See also:
What is the most important information I should know about Xeractan 20mg?
Hypersensitivity to Xeractan 20mg or to any of the excipients of Xeractan 20mg. Hepatic or renal insufficiency; hypervitaminosis A; patients with excessively elevated blood lipid values.
Use in pregnancy: Pregnancy Category X: Xeractan 20mg is highly teratogenic. It is, therefore, contraindicated not only in women who are pregnant or who may become pregnant while undergoing treatment but also in all women of childbearing potential. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking Xeractan 20mg in any amount even for short periods. Potentially all exposed foetuses can be affected.
Xeractan 20mg is contraindicated in women of childbearing potential unless the female patient meets all of the following conditions: Severe disfiguring cystic acne resistant to standard therapies; reliability in understanding and carrying out instructions; compliance with the mandatory contraceptive measures; informed by the physician of the hazards of becoming pregnant during and 1 month after treatment with Xeractan 20mg and warned of the possibility of contraceptive failure; confirms that patient has understood the warnings; negative pregnancy test within 2 weeks prior to beginning therapy, monthly repetition of pregnancy testing is recommended; use effective contraception without any interruption for at least 1 month before beginning Xeractan 20mg therapy, during therapy and for 1 month following discontinuation of therapy. At least 1 and preferably 2 complementary forms of contraception including a barrier method should be used. Microdosed progesterone preparations (minipills) may be an inadequate method of contraception during Xeractan 20mg therapy. If the patient starts Xeractan 20mg therapy only on the 2nd or 3rd day of the next menstrual period; in the event of relapse treatments, patient must also use the same uninterrupted and effective contraceptive measures 1 month prior to, during and for 1 month after Xeractan 20mg therapy; must fully understand the precautions and confirm patient understanding and willingness to comply with reliable contraceptive measures as explained.
Even female patients, who normally do not employ contraception because of a history of infertility, should be advised to do so while taking Xeractan 20mg, following the previously stated guidelines.
Should pregnancy occur inspite of these precautions during treatment with Xeractan 20mg or in the month following, there is a great risk of very severe malformation of the foetus (involving in particular the central nervous system, heart and large blood vessels). If pregnancy does occur, the physician and patient should discuss the advisability of continuing the pregnancy.
Major human foetal abnormalities related to Xeractan 20mg administration have been documented, including hydrocephalus, microcephalus, abnormalities of the external ear (micropinna, small or absent external auditory canals), microphthalmia, cardiovascular abnormalities, facial dysmorphia, thymus gland abnormalities, parathyroid hormone deficiency and cerebellar malformation. There is also an increased risk of spontaneous abortion.
Xeractan 20mg is highly teratogenic and must not be given to women who are pregnant. Xeractan 20mg crosses the placental barrier in amounts that lead to congenital deformities. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking Xeractan 20mg in any amount even for short periods. Potentially all exposed foetuses can be affected.
See also:
What are the possible side effects of Xeractan 20mg?
The following adverse reactions with Xeractan 20mg or other Xeractan 20mg products are described in more detail in other sections of the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Xeractan 20mg cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.
The adverse reactions listed below reflect both clinical experience with Xeractan 20mg, and consider other adverse reactions that are known from clinical trials and the post-marketing surveillance with oral Xeractan 20mg. The relationship of some of these events to Xeractan 20mg therapy is unknown. Many of the side effects and adverse events seen in patients receiving Xeractan 20mg 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 RelationshipCheilitis and hypertriglyceridemia are adverse reactions that are usually dose related. Most adverse reactions reported in clinical trials with Xeractan 20mg were reversible when therapy was discontinued; however, some persisted after cessation of therapy.
Body as a WholeThe following adverse reactions have been reported in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): fatigue, irritability, pain. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: allergic reactions, including vasculitis, systemic hypersensitivity, edema, lymphadenopathy, weight loss.
CardiovascularThe following adverse reactions have been reported with Xeractan 20mg: vascular thrombotic disease, stroke, palpitation, tachycardia.
Endocrine/Metabolism and NutritionalThe following adverse reactions have been reported in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): decreased appetite, weight fluctuation, hyperlipidaemia. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: hypertriglyceridemia, alterations in blood sugar.
GastrointestinalThe following adverse reactions have been reported in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): lip dry, chapped lips, cheilitis, nausea, constipation, diarrhea, abdominal pain, vomiting. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, and other nonspecific gastrointestinal symptoms.
HematologicThe following adverse reactions have been reported with Xeractan 20mg: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis.
Infections and infestationsThe following adverse reactions have been reported in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): nasopharyngitis, hordeolum, upper respiratory tract infection. In addition to the above adverse reactions, the following adverse reaction has been reported with Xeractan 20mg: infections (including disseminated herpes simplex).
Laboratory AbnormalitiesThe following changes in laboratory tests have been noted in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): blood creatine phosphokinase (CPK) increased, blood triglycerides increased, alanine aminotransferase (SGPT) increased, aspartate aminotransferase (SGOT) increased, gamma-glutamyltransferase (GGTP) increased, blood cholesterol increased, low density lipoprotein (LDL) increased, white blood cell count decreased, blood alkaline phosphatase increased, blood bilirubin increased, blood glucose increased, high density lipopoprotein (HDL) decreased, bone mineral density decreased. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: increased LDH, elevation of fasting blood sugar, hyperuricemia, decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis), elevated sedimentation rates, elevated platelet counts, thrombocytopenia, white cells in the urine, proteinuria, microscopic or gross hematuria.
Musculoskeletal and Connective TissueThe following adverse reactions have been reported in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): decreases in bone mineral density, musculoskeletal symptoms (sometimes severe) including back pain, athralgia, musculoskeletal discomfort, musculoskeletal pain, neck pain, pain in extremity, myalgia, musculoskeletal stiffness. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, tendonitis, arthritis, transient pain in the chest, and rare reports of rhabdomyolysis.
NeurologicalThe following adverse reactions have been reported in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): headache, syncope. In addition to the above adverse reactions, other adverse reactions reported with Xeractan 20mg include: pseudotumor cerebri, dizziness, drowsiness, lethargy, malaise, nervousness, paresthesias, seizures, stroke, weakness.
PsychiatricThe following adverse reactions have been reported in clinical trials conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): suicidal ideation, insomnia, anxiety, depression, irritability, panic attack, anger, euphoria, violent behaviors, emotional instability. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: suicide attempts, suicide, aggression, psychosis and hallucination auditory. Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.
Reproductive SystemThe following adverse reaction has been reported with Xeractan 20mg: abnormal menses.
RespiratoryThe following adverse reactions have been reported in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): epistaxis, nasal dryness. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: bronchospasms (with or without a history of asthma), respiratory infection, voice alteration.
Skin and Subcutaneous TissueThe following adverse reactions have been reported in a clinical trial conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): dry skin, dermatitis, eczema, rash, dermatitis contact, alopecia, pruritus, sunburn, erythema. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: acne fulminans, alopecia (which in some cases persists), bruising, dry nose, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener's granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).
Special SensesHearing: The following adverse reactions have been reported with Xeractan 20mg: tinnitus and hearing impairment.
Ocular: The following adverse reactions have been reported in clinical trials conducted with Xeractan 20mg and a generic product of Xeractan 20mg® (Xeractan 20mg): dry eye, visual acuity reduced, vision blurred, eye pruritis, eye irritation, asthenopia, decreased night vision, ocular hyperemia, increased lacrimation, and conjunctivitis. In addition to the above adverse reactions, the following adverse reactions have been reported with Xeractan 20mg: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, eyelid inflammation, keratitis, optic neuritis, photobia, visual disturbances.
Renal and UrinaryThe following adverse reactions have been reported in clinical trials conducted with Xeractan 20mg: glomerulonephritis, nonspecific urogenital findings.
Xeractan 20mg (isotret (isotret (Xeractan 20mg capsules) inoin capsules) inoin capsules) 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, means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use. Xeractan 20mg (isotret (isotret (Xeractan 20mg capsules) inoin capsules) inoin capsules) should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Xeractan 20mg (isotret (isotret (Xeractan 20mg capsules) inoin capsules) inoin capsules) is indicated only for those female patients who are not pregnant, because Xeractan 20mg can cause severe birth defects.
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. 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 isotret (isotret (isotret (Xeractan 20mg capsules) inoin capsules) inoin capsules) inoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth.
Xeractan 20mg is used to treat severe, disfiguring nodular acne. It should be used only after other acne medicines have been tried and have failed to help the acne. Xeractan 20mg may also be used to treat other skin diseases as determined by your doctor.
Xeractan 20mg must not be used to treat women who are able to bear children unless other forms of treatment have been tried first and have failed. Xeractan 20mg must not be taken during pregnancy because it causes birth defects in humans. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for Xeractan 20mg.
Xeractan 20mg is available only under a registered distribution program called the iPLEDGE™ program.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Xeractan 20mg is used in certain patients with the following medical conditions:
Xeractan 20mg is a medication used for the treatment of severe acne. It is sometimes used in prevention of certain skin cancers. It is a retinoid, meaning it derives from vitamin A and is found in small quantities naturally in the body. Xeractan 20mg binds to and activates nuclear retinoic acid receptors (RAR), thereby regulating cell proliferation and differentiation. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization.
Use Xeractan 20mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Xeractan 20mg.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This medication is used to treat severe cystic acne (also known as nodular acne) that has not responded to other treatment (e.g., benzoyl peroxide or clindamycin applied to the skin or tetracycline or minocycline taken by mouth). It belongs to a class of drugs known as retinoids. It works by decreasing facial oil (sebum) production. High amounts of sebum can lead to severe acne. If left untreated, severe acne may cause permanent scarring.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat a certain type of cancer (neuroblastoma).
How to use Xeractan 20mgRead the Medication Guide provided by your pharmacist before you start using Xeractan 20mg and each time you get a refill. Read and sign a Patient Information/Informed Consent form before you start taking this medication. If you have any questions about Xeractan 20mg, consult your doctor or pharmacist before taking the medication.
Swallow capsules whole. Do not crush or chew them. Xeractan 20mg is usually taken twice daily for 15-20 weeks, or as directed by your doctor. Directions for most generic forms of Xeractan 20mg state that it should be taken with meals. However, the FDA has indicated that the Xeractan 20mg brand may be taken with or without food. Food helps increase absorption of this drug into your bloodstream. Ask your doctor or pharmacist for more information. Take this drug with a full glass of water, and do not lie down for 10 minutes after taking it.
The dosage is based on your medical condition, weight, and response to treatment.
Your acne may worsen during the first few days of taking this drug, and it may take up to 1-2 months before you notice the full benefit of this medication. If severe acne returns, a second course of treatment may be started after you have stopped taking the drug for 2 months. The manufacturer does not recommend long-term use of Xeractan 20mg. Do not take more than the recommended dose.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
Xeractan 20mg (Xeractan 20mg) should be administered with a meal.
The recommended dosage range for Xeractan 20mg (Xeractan 20mg) 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 Xeractan 20mg (Xeractan 20mg) 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 Xeractan 20mg (Xeractan 20mg) 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 Xeractan 20mg (Xeractan 20mg), even in low doses, has not been studied, and is not recommended. It is important that Xeractan 20mg (Xeractan 20mg) be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Xeractan 20mg on bone loss is unknown.
Contraceptive measures must be followed for any subsequent course of therapy.
Table 4 : Xeractan 20mg (Xeractan 20mg) 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* |
| 40 | 88 | 20 | 40 | 80 |
| 50 | 110 | 25 | 50 | 100 |
| 60 | 132 | 30 | 60 | 120 |
| 70 | 154 | 35 | 70 | 140 |
| 80 | 176 | 40 | 80 | 160 |
| 90 | 198 | 45 | 90 | 180 |
| 100 | 220 | 50 | 100 | 200 |
| *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 Xeractan 20mg (Xeractan 20mg) 10 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0155-49).
Soft gelatin capsules, 20 mg (maroon), imprinted Xeractan 20mg (Xeractan 20mg) 20 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0169-49).
Soft gelatin capsules, 40 mg (yellow), imprinted Xeractan 20mg (Xeractan 20mg) 40 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules (NDC 0004-0156-49).
StorageStore at controlled room temperature (59° to 86°F, 15° to 30°C). Protect from light.
REFERENCES
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. Xeractan 20mg 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.
See also:
What other drugs will affect Xeractan 20mg?
REFERENCES
7. Dicken CH, Connolly SM. Eruptive xanthomas associated with Xeractan 20mg (13-cis-retinoic acid). Arch Dermatol 116:951-952, 1980.
