Surmontil

Generic name: Trimipramine
Drug class: Tricyclic antidepressants

Usage of Surmontil

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

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

Surmontil 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

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 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 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.

Before taking Surmontil

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 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 problems have been documented to date. However, 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 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.

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 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.

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 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

Dicumarol

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.

Relate drugs

How to use Surmontil

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.

Warnings

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 (eg, 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 (eg, 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.

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