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Comprehensive Treatment Information for Canadian Dermatologists
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Acne - Patient's guide
Isotretinoin - Side Effects That Need Medical Monitoring By The Physician
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Click here to view the A-Detail™ on Accutane®.
Certain Isotretinoin (Accutane®) side effects will not be as apparent to your patient and will need to be monitored by you during their acne treatment. These include effects on the patient's bones, lipids, liver and pregnancy status.
Pregnancy:
- This drug is teratogenic and causes fetal abnormalities
- Patients cannot risk becoming pregnant
- Patients must avoid pregnancy 1 month before, during, and 1 month after use of this drug
- Pregnancy prevention programs are offered to ensure that your patient will avoid getting pregnant, talk to your patient about this
Bones:
- Hyperostosis, osteophytes (bony spurs) may develop, but are usually of little consequence
- There is a possible risk that your patient's bones will become thinner (osteoporosis)
- (however, more work needs to be done, as studies have been inconclusive)
- Premature closure of bony epiphyses can occur in children, which may reduce long bone growth
Lipids:
- Cholesterol/ triglyceride levels may increase, this must be followed by the doctor
- Patients may experience a short term increase in cholesterol, though this is not thought to be very significant
- Pancreatitis is a risk if their triglycerides rise quickly and the level becomes high, this is very rare, however
Liver:
- May be mildly irritating to the patient's liver
Neurologic:
- A pseudotumor in the cerebrum can occur, which can cause increased brain fluid pressure, headaches, vomiting, and visual disturbances
- Depression and suicidal thoughts have been reported in some patients,
- nobody knows for sure, though, if it was isotretinoin or other factors that caused these feelings
- Your patient may experience headaches
Muscloskeletal:
- There is a risk of inflammation around joints, and tendonitis
- Aches and pains around joints, and lower back pain are common
Blood:
- Your patient's ability to produce white blood cells may be diminished (called leukopenia) however, this is rare.
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INTRODUCTION
Clinical experience confirms what has been shown in clinical trials, that Clindoxyl Gel is effective and well tolerated Once daily application of topical that combines two active anti-acne agents may well increase patient compliance... | Read more ... -
CLININCAL EXPERIENCE
More than six international studies involving over 6,000 patients have shown reductions in the PASI (Psoriasis Area and Severity Index) of approximately 40% after one week of treatment and 70% after four weeks... | Read more ... -
INDICATIONS
Moderate comedonal and papulo-pustular acne Approved in Canada as a once daily topical for moderate Acne in December 2000... | Read more ... -
PATIENT PROFILE
Any patient who has inflammatory acne can be treated with Clindoxyl Gel Acne patients with comedones only are best treated by topical retinoids Patients with cystic acne usually require systemic therapy... | Read more ... -
DOSING
Once daily application of Clindoxyl Gel is recommended The product needs to be applied to the whole region of skin that is affected with acne. In other words... | Read more ... -
EFFICACY
The following figures show pooled data from randomized, controlled double-blind trials involving 673 patients with acne... | Read more ... -
COMPLIANCE
Three factors to consider for good compliance of Clindoxyl Gel are: Well tolerated by most patients, results are often seen within 2 weeks... | Read more ... -
SIDE EFFECTS, SAFETY AND RISKS
Overall tolerance was rated as excellent in 94% of patients. Potential side effects expected in some patients... | Read more ... -
COST OF TREATMENT
This is a cost effective product. Reducing inflammation can reduce the risks of scarring... | Read more ...
View the entire Clindoxyl® Gel presentation.
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INTRODUCTION
There are limitations for regulators, pharmaceutical companies and pharmaceutical sales representatives to present clinical evidence following development of product monograph and drug approval... | Read more ... -
CLININCAL EXPERIENCE
Diane-35® (2mg cyproterone acetate and 0.035mg ethinyl estradiol) is approved for use in Canada to treat women with severe acne who are unresponsive to other available treatments and who have associated symptoms of androgenization, such as seborrhea and mild hirsutism. In addition to treating acne, Diane-35® also provides reliable contraception... | Read more ... -
INDICATIONS
Used to treat women with severe* acne and its associated symptoms of androgenization, including seborrhea and mild hirsutism.. | Read more ... -
PATIENT PROFILE
Women who have acne associated or not with signs of hyperandrogenism. Any woman who has acne that is not controlled with topical medication... | Read more ... -
DOSING
Diane-35® is sold in blister pack units containing 21 tablets. Each tablet contains 2mg of cyproterone acetate and 0.035mg of ethinyl estradiol. Each cycle consists of 21 days on the medication and a 7-day interval without it... | Read more ... -
EFFICACY
Improvements in seborrhea are generally seen after 2 to 3 months. Improvements to acne are generally seen after 3 to 4 months. Numerous studies have proven the efficacy of hormonal therapy in treating acne over 6 or more months of use... | Read more ... -
COMPLIANCE
Patients should take Diane-35® at the same time each day with liquid... | Read more ... -
SIDE EFFECTS, SAFETY AND RISKS
Side effects are typical of most oral contraceptives and can include breast tenderness, headache, nausea, breakthrough bleeding, ankle swelling and weight gain. These side effects are typically mild and tend to resolve by the second or third cycle of therapy... | Read more ... -
COST OF TREATMENT
Diane-35 is sold to pharmacy wholesalers at a cost of $19.00 per cycle... | Read more ...
View the entire Diane-35® presentation.
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Last modified: Tuesday, 17-Aug-2010 12:02:19 MDT