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BDK Black box/ ON
BDK Black Box Warnings and Other Notes
Question | Answer |
---|---|
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 |