Sinequan 75mg Capsules

Doxepin is a tricyclic antidepressant (TCA) that primarily inhibits the reuptake of norepinephrine and serotonin at presynaptic neuronal membranes, thereby increasing the concentrations of these neurotransmitters in the synaptic cleft. It also possesses potent antihistaminic (H1), anticholinergic (muscarinic), and alpha-1 adrenergic blocking properties, which contribute to its sedative and adverse effects.

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 immediate medical attention:

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 Asthma Patients

If you have asthma, use this medication with caution. Some people with asthma have experienced worsening symptoms while taking this medication. If your asthma symptoms worsen, contact your doctor right away.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects and they bother you or do not go away, contact your doctor or seek medical help:

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 an exhaustive list of 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. Be sure to describe the allergic reaction you experienced.
Certain health conditions, such as:
+ Difficulty urinating
+ Glaucoma
Current or recent use of specific medications, including:
+ Linezolid or methylene blue
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as this may lead to very high blood pressure)
Use of other medications that can cause drowsiness, as there are many drugs with this potential effect. If you are unsure, consult your doctor or pharmacist.
* If you are breastfeeding, as you should not breastfeed while taking this medication.

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 provide guidance on how to gradually stop taking it.

While taking this drug, avoid consuming alcohol. Additionally, consult with your doctor before using marijuana, cannabis, or 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 sunburn.

If you have diabetes, 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 the ability to conceive. If you have concerns, 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 pose health risks to the newborn, so it is crucial to discuss this with your doctor.

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline, linezolid, methylene blue) - risk of serotonin syndrome, hyperpyretic crises, convulsions, and death. Allow at least 14 days between discontinuing MAOIs and initiating doxepin, and vice versa.
• Cisapride (risk of QT prolongation and arrhythmias)

• CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics, antihistamines) - additive CNS depression, increased sedation, respiratory depression.
• Anticholinergic Agents (e.g., atropine, benztropine, diphenhydramine, oxybutynin) - additive anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, delirium).
• CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine) - may significantly increase plasma concentrations of doxepin and its active metabolite, leading to increased toxicity.
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - TCAs may potentiate the cardiovascular effects of direct-acting sympathomimetics.
• Thyroid Hormones (e.g., levothyroxine) - increased risk of cardiac arrhythmias and toxicity.
• Antihypertensives (e.g., guanethidine, clonidine) - doxepin may antagonize the antihypertensive effects.

• Adrenergic Neuron Blockers (e.g., guanadrel, reserpine) - may decrease antihypertensive effect.
• Anticoagulants (e.g., warfarin) - potential for increased anticoagulant effect (monitor INR).
• Barbiturates - may decrease doxepin plasma levels due to enzyme induction.
• Carbamazepine - may decrease doxepin plasma levels; doxepin may increase carbamazepine levels.
• Tramadol - increased risk of seizures and serotonin syndrome.
• St. John's Wort - increased risk of serotonin syndrome.

• Not available

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, hostility, aggressiveness, akathisia, hypomania, mania)
• Dizziness or lightheadedness (especially when standing)
• Dry mouth
• Blurred vision
• Constipation
• Difficulty urinating
• Sedation or drowsiness
• Confusion or disorientation (especially in elderly)
• Tremor
• Palpitations or irregular heartbeat
• Seizures

Category C. Doxepin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to TCAs in the third trimester have developed withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypertonia, hypotonia, seizures).

Doxepin and its active metabolite are excreted into breast milk. The American Academy of Pediatrics considers doxepin to be a drug for which the effect on the nursing infant is unknown but may be of concern. Monitor infants for sedation, poor feeding, and weight gain. Use with caution, or consider alternative agents.

Safety and efficacy for depression/anxiety in pediatric patients have not been established. Antidepressants, including doxepin, increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (see Black Box Warning). Use is generally not recommended.

Elderly patients are more sensitive to the anticholinergic, sedative, and hypotensive effects of doxepin. Initiate at lower doses (e.g., 10-25 mg/day) and titrate slowly. Monitor closely for orthostatic hypotension, urinary retention, constipation, confusion, and falls. Consider lower target plasma levels if TDM is used.

• Doxepin is one of the most sedating TCAs due to its potent H1 antihistaminic activity, making it useful for patients with depression accompanied by insomnia or severe anxiety.
• Its potent anticholinergic effects can be problematic, especially in the elderly, leading to dry mouth, constipation, urinary retention, and cognitive impairment.
• Low-dose doxepin (3-6 mg, brand name Silenor) is specifically approved for insomnia and has minimal antidepressant effects at these doses.
• Due to its long half-life and that of its active metabolite, once-daily dosing (usually at bedtime) is common.
• Orthostatic hypotension is a significant risk, particularly at treatment initiation and with dose increases; advise patients to rise slowly.
• Therapeutic drug monitoring can be useful in cases of non-response, suspected toxicity, or drug interactions, though not routinely required.

• Other Tricyclic Antidepressants (TCAs): Amitriptyline, Imipramine, Nortriptyline, Desipramine
• Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine, Desvenlafaxine
• Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone
• Benzodiazepines (for anxiety, short-term use): Alprazolam, Lorazepam, Diazepam
• Other hypnotics (for insomnia): Z-drugs (zolpidem, eszopiclone), Ramelteon, Suvorexant

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.