Surmontil

DRUG DESCRIPTION

Surmontil (trimipramine maleate) is 5-(3-dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form).

Surmontil (trimipramine maleate) structural formula illustration

Molecular Formula: C20H26N2 • C4H4O4      Molecular Weight: 410.5

Surmontil capsules contain trimipramine maleate equivalent to 25 mg, 50 mg, or 100 mg of trimipramine as the base. The inactive ingredients present are black ink, FD&C Blue 1, gelatin, lactose, magnesium stearate, and titanium dioxide. The 25 mg dosage strength also contains benzyl alcohol, D&C Yellow 10, edetate calcium disodium, FD&C Yellow 6, parabens (butyl, propyl and methyl), sodium lauryl sulfate, and sodium propionate; the 50 mg dosage strength also contains benzyl alcohol, D&C Red 28, edetate calcium disodium, FD&C Red 40, FD&C Yellow 6, parabens (butyl, propyl and methyl), sodium lauryl sulfate, and sodium propionate.

Trimipramine maleate is prepared as a racemic mixture which can be resolved into levorotatory and dextrorotatory isomers. The asymmetric center responsible for optical isomerism is marked in the formula by an asterisk. Trimipramine maleate is an almost odorless, white or slightly cream-colored, crystalline substance, melting at 140°-144° C. It is very slightly soluble in ether and water, is slightly soluble in ethyl alcohol and acetone, and freely soluble in chloroform and methanol at 20° C.

What are the possible side effects of trimipramine (Surmontil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these...

Read All Potential Side Effects and See Pictures of Surmontil »

What are the precautions when taking trimipramine (Surmontil)?

See also the Warning section.

Before taking trimipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., agranulocytosis, thrombocytopenia), breathing problems (e.g., asthma, chronic obstructive pulmonary disorder-COPD), diabetes,...

Read All Potential Precautions of Surmontil »


Surmontil Consumer (continued)

SIDE EFFECTS: See also the Warning section.

Dizziness, drowsiness, difficulty urinating, headache, weakness, changes in appetite/weight, dry mouth, blurred vision, and constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., confusion, depression, hallucinations, nervousness), numbness/tingling of the hands/feet, ringing in the ears, sexual problems, shakiness (tremors), severe vomiting/constipation.

Tell your doctor immediately if any of these rare but very serious side effects occur: slow/fast/irregular heartbeat, severe headache, pain/redness/swelling of arms or legs.

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, slurred speech, weakness on one side of the body, vision changes, chest pain, jaw/left arm pain.

This medication may rarely cause serious blood problems (e.g., agranulocytosis, thrombocytopenia) or liver problems. Tell your doctor immediately if you notice any of the following rare but very serious side effects: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), severe stomach/abdominal pain, dark urine, yellowing of the eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also the Warning section.

Before taking trimipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., agranulocytosis, thrombocytopenia), breathing problems (e.g., asthma, chronic obstructive pulmonary disorder-COPD), diabetes, electroshock therapy, certain eye problems (e.g., glaucoma, increased intraocular pressure), heart problems (e.g., arrhythmias, coronary artery disease, heart failure), intestinal problems (e.g., chronic constipation, ileus), kidney problems, liver problems, other mental/mood conditions (e.g., bipolar disorder, psychosis), family history of mental/mood conditions (e.g., suicide, bipolar disorder), seizures, conditions that may increase your risk of seizures (e.g., bulimia, organic brain disease, alcohol withdrawal), overactive thyroid (hyperthyroidism), problems urinating (urinary retention, enlarged prostate).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. If you have diabetes, check your blood sugar level regularly as directed by your doctor. Tell your doctor immediately if you have symptoms such as increased thirst or urination, unusual sweating, shakiness or hunger. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug (e.g., dizziness, confusion).

Caution is advised when using this drug in children (see also the Warning section).

This medication should be used only when clearly needed during pregnancy. Infants born to mothers who have taken similar medications during pregnancy may develop trouble urinating, lethargy, shaking (tremors), and seizures. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Surmontil Patient Information Including Side Effects

Brand Names: Surmontil

Generic Name: trimipramine (Pronunciation: trye MI pra meen)

  • What is trimipramine (Surmontil)?
  • What are the possible side effects of trimipramine (Surmontil)?
  • What is the most important information I should know about trimipramine (Surmontil)?
  • What should I discuss with my healthcare provider before taking trimipramine (Surmontil)?
  • How should I take trimipramine (Surmontil)?
  • What happens if I miss a dose (Surmontil)?
  • What happens if I overdose (Surmontil)?
  • What should I avoid while taking trimipramine (Surmontil)?
  • What other drugs will affect trimipramine (Surmontil)?
  • Where can I get more information?

What is trimipramine (Surmontil)?

Trimipramine is in a group of drugs called tricyclic antidepressants. Trimipramine affects chemicals in the brain that may become unbalanced.

Trimipramine is used to treat symptoms of depression.

Trimipramine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of trimipramine (Surmontil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heart rate;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • confusion, hallucinations, or seizure (convulsions);
  • easy bruising or bleeding, unusual weakness;
  • feeling light-headed, fainting;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • urinating more or less than usual;
  • extreme thirst with headache, nausea, vomiting, and weakness; or
  • skin rash, bruising, severe tingling, numbness, pain, and muscle weakness.

Less serious side effects may be more likely to occur, such as:

  • nausea, vomiting, stomach pain, loss of appetite;
  • constipation or diarrhea;
  • dry mouth, unpleasant taste;
  • weakness, lack of coordination;
  • numbness or tingly feeling;
  • feeling dizzy, or drowsy;
  • blurred vision, headache, ringing in your ears;
  • mild skin rash;
  • low fever;
  • breast swelling (in men or women); or
  • decreased sex drive, impotence, or difficulty having an orgasm.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about trimipramine (Surmontil)?

Do not use this medication if you are allergic to trimipramine, or if you have recently had a heart attack.

Do not use trimipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

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