Sinequan 50mg 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 their concentrations in the synaptic cleft. It also possesses potent antihistaminic (H1), anticholinergic, and alpha-1 adrenergic blocking properties, which contribute to its sedative, anxiolytic, 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 drive
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 immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Dizziness, drowsiness, tiredness, or weakness
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 list is not exhaustive, and you may experience other 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:
+ Urinary retention (trouble passing urine)
+ Glaucoma
Current or recent use of specific medications, including:
+ Linezolid or methylene blue
+ Monoamine oxidase inhibitors (MAOIs) for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days (as this may increase the risk of very high blood pressure)
Use of other medications that can cause drowsiness, as there are many drugs that can have this effect. If you are unsure, consult your doctor or pharmacist.
* 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 drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose 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.

When you first start taking this drug, be cautious when driving or performing tasks that require your full attention, as it may affect your alertness. You may not experience the full effects of this medication for several weeks.

To minimize the risk of side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will provide guidance on how to gradually taper off the medication.

While taking this drug, it is recommended that you avoid consuming alcohol. Additionally, consult 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 spending time outdoors, and inform your doctor if you experience excessive sunburn.

If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication. Be aware of the signs of high or low blood sugar, which may include 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.

Older adults (65 years and older) should use this medication with caution, as they may be more susceptible to side effects.

Certain medications, including this one, may affect fertility. If you have concerns about your ability to have children, discuss this with your doctor.

If you are pregnant or planning to become pregnant, consult your doctor to weigh the benefits and risks of taking this medication. Using this drug during the third trimester of pregnancy may pose health risks to 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.
• Anticholinergics (e.g., atropine, benztropine, diphenhydramine) - additive anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, delirium).
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - potentiation of cardiovascular effects (hypertension, arrhythmias).
• CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased doxepin plasma concentrations.
• Thyroid hormones - increased risk of cardiac arrhythmias and toxicity.
• Antihypertensives (e.g., guanethidine, clonidine) - may antagonize antihypertensive effects.

• Cimetidine - increased doxepin plasma concentrations.
• Warfarin - potential for altered anticoagulant effect (monitor INR).
• Anticonvulsants (e.g., carbamazepine, phenytoin) - altered doxepin levels or increased risk of seizures.
• Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans) - risk of serotonin syndrome (though less pronounced than with MAOIs).

• Not available

• Worsening depression
• Emergence of suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity, mania/hypomania)
• Anxiety
• Panic attacks
• Insomnia
• Restlessness
• Severe dry mouth
• Constipation
• Urinary retention
• Blurred vision
• Dizziness or lightheadedness (especially upon standing)
• Palpitations or irregular heartbeat
• Confusion or delirium (especially in elderly)
• Seizures

Doxepin is Pregnancy Category C. Use during pregnancy should only be considered 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, 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. Potential for sedation, poor feeding, and weight gain in the infant. Use with caution, or consider alternative agents, especially in neonates or preterm infants.

Generally not recommended for depression/anxiety in children and adolescents due to the Black Box Warning regarding increased risk of suicidality. Safety and efficacy for these indications have not been established. May be used off-label for pruritus in children, but with careful dose titration and monitoring.

Elderly patients are more sensitive to the anticholinergic, sedative, and orthostatic hypotensive effects of doxepin. Start with lower doses and titrate slowly. Increased risk of falls, confusion, and urinary retention. Avoid in patients with dementia due to anticholinergic burden. Monitor closely for adverse effects and consider lower therapeutic ranges.

• Doxepin is a potent H1 antagonist, making it highly sedating. This property is leveraged for its use in insomnia at very low doses (3-6 mg).
• Due to its anticholinergic properties, doxepin should be used with extreme caution or avoided in patients with benign prostatic hyperplasia (BPH), narrow-angle glaucoma, or severe constipation.
• Orthostatic hypotension is a common side effect, especially at higher doses or in elderly patients. Advise patients to rise slowly.
• The full antidepressant effect may take 2-4 weeks to develop, but sedative effects are immediate.
• Withdrawal symptoms (e.g., nausea, headache, malaise, flu-like symptoms, sleep disturbance, irritability) can occur if discontinued abruptly, especially after prolonged use. Taper dose gradually.
• Overdose can be life-threatening due to cardiac arrhythmias and CNS depression. Always prescribe the smallest effective quantity, especially for patients at risk of suicide.

• Other Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Imipramine
• Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine, Sertraline, Escitalopram
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine
• Other Antidepressants: Mirtazapine, Bupropion
• For Insomnia: Zolpidem, Eszopiclone, Trazodone, Suvorexant, Lemborexant
• For Pruritus: Antihistamines (e.g., Hydroxyzine, Diphenhydramine), topical corticosteroids

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 or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable 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, we encourage you 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 detailed information, including the substance taken, the amount, and the time it occurred.