Doxepin 10mg 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 significant antihistaminic (H1), anticholinergic (muscarinic), and alpha-1 adrenergic blocking activities, which contribute to its sedative and adverse effects. At low doses (e.g., for insomnia), its primary mechanism is thought to be 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 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 drug. If your asthma symptoms worsen, contact your doctor immediately.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:

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 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.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. 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. 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 medication, avoid consuming alcohol. Additionally, consult with your doctor before using marijuana, cannabis, or prescription or over-the-counter drugs 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 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, closely monitor your blood sugar levels. 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.

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) - risk of hyperpyretic crisis, severe convulsions, and death.
• Cisapride - risk of QT prolongation and arrhythmias.
• Patients with glaucoma (untreated narrow-angle) or urinary retention (severe) - due to anticholinergic effects.

• 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).
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - enhanced pressor response.
• CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased doxepin plasma concentrations.
• Thyroid Hormones - increased risk of cardiac arrhythmias and CNS stimulation.
• Antiarrhythmics (e.g., quinidine, propafenone, flecainide) - increased risk of QT prolongation and arrhythmias.
• Other drugs that prolong QT interval (e.g., antipsychotics, macrolide antibiotics, fluoroquinolones).

• Antihypertensives (e.g., clonidine, guanethidine) - doxepin may antagonize their effects, leading to loss of blood pressure control.
• Cimetidine - may inhibit doxepin metabolism, increasing plasma levels.
• Tobacco smoking - may induce doxepin metabolism, decreasing plasma levels.
• St. John's Wort - may increase risk of serotonin syndrome.

• Oral Contraceptives - may alter doxepin metabolism (variable effects).

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity, mania/hypomania)
• Orthostatic dizziness or syncope
• Dry mouth
• Constipation
• Blurred vision
• Urinary retention or hesitancy
• Excessive sedation or drowsiness
• Confusion or disorientation (especially in elderly)
• Tremor
• Tachycardia
• Arrhythmias

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, cyanosis, apnea, seizures, feeding difficulties, hypotonia, hypertonia, tremor, irritability, constant crying).

L3 (Moderate Risk). Doxepin and its active metabolite are excreted into breast milk. While levels are generally low, sedation, poor feeding, and weight gain have been reported in infants. Monitor infant for drowsiness, poor feeding, and developmental milestones. Consider alternative agents or use lowest effective dose.

Safety and efficacy not established for depression/anxiety in pediatric patients. Not approved for insomnia in pediatric patients. Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults. Use is generally not recommended.

Use with extreme caution due to increased sensitivity to anticholinergic and sedative effects, and orthostatic hypotension. Start with lower doses (e.g., 10-25 mg/day for depression/anxiety, 3 mg for insomnia) and titrate slowly. Elderly patients are at higher risk for falls, confusion, and urinary retention. Monitor closely for adverse effects.

• Doxepin is a potent sedative due to its strong antihistaminic properties, making it useful for insomnia at low doses (3-6 mg).
• At higher doses, it acts as a tricyclic antidepressant, but its significant anticholinergic and sedative side effects often limit its use compared to newer antidepressants.
• Orthostatic hypotension is a common and potentially serious side effect, especially in the elderly; advise patients to rise slowly.
• Anticholinergic side effects (dry mouth, constipation, blurred vision, urinary retention) are prominent and can be dose-limiting.
• Due to its long half-life and active metabolite, once-daily dosing (especially at bedtime) is often preferred for depression/anxiety.
• Avoid abrupt discontinuation to prevent withdrawal symptoms (e.g., nausea, headache, malaise, vivid dreams, irritability).

• For Depression/Anxiety: SSRIs (e.g., fluoxetine, sertraline, escitalopram), SNRIs (e.g., venlafaxine, duloxetine), other TCAs (e.g., amitriptyline, imipramine, nortriptyline), atypical antidepressants (e.g., bupropion, mirtazapine).
• For Insomnia: Other hypnotics (e.g., zolpidem, eszopiclone, zaleplon), melatonin receptor agonists (e.g., ramelteon), orexin receptor antagonists (e.g., suvorexant, lemborexant), low-dose trazodone, cognitive behavioral therapy for insomnia (CBT-I).

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. If you have any questions or concerns about this medication, don't hesitate to consult 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.