Doxepin 5% Cream 45gm

Doxepin is a tricyclic antidepressant (TCA) derivative that, when applied topically, acts as a potent H1-receptor antagonist. Its antipruritic effect is primarily due to its antihistaminic activity, blocking histamine at peripheral H1 receptors, thereby reducing itching associated with various dermatoses.

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Confusion
- Severe skin irritation

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 persist or bother you:
- Burning or stinging sensations
- Drowsiness
- Dry mouth
- Unusual thirst

Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for medical advice. 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Difficulty urinating or glaucoma.
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure.
Current use of linezolid or methylene blue, as these medications may interact with this drug.
* If the patient is a child, as this medication is not intended for pediatric use.

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 adjust the dosage of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you. It is also crucial to discuss the use of alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter medications that may cause drowsiness, with your doctor beforehand.

When applying this medication to a large area of skin, exercise caution and consult with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs): Concomitant use with oral doxepin is contraindicated due to risk of hyperpyretic crises, severe convulsions, and death. While systemic absorption from topical doxepin is minimal, caution is advised, and concurrent use should generally be avoided or closely monitored.
• CNS Depressants (e.g., alcohol, benzodiazepines, opioids, sedating antihistamines): May potentiate CNS depression (drowsiness, dizziness) if significant systemic absorption occurs.

• Anticholinergic Agents (e.g., atropine, scopolamine, other TCAs): May potentiate anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation) if significant systemic absorption occurs.
• Cimetidine: May inhibit metabolism of systemically absorbed doxepin, leading to increased plasma concentrations and potential for enhanced side effects.
• Thyroid Hormones: May increase cardiovascular toxicity of TCAs; caution with systemic absorption.

• Topical corticosteroids: No known direct interaction, but concurrent use should be monitored for skin irritation.

• Drowsiness
• Dizziness
• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Worsening of rash or new skin irritation
• Increased itching

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but potential for fetal exposure exists.

Caution is advised. Doxepin and its active metabolite are excreted in breast milk following oral administration. While systemic absorption from topical application is minimal, there is a potential for infant exposure and adverse effects (e.g., sedation, anticholinergic effects). Weigh benefits of treatment against potential risks to the infant.

Not recommended for children under 12 years of age due to potential for increased systemic absorption and CNS side effects (e.g., sedation, respiratory depression). Children may be more susceptible to systemic effects due to higher body surface area to weight ratio.

Use with caution. Elderly patients may be more susceptible to the systemic anticholinergic and sedative effects of doxepin due to decreased renal and hepatic function, and increased sensitivity of the central nervous system. Start with the lowest effective dose and monitor closely for adverse effects.

• Doxepin cream is for short-term use only (maximum 8 days) and should not be applied to large areas of the body (max 20% BSA) to minimize systemic absorption and associated side effects.
• Patients should be warned about potential drowsiness, especially during the first few days of treatment. Advise against driving or operating machinery if affected.
• Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
• Do not apply to broken, inflamed, or oozing skin, as this can increase systemic absorption.
• The cream may cause a transient stinging or burning sensation upon application, which usually subsides.
• Patients should avoid alcohol and other CNS depressants while using doxepin cream due to additive sedative effects.
• While systemic interactions are rare due to minimal absorption, patients should inform their healthcare provider about all medications they are taking, especially other CNS depressants or anticholinergics.

• Topical corticosteroids (e.g., hydrocortisone, triamcinolone)
• Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
• Oral antihistamines (e.g., cetirizine, loratadine, diphenhydramine)
• Topical anesthetics (e.g., pramoxine)
• Emollients and moisturizers
• Phototherapy

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. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, 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 medication taken, the amount, and the time it happened.