Trandate

Trandate

labetalol

Manufacturer:

Aspen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Labetalol HCl
Indications/Uses
Tab: MIld, moderate or severe HTN; HTN in pregnancy; Angina pectoris w/ coexisting HTN. Soln for inj: Severe HTN including severe HTN in pregnancy when rapid BP control is essential; controlled hypotension during anaesth.
Dosage/Direction for Use
Tab Mild, moderate or severe HTN & angina pectoris w/ coexisting HTN Initially 100 mg bd, increase at intervals of 2-14 days. Severe, refractory HTN 2,400 mg daily in 3 or 4 divided doses. HTN in pregnancy Initially 100 mg bd, increase at wkly intervals. Max total dose: 2,400 mg. Severe HTN Adult Bolus inj 50 mg IV for at least 1 min. If necessary, repeat at 5-min intervals until satisfactory response occurs. Max total dose: 200 mg. IV infusion 160 mg/hr, adjusted individually. Dose range: 60-200 mg until satisfactory response is obtained. Severe HTN in pregnancy IV infusion Start infusion at rate of 20 mg/hr & doubled every 30 min until satisfactory response obtained or 160 mg/hr is reached. Hypotensive anaesth 10-20 mg IV, 5-10 mg increments may be given until desired BP is achieved. HTN due to other causes 120-160 mg/hr, until satisfactory response is obtained. Dose range: 50-200 mg. Hypertensive episodes following acute MI Start infusion at 15 mg/hr & gradually increased to a max of 120 mg/hr.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Asthma or history of obstructive airway disease; 2nd- or 3rd-degree heart block, cardiogenic shock, severe & prolonged hypotension or bradycardia; uncompensated heart failure; unstable/uncontrolled heart insufficiency; sick sinus syndrome including sinus atrial block unless pacemaker in situ; Prinzmetal angina; sinus node dysfunction.
Special Precautions
History of severe anapylactic reaction. Discontinue use if evidence of liver injury or jaundice is present. Peripheral arteriolary disease (Raynaud's syndrome, claudicatio intermittens); symptomatic bradycardia; 1st-degree AV block; skin rashes, dry eyes; intraoperative floppy iris syndrome; heart failure or poor left ventricular systolic function, reduced contractility; metabolic acidosis, pheochromocytoma. May mask symptoms of hypoglycaemia & thyrotoxicosis. Avoid abrupt w/drawal. Gradually decrease if co-administered w/ other hypotensives eg, diuretics, methyldopa. Concomitant use w/ adrenaline, inhalational anaesth, Ca antagonists, verapamil or Class I antiarrhythmics. May affect ability to drive or operate machinery. Hepatic impairment. Severe renal impairment (GFR 15-29 mL/min/1.73 m2). Pregnancy & lactation. Paed 0-18 yr. Elderly. Inj: May mask compensatory physiological responses of sudden haemorrhage.
Adverse Reactions
Hypersensitivity, drug fever; CHF; postural hypotension; nasal congestion; raised liver function tests; erectile dysfunction. Tab: Positive anti-nuclear Ab unassociated w/ disease. Lichenoid rash; dizziness, headache, tingling sensation in scalp; blurred vision; nausea; difficulty in micturition; ejaculatory failure; tiredness, lethargy.
Drug Interactions
Reduced hypotensive effect w/ prostaglandin synthetase inhibitors. Additive synergism w/ other antihypertensives. Reduced uptake of metaiodobenzylguanidine radioisotopes. Increased risk of hypotension w/ dihydropyridine Ca antagonists eg, nifedipine. Enhanced digoxin effect in reducing ventricular rate. Bradycardia & HTN w/ adrenaline, Ca antagonists w/ negative inotropic effect eg, verapamil, diltiazem. Increased risk of myocardial depression w/ class I antiarrhythmics eg, disopyramide and quinidine & class II antiarrhythmics eg, amiodarone. Increased risk of bradycardia w/ cholinesterase inhibitors. Increased risk of increased BP w/ α-stimulating adrenergics eg, phenylpropanolamine, adrenaline. Increased risk of vasospastic reactions w/ ergotamine derivates. Increased effect of imipramine. Increased incidence of tremor w/ TCAs. Interference w/ assays of certain fluorescent substances including catecholamines. Tab: Increased bioavailabiltiy w/ cimetidine. Enhanced BP reduction w/ nitrates, antipsychotics (fentiazine derivates eg, chloropromazine), other antipsychotics, antidepressants. Inj: Enhanced hypotensive effects of volatile anaesth.
MIMS Class
Beta-Blockers
ATC Classification
C07AG01 - labetalol ; Belongs to the class of alpha and beta blocking agents. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Trandate FC tab 100 mg
Packing/Price
50's
Form
Trandate soln for inj 5 mg/mL
Packing/Price
5 mL x 5 × 1's
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