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The program mandated two consecutive negative pregnancy tests, birth defect risk counseling and a pledge to use two forms of contraception when engaging in intercourse for all people assigned female at birth of childbearing age seeking an isotretinoin prescription. A voluntary registration program called The Accutane Survey was also established.
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
Isotretinoin, also known as 13-cis-retinoic acid and sold under the brand name Accutane among others, is a medication used to treat skin diseases like harlequin-type ichthyosis, and lamellar ichthyosis, and severe cystic acne or moderate acne that is unresponsive to antibiotics. [6]
Accutane can be an effective solution for combating moderate to severe acne, but it comes with a unique set of instructions and some uncomfortable side effects. One reaction many Accutane users ...
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From or to a drug trade name: This is a redirect from (or to) the trade name of a drug to (or from) the international nonproprietary name (INN). When appropriate, protection levels are automatically sensed, described and categorized.
Dosage forms (also called unit doses) are pharmaceutical drug products presented in a specific form for use. They contain a mixture of active ingredients and inactive components ( excipients ), configured in a particular way (such as a capsule shell) and apportioned into a specific dose .
Dosage typically includes information on the number of doses, intervals between administrations, and the overall treatment period. [3] For example, a dosage might be described as "200 mg twice daily for two weeks," where 200 mg represents the individual dose, twice daily indicates the frequency, and two weeks specifies the duration of treatment.