

Some side effects of protriptyline 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: