Oleptro

Oleptro is a prescription medication used to treat depression. Oleptro belongs to a group of drugs called serotonin modulators, which affect the natural substance, serotonin, in the brain.

This medication comes as an extended release tablet and is taken once a day in the late evening, preferably at bedtime, on an empty stomach.

Oleptro tablets should be swallowed whole or broken in half along the score line. Do not chew or crush tablets.

Common side effects of Oleptro include drowsiness, dizziness, and dry mouth.  Do not drive or operate machinery until you know how Oleptro will affect you.

Oleptro is a prescription medication used to treat depression. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Angelini Pharma Inc.

Oleptro and other antidepressant medications can cause serious side effects (see "Drug Precautions").

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

Some of the less serious side effects of Oleptro are:

• drowsiness
• dizziness
• dry mouth
• nausea/vomiting
• headache

This is not a complete list of Oleptro side effects. Ask your doctor for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Many medicines can interact with Oleptro. Talk to your doctor if you take one of the following medicines:

• antifungal medicine (ketoconazole, itraconazole, fluconazole)
• warfarin (coumadin)
• antidepressants
• MAO inhibitors
• digoxin
• phenytoin
• carbamazepine
• HIV medicines

These are not all the possible drug interactions with Oleptro. Ask your doctor or pharmacist for more information.

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.

Grapefruit and grapefruit juice may interact with Oleptro and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor if you are allergic to any ingredient in Oleptro.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Oleptro is excreted in human breast milk or if it will harm your nursing baby.

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.

Take Oleptro exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The recommended dose of Oleptro is 150 mg once daily. May be increased by 75 mg per day every three days. Maximum dose: 375 mg per day.

If you take too much Oleptro, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

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

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Oleptro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Oleptro tablets are not approved for use in pediatric patients.