ADR

TUGAS

• Reserpin :• Klonidin• Metildopa• Doksazozin• propranolol• Minoksidil• Diltiazem• ARB

Reserpin• Vomiting, diarrhea, nausea, anorexia, dryness of mouth, hypersecretion.• Arrhythmias (particularly when used concurrently with digitalis or

quinidine), syncope, angina-like symptoms, bradycardia, edema.• Dyspnea, epistaxis, nasal congestion.• Rare parkinsonian syndrome and other extrapyramidal tract symptoms;

dizziness; headache; paradoxical anxiety; depression; nervousness; nightmares; dull sensorium; drowsiness.

• Muscular aches.• Pseudolactation, impotence, dysuria, gynecomastia, decreased libido,

breast engorgement.• Weight gain.• Deafness, optic atrophy, glaucoma, uveitis, conjunctival injection.• Purpura, rash, pruritus.

Klonidin• Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. • Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest,

junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud’s phenomenon, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.

• Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.

• Alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.• Abdominal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver

function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain, and vomiting.

• Decreased sexual activity, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

• Thrombocytopenia.• Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight

gain.• Leg cramps and muscle or joint pain.• Dryness of the nasal mucosa.• Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness

of eyes.

Metildopa• Aggravation of angina pectoris, congestive heart failure, prolonged carotid sinus

hypersensitivity, orthostatic hypotension (decrease daily dosage), edema or weight gain, bradycardia.

• Pancreatitis, colitis, vomiting, diarrhea, sialadenitis, sore or "black" tongue, nausea, constipation, distension, flatus, dryness of mouth.

• Hyperprolactinemia.• Bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, hemolytic

anemia• Liver disorders including hepatitis, jaundice, abnormal liver function tests • Myocarditis, pericarditis, vasculitis, lupus-like syndrome, drug-related fever, eosinophilia.• Parkinsonism, Bell's palsy, decreased mental acuity, involuntary choreoathetotic movements,

symptoms of cerebrovascular insufficiency, psychic disturbances including nightmares and reversible mild psychoses or depression, headache, sedation, asthenia or weakness, dizziness, light-headedness, paresthesias.

• Rise in BUN.• Arthralgia, with or without joint swelling; myalgia.• Nasal stuffiness.• Toxic epidermal necrolysis, rash.• Amenorrhea, breast enlargement, gynecomastia, lactation, impotence, decreased libido.

Table 4 ADVERSE REACTIONS DURING PLACEBO-CONTROLLED STUDIES HYPERTENSION Doxazosin

(N=339) PLACEBO

(N=336) CARDIOVASCULAR SYSTEM

Dizziness 19% 9% Vertigo 2% 1% Postural Hypotension 0.3% 0% Edema 4% 3% Palpitation 2% 3% Arrhythmia 1% 0% Hypotension 1% 0% Tachycardia 0.3% 1% Peripheral Ischemia 0.3% 0% SKIN & APPENDAGES Rash 1% 1% Pruritus 1% 1% MUSCULOSKELETAL SYSTEM

Arthralgia/Arthritis

1% 0%

Muscle Weakness 1% 0% Myalgia 1% 0% CENTRAL & PERIPHERAL N.S

Headache 14% 16% Paresthesia 1% 1% Kinetic Disorders 1% 0% Ataxia 1% 0% Hypertonia 1% 0% Muscle Cramps 1% 0% AUTONOMIC Mouth Dry 2% 2% Flushing 1% 0% SPECIAL SENSES Vision Abnormal 2% 1% Conjunctivitis/Eye Pain

1% 1%

Tinnitus 1% 0.3% PSYCHIATRIC Somnolence 5% 1% Nervousness 2% 2% Depression 1% 1% Insomnia 1% 1% Sexual Dysfunction 2% 1% GASTROINTESTINAL

Nausea 3% 4% Diarrhea 2% 3% Constipation 1% 1% Dyspepsia 1% 1% Flatulence 1% 1% Abdominal Pain 0% 2% Vomiting 0% 1% RESPIRATORY Rhinitis 3% 1% Dyspnea 1% 1% Epistaxis 1% 0% URINARY Polyuria 2% 0% Urinary Incontinence 1% 0% Micturition Frequency 0% 2% GENERAL Fatigue/Malaise

12% 6%

Chest Pain 2% 2% Asthenia 1% 1% Face Edema 1% 0% Pain 2% 2%

Propranolol• Bradycardia; congestive heart failure; intensification of AV block; hypotension;

paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type.

• Light-headedness; mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics. For immediate release formulations, fatigue, lethargy, and vivid dreams appear dose related.

• Nausea, vomiting, epigastric distress, abdominal cramping, diarrhea, constipation, mesenteric arterial thrombosis, ischemic colitis.

• Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions; pharyngitis and agranulocytosis; erythematous rash; fever combined with aching and sore throat; laryngospasm; respiratory distress.

• Bronchospasm.• Agranulocytosis, nonthrombocytopenic purpura, and thrombocytopenic purpura.• Systemic lupus erythematosus (SLE).• Stevens-Johnson Syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis,

erythema multiforme, urticaria, alopecia, SLE-like reactions, and psoriasisiform rashes. Oculomucocutaneous syndrome involving the skin, serous membranes, and conjunctivae reported for a beta-blocker (practolol) have not been associated with Propranolol.

• Male impotence; Peyronie's disease.

Minoksidil• 1. Salt and Water Retention - Temporary edema developed in

7% of patients who were not edematous at the start of therapy.

• 2. Pericarditis, Pericardial• 3. Dermatologic -Hypertrichosis-Elongation, thickening, and

enhanced pigmentation of fine body hair are seen in about 80% of patients taking Minoxidil tablets. This develops within 3 to 6 weeks after starting therapy. It is usually first noticed on the temples, between the eyebrows, between the hairline and the eyebrows, or in the side-burn area of the upper lateral cheek, later extending to the back, arms, legs, and scalp

Diltiazem• Allergic - Rashes have been reported, including rare reports of

bullous eruptions, toxic epidermal necrolysis, and Stevens-Johnson Syndrome.

• 4. Hematologic -Thrombocytopenia and leukopenia (WBC<3000/mm3) have rarely been reported.

• 5. Gastrointestinal -Nausea and/or vomiting has been reported. In clinical trials the incidence of nausea and vomiting associated with the underlying disease has shown a decrease from pretrial levels.

• 6. Miscellaneous -Breast tenderness - This developed in less than 1% of patients.

• 7. Altered Laboratory Findings :ECG, ALP

• Angina, arrhythmia, AV block (second- or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles

• Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor

• Anorexia, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase, thirst, vomiting, weight increase

• Petechiae, photosensitivity, pruritus, urticaria

Valsartan (n = 3,282) Placebo (n = 2,740)

Dizziness 17% 9%

Hypotension 7% 2%

Diarrhea 5% 4%

Arthralgia 3% 2%

Fatigue 3% 2%

Back Pain 3% 2%

Dizziness, postural 2% 1%

Hyperkalemia 2% 1%

Hypotension, postural 2% 1%

• Nifedipin vs amlodipin (Amlodipin is long acting)

• Nifedipin (oral) vs nicardipin (i.v)

The Kahn and McAlister meta-analysis1 pooled data from 21 randomized hypertension trials (including 6 placebo-controlled trials) that evaluated the efficacy of beta-blockers as first-line therapy for hypertension in preventing major cardiovascular outcomes (death, nonfatal MI, or nonfatal stroke).The results were analyzed by age group: trials enrolling patients with a mean age of 60 years or older at baseline vs trials enrolling patients with a mean age of under 60 years.

Conclusion. They concluded that in trials comparing other antihypertensive medications with beta-blockers, all agents showed similar efficacy in younger patients, while in older patients, beta-blockers were associated with a higher risk of both composite events and strokes

Beta bloker utk lansia