Doxepin 75mg Capsules
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. If you're taking this medication once a day, take it at bedtime. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets to ensure their safety. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) as they can increase drowsiness and other side effects.
- Avoid driving or operating heavy machinery until you know how this medication affects you, especially when starting treatment or changing doses.
- Rise slowly from a sitting or lying position to prevent dizziness or fainting due to orthostatic hypotension.
- Maintain good oral hygiene due to potential dry mouth (a common side effect).
- Avoid excessive sun exposure as doxepin can increase sensitivity to sunlight.
Available Forms & Alternatives
Available Strengths:
- Doxepin 150mg Capsules
- Doxepin Hcl 10mg/ml Conc 118ml
- Doxepin Hcl 10mg/ml Con 120ml
- Doxepin 100mg (hundred Mg) Capsules
- Doxepin 10mg Capsules
- Doxepin 25mg Capsules
- Doxepin 50mg Capsules
- Doxepin 75mg Capsules
- Doxepin 5% Cream 45gm
- Doxepin 3mg Tablets
- Doxepin 6mg Tablets
- Doxepin 3mg Tablets
- Doxepin 6mg Tablets
- Doxepin 6mg Tablets
- Doxepin 3mg Tablets
- Doxepin 5% Cream 45gm
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 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 (tinnitus)
Changes in sex drive
Enlarged breasts or nipple discharge
Swelling of the testicles
Important Warning for People with Asthma
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 a comprehensive list of all 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.
Seek Immediate Medical Attention If You Experience:
- Worsening depression or anxiety
- New or worsening thoughts of self-harm or suicide
- Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, irritability, aggression, impulsivity, severe insomnia, hypomania, mania)
- Severe dizziness or fainting
- Fast, pounding, or irregular heartbeat
- Difficulty urinating
- Severe constipation
- Blurred vision or eye pain
- Muscle stiffness or tremors
- Seizures
- Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Urinary retention (trouble passing urine)
+ Glaucoma
Current or recent use of specific medications, such as:
+ 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 they may cause 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.
Precautions & Cautions
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 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 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 and impact the ability to conceive. If you have concerns or questions, 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 essential to discuss this with your doctor.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or coma
- Confusion or agitation
- Hallucinations
- Seizures
- Fast, irregular, or pounding heartbeat (arrhythmias)
- Low blood pressure (hypotension)
- Respiratory depression (slow, shallow breathing)
- Dilated pupils
- Dry mouth
- Urinary retention
- Hypothermia (low body temperature)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose can be fatal, especially with TCAs.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome, hyperpyretic crises, convulsions, and death.
- Cisapride - risk of QT prolongation and arrhythmias.
Major Interactions
- 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.
- QT-prolonging drugs (e.g., antiarrhythmics, antipsychotics, fluoroquinolones) - increased risk of QT prolongation and torsades de pointes.
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - increased doxepin plasma concentrations.
- Thyroid hormones - increased risk of cardiac arrhythmias.
Moderate Interactions
- Cimetidine - increased doxepin plasma concentrations.
- Warfarin - potential for altered anticoagulant effect (monitor INR).
- Antihypertensives (e.g., guanethidine, clonidine) - may antagonize hypotensive effects.
- St. John's Wort - increased risk of serotonin syndrome.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To assess for pre-existing cardiac conduction abnormalities or QT prolongation, especially in patients with cardiac disease or elderly.
Timing: Prior to initiation of therapy.
Rationale: Doxepin is extensively metabolized by the liver; to assess baseline hepatic function.
Timing: Prior to initiation of therapy.
Rationale: Metabolites are renally excreted; to assess baseline renal function.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline mood, anxiety, and suicidality for monitoring treatment response and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Weekly during titration, then monthly or as clinically indicated.
Target: Improvement in target symptoms without intolerable side effects.
Action Threshold: Lack of improvement after adequate trial, or worsening symptoms, requires dose adjustment or re-evaluation.
Frequency: At each visit, especially during titration.
Target: Tolerable side effect profile.
Action Threshold: Intolerable side effects require dose reduction, change in timing, or discontinuation.
Frequency: Weekly during initial therapy and dose changes, then regularly.
Target: Absence of suicidal ideation or behavior.
Action Threshold: Emergence or worsening of suicidal thoughts/behavior requires immediate clinical intervention.
Frequency: Periodically, especially in elderly or those with cardiovascular disease.
Target: Within normal limits for the patient.
Action Threshold: Significant orthostatic hypotension or tachycardia requires intervention.
Symptom Monitoring
- 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
- Constipation
- Urinary retention
- Dizziness or lightheadedness (especially upon standing)
- Sedation or drowsiness
- Palpitations or irregular heartbeat
- Seizures
Special Patient Groups
Pregnancy
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, jitteriness, irritability, constant crying).
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). Doxepin and its active metabolite are excreted into breast milk. While some infants may experience no adverse effects, drowsiness, poor feeding, and weight gain have been reported. Monitor the infant for sedation, poor feeding, and developmental milestones. Consider alternative antidepressants with lower milk transfer or shorter half-lives, especially in preterm or neonates.
Pediatric Use
Generally not recommended for children and adolescents due to the Black Box Warning regarding increased risk of suicidal thoughts and behavior. Safety and efficacy have not been established in this population. If used, extreme caution and close monitoring are required.
Geriatric Use
Use with extreme caution. Elderly patients are more sensitive to the anticholinergic (e.g., dry mouth, constipation, urinary retention, confusion), sedative, and hypotensive effects (orthostatic hypotension) of doxepin. Start with lower doses and titrate slowly. Increased risk of falls, delirium, and cardiac conduction abnormalities. Consider lower maximum doses.
Clinical Information
Clinical Pearls
- Doxepin has significant sedative properties, making it useful for patients with depression or anxiety accompanied by insomnia. It is typically dosed at bedtime.
- Due to its anticholinergic effects, doxepin should be used with caution in patients with benign prostatic hyperplasia (BPH), narrow-angle glaucoma, or a history of urinary retention.
- Orthostatic hypotension is a common side effect, especially in the elderly; advise patients to rise slowly.
- The full antidepressant effect may take 2-4 weeks to develop, but sedative effects are immediate.
- Abrupt discontinuation can lead to withdrawal symptoms (e.g., nausea, headache, malaise, flu-like symptoms, sleep disturbance, irritability); taper dose gradually.
- Monitor for signs of serotonin syndrome when co-administered with other serotonergic agents.
Alternative Therapies
- Other Tricyclic Antidepressants (TCAs): Amitriptyline, Imipramine, Nortriptyline
- Selective Serotonin Reuptake Inhibitors (SSRIs): Fluoxetine, Sertraline, Escitalopram
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine
- Atypical Antidepressants: Bupropion, Mirtazapine
- For insomnia (low-dose doxepin): Zolpidem, Eszopiclone, Trazodone, Suvorexant