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Local Anesthetic Agents,
Injectable Local Anesthetics
Isotretinoin CAS:4759-48-2 Yellow Powder for Treatment of Acne Embolism
Alias: 13-cis Vitamin A acid
Categories:Antibiotics, Organicacids, APIs, Pharmaceuticals, Retinoids
Character: yellow or orange crystalline powder
Solubility: practically insoluble in water, soluble in methylene chloride, slightly soluble in ethanol (96%);
Stability: air, light, heat-sensitive, solution stability worse
Loss on drying: ≤0.5%
Heavy Metal: ≤20ppm
Cell culture Test: Pass
Uses: For the treatment of severe acne embolism
Storage conditions: room temperature, damp and dark airtight and dry.
|Product name||Isotretinoin (13-cis Vitamin A acid)|
|Date of manufacturing||2th, July, 2016||Shelf life||1th, July, 2018|
|Appearance||Yellow or orange crystalline powder||Complies|
|Loss on drying||Not more than 0.5%||0.05%|
|Residue on ignition||Not more than 0.1%||0.02%|
|Heavy metals||Not more than 0.002%||<0.002|
|Tretinoin||Not more than 1.0%||0.1%|
Isotretinoin is used primarily for severe cystic acne and acne that has not responded to other treatments.Many dermatologists also support its use for treatment of lesser degrees of acne that prove resistant to other treatments, or that produce physical or psychological scarring.
It is also somewhat effective for hidradenitis suppurativa and some cases of severe acne rosacea.It can also be used to help treat harlequin ichthyosis, lamellar ichthyosis and is used in xeroderma pigmentosum cases to relieve keratoses. Isotretinoin has been used to treat the extremely rare condition fibrodysplasia ossificans progressiva. It is also used for treatment of neuroblastoma, a form of nerve cancer.
Isotretinoin therapy has furthermore proven effective against genital warts in experimental use, but is rarely used for this indication as there are more effective treatments. Isotretinoin may represent an efficacious and safe alternative systemic form of therapy for RCA of the cervix. In most countries this therapy is currently unapproved and only used if other therapies failed.
Mechanism of Action:
Isotretinoin is the only therapy that impacts on all of the major aetiological factors implicated in acne. It achieves this remarkable efficacy by influencing cell-cycle progression, cellular differentiation, cell survival and apoptosis.1–7 It results in a significant reduction in sebum production, influences comedogenesis, lowers surface and ductal P. acnes and has anti-inflammatory properties. A dose of 0.5–1.0 mg/kg/day dramatically reduces sebum excretion by the order of 90% within 6 weeks. Unlike tretinoin (all-trans retinoic acid), isotretinoin has little or no ability to bind to cellular retinol-binding proteins or retinoic acid nuclear receptors (RARs and RXRs) but may act as a pro-drug that is converted intracellularly to metabolites that are agonists for RAR and RXR nuclear receptors.
Do NOT use isotretinoin if:
you are allergic to any ingredient in isotretinoin or to vitamin A
you are pregnant, may become pregnant, or if you are planning to become pregnant
you are breast-feeding
you do not understand the possible risks of isotretinoin or you are not able to follow all of the instructions in the Medication Guide
you are taking tetracycline antibiotics (eg, doxycycline) or vitamin A-type medicines (eg, etretinate, vitamin A)
Contact your doctor or health care provider right away if any of these apply to you.
How should this medicine be used?
Isotretinoin comes as a capsule to take by mouth. Isotretinoin is usually taken twice a day with meals for 4 to 5 months at a time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take isotretinoin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole with a full glass of liquid. Do not chew or suck on the capsules.
Your doctor will probably start you on an average dose of isotretinoin and increase or decrease your dose depending on how well you respond to the medication and the side effects you experience. Follow these directions carefully and ask your doctor or pharmacist if you are not sure how much isotretinoin you should take.
It may take several weeks or longer for you to feel the full benefit of isotretinoin. Your acne may get worse during the beginning of your treatment with isotretinoin. This is normal and does not mean that the medication is not working. Your acne may continue to improve even after you finish your treatment with isotretinoin.
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