Indications
Aknill topical gel is formulated to effectively treat mild to moderate cases of inflammatory and non-inflammatory acne vulgaris.
Pharmacology
Isotretinoin exerts its therapeutic effects by modulating the cell cycle, influencing cell differentiation, and inducing apoptosis. These mechanisms help decrease sebum production, thereby preventing pore blockage and limiting the proliferation of acne-causing bacteria. Both Isotretinoin and its metabolite, 4-oxo-isotretinoin, have been shown to significantly lower sebum secretion. Notably, Isotretinoin has minimal interaction with retinol binding proteins (RBPs) and retinoic acid nuclear receptors (RARs). Tretinoin and 4-oxo-tretinoin have an affinity for the RAR-γ receptor, which is believed to contribute to the anti-acne effects of Isotretinoin. Additionally, Isotretinoin promotes apoptosis in sebocytes, resulting in reduced sebum production, and diminishes the formation of comedones by decreasing hyperkeratinization through an unidentified mechanism. While Isotretinoin does not directly eliminate bacteria, it reduces the size of sebaceous ducts and creates an environment that is less conducive to the growth of acne pathogens. Furthermore, it may enhance immune responses and modify the chemotaxis of monocytes to mitigate inflammation.
Dosage & Administration
Gently apply Isotretinoin 0.05% gel to the affected areas once or twice daily. Patients should be informed that it may take 6-8 weeks of consistent treatment to observe significant results. The safety and efficacy of Isotretinoin have not been established for children, as acne vulgaris is uncommon in this demographic. Specific guidelines for use in elderly patients are not available, given that acne vulgaris is rare in older adults.
Please use this medication as directed by a registered healthcare professional.
Interactions
Caution is advised when using concurrent topical medications during treatment with Aknill. Special care should be taken when combining it with products that contain peeling agents (such as Benzoyl Peroxide) or abrasive cleansers.
Contraindications
Isotretinoin 0.05% gel is contraindicated in individuals with a known hypersensitivity to Isotretinoin.
Side Effects
Common side effects of Aknill may include stinging, burning, or irritation at the application site, as well as erythema and peeling. If excessive irritation occurs, it is advisable to temporarily halt treatment until symptoms improve. Persistent irritation warrants discontinuation of the medication. Generally, these reactions resolve upon stopping the treatment.
Pregnancy & Lactation
Categorized as Pregnancy Category B, there is insufficient evidence regarding the safety of topical Isotretinoin during human pregnancy. Systemic administration of Isotretinoin has been linked to teratogenic effects. However, studies in rabbits applying Isotretinoin topically at doses up to 60 times higher than those used in humans revealed no adverse effects on the fetus. Therefore, Isotretinoin should be avoided during pregnancy. While percutaneous absorption of Isotretinoin from the 0.05% gel is minimal, it remains unclear whether Isotretinoin is excreted in breast milk. Hence, its use is not recommended during lactation.
Precautions & Warnings
Avoid contact with the mouth, eyes, and mucous membranes, as well as with damaged or eczematous skin. Take care to prevent accumulation of the product in skin folds and around the nose. Caution is warranted when applying to sensitive areas, such as the neck. While Tretinoin has not been proven to initiate or promote cancer in humans, studies on albino hairless mice indicated a dose-related increase in ultraviolet-B radiation-induced skin tumors. Conversely, other studies with low, non-irritating concentrations of Tretinoin showed an opposite effect. The relevance of these findings to humans remains uncertain; therefore, caution should be exercised in patients with a personal or family history of skin cancers. Sun exposure to treated areas should be minimized. When avoidance is not possible, use sunscreen and protective clothing. Patients with sunburn should refrain from using Aknill due to heightened sensitivity to sunlight, and sunlamps should be avoided during treatment.
Overdose Effects
As of now, acute overdose cases of Aknill have not been documented. However, accidental ingestion may result in symptoms associated with hypervitaminosis A, including severe headaches, nausea or vomiting, drowsiness, irritability, and itching.
Therapeutic Class
Topical retinoid and related formulations.
Storage Conditions
Store in a cool, dry place, away from light.
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