Doxepin 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 the concentrations of these neurotransmitters in the synaptic cleft. It also possesses potent antihistaminic (H1), moderate anticholinergic (muscarinic), and moderate alpha-1 adrenergic blocking properties, which contribute to its sedative and adverse effects.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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 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 using this medication have experienced worsening of their asthma symptoms. 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 side effects. However, if you notice any of the following side effects or if they 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

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 symptoms 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 medications 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 your full attention, such as driving, wait until you understand how this medication affects you. The full effects of this drug may not be apparent for several weeks.

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

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 around the eye, contact your doctor immediately.

This medication may increase your susceptibility to sunburn. Exercise caution when spending time in the sun, and inform your doctor if you experience excessive sunburn.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. Be aware of the signs of high or low blood sugar, which may include fruity-smelling breath, dizziness, rapid breathing, rapid heartbeat, confusion, sleepiness, 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 prone to side effects.

Certain medications can affect fertility, potentially impacting your 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. Using this medication in the third trimester may pose health risks to the newborn, so it is essential to discuss this with your doctor.

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): Risk of serotonin syndrome, hyperpyretic crisis, severe convulsions, and death. Allow at least 14 days between discontinuing MAOIs and starting doxepin, and vice versa.

• CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics, antihistamines): Potentiation of CNS depression, including respiratory depression and profound sedation.
• Anticholinergic Agents (e.g., atropine, scopolamine, benztropine, diphenhydramine): Additive anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, confusion, paralytic ileus).
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine, pseudoephedrine): Potentiation of cardiovascular effects (e.g., hypertension, arrhythmias).
• CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine, cimetidine): Increased plasma concentrations of doxepin and desmethyldoxepin, leading to increased risk of adverse effects.
• Thyroid Hormones (e.g., levothyroxine): Increased risk of cardiac arrhythmias and toxicity.

• Antihypertensives (e.g., guanethidine, clonidine, reserpine, beta-blockers): May antagonize the antihypertensive effects of adrenergic neuron blockers; additive hypotensive effects with other antihypertensives.
• Cimetidine: May inhibit doxepin metabolism, leading to increased plasma levels.
• Warfarin: May increase or decrease anticoagulant effect; monitor INR.
• Tramadol: Increased risk of seizures and serotonin syndrome.

• Oral Contraceptives: May alter doxepin metabolism, though clinical significance is usually minor.
• Tobacco Smoking: May induce CYP1A2, potentially decreasing doxepin levels.

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
• Blurred vision
• Dry mouth
• Urinary retention
• Constipation
• Dizziness or lightheadedness (especially upon standing)
• Sedation or drowsiness
• Confusion or disorientation (especially in elderly)
• Irregular heartbeat or palpitations
• Seizures
• Muscle stiffness or tremors

Category C. Doxepin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data suggest potential for neonatal withdrawal symptoms if used late in pregnancy.

Doxepin and its active metabolite are excreted into breast milk. Use with caution. Monitor breastfed infant for sedation, poor feeding, and weight gain.

Not approved for depression or anxiety in pediatric patients. Black Box Warning regarding increased risk of suicidal thinking and behavior in children, adolescents, and young adults. Use for other indications (e.g., pruritus) in children >12 years should be done with extreme caution and close monitoring.

Elderly patients are more sensitive to the anticholinergic, sedative, and hypotensive effects of doxepin. Increased risk of falls, confusion, urinary retention, and constipation. Start with lower doses (e.g., 10-25 mg/day) and titrate slowly. Avoid if possible in patients with dementia or significant cognitive impairment due to anticholinergic burden.

• Doxepin is a potent H1 antagonist, leading to significant sedation. This makes it useful for insomnia (at low doses) but can be a limiting side effect for daytime use.
• Due to its anticholinergic properties, it should be used with caution or avoided in patients with benign prostatic hyperplasia (BPH), narrow-angle glaucoma, or severe constipation.
• Orthostatic hypotension is a common side effect, especially in the elderly or those on concomitant antihypertensives. Advise patients to rise slowly.
• Therapeutic effects for depression may take 2-4 weeks to manifest, while sedative effects are immediate.
• Plasma level monitoring can be useful in cases of non-response or suspected toxicity, though not routinely performed.
• The 50mg capsule is typically used for depression/anxiety. Lower doses (e.g., 3-6mg, available as a different formulation, Silenor) are specifically approved for insomnia.

• Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., fluoxetine, sertraline, escitalopram) for depression/anxiety.
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine, duloxetine) for depression/anxiety.
• Other classes of antidepressants (e.g., bupropion, mirtazapine).
• Benzodiazepines (e.g., lorazepam, alprazolam) for short-term anxiety relief (different mechanism, higher abuse potential).
• Non-benzodiazepine hypnotics (e.g., zolpidem, eszopiclone) for insomnia.
• Cognitive Behavioral Therapy (CBT) or other psychotherapies.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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. Please read this guide carefully and review it again whenever you receive a refill. 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 seeking help, be prepared to provide details about the overdose, including the substance taken, the amount, and the time it occurred.