Tretinoin 0.05% Cream 45gm

Tretinoin is a metabolite of Vitamin A that binds to specific retinoic acid receptors (RARs) located in the nucleus, including RAR-alpha, RAR-beta, and RAR-gamma. This binding modulates gene expression, leading to altered cellular differentiation, proliferation, and intercellular communication. In acne, tretinoin reduces the cohesiveness of follicular epithelial cells, leading to decreased microcomedone formation. It also stimulates mitotic activity and increased turnover of follicular epithelial cells, resulting in extrusion of existing comedones and inhibition of new comedone formation. It also has anti-inflammatory effects.

Important Side Effects to Report to Your Doctor 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, 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
A severe skin reaction that bothers you or does not go 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. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:

Feeling of warmth
Burning or stinging
Change in skin color
Skin reactions, such as:
+ Dry skin
+ Redness
+ Swelling
+ Blisters
+ Peeling

If you experience any skin reactions, consult your doctor, as they may recommend temporarily stopping the medication, adjusting the dosage, or changing the frequency of use.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
Skin conditions, including sunburn, sensitivity to light, or other skin problems.
Any medications you are taking that may increase your skin's sensitivity to light. There are numerous drugs that can cause this interaction, so consult your doctor or pharmacist if you are unsure.
If you are pregnant, as this may affect the safety of taking this medication.

This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your overall health and any existing medical conditions

To ensure your safety, carefully review all your medications and health problems with your doctor before taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

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 your safety and prevent any potential interactions with other treatments.

Using Your Medication Correctly

To achieve the full benefits of this medication, it may take several weeks of consistent use. It is crucial to follow your doctor's instructions carefully and not exceed the recommended dosage or frequency of application. Using more than prescribed or for a longer period than recommended may increase the risk of severe side effects.

Skin Precautions

Do not apply this medication to sunburned skin, cuts, scrapes, eczema, or damaged skin, as this may cause further irritation. To minimize the risk of skin problems, practice good skin care and avoid excessive sun exposure. You may be more susceptible to sunburn while using this medication, so take necessary precautions:

Avoid direct sunlight, sunlamps, and tanning beds
Use sunscreen and lip balm with a Sun Protection Factor (SPF) of 15 or higher when outdoors
Wear protective clothing and eyewear to shield your skin from the sun
Be aware that cold and windy weather conditions may irritate your skin; consult your doctor or pharmacist for advice on how to protect your skin in these conditions

Interactions with Other Products

Avoid contact with lime peels, as they may interact with this medication. When using other skin products, including soaps, be sure to consult your doctor first, as they may increase the risk of irritation. If you experience dry skin due to this medication, you may use a moisturizer; however, discuss the suitable type with your doctor or pharmacist. You can use makeup unless your doctor advises against it; if you do use makeup, clean the treatment area before applying this medication.

Safety Precautions

If this medication is swallowed, it can cause harm. In case of accidental ingestion, immediately contact a doctor or poison control center. Additionally, this medication may pose risks to an unborn baby if taken during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, notify your doctor right away.

Breastfeeding

If you are breastfeeding, inform your doctor, as they will need to discuss potential risks to your baby and determine the best course of action.

• Topical products containing sulfur, resorcinol, salicylic acid, or benzoyl peroxide (may cause excessive irritation)
• Astringents, medicated soaps/cleansers, abrasive soaps/cleansers, strong drying agents (e.g., alcohol, lime, menthol)
• Products with high concentrations of alcohol (e.g., shaving lotions, perfumes)
• Other topical preparations that may cause irritation or dryness
• Photosensitizing agents (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) - increased risk of sunburn

• Excessive skin dryness
• Peeling or flaking of skin
• Redness (erythema)
• Burning sensation
• Stinging sensation
• Itching
• Swelling
• Blistering or crusting (rare, severe reaction)

Tretinoin topical is Pregnancy Category C. While systemic absorption is minimal, oral retinoids are highly teratogenic. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception during treatment.

Lactation Risk L3 (Moderately Safe). It is not known whether tretinoin is excreted in human milk after topical application. Due to minimal systemic absorption, significant transfer to breast milk is unlikely. However, caution should be exercised. Avoid applying to areas where the infant may come into direct contact with the medication.

Safety and efficacy have not been established in pediatric patients younger than 12 years of age. For adolescents (12 years and older), dosing is generally the same as adults, but skin sensitivity may be higher.

No specific dosage adjustments are necessary. However, geriatric patients may have more fragile or sensitive skin, which could increase susceptibility to irritation. Use with caution and monitor for excessive dryness or irritation.

• The 'retinoid purge' is a common initial worsening of acne (increased breakouts) that occurs during the first few weeks of treatment as the skin adjusts and speeds up cell turnover. Patients should be counseled that this is temporary and to continue treatment.
• Consistency is key: Tretinoin must be used regularly for several weeks to months to see optimal results.
• Start low, go slow: For patients with sensitive skin, starting with a lower concentration (e.g., 0.025%) or applying every other night can help minimize irritation.
• Apply to dry skin: Wait 20-30 minutes after washing face before applying tretinoin to minimize irritation.
• Sun protection is non-negotiable: Emphasize daily use of broad-spectrum sunscreen (SPF 30+) and protective clothing, even on cloudy days.
• Moisturize: Using a gentle, non-comedogenic moisturizer can help mitigate dryness and irritation.

• Adapalene (topical retinoid)
• Tazarotene (topical retinoid)
• Benzoyl Peroxide (topical)
• Topical antibiotics (e.g., clindamycin, erythromycin)
• Oral antibiotics (e.g., doxycycline, minocycline)
• Azelaic acid (topical)
• Salicylic acid (topical)
• Isotretinoin (oral, for severe recalcitrant acne)

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.