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ACCUTANE (ISOTRETINOIN) CAPSULES: PRESCRIBING INFORMATION
Isotretinoin, a retinoid, is available as Accutane in 10 mg, 20 mg and 40 mg soft gelatin capsules for oral administration. Each capsule contains butylated hydroxyanisole, beeswax, edetate disodium, hydrogenated vegetable oil, hydrogenated soybean oil flakes, soybean oil. Gelatin capsules contain glycerin and parabens (methyl and propyl), with the following dye systems: 10 mg - iron oxide (red) and titanium dioxide; 20 mg - FD&C Red No. 3, FD&C Blue No. 1, and titanium dioxide; 40 mg - FD&C Yellow No. 6, D&C Yellow No. 10, and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44.
Accutane clinical pharmacology
INDICATIONS AND USAGE
Severe Recalcitrant Nodular Acne
Accutane (Isotretinoin) capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe", by definition, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, Accutane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Accutane is indicated only for those female patients who are not pregnant, because Accutane can cause severe birth defects.
A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Accutane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth.
Isotretinoin (Accutane) capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components. Accutane should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.
WARNINGS FOR SKELETAL SYSTEM
Accutane warnings for skeletal system
Accutane special warnings
PRECAUTIONS FOR WHOLESALERS
Accutane precautions for wholesalers
PRECAUTIONS FOR PRESCRIBERS
Accutane precautions for prescribers
PRECAUTIONS FOR PATIENTS
Accutane precautions for patients
PRECAUTIONS FOR PHARMACISTS
Accutane precautions for pharmacists
Accutane drug interactions
Accutane laboratory tests
Accutane nonclinical toxicology
USE IN SPECIFIC POPULATIONS
Accutane use in specific populations
Accutane adverse reactions
DOSAGE AND ADMINISTRATION
Accutane dosage and administration
Soft gelatin capsules, 10 mg (light pink), imprinted ACCUTANE 10 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules.
Soft gelatin capsules, 20 mg (maroon), imprinted ACCUTANE 20 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules.
Soft gelatin capsules, 40 mg (yellow), imprinted ACCUTANE 40 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules.
Store at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light.
Manufactured and distributed by Roche pharmaceutical company and its divisions.
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