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BDK Black box/ ON

BDK Black Box Warnings and Other Notes

QuestionAnswer
promethazine and codeine (PO)--> Phenergan with Codeine US Boxed Warning: concomitant use of opioids with benzodiazepines or other CNS depressants (including alcohol), may result in profound sedation, respiratory depression, coma, and death Other Notes: opioid-containing cough and cold products no longer indicated for use in patients <18 years of age
codeine and guaifenesin (PO)--> Robitussin AC, Cheratussin AC Other Notes: opioid-containing cough and cold products no longer indicated for use in patients <18 years of age
benzonatate (PO-->Tesslon Perles Other Notes: do not break capsule because it may cause choking
hydroxyzine (PO, IV)--> Atarax, Vistaril Key Side Effects: dizziness, somnolence, xerostomia, blurred vision, QTc prolongation
clobetasol (topical)--> Temovate/Clobex triamcinolone (topical)--> Kenalog Other Notes: do not use for > 2 weeks because it may cause adrenal suppression
tamsulosin (PO)--> Flomax Other Notes: take 30 min after the same meal daily
Tolterodine--> Detrol/ Detrol LA Other Notes: CI in uncontrolled narrow-angle glaucoma
Finasteride--> Proscar/Propecia Dutasteride--> Avodart ON: women who are of child-bearing age should not touch
Phenazopyridine--> Azo Urinary Pain Releif, Pyridium Other notes: may change bodily fluids red/orange
Solifenacin--> Vesicare Other Notes: CI in uncontrolled narrow-angle glaucoma
Oxybutynin--> Ditropan, Ditropan XL Other Notes: CI in uncontrolled narrow-angle glaucoma
calcium gluconate (IV) Other Notes: precipitation occurs with phosphate; do not administer IM; vesicant
magnesium sulfate (IV, IM) Key Side Effect: cardiac arrest (with rapid undiluted IV infusion) Other Notes: dilute before infusion
potassium chloride (PO, IV)--> K-Tab, Klor-Con, Micro-K Key Side Effects (IV): hyperkalemia, cardiac arrest with rapid undiluted infusion Key Side Effects (PO): hyperkalemia, abdominal discomfort/pain, diarrhea, flatulence, nausea, vomiting Other Notes: dilute before infusion; do not administer IV push; vesicant; tablets with wax coating may appear in stool
ergocalciferol (vitamin D2) (PO) Key Side Effects: hypervitaminosis D Other Notes: CI with hypercalcemia
Angiotensin-converting enzyme (ACE) inhibitor US Boxed Warnings: fetal toxicity (CI in pregnancy)
Angiotensin II receptor blocker (ARB) US Boxed Warnings: fetal toxicity (CI in pregnancy)
ARB and neprilysin inhibitor (ARNI) US Boxed Warnings: fetal toxicity (CI in pregnancy)
Loop diuretic US Boxed Warnings: fluid and electrolyte loss
atenolol (PO)--> Tenormin metoprolol tartrate (PO, IV)--> Lopressor US Boxed Warnings: avoid abrupt discontinuation Other Notes: masks symptoms of hypoglycemia
metoprolol succinate (PO)--> Toprol-XL nebivolol (PO)--> Bystolic Other Notes: masks symptoms of hypoglycemia
carvedilol (PO)--> Coreg, Coreg CR abetalol (PO, IV)--> Trandate Other Notes: masks symptoms of hypoglycemia
propranolol (PO)--> Inderal LA, Inderal XL US Boxed Warnings: avoid abrupt discontinuation Other Notes: masks symptoms of hypoglycemia
clonidine (PO, transdermal)--> PO: Catapres, Transdermal: Catapres-TTS US Boxed Warnings: avoid epidural use Other Notes: do not discontinue abruptly; taper to reduce rebound HTN
norepinephrine (IV)--> Levophed US Boxed Warning: extravasation (central line administration preferred)
dabigatran (PO)--> Pradaxa US Boxed Warnings: premature discontinuation increases risk of thrombotic events. Other Notes: swallow whole; dispense and store in original packaging; discard 4 months after opening
apixaban (PO)--> Eliquis rivaroxaban--> Xarelto US Boxed Warnings: premature discontinuation increases risk of thrombotic events
warfarin (PO)--> Coumadin, Jantoven US Boxed Warnings: bleeding risk Other Notes: narrow therapeutic index drug (toxicity may occur at concentrations close to therapeutic range; therapeutic monitoring recommended with INR) Other Notes: dose dependent tablet colors; uniform vitamin K intake recommended; many drug interactions
enoxaparin (SQ)--> Lovenox US Boxed Warnings: increased risk of epidural or spinal hematoma in patient undergoing spinal puncture. Other Notes: do not expel air bubble from syringe prior to injection
clopidogrel (PO)--> Plavix US Boxed Warnings: diminished effectiveness in poor metabolizers
prasugrel (PO)--> Effient US Boxed Warnings: bleeding risk Other Notes: CI in patients with history of stroke
alteplase (intracatheter, IV)--> Intracatheter: Cathflo, IV: Activase Other Notes: CI in patients with severe uncontrolled HTN
amiodarone (PO, IV)--> Pacerone, Nexterone US Boxed Warnings: life-threatening arrhythmias, pulmonary toxicity, hepatotoxicity Other Notes: many drug interactions
digoxin (PO, IV)--> Digitek, Digox, Lanoxin Other Notes: narrow therapeutic index drug (toxicity may occur at concentrations close to therapeutic range; therapeutic drug monitoring is recommended); signs of toxicity include nausea, vomiting and visual changes; many drug interactions
HMG-CoA reductase inhibitors (STATINS) Key Side Effects: myopathy/rhabdomyolysis Other Notes: avoid excessive grapefruit juice intake, avoid in pregnancy and breastfeeding
Inhaled corticosteroid (ICS) Other Notes: rinse mouth with water and spit to prevent Candida infection
Inhaled corticosteroid (ICS) and long-acting beta2 agonist (LABA) Other Notes: rinse mouth with water and spit to prevent Candida infection
theophylline (PO)--> Theo-24, Theochron Other Notes: narrow therapeutic index drug (toxicity may occur at concentrations close to therapeutic range; therapeutic drug monitoring is recommended); may cause seizures and cardiac arrhythmias at high concentrations
montelukast (PO)--> Singulair US Boxed Warning: risk of serious neuropsychiatric effects (i.e., serious behavior and mood-related changes, including suicidal thoughts and actions)
amoxicillin and clavulanate (PO)--> Augmentin, Augmentin XR Other Notes: various ratios of amoxicillin and clavulanate available
Fluoroquinolone antibiotics (3) USBW: may cause serious adverse reactions including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects; may exacerbate muscle weakness in patients with myasthenia gravis ON: take oral fluoroquinolones 2 hours before or 6 hours after products containing divalent or trivalent cations (i.e., dairy products, calcium-fortified juices, oral MV, mineral supplements); increased risk of aortic dissection or rupture, dysglycemias, CNS side effects (i.e., disorientation and delirium)
Tetracycline antibiotic (2) Other Notes: may cause permanent gray-brown discoloration of teeth and/or enamel hypoplasia when given to children; take oral tetracyclines 2 hours before or 6 hours after products containing divalent or trivalent cations (i.e., dairy products, calcium-fortified juices, oral multivitamins, mineral supplements)
fidaxomicin (PO)--> Dificid Other Notes: do not use for systemic infections (no systemic absorption)
clindamycin (PO, IV)--> Cleocin US Boxed Warnings: Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis
sulfamethoxazole and trimethoprim (PO, IV)--> Bactrim, Bactrim DS Other Notes: fixed ratio (5:1) of sulfamethoxazole and trimethoprim; dosing based on trimethoprim component
ketoconazole (PO, topical)--> Nizoral US Boxed Warnings: serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation, have occurred; may cause QTc prolongation and drug interactions leading to QTc prolongation
betamethasone and clotrimazole (topical)--> Lotrisone Other Notes: do not use for diaper dermatitis; adrenal suppression with long-term use over large areas of skin
hydroxychloroquine (PO)--> Plaquenil Other Notes: use has been associated with cardiomyopathy, bone marrow suppression, and neuromuscular effects (i.e., myopathy, palsies, and progressive weakness)
NSAIDS US Boxed Warnings: may increase the risk of serious (and potentially fatal) cardiovascular thrombotic events, MI, and stroke; may increase the risk for serious (and potentially fatal) gastrointestinal adverse events including ulceration, bleeding, and perforation US Boxed Warning (only for ketorolac): indicated for short term use (≤ 5 days) Other Notes: may reduce renal blood flow and compromise existing renal function (avoid in patients with renal disease, heart failure, and cirrhosis)
cyclobenzaprine (PO)--> Flexeril Other Notes: use may cause prolonged cardiac arrhythmias, and tachycardia; CI within 14 days of MAOI inhibitor therapy
carisoprodol (PO)--> Soma Other Notes: drug abuse potential (carisoprodol only)
lidocaine (transdermal *, IV)--> Transdermal: Lidoderm, IV: Xylocaine Key Side Effects (IV): bradycardia Other Notes: patch may remain in place for up to 12 hours in any 24-hour period, patch may be cut
allopurinol (PO)--> Zyloprim Other Notes: rare association with severe (and potentially fatal) allopurinol hypersensitivity syndrome (risk highest in certain Asian populations)
succinylcholine (IV)--> Anectine US Boxed Warning: acute rhabdomyolysis and hyperkalemia leading to cardiac arrest and death in pediatric patients with undiagnosed skeletal muscle disease
metformin (PO)--> Glucophage, Glucophage XR US Boxed Warnings: lactic acidosis
pioglitazone (PO)--> Actos US Boxed Warnings: may exacerbate congestive heart failure and CI in NYHA Class III and IV
liraglutide (SQ)--> Victoza, Saxenda US Boxed Warnings: may increase risk of thyroid c-cell tumor
Thyroid products: Levothyroxine--> (Synthroid/ Levoxyl Thyroid, dessicated (PO)--> Armour Thyroid US Boxed Warnings: not intended for use for weight loss Other Notes: narrow therapeutic index drug (therapeutic monitoring is recommended); not all generic products are therapeutically equivalent
Contraceptives US Boxed Warnings: increased risk of cardiovascular events in women >35 years old who smoke Other Notes: CI in hepatic dysfunction, thromboembolic disorders, breast cancer, and cardiovascular disease
Estrogen derivatives: estrogens, conjugated (equine) (PO, topical)-->Premarin estradiol (transdermal, PO)--> Transdermal: Vivelle Dot, PO: Estrace US Boxed Warnings: increased risk of breast cancer; should not be used for dementia prevention; increased risk of endometrial cancer if not used concomitantly with progestin in women with a uterus; should not be used for prevention of cardiovascular disease Other Notes: CI in hepatic dysfunction, thromboembolic disorders, cardiovascular disease, breast cancer, and estrogen-dependent tumor
medroxyprogesterone (PO)--> Provera US Boxed Warnings: increased risk of breast cancer; should not be used for dementia prevention; should not be used for prevention of cardiovascular disease Other Notes: CI in thromboembolic disorders, cardiovascular disease, estrogen or progesterone-dependent tumors, undiagnosed abnormal genital bleeding, hepatic impairment
testosterone gel (topical)--> AndroGel, Fortesta, Vogelxo US Boxed Warnings: secondary exposure may result in virilization (especially in children); CI in males with breast or prostate cancer and pregnant women
alendronate (PO)--> Fosamax Other Notes: CI in patients with abnormalities of the esophagus; administer ≥30 minutes before food or drink (except plain water); remain upright for 30 minutes following dose to reduce esophageal irritation
ibandronate (PO, IV)--> Boniva Other Notes (oral only): CI in patients with abnormalities of the esophagus; administer ≥60 minutes before food or drink (except plain water); remain upright for 60 minutes following dose to reduce esophageal irritation
raloxifene (PO)--> Evista US Boxed Warnings: increased risk of thromboembolism; increased risk of death caused by stroke in patients with cardiovascular disease
Phosphodiesterase-5 enzyme (PDE5) inhibitors (2) Other Notes: CI with concomitant use of nitrates (may cause severe hypotension)
mirtazapine (PO)--> Remeron US Boxed Warnings: increased risk of suicidal thinking and behavior in children, adolescents, and young adults
bupropion (PO)--> Wellbutrin SR, Wellbutrin XL US Boxed Warnings: increased risk of suicidal thinking and behavior in children, adolescents, and young adults; serious neuropsychiatric reactions have occurred Other Notes: use may increase risk of seizures (CI in patients with seizure disorders and/or eating disorders)
atomoxetine (PO)--> Strattera US Boxed Warnings: increased risk of suicidal ideation in children or adolescents Other Notes: CI within 14 days of MAOI; do not discontinue abruptly
SNRI's and SSRI's US Boxed Warnings: increased risk of suicidal thinking and behavior in children, adolescents, and young adults Other Notes: CI within 14 days of MAOI; do not discontinue abruptly
trazodone (PO)--> Desyrel US Boxed Warnings: antidepressants increase the risk of suicidal thinking and behavior in children, adolescents and young adults
vilazodone (PO)--> Viibryd US Boxed Warnings: increased risk of suicidal thinking and behavior in children, adolescents, and young adults
amitriptyline (PO)--> Elavil nortriptyline (PO)--> Pamelor US Boxed Warnings: increased risk of suicidal thinking and behavior in children, adolescents, and young adults Other Notes: CI within 14 days of MAOI; do not discontinue abruptly
doxepin (PO)--> Silenor Key Side Effects: somnolence, sedation, nausea Other Notes: CI within 14 days of MAOI; do not discontinue abruptly
CNS Stimulants US Boxed Warnings: high potential for abuse
carbidopa and levodopa (PO)--> Sinemet, Sinemet CR Key Side Effects: nausea, orthostatic hypotension, DYSKINESIAS Other Notes: CI within 14 days of MAOI, CI in narrow-angle glaucoma
lithium (PO)--> Lithobid Key Side Effects: tremor, acne, HYPOTHYROIDISM, weight gain, POLYURIA, POLYDIPSIA US Boxed Warnings: ability to promptly monitor levels is necessary Other Notes: narrow therapeutic index drug (toxicity may occur at concentrations close to therapeutic range; therapeutic drug monitoring is recommended)
sumatriptan (PO, intranasal, SQ)--> Imitrex Other Notes: CI in ischemic heart disease, history of stroke or TIA, peripheral vascular disease, and uncontrolled hypertension
haloperidol (PO, IV, IM)--> Haldol Key Side Effects: sedation, EPS, PARKINSONISM, xerostomia, orthostatic hypotension, weight gain, QTc prolongation US Boxed Warnings: elderly patients with dementia-related psychosis treated with antipsychotic drugs at increased risk of death
clozapine (PO)--> Clozaril US Boxed Warnings: may cause SEVERE NEUTROPENIA; may cause orthostatic hypotension, bradycardia, and syncope; may cause seizures; may cause fatal myocarditis and cardiomyopathy; elderly patients with dementia-related psychosis treated with antipsychotic drugs at increased risk of death Other Notes: risk of neutropenia requires monitoring of absolute neutrophil count (ANC) to receive prescription
aripiprazole (PO, IM)--> Abilify quetiapine (PO)--> Seroquel, Seroquel XR US Boxed Warnings: antidepressants increase the risk of suicidal thinking and behavior in children, adolescents and young adults; elderly patients with dementia-related psychosis treated with antipsychotic drugs at increased risk of death
olanzapine (PO, IM)-->Zyprexa risperidone (PO, IM)--> Risperdal (PO). Risperdal Consta (IM) ziprasidone (PO, IM)--> Geodon US Boxed Warnings: elderly patients with dementia-related psychosis treated with antipsychotic drugs at increased risk of death
carbamazepine (PO)--> Tegretol US Boxed Warnings: risk of serious dermatologic reactions (including SJS and TEN) in patients with certain genetic predisposition; may cause aplastic anemia and agranulocytosis
lamotrigine (PO)--> Lamictal US Boxed Warnings: risk of serious dermatologic reactions, including SJS
divalproex (valproic acid derivative) (PO)--> Depakote, Depakote ER, Depakene Key Side Effects: drowsiness, weight gain, tremor, hair loss, THROMBOCYTOPENIA US Boxed Warnings: may cause fatal hepatic failure; may cause life-threatening pancreatitis; fetal toxicity
phenytoin (PO, IV)--> Dilantin Key Side Effects: somnolence, dizziness, GINGIVAL HYPERPLASIA, HIRSUTISM, risk of SJS US Boxed Warning: cardiovascular risk with rapid infusion Other Notes: narrow therapeutic index drug (toxicity may occur at concentrations close to therapeutic range; therapeutic drug monitoring is recommended)
Benzodiazepines Key Side Effects: daytime sedation, performance impairment, tolerance, dependence, ANTEROGRADE AMNESIA, withdrawal US Boxed Warning: risk of profound sedation, respiratory depression, coma and death with opioids; risk of abuse, misuse, and addiction; risk of dependence and withdrawal reactions Other Notes (lorazepam IV only): parenteral formulation contains propylene glycol and may be associated with toxicity if used ≥ 48 hours
Hypnotics (2) US Boxed Warning: serious injuries, including death, have occurred because of complex sleep behaviors (i.e., sleepwalking, sleep driving, and engaging in other activities while not fully awake); contraindicated in patients with history of complex sleep behaviors Anterograde Amneisa (Zolpidem)
dicyclomine (PO)--> Bentyl Other Notes: Caution in cardiovascular disease, hepatic impairment, renal impairment, and hyperthyroidism
lubiprostone (PO)--> Amitiza Other Notes: CI in known or suspected gastrointestinal obstruction
Corticosteroids (5) Key Side Effects: hyperglycemia, increased appetite with weight gain, depression, irritability, osteoporosis (chronic use), CUSHING'S SYNDROME (chronic use) Other Notes: risk of adrenal suppression with prolonged use
metoclopramide (PO, IV)--> Reglan US Boxed Warnings: may cause tardive dyskinesia
prochlorperazine (PO, PR, IM, IV)--> Compazine US Boxed Warnings: increased risk of death in elderly patients with dementia-related psychosis Other Notes: do not administer IV push
promethazine (PO, IM, IV, PR)--> Phenergan US Boxed Warnings: potential for fatal respiratory depression in patients < 2 years old; injection can cause peripheral extravasation (preferred parenteral route is IM)
Proton pump inhibitors (PPI) Key Side Effects: abdominal pain, nausea, diarrhea, bone fracture, vitamin B12 deficiency, hypomagnesemia US Boxed Warnings: increased risk of Clostridioides difficile infection
Opioid Analgesiscs USBW:(all opioid analgesics): risk of opioid addiction,abuse,and misuse which can lead to ODand death; serious,life-threatening, or fatal res. depression may occur; accidental ingestion may result in fatal OD; prolonged use in pregnancy may result in neonatal opioid withdrawal syndrome; abrupt discontinuation may result in serious opioid induced withdrawal syndrome; concomitant use of opioids with benzo or CNS depressants (including alcohol), may result in profound sedation, res. depression, coma, and death
methadone (PO, IV)--> Dolophine US Boxed Warnings (only for methadone): QTc interval prolongation and serious arrhythmia (Torsades de Pointes) have occurred during treatment
acetaminophen (PO, PR, IV) *--> PO/PR: Tylenol, IV: Ofirmev US Boxed Warnings: total daily dose from all sources should not exceed maximum daily limit; hepatotoxicity
tramadol (PO)--> Ultram, Ultram ER US Boxed Warnings: serious or fatal respiratory depression may occur Other Notes: lowers seizure threshold
naloxone (IV, IM, SQ, intranasal)-->Narcan buprenorphine and naloxone (SL)--> Suboxone Key Side Effects: headache, opioid withdrawal syndrome in opioid dependent populations, pain, diaphoresis Other Notes: potentially life-threatening respiratory depression (when combined with other CNS and respiratory depressants); addition of naloxone to buprenorphine reduces possibility of parenteral misuse by producing opioid withdrawal symptoms when injected
methotrexate (PO)--> Trexall serious toxic rxns: only use in life-threatening neoplastic disease; severe psoriasis, or severe RA; may cause fata death and/or congenital abnormalities (avoid in pregnancy); severe bone marrow supp. aplastic anemia, and toxicity have been reported with concomitant admin of methotrexate and NSAIDS; hepatoxicity; methotrexate-induced lung disease; acute/chronic interstitial pneumonitis; severe GI toxicity with NSAIDS ON: Folic acid may be taken to reduce hematologic/GI/ hepatic SE
anastrozole (PO)--> Arimidex Other Notes: cardiovascular side effects (i.e., hypercholesterolemia, CAD); fetal toxicity (CI in pregnancy)
phentermine (PO)--> Adipex-P Key Side Effects: hypertension, nausea, dizziness, xerostomia, primary pulmonary hypertension (rare) Other Notes: only approved for short-term use; CI in those with a history of cardiovascular disease or drug abuse, pregnancy, hyperthyroidism, or within 14 days of MAOI inhibitor therapy
ferrous sulfate (PO) *--> FeroSul, SlowFe Boxed Warning: Accidental overdose of iron is leading cause of fatal poisoning in children under 6 years old Key Side Effects: nausea, stomach upset, constipation (dose-related), dark and tarry stools
Created by: Xander635
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