Vivactil

Vivactil is a prescription medication used to treat the symptoms of depression in people who are under close medical supervision. Vivactil is in a class of medications called tricyclic antidepressants (TCAs). It works by increasing the levels of certain natural substances in the brain that play a part in mental balance.

Vivactil is available as an oral (by mouth) tablet and is usually taken 3 or 4 times a day.

Common side effects of Vivactil include nausea, vomiting, and dry mouth. Vivactil can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Vivactil affects you.

Vivactil is a prescription medication used to treat the symptoms of depression in people who are under close medical supervision.

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

• Odyssey Pharmaceuticals, Inc.

Serious side effects have been reported with Vivactil. See the “Vivactil Precautions” section.

Common side effects of Vivactil include the following:

• nausea
• vomiting
• dry mouth
• loss of appetite
• weight changes
• stomach pain or cramps
• heartburn
• changes in urination habits
• changes in sex drive
• rining in the ears
• dizziness
• drowsiness
• blurred vision

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

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

• cisapride (Propulsid) (not available in the U.S.)
• monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• amiodarone (Cordarone, Pacerone)
• antihistamines; bupropion (Wellbutrin)
• celecoxib (Celebrex)
• cimetidine (Tagamet)
• doxorubicin (Adriamycin)
• guanethidine (Ismelin)
• ipratropium (Atrovent)
• medications for anxiety, asthma, colds, diabetes, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• medications for irregular heartbeat such as flecainide (Tambocor), moricizine (Ethmozine), and propafenone (Rythmol)
• methadone (Dolophine)
• metoclopramide (Reglan)
• other antidepressants
• quinidine
• ranitidine (Zantac)
• reserpine (Serpasil)
• ritonavir (Norvir)
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)
• sedatives or sleeping pills
• terbinafine (Lamisil)
• thyroid medications
• tramadol (Ultram
• tranquilizers

This is not a complete list of Vivactil drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vivactil including the following:

• Cardiovascular side effects. Tell your healthcare provider right away if you have some or all of the following symptoms of cardiovascular side effects:
  • heart attack
  • stroke
  • heart block
  • rapid or irregular heartbeat
  • changes in blood pressure
• Psychiatric side effects. Tell your healthcare provider right away if you have some or all of the following symptoms of psychiatric side effects:
  • confusion
  • delusions
  • anxiety
  • restlessness
  • disorientation
  • panic
  • insomnia
  • agitation
  • nightmares
• Neurological side effects. Tell your healthcare provider right away if you have some or all of the following symptoms of neurological side effects:
  • seizures
  • incoordination
  • tremors
  • numbness or tingling in arms or legs
  • drowsiness
  • dizziness
  • weakness or fatigue
  • headache
  • ringing in the ears
• Allergic reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction:
  • fever
  • rash, hives, or itching
  • swelling or face or tongue

Vivactil can cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Vivactil affects you.

Do not take Vivactil if you:

• are allergic to Vivactil or any of its ingredients
• have taken a monoamine oxidase inhibitor within the last 14 days
• are taking cisapride
• have recently had a heart attack

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vivactil, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vivactil, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Vivactil or to any of its ingredients
• have recently had a heart attack
• drink large amounts of alcohol
• are undergoing electroshock therapy
• have an enlarged prostate
• have difficulting urinating
• have a history of mental illness
• have had seizures
• have hyperthyroidism
• have diabetes

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.

Vivactil has not been classified into one of these categories because safe use in pregnancy has not been established. The use of Vivactil in pregnant women or women who may become pregnant requires that possible benefits be weighed against possible hazards to the mother and child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Safe use of Vivactil during breastfeeding has not been established. The use of Vivactil in nursing women requires that possible benefits be weighed against possible hazards to the mother and child.

Take Vivactil exactly as prescribed.

Vivactil comes in oral tablet form and is taken 3 or 4 times a day, with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Vivactil at the same time.

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

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended initial dose of Vivactil is 15 to 40 mg per day divided into 3 or 4 doses. The maximum recommended dose of Vivactil is 60 mg per day.

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

If Vivactil is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Store Vivactil at room temperature.
• Keep this and all medications out of the reach of children.
• Avoid prolonged exposure to the sun while taking Vivactil.

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 protriptyline hydrochloride 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. Protriptyline hydrochloride is not approved for use in pediatric patients.