Acitretin 25 mg Capsule, 30-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Retinoid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Acitretin is a retinoid — a vitamin A-related compound — that helps slow down the out-of-control skin cell growth that causes psoriasis plaques. It's used for severe psoriasis when...
- What exactly is acitretin supposed to do for my psoriasis?
- Yes, it really does matter. Taking acitretin with your main meal — not just a snack — significantly improves how much of the drug your body actually absorbs. All the clinical studi...
- Why do I have to take this with food, and does it matter how much I eat?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Acitretin — tap one for details:
Acitretin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
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UNII 7T9FYH5QMK
A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
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UNII TUF2IVW3M2
Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII S033EH8359
Sodium ascorbate is a salt form of vitamin C. It serves as an antioxidant to prevent degradation of other ingredients and as a pH buffer to maintain stable acidity in the medicine.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.602 | $108.06 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $7.07 | $212.10 / 30 capsules |
| Medicare drug plans payPart D · Q2 2026 | $6.56 | $196.87 / 30 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Acitretin 25 mg 00093-1136-56 | Teva | 30 capsules | $3.602 | AB | Availability likely | — |
| Acitretin 25 mg 00115-1753-08 | Amneal | 30 capsules | $3.602 | AB | Discontinued | — |
| Acitretin 25 mgthis 00378-7023-93 | Mylan | 30 capsules | $3.602 | AB | Availability likely | — |
| Acitretin 25 mg 42794-0083-08 | Sigmapharm | 30 capsules | $3.602 | AB | Availability likely | — |
| Acitretin 25 mg 62332-0743-30 | Alembic | 30 capsules | $3.602 | AB | Availability likely | — |
| Acitretin 25 mg 42291-0088-30 | AvKARE | 30 capsules | — | AB | FDA listed | — |
| Acitretin 25 mg 46708-0743-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| Acitretin 25 mg 72162-2223-03 | Bryant | 30 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00378-7023-93 You're viewing this | 30 CAPSULE in 1 BOTTLE, PLASTIC (0378-7023-93) | 2016-03-10 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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 boxed CONTRAINDICATIONS AND WARNINGS - 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION There is intersubject variation in the pharmacokinetics, clinical efficacy, and incidence of side effects with acitretin capsules. 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 capsules should be initiated at 25 to 50 mg per day, given as a single dose with the main meal. Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patient’s response to initial treatment. Relapses may be treated as outlined for initial therapy.
When acitretin capsules are used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patient’s individual response (see PRECAUTIONS: General ). Females who have taken TEGISON (etretinate) must continue to follow the contraceptive recommendations for TEGISON. TEGISON is no longer marketed in the U.S.; for information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).
Information for Pharmacists Acitretin capsules must only be dispensed in no more than a monthly supply. An acitretin capsules Medication Guide must be given to the patient each time acitretin capsules are dispensed, as required by law.
⛔ Contraindications ▾
CONTRAINDICATIONS Pregnancy See boxed CONTRAINDICATIONS AND WARNINGS . Acitretin capsules are contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed WARNINGS: Hepatotoxicity , WARNINGS: Lipids and Possible Cardiovascular Effects , and PRECAUTIONS ). An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate.
Consequently, the combination of methotrexate with acitretin capsules is also contraindicated (see PRECAUTIONS: Drug Interactions ). Since both acitretin capsules and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see WARNINGS: Pseudotumor Cerebri ). Acitretin capsules are contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids .
⚠️ Warnings ▾
WARNINGS (See also boxed CONTRAINDICATIONS AND WARNINGS .) Hepatotoxicity: Of the 525 subjects treated in U.S. clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered related to treatment with acitretin capsules. Liver function test results in these subjects returned to normal after acitretin capsules were discontinued. Two of the 1,289 subjects treated in European clinical trials developed biopsy-confirmed toxic hepatitis.
A second biopsy in one of these subjects revealed nodule formation suggestive of cirrhosis. One subject in a Canadian clinical trial of 63 subjects developed a 3-fold increase of transaminases. A liver biopsy of this subject showed mild lobular disarray, multifocal hepatocyte loss, and mild triaditis of the portal tracts compatible with acute reversible hepatic injury.
The subject’s transaminase levels returned to normal 2 months after acitretin capsules were discontinued. The potential of therapy with acitretin capsules to induce hepatotoxicity was prospectively evaluated using liver biopsies in an open-label trial of 128 subjects. Pretreatment and posttreatment biopsies were available for 87 subjects.
A comparison of liver biopsy findings before and after therapy revealed 49 (58%) subjects showed no change, 21 (25%) improved, and 14 (17%) subjects had a worsening of their liver biopsy status. For 6 subjects, the classification changed from class 0 (no pathology) to class I (normal fatty infiltration; nuclear variability and portal inflammation; both mild); for 7 subjects, the change was from class I to class II (fatty infiltration, nuclear variability, portal inflammation, and focal necrosis; all moderate to severe); and for 1 subject, the change was from class II to class IIIb (fibrosis, moderate to severe).
No correlation could be found between liver function test result abnormalities and the change in liver biopsy status, and no cumulative dose relationship was found. Elevations of AST (SGOT), ALT (SGPT), GGT (GGTP), or LDH have occurred in approximately 1 in 3 subjects treated with acitretin capsules. Of the 525 subjects treated in clinical trials in the U.S., treatment was discontinued in 20 (3.8%) due to elevated liver function test results.
If hepatotoxicity is suspected during treatment with acitretin capsules, the drug should be discontinued and the etiology further investigated. Ten of 652 subjects treated in U.S. clinical trials of etretinate, of which acitretin is the active metabolite, had clinical or histologic hepatitis considered to be possibly or probably related to etretinate treatment. There have been reports of hepatitis-related deaths worldwide; a few of these subjects had received etretinate for a month or less before presenting with hepatic symptoms or signs.
Skeletal Abnormalities In adults receiving long-term treatment with acitretin capsules, appropriate examinations should be periodically performed in view of possible ossification abnormalities (see ADVERSE REACTIONS ). 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 capsules. 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 capsules, 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 capsules, 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 1½ to 2½ years. Six of 128 subjects…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 capsules resemble those of the hypervitaminosis A syndrome. Adverse Events/Postmarketing Reports In addition to the events listed in the tables for the clinical trials, the following adverse events have been identified during postapproval use of acitretin capsules.
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. Cardiovascular: Acute myocardial infarction, thromboembolism (see WARNINGS ), stroke. Immune System Disorders: Hypersensitivity, including angioedema and urticaria (see CONTRAINDICATIONS ).
Nervous System: Myopathy with peripheral neuropathy has been reported during therapy with acitretin capsules. Both conditions improved with discontinuation of the drug. Psychiatric: Aggressive feelings and/or suicidal thoughts have been reported.
These events, including self-injurious behavior, have been reported in patients taking other systemically administered retinoids, as well as in patients taking acitretin capsules. Since other factors may have contributed to these events, it is not known if they are related to acitretin capsules (see PRECAUTIONS ). Reproductive: Vulvo-vaginitis due to Candida albicans.
Skin and Appendages: Thinning of the skin, skin fragility, and scaling may occur all over the body, particularly on the palms and soles; nail fragility is frequently observed. Madarosis and exfoliative dermatitis/erythroderma have been reported (see WARNINGS ). Vascular Disorders: Capillary leak syndrome (see WARNINGS ).
Clinical Trials During clinical trials with acitretin capsules, 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. In clinical trials, acitretin capsules were associated with elevations in liver function test results or triglyceride levels and hepatitis. 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) Body System > 75% 50% to 75% 25% to 50% 10% to 25% CNS Rigors Eye Disorders Xerophthalmia Mucous Membranes Cheilitis Rhinitis Dry mouth Epistaxis Musculoskeletal Arthralgia Spinal hyperostosis (progression of existing lesions) Skin and Appendages Alopecia Skin peeling Dry skin Nail disorder Pruritus Erythematous rash Hyperesthesia Paresthesia Paronychia Skin atrophy Sticky skin 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) Body System 1% to 10% < 1% Body as a Whole Anorexia Edema Fatigue Hot flashes Increased appetite Alcohol intolerance Dizziness Fever Influenza-like symptoms Malaise Moniliasis Muscle weakness Weight increase Cardiovascular Flushing Chest pain Cyanosis Increased bleeding time Intermittent claudication Peripheral ischemia CNS (also see Psychiatric) Headache Pain Abnormal gait Migraine Neuritis Pseudotumor cerebri (intracranial hypertension) Eye Disorders Abnormal/ blurred vision Blepharitis Conjunctivitis/ irritation Corneal epithelial abnormality Decreased night vision/night blindness Eye abnormality Eye pain Photophobia Abnormal lacrimation Chalazion Conjunctival hemorrhage Corneal ulceration Diplopia Ec…
🔄 Drug Interactions ▾
Drug Interactions Ethanol Clinical evidence has shown that etretinate can be formed with concurrent ingestion of acitretin and ethanol (see boxed CONTRAINDICATIONS AND WARNINGS and CLINICAL PHARMACOLOGY: Pharmacokinetics ). Glyburide In a trial of 7 healthy male volunteers, acitretin treatment potentiated the blood glucose-lowering effect of glyburide (a sulfonylurea similar to chlorpropamide) in 3 of the 7 subjects. Repeating the trial with 6 healthy male volunteers in the absence of glyburide did not detect an effect of acitretin on glucose tolerance.
Careful supervision of diabetic patients under treatment with acitretin capsules is recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics and DOSAGE AND ADMINISTRATION ). Hormonal Contraceptives 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 “minipill” preparations.
Microdosed “minipill” progestin preparations are not recommended for use with acitretin capsules (see CLINICAL PHARMACOLOGY: Pharmacokinetic Drug Interactions ). It is not known whether other progestin-only contraceptives, such as implants and injectables, are adequate methods of contraception during acitretin therapy. Methotrexate 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 CONTRAINDICATIONS ). Phenytoin If acitretin is given concurrently with phenytoin, the protein binding of phenytoin may be reduced. Tetracyclines Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see CONTRAINDICATIONS and WARNINGS: Pseudotumor Cerebri ).
Vitamin A and Oral Retinoids Concomitant administration of vitamin A and/or other oral retinoids with acitretin must be avoided because of the risk of hypervitaminosis A. Other There appears to be no pharmacokinetic interaction between acitretin and cimetidine, digoxin, or glyburide. Investigations into the effect of acitretin on the protein binding of anticoagulants of the coumarin type (warfarin) revealed no interaction.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects (See boxed CONTRAINDICATIONS AND WARNINGS .) In a study in which acitretin was administered to male rats only at a dosage of 5 mg per kg per day for 10 weeks (approximate duration of one spermatogenic cycle) prior to and during mating with untreated female rats, no teratogenic effects were observed in the progeny (see boxed CONTRAINDICATIONS AND WARNINGS for information about male use of acitretin capsules). Nonteratogenic Effects In rats dosed at 3 mg per kg per day (approximately one-half the maximum recommended therapeutic dose based on a mg-per-m 2 comparison), slightly decreased pup survival and delayed incisor eruption were noted.
At the next lowest dose tested, 1 mg per kg per day, no treatment-related adverse effects were observed.
🧒 Pediatric Use ▾
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 capsules.
A causal relationship between these effects and acitretin capsules 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 WARNINGS: Hyperostosis ).
🧓 Geriatric Use ▾
Geriatric Use Clinical trials of acitretin capsules 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 CLINICAL PHARMACOLOGY: Special Populations ).
🆘 Overdosage ▾
OVERDOSAGE In the event of acute overdosage, acitretin capsules must be withdrawn at once. Symptoms of overdose are identical to acute hypervitaminosis A (e.g., headache and vertigo). The acute oral toxicity (LD 50 ) 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 Darier’s 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 who have taken an overdose of acitretin capsules must: 1) Have a pregnancy test at the time of overdose; 2) Be counseled as per the boxed CONTRAINDICATIONS AND WARNINGS and PRECAUTIONS sections regarding birth defects and contraceptive use for at least 3 years’ duration after the overdose.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The mechanism of action of acitretin capsules is unknown. Pharmacokinetics 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 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.
Distribution Acitretin is more than 99.9% bound to plasma proteins, primarily albumin. Metabolism (See Pharmacokinetic Drug Interactions: Ethanol .) 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. 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. Special Populations Psoriasis In an 8-week trial of acitretin pharmacokinetics in subjects with psoriasis, mean steady-state trough concentrations of acitretin increased in a dose-proportional manner with dosages ranging from 10 to 50 mg daily.
Acitretin plasma concentrations were nonmeasurable (< 4 ng per mL) in all subjects 3 weeks after cessation of therapy. Elderly In a multiple-dose trial in healthy young (n = 6) and elderly (n = 8) subjects, a 2-fold increase in acitretin plasma concentrations were seen in elderly subjects, although the elimination half-life did not change. Renal Failure Plasma concentrations of acitretin were significantly (59.3%) lower in subjects with end-stage renal failure (n = 6) when compared with age-matched controls, following single 50-mg oral doses.
Acitretin was not removed by hemodialysis in these subjects. Pharmacokinetic Drug Interactions (See also boxed CONTRAINDICATIONS AND WARNINGS and PRECAUTIONS: Drug Interactions .) In studies of in vivo pharmacokinetic drug interactions, no interaction was seen between acitretin and cimetidine, digoxin, phenprocoumon, or glyburide. Ethanol Clinical evidence has shown that etretinate (a retinoid with a much longer half-life, see below) can be formed with concurrent ingestion of acitretin and ethanol.
In a 2-way crossover trial, all 10 subjects formed etretinate with concurrent ingestion of a single 100-mg oral dose of acitretin during a 3-hour period of ethanol ingestion (total ethanol, approximately 1.4 g per kg body weight). A mean peak etretinate concentration of 59 ng per mL (range: 22 to 105 ng per mL) was observed, and extrapolation of AUC values indicated that the formation of etretinate in this trial was comparable to a single 5-mg oral dose of etretinate. There was no detectable formation of etretinate when a single 100-mg oral dose of acitretin was administered without concurrent ethanol ingestion, although the formation of etretinate without concurrent ethanol ingestion cannot be excluded (see boxed CONTRAINDICATIONS AND WARNINGS ).
Of 93 evaluable psoria…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Acitretin Capsules, USP are available containing 10 mg or 25 mg of acitretin, USP. The 10 mg capsules are hard shell gelatin capsules with a swedish orange opaque cap and swedish orange opaque body filled with yellow granular powder. The capsules are axially printed with MYLAN over AC I 02 in black ink on the cap and body.
They are available as follows: NDC 0378-7020-93 bottles of 30 capsules The 25 mg capsules are hard shell gelatin capsules with a brown opaque cap and yellow opaque body filled with yellow granular powder. The capsules are axially printed with MYLAN over AC I 13 in white ink on the cap and body. They are available as follows: NDC 0378-7023-93 bottles of 30 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.
Avoid exposure to high temperatures and humidity after the bottle is opened. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
📋 Description ▾
DESCRIPTION Acitretin capsules, USP (acitretin), a retinoid, are available in 10-mg or 25-mg gelatin capsules for oral administration. Chemically, acitretin, USP is ( all-E )-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 or greenish crystalline powder with a molecular weight of 326.44. The structural formula is: Each capsule contains acitretin, edetate disodium, gelatin, maltodextrin, microcrystalline cellulose, poloxamer 407, red iron oxide, sodium ascorbate and titanium dioxide. The 25 mg capsules also contain black iron oxide and yellow iron oxide.
The black imprinting ink for the 10 mg capsules contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. The white imprinting ink for the 25 mg capsules contains povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide. Acitretin structural formula
💬 Information for Patients ▾
Information for Patients (See 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.
💬 Medication Guide ▾
Medication Guide Acitretin Capsules, USP (a" si tre' tin) Read this Medication Guide carefully before you start taking acitretin capsules and read it each time you get more acitretin capsules. There may be new information. The first information in this Medication Guide is about birth defects and how to avoid pregnancy.
After this section there is important safety information about possible effects for any patient taking acitretin capsules. All patients should read this entire Medication Guide carefully. This information does not take the place of talking with your prescriber about your medical condition or treatment.
What is the most important information I should know about acitretin capsules? Acitretin capsules can cause serious side effects, including: • Severe birth defects. If you are a female who can get pregnant, you should use acitretin capsules only if you are not pregnant now, can avoid becoming pregnant for at least 3 years, and other medicines do not work for your severe psoriasis or you cannot use other psoriasis medicines.
Information about effects on unborn babies and about how to avoid pregnancy is found in the next section: “What are the important warnings and instructions for females taking acitretin capsules?” • Liver problems, including abnormal liver function tests and inflammation of your liver (hepatitis). Your prescriber should do blood tests to check how your liver is working before you start taking and during treatment with acitretin capsules. Stop taking acitretin capsules and call your prescriber right away if you have any of the following signs or symptoms of a serious liver problem: o yellowing of your skin or the whites of your eyes o nausea and vomiting o loss of appetite o dark urine What are the important warnings and instructions for females taking acitretin capsules? • Before you receive your first prescription for acitretin capsules, you should have discussed and signed a Patient Agreement/Informed Consent for Female Patients form with your prescriber.
This is to help make sure you understand the risk of birth defects and how to avoid getting pregnant. If you did not talk to your prescriber about this and sign the form, contact your prescriber. Important: If you are a female who can become pregnant: • You must not take acitretin capsules if you are pregnant or might become pregnant during treatment or at any time for at least 3 years after you stop treatment because acitretin capsules can cause severe birth defects. • During treatment with acitretin capsules and for 2 months after you stop treatment with acitretin capsules, you must avoid drinks, foods, and all medicines that contain alcohol.
This includes over-the-counter products that contain alcohol. Avoiding alcohol is very important, because alcohol changes acitretin into a drug that may take longer than 3 years to leave your body. The chance of birth defects may last longer than 3 years if you swallow any form of alcohol during treatment with acitretin capsules and for 2 months after you stop taking acitretin capsules.
You and your prescriber must be sure you are not pregnant before you start therapy with acitretin capsules. You must have negative results from 2 pregnancy tests before you start treatment with acitretin capsules. A negative result shows you are not pregnant.
Because it takes a few days after pregnancy begins for a test to show that you are pregnant, the first negative test may not ensure you are not pregnant. Do not start acitretin capsules until you have negative results from 2 pregnancy tests. o The first pregnancy test (urine or blood) will be done at the time you and your prescriber decide if acitretin capsules might be right for you. o The second pregnancy test will usually be done during the first 5 days of your menstrual period. You must start taking acitretin capsules within 7 days of when the urine or blood for the second pregnancy test is collected. • After you start taking acitretin capsules, you must have a…