Betaloc H 100/12.5mg Tab 10s

Side Effects of Betaloc H 100/12.5mg Tab 10s

Fluid and electrolyte imbalance; dizziness, headache, tiredness (do not drive if affected), depression; bradycardia; cold extremities; Raynaud's type phenomena; congestive failure; reduced exercise tolerance; dyspnoea, bronchospasm; gout; impotence; pruritus; rash; nightmares; insomnia; azotemia in renal disease; paraesthesia; palpitation; cough; abdominal pain, anorexia, diarrhoea, nausea, vomiting; arthralgia, myalgia; QTc interval prolongation. Potentially Fatal: Hypersensitivity reactions, hypotension and severe bradycardia.

Drug Interactions

Effects of tubocurarine may be prolonged while corticosteroids may increase the risk of hypokalaemia; may precipitate azotemia in renal patients; increased hypotensive effects with: alcohol, α-blockers, general anaesthetics, hydralazine, levodopa, MAOIs, methyldopa, nitrates, phenothiazines, ACE inhibitors, adrenergic neurone blockers, aldesleukin, alprostadil, antiotensin-II receptor antagonists, TCAs, anxiolytics and hypnotics, baclofen, calcium-channel blockers, clonidine, diazoxide, minoxidil, moxisylyte, moxonidine, sodium nitroprusside, tizanidine; hydrochlorothiazide increases plasma concentration of fluconazole; β-blockers may mask warning signs of hypoglycaemia with antidiabetics, increased hypoglycaemic effect of insulin; hypotensive effect antagonised by corticosteroids, NSAIDs, oestrogens, indomethacin, ketorolac; reduced metoprolol plasma concentration with barbiturates, rifampicin; increased metoprolol plasma concentration with cimetidine, citalopram, escitalopram, paroxetine, propafenone; hypokalaemia potentially caused by hydrochlorothiazide may antagonise action of lidocaine, mexiletine, reboxetine; increased risk of hypokalaemia with acetazolamide, amphotericin, corticosteroids, theophylline; increased risk of hyponatraemia with carbamazepine, chlorpropamide; increased risk of sensitivity with allopurinol (especially in renal impairment); increased risk of hypercalcaemia with calcium salts, toremifene, vitamin D; increased risk of hypermagnesaemia with ciclosporin (and risk of nephrotoxicity); absorption of thiazides reduced by colestipol and colestyramine (take at least 2 hr apart). Potentially Fatal: Catecholamine - depleting drugs such as reserpine, may cause additive effects and precipitate marked hypotension or bradycardia; β-blockers may increase patients' response to allergens and reduce the effectiveness of usual doses of adrenaline in treating allergic reactions; increased levels of metoprolol with artemether/lumefantrine (manufacturer advises to avoid); possible severe hypotension and heart failure with nifedipine, nisoldipine, verapamil; risk of severe hypertension with adrenaline, noradrenaline (norephedrine); increased risk of bradycardia, AV block and myocardial depression with amiodarone (potential risk may last several weeks due to amiodarone's long half life), antiarrhythmics (including cardiac glycosides), diltiazem, flecainide, mefloquine (bradycardia); hydrochlorothiazide may reduce the excretion of lithium, increasing the risk of lithium toxicity; hypokalaemia potentially caused by metoprolol and/or hydrochlorothiazide may increase risk of ventricular arrhythmias with amisulpride, pimozide, atomoxetine, sertindole, cardiac glycosides, disopyramide, flecainide, sotalol; increased risk of nephrotoxicity and ototoxicity with platinum compounds and aminoglycosides.

Contraindications

2nd or 3rd degree AV block, sinus bradycardia, cardiogenic shock, congestive heart failure; anuria; systolic hypotension (<100 mmHg); severe kidney or liver failure; therapy resistant hypokalaemia and hyponatraemia; hypercalcaemia; symptomatic hyperuricaemia; lactation.

Mechanism of Action

Metoprolol is a cardioselective β-blocker causing reduction in heart rate, cardiac output and blood pressure. Hydrochlorothiazide increases renal excretion of sodium and chloride and reduces cardiac load. The two drugs exert additive effects in hypertension. Onset: metoprolol: Peak effect: 1.5-4 hr; hydrochlorothiazide: approx 2 hr for diuresis, peak effect: 4-6 hr. Duration: metoprolol: 10-20 hr; hydrochlorothiazide: 6-12 hr. Absorption: Metoprolol: 95%, rapid and complete; hydrochlorothiazide: approx 50-80%. Absorption and bioavailability of both metoprolol and hydrochlorthiazide are increased when taken with food. Distribution: Protein binding: metoprolol: 12% to albumin. Hydrochlorothiazide: 68%. Distribution of hydrochlorothiazide: 3.6-7.8 l/kg. Metabolism: Metoprolol: extensively 1st pass hepatic metabolism via CYP2D6; bioavailability: approx 50%. Hydrochlorothiazide: not metabolized; bioavailability: 50-80%. Excretion: Metoprolol: half life elimination: 3-8 hr; excreted via urine (<5-10% as unchanged drug). Hydrochlorothiazide: half life elimination: 5.6-14.8 hr; excretion via urine as unchanged drug.

Special Precautions

Renal or hepatic impairment; DM; hyperlipidaemia; hyperuricaemia; left ventricular hypertension and ventricular ectopics; thyrotoxicosis; major surgery; gradual withdrawal; pregnancy; Prinzmetal's angina; reversible obstructive airways disease; elderly; psoriasis; general anaesthesia; not recommended for initial treatment of hypertension.

How to Use

Take orally with food and water, as directed by your physician.

How to Store

Keep in a cool, dry place away from sunlight and moisture.

Safety Concerns

• Alcohol: Avoid during treatment.
• Breastfeeding: Not recommended.
• Pregnancy: Contraindicated.
• Liver/Kidney: Use with caution.

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