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Oleptro™ (trazodone hydrochloride extended-release tablets), a novel once-daily formulation of the antidepressant trazodone, is now commercially available in the United States. Oleptro is approved as a treatment for major depressive disorder in adults. Your doctor may also prescribe it for other conditions.
This new formulation is thought to increase the activity of serotonin, one of the brain chemicals that helps elevate mood.
How to take this medication
- Take Oleptro exactly as your healthcare provider tells you.
- Oleptro should be taken once a day.
- Oleptro should be taken at the same time each day in the late evening, if possible at bedtime, on an empty stomach.
- Oleptro should be swallowed whole or broken in half along the score line. Do not chew or crush Oleptro.
- If you miss a dose of Oleptro, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
- Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
What are possible side effects?
The most common side effects of Oleptro include:
- Sleepiness
- Dizziness
- Constipation
- Blurry vision
- Decreased sexual desire or ability
These effects may be worse if you take it with alcohol or certain medicines.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Serious side effects include:
- Serotonin syndrome. Symptoms include: agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, nausea, vomiting, diarrhea.
- Feeling high or in a very good mood, then becoming irritable, or having too much energy, talkativeness, not sleeping (Mania).
- Irregular or fast heartbeat or faint.
- Low blood pressure: Feeling dizzy or faint when you change positions.
- Unusual bruising or bleeding.
- Erection lasting for more than 6 hours.
- Low blood sodium: Symptoms include: headache, feeling weak, feeling confused, trouble concentrating, memory problems and unsteadiness.
- Severe allergic reactions: rash, hives, itching, difficulty breathing, tightness in the chest.
Get medical help right away if you have any of the symptoms listed above.
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Contact your doctor right away if you have any suicidal thoughts.
This is not a complete list of all side effects that may occur. For more information, ask your healthcare provider or pharmacist.
What should I tell my doctor before taking Oleptro?
Tell your healthcare provider if you:
- Have heart problems or a family history of it.
- Have ever had a heart attack.
- Have bipolar disorder.
- Have liver or kidney problems.
- Have other serious medical conditions.
- Are pregnant or plan to become pregnant. Oleptro may harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
- Are breastfeeding or plan to breastfeed. It is not known if Oleptro passes into your breast milk. You and your healthcare provider should decide if you will take Oleptro or breastfeed.
- Have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks.
- Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using Oleptro with certain other medicines can cause serious side effects.
- Tell your doctor or dentist that you take Oleptro Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
| Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. |
Read complete patient information for Oleptra here.
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Sources:
Angelini Labopharm: Oleptra
U.S. Food and Drug Administration (FDA)
Page updated October 1, 2010 |
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