tretinoin (Rx)

Brand and Other Names:Vesanoid (DSC)

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 10mg (generic)

Acute Promyelocytic Leukemia

For use in patients with APL classification M3, which is characterized by the presence of t(15;17) translocation and/or the presence of the PML/RAR-alpha gene, who are refractory to, or have relapsed from, anthracycline chemotherapy, as well as for use in patients for whom anthracycline-based chemotherapy is contraindicated

Remission Induction

  • 45 mg/m²/day PO divided q12hr  
  • Discontinue 30 days after complete remission or 90 days after start of treatment (whichever comes first)

Remission Induction In Combination with an Anthracycline

  • 45 mg/m²/day PO divided q12hr  
  • Discontinue 30 days after complete remission or 90 days after start of treatment (whichever comes first)

Consolidation Therapy (Off-label)

  • Intermediate and high risk patients: 45 mg/m² PO divided q12hr for 15 days/month for 3 months

Maintenance of Remission (Off-label)

  • 45 mg/m²/day PO divided q12hr for 15 days every 3 months for 2 years

Dosing Adjustment (Toxicity)

APL differentiation syndrome: 10 mg dexamethasone IV q12hr for 3-5 days; consider interrupting tretinoin until resolution of hypoxia

Liver function tests >5 times upper limit of normal: Consider withholding treatment temporarily

Patient Monitoring

Monitor CBC, coagulation, liver function tests, serum lipids

Dosage Forms & Strengths

capsule

  • 10mg (generic)

Acute promyelocytic leukemia

For use in patients with APL classification M3, which is characterized by the presence of t(15;17) translocation and/or the presence of the PML/RAR-alpha gene, who are refractory to, or have relapsed from, anthracycline chemotherapy, as well as in patients in whom anthracycline-based chemotherapy is contraindicated

Remission Induction

  • 45 mg/m²/day PO divided q12hr  
  • Discontinue 30 days after remission or 90 days after start of treatment (whichever comes first)

Remission Induction with an Anthracycline

  • 25 mg/m²/day PO divided q12hr until complete remission or 90 days

Consolidation Therapy (Off-label)

  • Intermediate and high risk patients: 25 mg/m² PO divided q12hr for 15 days/month for 3 months

Maintenance of Remission (Off-label)

  • 25 mg/m²/day PO divided q12hr for 15 days every 3 months for 2 years

Dosing Adjustment (Toxicity)

APL differentiation syndrome: 10 mg dexamethasone IV q12hr for 3-5 days; consider interrupting tretinoin until resolution of hypoxia

Liver function tests >5 times upper limit of normal: Consider withholding treatment temporarily

Patient Monitoring

Monitor CBC, coagulation, liver function tests, serum lipids

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Interactions

Interaction Checker

and tretinoin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (3)

            • doxycycline

              doxycycline, tretinoin. Either increases toxicity of the other by unspecified interaction mechanism. Contraindicated. Both tretinoin and tetracyclines can cause increased intracranial pressure.

            • minocycline

              minocycline, tretinoin. Either increases toxicity of the other by Other (see comment). Contraindicated. Comment: Both tretinoin and tetracyclines can cause increased intracranial pressure.

            • tetracycline

              tetracycline, tretinoin. Either increases toxicity of the other by unspecified interaction mechanism. Contraindicated. Both tretinoin and tetracyclines can cause increased intracranial pressure.

            Serious - Use Alternative (34)

            • aminolevulinic acid oral

              aminolevulinic acid oral, tretinoin. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid administering other phototoxic drugs with aminolevulinic acid oral for 24 hr during perioperative period.

            • aminolevulinic acid topical

              tretinoin, aminolevulinic acid topical. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

            • chlorothiazide

              chlorothiazide, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • chlorpromazine

              chlorpromazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • chlorthalidone

              chlorthalidone, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • ciprofloxacin

              ciprofloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Both drugs have increased risk of phototoxicity, use caution with concomitant use.

            • demeclocycline

              demeclocycline, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • doxycycline

              doxycycline, tretinoin. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • etrasimod

              etrasimod, tretinoin. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.

            • fluphenazine

              fluphenazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • gemifloxacin

              gemifloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • hydrochlorothiazide

              hydrochlorothiazide, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • indapamide

              indapamide, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • levofloxacin

              levofloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • methyclothiazide

              methyclothiazide, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • methyl aminolevulinate

              tretinoin, methyl aminolevulinate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Each drug may increase the photosensitizing effect of the other.

            • metolazone

              metolazone, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • minocycline

              minocycline, tretinoin. Either increases levels of the other by Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • moxifloxacin

              moxifloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • ofloxacin

              ofloxacin, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • omadacycline

              tretinoin increases toxicity of omadacycline by Mechanism: unknown. Avoid or Use Alternate Drug. Concomitant use of oral retinoids with tetracyclines may increase risk of pseudotumor cerebri/intracranial hypertension. .

            • palifermin

              palifermin increases toxicity of tretinoin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

            • palovarotene

              tretinoin, palovarotene. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Vitamin A in doses higher than the recommended daily allowance and/or other oral retinoids coadministered with palovarotene increases risk of hypervitaminosis A. .

            • perphenazine

              perphenazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • prochlorperazine

              prochlorperazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • promazine

              promazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • promethazine

              promethazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • sarecycline

              tretinoin increases toxicity of sarecycline by Mechanism: unknown. Avoid or Use Alternate Drug. Concomitant use of oral retinoids with tetracyclines may increase risk of pseudotumor cerebri/intracranial hypertension. .

            • sulfadiazine

              sulfadiazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • sulfamethoxazole

              sulfamethoxazole, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • sulfisoxazole

              sulfisoxazole, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • tetracycline

              tetracycline, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • thioridazine

              thioridazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            • trifluoperazine

              trifluoperazine, tretinoin. Mechanism: pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased phototoxicity.

            Monitor Closely (16)

            • cannabidiol

              cannabidiol will increase the level or effect of tretinoin by decreasing metabolism. Modify Therapy/Monitor Closely. Cannabidiol may potentially inhibit CYP2C8 activity. Consider reducing the dose when concomitantly using CYP2C8 substrates.

            • dichlorphenamide

              dichlorphenamide, tretinoin. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.

            • ketoconazole

              ketoconazole increases levels of tretinoin by decreasing metabolism. Use Caution/Monitor.

            • levoketoconazole

              levoketoconazole increases levels of tretinoin by decreasing metabolism. Use Caution/Monitor.

            • methotrexate

              methotrexate, tretinoin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Patients receiving other agents that may cause hepatotoxicity, including systemic retinoids, could be at increased risk of liver-related side effects of methotrexate and such patients should be monitored closely during methotrexate therapy.

            • mifepristone

              mifepristone will increase the level or effect of tretinoin by Other (see comment). Use Caution/Monitor. Inhibits CYP2C8/2C9; use smallest recommended doses for substrates and monitor

            • ofatumumab SC

              ofatumumab SC, tretinoin. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • omaveloxolone

              omaveloxolone will decrease the level or effect of tretinoin by Other (see comment). Use Caution/Monitor. Omaveloxolone may reduce systemic exposure of sensitive CYP2C8 substrates. Check prescribing information of substrate if dosage modification is needed.

            • siponimod

              siponimod and tretinoin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • stiripentol

              stiripentol will increase the level or effect of tretinoin by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a CYP2C8 inhibitor. Consider dosage reduction for CYP2C8 substrates if adverse effects are experienced when coadministered.

            • tecovirimat

              tecovirimat will increase the level or effect of tretinoin by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor. Tecovirimat is a weak inhibitor of CYP2C8 and CYP2C19. Monitor for adverse effects if coadministered with sensitive substrates of these enzymes.

            • teriflunomide

              teriflunomide increases levels of tretinoin by Other (see comment). Use Caution/Monitor. Comment: Teriflunomide inhibits CYP2C8; caution when coadministered with CYP2C8 substrates.

            • tobramycin inhaled

              tobramycin inhaled and tretinoin both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity

            • tranexamic acid oral

              tranexamic acid oral, tretinoin. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration may increase procoagulant effect.

            • trastuzumab

              trastuzumab, tretinoin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, tretinoin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            Minor (1)

            • benazepril

              tretinoin, benazepril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.

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            Adverse Effects

            >10%

            Headache (86%)

            Fever (83%)

            Bone pain (77%)

            Dry mucous membranes (77%)

            Malaise (67%)

            URI (63%)

            Shivering (60%)

            Dyspnea (60%)

            Hemorrhage (60%)

            Elevated liver function tests (50-60%)

            Hyperlipidemia (60%)

            Infections (58%)

            Nausea and vomiting (57%)

            Rash (54%)

            Peripheral edema (52%)

            Leukocytosis (40%)

            Pain (37%)

            Abdominal pain (31%)

            DIC (26%)

            Respiratory insufficiency (26%)

            Mucositis (26%)

            GI disorder (26%)

            Retinoic acid-APL syndrome (25%)

            Ear ache (23%)

            Diarrhea (23%)

            Pleural effusion (20%)

            Dizziness (20%)

            Pruritus (20%)

            Sweating (20%)

            Anxiety (17%)

            Paresthesia (17%)

            Constipation (17%)

            Vision changes (17%)

            Dyspepsia (14%)

            Rales (14%)

            Depression (14%)

            Insomnia (14%)

            Alopecia (14%)

            Skin changes (14%)

            Confusion (11%)

            Abdominal distention (11%)

            Renal insufficiency (11%)

            1-10% (selected)

            Cardiac failure (6%)

            Pallor (6%)

            Cardiac arrest (3%)

            Cardiomyopathy (3%)

            Myocarditis (3%)

            Stroke (3%)

            Heart murmur (3%)

            Hemmorrhage (9%)

            Facial edema (6%)

            Intracranial hypertension (9%)

            Hypotaxia (3%)

            Seizure (3%)

            Somnolence (3%)

            Facial paralysis (3%)

            Spinal cord disorder (3%)

            Light reflex absent (3%)

            Ulcer (3%)

            Cellulitis (8%)

            Hepatosplenomegaly (9%)

            Dysuria (9%)

            Enlarged prostate (3%)

            Ascites (3%)

            Hepatitis (3%)

            Tremor (3%)

            Bone inflammation (3%)

            Hearing loss (6%)

            <1%

            Arterial thrombosis

            Hypercalcemia

            Myositis

            Pancreatitis

            Thrombocytosis

            Venous thrombosis

            Irreversible hearing loss

            Genital ulceration

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            Warnings

            Black Box Warnings

            Should be administered under the supervision of an experienced cancer chemotherapy physician in a facility with laboratory and supportive services sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity, including respiratory compromise; therapy requires that the physician concludes that the possible benefit to patient outweighs the known adverse effects of the therapy

            Teratogenic effects

            • High risk of severe infant deformity if administered during pregnancy; if treatment with tretinoin is required in women of childbearing potential, 2 reliable forms of contraception should be used during, and for 1 month after, therapy; if it is determined that tretinoin represents the best available treatment for a pregnant woman, patients should be informed of the risk to the fetus

            Retinoic acide-APL syndrome

            • About 25% of patients with APL treated with tretinoin experience a syndrome called the retinoic acid-APL syndrome, which can be fatal and is characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural or pericardial effusions, edema, and hepatic, renal, and/or multiorgan failure; this syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension; management has not been defined rigorously, but high-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality
            • At first signs suggestive of the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings, or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously administered every 12 hours for 3 days or until the resolution of symptoms) should be immediately initiated, irrespective of leukocyte count; the majority of patients do not require termination of therapy during treatment of RA-APL syndrome; however, in cases of moderate and severe RA-APL syndrome, temporary interruption of therapy should be considered

            Rapidly evolving leukocytosis

            • About 40% of patients will develop rapidly evolving leukocytosis; those who present with high WBC at diagnosis (ie, >5 x10^9/L) have an increased risk; if signs and symptoms of the RA-APL syndrome are present together with leukocytosis, treatment with high-dose steroids should be initiated immediately
            • Consideration could be given to adding full-dose chemotherapy (including an anthracycline if not contraindicated) to the therapy on day 1 or 2 for patients presenting with a WBC count of >5x109/L, or immediately, for patients presenting with a WBC count of <5x109/L, if WBC count reaches ≥6x109/L by day 5, or ≥10x109/L by day 10, or ≥15x109/L by day 28

            Contraindications

            Hypersensitivity to retinoids, parabens, or formulation components

            Cautions

            Ability to drive or operate machinery might be impaired in patients receiving therapy, particularly if they are experiencing dizziness or severe headache

            Microdosed progesterone oral contraception (“minipill”) may not be adequate for contraception during tretinoin therapy

            Initiation of therapy with may be based on morphological diagnosis of acute promyelocytic leukemia; confirmation of diagnosis of APL should be sought by detection of the t(15;17) genetic marker by cytogenetic studies; if these are negative, 200 PML/RARα fusion should be sought using molecular diagnostic techniques; patients without the t(15;17) translocation genetic marker should be considered for alternative treatment

            Therapy has potentially significant toxic side effects in APL patients; patients undergoing therapy should be closely observed for signs of respiratory compromise and/or leukocytosis; supportive care appropriate for APL patients, eg, prophylaxis for bleeding, prompt therapy for infection, should be maintained during therapy (see Black Box Warnings)

            Leukocytosis may occur (see Black Box Warnings)

            Up to 60% incidence of hypercholesterolemia and/or hypertriglyceridemia, which were reversible upon completion of treatment reported; the clinical consequences of temporary elevation of triglycerides and cholesterol are unknown, but venous thrombosis and myocardial infarction reported in patients who ordinarily are at low risk for such complications

            Elevated liver function test results occur in 50% to 60% of patients during treatment; liver function test results should be carefully monitored during treatment and consideration given to a temporary withdrawal of the drug if test results reach >5 times upper limit of normal values; however, majority of these abnormalities resolve without interruption of therapy or after completion of treatment

            There is risk of thrombosis (both venous and arterial) which may involve any organ system, during first month of treatment; therefore, caution should be exercised when treating patients with combination of tretinoin with anti-fibrinolytic agents, such as tranexamic acid, aminocaproic acid or aprotinin

            Do not coadminister with other retinoids or in combination with vitamin A because symptoms of hypervitaminosis A

            Teratogenic effects

            • There is high risk that a severely deformed infant will result if therapy is administered during pregnancy; if, nonetheless, it is determined that VESANOID represents the available treatment for a pregnant woman or a woman of childbearing potential, it must be assured that patient has received full information and warnings of the risk to the fetus if she were to be pregnant and of the risk of possible contraception failure and has been instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy, and has acknowledged her understanding of need for using dual contraception, unless abstinence is the chosen method
            • Within 1 week prior to institution of therapy, patient should have blood or urine collected for a serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL; when possible, the therapy should be delayed until a negative result from this test is obtained; when a delay is not possible, the patient should be placed on two reliable forms of contraception; pregnancy testing and contraception counseling should be repeated monthly throughout the period of treatment

            Pseudotumor cerebri

            • Retinoids have been associated with pseudotumor cerebri (benign intracranial hypertension), especially in pediatric patients; the concomitant use of other agents known to cause pseudotumor cerebri/intracranial hypertension, such as tetracyclines, might increase risk of this condition
            • Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances; patients with these symptoms should be evaluated for pseudotumor cerebri, and, if present, appropriate care should be instituted in concert with neurological assessment
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            Pregnancy & Lactation

            Pregnancy

            This drug is a retinoid and increased spontaneous abortions and major fetal abnormalities related to the use of retinoids have been documented in humans; reported malformations include abnormalities of the central nervous system, musculoskeletal system, external ear, eye, thymus, and great vessels; and facial dysmorphia, cleft palate, and parathyroid hormone deficiency; some of these abnormalities were fatal; IQ scores less than 85, with or without obvious CNS abnormalities, have been reported in pediatrics exposed to retinoids in utero

            Verify pregnancy status in females of reproductive potential prior to initiating therapy; females of reproductive potential must have a negative pregnancy test within 1 week prior to initiating this medication with a sensitivity of at least 50 mIU/mL

            Based on testicular toxicities observed in dogs, this drug may impair male fertility; the reversibility of effect on fertility is unknown

            Contraception

            • Advise females of reproductive potential to abstain continuously from sexual intercourse or to use two effective methods of contraception; counsel patients to use two effective methods of contraception during treatment and for 1 month after last dose
            • Two methods of effective contraception indicated even where there had been history of infertility, unless due to hysterectomy; refer females of reproductive potential to a qualified provider of contraceptive methods if needed
            • Advise males with female partners of reproductive potential to use effective contraception during and after treatment and for 1 week after last dose

            Animal data

            • Based on findings in animals and its mechanism of action can cause embryo-fetal loss and malformations when administered to a pregnant woman; this drug is a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to retinoids during pregnancy in humans
            • Tretinoin was teratogenic and embryotoxic in mice, rats, hamsters, rabbits and pigtail monkeys at doses less than the human dose on mg/m2 basis; advise pregnant women of potential risk to a fetus
            • The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes

            Lactation

            There are no data on presence of tretinoin in human milk; the effects on breastfeeding child or effects on milk production; because of potential for serious adverse reactions from this drug in breastfed infants, advise women not to breastfeed during treatment with and for 1 week after last dose

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Retinoid, induces differentiation and decreased proliferation of APL cells; produces an initial maturation of promyelocytes, followed by a repopulation of the bone marrow and peripheral blood by normal polyclonal hematopoietic cells in patients achieving complete remission

            Absorption

            Peak plasma time: 1-2 hours

            Peak plasma concentration: 347 ng/mL

            Distribution

            Protein bound: 95%

            Metabolism

            Metabolized by hepatic cytochrome 450

            Metabolites: 13-cis retinoic acid, 4-oxo trans retinoic acid, 4-oxo cis retinoic acid, 4-oxo trans retinoic acid glucuronide

            Elimination

            Half-life: 0.5-2 hours

            Excretion: urine 63%; feces 30%

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Avita topical
            -
            0.025 % gel
            Avita topical
            -
            0.025 % cream
            Avita topical
            -
            0.025 % cream
            Avita topical
            -
            0.025 % gel
            Retin-A topical
            -
            0.01 % gel
            Retin-A topical
            -
            0.01 % gel
            Retin-A topical
            -
            0.025 % gel
            Retin-A topical
            -
            0.025 % gel
            Retin-A topical
            -
            0.1 % cream
            Retin-A topical
            -
            0.05 % cream
            Retin-A topical
            -
            0.025 % cream
            Retin-A topical
            -
            0.1 % cream
            Retin-A topical
            -
            0.05 % cream
            Retin-A topical
            -
            0.025 % cream
            tretinoin topical
            -
            0.01 % gel
            tretinoin topical
            -
            0.1 % cream
            tretinoin topical
            -
            0.1 % cream
            tretinoin topical
            -
            0.05 % cream
            tretinoin topical
            -
            0.025 % gel
            tretinoin topical
            -
            0.01 % gel
            tretinoin topical
            -
            0.025 % cream
            tretinoin topical
            -
            0.025 % cream
            tretinoin topical
            -
            0.05 % cream
            tretinoin topical
            -
            0.1 % cream
            tretinoin topical
            -
            0.025 % gel
            tretinoin topical
            -
            0.05 % cream
            tretinoin topical
            -
            0.1 % cream
            tretinoin topical
            -
            0.05 % gel
            tretinoin topical
            -
            0.025 % cream
            tretinoin topical
            -
            0.025 % cream
            tretinoin topical
            -
            0.1 % cream
            tretinoin topical
            -
            0.05 % cream
            tretinoin topical
            -
            0.05 % cream
            Atralin topical
            -
            0.05 % gel
            Altreno topical
            -
            0.05 % lotion

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            tretinoin topical

            TRETINOIN - TOPICAL

            (tret-ih-NO-in)

            COMMON BRAND NAME(S): Retin-A

            USES: This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Tretinoin belongs to a class of medications called retinoids. It works by affecting the growth of skin cells.

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacistWash your hands before applying this medication. Gently clean the affected skin with a mild or soapless cleanser and pat dry. Use your fingertips to apply a small amount of medication (about the size of a pea) in a thin layer as directed by your doctor, usually once daily at bedtime. A gauze pad or cotton swab can be used to apply the liquid. For some preparations, you should wait 20-30 minutes after cleaning your face before applying this medication. Consult the label directions, the Patient Information Leaflet, or your pharmacist if you have any questions.Use this medication on the skin only. Do not apply to the inner lip area or inside the nose/mouth. Do not apply to cut, scraped, sunburned, or eczema-affected skin.Avoid getting this medication in your eyes. If this medication gets into your eyes, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes.During the first few weeks of using tretinoin, your acne might appear worse because the medication is working on pimples forming inside the skin. It may take up to 8-12 weeks to notice results from this medication.Use it regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not use a larger amount or use it more often than recommended. Your skin will not improve any faster, and it will increase the risk of developing redness, peeling and pain.This medication is available in different strengths and forms (such as gel, cream, solution). The best type of medication for you to use will depend on the condition of your skin and your response to therapy. Tell your doctor if your condition lasts or gets worse.

            SIDE EFFECTS: Warmth or stinging may occur right after applying the medication. Skin redness, dryness, itching, scaling, mild burning, or worsening of acne may occur during the first 2 to 4 weeks of using the medication. These effects usually decrease with continued use. A daytime moisturizer may be helpful for very dry skin (see Notes). If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: blistering/crusting of the skin, severe burning/swelling of the skin, skin discoloration.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before using tretinoin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients (such as fish proteins), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: eczema.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Weather extremes such as wind or cold may also be irritating to the skin. Use sunscreen daily and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Wait until your skin has completely recovered from a sunburn before using tretinoin.Avoid electrolysis, waxing and chemical depilatories for hair removal on the treated areas while using this product.If you have recently used products containing sulfur, resorcinol or salicylic acid, use tretinoin with caution. Wait until the effects of such products on the skin have decreased before using tretinoin.During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also Precautions section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Avoid using other skin products that are harsh, irritating, or drying on the treated area. These products include hair perming solutions, alcohol/lime/menthol-containing products (such as astringents, toners, shaving lotion), medicated or abrasive soaps or cleansers, soaps and cosmetics with a strong drying effect (such as alpha hydroxy acids, glycolic acid), and products containing sulfur, resorcinol, or salicylic acid.Benzoyl peroxide can be very irritating and may decrease the effectiveness of tretinoin if the two products are applied at the same time. Talk with your doctor or pharmacist about the safe use of prescription and non-prescription benzoyl peroxide products.

            OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Cosmetics may be used, but clean skin thoroughly before applying the medication.Some cosmetics and soaps may worsen your acne. Moisturizers may be safe to use. When buying cosmetics, moisturizers or other skin care products, check the label for "non-comedogenic" or "non-acnegenic." These products are unlikely to worsen your acne. Ask your doctor or pharmacist which products are safe to use. Remember, acne is not caused by dirt. Cleaning your skin too often or too vigorously can irritate your skin and worsen acne.

            MISSED DOSE: If you forget to use this medication, use it as soon as you remember if you remember the same day. If you don't remember until morning, wait until your next dose is scheduled.

            STORAGE: Store at room temperature. Gel preparations are flammable. Do not expose to heat or fire sources. Do not smoke during use. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.