Isotretinoin 30 mg/1
Isotretinoin · CAPSULE · Zydus Pharmaceuticals USA Inc.
Isotretinoin is a capsule containing isotretinoin at 30 mg/1, taken oral. Manufactured by Zydus Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Isotretinoin
- Generic Name
- Isotretinoin
- NDC Code (Product)
70710-1577- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Strength
- 30 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216633
- Drug Class
- Retinoid [EPC]
- Marketing Start
- 06/09/2025
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.
Akorn Inc
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Akorn, Inc.
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Ranbaxy Inc.
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Teva Pharmaceuticals USA, Inc
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Sun Pharmaceutical Industries, Inc.
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Teva North America
Failed Impurities/Degradation Specifications.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
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 Isotretinoin capsules are 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, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS ). 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 isotretinoin capsules. The optimal interval before retreatment has not bee…
Dosage & Administration
DOSAGE AND ADMINISTRATION Isotretinoin capsules should be administered with a meal (see PRECAUTIONS: Information for Patients ). The recommended dosage range for isotretinoin capsules are 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 isotretinoin capsules 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 isotretinoin capsules have 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 w…
Warnings
WARNINGS Psychiatric Disorders Isotretinoin capsules may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these events (see ADVERSE REACTIONS: Psychiatric ). Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin. Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of isotretinoin capsules therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary. Signs and symptoms of depression, as described in the brochure ("Recognizing Psychiatric Disorders in Adolescents and Young Adults"), include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in slee…
Contraindications
CONTRAINDICATIONS Pregnancy Category X See Boxed CONTRAINDICATIONS AND WARNINGS . Allergic Reactions Isotretinoin capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components (see PRECAUTIONS: Hypersensitivity ).
Drug Interactions
Drug Interactions Vitamin A: Because of the relationship of isotretinoin capsules to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects. Tetracyclines: Concomitant treatment with isotretinoin capsules and tetracyclines should be avoided because isotretinoin capsules 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 isotretinoin capsules 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 isotretin…
Adverse Reactions
ADVERSE REACTIONS Clinical Trials and Postmarketing Surveillance The adverse reactions listed below reflect the experience from investigational studies of isotretinoin , and the postmarketing experience. The relationship of some of these events to isotretinoin therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving isotretinoin 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 …
Frequently Asked Questions
What is Isotretinoin used for?
Isotretinoin contains Isotretinoin. It is a capsule taken oral. Consult your doctor for specific uses.
Is Isotretinoin a controlled substance?
Isotretinoin is not classified as a controlled substance by the DEA.
What is the generic name for Isotretinoin?
The generic name for Isotretinoin is Isotretinoin. There are 4 other brand versions of Isotretinoin.
What is the NDC code for Isotretinoin 30 mg/1?
The NDC (National Drug Code) for Isotretinoin 30 mg/1 is 70710-1577, listed by Zydus Pharmaceuticals USA Inc..