ZENATANE 40 mg/1
ISOTRETINOIN · CAPSULE, GELATIN COATED · BluePoint Laboratories
ZENATANE is a capsule, gelatin coated containing isotretinoin at 40 mg/1, taken oral. Manufactured by BluePoint Laboratories.
Key Facts
- Brand Name
- ZENATANE
- Generic Name
- ISOTRETINOIN
- NDC Code (Product)
68001-655- Manufacturer
- BluePoint Laboratories
- Strength
- 40 mg/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202099
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 12/24/2025
Recall History
Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications - low dissolution results at S3 stage.
Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications - low dissolution results at S3 stage.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications
Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications - low dissolution results at S3 stage.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications - low dissolution results at S3 stage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition, 2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNING S ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Zenatane. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see…
Dosage & Administration
DOSAGE AND ADMINISTRATION Zenatane should be administered with a meal (see PRECAUTIONS : Information for Patients ). The recommended dosage range for Zenatane is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1 mg/kg/day, 8 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 mg/kg/day, as tolerated. Failure to take Zenatane 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 Zenatane 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…
Warnings
Special Patient Populations Pediatric Patients The pharmacokinetics of isotretinoin were evaluated after single and multiple doses in 38 pediatric patients (12 to 15 years) and 19 adult patients (≥18 years) who received Zenatane for the treatment of severe recalcitrant nodular acne. In both age groups, 4-oxo-isotretinoin was the major metabolite; tretinoin and 4-oxo-tretinoin were also observed. The dose-normalized pharmacokinetic parameters for isotretinoin following single and multiple doses are summarized in Table 3 for pediatric patients. There were no statistically significant differences in the pharmacokinetics of isotretinoin between pediatric and adult patients. Table 3. Pharmacokinetic Parameters of Isotretinoin Following Single and Multiple Dose Administration in Pediatric Patients, 12 to 15 Years of Age Mean ( ± SD), N=38* Parameter Isotretinoin (Single Dose) Isotretinoin (Steady-State) C max (ng/mL) 573.25 (278.79) 731.98 (361.86) AUC (0-12) (ng⋅hr/mL) 3033.37 (1394.17) 5082 (2184.23) AUC (0-24) (ng⋅hr/mL) 6003.81 (2885.67) – T max (hr)† 6 (1 to 24.6) 4 (0 to12) C ss min (ng/mL) – 352.32 (184.44) T 1/2 (hr) – 15.69 (5.12) CL/F (L/hr) – 17.96 (6.27) *The single and multi…
Contraindications
CONTRAINDICATIONS Pregnancy: Category X. See Boxed CONTRAINDICATIONS AND WARNINGS . Allergic Reactions Zenatane is contraindicated in patients who are hypersensitive to this medication or to any of its components (see PRECAUTIONS: Hypersensitivity).
Drug Interactions
Drug Interactions Drug Interactions Vitamin A: Because of the relationship of Zenatane to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects. Tetracyclines: Concomitant treatment with Zenatane and tetracyclines should be avoided because Zenatane 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 Zenatane therapy. Although other hormonal contraceptives are highly effective, there have been reports of pregnancy from patients who can become pregnant 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 patients who can become pregnant who use only a single form of contraception. It is not known if hormonal contraceptives differ in their effectiveness when used with Zenatane. Therefore, it is critically impor…
Adverse Reactions
ADVERSE REACTIONS Clinical Trials and Postmarketing Surveillance The adverse reactions listed below reflect the experience from investigational studies of Zenatane, and the postmarketing experience. The relationship of some of these events to Zenatane therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Zenatane are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage, and eyes). Dose Relationship Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy (see WARNINGS and ADVERSE REACTIONS ). Body as a Whole allergic reactions, including vasculitis, systemic hypersensitivity (see PRECAUTIONS : Hypersensitivity ), edema, fatigue, lymphadenopathy, weight loss Cardiovascular palpitation, tachycardia, vascular thrombotic disease, stroke Endocrine/Metabolic hypertriglyceridemia (see WARNINGS : Lipids ), alterations in blood sugar levels (see PRECAUTIONS : Laboratory Tests ) Gastrointestinal inflammato…
Frequently Asked Questions
What is ZENATANE used for?
ZENATANE contains ISOTRETINOIN. It is a capsule, gelatin coated taken oral. Consult your doctor for specific uses.
Is ZENATANE a controlled substance?
ZENATANE is not classified as a controlled substance by the DEA.
What is the generic name for ZENATANE?
The generic name for ZENATANE is ISOTRETINOIN. There are 11 other brand versions of ISOTRETINOIN.
What is the NDC code for ZENATANE 40 mg/1?
The NDC (National Drug Code) for ZENATANE 40 mg/1 is 68001-655, listed by BluePoint Laboratories.