How do you administer this medicine?
Dosage of Curacne in details
Curacne (Curacne) should be administered with a meal.
The recommended dosage range for Curacne (Curacne) is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects — some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Curacne (Curacne) with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Curacne (Curacne) has not been established. Once daily dosing is not recommended.
If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Curacne (Curacne), even in low doses, has not been studied, and is not recommended. It is important that Curacne (Curacne) be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Curacne on bone loss is unknown.
Contraceptive measures must be followed for any subsequent course of therapy.
Table 4 : Curacne (Curacne) Dosing by Body Weight (Based on Administration With Food)
|Body Weight||Total mg/day|
|kilograms||pounds||0.5 mg/kg||1 mg/kg||2 mg/kg*|
|*See DOSAGE AND ADMINISTRATION: the recommended dosage range is 0.5 to 1.0 mg/kg/day.|
Soft gelatin capsules, 10 mg (light pink), imprinted Curacne (Curacne) 10 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0155-49).
Soft gelatin capsules, 20 mg (maroon), imprinted Curacne (Curacne) 20 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0169-49).
Soft gelatin capsules, 40 mg (yellow), imprinted Curacne (Curacne) 40 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0156-49).
Store at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light.
1. Peck GL, Olsen TG, Yoder FW, et al. Prolonged remissions of cystic and conglobate acne with 13-cis-retinoic acid. N Engl J Med 300:329-333, 1979.
2. Pochi PE, Shalita AR, Strauss JS, Webster SB. Report of the consensus conference on acne classification. J Am Acad Dermatol 24:495-500, 1991.
3. Farrell LN, Strauss JS, Stranieri AM. The treatment of severe cystic acne with 13-cis-retinoic acid: evaluation of sebum production and the clinical response in a multiple-dose trial. J Am Acad Dermatol 3:602-611, 1980.
4. Jones H, Blanc D, Cunliffe WJ. 13-cisretinoic acid and acne. Lancet 2:1048-1049, 1980.
8. Strauss JS, Rapini RP, Shalita AR, et al. Curacne therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol 10:490-496, 1984.
Distributed by: Roche Laboratories Inc., 340 Kingsland Street, Nutley, New Jersey 07110-1199. PI Revised: January 2010.
What other drugs will affect Curacne?
Before taking Curacne, tell your doctor if you are also taking:
steroids (prednisone and others);
seizure medication such as phenytoin (Dilantin); or
a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Brodspec, Sumycin, Tetracap).
This list is not complete and other drugs may interact with Curacne. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
- Vitamin A: Because of the relationship of Curacne (Curacne) to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
- Tetracyclines: Concomitant treatment with Curacne (Curacne) and tetracyclines should be avoided because Curacne (Curacne) use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines.
- Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations (“minipills” that do not contain an estrogen) may be an inadequate method of contraception during Curacne (Curacne) therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from female patients who have used combined oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products. These reports are more frequent for female patients who use only a single method of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Curacne (Curacne). Therefore, it is critically important for female patients of childbearing potential to select and commit to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form.
- Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum® 7/7/7 Tablets as an oral contraceptive agent, Curacne (Curacne) at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Prescribers are advised to consult the package insert of medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
- St. John's Wort: Curacne (Curacne) use is associated with depression in some patients. Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John's Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John's Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's Wort.
- Phenytoin: Curacne (Curacne) has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither Curacne nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and Curacne (Curacne). Therefore, caution should be exercised when using these drugs together.
- Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between systemic corticosteroids and Curacne (Curacne). Therefore, caution should be exercised when using these drugs together.
- Pregnancy Test
- Female patients of childbearing potential must have had two negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Curacne (Curacne) prescription. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue qualification of the patient for Curacne (Curacne). The second pregnancy test (a confirmation test) must be done in a CLIA-certified laboratory. The interval between the two tests must be at least 19 days.
- For patients with regular menstrual cycles, the second pregnancy test must be done during the first 5 days of the menstrual period immediately preceding the beginning of Curacne (Curacne) therapy and after the patient has used 2 forms of contraception for 1 month.
- For patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding, the second pregnancy test must be done immediately preceding the beginning of Curacne (Curacne) therapy and after the patient has used 2 forms of contraception for 1 month.
- Each month of therapy, patients must have a negative result from a urine or serum pregnancy test. A pregnancy test must be repeated each month, in a CLIA-certified laboratory, prior to the female patient receiving each prescription.
- Lipids: Pretreatment and follow-up blood lipids should be obtained under fasting conditions. After consumption of alcohol, at least 36 hours should elapse before these determinations are made. It is recommended that these tests be performed at weekly or biweekly intervals until the lipid response to Curacne (Curacne) is established. The incidence of hypertriglyceridemia is 1 patient in 4 on Curacne therapy.
- Liver Function Tests: Since elevations of liver enzymes have been observed during clinical trials, and hepatitis has been reported, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to Curacne has been established.
- Glucose: Some patients receiving Curacne (Curacne) have experienced problems in the control of their blood sugar. In addition, new cases of diabetes have been diagnosed during Curacne (Curacne) therapy, although no causal relationship has been established.
- CPK: Some patients undergoing vigorous physical activity while on Curacne (Curacne) therapy have experienced elevated CPK levels; however, the clinical significance is unknown. There have been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity. In a clinical trial of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne, transient elevations in CPK were observed in 12% of patients, including those undergoing strenuous physical activity in association with reported musculoskeletal adverse events such as back pain, arthralgia, limb injury, or muscle sprain. In these patients, approximately half of the CPK elevations returned to normal within 2 weeks and half returned to normal within 4 weeks. No cases of rhabdomyolysis were reported in this trial.
7. Dicken CH, Connolly SM. Eruptive xanthomas associated with Curacne (13-cis-retinoic acid). Arch Dermatol 116:951-952, 1980.
- DailyMed. "ISOTRETINOIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- FDA/SPL Indexing Data. "EH28UP18IF: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Teratogens". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Curacne are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Curacne. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
7 consumers reported frequency of useHow frequently do I need to take Curacne?
It was reported by ndrugs.com website users that Curacne should ideally be taken Once in a day as the most common frequency of the Curacne. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Curacne should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
|Once in a day||6||85.7%|
|Twice in a day||1||14.3%|
3 consumers reported dosesWhat doses of Curacne drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Curacne drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
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Information checked by Dr. Sachin Kumar, MD Pharmacology