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Pharmacologic class: Retinoid
Therapeutic class:乐动体育开户 Antineoplastic, dermatologic agent (topical)
Pregnancy risk category C (topical), D (oral)
FDA Box Warning
• Patients with acute promyelocytic leukemia (APL) are at high risk in general and may have severe adverse reactions. Give drug under supervision of physician experienced in managing patients with acute leukemia, in facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain patient compromised by drug toxicity.
乐动体育开户• Before using drug, physician must conclude that possible benefit to patient outweighs the following known adverse effects:
• Retinoic acid-APL (RA-APL syndrome), which may be accompanied by impaired myocardial contractility, hypotension, and progressive hypoxemia. Several patients have died with multiorgan failure. Syndrome generally occurs during first month of therapy (in some cases, after first dose).
• Leukocytosis at presentation or evolving rapidly during drug therapy. Patients with high white blood cell (WBC) at diagnosis (above 5 × 109/L) have increased risk of further rapid rise in WBC counts. Rapidly evolving leukocytosis raises risk of life-threatening complications.
• Teratogenic effects. Drug therapy during pregnancy carries high risk of severe birth defects. Nonetheless, if drug is best available treatment for pregnant woman or woman of childbearing potential, ensure that she has received full information and warnings of risk to fetus and of risk of possible contraception failure, and has been taught to use two reliable contraceptive methods simultaneously during therapy and for 1 month afterward.
Unknown. Thought to cause differentiation of promyelocytic leukemic blast cells, leading to apoptosis (cell shrinkage and death) and cancer remission.
Capsules: 10 mg
Topical cream: 0.02%, 0.025%, 0.05%, 0.1%
Topical gel:乐动体育开户 0.01%, 0.025%, 0.04%, 0.1%
Indications and dosages
➣ APL when anthracycline chemotherapy fails or is contraindicated
Adults and children ages 1 and older: 45 mg/m2乐动体育开户/day P.O. in two evenly divided doses. Discontinue after 90 days of therapy or 30 days after complete remission occurs, whichever comes first.
➣乐动体育开户 Acne vulgaris
Adults:乐动体育开户 Apply Avita cream, Retin-A cream gel, or Retin-A Micro gel daily before bedtime or in evening. Cover entire affected area lightly.
➣ Adjunct for mitigating fine wrinkles in patients who use comprehensive skin care and sun avoidance programs
Adults: Apply Renova 0.02% cream to face daily in evening for up to 52 weeks, using only enough to lightly cover entire affected area.
➣乐动体育开户 Adjunct for mitigating fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin when comprehensive skin care and sun avoidance programs alone fail
Adults ages 50 and younger: Apply Renova 0.05% cream to face daily in evening for up to 48 weeks, using only enough to lightly cover entire affected area.
• Hypersensitivity to drug or parabens
乐动体育开户• Pregnancy or breastfeeding (oral use)
乐动体育开户Use cautiously in:
乐动体育开户• eczema, sunburn, photosensitivity
乐动体育开户• concurrent use of over-the-counter (OTC) acne products or abrasive soaps or cleansers with strong drying effects or high alcohol or lime content (with all topical forms)
• concurrent use of astringents, spices, permanent wave solutions, electrolysis, hair depilatories or waxes, or photosensitizing drugs (such as fluoroquinolones, phenothiazines, tetracyclines, thiazides)
乐动体育开户• heavily pigmented, elderly, pregnant, or breastfeeding patients (safety and efficacy not established for topical use)
乐动体育开户• children younger than age 1 for oral use or younger than age 18 for topical use (safety and efficacy not established).
• Verify that female patient has had required pregnancy test before P.O. therapy starts.
• Know that Renova topical cream isn't indicated for acne vulgaris, and that other topical forms are indicated only for acne vulgaris. Also know that some absorption of topical products occurs.
CNS: dizziness, headache, asthenia, paresthesia, confusion, agitation, hallucinations, anxiety, aphasia, depression, agnosia, insomnia, asterixis, cerebellar edema, hypotaxia, drowsiness, slow speech, facial paralysis, hemiplegia, hyporeflexia, hypotaxia, dementia, spinal cord disorder, tremors, dysarthria, cerebrovascular accident (CVA), coma, seizures, intracranial hypertension, cerebral hemorrhage
CV: heart murmur, chest discomfort, peripheral edema, hypertension, hypotension, phlebitis, edema, enlarged heart, ischemia, arrhythmias, secondary cardiomyopathy, myocarditis, myocardial infarction (MI), heart failure, pericardial effusion, impaired myocardial contractility, progressive hypoxemia
EENT: vision disturbances, visual acuity changes, visual field defect, absence of light reflex, hearing loss, earache, full sensation in ears
GI: nausea, vomiting, constipation, diarrhea, abdominal pain and distention, GI disorders, mucositis, dyspepsia, ulcer, anorexia, GI hemorrhage
GU: dysuria, urinary frequency, enlarged prostate, renal insufficiency, renal tubular necrosis, acute renal failure
Hematologic: leukocytosis, disseminated intravascular coagulation (DIC), hemorrhage
Hepatic: ascites, hepatosplenomegaly, hepatitis
Metabolic: fluid imbalance, acidosis
Musculoskeletal:乐动体育开户 bone pain or inflammation, myalgia, flank pain
Respiratory: respiratory tract disorders, dyspnea, expiratory wheezing, crackles, pneumonia, laryngeal edema, pulmonary infiltrates, pleural effusion, bronchial asthma, pulmonary hypertension
Skin: rash; pallor; flushing; diaphoresis; alopecia; dry skin and mucous membranes; skin changes; pruritus; cellulitis; burning, erythema, peeling, and stinging (with topical use)
Other: weight changes, fever, lymphatic disorder, hypothermia, infections, facial edema, pain, RA-APL syndrome, multisystem failure, septicemia
Drug-drug. Photosensitizing drugs (such as fluoroquinolones, phenothiazines, tetracyclines, thiazides): increased risk of photosensitivity reaction (with topical forms)
Drug-diagnostic tests. Cholesterol, triglycerides: increased levels
Drug-food. Any food: enhanced tretinoin absorption
Drug-behaviors. Sun exposure:乐动体育开户 increased risk of photosensitivity
☞乐动体育开户 Watch closely for septicemia, multisystem failure, and retinoic acid-APL syndrome (which causes pulmonary and pericardial effusion, fever, weight gain, and dyspnea).
☞乐动体育开户 Monitor for significant adverse CNS reactions, including seizures, CVA, and cerebral hemorrhage.
☞ Monitor cardiovascular status. Stay alert for signs and symptoms of arrhythmias, MI, and heart failure.
☞ Closely monitor liver and kidney function tests. Watch for evidence of hepatitis and renal failure.
☞ Monitor coagulation studies. Watch closely for DIC and hemorrhage.
• Evaluate respiratory status. Stay alert for indications of pulmonary hypertension and respiratory insufficiency.
• Frequently assess lipid panel and CBC with white cell differential.
乐动体育开户• Instruct patient to take oral doses with food.
☞ Teach patient to recognize and immediately report serious adverse reactions.
• Tell patient he will undergo regular blood testing during oral therapy.
• Instruct patient using topical form to gently wash face with mild soap, pat skin dry, and then wait 20 to 30 minutes before applying. Advise him to apply to face in evening, using only enough to cover entire affected area lightly and only for prescribed duration.
• Caution patient to avoid OTC acne drugs and extreme weather conditions (such as wind and cold). Urge him to adhere to prescribed skin care and sunlight avoidance programs when using topical form.
乐动体育开户• Tell patient using topical form that transient burning, erythema, peeling, pruritus, and stinging may occur. Advise him to notify prescriber if these symptoms become severe.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.