Surmontil (Oral)

Trimipramine is used to treat depression. It belongs to a group of medicines called tricyclic antidepressants (TCA). These medicines are believed to work by increasing the activity of certain chemicals in the brain.

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

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 trimipramine with a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], linezolid (Zyvox®), methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking trimipramine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping trimipramine before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Trimipramine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use trimipramine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, or some pain or migraine medicines (for example, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with trimipramine.

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.

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 it 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 may cause some people to become dizzy or 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.

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

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, 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.

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.

In deciding to use a medication, the chances of using 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

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other medicines. Additionally inform 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 trimipramine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of trimipramine have not been performed in the geriatric population, no geriatric-specific issues have been documented to date. Nevertheless, elderly patients are more likely to have unwanted effects (eg, confusion or unusual drowsiness) or age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients receiving trimipramine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medicine during breastfeeding. Weigh the potential benefits against the potential chances prior to using this drug while breastfeeding.

Interactions with Medicines

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

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

• Bepridil
• Bromopride
• Cisapride
• Clorgyline
• Dronedarone
• Furazolidone
• Grepafloxacin
• Iproniazid
• Isocarboxazid
• Levoketoconazole
• Levomethadyl
• Linezolid
• Mesoridazine
• Methylene Blue
• Metoclopramide
• Moclobemide
• Pargyline
• Phenelzine
• Pimozide
• Piperaquine
• Potassium Citrate
• Procarbazine
• Ranolazine
• Rasagiline
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tranylcypromine
• Ziprasidone

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

• Abiraterone Acetate
• Acecainide
• Aceclofenac
• Acemetacin
• Adagrasib
• Albuterol
• Alfentanil
• Alfuzosin
• Amantadine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Apomorphine
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Benzhydrocodone
• Benzphetamine
• Bretylium
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Carisoprodol
• Celecoxib
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Choline Salicylate
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clonidine
• Clonixin
• Clothiapine
• Clozapine
• Cobicistat
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desmopressin
• Desvenlafaxine
• Deutetrabenazine
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Diclofenac
• Diflunisal
• Dihydrocodeine
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Droxicam
• Duloxetine
• Efavirenz
• Encorafenib
• Enflurane
• Entrectinib
• Epinephrine
• Erythromycin
• Escitalopram
• Etodolac
• Etofenamate
• Etoricoxib
• Etrasimod
• Fedratinib
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Formoterol
• Foscarnet
• Fostemsavir
• Frovatriptan
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Iloperidone
• Indomethacin
• Inotuzumab Ozogamicin
• Iobenguane I 123
• Iobenguane I 131
• Isoflurane
• Isradipine
• Ivabradine
• Ivosidenib
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Lasmiditan
• Lefamulin
• Lenvatinib
• Leuprolide
• Levalbuterol
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lidoflazine
• Lisdexamfetamine
• Lithium
• Lofexidine
• Lopinavir
• Lorcainide
• Lornoxicam
• Loxapine
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Macimorelin
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Meperidine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Metronidazole
• Mifepristone
• Milnacipran
• Mirtazapine
• Mobocertinib
• 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
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Oxyphenbutazone
• Ozanimod
• Pacritinib
• Paliperidone
• Palonosetron
• Panobinostat
• Parecoxib
• Paroxetine
• Pasireotide
• Pazopanib
• Peginterferon Alfa-2b
• Pentamidine
• Pentazocine
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Piroxicam
• Pitolisant
• Ponesimod
• Posaconazole
• Pranoprofen
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Relugolix
• Remifentanil
• Revefenacin
• Ribociclib
• Risperidone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Scopolamine
• Secretin Human
• Selpercatinib
• Sematilide
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sufentanil
• Sulfamethoxazole
• Sulindac
• Sulpiride
• Sultopride
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tapentadol
• Tedisamil
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tiaprofenic Acid
• Tiotropium
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Toremifene
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Triptorelin
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Voriconazole
• Vortioxetine
• Zolmitriptan
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following drugs may cause an increased risk of certain side effects, but using both drugs may be the best therapy 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
• Dicumarol
• Phenprocoumon
• S-Adenosylmethionine

Interactions with Food/Tobacco/Alcohol

Certain medications 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 inform your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with mania and depression), or chance of or
• Diabetes or
• Glaucoma (angle-closure type) or
• Mania, history of 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.

• Heart or blood vessel disease or
• Hyperthyroidism (overactive thyroid)—Use with caution. May cause side effects to become worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

Along with its needed effects, Surmontil (Oral) may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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
• agitation
• black, tarry stools
• bleeding or bruising
• blood in the 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
• confusion about identity, place, and time
• continuing ringing, buzzing, or other unexplained noise in the ears
• convulsions
• cool, pale skin
• cough or hoarseness
• dark urine
• decrease in the frequency of urination
• decreased urine output or volume
• depression
• difficulty in passing urine (dribbling)
• difficulty with speaking
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• drooling
• dry mouth
• false beliefs that cannot be changed by facts
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling, seeing, or hearing things that are not there
• 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 the arms, legs, or facial muscles
• inability to speak
• increased hunger
• increased need to urinate
• increased thirst
• increased urination
• irritability
• itching or rash
• 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 stiffness
• muscle twitching
• nausea
• nightmares
• pain or discomfort in the arms, jaw, back, or neck
• painful or difficult urination
• passing urine more often
• pinpoint red or purple spots on the skin
• pounding in the ears
• rapid weight gain
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• shakiness and unsteady walk
• shuffling walk
• slow speech
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiffness of the limbs
• sudden loss of consciousness
• sweating
• swelling of the face, ankles, legs, or hands
• swollen glands
• talking, feeling, and acting with excitement
• trouble in holding or releasing urine
• trouble sleeping
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unpleasant breath odor
• unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
• unusual behavior
• unusual tiredness or weakness
• vomiting of blood
• weakness in the arms, hands, legs, or feet
• weight gain or loss
• yellow eyes or skin

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 Surmontil (Oral). 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 or stomach cramps
• bigger, dilated, or enlarged pupils (black part of the eye)
• black tongue
• bloating
• decreased interest in sexual intercourse
• diarrhea
• difficulty having a bowel movement (stool)
• disturbance of accommodation
• enlargement of the breast
• hair loss or thinning of the hair
• heartburn
• hives or welts
• inability to have or keep an erection
• increase in sexual ability, desire, drive, or performance
• increased sensitivity of the eyes to light
• increased sensitivity of the skin to sunlight
• loss in sexual ability, desire, drive, or performance
• pain or discomfort in the chest, upper stomach, or throat
• peculiar taste
• redness or other discoloration of the skin
• severe sunburn
• small red or purple spots on the skin
• swelling of the breasts or breast soreness in both women and men
• swelling of the testicles
• swelling or inflammation of the mouth
• swollen, painful, or tender lymph glands in the neck
• unexpected milk flow from the breasts

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.

In the U.S.

• Surmontil

Available Dosage Forms:

• Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

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 or pharmacist if you have any questions.

Trimipramine can make you sleepy so your doctor may tell you to take the capsule at bedtime.

You may have to take this medicine for a month or longer before you begin to feel better.

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 (capsules):For depression: Adults—At first, 75 milligrams (mg) per day, taken in divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day. Teenagers and older adults—At first, 50 mg per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day. 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.