Doxepin Hcl 10mg/ml Con 120ml

Doxepin is a tricyclic antidepressant (TCA) that primarily inhibits the reuptake of norepinephrine and serotonin at presynaptic neuronal membranes, thereby increasing the concentration of these neurotransmitters in the synaptic cleft. It also possesses significant antihistaminic (H1), anticholinergic (muscarinic), 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 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. 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 bother you or do not go away:

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 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:
+ 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 guide you on how to gradually stop taking it to minimize potential side effects.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, consult your doctor before using marijuana, cannabis, or prescription and 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 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, it is crucial to 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 your doctor to weigh the benefits and risks of taking this medication during pregnancy. Taking this drug in the third trimester may lead to health problems in 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 - increased risk of QT prolongation and arrhythmias.
• Linezolid, Methylene Blue (IV) - risk of serotonin syndrome.

• CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - additive CNS depression.
• Anticholinergic Agents (e.g., atropine, benztropine, antihistamines, phenothiazines) - additive anticholinergic effects (e.g., severe constipation, urinary retention, blurred vision, delirium).
• QT-prolonging Drugs (e.g., antiarrhythmics, antipsychotics, fluoroquinolones) - increased risk of QT prolongation and Torsade de Pointes.
• CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased doxepin plasma concentrations.
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - potentiation of cardiovascular effects (hypertension, arrhythmias).

• Thyroid Hormones - increased risk of cardiac arrhythmias.
• Cimetidine - increased doxepin plasma concentrations.
• Warfarin - potential for altered anticoagulant effect (monitor INR).
• Antihypertensives (e.g., guanethidine, clonidine) - may antagonize hypotensive effects.
• Other Serotonergic Drugs (e.g., SSRIs, SNRIs, triptans, tramadol) - increased risk of serotonin syndrome.

• Not many specific minor interactions, but general caution with any drug affecting CNS or hepatic metabolism.

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, hypomania, mania)
• Blurred vision
• Dry mouth
• Constipation
• Urinary retention
• Dizziness
• Sedation
• Orthostatic hypotension
• Palpitations
• Tremor
• Confusion (especially in elderly)

Category C. Doxepin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Neonates exposed to TCAs in the third trimester have developed withdrawal symptoms.

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. Use with caution.

Not approved for depression or anxiety in pediatric patients due to the Black Box Warning regarding increased risk of suicidality. If used off-label for other conditions (e.g., pruritus, insomnia), extreme caution, very low doses, and close monitoring are required. Safety and efficacy for these uses are not well-established.

Elderly patients are more sensitive to the anticholinergic, sedative, and hypotensive effects of doxepin. They are also at increased risk for falls, confusion, and cardiac conduction abnormalities. Lower initial doses (e.g., 10-25 mg/day) and slower titration are recommended. Monitor closely for adverse effects, especially cognitive impairment and orthostatic hypotension.

• Doxepin oral concentrate allows for flexible dosing, which is particularly useful for titration or for patients who have difficulty swallowing tablets.
• Due to its potent H1 antihistaminic properties, doxepin is highly sedating and is often dosed at bedtime, especially for insomnia or when sedation is desired for anxiety/depression.
• The anticholinergic side effects (dry mouth, constipation, urinary retention, blurred vision) are common and can be particularly troublesome in the elderly.
• Orthostatic hypotension is a significant risk, especially at higher doses or in the elderly; advise patients to rise slowly.
• Monitor for signs of serotonin syndrome, especially if co-administered with other serotonergic agents.
• The Black Box Warning for suicidality applies to children, adolescents, and young adults; close monitoring is crucial in these age groups.
• Therapeutic effects for depression may take 2-4 weeks to manifest, while sedative effects are more immediate.

• SSRIs (e.g., Fluoxetine, Sertraline, Escitalopram) for depression/anxiety
• SNRIs (e.g., Venlafaxine, Duloxetine) for depression/anxiety and neuropathic pain
• Other anxiolytics (e.g., Buspirone, benzodiazepines for short-term use)
• Other hypnotics (e.g., Z-drugs like Zolpidem, Eszopiclone; Ramelteon; Suvorexant) for insomnia
• Gabapentin or Pregabalin for neuropathic pain
• Mirtazapine (another sedating antidepressant with H1 antagonism)

If your symptoms or health issues persist or worsen, it's 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, 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, and the time it occurred.