Isotretinoin capsules

Cremophor RH 60/ Hydrogenated oil/Glyceryl monooleate Soybean oil/Hydrogenated vegetable oils/ Hydrogenated soybean oil Indomethacin famesil/ Infree Capsules Isotretinoin/Accutane ... 

Isotretinoin Capsules 10, 20, 40 mg 0.5-1 mg/kg/per day in two divided doses Maximum dose 2 mg/kg per day Cumulative dose 120-150 mg/day Dry skin and mucous membranes, muscle and joint pain, elevated liver enzymes and triglycerides, depression, teratogenicity... 

In mild-to-moderate acne topical treatment such as benzoyl peroxide (Ponoxyl gel) is usually recommended, followed by clindamycin (Dalacin capsules). Rooccutone capsules, which contain isotretinoin, ore reserved for more severe cases of acne. 

Absorption - Because of its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal. In a crossover study, 74 healthy adult subjects received a single 80 mg oral dose (two 40 mg capsules) of isotretinoin under fasted and fed conditions. Peak plasma concentration (Cmax)... 

Isotretinoin is a retinoid, recently approved for use in capsule form (10-20 mg). It decreases the amount of sebum that sebaceous glands produce. Isotretinoin exhibits antiproliferative and antiandrogenic effects on the sebaceous glands. It also interacts with the formation of androgens in sebaceous glands. It is indicated in the treatment of severe nodular acne, acne conglobata and recalcitrant acne. It is available in International market under the brand name ACCUTANE by Roche pharmaceuticals. 

Similar labeling language also in the labeling of AMNESTEEM (Isotretinoin) Mylan, May 2004 and SORIATANE (Connetics) (acitretin) capsules, March 2004. 

Isotretinoin, a retinoid, is available as in 10-mg, 20-mg, and 40-mg soft gelatin capsules for oral administration. Each capsule also contains beeswax, butylated hydroxy-anisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems 10 mg, iron oxide... 

There are many types of preparations that contain retinol. Absorption is greatest for aqueous preparations, intermediate for emulsions, and slowest for oil solutions. Whereas oil-soluble preparations may lead to greater hepatic storage of the vitamin, water-miscible preparations usually provide higher concentrations in plasma. Vitamin A is available as capsules. Tretinoin (all-trans-retinoic acid Retin A) is available for topical use. Isotretinoin (13-ri.s-retinoic acid Accutane) is available for oral use, as is etretinate (Tegison). 

Contraindications Women who are or may become pregnant while undergoing treatment extremely high risk of major deformities in fetus while taking any amounts even for short periods of time Hypersensitivity to isotretinoin or parabens (component of capsules) Cautions Renal, hepatic dysfunction... 

Isotretinoin/ Ac cutane /Roche/ Antiachne HsC CH3 1 ]l COOH XHg 0.5-2 mg/ kg/day (1-4 capsules) Soft gelatin capsule 10,20,40 mg Beeswax BHA EDTA Hydrogenated soybean oil flakes Hydrogenated vegetable oils Soybean oil RT, Protect from light... 

A 22-year-old man who had taken isotretinoin 20 mg bd for 5 days for nodular acne developed melena. Upper gastrointestinal endoscopy showed edema and hyperemia of the gastric mucosa of the body and antrum. Flexible sigmoidoscopy showed edema and hyperemia of the mucosa of the rectum and sigmoid colon, with numerous erosions. To exclude the possibility of small bowel involvement, he underwent video capsule endoscopy, which showed diffuse and extensive intestinal inflammation with aphthae and multiple linear, irregular-shaped jejunal ulcers. Isotretinoin was withdrawn and he had a complete resolution. 

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