Effect of medications on Speaking, Hearing and [Autosaved] · 2/26/2015 3 Hepatic: Abnormal hepatic...

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EFFECT OF MEDICATIONS ON SPEAKING, HEARING AND SWALLOWINGLinda Hughes, Pharm.D, BCPS, BCACP

Public Service Assistant

University of Georgia

Colleges of Pharmacy and Education

DISCLOSURE

I have no relevant financial or nonfinancial relationship(s) within the products or services described, reviewed, evaluated or compared in this presentation.

OBJECTIVES

Understand basic principles of pharmacology

Identify medications with negative side effects on hearing, swallowing, speech and cognition

Identify medications used to treat ototoxicity, vestibular toxicity and tinnitus

Use medication knowledge to positively impact a patient’s therapeutic plan

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METHYLPHENIDATE (CONCERTA)

Attention Deficit Hyperactivity Inattention

Hyperactivity and Impulsivity

Mixed

Central nervous system: Headache (adults 22%; children & adolescents 12%), insomnia (3% to 12%),

emotional lability (children 9%, adults 1%), anxiety (8%), dizziness (adults 7%; children & adolescents 2%), nervousness (3%), restlessness (3%), aggressive behavior (2%), agitation (2%), depression (2%), vertigo (2%), vocal tics (children 2%), confusion (1%), paresthesia (1%), tension (1%), cerebral arteritis, cerebral hemorrhage, drowsiness, fatigue, Gilles de la Tourette's syndrome (rare), hypertonia, hypervigilance, irritability, lethargy, neuroleptic malignant syndrome (rare), outbursts of anger, toxic psychosis

Lexicomp; Methylphenidate Monograph, accessed 2-23-2015

METHYLPHENIDATE (CONCERTA) Cardiovascular: Tachycardia (5%), palpitations (3%), angina pectoris, cardiac

arrhythmia, cerebrovascular accident, cerebrovascular occlusion, decreased pulse, heart murmur, hypertension, hypotension, increased pulse, myocardial infarction, necrotizing angitis, Raynaud’s phenomenon, vasculitis

Dermatologic: Hyperhidrosis (5%), excoriation (children 4%), skin rash (children 2%), alopecia, erythema multiforme, exfoliative dermatitis, urticaria

Endocrine & metabolic: Weight loss (7%), decreased libido (2%), growth suppression

Gastrointestinal: Decreased appetite (adults 25%; children 2%), xerostomia (14%), nausea (13%), anorexia (children & adolescents 9%; adults 2%), abdominal pain (children & adolescents 6% to 7%), vomiting (2% to 7%), bruxism (2%), dyspepsia (2%), motion sickness (children 2%), constipation (1%), diarrhea

Genitourinary: Dysmenorrhea, erectile dysfunction Hematologic & oncologic: Anemia, immune thrombocytopenia, leukopenia,

pancytopenia, thrombocytopenia


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Hepatic: Abnormal hepatic function tests, hepatic coma, increased serum bilirubin, increased serum transaminases

Hypersensitivity: Hypersensitivity reaction

Neuromuscular & skeletal: Tremor (3%), arthralgia, dyskinesia

Ophthalmic: Blurred vision (2%), eye pain (children 2%), accommodation disturbance, dry eye syndrome, mydriasis

Respiratory: Upper respiratory tract infection (2%), dyspnea, increased cough, pharyngitis, pharyngolaryngeal pain, rhinitis, sinusitis

Miscellaneous: Fever (children & adolescents 2%), accidental injury

Post marketing and/or case reports: Bradycardia, change in libido, chest pain, decreased visual acuity, diplopia, disorientation, erythema, extrasystoles, hallucination, increased serum alkaline phosphatase, mania, migraine, muscle twitching, myalgia, obsessive-compulsive disorder, peripheral vascular insufficiency, priapism, seizure, supraventricular tachycardia, talkativeness, ventricular premature contractions


GABAPENTIN (NEURONTIN)

Uses Seizures

Post – herpetic neuralgia (Shingles)

Neuropathic pain

Diabetic peripheral neuropathy

Fibromyalgia

Post-operative pain (adjunct)

Restless leg syndrome

Hot Flashes

Side Effects >10%: Central nervous system: Dizziness

(IR: 17% to 28%; children 3%; Gralise: 11%), drowsiness (IR: 19% to 21%; children 8%; Gralise: 5%), ataxia (1% to 13%), fatigue (11%; children 3%)

Infection: Viral infection (children 11%)

Lexicomp; Gabapentin Monograph, accessed 2-19-2015

1% to 10%: Cardiovascular: Peripheral edema (IR: 2% to 8%; Gralise: 4%), vasodilatation (1%) Central nervous system: Hostility (children 5% to 8%), tremor (7%), emotional lability

(children 4% to 6%), hyperkinesia (children 3% to 5%), headache (Gralise: 4%; IR: 3%), abnormality in thinking (2% to 3%; children 2%), abnormal gait (2%), amnesia (2%), depression (2%), nervousness (2%), pain (Gralise: 1% to 2%), hyperesthesia (1%), lethargy (Gralise: 1%), twitching (1%), vertigo (Gralise: 1%)

Dermatologic: Pruritus (1%), skin rash (1%) Endocrine & metabolic: Weight gain (IR: Adults and children 2% to 3%; Gralise: 2%),

hyperglycemia (1%) Gastrointestinal: Diarrhea (IR: 6%; Gralise: 3%), nausea and vomiting (3% to 4%; children

8%), xerostomia (IR: 2% to 5%; Gralise: 3%), constipation (IR: 1% to 4%; Gralise: 1%), abdominal pain (3%), dyspepsia (IR: 2%; Gralise: 1%), dry throat (2%), dental disease (2%), flatulence (2%), increased appetite (1%)

Genitourinary: Impotence (2%), urinary tract infection (Gralise: 2%) Hematologic & oncologic: Decreased white blood cell count (1%), leukopenia (1%) Infection: Infection (5%) Neuromuscular & skeletal: Weakness (6%), back pain (IR: 2%; Gralise: 2%), dysarthria (2%),

limb pain (Gralise: 2%), myalgia (2%), bone fracture (1%) Ophthalmic: Nystagmus (8%), diplopia (1% to 6%), blurred vision (3% to 4%), conjunctivitis

(1%) Otic: Otitis media (1%) Respiratory: Rhinitis (4%), bronchitis (children 3%), nasopharyngitis (Gralise: 3%),

respiratory tract infection (children 3%), pharyngitis (1% to 3%), cough (2%) Miscellaneous: Fever (children 10%)


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Postmarketing and case reports: Acute renal failure, altered serum glucose, anemia, angina pectoris,

angioedema, aphasia, aspiration pneumonia, blindness, blood coagulation disorder, bradycardia, brain disease, breast hypertrophy, bronchospasm, cardiac arrhythmia (various), cardiac failure, cerebrovascular accident, CNS neoplasm, colitis, confusion, Cushingoid appearance, DRESS syndrome, drug abuse, drug dependence, dyspnea, erythema multiform, facial paralysis, fecal incontinence, gastroenteritis, glaucoma, glycosuria, hearing loss, heart block, hematemesis, hematuria, hemiplegia, hemorrhage, hepatitis, hepatomegaly, herpes zoster, hyperlipidemia, hypertension, hyperthyroidism, hyperventilation, hyponatremia, hypotension, hypothyroidism, hypoventilation, increased creatine phosphokinase, increased liver enzymes, increased serum creatinine, jaundice, joint swelling, leukocytosis, lymphadenopathy, lymphocytosis, memory impairment, meningism, migraine, movement disorder, myocardial infarction, myoclonus (local), nephrolithiasis, nephrosis, nerve palsy, non-Hodgkin's lymphoma, ovarian failure, palpitations, pancreatitis, paresthesia, peptic ulcer, pericardial effusion, pericardial rub, pericarditis, peripheral vascular disease, pneumonia, psychosis, pulmonary thromboembolism, purpura, retinopathy, rhabdomyolysis, seasonal allergy, skin necrosis, status epilepticus, Stevens-Johnson syndrome, subdural hematoma, suicidal ideation, suicidal tendencies, syncope, tachycardia, thrombocytopenia, thrombophlebitis, tumor growth, withdrawal syndrome


CITALOPRAM (CELEXA)

Uses

Major Depressive Disorder Binge Eating Disorder Generalized Anxiety Disorder Panic Disorder Social Phobia Hot Flashes Obsessive Compulsive

Disorder Pathological Gambling

Alcohol Dependence

Premenstrual Dysphoric Disorder

Premature Ejaculation

Diabetic Neuropathy

Lexicomp; Citalopram Monograph, accessed 2-19-2015

Side Effects >10%: Central nervous system: Somnolence (18%; dose related), insomnia (15%; dose related)

Gastrointestinal: Nausea (21%), xerostomia (20%)

Miscellaneous: Diaphoresis (11%; dose related)

Side Effects 1-10%: Cardiovascular: QT prolongation (2%), hypotension (≥1%), orthostatic hypotension (≥1%),

tachycardia (≥1%), bradycardia (1%)

Central nervous system: Fatigue (5%; dose related), anxiety (4%), agitation (3%), fever (2%), yawning (2%; dose related), amnesia (≥1%), apathy (≥1%), concentration impaired (≥1%), confusion (≥1%), depression (≥1%), migraine (≥1%), suicide attempt (≥1%)

Dermatologic: Rash (≥1%), pruritus (≥1%)

Endocrine & metabolic: Libido decreased (1% to 4%), dysmenorrhea (3%), amenorrhea (≥1%)

Gastrointestinal: Diarrhea (8%), dyspepsia (5%), anorexia (4%), vomiting (4%), abdominal pain (3%), appetite increased (≥1%), flatulence (≥1%), salivation increased (≥1%), taste perversion (≥1%), weight gain/loss (≥1%)

Genitourinary: Ejaculation disorder (6%), impotence (3%; dose related), polyuria (≥1%)

Neuromuscular & skeletal: Tremor (8%), arthralgia (2%), myalgia (2%), paresthesia (≥1%)

Ocular: Abnormal accommodation (≥1%)

Respiratory: Rhinitis (5%), upper respiratory tract infection (5%), sinusitis (3%), cough (≥1%)


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<1%, post marketing, and/or case reports: Acne, aggressiveness, akathisia, alkaline phosphatase increased, allergic reaction, allergic rhinitis, alopecia, anal itching, anaphylaxis, angioedema, anemia, angina pectoris, arthritis, asthma, ataxia, atrial fibrillation, bilirubinemia, bleeding gums, breast enlargement, breast pain, bronchitis, bronchospasm, bruising, bruxism, bundle branch block, bursitis, cardiac arrest, cardiac failure, cataracts, catatonia, cellulitis, cerebrovascular accident, cholecystitis, cholelithiasis, choreoathetosis, coagulation abnormalities, colitis, conjunctivitis, coordination abnormal, dehydration, delirium, delusions, dependence, depersonalization, dermatitis, diplopia, diverticulitis, dry eyes, dry skin, duodenal ulcer, dyskinesia,dysphagia, dyspnea, dystonia, dysuria, eczema, emotional lability, epidermal necrolysis, epistaxis, eructation, erythema multiforme, esophagitis, euphoria, extrapyramidal symptoms, extrasystoles, eye pain, facial edema, flu-like syndrome, flushing, gait instability, galactorrhea, gastric ulcer, gastritis, gastroenteritis, gastroesophageal reflux, gastrointestinal hemorrhage, gingivitis, glaucoma, glossitis, glucose tolerance abnormal, goiter, granulocytopenia, gynecomastia, hallucinations, hematuria, hemorrhoids, hemolytic anemia, hepatic necrosis, hepatitis, hiccups, hot flashes, hyper-/hypoesthesia, hyper-/hypokinesia, hyperpigmentation, hypertension, hypertonia, hypertrichosis, hypochromic anemia, hypoglycemia, hypokalemia, hyponatremia, hypothyroidism, involuntary muscle movement, jaundice, keratitis, lacrimation abnormal, laryngitis, leg cramps, libido increased, leukocytosis, leukopenia, liver enzymes increased, lymphadenopathy, lymphocytosis, lymphopenia, muscle weakness, myocardial infarction, myocardial ischemia, mydriasis, myoclonus, neuralgia, neuroleptic malignant syndrome, nightmares, nystagmus, obesity, oliguria, osteoporosis, panic attacks, paranoia, pancreatitis, peripheral edema, phlebitis, photophobia, photosensitivity, pneumonia, pneumonitis, priapism, prolactinemia, prothrombin decreased, psoriasis, psychosis, ptosis, pulmonary embolism, purpura, pyelonephritis, renal calculi, renal failure, renal pain, rhabdomyolysis, rigors, seizures, serotonin syndrome, SIADH, skeletal pain, skin discoloration, spontaneous abortion, stomatitis, stupor, sweating decreased, syncope, thirst, thrombocytopenia, thrombosis, tinnitus, torsade de pointes, transient ischemic attack, urinary incontinence, urinary retention, urticaria, vaginal bleeding, ventricular arrhythmia, vertigo, withdrawal syndrome


TOPIRAMATE

Epilepsy

Migraine prophylaxis

Alcohol dependence

Binge Eating Disorder

Bulimia Nervosa

Cluster HA prophylaxis

Infantile Spasms

Weight Loss

Neuropathic Pain

Uses

Lexicomp; Topiramate Monograph, accessed 2-19-2015

Side Effects > 10% : Central nervous system: Paresthesia (19% to 40%; dose dependent in migraine: 35% to

51%; adjunctive therapy in epilepsy: adults 11% to 19%, children 2 to 16 years 1%; monotherapy in epilepsy: children 10 to 16 years 2% to 16%; adjunctive therapy in partial-onset seizures: 7% to 9%), nervousness (9% to 19%; dose-related, adjunctive therapy in partial-onset seizures: adults 13% to 19%; monotherapy in epilepsy: children 10 to 16 years 4% to 5%; migraine: ≥2% to 4%), fatigue (7% to 16%; adjunctive therapy in epilepsy: adults 15% to 30%; dose-related, adjunctive therapy in partial-onset seizures: adults 11% to 30%; dose dependent in migraine: 14% to 19%; partial-onset seizures: 6% to 9%), ataxia (adjunctive therapy in epilepsy: adults 3% to 16%, children 6%; migraine: 1% to 4%), drowsiness (2% to 15%; adjunctive therapy in epilepsy: 26% to 29%, dose dependent in migraine: 7% to 10%), lack of concentration (2% to 15%; dose-related, adjunctive therapy in partial-onset seizures: adults 7% to 14%; dose dependent in migraine: 3% to 10%; adjunctive therapy in partial-onset seizures: adults 5%), language problems (1% to 15%; dose-related, adjunctive therapy in partial-onset seizures: adults 2% to 10%), dizziness (≤14%; adjunctive therapy in epilepsy: adults 25% to 32%, children 2 to 16 years 4%; dose dependent in migraine: 8% to 12%), memory impairment (≤14%; dose dependent in migraine: 7% to 11%; monotherapy in epilepsy: children 6 to <16 years 1% to 3%; adjunctive therapy in partial-onset seizures: adults 2%), confusion (adults: 9% to 14%; dose-related, adjunctive therapy in partial-onset seizures: adults 9% to 14%; monotherapy in epilepsy: adults 3% to 4%, children 6 to <16 years ≤3%; adjunctive therapy in epilepsy: children 2 to 16 years 4%; dose dependent in migraine: 2% to 4%), weight loss (6% to 13%; migraine: adolescents 12 to 17 years 4% to 31%; monotherapy in epilepsy: 6% to 21%; dose-related, adjunctive therapy in partial-onset seizures: adults 4% to 13%; dose dependent in migraine: 6% to 11%), depression (epilepsy: adults 5% to 13%; dose-related, adjunctive therapy in partial-onset seizures: adults 7% to 13%; dose dependent in migraine: 3% to 6%; monotherapy in epilepsy: children 6 to <16 years ≤3%), behavioral problems (adjunctive therapy in epilepsy: children 2 to 16 years 11%; monotherapy in epilepsy: children 6 to <16 years ≤3%), mood disorder (1% to 11%; dose-related, adjunctive therapy in partial-onset seizures: adults ≤9%; dose dependent in migraine: 3% to 6%


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Side Effects >10% Endocrine & metabolic: Decreased serum bicarbonate (migraine: adolescents 12 to

17 years 27% to 77%, adults 23% to 44%; children 2 to 16 years 9% to 67%; epilepsy: 14% to 32%; marked reductions [to <17 mEq/L] 1% to 11%), hyperammonemiawith/without encephalopathy, with/without valproate (migraine: adolescents 12 to 17 years 14% to 26%; migraine, markedly high [≥50% above ULN] adolescents 12 to 17 years ≤9%)

Gastrointestinal: Abdominal pain (6% to 15%; adjunctive therapy in partial-onset seizures: adults 5%), anorexia (4% to 15%; adjunctive therapy in epilepsy: children 2 to 16 years 24%; dose-related, adjunctive therapy in partial-onset seizures: adults 4% to 12%, dose-related in migraine: 9% to 15%; adjunctive therapy in partial-onset seizures: 2%), dysgeusia (migraine: 2% to 15%; epilepsy: adults 2% to 5%), nausea (≤12%; dose dependent in migraine: 9% to 14%), diarrhea (2% to 11%; dose dependent in migraine: 9% to 11%; adjunctive therapy in partial-onset seizures: adults 2%)

Infection: Viral infection (3% to 15%; migraine: 3% to 4%; adjunctive therapy in epilepsy: adults <1% to 2%)

Ophthalmic: Nystagmus (adjunctive therapy in epilepsy: adults 10% to 11%) Renal: Increased serum creatinine (children and adolescents 12 to 16 years 18% with

100 mg dose; epilepsy: <1%) Respiratory: Upper respiratory tract infection (12% to 26%), sinusitis (4% to 15%;

monotherapy in epilepsy: children 6 to 16 years 1% to 5%) Miscellaneous: Trauma (6% to 14%; migraine: adolescents 12 to 17 years ≥2%), fever

(children 6 to 17 years ≤12%; migraine: 1% to 2%)


Side Effects 1 – 10%

Cardiovascular: Flushing (monotherapy in epilepsy: children 6 to <16 years ≥5%; epilepsy: ≤1%), chest pain (adults: 1% to 4%; migraine: >1%), hypertension (1% to 3%), edema (adjunctive therapy in epilepsy: adults 1% to 2%), syncope (epilepsy: ≥1%), bradycardia (adjunctive therapy in epilepsy: children 2 to 16 years 1%), angina pectoris (epilepsy: ≤1%), atrioventricular block (epilepsy: ≤1%), deep vein thrombosis (epilepsy: ≤1%), facial edema (epilepsy: ≤1%), hypotension (epilepsy: ≤1%), orthostatic hypotension (epilepsy: ≤1%), phlebitis (epilepsy: ≤1%), pulmonary embolism (epilepsy: ≤1%), vasodilatation (epilepsy: ≤1%)

Central nervous system: Aggressive behavior (adjunctive therapy in epilepsy: children 2 to 16 years 9%; adults: 2% to 3%), insomnia (≤9%), abnormal gait (adjunctive therapy in epilepsy: children 2 to 16 years 8%, adults 2% to 3%), anxiety (≤8%; dose-related, adjunctive therapy in partial-onset seizures: adults 2% to 10%; dose dependent in migraine: 4% to 6%), cognitive dysfunction (epilepsy: ≤7%; migraine: <1% to 2%), psychomotor retardation (2% to 5%; adjunctive therapy in epilepsy: adults 13% to 21%; migraine: adolescents 12 to 17 years ≤8%), hypoesthesia (1% to 5%; dose dependent in migraine: 6% to 8%), speech disturbance (<1% to 4%; adjunctive therapy in epilepsy: adults 11% to 13%), emotional lability(adjunctive therapy in epilepsy: adults 3%), agitation (1% to 3%), apathy (adjunctive therapy in epilepsy: adults 1% to 3%), hypertonia (monotherapy in epilepsy: adults: ≤3%), vertigo (≤3%), pain (migraine: >1% to ≥2%), aphasia (adjunctive therapy in partial-onset seizures: 2%), dysarthria (adjunctive therapy in partial-onset seizures: 2%), hyporeflexia (adjunctive therapy in epilepsy: children 2 to 16 years 2%), irritability (adjunctive therapy in partial-onset seizures: 2%), depersonalization (adjunctive therapy in epilepsy: adults 1% to 2%), exacerbation of depression (migraine: 1% to 2%), stupor (adjunctive therapy in epilepsy: adults 1% to 2%), exacerbation of migraine headache (migraine: >1%), headache (migraine: >1%, adolescents 12 to 17 years 2% to 8%), sensory disturbance (migraine: >1%), hallucination(epilepsy: ≥1%), psychosis (epilepsy: ≥1%), psychoneurosis (adjunctive therapy in epilepsy: children 2 to 16 years 1%), tonic-clonic seizures (adjunctive therapy in epilepsy: children 2 to 16 years 1%), abnormal electroencephalogram (epilepsy: ≤1%), altered sense of smell (epilepsy: ≤1%), apraxia (epilepsy: ≤1%), brain disease (epilepsy: ≤1%), delirium (epilepsy: ≤1%), delusions (epilepsy: ≤1%), dystonia (epilepsy: ≤1%), euphoria (epilepsy: ≤1%), hyperesthesia (epilepsy: ≤1%), neuropathy (epilepsy: ≤1%), paranoia (epilepsy: ≤1%), rigors (adjunctive therapy in epilepsy: adults ≤1%), voice disorder (epilepsy: ≤1%)


Side Effects 1-10%

Dermatologic: Erythematous rash (migraine: adolescents 12 to 17 years ≤8%; adjunctive therapy in epilepsy: ≤1% to 2%), alopecia (1% to 5%; migraine: >1%), pruritus (1% to 4%), skin rash (1% to 4%), acne vulgaris (monotherapy in epilepsy: adults 2% to 3%), dermatological disease (adjunctive therapy in epilepsy: 1% to 3%), dermatitis (adjunctive therapy in epilepsy: children 2 to 16 years 2%), hypertrichosis (adjunctive therapy in epilepsy: children 2 to 16 years 2%), eczema (adjunctive therapy in epilepsy: children 2 to 16 years 1%), pallor (adjunctive therapy in epilepsy: children 2 to 16 years 1%), seborrhea (adjunctive therapy in epilepsy: children 2 to 16 years 1%), skin discoloration (adjunctive therapy in epilepsy: children 2 to 16 years 1%), abnormal hair texture (epilepsy: ≤1%), body odor (adjunctive therapy in epilepsy: adults ≤1%), diaphoresis (adjunctive therapy in epilepsy: adults: ≤1%), skin photosensitivity (epilepsy: ≤1%), urticaria (epilepsy: ≤1%)

Endocrine & metabolic: Hyperthyroidism (migraine: adolescents 12 to 17 years ≤8%), decreased serum phosphate (adjunctive therapy in partial-onset seizures: adults 6%), increased gamma-glutamyltransferase (monotherapy in epilepsy: adults 1% to 3%), menstrual disease (1% to 3%), decreased libido (≤3%), intermenstrual bleeding (≤3%), amenorrhea (adjunctive therapy in epilepsy: adults 2%), hot flash (adjunctive therapy in epilepsy: adults 1% to 2%), hypermenorrhea (adjunctive therapy in epilepsy: adults 1% to 2%), increased thirst (1% to 2%), hypoglycemia (adjunctive therapy in epilepsy: children 2 to 16 years 1%), weight gain (adjunctive therapy in epilepsy: children 2 to 16 years 1%), albuminuria (epilepsy: ≤1%), dehydration (epilepsy: ≤1%), diabetes mellitus (epilepsy: ≤1%), hyperglycemia (epilepsy: ≤1%), hyperlipidemia (epilepsy: ≤1%), hypocalcemia (epilepsy: ≤1%)

Gastrointestinal: Dyspepsia (3% to 7%; adjunctive therapy in partial-onset seizures: adults 2%), sialorrhea (adjunctive therapy in epilepsy: children 2 to 16 years 6%), xerostomia (dose dependent in migraine: 2% to 5%; adults: 1% to 4%), constipation (1% to 5%; migraine: >1%), decreased appetite (adjunctive therapy in partial-onset seizures: 4%), gastroenteritis (1% to 3%), vomiting (migraine: 1% to 3%), gastritis (≤3%), ageusia (≤2%), gastroesophageal reflux disease (1% to 2%), dysphagia (adjunctive therapy in epilepsy: children 2 to 16 years 1%), fecal incontinence (adjunctive therapy in epilepsy: children 2 to 16 years 1%), flatulence (adjunctive therapy in epilepsy: children 2 to 16 years 1%), gastrointestinal disease (adjunctive therapy in epilepsy: adults 1%), gingival hyperplasia (adjunctive therapy in epilepsy: children 2 to 16 years 1%), gingivitis (adjunctive therapy in epilepsy: adults 1%), glossitis (adjunctive therapy in epilepsy: children 2 to 16 years 1%), increased appetite (adjunctive therapy in epilepsy: children 2 to 16 years 1%), enlargement of abdomen (epilepsy: ≤1%), esophagitis(epilepsy: ≤1%), gingival hemorrhage (epilepsy: ≤1%), hemorrhoids (epilepsy: ≤1%), melena (epilepsy: ≤1%), stomatitis (epilepsy: ≤1%)


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Side Effects 1-10% Genitourinary: Mastalgia (adjunctive therapy in epilepsy: adults ≤4%), urinary incontinence

(1% to 4%), urinary tract infection (1% to 4%), premature ejaculation (migraine: ≤3%), urinary frequency (epilepsy: ≤3%), vaginal hemorrhage (monotherapy in epilepsy: adults ≤3%), cystitis (adults: 1% to 3%), hematuria (adjunctive therapy in epilepsy: adults <1% to 2%), leukorrhea (adjunctive therapy in epilepsy: children 2 to 16 years 2%), dysuria (monotherapy in epilepsy: adults ≤2%), prostatic disease (adjunctive therapy in epilepsy: adults ≤2%), genital candidiasis (migraine: >1%), impotence (epilepsy: ≥1%), nocturia(adjunctive therapy in epilepsy: children 2 to 16 years 1%), ejaculatory disorder (epilepsy: ≤1%), nipple discharge (epilepsy: males ≤1%), oliguria (epilepsy: ≤1%), urinary retention (epilepsy: ≤1%), urine abnormality (adjunctive therapy in epilepsy: adults ≤1%)

Hematologic & oncologic: Purpura (adjunctive therapy in epilepsy: children 2 to 16 years 8%), hemorrhage (4% to 5%), anemia (epilepsy: ≥1% to 3%), neoplasm (migraine: 2%), leukopenia (adjunctive therapy in epilepsy: 1% to 2%), hematoma (adjunctive therapy in epilepsy: children 2 to 16 years 1%), prolonged prothrombin time (adjunctive therapy in epilepsy: children 2 to 16 years 1%), thrombocytopenia (adjunctive therapy in epilepsy: children 2 to 16 years 1%), eosinophilia (epilepsy: ≤1%), granulocytopenia (epilepsy: ≤1%), lymphadenopathy (epilepsy: ≤1%), lymphocytopenia (epilepsy: ≤1%), thrombocythemia(epilepsy: ≤1%)

Hepatic: Increased serum alkaline phosphatase (adjunctive therapy in partial-onset seizures: adults 3%), increased serum ALT (epilepsy: ≤1%), increased serum AST (epilepsy: ≤1%)

Hypersensitivity: Hypersensitivity reaction (<1% to 3%; migraine: adolescents 12 to 17 years ≤8%)

Infection: Infection (>1% to ≥2%; monotherapy in epilepsy: 2% to 8%), candidiasis (adjunctive therapy in epilepsy: adults ≥1%)


Side Effects 1-10%

Neuromuscular & skeletal: Tremor (adjunctive therapy in epilepsy: adults 9%; adjunctive therapy in partial-onset seizures: adults 3%; migraine: >1%), muscle spasm (≤8%; dose dependent in migraine: 2% to 4%; adjunctive therapy in epilepsy: adults: 2%), leg pain (2% to 8%), arthralgia (migraine: 1% to 7%; epilepsy: ≥1%), weakness (epilepsy: ≤6%; adjunctive therapy in partial-onset seizures: 2%; migraine: <1% to 2%), hyperkinesia (adjunctive therapy in epilepsy: children 2 to 16 years 5%), back pain (≥2% to 5%; adjunctive therapy in epilepsy: children 2 to 16 years 1%), leg cramps (adjunctive therapy in partial-onset seizures: adults 2%), myalgia (>1% to ≥2%), arthropathy (epilepsy: ≤1%), dyskinesia (epilepsy: ≤1%), skeletal pain (adjunctive therapy in epilepsy: adults ≤1%)

Ophthalmic: Diplopia (adjunctive therapy in epilepsy: adults 10%, children 2 to 16 years 1%; adjunctive therapy in partial-onset seizures: adults 2%), blurred vision (migraine: 2% to 4%), visual disturbance (≥2%; adjunctive therapy in epilepsy: adults: 10% to 13%; dose dependent in migraine: 1% to 3%), eye pain (migraine: >1% to ≥2%), eye disease (adjunctive therapy in epilepsy: children 2 to 16 years 2%), conjunctivitis (1% to 2%; migraine: adolescents 12 to 15 years ≤7%), accommodation disturbance (migraine: ≥1%), abnormal lacrimation (adjunctive therapy in epilepsy: children 2 to 16 years 1%), myopia (adjunctive therapy in epilepsy: children 2 to 16 years 1%), blepharoptosis (epilepsy: ≤1%), photophobia (epilepsy: ≤1%), scotoma (epilepsy: ≤1%), strabismus (epilepsy: ≤1%), visual field defect (epilepsy: ≤1%), xerophthalmia (epilepsy: ≤1%)

Otic: Hearing loss (adjunctive therapy in epilepsy: adults 1% to 2%), otitis media (migraine: 1% to 2%, adolescents 12 to 17 years ≤8%), tinnitus (<1% to 2%)

Renal: Nephrolithiasis (1% to ≤3%; dose dependent in migraine: ≤2%), polyuria (epilepsy: ≤1%), renal pain (epilepsy: ≤1%)

Respiratory: Laryngitis (migraine: adolescents 12 to 17 years ≤8%), pharyngeal edema (migraine: adolescents 12 to 17 years ≤8%), epistaxis (2% to 8%; adjunctive therapy in epilepsy: adults 1% to 2%; migraine: >1%), rhinitis (adults: 2% to 8%; migraine: adults 1% to 2%), cough (migraine: 2% to 7%), bronchitis (monotherapy in epilepsy: 1% to 7%; migraine: ≥2% to 3%), pharyngitis (≥2% to 6%), pneumonia (adjunctive therapy in epilepsy: children 2 to 16 years 5%; migraine: >1%), flu-like symptoms (<1% to 4%), dyspnea (migraine: 1% to 3%), asthma (migraine: >1% to ≥2%), respiratory tract disease (adjunctive therapy in epilepsy: children 2 to 16 years 1%)


Side Effects <1%

Alcohol intolerance (epilepsy), bone marrow depression (epilepsy), bullous skin disease, cerebellar syndrome (epilepsy), chloasma (epilepsy), erythema multiform, hepatic failure (including fatalities), hepatitis, hypernatremia (epilepsy), hypocholesterolemia (epilepsy), hypokalemia (adjunctive therapy in adults with partial-onset seizures), hyponatremia (epilepsy), increased libido (epilepsy), iritis (epilepsy), lymphocytosis (epilepsy), maculopathy, manic reaction (epilepsy), mydriasis (epilepsy), pancreatitis, pancytopenia (epilepsy), pemphigus, polycythemia (epilepsy), Stevens-Johnson syndrome, suicidal ideation, tongue edema (epilepsy), tongue paralysis (epilepsy), toxic epidermal necrolysis, upper motor neuron lesion (epilepsy), vasospasm (epilepsy)

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Medications with Negative Side Effects

Medications used to Treat

Using knowledge to effect patient care

BASED ON YOUR PRACTICE SITE:(OR WHATEVER YOU MAY BE CURIOUS ABOUT)

Jot down

Question

Clinical dilemma

Case scenario

PHARMACO…..WHAT???

Pharmacology: study of drugs and interactions with living organisms

Pharmacotherapeutics: use of drugs to prevent, diagnosis and treat diseases

Pharmacodynamics: the biochemical and physical effects of drugs and MOA (mechanism of action)

Pharmacokinetics: how drugs move through body Absorption

Distribution

Metabolism

Excretion

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PHARMACO…..WHAT???

Pharmacogenetics: how genetic makeup of different people, ethnicities, gender affects response to certain drugs

Pharmacogenomics: use of genome technology to discover new drugs

DRUG NAMES

Chemical Formula C13-H18-O2

Chemical Name α-p-isobutylphenylpropionic acid

Generic: Ibuprofen

Brand Name: Advil®, Motrin®, Nurofen®

IT’S ALL IN THE NAME

Chemical Name

sodium [(9S,13S,14S)-13-methyl-17-oxo-9,11,12,14,15,16-hexahydro-6H-cyclopenta[a]phenanthren-3-yl] sulfate

Source: Pregnant Mare’s Urine

Generic Name: Conjugated Estrogens

Brand Name: Premarin

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WHERE DO DRUGS COME FROM

Plants Alkaloids – most active component of plants (atropine, caffeine, nicotine)

Glycosides – active component (digoxin)

Gums – interact and hold water

Resins - pine tree sap – irritant, laxative

Oils – volatile – peppermint, spearmint, juniper or fixed – castor oil, olive oil

YamsEstrogenHormone Replacement Therapy

Opium PoppyMorphineHeroin

Colchicum autumnaleColchicineGout

Rose HipsVitamin C

Willow BarkAspirin

Cinchona BarkQuinine

Black CohoshHot flashes

DaffodilsGalantamineAlzheimer's

Calcium

Zinc

Iron

Ferrous Sulfate

Potassium

Potassium Choloride

Iodine

Potassium Choloride

Povidone Iodine

Sodium Iodide,Potassium Iodide

Tums

Zinc Chloride

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Brazilian Arrowhead ViperCaptoprilHypertension

Pregnant Mare UrinePremarinHormone Replacement

Coho SalmonCalcitonin, MiacalcinOsteoporosis

Beef and PorkInsulinDiabetes

Gila Monster SpitByettaDiabetes

SheepLanolin

DRUG DEVELOPMENT Ancient sources

New Chemical from environment

Isomers

Recombinant DNA technology

Stem cell therapy

Gene therapy

HOW DRUGS ARE ADMINISTERED

Oral routes of administration Buccal, sublingual, translingual, gastric tube

Injections Subcutaneous, intradermal, intramuscular, intravenous, intrathecal, epidural,

intraplueral, intraosseous

Topically respiratory

skin

rectal

vaginal

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HOW DRUGS COME….

Solids Oral: Tablets, capsules, orally dispersible tablets, troches, lozenges

Topical: suppositories

Immediate vs Sustained Released tablets/capsules donotcrush(4).pdf

http://www.drugguide.com/ddo/ub/view/Davis-Drug-Guide/109642/all/

http://www.philly.com/philly/blogs/healthcare/Certain-medicines-should-never-be-crushed-or-chewed.html

HOW DRUGS COME….

Liquids Solutions, suspensions, emulsions

Topical Application Solutions, Creams, Ointments

Respiratory Inhalation of aerosolized liquids or powders

Sprays

Nebulization

TESTING NEW DRUGS

Animal testing Frequency distribution curve

Half-life

Median effective dose

Median toxic dose

Therapeutic index

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“This drug was tested on 2000 white mice, and they had a ball.”

David W. Harbaugh.

PROCESS FOR CLINICAL TRIALS

IND

Phase I Clinical Trial Healthy volunteers

Phase II 50 to 500 of people with disease

Phase III Several hundred – thousands people

PROCESS FOR CLINICAL TRIALS

New Drug Application to FDA 20% receive final approval

Phase IV Clinical testing Post Marketing Surveillance

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PHARMACOTHERAPEUTICS

Use of drugs to treat disease

Patient’s response to the drug Patient specific factors

Drug tolerance

Drug dependence

PHARMACODYNAMICS

Study of how the drug causes the changes in the body

On a cellular level, drugs alter target cell’s function by modiyfing the cells physical or chemical environment

interacting with a receptor on the cell

© The McGraw-Hill Companies, Inc, 2011

PHARMACODYNAMICS

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PHARMACOKINETICS

Distribution

Metabolism

Excretion

PHARMACOKINETICS

ABSORPTION

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FACTORS AFFECTING DRUG ABSORBTION

Drugs absorbed through the skin Thickness of skin

Open wounds

Age

Drugs absorbed in the GI Tract Vomiting

Diarrhea

Ostomy

Surgical removal of intestines

http://www.nursingbuddy.com/2011/02/10/drugs-and-the-body/

PHARMACOKINETICS

Distribution

Metabolism

Excretion

DISTRIBUTION

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PHARMACOKINETICS

Distribution

Metabolism

Excretion

METABOLISM

Biotransformation of the drug Active metabolites (pro-drugs)

Inactive metabolites

Liver, kidney, lungs, intestines, skin, brain, CNS

http://www.doctorfungus.org/thedrugs/antif_interaction.php

PHARMACOKINETICS

Distribution

Metabolism

Excretion

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EXCRETION-RENAL

EXCRETION

GI Excretion Unabsorbed drug

Metabolites

Respiratory General anesthetics

BLOOD LEVELS

Half- Life Steady State

Time it takes concentration of drug to decrease by 1/2 the original level

Consistent Blood level

http://www.rxkinetics.com/pktutorial/1_6.htmlhttp://apps.who.int/medicinedocs/en/d/Jwhozip23e/7.1.4.3.html

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THERAPEUTIC INDEX

PHARMACOKINETICS AFFECTS:

Onset of action SSRIs

Peak concentration

Duration of action




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ADVERSE DRUG REACTIONS Undesirable, harmful response to a medication

Chemical Patient specific parameters

Side Effects Secondary effects – therapeutic response AND not intended therapeutic response

Morphine = Pain AND sedation, respiratory, distress, constipationBenadryl= Antihistamine OR sleep aid because of side effects

Enhanced action – caused by patient specific parameters effecting pharmacokinetics resulting in a higher blood concentration

Toxicity: Ototoxicity with aminoglycosides or lasix

Drug allergy (resulting from patient’s immune system) or idiosyncratic reaction (genetically specific)

DRUG INTERACTIONS

Drug-drug

Drug-food

Drug-herbal

Drug-labs

DRUGS THAT AFFECT

Swallowing (aphagia, dysphagia)

Balance

Hearing (ototoxicity, tinnitus)

Cognition

Movement

Speech (apraxia, aphasia,)

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DRUG INDUCED DYSPHAGIA

No apparent abnormality of esophageal transit

No prior esophageal disease

Al-Sheri A, Dysphagia as a Drug Side Effect, The Internet Journal of Otorhinolarngology; 2001, Vol 1 Number 2


Consider: When is med taken? Bedtime?

Inadequate fluid to swallow medication

Decreased swallowing, saliva, peristalsis

Size and shape of tablets and capsules 2cm tablets more delayed than <1cm

Elderly patients More meds

More likely to have anatomic or motility abnormalities of esophagus

More likely to have cardiac enlargement with concomitant compression of mid-esophagus

Motility problems due to diabetes or autonomic neuropathy

Swallowing dysfunction due to stroke or connective tissue disease

Decreased saliva leading to decreased esophageal lubrication and increased likelihood of the drug to the esophageal mucosa



Alleviate problem Correctly formulated drug

Sublingual, buccal or dissolvable tablets

Liquid preparations

Timing of medication administration


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Drugs acting on CNS Sedatives

Narcotics

Drugs acting on striated muscle

Muscle relaxants (pancuronium, succinlycholine)

Local Anesthetics (benzonatate, Tessalon Perles)

Extrapyramidal motor movements Antipsychotics

Xerostomia


Alcohol

Cytotoxic agents Predispose patient to viral and fungal infections

Esophagitis

Drug Induced Esophageal Injury Drugs with pH <3

Doxycycline, tetracycline, ascorbic acid, ferrous sulfate

Esophagitis or esophageal stricture formation

NSAIDs, low dose aspirin

WHEN TO SUSPECT MEDICATION IN HEARING LOSS

Patient has history of Cancer

Renal Disease

Infection

Love et al. Ototoxicity and Vestibulotoxicity Considerations in Primary Care; Clinician Review; April 2013

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OTOTOXICITY Aminoglycosides (8%)

gentamicin, tobramycin, streptomycin (vestibular toxicty)

May or may not have hearing loss

Usually noted with standing up. Sitting down, during head movement or when eyes are closed

Adaption often develops over 2 weeks to 2 months

amikacin, netilmycin, kanamycin (auditory toxicity)

Irreversible, occurs within 2-6 days of therapy initiation or discontinuation, may not be evident for several weeks

Genetic predisposition

Destruction of hair cells in the inner ear

Dependent on cumulative dose and duration of therapy


OTOTOXICITY Erythromycin/Macrolides (20-30%)

Erythromycin

“blowing sound” with vertigo

Begin 4 – 8 days into high dose therapy and resolve in days to weeks of discontinuation

Vancomycin

High frequency hearing loss with tinnitus

Minocycline

Dose dependent, reversible vestibulotoxicity

75mg twice daily – 50% patients

100mg twice daily – 100% patients develop vertigo

Incidence is 2-3 times in female > male

Resolves with 48 hours of drug discontinuation in 75% of patients


OTOTOXICITY NSAIDS

Aspirin Ototoxicity: 0.3% to 1.7% in patients > 2.7g/day Tinnitus: 50% of patients taking > 4g/day Hearing loss: 25% of patients taking > 4g/day

Loop Diuretics (furosemide, bumetanide) Dose dependent or rapid IV infusion

Drugs for Erectile Dysfunction (Viagra, Cialis) Sudden hearing loss Vertigo, dizziness, tinnitus

Chemotherapeutic Agents Platinum (cisplatin, carboplatin)

Tinnitus High-frequency hearing loss Children are more susceptible


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OTOTOXICITY

Risk Factors for Ototoxic Reactions Patient populations more vulnerable

Extremes in age (very young or very old)

Renal or Hepatic failure

Rapid IV infusion rates

High-dose regimens

Lengthy duration of treatment

Combination of ototoxic drugs


BALANCE AND VERTIGO

Balance Vision

Inner Ear

Cerebellum

Proprioceptive pathways

Vasovagal system

Vertigo Unbalanced input by central

vestibular apparatus

Unbalanced processing of vestibular visual and somatosensory inputs

Lin E, Aligne K, Pharmacology of balance and dizziness, NeuroRehabilitation 32(2013) 529-542

DRUGS THAT CAUSE DIZZINESS

Antibiotics Aminoglycosides

Tetracyclines

Antihypertensives Orthostatic Hypotension

Clonidine

Methyldopa

Phentolamine

Nifedipine

Ranolazine

Labetalol

Diuretics Furosemide, bumetanide

Hydrochlorothiazide

Antipsychotics Phenothiazines

Antidepressants SSRIs (SE and upon discontinuation)

TCAs (orthostatic hypotension)

SNRIs

Bupropion (Wellbutrin®)


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Anticonvulsants Ethosuximide, levetiracetam,

tiagabine, vigabatrin, lacosamide

Gabapentin and pregabalin (ataxia)

Lamotrigine (diplopia)

Retigabine (blurred vision)

Sedative/Hypnotics Ramelteon

Buspirone

Flumazenil

Chemotherapy Drugs Vertigo without ototoxicity

Cetuximab

Dasatinib

Imatinib

Sunifinib

Taxtuzeumab

Tretinioin

Mefanamic acid

Azathiprine

Tacrolimus

Natalizumab

Hypotension Etoposide

Docetaxel

Bortezomib



AlcoholEnhanced with smoking

Tobacco Products (including oral tobacco)

Caffeine



Medications used to Treat/Prevent


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OTOTOXICITY - PROTECTION

Statin drugs

Simvastatin - Protection in vitro

Atorvastatin – irreversible ototoxicity

Brand et al. BMC Neuroscience 2011,12:114Liu et al. Pharmacotherapy 2012, Vol 32 Number 2, e27-34

OTOTOXICITY - PROTECTIONDexamethasoneTacrolimusMelatonin

Prevent hair cell death by acting at different points in cell death pathway Melatonin – potent antioxidant and free radical scavenging hormone

Dexamethasone – anti-inflammatory, anti-allergy drug that inhibits AP-1

Tacrolimus – immunosuppressant that limits formation of AP-1

Activating Protein-1 (AP-1) Gentamicin increases AP-1 activity in outer hair cells

British Journal of Pharmacology (2012) 166 188-1904

OTOTOXICITY

Development of local long-term delivery techniques to the cochlea will be a breakthrough in terms of reducing the levels of drugs required for effective treatment, decreasing or eliminating side effects and avoiding alteration of drugs by liver metabolism, thereby assuring that the desired concentration of a drug is achieved only in the target area 9ie, the perilymph within the scala tympani. The results of our study show that local treatment of cochlea with dexamethasone, melatonin or tacrolimus can conserve auditory function and prevent hair cell loss.

British Journal of Pharmacology (2012) 166 188-1904

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TINNITUS

Supplements Traditional treatments

Lipo-Flavonoid (B Vitamins, Vitamin C)

Quietus, RingStop(homeopathic dilutions of cinchona)

Ginkgo biloba

Melatonin

Zinc

NO DRUGS APPROVED FOR TINNITUS

Antidepressants (TCAs, SSRIs)

Benzodiazepines (alprazolam)

Anticonvulsants (carbamazepine, gabapentin)

Glutamate Antagonists (memantine, acamprosate)

AHRQ Comparative Effect5iveness Review 122; Evaluation and Treatment of Tinnitus: Comparative EffectivenessPharmacist’s Letter Detail Document #260195

TREATING TINNITUS

Lifestyle Modifications Therapy

Avoid: Salt

Caffeine

Simple Sugars

MSG

Artificial Sweeteners

Food dyes

Cognitive Behavioral Therapy

Counseling

Sound therapy

Meditation

Pharmacist’s Letter Detail Document #260195; 9/2010, Volume 26, number 260915)

TREATING DIZZINESS AND BALANCE DEFICIENCIES

Suppress Vestibular System: Manage Symptoms of Nausea:

Antihistamines

Meclizine (anticholinergic, antiemetic)

Dimenhydrinate (Dramamine)

Anticholinergics

Scopolamine (Transderm Scop)

Atropine

Benzodiazepines

Diazepam (Valium)

Lorazepam (Ativan)

Clonazepam (Klonipin)

Calcium Channel Antagonists

Nimodipine

Phenothiazines Prochlorperazine (Compazine)

Promethazine (Phenergan)

Metoclopramide (Reglan)

Ondansetron (Zofran)


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TREATING DIZZINESS AND BALANCE DEFICIENCIES

Baclofen Used in patients with microvascular compression of CN VIII

Vestibulocochlear nerve

Amantadine Promote compensation in patients with brain injury





CASES

Dysphagia in a 62 yr old female patient Medical History includes:

Diabetes

Hypertension

Cough

Medications include: Lisinopril 10mg daily for hypertension

Tessalon Perles 200mg three times daily as needed for cough

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CASES

Tardive Dyskinesia in a 12 yr old

Paradoxical Delirium in a 74 yr old post op patient

[email protected]

REFERENCES

Cianfrone G, et al. Pharmacological drugs inducing ototoxicity, vestibular symptoms and tinnitus: a reasoned and updated guide, European Review for Medical and Pharmacological Sciences 2011;15: 601-636.

Gallagher L, Naidoo P, Prescription Drugs and Their Effects on Swallowing, Dysphagia (2009)24:159-166.

Lin E, Aligne K, Pharmacology of balance and dizziness, NeuroRehabilitation 32(2013) 529-542.

Mitchell JF, Oral Dosage Forms That Should Not Be Crushed; http://www.ismp.org/tools/donotcrush.pdf ; accessed February 2015.

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