Doxepin Hcl 10mg/ml Conc 118ml

Doxepin is a tricyclic antidepressant (TCA) that primarily inhibits the reuptake of norepinephrine and serotonin at the presynaptic neuronal membrane, thereby increasing the concentration of these neurotransmitters in the synaptic cleft. It also possesses potent antihistaminic (H1 and H2), anticholinergic, and alpha-1 adrenergic blocking properties, which contribute to its sedative, anxiolytic, and adverse effects.

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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
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 using this medication have experienced worsening of 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 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

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, including any symptoms that occurred.
Certain health conditions, such as:
+ Difficulty urinating
+ Glaucoma
Current or recent use of specific medications, including:
+ Linezolid or methylene blue
+ Certain antidepressant or Parkinson's disease medications taken within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (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 for guidance.
* 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. This will help ensure that you receive the best possible care.

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

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

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 spending time outdoors, and inform your doctor if you experience excessive sunburn.

If you have diabetes, it is crucial to monitor your blood sugar levels closely 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, increased 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.

Some 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 with your doctor to weigh the benefits and risks of taking this medication. Taking 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 serotonin syndrome, hyperpyretic crises, convulsions, and death.
• Cisapride - risk of QT prolongation and arrhythmias.
• Patients with glaucoma or urinary retention (especially prostatic hypertrophy) due to anticholinergic effects.

• CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - additive CNS depression.
• Anticholinergics (e.g., atropine, benztropine, diphenhydramine) - increased risk of anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation, delirium).
• Sympathomimetics (e.g., epinephrine, norepinephrine) - potentiation of cardiovascular effects.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased doxepin plasma concentrations.
• Thyroid hormones - increased risk of cardiac arrhythmias.
• Antihypertensives (e.g., guanethidine, clonidine) - may antagonize hypotensive effects.
• QT-prolonging drugs (e.g., antiarrhythmics, antipsychotics, macrolides) - increased risk of QT prolongation and torsades de pointes.

• Cimetidine - increased doxepin plasma concentrations.
• Oral anticoagulants (e.g., warfarin) - potential for altered anticoagulant effect (monitor INR).
• Barbiturates - may decrease doxepin plasma concentrations.
• Tobacco smoking - may decrease doxepin plasma concentrations (CYP1A2 induction).

• Not readily available for minor interactions, but general caution with other drugs metabolized by CYP enzymes.

• Worsening depression
• Emergence of suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, hypomania, mania)
• New or worsening cardiac symptoms (e.g., palpitations, dizziness, syncope)
• Signs of anticholinergic toxicity (e.g., severe dry mouth, blurred vision, urinary retention, constipation, confusion, delirium)
• Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting)
• Signs of bone marrow suppression (e.g., fever, sore throat, unusual bleeding/bruising)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Doxepin crosses the placenta. Neonatal withdrawal symptoms (e.g., respiratory distress, cyanosis, apnea, seizures, feeding difficulties, hypotonia, hypertonia, tremor, jitteriness, irritability, constant crying) have been reported with TCAs during the third trimester.

L3 (Moderately Safe). Doxepin and its active metabolite are excreted into breast milk. While some sources suggest it's generally compatible with breastfeeding at low doses (e.g., for insomnia), caution is advised, especially with higher doses for depression/anxiety. Monitor the infant for sedation, poor feeding, and weight gain.

Generally not recommended for depression/anxiety in children and adolescents due to the Black Box Warning regarding increased risk of suicidality. If used, close monitoring for clinical worsening and suicidality is crucial. For pruritus, off-label use may occur with careful dose titration and monitoring.

Elderly patients are more sensitive to the anticholinergic and sedative effects of doxepin, as well as orthostatic hypotension. Start with lower doses (e.g., 10-25 mg/day for depression/anxiety, 3 mg for insomnia) and titrate slowly. Monitor closely for falls, cognitive impairment, urinary retention, and cardiac effects. The Beers Criteria recommend avoiding TCAs in older adults due to their highly anticholinergic properties and risk of orthostatic hypotension.

• Doxepin's strong antihistaminic properties make it particularly useful for insomnia (at low doses) and pruritus, in addition to its antidepressant effects.
• The oral concentrate formulation allows for flexible and precise dosing, which is beneficial for titration and for administering very low doses (e.g., 3 mg for insomnia).
• Due to its anticholinergic and sedative effects, doxepin is often dosed at bedtime, especially for depression/anxiety, to minimize daytime drowsiness.
• Patients should be warned about the potential for orthostatic hypotension, especially when initiating therapy or increasing the dose.
• The Black Box Warning for suicidality in young adults is critical; close monitoring is essential, particularly during the initial weeks of treatment and dose changes.
• Avoid abrupt discontinuation to prevent withdrawal symptoms (e.g., nausea, headache, malaise, vivid dreams, irritability).

• For Depression/Anxiety: SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), other TCAs (e.g., amitriptyline, imipramine), atypical antidepressants (e.g., bupropion, mirtazapine).
• For Insomnia: Other hypnotics (e.g., zolpidem, eszopiclone), melatonin receptor agonists (e.g., ramelteon), orexin receptor antagonists (e.g., suvorexant), other sedating antidepressants (e.g., mirtazapine, trazodone).
• For Pruritus: Antihistamines (e.g., hydroxyzine, diphenhydramine), topical corticosteroids, calcineurin inhibitors, systemic immunomodulators.

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 provides crucial information 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 details about the medication taken, the amount, and the time it occurred.