SINEquan

SINEquan is a prescription medication used to treat depression and anxiety. SINEquan belongs to a group of drugs called TCAs. These work by altering chemical signals in the brain.

This medication comes in capsule and in an oral solution form.

The capsule and oral solutions can be taken one or multiple times a day.

Common side effects of SINEquan include sleepiness, nausea and upset stomach.

SINEquan may cause drowsiness. Do not drive or operate heavy machinery until you know how SINEquan affects you.

SINEquan is a prescription medication used to treat:

• Psychoneurotic patients with depression and/or anxiety.
• Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol).
• Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly).
• Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.

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

Common side effects of SINEquan include sleepiness, nausea and upset stomach.

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

These are not all the possible side effects of SINEquan. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

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

SINEquan and other medicines may affect each other causing side effects. SINEquan may affect the way other medicines work, and other medicines may affects how SINEquan works. Especially tell your healthcare provider if you take:

• a monoamine oxidase inhibitor (MAOI)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac,Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• cimetidine (Tagamet) or other medicines that can affect certain liver enzymes
• certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathing
• the diabetes medicine tolazamide

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Take SINEquan exactly as prescribed

What is the most important information I should know about this medication, depression, and other serious mental illnesses, and suicidal thoughts or actions?

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

• 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.

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 this medication 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.

2. Psychosis. SINEquan may cause changes in behavior. Tell your doctor if you notice any changes in behavior.

3. Drowsiness. SINEquan can cause drowsiness. Do not drive or operate heavy machinery until you know how SINEquan affects you.

Do not take SINEquan if you:

• take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI in the last 14 days (2 weeks). Ask your healthcare provider if you are not sure if your medicine is an MAOI.
• have an eye problem called narrow angle glaucoma that is not being treated
• have trouble urinating
• are allergic to any of the ingredients in SINEquan.

While taking SINEquan, avoid the following:

• You should not drink alcohol while taking SINEquan. Alcohol can increase your chances of getting serious side effects with SINEquan.
• You should not drive, operate heavy machinery, or do other dangerous activities after taking SINEquan.
• Avoid taking other medicines that can make you sleepy. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take SINEquan with your other medicines

Medicines 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 SINEquan there are no specific foods that you must exclude from your diet when receiving SINEquan.

Before you take SINEquan, tell your healthcare provider if you:

• have a history of depression, mental illness, or suicidal thoughts
• have severe sleep apnea
• have kidney or liver problems
• have a history of drug or alcohol abuse or addiction
• have a history of glaucoma or urinary retention
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if SINEquan will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. SINEquan can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take SINEquan. You should not breast-feed while taking SINEquan.

Tell your doctor about all of the medicines you take including prescription and nonprescription 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. SINEquan can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take SINEquan. You should not breast-feed while taking SINEquan.

Take SINEquan exactly as prescribed.

SINEquan comes in capsule and in an oral solution form and is taken taken one or multiple times a day.

• In more severely ill patients higher doses may be required with a gradual increase to 300 mg/day if necessary.
• If taking once a day, take the dose at bedtime.
• Anti-anxiety effect will be seen before the antidepressant effect. The antidepressant effect may take 2 to 3 weeks to occur.

• For most patients, a starting daily dose of 75 mg is recommended. Dosage may be increased or decreased at appropriate intervals and according to dose response. The usual dose range is 75 mg/day to 150 mg/day.
• In more severely ill patients higher doses may be required with a gradual increase to 300 mg/day if necessary.
• In patients with very mild symptoms, some patients may be on doses as low as 25-50 mg/day.
• The total daily dosage of SINEquan capsules may be given on a divided or once-a-day dosage schedule. If the once-a-day schedule is employed, the maximum recommended dose is 150 mg/day. This dose may be given at bedtime. The 150 mg capsule strength is not recommended for starting treatment.
• Anti-anxiety effect will be seen before the antidepressant effect. The antidepressant effect may take 2 to 3 weeks to occur.

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

• Keep SINEquan and all medicines out of the reach of children.
• Store SINEquan capsules and SINEquan oral solution at 20°-25°C (68°-77°F).

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 SINEquan 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. SINEquan is not approved for use in pediatric patients.