RiteMED Metoprolol

Concise Prescribing Info Manufacturer Info

Concise Prescribing Info
Manufacturer
RiteMED
Distributor
United Lab
Contents
Metoprolol tartrate
Indications / Uses
HTN & angina pectoris.
Dosage / Direction for Use
HTN Initially 100 mg daily, dose may be increased at wkly intervals to max of 400 mg daily.
Angina pectoris Initially 25-50 mg bid, usual dose range of 100-400 mg daily in 2 divided
doses.
Administration
May be taken with or without food.
Contraindications
AV block, refractory heart failure, severe & sinus bradycardia, cardiogenic shock, acute
bronchospasm, MAOIs.
Special Precautions
Hyperthyroidism or thyrotoxicosis, DM, asthma or pulmonary conditions, severe hepatic disease.
Pregnancy.
Side Effects / Adverse Reactions
GI & sleep disturbances, exertional tiredness & lassitude, headache, dizziness.
Interactions
Propafenone & cimetidine increase plasma level. Anesth agents may have additive inotropic
effects.
Preg Safety (US)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or
embryocidal or other) and there are no controlled studies in women or studies in women and
animals are not available. Drugs should be given only if the potential benefit justifies the
potential risk to the foetus.
MIMS Class
Beta-Blockers
ATC Classification
C07AB02 - metoprolol ; Belongs to the class of selective beta-blocking agents. Used in the
treatment of cardiovascular diseases.
Regulatory Classification
Rx
 Concise Info

Metoprolol
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> Dosage Available Brands
> Dosage Details Cardiostat
> Renal Impairment Hypetor
> Hepatic Impairment Neobloc
> Administration Pharex Met...
> Incompatibility RiteMED Me...
> Contraindications
> Special Precaution
> Adverse Drug Reactions
> Pregnancy Category (US FDA) Other Known Brands
> Patient Counselling Angimet
> Monitoring Parameters Betaloc
> Overdosage Betazok
> Drug Interactions Boie Metop...
> Food Interaction Cardiosel
> Mechanism of Action Cardiosel-...
> Storage Cardiotab
> MIMS Class Carditec
Drugmaker'...
Meprobloc

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 Listed in Dosage.
Indications
Adult : PO HTN Conventional tab: Initial: 100 mg/day in single or 2 divided
Dosage doses, may increase wkly to 400 mg/day depending on response. Maintenance:
100-200 mg/day. Extended-release tab: Initially, 25-100 mg once daily. Angina
pectoris 50-100 mg bid or tid. Cardiac arrhythmias 50 mg bid or tid, may
increase to 300 mg/day in divided doses if needed. Stable symptomatic heart
failure Conventional tab: Initial: 12.5-25 mg once daily, increase at 2 wk
intervals to target dose 200 mg once daily if tolerated. Extended release tab: 25
mg once daily for 2 wk, 12.5 mg for patient's w/ severe heart failure. Increase
at 2 wk intervals to target dose 200 mg once daily if tolerated. Adjunct in
hyperthyroidism 50 mg 4 times/day. Migraine prophylaxis Conventional tab:
100-200 mg/day in divided doses. Extended-release tab: 100 mg once daily. IV
Emergency treatment of cardiac arrhythmias Initial: Up to 5 mg at a rate of 1-2
mg/min; may repeat at 5-min intervals if needed up to a total dose of 10-15
mg. Prophylaxis or control of arrhythmias on induction of anaesth 2-4 mg as
slow inj, may repeat injections of 2 mg as necessary. Max: 10 mg. Adjunct in
the early management of acute MI Admin w/in 12 hr of the onset of chest
pain, 5 mg at 2-min intervals to a total of 15 mg, if tolerated. Patients who have
received full IV dose: After 15 min, initiate PO therapy of 50 mg 6 hrly for 2
days. Patients who did not tolerate the full IV dose: Reduced PO dose should be
given as and when their condition permits. Subsequent maintenance: 100 mg
bid (PO). Patients not given an IV inj: 200 mg in 2 or 4 divided doses started
when patient's condition stabilises.
Intravenous
Dosage Details Prophylaxis or control of arrhythmias on induction of anaesthesia
Adult: 2-4 mg as slow inj, may repeat injections of 2 mg as necessary up to max
10 mg.

Intravenous
Adjunct in the early management of acute myocardial infarction
Adult: Admin w/in 12 hr of the onset of chest pain, 5 mg at 2-min intervals to a
total of 15 mg, if tolerated. Patients who have received full IV dose: After 15
min, initiate oral therapy of 50 mg 6 hrly for 2 days. Patients who did not
tolerate the full IV dose: Reduced oral dose should be given as and when their
condition permits. Subsequent maintenance: 100 mg bid (oral). Patients not
given an IV inj: 200 mg in 2 or 4 divided doses started when patient's condition
stabilises.

Intravenous
Emergency treatment of cardiac arrhythmias
Adult: Initially, up to 5 mg at a rate of 1-2 mg/min, may repeat at 5-min
intervals if needed up to a total dose of 10-15 mg.

Oral
Adjunct in hyperthyroidism
Adult: 50 mg 4 times/day.
Oral
Angina pectoris
Adult: Conventional tab: 50-100 mg bid or tid. Extended release tab: 100 mg
once daily. Max: 200 mg once daily.

Oral
Hypertension
Adult: Conventional tab: Initially, 100 mg/day in single or 2 divided doses, may
increase wkly to 400 mg/day depending on response. Maintenance: 100-200
mg/day. Extended-release tab: 25-100 mg once daily.

Oral
Cardiac arrhythmias
Adult: 50 mg bid or tid, may increase to 300 mg/day in divided doses if needed.

Oral
Prophylaxis of migraine
Adult: Conventional tab: 100-200 mg/day in divided doses. Extended release
tab: 100 mg once daily.

Oral
Stable symptomatic heart failure
Adult: Conventional tab: Initially, 12.5-25 mg once daily, may increase at 2 wk
intervals to target dose 200 mg once daily if tolerated. Extended release: 25 mg
once daily for 2 wk, 12.5 mg for patient's w/ severe heart failure. Increase at 2
wk intervals to target dose 200 mg once daily if tolerated.
Renal No dosage adjustment needed.
Impairment

Hepatic Reduce dose.

Impairment
May be taken with or without food.
Administration
Y-site: Amphotericin B, cholesteryl sulfate complex, nitroglycerin, lidocaine.
Incompatibility
2nd or 3rd degree AV block, sick sinus syndrome, hypotension, decompensated
Contraindications heart failure, sinus bradycardia, severe peripheral arterial circulatory disorders,
cardiogenic shock, severe asthma and bronchospasm, untreated
phaeochromocytoma, Prinzmetal's angina, metabolic acidosis.
Patients w/ myasthenia gravis, well-compensated heart failure, bronchospastic
Special disease, AV conduction disorders, substantial cardiomegaly. May mask signs
Precautions and symptoms of hyperthyroidism and hypoglycaemia. Patients w/ history of
cardiac failure or those w/ minimal cardiac reserve. Patients undergoing major
surgery involving general anaesth. Avoid abrupt withdrawal as it may
precipitate thyroid storm or MI, and may exacerbate angina and ventricular
arrhythmias. Hepatic impairment. Pregnancy and lactation.
Dizziness, insomnia, tiredness, headache, vertigo, confusion, bradycardia,
Adverse Drug shortness of breath, hypotension, Raynaud's phenomenon, CHF, peripheral
Reactions oedema, cold extremities, syncope, chest pain, palpitations, gangrene,
claudication, hallucinations, nightmares, visual disturbances; diarrhoea,
constipation, flatulence, GI pain, heartburn, nausea, hiccups, xerostomia;
bronchoconstriction, wheezing, dyspnoea; dry skin, maculopapular,
psoriasiform, pruritus, worsening of psoriasis, urticarial rash. Rarely, Peyronie's
disease, tinnitus, restless legs, musculoskeletal pain, a polymyalgia-like
syndrome, decreased libido, blurred vision, dry mucous membranes, sweating;
reversible alopecia, thrombocytopenia, agranulocytosis, retroperitoneal
fibrosis, wt gain, arthritis, dry eyes.
ROUTE(S) : Parenteral/PO
Pregnancy
Category (US
FDA) Category C: Either studies in animals have revealed adverse effects on the
foetus (teratogenic or embryocidal or other) and there are no controlled
studies in women or studies in women and animals are not available. Drugs
should be given only if the potential benefit justifies the potential risk to the
foetus.

Patient May affect ability to drive or operate machinery.

Counselling
Monitor BP, ECG and heart rate.
Monitoring
Parameters
Symptoms: Symptomatic bradycardia, bronchospasm, hypotension, acute
Overdosage cardiac failure, impaired conduction, decreased cardiac contractility, AV block,
shock, cardiac arrest, cardiogenic shock, impairment of consciousness, nausea,
vomiting, and cyanosis. Management: Supportive and symptomatic treatment.
Perform gastric lavage. Admin atropine sulfate IV for symptomatic bradycardia;
isoproterenol HCL IV for bradycardia; vasopressor (e.g. dopamine,
norepinephrine) for severe hypotension; glucagon IV for hypotension which is
refractory to vasopressors and heart failure; isoproterenol and/or a
theophylline derivative for bronchospasm; cardiac glycoside, oxygen, diuretic
for heart failure.
Additive effect w/ catecholamine-depleting drugs (e.g. reserpine) and MAOIs.
Drug Interactions May antagonise 1-adrenergic stimulating effects of sympathomimetics.
Additive negative effects on SA or AV nodal conduction w/ cardiac glycosides,
nondihydropyridine Ca channel blockers. Paradoxical response to epinephrine
may occur. Increased plasma concentrations w/ CYP2D6 inhibitors (e.g.
bupropion, cimetidine). Increased risk of hypotension and heart failure w/
myocardial depressant general anaesth (e.g. diethyl ether). Risk of pulmonary
HTN w/ vasodilators (e.g. hydralazine) in uraemic patients. Reduced plasma
levels w/ rifampicin. May increase negative inotropic and negative dromotropic
effect of antiarrhythmic drugs (e.g. quinidine, amiodarone). May reduce
antihypertensive efficacy w/ indometacin. May increase effects of
hypoglycaemics.

Food Interaction May increase bioavailability w/ food.

Description: Metoprolol selectively inhibits 1-adrenergic receptors but has
Mechanism of little or no effect on 2-receptors except in high doses. It does not exhibit
Action membrane stabilising or intrinsic sympathomimetic activity.
Onset: 1-2 hr (oral); 20 min, when infused over 10 min (IV).
Duration: Oral: Approx 3-6 hr (immediate-release); approx 24 hr (extended
release). IV: 5-8 hr.
Pharmacokinetics:
Absorption: Absorbed readily and completely for the GI tract. Bioavailability
increased by food. Bioavailability: Approx 50%. Time to peak plasma
concentration: Approx 1.5-2 hr (oral).
Distribution: Widely distributed, enters breast milk, crosses the placenta and
blood-brain barrier. Volume of distribution: 3.2-5.6 L/kg. Plasma protein
binding: Approx 12%.
Metabolism: Extensively hepatic via CYP2D6 isoenzyme and undergoes
oxidative deamination, O-dealkylation followed by oxidation and aliphatic
hydroxylation.
Excretion: Via urine (as metabolites and unchanged drug). Elimination half-life:
3-4 hr (fast hydroxylators); approx 7 hr (poor hydroxylators).

Store between 15-30C.

Storage
 Beta-Blockers
MIMS Class