Protriptyline (Oral route)
In short-term studies, antidepressants increased the risk of suicidal thinking and behavior compared with placebo in children, adolescents, and young adults with psychiatric disorders, including major depressive disorder (MDD); there was not an increased risk of suicidality with antidepressants in adults older than 24 years and there was a decreased risk of suicidality in adults aged 65 years or older. The risk of suicidal thinking and behavior should be balanced with the clinical need for therapy and patients should be monitored closely; instruct families and caregivers to communicate any changes in behavior with the prescriber. Not approved for use in pediatric patients .
Uses of This Medicine:
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 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:
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.
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.
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.
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.
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.
- Methylene Blue
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.
- Arsenic Trioxide
- Iobenguane I 123
- Morphine Sulfate Liposome
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
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:
- Behavior or mood changes (eg, aggression, panic attacks) or
- Bipolar disorder (mood disorder with mania and depression), or risk of or
- Diabetes or
- Glaucoma (angle-closure type) or
- Heart or blood vessel disease or
- Hyperthyroidism (overactive thyroid) or
- Schizophrenia (mental illness) or
- Seizures, history of or
- Urinary retention (trouble urinating), history of—Use with caution. May make these conditions worse.
- Heart attack, recent—Should not be used in patients with this condition.
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 carefully. Ask your doctor if you have any questions.
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.
- For depression:
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.
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.
Do not take protriptyline with a monoamine oxidase (MAO) inhibitor (eg, 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 this medicine together with cisapride (Propulsid®). Using these medicines together may increase the chance of having serious side effects.
For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide. i
Do not stop taking this medicine without checking first 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, medicine for seizures or barbiturates, 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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- 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
- cool, pale skin
- difficulty with speaking
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- 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
- 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
- pain or discomfort in the arms, jaw, back, or neck
- 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
- 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
- Symptoms of overdose
- Change in consciousness
- 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
- trouble breathing
- weak or feeble pulse
- Incidence not known
- Abdominal or stomach cramps
- bigger, dilated, or enlarged pupils (black part of the eye)
- black tongue
- difficulty having a bowel movement (stool)
- enlargement or swelling of the breasts
- hair loss or thinning of the hair
- hives or welts
- increased in sexual ability, desire, drive, or performance
- increased sensitivity of the eyes to light
- increased sensitivity of the skin to sunlight
- pain or discomfort in the chest, upper stomach, or throat
- peculiar taste
- severe sunburn
- small red or purple spots on the skin
- swelling of the testicles
- swelling or inflammation of the mouth
- swollen, painful, or tender lymph glands on side of the face or neck
- unexpected or excess milk flow from the breasts
- waking to urinate at night
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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: 11/4/2014