What is CIP isotretinoin?
CIP isotretinoin is a form of the drug isotretinoin that provides more consistent absorption than existing isotretinoin products. Isotretinoin is an important medication that is used to treat severe or persistent forms of acne and other skin conditions. CIP isotretinoin has recently been approved for use in the United States of America, but is not yet available in other countries (July 2012).
Why is constant absorption of isotretinoin important?
A major problem for existing isotretinoin products is patient compliance, as the active ingredient must be taken with a high-fat meal to ensure consistent absorption. Isotretinoin is often taken by teens. The eating habits of adolescents are often irregular compared to adults of working age. On May 25, 2012, the FDA approved CIP-isotretinoin (Absorica ™; CIPher Pharmaceuticals Canada), which provides more consistent absorption under food and fasting conditions compared to existing isotretinoin products that exhibit a reduction of 65% in absorption under fasting conditions. CIP isotretinoin can be taken with or without food.
CIP isotretinoin is very similar to isotretinoin (marketed under various brands by various manufacturers). However, it is not exactly the same as isotretinoin, due to the differences in how well the drug is absorbed; CIP isotretinoin is well absorbed with or without food, while the other isotretinoin products should be taken with food to achieve good absorption.
When is CIP-isotretinoin prescribed?
Isotretinoin CIP is an innovative formulation of the active ingredient isotretinoin and is used for patients at least 12 years of age with severe nodular acne that does not respond to conventional therapy, including systemic antibiotics
What is the usual dose and the course of treatment?
In most cases, the recommended dose of isotretinoin CIP is 0.5 mg to 1 mg per kg of body weight (approximately 0.23 mg to 0.45 mg per lb) each day, divided into two daily doses. For adults with severe acne or acne limited primarily to the trunk of the body, up to 2 mg per kg (approximately 0.91 mg per lb) per day may rarely be prescribed.
In most cases, CIP-isotretinoin is taken for 15 to 20 weeks. A second course may be recommended if acne is still a problem eight weeks after completing the first course. Due to the risk of teratogenicity and to minimize fetal exposure, in the United States, CIP-isotretinoin is available only through a restricted program under a Risk Assessment and Mitigation Strategy (REMS) called iPLEDGE ™. According to the REMS for Isotretinoin CIP, prescribers, patients, pharmacies, and distributors must enroll and register in the program.
Women of childbearing age should use two effective forms of childbirth. control while taking CIP-isotretinoin and may require pregnancy tests during treatment to avoid using this medicine during pregnancy.
In the United States, CIP isotretinoin can only be:
- prescribed by doctors registered in the iPLEDGE program
- dispensed by a pharmacy that is registered with the iPLEDGE program
- administered to patients who are enrolled in the iPLEDGE program and agree to do whatever is necessary in the program
Research evidence for isotretinoin CIP
In a randomized double-blind In a study involving 925 patients with severe nodular acne, CIP-isotretinoin was as effective as isotretinoin in achieving a 90% reduction in nodular lesions over a period of 20 weeks.
From a security perspective, the first-line data was positive and did not show general statistical differences in the adverse event profile between the two products. The most frequent side effects observed were dry skin and dry lips. Also, initial statistics on psychiatric disorders, eye disorders, ear disorders, musculoskeletal, vascular disorders, cardiac disorders and gastrointestinal disorders, illustrate that there were no significant differences in the extent of adverse events between CIP-isotretinoin and the reference product.
Certain antibiotics, St. John's wort, or progestin-Only birth control pills in combination with CIP-isotretinoin can cause potentially serious drug interactions. In some cases, these reactions can increase the risk of osteoporosis, high pressure in the head, or other serious problems.