Oleptro

Name: Oleptro

Description

Oleptro (trazodone hydrochloride) is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water.

Chemical Name: 2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]-s-triazolo[4,3-a]pyridin-3(2H)-one monohydrochloride

Structural Formula:

Molecular Formula: C19H22ClN5O •HCl

Molecular Weight: 408.32

Oleptro tablets containing 150 mg or 300 mg of trazodone hydrochloride are designed to release their drug content over a 24-hour period and are intended for once-a-day dosing.

Inactive Ingredients:
Hydroxypropyl distarch phosphate (Contramid®)
Hypromellose
Sodium stearyl fumarate
Colloidal silicon dioxide
Iron Oxide Yellow
Iron Oxide Red
Talc
Polyethylene Glycol 3350
Titanium Dioxide
Polyvinyl Alcohol
Black ink (food grade)

Oleptro Precautions

Important Information about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions:

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

More information about antidepressant medications:

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

Do not drink alcohol with Oleptro.

Oleptro can cause drowsiness and dizziness. Avoid getting up too fast from a sitting or lying position.

Do not drive or operate machinery until you know how Oleptro affects you.

Oleptro and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Oleptro Usage

Take Oleptro exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

  • Take Oleptro at the same time every day in the late evening, preferably at bedtime, on an empty stomach.
  • Swallow Oleptro tablets whole or you can break the tablets in half along the score line.
  • Do not chew or crush Oleptro tablets.
  • When discontinued, gradual dose reduction is recommended.
  • Avoid alcohol.

Other Requirements

  • Store this medicine at room temperature (20°-25°C [68°-77°F]).
  • Keep this and all medicines out of the reach of children.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of trazodone can be fatal when it is taken with alcohol, barbiturates such as phenobarbital, or sedatives such as diazepam (Valium).

Overdose symptoms may include extreme drowsiness, vomiting, penis erection that is painful or prolonged, fast or pounding heartbeat, seizure (black-out or convulsions), or breathing that slows or stops.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Very bad headache.
  • Very bad dizziness or passing out.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Swelling.
  • Feeling confused.
  • Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Oleptro is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Oleptro or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Oleptro. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Patient Counseling Information

See Medication Guide (17.2).

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Oleptro and should counsel them in its appropriate use.

Patients should be warned that:

  • There is a potential for increased risk of suicidal thoughts especially in children, teenagers and young adults.
  • The following symptoms should be reported to the physician: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania and mania.
  • They should inform their physician if they have a history of bipolar disorder, cardiac disease or myocardial infarction.
  • Serotonin syndrome could occur and symptoms may include changes in mental status (e.g., agitation, hallucinations, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
  • Patients should be advised that taking Oleptro can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. [see Warnings and Precautions (5.3)]
  • Trazodone hydrochloride has been associated with the occurrence of priapism.
  • There is a potential for hypotension, including orthostatic hypotension and syncope.
  • There is a potential risk of bleeding (including life-threatening hemorrhages) and bleeding related events (including ecchymosis, hematoma, epistaxis, and petechiae) with the concomitant use of trazodone hydrochloride and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding.
  • Withdrawal symptoms including anxiety, agitation and sleep disturbances, have been reported with trazodone. Clinical experience suggests that the dose should be gradually reduced.

Patients should be counseled that:

  • Oleptro may cause somnolence or sedation and may impair the mental and/or physical ability required for the performance of potentially hazardous tasks. Patients should be cautioned about operating hazardous machinery, including automobiles until they are reasonably certain that the drug treatment does not affect them.
  • Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.
  • Women who intend to become pregnant or who are breastfeeding should discuss with a physician whether they should continue to use Oleptro, since use in pregnant and nursing women is not recommended.

Important Administration Instructions:

  • Oleptro should be swallowed whole or broken in half along the score line.
  • In order to maintain its controlled-release properties, it should not be chewed or crushed.
  • Oleptro should be taken at the same time every day, in the late evening preferably at bedtime, on an empty stomach.

Angelini Pharma Inc.

Gaithersburg, MD 20877

© 2014, Angelini Pharma Inc.

All rights reserved.

U.S. Patent Nos. 6,607,748, 7,829,120 and 8,133,893

Oleptro™ is a trademark of Angelini Pharma Inc.

Contramid® is a registered trademark of Paladin Labs Inc.

[June 2014]

Before taking this medicine

You should not use Oleptro if you are allergic to trazodone, or if you are being treated with methylene blue injection.

Do not use Oleptro if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking trazodone, you must wait at least 14 days before you start taking an MAOI.

To make sure Oleptro is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • heart disease;

  • a bleeding or blood clotting disorder;

  • seizures or epilepsy;

  • narrow-angle glaucoma;

  • bipolar disorder (manic depression);

  • a history of Long QT syndrome;

  • a history of drug abuse or suicidal thoughts; or

  • if you have recently had a heart attack.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Oleptro. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking Oleptro. Do not start or stop taking this medicine during pregnancy without your doctor's advice.

It is not known whether trazodone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. Oleptro is not approved for use in children.

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