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acitretin 17.5 mg capsule generic soriatane

In stock Manufacturer SIGMAPHARM LABO 42794008108
$9.68 / Capsule

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Uses

Psoriasis

Acitretin is used for the symptomatic management of severe psoriasis.The drug should not be used as a first-line antipsoriatic therapy in women of childbearing potential. Acitretin should be used only in nonpregnant patients with severe psoriasis that is refractory to alternative therapies or in whom other therapies are contraindicated.

Relapse may occur when acitretin is discontinued; if clinically indicated, repeat courses of the drug may be used since clinical efficacy in relapse has been similar to that of the initial course.

Discoid Lupus Erythematosus

Acitretin has been used in a limited number of patients for the management of discoid lupus erythematosus; efficacy was similar to that of hydroxychloroquine, but adverse effects were more severe and frequent with acitretin. Further study is needed to establish the role of acitretin in treating this condition.

Dosage and Administration

General

Acitretin should only be prescribed by clinicians 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.(See Do Your PART Program under Cautions: General Precautions.)

Dosage of acitretin should be individualized according to therapeutic response and the appearance of adverse effects.

If a patient misses an acitretin dose, the next dose should not be doubled. Patients concomitantly receiving phototherapy may require dosage reduction of phototherapy.(See Phototherapy under Cautions: General Precautions.)

Administration

Acitretin should be administered orally once daily with the main meal.(See Food under Pharmacokinetics: Absorption.)

Dosage

Psoriasis

The initial adult dosage of acitretin is 25-50 mg given orally once daily. The maintenance oral dosage of acitretin is 25-50 mg (dependent on the patient's response to initial therapy) once daily. Dosages exceeding 50 mg daily have not been evaluated in controlled studies.

Relapses of psoriasis may be treated with the same oral dosage of acitretin used for initial therapy (25-50 mg once daily).

In clinical studies, oral acitretin therapy was continued for up to 18 months in some patients.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.(See Contraindications under Cautions.)

Renal Impairment

No specific dosage recommendations at this time.(See Contraindications under Cautions.)

Geriatric Patients

Acitretin dosage should be selected with caution in geriatric patients (usually starting at the low end of the dosage range) because of possible age-related decreased hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Cautions

Contraindications

Acitretin is contraindicated in females who are or may become pregnant during acitretin therapy or within at least 3 years following discontinuance of the drug.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Acitretin is contraindicated in patients with severely impaired renal or hepatic function.(See Hepatic Effects under Warnings/Precautions: Warnings, in Cautions.) The drug also is contraindicated in patients with chronic, abnormally elevated blood lipids.(See Effects on Lipoproteins under Warnings/Precautions: Warnings, in Cautions.)

Concomitant use of acitretin with methotrexate, tetracyclines, or vitamin A and/or other oral retinoids is contraindicated.(See Drug Interactions.)

The drug is contraindicated in patients with known hypersensitivity to acitretin, any ingredient in the formulation, or other retinoids.

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Acitretin is a known human teratogen, and there is a very high risk of severe birth defects if a patient becomes pregnant while receiving acitretin or upon drug discontinuance (birth defects have been reported 2 years or longer after the last dose of acitretin). Teratogenicity generally is characterized by malformations involving craniofacial, cardiovascular, skeletal, and CNS structures.

Use of acitretin is contraindicated during pregnancy. The drug must not be used in female patients who are or may become pregnant during acitretin therapy or within at least 3 years following drug discontinuance or in females who may not use reliable contraception during and for at least 3 years following cessation of therapy. If pregnancy occurs during therapy or at any time for at least 3 years following drug discontinuance, the clinician and patient should discuss the possible effects on the pregnancy.(See Pregnancy under Cautions.)

The Do Your PART program was developed to educate females of childbearing potential and their clinicians about risks associated with acitretin and to aid in the prevention of pregnancies during and for 3 years following drug discontinuance.(See Do Your PART Program under Cautions: General Precautions.)

Concomitant use of acitretin and alcohol results in formation of etretinate (a known human teratogen with a longer elimination half-life than acitretin), prolonging the duration of potential teratogenic effects of acitretin; therefore, alcohol must not be used in female patients of childbearing potential during acitretin treatment and for 2 months following drug discontinuance.(See Drug Interactions: Alcohol.)

Hepatic Effects

Jaundice, acute hepatic injury, toxic hepatitis, and cirrhosis have been reported in a limited number of patients; generally, transaminase levels returned to normal after drug discontinuance.

Elevations of AST, ALT, γ-glutamyltransferase (GGT, γ-glutamyltranspeptidase, GGTP), or LDH have been reported in approximately one-third of patients receiving acitretin; elevations generally were mild to moderate and resolved with continued therapy, a reduction in acitretin dosage, or upon drug discontinuance. Transient elevations of alkaline phosphatase also have been reported.

Hepatic enzyme levels should be monitored prior to initiating therapy, at weekly or biweekly intervals until stable, and thereafter at intervals based on the clinician's discretion. More frequent monitoring is recommended if alcoholism, diabetes mellitus, concomitant use of other hepatotoxic drugs, and/or obesity is present.

If hepatotoxicity is suspected during therapy, acitretin should be discontinued and the cause of the abnormality investigated.

Concomitant use of acitretin and methotrexate is contraindicated.(See Methotrexate under Drug Interactions.)

Blood Donation

Both male and female patients receiving acitretin should not donate blood during therapy and for at least 3 years following drug discontinuance because women of childbearing potential must not receive blood from patients receiving acitretin.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Hyperostosis

Hyperostosis (including diffuse interstitial skeletal hyperostosis syndrome [DISH]) has been reported in patients receiving acitretin. Changes may involve worsening of preexisting skeletal overgrowth.

Patients receiving long-term acitretin therapy should be monitored periodically for ossification abnormalities; radiography is recommended only in the presence of symptoms or long-term acitretin use. If symptoms arise, the potential benefits of continued therapy should be considered compared with the potential risks for the development of hyperostosis.(See Pediatric Use under Cautions: Specific Populations.)

Effects on Lipoproteins

In clinical trials with acitretin, 66, 33, and 40% of patients experienced elevated triglycerides, elevated cholesterol, and decreased HDL-cholesterol, respectively; lipid abnormalities usually were reversible with cessation of therapy.

Fasting blood lipid concentrations should be monitored prior to initiating therapy and at weekly or biweekly intervals until lipid response is established (usually within 4-8 weeks).

There is an increased risk of hypertriglyceridemia in patients with diabetes mellitus, obesity, increased alcohol intake, lipid metabolism disorder, or familial history of these conditions. Close monitoring of serum lipid and/or glucose in these patients and in patients receiving long-term therapy is recommended.

Acitretin is contraindicated in patients with chronic, abnormally elevated blood lipid concentrations.

Dietary modifications, acitretin dosage reductions, or lipid-lowering agents should be used to control clinically important triglyceride elevations; acitretin discontinuance should be considered if hypertriglyceridemia and decreased HDL-cholesterol persist.

Ocular Effects

Dry eyes, irritation, and brow/lash loss have been reported in 23, 9, and 5%, respectively, of acitretin recipients evaluated in one study. Other adverse ocular effects, including decreased night vision, were reported in less than 5% of patients.(See Advice to Patients.)

If visual difficulties occur during therapy, the drug should be discontinued and an ophthalmologic examination performed.

Pancreatitis

Lipid elevations were reported in 25-50% of acitretin recipients. Elevations of triglycerides to concentrations associated with fatal fulminant pancreatitis are rare; however, cases have been reported with acitretin. Rare cases of pancreatitis withouthypertriglyceridemia also have been reported.

Pseudotumor Cerebri

Pseudotumor cerebri (benign intracranial hypertension) has been reported with acitretin and other oral retinoids (e.g., isotretinoin). Some patients with pseudotumor cerebri were receiving concomitant isotretinoin and tetracycline therapy. However, pseudotumor cerebri also has been reported in one patient receiving acitretin without concomitant tetracycline.

Patients who develop manifestations of pseudotumor cerebri (e.g., headache, nausea and vomiting, visual disturbances) should be screened for the presence of papilledema and, if present, the drug discontinued immediately and the patient referred to a neurologist for further evaluation and care.

Concomitant use of acitretin and tetracyclines is contraindicated.(See Tetracyclines under Drug Interactions.)

Sensitivity Reactions

Photosensitivity

Patients receiving acitretin should avoid exposure to natural or artificial (e.g., sun lamps) sunlight; effects of ultraviolet light are enhanced by acitretin.(See Phototherapy under Cautions: General Precautions.)

General Precautions

Do Your PART Program

The Do Your PART program was developed to reinforce the importance of pregnancy prevention in patients receiving acitretin by providing information on risks of fetal exposure to the drug and to help prevent pregnancy.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Patient must complete and sign a Patient Agreement/Informed Consent form detailing risks of potential birth defects, contraceptive failure, and alcohol ingestion, and importance of pregnancy prevention during and after drug discontinuance. A Soriatane Patient/Contraceptive Counseling Referral form also is provided, allowing for a free initial contraceptive counseling session and pregnancy testing. A Medication Guide for all patients and a patient survey for women of childbearing potential also are included.

Prior to issuing the initial prescription for acitretin, pregnancy should be excluded by 2 negative serum or urine tests (the second test should be performed during the first 5 days of the menstrual period immediately prior to initiation of acitretin therapy). Pregnancy should be excluded by monthly testing during therapy and every 3 months after therapy discontinuance. Initial testing should be performed by a clinician.

To enhance compliance with pregnancy testing, a limited supply of acitretin should be prescribed.

Pregnancy must be prevented by simultaneous use of 2 forms of reliable contraception (unless the patient is absolutely abstinent, has undergone a hysterectomy, or is postmenopausal) for at least 1 month prior to therapy initiation, during therapy, and for at least 3 years following cessation of therapy.(See Advice to Patients.)

For detailed information regarding the program's requirements, the manufacturer's prescribing information should be consulted; prescribers should contact the manufacturer to obtain information on materials available for the program. To obtain further information regarding contraception options, patients should contact the Birth Control Counseling line at 800-739-6700.

Psychiatric Disorders

Depression and other psychiatric symptoms (e.g., aggressive feelings, self-injurious thoughts or behaviors, suicidal thoughts) have been reported in patients receiving acitretin; it is not known whether these adverse effects were related to acitretin or to other factors. Such events also have been reported with other systemic retinoids.

Patients who experience symptoms of depression or other psychiatric symptoms during acitretin therapy should discontinue the drug and immediately notify their prescribing clinician.

Phototherapy

Concomitant use of phototherapy and acitretin may result in increased risk of erythema (e.g., burning); if concomitant use cannot be avoided, the phototherapy dose should be reduced based upon patient response.

Specific Populations

Pregnancy

Category X. All pregnancies during acitretin therapy or within 3 years following drug discontinuance should be reported to Stiefel Laboratories at 888-500-3376 or to the FDA MedWatch Program at 800-FDA-1088.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Lactation

Acitretin is distributed into milk; women receiving the drug should not breast-feed.

Pediatric Use

Safety and efficacy have not been established in pediatric patients.

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 receiving other systemic retinoids, including etretinate (no longer commercially available in US). A causal relationship has not been established between the use of acitretin and these effects, and it is unknown whether these occurrences are more severe or appear more frequently in children. However, the manufacturer states that there is special concern because of the implications for growth potential in this population.

Geriatric Use

Clinical trial experience in patients 65 years of age or older is insufficient to determine whether geriatric patients respond differently than younger adults. Other reported clinical experience has not identified differences in responses between geriatric and younger patients.(See Geriatric Patients under Dosage and Administration: Special Populations.)

Common Adverse Effects

Adverse effects reported in 10% or more of patients receiving acitretin in clinical trials include cheilitis, alopecia, skin peeling, rhinitis, dry skin, nail disorder, pruritus, rigors, xerophthalmia, dry mouth, epistaxis, arthralgia, spinal hyperostosis, rash, hyperesthesia, paresthesia, paronychia, and skin atrophy. Many reported adverse effects resemble those associated with hypervitaminosis A.

Laboratory abnormalities reported include increased or decreased electrolytes, hematocrit, hemoglobin, and glucose; increased liver transaminases, uric acid, BUN, and total and LDL-cholesterol; and decreased HDL-cholesterol.(See Hepatic Effects under Warnings/Precautions: Warnings, in Cautions and also see Effects on Lipoproteins under Warnings/Precautions: Warnings, in Cautions.)

Drug Interactions

Acitretin is not metabolized by hepatic microsomal enzymes.

Alcohol

Concomitant administration of alcohol and acitretin resulted in formation of etretinate, a known human teratogen with a longer elimination half-life than acitretin; this interaction may increase the duration of teratogenic effects of acitretin. Concomitant use also may result in hepatotoxicity.

Concomitant use of alcohol from any source should be avoided during and for 2 months after acitretin therapy cessation in women of childbearing potential.(See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)

Antidiabetic Agents

Pharmacokinetic interaction is unlikely when acitretin is used concomitantly with glyburide.

Potentiation of hypoglycemic effects of glibenclamide (not commercially available in US) was observed in one trial in healthy individuals. Acitretin and glibenclamide should be used concomitantly with caution.

Careful monitoring of diabetic patients is recommended.

Aspirin

Potentiation of mucosal damage is possible when acitretin is used concomitantly with high-dose aspirin therapy. Concomitant therapy with high-dose aspirin should be avoided.

Cimetidine

Pharmacokinetic interaction between acitretin and cimetidine is unlikely.

Contraceptives

Estrogen-Progestin Combinations

It is unknown whether a pharmacokinetic interaction exists between acitretin and combination hormonal contraceptives.

Progestin-only Contraceptives

Acitretin interferes with the contraceptive effect of low-dose oral progestin-only preparations (i.e., minipill). It is unknown whether other progestational contraceptives (e.g., implants, injectables) are adequate methods of contraception during acitretin therapy. Concomitant use of acitretin and progestin-only contraceptives is not recommended.

Corticosteroids

Concomitant use of acitretin and corticosteroids may result in hyperlipidemia or pseudotumor cerebri. Careful monitoring is recommended if the drugs are used concomitantly.

Digoxin

Pharmacokinetic interaction is unlikely when acitretin is used concomitantly with digoxin.

Methotrexate

There is an increased risk of hepatitis in patients concomitantly receiving acitretin and methotrexate.(See Hepatic Effects under Warnings/Precautions: Warnings, in Cautions.) Concomitant use is contraindicated.

Phenytoin

Pharmacokinetic interaction (reduced phenytoin protein binding) is possible in patients concomitantly receiving phenytoin and acitretin.

Retinoids

Additive adverse effects (e.g., hypervitaminosis A) are possible in patients concomitantly receiving acitretin with oral retinoids. Concomitant use is not recommended.

St. John's wort (Hypericum perforatum)

There is a possible risk of hormonal contraceptive failure during concomitant use of acitretin and St. John's wort. Concomitant use is not recommended.

Tetracyclines

An increased risk for pseudotumor cerebri and photosensitivity is possible when acitretin is used concomitantly with tetracyclines (e.g., minocycline).(See Pseudotumor Cerebri under Warnings/Precautions: Warnings, in Cautions.) Concomitant use is contraindicated.

Vitamin A

Additive adverse effects (e.g., hypervitaminosis A) are possible in patients concomitantly receiving acitretin with vitamin A. Concomitant use is contraindicated.

Warfarin

No effect on warfarin protein binding has been observed in patients receiving acitretin concomitantly with warfarin.

Pharmacokinetics

Absorption

Bioavailability

Absorption from GI tract is linear with dose-proportional increases at doses of 25-100 mg.

Following administration of a single 50-mg oral acitretin dose to healthy individuals, approximately 60-72% (range: 36-109%) of dose was absorbed.

High interindividual and intraindividual variation in peak plasma concentrations; mean peak plasma concentration in healthy individuals was achieved in an average of 2.7 hours (range: 2-5 hours). Following multiple doses in healthy individuals, steady state achieved within approximately 1-3 weeks.

In patients with psoriasis, mean steady-state trough concentrations demonstrated dose-dependent increases with daily dosages of 10-50 mg. Plasma concentrations were nonmeasurable 3-4 weeks after cessation of therapy.

Onset

Improvement seen within first 8 weeks of treatment in clinical trials; full efficacy usually evident within 2-3 months.

Food

Food enhances absorption and reduces the interindividual variability in absorption.

Special Populations

In healthy geriatric individuals receiving multiple doses of acitretin, plasma concentrations increased twofold compared with those in younger individuals.(See Elimination: Special Populations, under Pharmacokinetics.)

In patients with end-stage renal failure receiving a single 50-mg oral acitretin dose, lower plasma concentrations (by 50-59%) were seen compared with healthy individuals; acitretin not removed by hemodialysis.

Distribution

Extent

Distributes into skin with highest concentrations in stratum corneum. Penetrates adipose tissue but does not accumulate in tissues.

Distributes into milk; crosses placenta.

Small amounts of acitretin are distributed into semen; appear to pose little, if any, risk to an unborn child while a male patient is receiving the drug.

Plasma Protein Binding

Greater than 99.9% (mainly albumin).

Elimination

Metabolism

Extensively metabolized by simple isomerization in liver by interconversion to 13-cis-acitretin with subsequent oxidation into chain-shortened breakdown products and conjugation to glucuronides. Metabolized to etretinate if alcohol used concomitantly (see Alcohol under Drug Interactions). Not metabolized by hepatic microsomal enzymes.

Elimination Route

Excreted in urine (16-53%) and feces (34-54%) as metabolites.

Half-life

Acitretin, following multiple doses: Estimated at about 49 hours but has been reported to range from 24-96 hours.

13-cis-Acitretin, following multiple doses: About 63 hours (range: 28-157 hours).

Special Populations

In healthy geriatric individuals, elimination half-life was similar to that in younger individuals.

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