TRANYLCYPROMINE SULFATE: Package Insert and Label Information (Page 4 of 4)

What are the possible side effects of Tranylcypromine Sulfate Tablets?

Tranylcypromine Sulfate tablets may cause serious side effects, including:

  • See “What is the most important information I should know about Tranylcypromine Sulfate tablets?”
  • Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Tranylcypromine Sulfate tablets with certain other medicines. See, “Who should not take Tranylcypromine Sulfate?” Symptoms of serotonin syndrome may include:
  • agitation, confusion
  • seeing or hearing things that are not real (hallucinations)
  • coma
  • rapid pulse
  • changes in blood pressure
  • dizziness
  • sweating
  • flushing
  • high body temperature (hyperthermia)
  • fever
  • seizures
  • tremors, stiff muscles, or muscle twitching
  • becoming unstable
  • nausea, vomiting, diarrhea

If you have these symptoms, call your healthcare provider or go to the nearest hospital emergency room right away.

  • Mania or hypomania (manic episodes) in people who have a history of bipolar disorder.
  • agitation, confusion
  • seeing or hearing things that are not real (hallucinations)
  • coma
  • rapid pulse
  • changes in blood pressure
  • dizziness
  • sweating
  • flushing
  • high body temperature (hyperthermia)
  • fever
  • seizures
  • tremors, stiff muscles, or muscle twitching
  • becoming unstable
  • nausea, vomiting, diarrhea
  • Low blood pressure (hypotension) including a drop in your blood pressure when you stand or sit up (postural hypotension). This can happen more often in people who have high blood pressure (hypertension) and when the Tranylcypromine Sulfate tablets dose is changed. Postural hypotension may cause you to feel dizzy and faint (syncope).
  • Changes in your blood pressure (hypotension or hypertension) during surgery and during the time around surgery (perioperative). Taking Tranylcypromine Sulfate tablets with certain medicines used for anesthesia can cause hypotension or hypertension. If you plan to have surgery, tell your surgeon or the healthcare provider who will give you anesthesia that you take Tranylcypromine Sulfate tablets. Your healthcare provider should stop Tranylcypromine Sulfate tablets as least 10 days before you have surgery.
  • Withdrawal symptoms. Talk with your healthcare provider before you stop taking Tranylcypromine Sulfate tablets. Symptoms of withdrawal may include:
  • dizziness
  • nausea
  • headache
  • irritability and agitation
  • problems sleeping
  • diarrhea
  • anxiety
  • abnormal dreams
  • sweating
  • confusion
  • electric shock sensation (paresthesia)
  • tiredness
  • changes in your mood
  • hypomania
  • ringing in your ears (tinnitus)
  • seizures
  • Liver problems
  • Seizures (convulsions). Seizures have happened in people who take too much Tranylcypromine Sulfate tablets.
  • Low blood sugar (hypoglycemia). Hypoglycemia has happened in people with diabetes who take medicines to lower blood sugar. Talk with your healthcare provider about checking your blood sugar during treatment with Tranylcypromine Sulfate tablets. Tell your healthcare provider if your blood sugar gets low.
  • Worsening of symptoms that can happen with depression, such as anxiety and agitation.

The most common side effects of Tranylcypromine Sulfate tablets include:

  • dry mouth
  • dizziness
  • problems sleeping
  • feeling sleepy
  • headache
  • overexcitement
  • constipation
  • blurry vision
  • shakiness (tremor)

These are not all the side effects of Tranylcypromine Sulfate.

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

How do I store Tranylcypromine Sulfate tablets?

  • Store Tranylcypromine Sulfate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]
  • Store Tranylcypromine Sulfate tablets in a tight, light resistant container.

Keep Tranylcypromine Sulfate tablets and all medicines out of the reach of children.

General information about the safe and effective use of Tranylcypromine Sulfate tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take Tranylcypromine Sulfate tablets for a condition for which it was not prescribed. Do not give Tranylcypromine Sulfate tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Tranylcypromine Sulfate tablets that is written for health professionals.

What are the ingredients in Tranylcypromine Sulfate tablets?
Active Ingredient: tranylcypromine sulfate
Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, talc, and Opadry® II pink 85F14289. Opadry pink is used for purposed of coating and contains the following: FD&C Red # 40, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide.

Manufactured by:
Par Pharmaceutical

Chestnut Ridge, NY 10977

For more information, contact Par Pharmaceutical at 1-800-828-9393

This Medication Guide has been approved by the U.S. Food and Drug Administration. R08/2018

PRINCIPAL DISPLAY PANEL

10 mg label
(click image for full-size original)
TRANYLCYPROMINE SULFATE tranylcypromine sulfate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRANYLCYPROMINE SULFATE (TRANYLCYPROMINE) TRANYLCYPROMINE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FD&C RED NO. 40
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
Product Characteristics
Color PINK (PINK) Score no score
Shape ROUND ((biconvex)) Size 9mm
Flavor Imprint Code 250;K
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-032-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040640 06/30/2006 11/30/2024
Labeler — Par Pharmaceutical, Inc. (092733690)
Registrant — Par Pharmaceutical Inc. (092733690)

Revised: 05/2022 Par Pharmaceutical, Inc.

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