Sinequan 10mg Capsules

Doxepin is a tricyclic antidepressant (TCA) that primarily inhibits the reuptake of norepinephrine (NE) and serotonin (5-HT) at presynaptic neuronal membranes, thereby increasing the concentration of these neurotransmitters in the synaptic cleft. It also possesses significant antagonistic activity at histamine H1, muscarinic cholinergic, and alpha-1 adrenergic receptors, contributing to its sedative, anticholinergic, and orthostatic hypotensive effects, respectively. At low doses (3-6 mg), its primary mechanism for insomnia is potent H1 receptor antagonism.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
Difficulty urinating
Feeling extremely nervous or excitable
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Yellowing of the skin or eyes (jaundice)
Ringing in the ears (tinnitus)
Changes in sex interest
Enlarged breasts or nipple discharge
Swelling of the testicles

Important Warning for People with Asthma

If you have asthma, use this medication with caution. Worsening of asthma has been reported in people taking this medication. If your asthma symptoms worsen while taking this medication, contact your doctor right away.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Feeling dizzy, sleepy, tired, or weak
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Dry mouth
Changes in taste
Mouth irritation or mouth sores
Weight gain
Excessive sweating
Flushing
Hair loss
* Headache

Reporting Side Effects

This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms.
Certain health conditions, including:
+ Difficulty urinating
+ Glaucoma
Current or recent use of specific medications, such as:
+ Linezolid
+ Methylene blue
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, including:
- Isocarboxazid
- Phenelzine
- Tranylcypromine
- Selegiline
- Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)
Use of other medications that can cause drowsiness, as combining them with this medication may increase the risk of excessive sleepiness. If you are unsure, consult your doctor or pharmacist.
If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

Your doctor needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Please note that it may take several weeks to experience the full effects of this medication. Do not abruptly stop taking this drug without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this medication, your doctor will instruct you on how to gradually stop taking it to minimize potential side effects.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, consult with your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or impair your reactions.

Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.

This medication may increase your sensitivity to the sun, making you more prone to sunburn. Take necessary precautions when exposed to sunlight, and inform your doctor if you experience excessive sunburning while taking this medication.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. Be aware of signs of high or low blood sugar, such as fruity breath odor, dizziness, rapid breathing, rapid heartbeat, confusion, drowsiness, weakness, flushing, headache, unusual thirst or hunger, frequent urination, shaking, or sweating. Report any of these symptoms to your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Certain medications, including this one, may affect fertility and impact your ability to have children. If you have concerns or questions, discuss them with your doctor.

If you are pregnant or planning to become pregnant, consult with your doctor to weigh the benefits and risks of taking this medication during pregnancy. Taking this drug in the third trimester may lead to health problems in the newborn, so it is essential to discuss this with your doctor.

• Monoamine Oxidase Inhibitors (MAOIs) - risk of hyperpyretic crisis, severe convulsions, and death.
• Cisapride - risk of QT prolongation and arrhythmias.
• Pimozide - risk of QT prolongation and arrhythmias.

• CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - additive CNS depression.
• Anticholinergic agents (e.g., atropine, benztropine, diphenhydramine) - additive anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, delirium).
• Adrenergic neuron blocking agents (e.g., guanethidine, clonidine) - may block antihypertensive effects.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased doxepin plasma levels.
• Thyroid hormones - increased risk of cardiac arrhythmias.
• Cimetidine - increased doxepin plasma levels.
• Sympathomimetics (e.g., epinephrine, norepinephrine) - enhanced pressor response.

• Anticoagulants (e.g., warfarin) - potential for increased anticoagulant effect (monitor INR).
• Barbiturates - may decrease doxepin plasma levels.
• Phenytoin - altered phenytoin levels.
• Oral contraceptives - may increase doxepin plasma levels.

• Not available

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, hypomania, mania)
• Orthostatic dizziness or lightheadedness
• Dry mouth
• Constipation
• Urinary retention
• Blurred vision
• Excessive sedation or drowsiness
• Confusion or disorientation (especially in elderly)
• Tremor
• Seizures
• Skin rash
• Sore throat, fever, or other signs of infection (potential blood dyscrasias)
• Yellowing of skin or eyes, dark urine (potential liver issues)

Category C. Doxepin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Neonates exposed to TCAs in the third trimester have developed withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypertonia, hypotonia, seizures).

L3 (Moderately Safe). Doxepin and its active metabolite (desmethyldoxepin) are excreted into breast milk. While levels are generally low, sedation, poor feeding, and weight gain have been reported in some infants. Use with caution, monitor infant for drowsiness, feeding difficulties, and developmental milestones. Consider alternative agents with better safety profiles if possible, especially in preterm or neonates.

Not FDA approved for depression or anxiety in pediatric patients due to increased risk of suicidality (Black Box Warning). Low-dose doxepin for insomnia is not FDA approved for pediatric use. Use in children and adolescents should be approached with extreme caution and only after careful consideration of risks vs. benefits, with close monitoring.

Elderly patients are more sensitive to the anticholinergic, sedative, and orthostatic hypotensive effects of doxepin. Start with lower doses (e.g., 10-25 mg/day for depression/anxiety, 3 mg for insomnia) and titrate slowly. Doxepin is on the Beers Criteria list for potentially inappropriate medication use in older adults due to its strong anticholinergic properties and risk of orthostatic hypotension and sedation. Monitor closely for falls, cognitive impairment, and urinary retention.

• Doxepin is one of the most sedating TCAs due to its potent H1 receptor antagonism, making it particularly useful for depression with prominent insomnia or for primary insomnia at low doses.
• The low-dose formulation (Silenor) for insomnia is specifically designed to target H1 receptors for sleep promotion with minimal antidepressant effects.
• Due to its anticholinergic properties, doxepin can cause significant dry mouth, constipation, and urinary retention, especially at higher doses. These effects can be particularly problematic in the elderly.
• Orthostatic hypotension is a common side effect, especially at the start of therapy or with dose increases, increasing the risk of falls.
• Withdrawal symptoms (e.g., nausea, headache, malaise, vivid dreams, irritability) can occur if discontinued abruptly, especially after prolonged use. Taper dose gradually.
• Therapeutic drug monitoring (TDM) for doxepin and nordoxepin levels can be useful in cases of non-response, suspected toxicity, or drug interactions, though not routinely performed for low-dose insomnia.

• Other Tricyclic Antidepressants (TCAs): Amitriptyline, Imipramine, Nortriptyline
• Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine
• Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone
• For Insomnia: Zolpidem, Eszopiclone, Zaleplon (Z-drugs), Ramelteon, Suvorexant, Lemborexant, Trazodone, Mirtazapine, Cognitive Behavioral Therapy for Insomnia (CBT-I)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which is a crucial resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the substance taken, the quantity, and the time it occurred.