6.1 CARDIAC DRUGS AGENT FOR CONGESTIVE HEART FAILURE
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1 6.1 CARDIAC DRUGS AGENT FOR CONGESTIVE HEART FAILURE GROUP 6 DIGOXIN Indication: Treatment of congestive heart failure and to slow the ventricular rate in tachyarrhythmias such as atrial fibrillation, atrial flutter, and supraventricular tachycardia (paroxysmal atrial tachycardia), cardiogenic shock. Usual Dose: Atrial dysrhythmias (rate control), CHF: Oral: mg, I.V. or I.M.: mg. Daily maintenance dose: Oral: mg, I.V. or I.M.: mg. Note Initial: Total digitalizing dose: Give 1/2 of the total digitalizing dose (TDD) in the initial dose, then give 1/4 of the TDD in each of two subsequent doses at 9- to 12-hour intervals. Obtain ECG 6 hours after each dose to assess potential toxicity. When changing from oral (tablets or liquid) or I.M. to I.V. therapy, dosage should be reduced by 20% to 25%. - Cardiovascular: Heart block, atrial tachycardia with block,av dissociation, ventricular, tachycardia or ventricular fibrillation, PR prolongation, ST segment depression - Central nervous system: Visual disturbances (blurred or yellow vision), headache, dizziness apathy, confusion, mental disturbances, anxiety, depression, delirium, hallucinations, fever - Dermatologic: Rash,shedding of fingernails or toenails, alopecia - Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain - Neuromuscular & skeletal: Weakness Lactation: Enters breast milk (small amounts)/compatible Preparations: Tablets 0.25mg ED(ก). Injection 0.5 mg ED(ก). ENALAPRIL MALEATE Indication: Management of mild to severe hypertension, congestive heart failure, left ventricular dysfunction after myocardial infarction. Unlabeled/investigation indication: Unlabeled: Hypertensive crisis, diabetic nephropathy, rheumatoid arthritis, diagnosis of anatomic renal artery stenosis, hypertension secondary to scleroderma renal crisis, diagnosis of aldosteronism, idiopathic edema, Bartter's syndrome, postmyocardial infarction for prevention of ventricular failure. Investigational: Severe congestive heart failure in infants, neonatal hypertension, acute pulmonary edema. Usual Dose : Asymptomatic left ventricular dysfunction: Oral: 2.5 mg twice daily, titrated as tolerated to 20 mg/day. Hypertension: Oral: mg/day then increase as required, usual dose range (JNC 7): mg/day in 1-2 divided doses. Heart failure: Oral: Initial: 2.5 mg once or twice daily, usual
2 range: 5-40 mg/day in 2 divided doses, target dose: mg twice daily (ACC/AHA 2005 Heart Failure Guidelines) - Cardiovascular: Hypotension, chest pain, syncope, orthostasis, orthostatic hypotension - Central nervous system: Headache, dizziness, fatigue - Dermatologic: Rash - Gastrointestinal: Abnormal taste, abdominal pain, vomiting, nausea, diarrhea, anorexia, constipation - Neuromuscular & skeletal: Weakness - Renal: Serum creatinine increased, worsening of renal function - Respiratory : Bronchitis, cough, dyspnea (1 st trimester) D (2 nd and 3 rd trimesters ) Lactation: Enters breast milk/not recommended Preparations: Tablet 5 mg ED(ก) ANTI-ARRHYTMIC AGENT PROPRANOLOL (See in autonomic drug section 4.5 page 31 ) ANTI-ANGINAL AGENT NITRATE GROUP ISOSORBIDE DINITRATE Indication: Prevention and treatment of angina pectoris, congestive heart failure. Unlabeled/investigation indication: Esophageal spastic disorders. Usual Dose: Angina: Oral: 5-40 mg 4 times/day, Sublingual: mg every 5-10 minutes for maximum of 3 doses in minutes (may also use prophylactically 15 minutes prior to activities which may provoke an attack). Congestive heart failure: Initial dose: 20 mg 3-4 times/day, target dose mg/day in divided doses. - Cardiovascular: Hypotension, postural hypotension, pallor, cardiovascular collapse, tachycardia, shock, flushing, peripheral edema - Central nervous system: Headache (most common), lightheadedness, dizziness, restlessness - Gastrointestinal: Nausea, vomiting, bowel incontinence, xerostomia - Genitourinary: Urinary incontinence - Neuromuscular & skeletal: Weakness - Ocular: Blurred vision - Miscellaneous: Cold sweat
3 Lactation: Excretion in breast milk unknown Preparations: Tablet 10 ED(ก), Sublingual tablets 5 mg ED(ก) CALCIUM ANTAGONIST GROUP AMLODIPINE Indication: Treatment of hypertension, symptomatic chronic stable angina, vasospastic (Prinzmetal's) angina. Usual Dose: Hypertension: Oral: Initial dose 5 mg once daily, maximum dose: 10 mg once daily, usual dosage range (JNC 7): mg once daily. Angina: Oral 5-10 mg. - Cardiovascular: Peripheral edema (dose related), flushing, palpitation - Central nervous system : Headache, dizziness, fatigue, somnolence - Dermatologic: Rash, pruritus - Endocrine & metabolic: Male sexual dysfunction - Gastrointestinal: Nausea, abdominal pain, dyspepsia, gingival hyperplasia - Neuromuscular & skeletal: Muscle cramps, weakness - Respiratory: Dyspnea, pulmonary edema Lactation: Excretion in breast milk unknown/not recommended Preparations: Tablets 5, 10mg ED(ก) NIFEDIPINE Indication: Angina and hypertension (sustained release only), pulmonary hypertension. Usual Dose: Oral Initial: 10 mg 3 times/day, maximum dose mg/day. - Cardiovascular: Flushing, peripheral edema, palpitations, transient hypotension - Central nervous system: Dizziness/lightheadedness/giddiness, headache - Gastrointestinal: Nausea/heartburn, diarrhea, constipation, cramps, flatulence - Dermatologic: Dermatitis, pruritus, urticaria - Endocrine & metabolic: Sexual difficulties - Neuromuscular & skeletal: Weakness, muscle cramps/tremor, joint stiffness - Ocular: Blurred vision - Respiratory: Cough/wheezing, nasal congestion/sore throat, dyspnea - Miscellaneous: Diaphoresis Lactation: Enters breast milk/compatible
4 Preparations: Capsules 20mg (sustained-release) NED BETA ADRENERGIC BLOCKING AGENT ATENOLOL, PROPRANOLOL See in autonomic drug section 4.5 page PERIPHERAL VASODILATORS AND CEREBRAL ACTIVATORS BETAHISTINE DIHYDROCHLORIDE Indication: Treatment of Meniere's disease (to decrease episodes of vertigo). Usual Dose: Oral 8-16 mg 3 times/day. - Central nervous system: Headache, somnolence - Cardiovascular: Ventricular extrasystoles - Dermatologic: Rash, pruritus, urticaria - Gastrointestinal: Dyspepsia, nausea, peptic ulcer disease Pregnancy risk factor: N/A Lactation: Excretion in breast milk unknown/use caution Preparations: Tablet 8 mg NED BETAHISTINE MYSYLATE Indication: Treatment of Meniere's disease (to decrease episodes of vertigo). Usual Dose: Oral: 6-12 mg 3 times/day. - Central nervous system: Headache, somnolence - Cardiovascular: Ventricular extrasystoles - Dermatologic: Rash, pruritus, urticaria - Gastrointestinal: Dyspepsia, nausea, peptic ulcer disease Pregnancy risk factor: N/A Lactation: Excretion in breast milk unknown/use caution Preparations: Tablet 6 mg ED( ) CINNARICINE Indication: Control of vestibular symptoms of both peripheral and central origin and of labyrinthine disorders including vertigo, dizziness, tinnitus, nystagmus, nausea, and vomiting. Prophylaxis of motion sickness. Adjunct therapy for symptoms of peripheral arterial disease. Usual Dose: Oral mg 3 times/day preferably with or after meal.
5 Pregnancy risk factor/ Lactation: N/A Preparations: Tablet 25 mg NED GINKGO BILOBA EXTRACT Indication: Disturbed cerebral performance. Supporting treatment in reduced hearing capacity due to cerebrovascular syndrome. Peripheral arterial circulatory disturbances with saved circulatory reserve. Usual Dose: Oral mg 3 times/day. Rarely, digestive disturbances, rashes Pregnancy risk factor: N/A Lactation: N/A Preparations: Tablets 40 mg NED NICERGOLINE Indication: Signs and symptoms of mental deterioration, impaired memory, decreased vigilance and impaired concognition, mood depression, apathy, interpersonal relationships, lack of self-care, asthenia, anorexia, tinnitus, dizziness. As a coadjuvant in the rehabilitative treatment of hemiplegic patients with ictus sequelae. Usual Dose: 10 mg 3 times/day or 30 mg 2 times/day. Hypotension, dizziness (rare) Pregnancy risk factor: N/A Lactation: N/A Preparations: Tablets 30 mg NED 6.3 ANTI-HYPERTENSIVE AGENT ANGIOTENSIN COVERTING ENZYME INHIBITORS (ACEIs) ENALAPRIL (see in section 6.1 page 36) PERINDOPRIL Indication: Treatment of essential hypertension.reduction of cardiovascular mortality or nonfatal myocardial infarction in patients with stable coronary artery disease. Unlabeled/investigation indication: Treatment of congestive heart failure with left ventricular dysfunction. Usual Dose: Essential hypertension: Oral Initial 4 mg/day,usual range 4-8 mg/day, maximum 16 mg/day. Stable coronary artery disease: Oral Initial: 4 mg once daily for 2 weeks, increase as tolerated to 8 mg once daily.
6 Cardiovascular: Edema, chest pain, ECG abnormal, palpitation - Central nervous system: Headache (24%),dizziness, sleep disorders, depression, fever nervousness, somnolence - Dermatologic: Rash - Endocrine & metabolic: Hyperkalemia, triglycerides increased, menstrual disorder - Gastrointestinal: Nausea, diarrhea, vomiting, dyspepsia, abdominal pain, flatulence - Genitourinary: Urinary tract infection - Hepatic: Increased - Neuromuscular & skeletal: Weakness, back pain, lower extremity pain, upper extremity pain hypertonia - Respiratory: Cough (12%), upper respiratory tract infection, sinusitis - Renal: Proteinuria - Otic: Tinnitus, ear infection - Miscellaneous: Viral infection, allergy (1 st trimester) / D (2 nd and 3 rd trimesters) Lactation: Excretion in breast milk unknown/use caution Preparations: Tablet 4 mg NED ANGIOTENSIN-II RECEPTOR ANTAGONIST GROUP OLMESARTAN Indication: Treatment of essential hypertension Unlabeled/investigation indication: Treatment of congestive heart failure with left ventricular dysfunction Usual Dose: Oral Initial starting dose is 20 mg once daily, may be increased to 40 mg once. - Central nervous system: Dizziness, headache - Endocrine & metabolic: Hyperglycemia, hypertriglyceridemia - Gastrointestinal: Diarrhea - Neuromuscular & skeletal: Back pain, CPK increased - Renal: Hematuria - Respiratory: Bronchitis, pharyngitis, rhinitis, sinusitis - Miscellaneous: Flu-like syndrome (1 st trimester), D (2 nd and 3 rd trimesters ) Lactation: Excretion in breast milk unknown/contraindicated Preparations: Tablets 40 mg NED
7 VALSARTAN Indication: Treatment of essential hypertension. Unlabeled/investigation indication: Note Non-approved by Thai FDA: Treatment of heart failure, reduction of cardiovascular mortality in patients with left ventricular dysfunction postmyocardial infarction. Usual Dose: Oral Initial: 80 mg or 160 mg once daily, maximum recommended dose: 320 mg/day. - Central nervous system: Dizziness (>10%), fatigue - Cardiovascular: Hypotension, postural hypotension - Endocrine & metabolic: Serum potassium increased, hyperkalemia - Gastrointestinal: Diarrhea, abdominal pain - Hematologic: Neutropenia - Neuromuscular & skeletal: Arthralgia, back pain - Renal: Creatinine increased - Respiratory: Cough - Miscellaneous: Viral infection (1 st trimester), D (2 nd and 3 rd trimesters ) Lactation: Excretion in breast milk unknown/contraindicated Preparations: Tablets 80 mg NED ADRENERGIC BLOCKING AGENTS GROUP ATENOLOL, PROPRANOLOL (see in section 4 page 31) CALCIUM ANTAGONIST GROUP AMLODIPINE (see in section 6 page 38) 6.4 ANTILIPEMIC AGENT GEMFIBROZIL Indication: Treatment of hypertriglyceridemia in types IV and V. Usual Dose: Oral 1200 mg/day in 2 divided doses (30 minutes before breakfast and dinner). - Central nervous system: Fatigue, vertigo, headache - Gastrointestinal: Dyspepsia (20%), abdominal pain, diarrhea, nausea/vomiting, constipation - Dermatologic: Eczema, rash Lactation: Excretion in breast milk unknown/contraindicated Preparations: Capsules 300 mg ED(ก)
8 SIMVASTATIN Indication: Treatment of hypertriglyceridemia, secondary prevention of cardiovascular events in hypercholesterolemic patients with established coronary heart disease (CHD) or at high risk for CHD. Usual Dose: Oral mg once daily in the evening. - Gastrointestinal: Constipation, dyspepsia, flatulence - Neuromuscular & skeletal: CPK elevation - Respiratory: Upper respiratory infection Pregnancy risk factor: X Lactation: Excretion in breast milk unknown/contraindicated Preparations: Tablets 20 mg ED(ก)
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