Propranolol

Propranolol - B.P.Norm, Betabloc, Betabloc Forte, Betacap T.R., Cardiolong, Ciplar
Use:

Management of hypertension, angina pectoris, pheochromocytoma, essential tremor, tetralogy of Fallot cyanotic spells, and arrhythmias (such as atrial fibrillation and flutter, A-V nodal re-entrant tachycardias, and catecholamine-induced arrhythmias); prevention of myocardial infarction, migraine headache;

symptomatic treatment of hypertrophic subaortic stenosis Unlabeled use: Tremor due to Parkinson’s disease, alcohol withdrawal, aggressive behavior, antipsychotic-induced akathisia, esophageal varices bleeding, anxiety, schizophrenia, acute panic, and gastric bleeding in portal hypertension

Pregnancy & Lactation :
Risk Factor - C (per manufacturer); D (in 2nd and 3rd trimesters, per expert analysis)
Warnings & Precautions:

Safety and efficacy in children have not been established; administer very cautiously to patients with CHF, asthma, diabetes mellitus, hyperthyroidism. Abrupt withdrawal of the drug should be avoided, drug should be discontinued over 1-2 weeks; do not use in pregnant women; use with caution in breast-feeding women; may potentiate hypoglycemia in a diabetic patient and mask signs and symptoms.

Contraindication:

Uncompensated congestive heart failure, cardiogenic shock, bradycardia or heart block, pulmonary edema, severe hyperactive airway disease or chronic obstructive lung disease, Raynaud’s disease, hypersensitivity to beta-blockers

Adverse Reactions :

>10%: Cardiovascular: Bradycardia; Central nervous system: Mental depression; Endocrine & metabolic: Decreased sexual ability.
1% to 10%: Cardiovascular: Congestive

heart failure, reduced peripheral circulation; Central nervous system: Confusion, hallucinations, dizziness Gastrointestinal: Diarrhea, nausea, vomiting, stomach discomfort; Neuromuscular & skeletal: Weakness; Respiratory: Wheezing.<1%: Chest pain, hypotension, impaired myocardial contractility, worsening of A-V conduction disturbances, nightmares, vivid dreams, lethargy, red, scaling, or crusted skin; hypoglycemia, hyperglycemia, GI distress, leukopenia, thrombocytopenia, agranulocytosis, bronchospasm, cold extremities


Interactions :

Decreased effect: Aluminum salts, barbiturates, calcium salts, cholestyramine, colestipol, NSAIDs, penicillins (ampicillin), rifampin, salicylates and sulfinpyrazone decrease effect of beta-blockers due to decreased bioavailability and plasma levels Beta-blockers may decrease the effect of sulfonylureas Ascorbic acid decreases propranolol Cpmax and AUC and increases the

Tmax significantly resulting in a greater decrease in the reduction of heart rate, possibly due to decreased absorption and first pass metabolism (n=5) Nefazodone decreased peak plasma levels and AUC of propranolol and increases time to reach steady state; monitoring of clinical response is recommended Increased effect: Increased effect/toxicity of beta-blockers with calcium blockers (diltiazem, felodipine, nicardipine), contraceptives, flecainide, haloperidol (hypotensive effects), H2-antagonists (cimetidine, possibly ranitidine), hydralazine, loop diuretics, possibly MAO inhibitors, phenothiazines, propafenone, quinidine (in extensive metabolizers), ciprofloxacin, thyroid hormones (metoprolol, propranolol, when hypothyroid patient is converted to euthyroid state) Beta-blockers may increase the effect/toxicity of flecainide, haloperidol (hypotensive effects), hydralazine, phenothiazines, acetaminophen, anticoagulants (warfarin), benzodiazepines, clonidine (hypertensive crisis after or during withdrawal of either agent), epinephrine (initial hypertensive episode followed by bradycardia), nifedipine and verapamil lidocaine, ergots (peripheral ischemia), prazosin (postural hypotension) Beta-blockers may affect the action or levels of ethanol, disopyramide, nondepolarizing muscle relaxants and theophylline although the effects are difficult to predict.


Over Dose / Poisoning :

Symptoms of intoxication include cardiac disturbances, CNS toxicity, bronchospasm, hypoglycemia and hyperkalemia. The most common cardiac symptoms include hypotension and bradycardia; atrioventricular block, intraventricular conduction disturbances, cardiogenic shock, and asystole may occur with severe overdose,

especially with membrane-depressant drugs (eg, propranolol); CNS effects include convulsions, coma, and respiratory arrest is commonly seen with propranolol and other membrane-depressant and lipid-soluble drugs.
Treatment includes symptomatic treatment of seizures, hypotension, hyperkalemia and hypoglycemia; bradycardia and hypotension resistant to atropine, isoproterenol or pacing may respond to glucagon; wide QRS defects caused by the membrane-depressant poisoning may respond to hypertonic sodium bicarbonate; repeat-dose charcoal, hemoperfusion, or hemodialysis may be helpful in removal of only those beta-blockers with a small Vd, long half-life or low intrinsic clearance (acebutolol, atenolol, nadolol, sotalol)


Dosage :

Tachyarrhythmias: Children: Initial: 0.5-1 mg/kg/day in divided doses every 6-8 hours; titrate dosage upward every 3-7 days; usual dose: 2-4 mg/kg/day; higher doses may be needed; do not exceed 16 mg/kg/day or 60 mg/day.

Adults: 10-30 mg/dose every 6-8 hours
Elderly: Initial: 10 mg twice daily; increase dosage every 3-7 days; usual dosage range: 10-320 mg given in 2 divided doses Hypertension:
Oral: Children: Initial: 0.5-1 mg/kg/day in divided doses every 6-12 hours; increase gradually every 3-7 days; maximum: 2 mg/kg/24 hours
Adults: Initial: 40 mg twice daily; increase dosage every 3-7 days; usual dose: < or =320 mg divided in 2-3 doses/day; maximum daily dose: 640 mg
Migraine headache prophylaxis: Oral: Children: 0.6-1.5 mg/kg/day or < or =35 kg: 10-20 mg 3 times/day >35 kg: 20-40 mg 3 times/day
Adults: Initial: 80 mg/day divided every 6-8 hours; increase by 20-40 mg/dose every 3-4 weeks to a maximum of 160-240 mg/day given in divided doses every 6-8 hours; if satisfactory response not achieved within 6 weeks of starting therapy, drug should be withdrawn gradually over several weeks
Tetralogy spells: Children: Oral: 1-2 mg/kg/day every 6 hours as needed, may increase by 1 mg/kg/day to a maximum of 5 mg/kg/day, or if refractory may increase slowly to a maximum of 10-15 mg/kg/day Thyrotoxicosis: Adolescents and Adults: Oral: 10-40 mg/dose every 6 hours
Adults: Oral: Angina: 80-320 mg/day in doses divided 2-4 times/day Pheochromocytoma: 30-60 mg/day in divided doses Myocardial infarction prophylaxis: 180-240 mg/day in 3-4 divided doses Hypertrophic subaortic stenosis: 20-40 mg 3-4 times/day Essential tremor: 40 mg twice daily initially; maintenance doses: usually 120-320 mg/day
Dosing adjustment in renal impairment: Clcr 31-40 mL/minute: Administer every 24-36 hours or administer 50% of normal dose Clcr 10-30 mL/minute: Administer every 24-48 hours or administer 50% of normal dose Clcr <10 mL/minute : Administer every 40-60 hours or administer 25% of normal dose
Hemodialysis: Not dialyzable (0% to 5%); supplemental dose is not necessary
Peritoneal dialysis: Supplemental dose is not necessary
Dosing adjustment/comments in hepatic disease: Marked slowing of heart rate may occur in cirrhosis with conventional doses; low initial dose and regular heart rate monitoring


Patient Information :

Take exactly as directed; do not increase, decrease, or discontinue without consulting prescriber. Take at the same time each day. Tablets may be crushed and taken with liquids. Do not alter dietary intake of protein or carbohydrates without consulting prescriber.

You may experience orthostatic hypotension, dizziness, drowsiness, or blurred vision (use caution when driving, climbing stairs,or changing position - rising from sitting or lying to standing - or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or stomach discomfort (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); decreased sexual ability (reversible). If diabetic, monitor serum glucose closely. Report unusual swelling of extremities, difficulty breathing, unresolved cough, or unusual weight gain, cold extremities, persistent diarrhea, confusion, hallucinations, headache, nervousness, lack of improvement, or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.





Comments

0098525, Philippines

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ricci, Philippines

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ASHISHMARBADE, India

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