Sinequan

DRUG DESCRIPTION

SINEQUAN® (doxepin hydrochloride) is one of a class of psychotherapeutic
agents known as dibenzoxepin tricyclic compounds. The molecular formula of the
compound is C₁₉H₂₁NO•HCl having a molecular weight of
316. It is a white crystalline solid readily soluble in water, lower alcohols
and chloroform.

Inert ingredients for the capsule formulations are: hard gelatin capsules (which may contain Blue 1, Red 3, Red 40, Yellow 10, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch.

Inert ingredients for the oral concentrate formulation are: glycerin; methylparaben; peppermint oil; propylparaben; water.

Chemistry

SINEQUAN (doxepin HCl) is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of:

1-Propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-,
hydrochloride.

What are the possible side effects of doxepin (Adapin, Sinequan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of...

Read All Potential Side Effects and See Pictures of Sinequan »

What are the precautions when taking doxepin (Sinequan)?

See also Warning section.

Before taking doxepin, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as nortriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, breathing problems, liver problems, recent heart attack, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis), family history of suicide, seizures,...

Read All Potential Precautions of Sinequan »

Sinequan Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, dry mouth, blurred vision, constipation, or trouble urinating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: persistent heartburn, mental/mood changes (such as anxiety, agitation, confusion), shaking, severe stomach/abdominal pain.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fast/irregular heartbeat, fainting, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking doxepin, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as nortriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, breathing problems, liver problems, recent heart attack, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), personal or family history of mental/mood conditions (such as bipolar disorder, psychosis), family history of suicide, seizures, conditions that may increase your risk of seizures (such as other brain disease, alcohol/sedative withdrawal).

Doxepin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using doxepin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using doxepin safely.

This drug may make you drowsy or dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

If you have diabetes, this drug may make it harder to control your blood sugar levels. Monitor your blood sugar levels regularly and tell your doctor of the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Caution is advised when using this drug in older adults because they may be more sensitive to its side effects, especially dry mouth, dizziness, drowsiness, confusion, and difficulty urinating.

During pregnancy, this medication should be used only when clearly needed. Since untreated depression can be a serious condition, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Sinequan Patient Information Including Side Effects

Brand Names: Adapin, Sinequan

Generic Name: doxepin (Pronunciation: DOX e pin)

• What is doxepin (Sinequan)?


• What are the possible side effects of doxepin (Sinequan)?


• What is the most important information I should know about doxepin (Sinequan)?


• What should I discuss with my healthcare provider before taking doxepin (Sinequan)?


• How should I take doxepin (Sinequan)?


• What happens if I miss a dose (Sinequan)?


• What happens if I overdose (Sinequan)?


• What should I avoid while taking doxepin (Sinequan)?


• What other drugs will affect doxepin (Sinequan)?


• Where can I get more information?

What is doxepin (Sinequan)?

Doxepin is in a group of drugs called tricyclic antidepressants. Doxepin affects chemicals in the brain that may become unbalanced.

Doxepin is used to treat symptoms of depression and/or anxiety associated with alcoholism, psychiatric conditions, or manic-depressive conditions.

Doxepin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of doxepin (Sinequan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heart rate;


• confusion, hallucinations, or seizure (convulsions);


• easy bruising or bleeding, unusual weakness;


• feeling light-headed, fainting;


• restless muscle movements in your eyes, tongue, jaw, or neck;


• tremors or uncontrollable shaking;


• urinating less than usual or not at all; or


• extreme thirst with headache, nausea, vomiting, and weakness.

Less serious side effects may include:

• nausea, vomiting, constipation, loss of appetite;


• dry mouth;


• weight changes;


• weakness, lack of coordination;


• numbness or tingly feeling;


• feeling dizzy, drowsy, or tired;


• sleep problems (insomnia), nightmares;


• blurred vision, headache, ringing in your ears;


• increased sweating;


• breast swelling (in men or women); or


• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about doxepin (Sinequan)?

Do not use this medication if you are allergic to doxepin, or if you have glaucoma or problems with urination.

Do not use doxepin if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take doxepin before the MAO inhibitor has cleared from your body.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

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