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thalidomide |
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thalidomide /tha·lid·o·mide/ (thah-lid´o-mīd) a sedative and hypnotic, commonly used in Europe in the early 1960's, and discovered to cause serious congenital anomalies in the fetus, notably amelia and phocomelia, when taken during early pregnancy; now used in the treatment of erythema nodosum leprosum.
thalidomide [thalid′əmīd] a sedative-hypnotic sometimes prescribed for the treatment of leprosy. It is never given to women who are or who might become pregnant. thalidomide a sedative and hypnotic compound whose use during early pregnancy in women was frequently followed by the birth of infants with phocomelia. thalidomide Warning - Hazardous drug! Thalomid Pharmacologic class: Synthetic glutamic acid derivative Therapeutic class: Immunomodulator, angiogenesis inhibitor Pregnancy risk category X FDA Boxed Warning• When taken during pregnancy, drug may cause severe, life-threatening birth defects or fetal death. Never administer to women who are pregnant or could become pregnant during therapy. Because of its toxicity and to reduce risk of fetal exposure, drug is approved for marketing only under special Food and Drug Administration-approved restricted distribution program, called System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) Only prescribers and pharmacists registered with program are allowed to prescribe and dispense drug. Also, patients must be advised of, agree to, and comply with program requirements. For special information about this distribution program for prescribers and patients, see complete boxed warnings in package insert. ActionSuppresses excess levels of tumor necrosis factor-alpha in patients with erythema nodosum leprosum (ENL). Alters leukocyte migration by changing cell surface characteristics. AvailabilityCapsules: 50 mg, 100 mg, 200 mg ⊘Indications and dosages ➣ Cutaneous manifestations of moderate to severe ENL; to prevent and suppress recurrent ENL Adults weighing 50 kg (110 lb) or more: 100 to 300 mg P.O. daily, or up to 400 mg P.O. daily, depending on disease severity or previous response. Continue therapy until symptoms of active reactions subside (usually after 2 weeks); then may taper in 50-mg decrements q 2 to 4 weeks. Adults weighing less than 50 kg (110 lb): Initially, 100 mg P.O. daily, or up to 400 mg P.O. daily, depending on disease severity or previous response. Continue therapy until symptoms of active reactions subside (usually after 2 weeks); then may taper in 50-mg decrements q 2 to 4 weeks. Off-label uses• Aphthous stomatitis Contraindications• Hypersensitivity to drug or its components PrecautionsUse cautiously in: Administration☞ Follow all instructions provided by System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.?) program, accessible at http://www.steps-info.com.
Adverse reactionsCNS: drowsiness, dizziness, vertigo, sedation, tremor, asthenia, peripheral neuropathy CV: bradycardia, orthostatic hypotension, peripheral edema EENT: rhinitis, sinusitis, pharyngitis GI: nausea, constipation, diarrhea, abdominal pain, oral moniliasis GU: erectile dysfunction Hematologic: neutropenia Musculoskeletal: back pain Skin: exfoliative, purpuric, bullous, or maculopapular rash; pruritus; fungal dermatitis; nail disorder; photosensitivity; toxic epidermal necrolysis, Stevens-Johnson syndrome Other: tooth pain, chills, accidental injury, hypersensitivity reactions, increased HIV viral load, severe birth defects, fetal death InteractionsDrug-drug. Barbiturates, chlorpromazine, reserpine, sedative-hypnotics, and other CNS depressants: increased sedation Drugs linked to peripheral neuropathy: increased risk of peripheral neuropathy Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, lipids, liver function tests: increased values Hemoglobin, neutrophils, white blood cells: decreased values Drug-food. High-fat meal: interference with drug absorption Drug-behaviors. Alcohol use: increased sedation Patient monitoring☞ Monitor for signs and symptoms of hypersensitivity reaction. If rash occurs, discontinue drug and contact prescriber immediately. Don't restart drug if Stevens-Johnson syndrome, toxic epidermal necrolysis, or exfoliative, purpuric, or bullous rash occurs. Patient teaching• Instruct patient to take with 8 oz of water just before bedtime, at least 1 hour after dinner. thalidomide Therapeutics A drug first marketed as a sedative and sleeping aid, which caused 12,000-15,000 cases of embryopathy, often in the form of phocomelia or 'flipper' extremities New indications Thalidomide may be
effective in combating wasting in AIDS Pts–especially with oral ulcers, as well as rheumatoid arthritis, photodermatitis, Behçet's disease, SLE, GVHD, asbestosis, IBD, lepromatous leprosy–erythema nodosum leprosum, possibly TB; it
is antiangiogenic, stops menstruation and may be useful for neoangiogenesis in macular degeneration and diabetic retinopathy. See Angiogenesis inhibitors GI disease Benefits Pts with refractory Crohn's disease, due to TNF-α inhibition
Oncology Thalidomide has orphan drug status for treating refractory myeloma, possibly due to thalidomide's inhibition of angiogenesis and modulation of cytokines; it may be used for Pts with head & neck SCC., and as an ancillary therapy in
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fetal rotation fetal scalp blood pH test fetal souffle fetal stage fetal status: antepartum fetal status: intrapartum fetal tachycardia Fetal thalidomide syndrome Fetal tissue transplantation fetal tobacco syndrome fetal varicella syndrome fetal viability fetal warfarin syndrome fetal wastage fetalization |
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