Oct 09, 2019 · 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. Zenatane may interact with vitamin A, tetracyclines, progesterone, oral contraceptives, St. John’s Wort, phenytoin, or corticosteroids. Tell your doctor all medications and supplements you use.
Therefore, it is critically important that females of reproductive potential use two effective methods of contraception simultaneously. Patients must receive written warnings about the rates of possible contraception failure included in patient education kits. Using two methods of contraception simultaneously substantially reduces the chances that a female will become pregnant over the risk of pregnancy with either method alone.
Although hormonal contraceptives are highly effective, prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. If a pregnancy does occur during isotretinoin treatment isotretinoin must be discontinued immediately. The patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. All Patients Isotretinoin is contraindicated in female patients who are pregnant.
The Responsible Site Pharmacist must register the pharmacy by signing and returning the completed registration form. I will train all pharmacists, who participate in the filling and dispensing of isotretinoin prescriptions, on the iPLEDGE Program requirements. I will comply and seek to ensure all pharmacists who participate in the filling and dispensing of isotretinoin prescriptions comply with the iPLEDGE Program requirements described in the booklet entitled Pharmacist Guide, specifically the “Key Information for Pharmacists” section including the following dispensing information.
I will not sell, buy, borrow, loan or otherwise transfer isotretinoin in any manner to or from another pharmacy. I will return to the manufacturer or delegate any unused product if the pharmacy is deactivated by the iPLEDGE Program of if the pharmacy chooses to not reactivate annually.
I will not fill isotretinoin for any party other than a qualified patient. Authorization signifies that the patient has met all program requirements and is qualified to receive isotretinoin. This Zenatane Medication Guide is an important part of the risk management program for the patients. Zenatane must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE Program. Only FDA-approved Zenatane products must be distributed, prescribed, dispensed, and used.
Patients must obtain Zenatane prescriptions only at US licensed pharmacies. General Although an effect of Zenatane on bone loss is not established, physicians should use caution when prescribing Zenatane to patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism. Patients may be at increased risk when participating in sports with repetitive impact where the risks of spondylolisthesis with and without pars fractures and hip growth plate injuries in early and late adolescence are known.
While causality to Zenatane has not been established, an effect must not be ruled out. Patients must be instructed to read the Medication Guide supplied as required by law when Zenatane is dispensed.
The complete text of the Medication Guide is reprinted at the end of this document. For additional information, patients must also be instructed to read the iPLEDGE program patient educational materials.
Female Females of reproductive potential must be instructed that they must not be pregnant when Zenatane therapy is initiated, and that they should use two methods of effective contraception simultaneously for 1 month before starting Zenatane, while taking Zenatane, and for 1 month after Zenatane has been stopped, unless they commit to continuous abstinence from heterosexual intercourse.
They should be given an opportunity to view the patient video provided by the manufacturer to the prescriber. Zenatane is found in the semen of male patients taking Zenatane, but the amount delivered to a female partner would be about 1 million times lower than an oral dose of 40 mg. While the no-effect limit for isotretinoin induced embryopathy is unknown, 20 years of post-marketing reports include 4 with isolated defects compatible with features of retinoid exposed fetuses; however 2 of these reports were incomplete, and two had other possible explanations for the defects observed.
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 Zenatane treatment, patients and family members should be asked about any history of psychiatric disorder, and at each visit during treatment 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 include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment. Discontinuation of Zenatane treatment may be insufficient; further evaluation may be necessary.
While such monitoring may be helpful, it may not detect all patients at risk. Patients may report mental health problems or family history of psychiatric disorders. A referral to a mental health professional may be necessary.
The physician should consider whether Zenatane therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Zenatane therapy.
Patients must be informed that some patients, while taking Zenatane or soon after stopping Zenatane, have become depressed or developed other serious mental problems. Some patients taking Zenatane have had thoughts about hurting themselves or putting an end to their own lives suicidal thoughts.
Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. There have been reports of patients on Zenatane becoming aggressive or violent. No one knows if isotretinoin caused these behaviors or if they would have happened even if the person did not take Zenatane. Some people have had other signs of depression while taking Zenatane.
Patients must be informed that they must not share Zenatane with anyone else because of the risk of birth defects and other serious adverse events. Patients must be informed not to donate blood during therapy and for one month following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to Zenatane. To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of liquid.
Patients should be informed that transient exacerbation flare of acne has been seen, generally during the initial period of therapy. Patients should be advised to avoid prolonged exposure to UV rays or sunlight.
In general, these symptoms were mild to moderate, but occasionally required discontinuation of the drug. Transient pain in the chest has been reported less frequently. There have been rare post marketing reports of rhabdomyolysis, some associated with strenuous physical activity see Laboratory Tests : CPK. Back pain was severe in Arthralgias were severe in 7. Appropriate evaluation of the musculoskeletal system should be done in patients who present with these symptoms during or after a course of Zenatane.
Consideration should be given to discontinuation of Zenatane if any significant abnormality is found. Neutropenia and rare cases of agranulocytosis have been reported. Zenatane should be discontinued if clinically significant decreases in white cell counts occur.
Patients should be advised that severe skin reactions Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in post-marketing data. Zenatane should be discontinued if clinically significant skin reactions occur.
Hypersensitivity Anaphylactic reactions and other allergic reactions have been reported. Cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura bruises and red patches of the extremities and extracutaneous involvement including renal have been reported. Severe allergic reaction necessitates discontinuation of therapy and appropriate medical management.
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.
It is not known if hormonal contraceptives differ in their effectiveness when used with Zenatane. 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.
John’s Wort. Phenytoin: Zenatane has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. 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 Zenatane. 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 Zenatane. The first test a screening test is obtained by the prescriber when the decision is made to pursue qualification of the patient for Zenatane. 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. 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. 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 Zenatane has been established see WARNINGS : Hepatotoxicity. Glucose: Some patients receiving Zenatane have experienced problems in the control of their blood sugar.
In addition, new cases of diabetes have been diagnosed during Zenatane therapy, although no causal relationship has been established. CPK: Some patients undergoing vigorous physical activity while on Zenatane 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 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. The incidence of adrenal medullary hyperplasia was also increased at the higher dosage in both sexes. The relatively high level of spontaneous pheochromocytomas occurring in the male Fischer rat makes it an equivocal model for study of this tumor; therefore, the relevance of this tumor to the human population is uncertain.
The Ames test was conducted with isotretinoin in two laboratories. No dose-response effect was seen and all other strains were negative. Additionally, other tests designed to assess genotoxicity Chinese hamster cell assay, mouse micronucleus test, S. In general, there was microscopic evidence for appreciable depression of spermatogenesis but some sperm were observed in all testes examined and in no instance were completely atrophic tubules seen.
In studies of 66 men, 30 of whom were patients with nodular acne under treatment with oral isotretinoin, no significant changes were noted in the count or motility of spermatozoa in the ejaculate. In a study of 50 men ages 17 to 32 years receiving Zenatane therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.
Nursing Mothers It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Zenatane.
Isotretinoin (Claravis, Amnesteem, Absorica, Myorisan, Zenatane, Sotret) a a prescription drug used to treat severe acne. The brand name Accutane is no longer available. Side effects include nosebleeds, dry mouth, joint aches, dry skin, and itching. Dosage, drug interactions, and pregnancy and breastfeeding safety should be reviewed prior to using this medication.
Oct 02, 2018 · Zenatane is a prescription medication used to treat the most severe form of acne called nodular acne.Zenatane belongs to a group of drugs called retinoids. It is thought to work by preventing oil production in glands under the skin.
Zenatane™ (isotretinoin) is an effective but potentially dangerous acne medication that is available by prescription only. Unlike many other acne medications, it is taken by mouth instead of applied to the skin. Although Zenatane can be extremely effective with just one course of treatment (or sometimes two), it is reserved for people who have severe nodular acne that has not responded well …
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Oct 09, 2019 · 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.
Does Zenatane Interact with other Medications? Severe Interactions. These medications are not usually taken together. Consult your healthcare professional (e.g., doctor or pharmacist) for more in …
Isotretinoin (Accutane, sotret, claravis, amnesteem, myorisan, zenatane) is an expensive drug used to treat severe acne that has not responded to other therapy like antibiotics. This drug is slightly more popular than comparable drugs. It is available in multiple brand and generic versions.
A Zenatane Medication Guide must be given to the patient each time Zenatane is dispensed, as required by law. This Zenatane Medication Guide is an important part of the risk management program for the patients. Zenatane must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE Program.