Acitretin

Drug overview for ACITRETIN (acitretin):

Generic name: ACITRETIN (A-si-TRE-tin)
Drug class: Antipsoriatics
Therapeutic class: Dermatological

Acitretin is an active metabolite of etretinate (no longer commercially available in US); acitretin is a retinoid.

No enhanced Uses information available for this drug.

DRUG IMAGES

ACITRETIN 25 MG CAPSULE
ACITRETIN 10 MG CAPSULE
ACITRETIN 17.5 MG CAPSULE

The following indications for ACITRETIN (acitretin) have been approved by the FDA:

Indications:
Severe recalcitrant psoriasis

Professional Synonyms:
Severe intractable psoriasis
Severe refractory psoriasis

Dosing information for ACITRETIN
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
ACITRETIN 10 MG CAPSULE	Maintenance	Adults take 2 capsules (20 mg) by oral route once daily with main meal
ACITRETIN 17.5 MG CAPSULE	Maintenance	Adults take 2 capsules (35 mg) by oral route once daily with main meal
ACITRETIN 25 MG CAPSULE	Maintenance	Adults take 1 capsule (25 mg) by oral route once daily with main meal

Generic dosing information for ACITRETIN
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
ACITRETIN 10 MG CAPSULE	Maintenance	Adults take 2 capsules (20 mg) by oral route once daily with main meal
ACITRETIN 25 MG CAPSULE	Maintenance	Adults take 1 capsule (25 mg) by oral route once daily with main meal
ACITRETIN 17.5 MG CAPSULE	Maintenance	Adults take 2 capsules (35 mg) by oral route once daily with main meal

The following drug interaction information is available for ACITRETIN (acitretin):

Contraindicated
Severe
Moderate

There are 2 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction	Drug Names
Acitretin/Methotrexate SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Additive hepatic toxicity.(1-3) CLINICAL EFFECTS: Methotrexate has a risk of causing hepatic fibrosis and cirrhosis.(1) Concurrent use with another hepatotoxic agent like acitretin increases the risk of hepatotoxicity.(2,3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of acitretin states that the concurrent use of acitretin and methotrexate is contraindicated.(2) DISCUSSION: Because of the risk of increased hepatotoxicity during concurrent administration of methotrexate and etretinate, the manufacturer of acitretin states that concurrent administration of methotrexate and acitretin is contraindicated.(2)	JYLAMVO, METHOTREXATE, METHOTREXATE SODIUM, OTREXUP, RASUVO, TREXALL, XATMEP
Selected Retinoids (Systemic)/Tetracyclines SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Both systemic tetracyclines(1-4,14) and systemic retinoids(5-14) have been independently associated with medication-induced intracranial hypertension. CLINICAL EFFECTS: The concurrent use of oral retinoids(5-12) with tetracyclines has been associated with pseudotumor cerebri (benign intracranial hypertension). Early signs of pseudotumor cerebri include papilledema (inflammation of the optic nerve), headache, nausea, vomiting, and visual disturbances such as blurred vision, double vision, and loss of vision.(15) PREDISPOSING FACTORS: Women of childbearing age who are overweight or have a previous history of intracranial hypertension are at a greater risk of developing intracranial hypertension.(15) PATIENT MANAGEMENT: The UK(5) and US(6) manufacturers of acitretin state state that concurrent use with tetracyclines is contraindicated. The UK manufacturer of isotretinoin states that concurrent use with tetracyclines is contraindicated.(7) The US manufacturer of isotretinoin states that the concurrent use of tetracyclines should be avoided.(8) The US manufacturer of minocycline states that the administration of isotretinoin should be avoided shortly before, during and shortly after minocycline therapy.(2) The UK manufacturers of oral tretinoin and alitretinoin states that concurrent use with tetracyclines is contraindicated.(9,11) The Canadian manufacturer of palovarotene states that coadministration of tetracycline derivatives should be avoided.(12) Patients who present with symptoms of pseudotumor cerebri should be screened for papilledema. If papilledema is present, they should discontinue the drug and be referred to a neurologist for further treatment.(5-13) DISCUSSION: The concurrent use of isotretinoin and tetracyclines has been associated with pseudotumor cerebri.(5-13) A review of ocular side effects from the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, the Food and Drug Administration, and medical journals from 1979 to 2003 found 6 patients who developed intracranial hypertension while taking concurrent minocycline or tetracycline with tretinoin, acitretin, or etretinate.(13)	AVIDOXY, AVIDOXY DK, BENZODOX 30, BENZODOX 60, BISMUTH-METRONIDAZOLE-TETRACYC, DEMECLOCYCLINE HCL, DORYX, DORYX MPC, DOXY 100, DOXYCYCLINE HYCLATE, DOXYCYCLINE IR-DR, DOXYCYCLINE MONOHYDRATE, EMROSI, MINOCIN, MINOCYCLINE ER, MINOCYCLINE HCL, MINOCYCLINE HCL ER, MONDOXYNE NL, MORGIDOX, NUZYRA, ORACEA, OXYTETRACYCLINE HCL, PYLERA, SEYSARA, TARGADOX, TETRACYCLINE HCL, TIGECYCLINE, TYGACIL, XERAVA, XIMINO

Drug Interaction

Drug Names

Acitretin/Methotrexate

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Additive hepatic toxicity.(1-3)

CLINICAL EFFECTS: Methotrexate has a risk of causing hepatic fibrosis and cirrhosis.(1) Concurrent use with another hepatotoxic agent like acitretin increases the risk of hepatotoxicity.(2,3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of acitretin states that the concurrent use of acitretin and methotrexate is contraindicated.(2)

DISCUSSION: Because of the risk of increased hepatotoxicity during concurrent administration of methotrexate and etretinate, the manufacturer of acitretin states that concurrent administration of methotrexate and acitretin is contraindicated.(2)

JYLAMVO, METHOTREXATE, METHOTREXATE SODIUM, OTREXUP, RASUVO, TREXALL, XATMEP

Selected Retinoids (Systemic)/Tetracyclines

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Both systemic tetracyclines(1-4,14) and systemic retinoids(5-14) have been independently associated with medication-induced intracranial hypertension.

CLINICAL EFFECTS: The concurrent use of oral retinoids(5-12) with tetracyclines has been associated with pseudotumor cerebri (benign intracranial hypertension). Early signs of pseudotumor cerebri include papilledema (inflammation of the optic nerve), headache, nausea, vomiting, and visual disturbances such as blurred vision, double vision, and loss of vision.(15)

PREDISPOSING FACTORS: Women of childbearing age who are overweight or have a previous history of intracranial hypertension are at a greater risk of developing intracranial hypertension.(15)

PATIENT MANAGEMENT: The UK(5) and US(6) manufacturers of acitretin state state that concurrent use with tetracyclines is contraindicated. The UK manufacturer of isotretinoin states that concurrent use with tetracyclines is contraindicated.(7) The US manufacturer of isotretinoin states that the concurrent use of tetracyclines should be avoided.(8)

The US manufacturer of minocycline states that the administration of isotretinoin should be avoided shortly before, during and shortly after minocycline therapy.(2) The UK manufacturers of oral tretinoin and alitretinoin states that concurrent use with tetracyclines is contraindicated.(9,11) The Canadian manufacturer of palovarotene states that coadministration of tetracycline derivatives should be avoided.(12)

Patients who present with symptoms of pseudotumor cerebri should be screened for papilledema. If papilledema is present, they should discontinue the drug and be referred to a neurologist for further treatment.(5-13)

DISCUSSION: The concurrent use of isotretinoin and tetracyclines has been associated with pseudotumor cerebri.(5-13) A review of ocular side effects from the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, the Food and Drug Administration, and medical journals from 1979 to 2003 found 6 patients who developed intracranial hypertension while taking concurrent minocycline or tetracycline with tretinoin, acitretin, or etretinate.(13)

AVIDOXY, AVIDOXY DK, BENZODOX 30, BENZODOX 60, BISMUTH-METRONIDAZOLE-TETRACYC, DEMECLOCYCLINE HCL, DORYX, DORYX MPC, DOXY 100, DOXYCYCLINE HYCLATE, DOXYCYCLINE IR-DR, DOXYCYCLINE MONOHYDRATE, EMROSI, MINOCIN, MINOCYCLINE ER, MINOCYCLINE HCL, MINOCYCLINE HCL ER, MONDOXYNE NL, MORGIDOX, NUZYRA, ORACEA, OXYTETRACYCLINE HCL, PYLERA, SEYSARA, TARGADOX, TETRACYCLINE HCL, TIGECYCLINE, TYGACIL, XERAVA, XIMINO

There are 5 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Selected Retinoids/Progestin-Only Oral Contraceptives SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The exact mechanism is unknown. CLINICAL EFFECTS: Concurrent use may result in increased progesterone levels and interference with the effect of the contraceptive. Major fetal abnormalities have been reported with the administration of acitretin(1) and isotretinoin.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Use of "mini-pill" progestin preparations are not recommended. Patients on acitretin(1) or isotretinoin(2) therapy should be using two reliable methods of contraception and should be advised that progestin-only mini-pills may fail. Consider switching to a combination estrogen-progestin contraceptive agent; intrauterine device (IUD); or injected, implanted, or inserted hormonal birth control products. Two methods of contraception are still required. DISCUSSION: According to the manufacturer of acitretin, this interaction has been documented in one patient who received concurrent therapy with acitretin and a progestin-only mini-pill.(1) Given the severe consequences of contraceptive failure during acitretin or isotretinoin therapy, caution is warranted. All females of reproductive age should use two reliable forms of contraception unless they have undergone a hysterectomy or practice abstinence.(1,2) In a study in 26 healthy women, concurrent use of isotretinoin and Ortho Novum 7/7/7 (ethinyl estradiol and norethindrone) resulted in small, inconsistent, although statistically significant, decreases in ethinyl estradiol (9%) and norethindrone (11%). However, there was large variability of pharmacokinetic and pharmacodynamic markers and the authors stressed that their results reinforced the need for additional contraceptive measures during therapy.(3)	CAMILA, DEBLITANE, EMZAHH, ERRIN, HEATHER, INCASSIA, JENCYCLA, LYLEQ, LYZA, NORA-BE, NORETHINDRONE, SHAROBEL, SLYND, TULANA
Vitamin A/Selected Retinoids SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The retinoids are structurally related to vitamin A. (1-6) CLINICAL EFFECTS: Concurrent use of retinoids with vitamin A supplements may result in signs of vitamin A toxicity.(1-6) Symptoms of vitamin A toxicity include nausea, vomiting, loss of appetite, weakness, dry or itchy skin or lips, irritability, and hair loss. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of acitretin states that concomitant use of vitamin A supplements should be avoided.(1) The manufacturer of bexarotene states that patients should be advised to limit vitamin A supplements. In clinical studies, patients were advised to limit their vitamin A intake to less than or equal to 15,000 International Units/day.(2) The manufacturer of isotretinoin states that patients should be advised against taking vitamin A supplements.(3) The manufacturer of palovarotene states that concomitant use of vitamin A must be avoided.(4) The manufacturer of tretinoin states that tretinoin must not be administered in combination with vitamin A.(5) The UK manufacturer of alitretinoin states that tretinoin must not be administered in combination with vitamin A.(6) DISCUSSION: The retinoids are structurally related to vitamin A. The concurrent use of retinoids with vitamin A may result in signs and symptoms of vitamin A toxicity.(1-6)	AQUASOL A, INFUVITE ADULT, INFUVITE ADULT VIAL 1, INFUVITE PEDIATRIC, INFUVITE PEDIATRIC VIAL 1, M.V.I. ADULT VIAL 1, VITALIPID N INFANT, VITLIPID N ADULT, VITLIPID N INFANT
Acitretin/Ethyl Alcohol SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Ethanol trans esterifies acitretin into etretinate,(1-3) which is stored in adipose tissue and slowly eliminated.(1) CLINICAL EFFECTS: Ingestion of ethanol, even sporadically, during acitretin usage and for 2 months after discontinuation of acitretin may result in formation of etretinate. Etretinate is also highly teratogenic and is slowly eliminated from the body over several years after discontinuation.(4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of acitretin states that use of ethanol during or for 2 months after acitretin therapy in females is contraindicated.(4) Females on acitretin therapy should be counseled to avoid consumption and use of ethanol containing products during and for two months after acitretin use.(4) Alcohol is used to improve docetaxel and paclitaxel solubility. - The quantity of alcohol in paclitaxel injection formulations (0.385-0.396 grams/mL) is similar across manufacturers. A paclitaxel 200 mg dose contains approximately 13 grams of alcohol. - The quantity of alcohol in docetaxel formulations varies approximately 3-fold depending upon the manufacturer. FDA data on alcohol content (6): Product Manufacturer Alcohol/200 mg dose Docetaxel Inj. Pfizer 6.4 grams Docetaxel Inj. Sandoz 5.5 grams Docetaxel Inj. Accord 4.0 grams Taxotere-one vial Sanofi 4.0 grams formulation Docetaxel Inj. Hospira 3.7 grams Docefrez Sun Pharma 2.9 grams Taxotere-two vial Sanofi 2.0 grams formulation DISCUSSION: In a 2-way cross-over study in 10 subjects, consumption of a single dose of acitretin (100 mg) during ethanol ingestion (1.4 g/kg) resulted in formation of etretinate in all 10 subjects. The levels of etretinate formed were comparable to a 5 mg dose of etretinate. There was no detectable etretinate levels in any subject during administration of acitretin without ethanol.(4) In a study in 10 subjects treated with acitretin (30 mg daily for 3 months), 7 patients had detectable etretinate levels, 4 of which were teratogenic. Consumption of ethanol was linked to the formation of etretinate.(1) In a study in 86 patients treated with acitretin, 30 patients had detectable levels of etretinate. No etretinate was found in 20 subjects who reported no ethanol intake. Etretinate was found in all 16 subjects with an average weekly alcohol consumption of greater than 200 g (approximately 15 servings/week). Etretinate was found in 15 of 50 patients with an average weekly ethanol intake less than 200 g.(5) The half-life of etretinate has been estimated at 120 days (range 84-168 days). In a study of 47 patients treated with etretinate, 5 had detectable etretinate levels 2.1 years to 2.9 years after discontinuation of therapy. However, one patient who reported sporadic ethanol intake had detectable etretinate levels 52 months after discontinuation of acitretin.(4)	ALCOHOL,DEHYDRATED, ERY, ERYGEL, ERYTHROMYCIN, GENADUR
Selected Retinoids (Systemic)/Growth Hormone SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Both systemic retinoids(1-8,11) and growth hormones(9-11) have been independently associated with medication-induced intracranial hypertension. CLINICAL EFFECTS: The concurrent use of oral retinoids(1-8) with growth hormones(9-10) may increase the risk of intracranial hypertension (pseudotumor cerebri). Early signs of intracranial hypertension include papilledema (inflammation of the optic nerve), headache, nausea, vomiting, and visual disturbances such as blurred vision, double vision, and loss of vision.(12) PREDISPOSING FACTORS: Women of childbearing age with high body mass may have a higher risk of developing intracranial hypertension.(8) PATIENT MANAGEMENT: The US manufacturer of tretinoin advises avoiding concomitant use of other products that can cause intracranial hypertension.(1) Patients who present with symptoms of intracranial hypertension should be screened for papilledema. If papilledema is present, they should discontinue the drug and be referred to a neurologist for further treatment.(1-8) DISCUSSION: Vitamin A derivatives and growth hormone have both been strongly associated with intracranial hypertension. A review of ocular side effects from the National Registry of Drug-Induced Ocular Side Effects, the World Health Organization, the Food and Drug Administration, and medical journals from 1979 to 2003 found 21 patients who developed intracranial hypertension while taking tretinoin, acitretin, or etretinate at prescribed doses. Symptom onset occurred at an average of 2-3 months after starting retinoid therapy and all except 3 cases resolved within a few months after discontinuing therapy.(8) In a systematic review of 580 reported cases of medication-induced intracranial hypertension between January 1900 and June 2019 found in MEDLINE, EMBASE, and Cochrane Review Databases, there were 259 verifiable cases of intracranial hypertension. Vitamin A derivatives were implicated in 84 cases, though 25 cases occurred with excessive vitamin A supplementation. Growth hormone was implicated in 24 cases, all of which occurred in pediatric patients and involved frequent or higher doses of growth hormone.(12)	GENOTROPIN, HUMATROPE, NGENLA, NORDITROPIN FLEXPRO, NUTROPIN AQ NUSPIN, OMNITROPE, SAIZEN-SAIZENPREP, SEROSTIM, SKYTROFA, SOGROYA, ZOMACTON
Selected Retinoids (Systemic)/Lithium SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Both systemic retinoids(1-7) and lithium(8-9) have been independently associated with medication-induced intracranial hypertension. CLINICAL EFFECTS: The concurrent use of oral retinoids(1-7) with lithium(8-9) may increase the risk of intracranial hypertension (pseudotumor cerebri). Early signs of intracranial hypertension include papilledema (inflammation of the optic nerve), headache, nausea, vomiting, and visual disturbances such as blurred vision, double vision, and loss of vision.(10) PREDISPOSING FACTORS: Women of childbearing age who are overweight or have a previous history of intracranial hypertension are at a greater risk of developing intracranial hypertension.(10) PATIENT MANAGEMENT: The US manufacturer of tretinoin advises avoiding concomitant use of other products that can cause intracranial hypertension.(1) Patients who present with symptoms of intracranial hypertension should be screened for papilledema. If papilledema is present, they should discontinue the drug and be referred to a neurologist for further treatment.(1-7) DISCUSSION: Vitamin A derivatives and lithium have both been strongly associated with intracranial hypertension. In a systematic review of 580 reported cases of medication-induced intracranial hypertension between January 1900 and June 2019 found in MEDLINE, EMBASE, and Cochrane Review Databases, there were 259 verifiable cases of intracranial hypertension. Vitamin A derivatives were implicated in 84 cases, though 25 cases occurred with excessive vitamin A supplementation. Lithium was implicated in 17 cases with lithium levels in therapeutic range.(10)	LITHIUM CARBONATE, LITHIUM CARBONATE ER, LITHIUM CITRATE, LITHIUM CITRATE TETRAHYDRATE, LITHOBID

There are 0 moderate interactions.

The following contraindication information is available for ACITRETIN (acitretin):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

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.

There are 5 contraindications. Absolute contraindication.

Contraindication List
Acute pancreatitis
Child-pugh class C hepatic impairment
Idiopathic intracranial hypertension
Lactation
Pregnancy

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Capillary leak syndrome
Depression
Disease of liver
Hyperlipidemia
Hypertriglyceridemia
Psychotic disorder
Skeletal hyperostosis

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus
High density lipoprotein deficiency

The following adverse reaction information is available for ACITRETIN (acitretin):

Overview
Severe
Less Severe

Adverse reaction overview.

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.)

There are 45 severe adverse reactions.

More Frequent	Less Frequent
Arthralgia Headache disorder Hypertonia Myalgia Nausea Spinal hyperostosis Vomiting	Chills Eye tearing Eyelid edema Ocular irritation Ocular pain Ocular redness Paresthesia Paronychia Photophobia Visual changes

Rare/Very Rare
Acute myocardial infarction Acute pancreatitis Allergic dermatitis Angioedema Capillary leak syndrome Cataracts Cerebrovascular accident Corneal erosion Depression Exfoliative dermatitis Flu-like symptoms Hepatitis Idiopathic intracranial hypertension Infection Jaundice Laryngitis Myopathy Night blindness Otitis externa eczema Pharyngitis Psoriasiform eruption Purpura Pyogenic granuloma Skin fissure Skin ulcer Suicidal ideation Thromboembolic disorder Vulvovaginitis

Rare/Very Rare

Acute myocardial infarction
Acute pancreatitis
Allergic dermatitis
Angioedema
Capillary leak syndrome
Cataracts
Cerebrovascular accident
Corneal erosion
Depression
Exfoliative dermatitis
Flu-like symptoms
Hepatitis
Idiopathic intracranial hypertension
Infection
Jaundice
Laryngitis
Myopathy
Night blindness
Otitis externa eczema
Pharyngitis
Psoriasiform eruption
Purpura
Pyogenic granuloma
Skin fissure
Skin ulcer
Suicidal ideation
Thromboembolic disorder
Vulvovaginitis

There are 35 less severe adverse reactions.

More Frequent	Less Frequent
Abnormal hepatic function tests Alopecia Ceruminosis Cheilosis Dry eye Dry nose Eyelid dermatitis Gingivitis Mixed hyperlipidemia Polydipsia Pruritus of skin Rhinitis Skin photosensitivity Skin scaling of feet Skin scaling of hands Stomatitis	Aphthous stomatitis Blepharitis Blurred vision Conjunctivitis Constipation Diarrhea Epistaxis Fatigue Hyperhidrosis Nail disorders

Rare/Very Rare
Aggressive behavior Bone pain Hordeolum Hyperesthesia Hyperglycemia Hypotrichosis of eyelid lashes Skin atrophy Symptoms of anxiety Urticaria

The following precautions are available for ACITRETIN (acitretin):

Pediatric
Pregnant
Lactation
Geriatric

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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category X. (See Users Guide.) 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.)

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

Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.

Drug Name	Excretion Potential	Effect on Infant	Notes
Acitretin	Excreted.This drug is known to be excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Not recommended by manufacturer, potential for toxicity

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.)

The following prioritized warning is available for ACITRETIN (acitretin):

WARNING: Do not use this medication if you are pregnant or planning to become pregnant within 3 years of stopping this drug because it has caused serious birth defects. Use 2 effective birth control methods starting 1 month before taking this medication and at least 3 years after treatment has stopped. Do not use "minipills" (non-estrogen-containing pills) for birth control because they may not work as well with this drug.

Consult your doctor for more details. Females who are able to have children must not use this medication unless the following requirements are met: test negative on 2 pregnancy tests (they should be taken 1 week before starting this drug or at least 11 days after the last act of unprotected sexual intercourse); start therapy within 7 days of taking the second pregnancy test; present severe psoriasis and other treatments cannot be used; receive oral and written information on using 2 methods of birth control while taking this drug and for 3 years after stopping it; aware of the dangers of birth control failure and use during pregnancy; understand and correctly follow all birth control requirements and instructions including monthly pregnancy tests during treatment and every 3 months for 3 years after treatment has stopped. Do not drink alcohol while using acitretin and for 2 months after stopping it because alcohol causes this drug to stay in the body longer.

It is not known if traces of this drug found in semen of male patients pose a risk to the unborn baby during use or after treatment has stopped. Acitretin may rarely cause serious (possibly fatal) liver disease (hepatitis) and increased fluid pressure on the brain (pseudotumor cerebri). If you notice any of the following unlikely but serious side effects, get medical help right away: headache that is severe or doesn't go away, nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, unusual tiredness, or vision changes (such as blurred/double vision, decreased vision).

Acitretin has also been linked to pancreatitis (inflammation of the pancreas). Tell your doctor right away if you develop lower abdominal pain that doesn't go away. Rarely, acitretin may cause serious mental/mood changes, even after stopping the medication. Get medical help right away if you have symptoms such as depression, irritability, aggressive or violent behavior, or thoughts of suicide.

The following icd codes are available for ACITRETIN (acitretin)'s list of indications:

Severe recalcitrant psoriasis
L40	Psoriasis
L40.0	Psoriasis vulgaris
L40.1	Generalized pustular psoriasis
L40.2	Acrodermatitis continua
L40.3	Pustulosis palmaris et plantaris
L40.4	Guttate psoriasis
L40.5	Arthropathic psoriasis
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.54	Psoriatic juvenile arthropathy
L40.59	Other psoriatic arthropathy
L40.8	Other psoriasis
L40.9	Psoriasis, unspecified