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DRUGS & SUPPLEMENTS
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How old is patient? |
Differin cream is indicated for the topical treatment of acne vulgaris.
Two vehicle-controlled clinical studies were conducted in patients 12 to 30 years of age with mild to moderate acne vulgaris, in which Differin cream was compared with its vehicle. Patients were instructed to apply their treatment medication once daily at bedtime for 12 weeks. In one study patients were provided with a soapless cleanser and were encouraged to refrain from using moisturizers. No other topical medications, other than Differin cream, were to be applied to the face during the studies. Differin cream was significantly more effective than its vehicle in the reduction of acne lesion counts. The mean percent reduction in lesion counts from baseline after treatment for 12 weeks are presented in the following table:
MEAN PERCENT REDUCTION IN LESION COUNTS FROM BASELINE TO WEEK 12 | ||||
Study No. 1 | Study No. 2 | |||
Efficacy Variable | Differin Cream, 0.1% N=119 | Cream Vehicle N=118 | Differin Cream, 0.1% N=175 | Cream Vehicle N=175 |
Non-inflammatory lesions | 34% | 18% | 35% | 15% |
Inflammatory lesions | 32% | 17% | 14% | 6% |
Total lesions | 34% | 18% | 30% | 15% |
The trend in the Investigator's global assessment of severity supported the efficacy of Differin cream when compared to the cream vehicle.
Differin cream should not be administered to individuals who are hypersensitive to Differin or any of the components in the cream vehicle.
Certain cutaneous signs and symptoms of treatment such as erythema, dryness, scaling, burning, or pruritus may be experienced with use of Differin cream. These are most likely to occur during the first two to four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to reduce the frequency of application or discontinue use.
If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during use of Differin. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with Differin.
Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of "waxing" as a depilatory method should be avoided on skin treated with Differin.
Patients using Differin cream should receive the following information and instructions:
As Differin cream has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with Differin cream. If these preparations have been used, it is advisable not to start therapy with Differin cream until the effects of such preparations in the skin have subsided.
Carcinogenicity studies with Differin have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day. These doses are up to 8 times (mice) and 6 times (rats) in terms of mg/m2/day the maximum potential exposure at the recommended topical human dose (MRHD), assumed to be 2.5 grams Differin cream, which is approximately 1.5 mg/m2 Differin. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed.
No photocarcinogenicity studies were conducted. Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources.
Differin did not exhibit mutagenic or genotoxic effects in vivo (mouse micronucleous test) and in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) studies.
Reproductive function and fertility studies were conducted in rats administered oral doses of Differin in amounts up to 20 mg/kg/day (up to 80 times the MRHD based on mg/m2 comparisons). No effects of Differin were found on the reproductive performance or fertility of the Fo males or females. There were also no detectable effects on the growth, development and subsequent reproductive function of the F1 generation.
No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day Differin. However, Differin administered orally at doses of≥ 25 mg/kg, (100 times the MRHD for rats or 200 times MRHD for rabbits) has been shown to be teratogenic. Cutaneous teratology studies in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day (24 times the MRHD for rats or 48 times the MRHD for rabbits) exhibited no fetotoxicity and only minimal increases in supernumerary ribs in rats. There are no adequate and well-controlled studies in pregnant women. Differin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Differin cream is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
Clinical studies of Differin cream were conducted in patients 12 to 30 years of age with acne vulgaris and therefore did not include subjects 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used Differin cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with Differin cream from the controlled clinical studies is provided in the following table:
Incidence of Local Cutaneous Irritations with Differin Cream from Controlled Clinical Studies (N=285) | ||||
None | Mild | Moderate | Severe | |
Erythema | 52% (148) | 38% (108) | 10% (28) | <1% (1) |
Scaling | 58% (166) | 35% (100) | 6% (18) | <1% (1) |
Dryness | 48% (136) | 42% (121) | 9% (26) | <1% (2) |
Pruritis (persistent) | 74% (211) | 21% (61) | 4% (12) | <1% (1) |
Burning/Stinging (persistent) | 71% (202) | 24% (69) | 4% (12) | <1% (2) |
Other reported local cutaneous adverse events in patients who used Differin cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%). Events occurring in less than 1% of patients treated with Differin cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
Differin cream is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. The acute oral toxicity of Differin cream in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
Differin cream should be applied to affected areas of the skin, once daily at nighttime. A thin film of the cream should be applied to the skin areas where acne lesions appear, using enough to cover the entire affected areas lightly. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Differin cream.
Differin Cream, 0.1% is supplied in a 45 g tube - NDC 0168-0424-46
Store at controlled room temperature 68° to 77°F (20° to 25°C). Excursions permitted between 59° and 86° F (15° and 30° C). Protect from freezing.
I2424B
R02/13
#187
E. FOUGERA & CO.
A division of Fougera
PHARMACEUTICALS INC.
Melville, New York 11747
NDC 0168-0424-46
Fougera ®
Differin CREAM 0.1%
Rx only
For topical use only.
Not for ophthalmic, oral or intravaginal use.
NET WT 45 grams
NDC 0168-0424-46
Rx only
Fougera ®
Differin CREAM 0.1%
For topical use only.
Not for ophthalmic, oral,
or intravaginal use.
NET WT 45 grams
Depending on the reaction of the Differin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Differin not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Differin addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology