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ACCUTANE (ISOTRETINOIN) CAPSULES: PRESCRIBING INFORMATION

DESCRIPTION

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.


CLINICAL PHARMACOLOGY

Accutane clinical pharmacology


PHARMACOKINETICS

Accutane pharmacokinetics


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.


CONTRAINDICATIONS

Pregnancy

Category X

Allergic Reactions

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

Accutane warnings


WARNINGS FOR SKELETAL SYSTEM

Accutane warnings for skeletal system


SPECIAL WARNINGS

Accutane special warnings


PRECAUTIONS

Accutane precautions


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


DRUG INTERACTIONS

Accutane drug interactions


LABORATORY TESTS

Accutane laboratory tests


NONCLINICAL TOXICOLOGY

Accutane nonclinical toxicology


USE IN SPECIFIC POPULATIONS

Accutane use in specific populations


ADVERSE REACTIONS

Accutane adverse reactions


OVERDOSAGE

Accutane overdosage


DOSAGE AND ADMINISTRATION

Accutane dosage and administration


HOW SUPPLIED

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.

Storage

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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