Acitretin (Acitretin)

Trade Name : Acitretin

Amneal Pharmaceuticals of New York LLC

CAPSULE

Strength 10 mg/1

ACITRETIN Retinoid [EPC],Retinoids [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Acitretin (Acitretin) which is also known as Acitretin and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 10 mg/1 per ml. Read more

Acitretin (Acitretin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • (10 mg, 17.5 mg, 22.5 mg and 25 mg)n
  • Rx onlyn n- u00a0n
  • Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected.
  • Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. Because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin or for 2 months after cessation of therapy. This allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. The mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. It is not known whether substances other than ethanol are associated with transesterification.
  • Acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg per kg, respectively. These doses are approximately 0.2, 0.3, and 3 times the maximum recommended therapeutic dose, respectively, based on a mg-per-m comparison.
  • Major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; facial dysmorphia; syndactyly; absence of terminal phalanges; malformations of hip, ankle, and forearm; low-set ears; high palate; decreased cranial volume; cardiovascular malformation; and alterations of the skull and cervical vertebrae. Acitretin should be prescribed only by those who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity.
  • Because of the teratogenicity of acitretin, a program called the Education and Pregnancy Prevention for Acitretin (EPPAu2122) Program, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation. The EPPAu2122 program requirements are described below and program materials are available at or may be requested by calling 1-877-835-5472 (see also section).
  • Arrayn- Important Information for Women of Childbearing Potential
  • Acitretin should be considered only for women with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.
  • Females of reproductive potential must not be given a prescription for acitretin until pregnancy is excluded. Acitretin is contraindicated in females of reproductive potential :
  • u00a0
  • Effective forms of contraception include both primary and secondary forms of contraception. Primary forms of contraception include: tubal ligation, partneru2019s vasectomy, intrauterine devices, birth control pills, and injectable/implantable/insertable/topical hormonal birth control products. Secondary forms of contraception include condoms (with or without spermicide), diaphragms and cervical caps (which must be used with a spermicide), and vaginal sponges (contains spermicide).
  • Any birth control method can fail. Therefore, it is critically important that women of childbearing potential use 2 effective forms of contraception (birth control) simultaneously. It has not been established if there is a pharmacokinetic interaction between acitretin and combined oral contraceptives. However, it has been established that acitretin interferes with the contraceptive effect of microdosed progestin preparations. Microdosed u201cminipillu201d progestin preparations are not recommended for use with acitretin. It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.
  • 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. Johnu2019s wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. Johnu2019s wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. Johnu2019s wort (see ).
  • If pregnancy does occur during therapy with acitretin or at any time for at least 3 years following discontinuation of acitretin, the prescriber and patient should discuss the possible effects on the pregnancy. The available information is as follows:
  • Acitretin, the active metabolite of etretinate, is teratogenic and is contraindicated during pregnancy. The risk of severe fetal malformations is well established when systemic retinoids are taken during pregnancy. Pregnancy must also be prevented after stopping acitretin therapy, while the drug is being eliminated to below a threshold blood concentration that would be associated with an increased incidence of birth defects. Because this threshold has not been established for acitretin in humans and because elimination rates vary among patients, the duration of post therapy contraception to achieve adequate elimination cannot be calculated precisely. It is strongly recommended that contraception be continued for at least 3 years after stopping treatment with acitretin, based on the following considerations:
  • However, etretinate was found in plasma and subcutaneous fat in one patient reported to have had sporadic alcohol intake, 52 months after she stopped acitretin therapy.
  • Arrayn- Important Information for Males Taking Acitretin
  • Patients should not donate blood during and for at least 3 years following therapy with acitretin because women of childbearing potential must not receive blood from patients being treated with acitretin.
  • Arrayn- There have been 25 cases of reported conception when the male partner was taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy was reported prior to knowledge of the outcome).
  • Arrayn- u00a0
  • u00a0
  • Acitretin, a retinoid, is available in 10 mg, 17.5 mg, 22.5 mg, and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3,6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44. The structural formula is:
  • Each capsule contains acitretin, microcrystalline cellulose, maltodextrin, sodium ascorbate, gelatin, black imprinting ink (the solid components are shellac glaze, propylene glycol and iron oxide black).
  • Gelatin capsule shells contain gelatin, red ferric oxide (10 mg, 22.5 mg and 25 mg only), yellow ferric oxide (17.5 mg and 25 mg only), sodium lauryl sulfate, and titanium dioxide (10 mg, 17.5 mg and 25 mg only).
  • USP dissolution test is pending.
  • The mechanism of action of acitretin is unknown.
  • Pharmacokinetics
  • Arrayn- Absorption
  • Oral absorption of acitretin is optimal when given with food. For this reason, acitretin was given with food in all of the following trials. After administration of a single 50 mg oral dose of acitretin to 18 healthy subjects, maximum plasma concentrations ranged from 196 to 728 ng per mL (mean: 416 ng per mL) and were achieved in 2 to 5 hours (mean: 2.7 hours). The oral absorption of acitretin is linear and proportional with increasing doses from 25 mg to 100 mg. Approximately 72% (range: 47% to 109%) of the administered dose was absorbed after a single 50 mg dose of acitretin was given to 12 healthy subjects.
  • Arrayn- Distribution
  • Acitretin is more than 99.9% bound to plasma proteins, primarily albumin.
  • Arrayn- Array
  • Following oral absorption, acitretin undergoes extensive metabolism and interconversion by simple isomerization to its 13-cis form (cis-acitretin). The formation of cis-acitretin relative to parent compound is not altered by dose or fed/fast conditions of oral administration of acitretin. Both parent compound and isomer are further metabolized into chain-shortened breakdown products and conjugates, which are excreted. Following multiple-dose administration of acitretin, steady-state concentrations of acitretin and cis-acitretin in plasma are achieved within approximately 3 weeks.
  • Arrayn- Elimination
  • The chain-shortened metabolites and conjugates of acitretin and cis-acitretin are ultimately excreted in the feces (34% to 54%) and urine (16% to 53%). The terminal elimination half-life of acitretin following multiple-dose administration is 49 hours (range: 33 to 96 hours), and that of cis-acitretin under the same conditions is 63 hours (range: 28 to 157 hours). The accumulation ratio of the parent compound is 1.2; that of cis-acitretin is 6.6.
  • Arrayn- Special Populations
  • Arrayn- Psoriasis
  • Arrayn- Elderly
  • Arrayn- Renal Failure
  • Arrayn- Array
  • In studies of pharmacokinetic drug interactions, no interaction was seen between acitretin and cimetidine, digoxin, phenprocoumon, or glyburide.
  • Arrayn- Array
  • Etretinate has a much longer elimination half-life compared with that of acitretin. In one trial the apparent mean terminal half-life after 6 months of therapy was approximately 120 days (range: 84 to 168 days). In another trial of 47 subjects treated chronically with etretinate, 5 had detectable serum drug levels (in the range of 0.5 to 12 ng per mL) 2.1 to 2.9 years after therapy was discontinued. The long half-life appears to be due to storage of etretinate in adipose tissue.
  • Arrayn- notn- It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.
  • In 2 double-blind, placebo-controlled trials, acitretin was administered once daily to subjects with severe psoriasis (e.g., covering at least 10% to 20% of the body surface area). At 8 weeks (see Table 1) subjects treated in Trial A with 50 mg of acitretin per day showed significant improvements (u2264 0.05) relative to baseline and to placebo in the physicianu2019s global evaluation and in the mean ratings of severity of psoriasis (scaling, thickness, and erythema). In Trial B, differences from baseline and from placebo were statistically significant (u2264 0.05) for all variables at both the 25 mg and 50 mg doses; it should be noted for Trial B that no statistical adjustment for multiplicity was carried out.
  • Table 1: Summary of the Efficacy Results of the 8-Week Double-Blind Phase of n- Trialsn- A and B of Acitretin
  • A subset of 141 subjects from both pivotal Trials A and B continued to receive acitretin in an open fashion for up to 24 weeks. At the end of the treatment period, all efficacy variables, as indicated in Table 2, were significantly improved ( u2264 0.01) from baseline, including extent of psoriasis, mean ratings of psoriasis severity, and physicianu2019s global evaluation.
  • Table 2: Summary of the First Course of Therapy with Acitretin (24 Weeks)
  • The efficacy variables consisted of: the mean severity rating of scale, lesion thickness, erythema, and the physicianu2019s global evaluation of the current status of the disease. Ratings of scaling, erythema, and lesion thickness, and the ratings of the global assessments were made using a 7-point scale (0=none, 1=trace, 2=mild, 3=mild-moderate, 4=moderate, 5=moderate-severe, 6=severe).
  • All efficacy variables improved significantly in a subset of 55 subjects from Trial A treated for a second, 6-month maintenance course of therapy (for a total of 12 months of treatment); a small subset of subjects (n=4) from Trial A continued to improve after a third 6-month course of therapy (for a total of 18 months of treatment).
  • Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see u2014 acitretin capsules can cause severe birth defects).
  • Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy.
  • Pregnancy Category X(n- Array
  • Acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed , and ).
  • An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see ).
  • Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see ).
  • Acitretin is contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids.
  • (n- also )
  • Skeletal Abnormalities
  • In adults receiving long-term treatment with acitretin, appropriate examinations should be periodically performed in view of possible ossification abnormalities (see . Because the frequency and severity of iatrogenic bony abnormality in adults is low, periodic radiography is only warranted in the presence of symptoms or long-term use of acitretin. If such disorders arise, the continuation of therapy should be discussed with the patient on the basis of a careful risk/benefit analysis. In clinical trials with acitretin, subjects were prospectively evaluated for evidence of development or change in bony abnormalities of the vertebral column, knees, and ankles.
  • Of 380 subjects treated with acitretin, 15% had preexisting abnormalities of the spine which showed new changes or progression of preexisting findings. Changes included degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of a cervical disc space. De novo changes (formation of small spurs) were seen in 3 subjects after 1u00bd to 2u00bd years.
  • Six of 128 subjects treated with acitretin showed abnormalities in the knees and ankles before treatment that progressed during treatment. In 5, these changes involved the formation of additional spurs or enlargement of existing spurs. The sixth subject had degenerative joint disease which worsened. No subjects developed spurs de novo. Clinical complaints did not predict radiographic changes.
  • Lipids and Possible Cardiovascular Effects
  • Blood lipid determinations should be performed before acitretin is administered and again at intervals of 1 to 2 weeks until the lipid response to the drug is established, usually within 4 to 8 weeks. In subjects receiving acitretin during clinical trials, 66% and 33% experienced elevation in triglycerides and cholesterol, respectively. Decreased high density lipoproteins (HDL) occurred in 40% of subjects. These effects of acitretin were generally reversible upon cessation of therapy.
  • Subjects with an increased tendency to develop hypertriglyceridemia included those with disturbances of lipid metabolism, diabetes mellitus, obesity, increased alcohol intake, or a familial history of these conditions. Because of the risk of hypertriglyceridemia, serum lipids must be more closely monitored in high-risk patients and during long-term treatment.
  • Hypertriglyceridemia and lowered HDL may increase a patientu2019s cardiovascular risk status. Although no causal relationship has been established, there have been postmarketing reports of acute myocardial infarction or thromboembolic events in patients on therapy with acitretin. In addition, elevation of serum triglycerides to greater than 800 mg per dL has been associated with fatal fulminant pancreatitis. Therefore, dietary modifications, reduction in dose of acitretin, or drug therapy should be employed to control significant elevations of triglycerides. If, despite these measures, hypertriglyceridemia and low HDL levels persist, the discontinuation of acitretin should be considered.
  • Ophthalmologic Effects
  • The eyes and vision of 329 subjects treated with acitretin were examined by ophthalmologists. The findings included dry eyes (23%), irritation of eyes (9%), and brow and lash loss (5%). The following were reported in less than 5% of subjects: Bellu2019s palsy, blepharitis and/or crusting of lids, blurred vision, conjunctivitis, corneal epithelial abnormality, cortical cataract, decreased night vision, diplopia, itchy eyes or eyelids, nuclear cataract, pannus, papilledema, photophobia, posterior subcapsular cataract, recurrent sties, and subepithelial corneal lesions.
  • Any patient treated with acitretin who is experiencing visual difficulties should discontinue the drug and undergo ophthalmologic evaluation.
  • Pancreatitis
  • Lipid elevations occur in 25% to 50% of subjects treated with acitretin. Triglyceride increases sufficient to be associated with pancreatitis are much less common, although fatal fulminant pancreatitis has been reported. There have been rare reports of pancreatitis during therapy with acitretin in the absence of hypertriglyceridemia.
  • Pseudotumor Cerebri
  • Acitretin and other retinoids administered orally have been associated with cases of pseudotumor cerebri (benign intracranial hypertension). Some of these events involved concomitant use of isotretinoin and tetracyclines. However, the event seen in a single patient receiving acitretin was not associated with tetracycline use. Early signs and symptoms include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these signs and symptoms should be examined for papilledema and, if present, should discontinue acitretin immediately and be referred for neurological evaluation and care. Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see ).
  • Capillary Leak Syndrome
  • Capillary leak syndrome, a potential manifestation of retinoic acid syndrome, has been reported in patients receiving acitretin. Features of this syndrome may include localized or generalized edema with secondary weight gain, fever, and hypotension. Rhabdomyolysis and myalgias have been reported in association with capillary leak syndrome, and laboratory tests may reveal neutrophilia, hypoalbuminemia, and an elevated hematocrit. Discontinue acitretin if capillary leak syndrome develops during therapy.
  • Exfoliative Dermatitis/Erythroderma
  • Exfoliative dermatitis/erythroderma has been reported in patients receiving acitretin. Discontinue acitretin if exfoliative dermatitis/erythroderma occurs during therapy.
  • A description of the materials is provided below. The main goals of the materials are to explain the program requirements, to reinforce the educational messages, and to assess program effectiveness.
  • The includes:
  • The also includes a voluntary patient survey for women of childbearing potential to assess the effectiveness of the . materials are available at or may be requested by calling 1-877-835-5472.
  • Information for Patients
  • (n- Medication Guide for all patients and Patient Agreement/Informed Consent for Female Patients at end of professional labeling).
  • Patients should be instructed to read the Medication Guide supplied as required by law when acitretin capsules are dispensed.
  • Arrayn- Females of Reproductive Potential
  • Acitretin can cause severe birth defects. n- Array
  • Females of reproductive potential should also be advised that they must not ingest beverages or products containing ethanol while taking acitretin and for 2 months after acitretin has been discontinued.
  • Female patients should be advised that any method of birth control can fail, including tubal ligation, and that microdosed progestin u201cminipillu201d preparations are recommended for use with acitretin (see ). Data from one patient who received a very low-dosed progestin contraceptive (levonorgestrel 0.03 mg) had a significant increase of the progesterone level after 3 menstrual cycles during acitretin treatment.
  • Female patients should sign a consent form prior to beginning therapy with acitretin (see n ).
  • Arrayn- Nursing Mothers
  • Studies on lactating rats have shown that etretinate is excreted in the milk. There is one prospective case report where acitretin is reported to be excreted in human milk. Therefore, nursing mothers should not receive acitretin prior to or during nursing because of the potential for serious adverse reactions in nursing infants.
  • Arrayn- All Patients
  • Depression and/or other psychiatric symptoms such as aggressive feelings or thoughts of self-harm have been reported.
  • Patients should be advised that a transient worsening of psoriasis is sometimes seen during the initial treatment period. Patients should be advised that they may have to wait 2 to 3 months before they get the full benefit of acitretin, although some patients may achieve significant improvements within the first 8 weeks of treatment as demonstrated in clinical trials.
  • Decreased night vision has been reported during therapy with acitretin. Patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night. Visual problems should be carefully monitored (see n n ). Patients should be advised that they may experience decreased tolerance to contact lenses during the treatment period and sometimes after treatment has stopped.
  • Patients should not donate blood during and for at least 3 years following therapy because acitretin can cause birth defects and women of childbearing potential must not receive blood from patients being treated with acitretin.
  • Because of the relationship of acitretin to vitamin A, patients should be advised against taking vitamin A supplements in excess of minimum recommended daily allowances to avoid possible additive toxic effects.
  • Patients should avoid the use of sun lamps and excessive exposure to sunlight (non-medical UV exposure) because the effects of UV light are enhanced by retinoids.
  • Patients should be advised that they must not give their acitretin capsules to any other person.
  • Arrayn- For Prescribers
  • Acitretin has not been studied in and is not indicated for treatment of acne.
  • Arrayn- Phototherapy
  • Significantly lower doses of phototherapy are required when acitretin is used because effects on the stratum corneum induced by acitretin can increase the risk of erythema (burning) (see ).
  • Drug Interactions
  • Arrayn- Arrayn- and n
  • Arrayn- Array
  • Arrayn- Arrayn- It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy.
  • Arrayn- Array
  • Arrayn- Phenytoin
  • Arrayn- Array
  • Arrayn- Vitamin A and Oral Retinoids
  • Arrayn- Other
  • Laboratory Tests
  • If significant abnormal laboratory results are obtained, either dosage reduction with careful monitoring or treatment discontinuation is recommended, depending on clinical judgment.
  • Arrayn- Blood Sugar
  • Arrayn- Array
  • Arrayn- Array
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Arrayn- Carcinogenesis
  • Arrayn- in vivo
  • Arrayn- Impairment of Fertility
  • No decreases in sperm count or concentration and no changes in sperm motility or morphology were noted in 31 men (17 psoriatic subjects, 8 subjects with disorders of keratinization, and 6 healthy volunteers) given 30 mg per day to 50 mg per day of acitretin for at least 12 weeks. In these trials, no deleterious effects were seen on either testosterone production, LH, or FSH in any of the 31 men. No deleterious effects were seen on the hypothalamic-pituitary axis in any of the 18 men where it was measured.
  • Pregnancy
  • Arrayn- Teratogenic Effects
  • Pregnancy Category X (n- Arrayn- Array
  • Arrayn- Nonteratogenic Effects
  • Pediatric Use
  • Safety and effectiveness in pediatric patients have not been established. No clinical trials have been conducted in pediatric subjects. Ossification of interosseous ligaments and tendons of the extremities, skeletal hyperostoses, decreases in bone mineral density, and premature epiphyseal closure have been reported in children taking other systemic retinoids, including etretinate, a metabolite of acitretin. A causal relationship between these effects and acitretin has not been established. While it is not known that these occurrences are more severe or more frequent in children, there is special concern in pediatric patients because of the implications for growth potential (see ).
  • Geriatric Use
  • Clinical trials of acitretin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. A 2-fold increase in acitretin plasma concentrations was seen in healthy elderly subjects compared with young subjects, although the elimination half-life did not change (see ).
  • Hypervitaminosis A produces a wide spectrum of signs and symptoms primarily of the mucocutaneous, musculoskeletal, hepatic, neuropsychiatric, and central nervous systems. Many of the clinical adverse reactions reported to date with administration of acitretin resemble those of the hypervitaminosis A syndrome.
  • Adverse Events/Postmarketing Reports
  • In to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of acitretin.
  • Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Arrayn- Array
  • Arrayn- Array
  • Arrayn- Nervous System
  • Arrayn- Array
  • Arrayn- Candida albicans
  • Arrayn- Array
  • Arrayn- Array
  • Clinical Trials
  • During clinical trials with acitretin, 513 of 525 (98%) subjects reported a total of 3,545 adverse events. One-hundred sixteen subjects (22%) left trials prematurely, primarily because of adverse experiences involving the mucous membranes and skin. Three subjects died. Two of the deaths were not drug-related (pancreatic adenocarcinoma and lung cancer); the other subject died of an acute myocardial infarction, considered remotely related to drug therapy. n
  • The tables below list by body system and frequency the adverse events reported during clinical trials of 525 subjects with psoriasis.
  • Table 3: Adverse Events Frequently Reported during Clinical Trials Percent of Subjects Reporting (N = 525)
  • Table 4: Adverse Events Less Frequently Reported during Clinical Trials (Some of Which May Bear No Relationship to Therapy) Percent of Subjects Reporting (N = 525)
  • Arrayn- Array
  • Table 5 lists the laboratory abnormalities reported during clinical trials.
  • Table 5: Abnormal Laboratory Test Results Reported during Clinical Trials Percent of Subjects Reporting
  • To report SUSPECTED ADVERSE EVENTS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
  • In the event of acute overdosage, acitretin must be withdrawn at once. Symptoms of overdose are identical to acute hypervitaminosis A (e.g., headache and vertigo). The acute oral toxicity (LD) of acitretin in both mice and rats was greater than 4,000 mg per kg.
  • In one reported case of overdose, a 32-year-old male with Darieru2019s disease took 21 x 25 mg capsules (525 mg single dose). He vomited several hours later but experienced no other ill effects.
  • All female patients of childbearing potential
  • 1) Have a pregnancy test at the time of overdose;
  • 2) Be counseled as per the and sections regarding birth defects and contraceptive use for at least 3 yearsu2019 duration after the overdose.
  • There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with acitretin. A number of the more common side effects are dose-related. Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. Therapy with acitretin should be initiated at 25 mg per day to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 mg per day to 50 mg per day may be given dependent upon an individual patientu2019s response to initial treatment. Relapses may be treated as outlined for initial therapy.
  • When acitretin is used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patientu2019s individual response (see ).
  • Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the US; for information, call n- Amneal Pharmaceuticals n- at 1-877-835-5472.
  • Information for Pharmacists
  • Acitretin must only be dispensed in no more than a monthly supply. An Acitretin Medication Guide must be given to the patient each time acitretin is dispensed, as required by law.
  • Acitretin Capsules USP, 10 mg are supplied as white to off-white body and a brown cap, u00a0imprinted in black u201cIXu201d on the capsule cap and u201c667u201d on the capsule body.They are available as follows:Bottles of 30: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1750-08
  • Acitretin Capsules USP, 17.5 mg are supplied as yellow to light yellow body and cap, imprinted in black u201cIXu201d on the capsule cap and u201c668u201d on the capsule body.They are available as follows:Bottles of 30:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1751-08
  • Acitretin Capsules USP, 22.5 mg are supplied as brown body and cap, imprinted in black with u201cIXu201d on the capsule cap and u201c698u201d on the capsule body.They are available as follows:Bottles of 30:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1752-08
  • Acitretin Capsules USP, 25 mg are supplied as yellow to light yellow body and a brown cap, u00a0imprinted in black u201cIXu201d on the capsule cap and u201c669u201d on the capsule body.They are available as follows:Bottles of 30: u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 0115-1753-08
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.
  • Manufactured by:n n Via Cantonale, 776998 Monteggio, Switzerland
  • Distributed by:n n Bridgewater, NJ 08807
  • Rev. 11-2018-00
  • 309207
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Rev. 11-2018-00
  • Arrayn- To be completed by the patient* and signed by her prescriber
  • Arrayn- Array
  • *Must also be initialed by the parent or guardian of a minor patient (under age 18).
  • Read each item below and initial in the space provided to show that you understand each item.
  • Do not sign this consent and do not take acitretin if there is anything that you do not understand.
  • u00a0
  • (Patientu2019s name)
  • 1.
  • INITIAL: ___________
  • 2.
  • INITIAL: ___________
  • 3.
  • INITIAL: ___________
  • 4. n- at the same time.
  • INITIAL: ___________
  • 5.
  • INITIAL: ___________
  • 6.
  • INITIAL: ___________
  • 7.
  • INITIAL: ___________
  • 8.
  • INITIAL: ___________
  • 9.
  • INITIAL: ___________
  • 10. n- sure
  • INITIAL: ___________
  • 11.
  • INITIAL: ___________
  • 12.
  • INITIAL: ___________
  • 13.
  • INITIAL: ___________
  • 14.
  • INITIAL: ___________
  • 15.
  • INITIAL: ___________
  • I have received a copy of the Education and Pregnancy Prevention for Acitretin (EPPAu2122) Program Booklet. My prescriber has answered all my questions about acitretin. I understand that it is my responsibility to follow my doctoru2019s instructions, and not to get pregnant during treatment with acitretin or for at least 3 years after I stop taking acitretin.
  • u00a0
  • I now authorize my prescriber, ________________________________________, to begin my treatment with acitretin.
  • Patient signature: ___________________________________________________________
  • Date: ___________________
  • Parent/guardian signature (if under age 18):
  • ___________________________________________________________________________
  • Date: ___________________
  • Please print: Patient name and address:
  • ___________________________________________________________________________
  • ___________________________________________________________________________
  • ___________________________________________________________________________
  • Telephone: ________________________________________________________________
  • I have fully explained to the patient, ______________________________________ ____________________________, the nature and purpose of the treatment described above and the risks to females of childbearing potential. I have asked the patient if she has any questions regarding her treatment with acitretin and have answered those questions to the best of my ability.
  • Prescriber signature: _________________________________________________
  • Date: __________________
  • Rev. 11-2018-00
  • No data
  • No data
  • u00a0
  • Arrayn- Array
  • No data

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