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LABETALOL SYNCHRONY is a brand name for Labetalol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Labetalol Injection is indicated for the treatment of: - Severe hypertension, including severe hypertension of pregnancy, when rapid control of blood pressure is essential. - Anaesthesia when a hypotensive technique is indicated. - Hypertensive episodes following acute myocardial infarction.
Verbatim from this product's MHRA label. Tap a section to expand.
Adults:
Labetalol injection is intended for intravenous use in hospitalised patients. The plasma concentrations achieved after intravenous dose of labetalol in severe hypertension are substantially greater than those following oral administration of the drug and provide a greater degree of blockade of alpha-adrenoceptors necessary to control the more severe disease.
Patients should, therefore, always receive the drug whilst in the supine or left lateral position. Raising the patient into the upright position, within three hours of intravenous labetalol administration, should be avoided since excessive postural hypotension may occur.
Bolus injection:
If it is essential to reduce blood pressure quickly, as for example in hypertensive encephalopathy, a dose of 50mg of labetalol hydrochloride should be given by intravenous injection (over a period of at least one minute). If necessary, doses of 50mg may be repeated at five minute intervals until a satisfactory response occurs.
The total dosage should not exceed 200mg. After bolus injection, the maximum effect usually occurs within five minutes and the effective duration of action is usually about 6 hours but may be as long as 18 hours. 6) An alternative method of administering labetalol is intravenous infusion of a solution made by diluting the contents of four 10ml ampoules (200mg) to 200ml with Sodium Chloride and Dextrose Injection, 5% dextrose Intravenous Infusion, Potassium Chloride and Glucose solution or Ringer Lactate.
The resultant infusion solution contains 1 mg/ml of labetalol hydrochloride. It should be administered using a paediatric giving set fitted with a 50 ml graduated burette to facilitate dosage.
In hypertension due to other causes:
The rate of infusion of labetalol hydrochloride should be about 2mg (2ml of infusion solution) per minute, until a satisfactory response is obtained; the infusion should then be stopped. The effective dose is usually in the range of 50-200mg depending on the severity of the hypertension.
For most patients it is unnecessary to administer more than 200mg but larger doses may be required, especially in patients with phaeochromocytoma. The rate of infusion may be adjusted according to the response, at the discretion of the physician.
Summary of safety profile Labetalol injection is usually well tolerated. Excessive postural hypotension may occur if patients are allowed to assume an upright position within three hours of receiving labetalol injection. Tabulated list of undesirable effects The frequency of adverse reactions is defined as follows: Very common 1/10 Common 1/100 <1/10 Sometimes 1/1000 <1/100 Rarely 1/10,000 < 1/1000 Very rarely < 1/10,000 Undesirable effects marked with a hash sign (#), Most side-effects are transient and occur during the first few weeks of treatment with labetalol.
They include:
System Organ Class Undesired effect Common Congestive heart failure Rarely Bradycardia Cardiac disorders Very rarely Heart block Common Postural hypotensionVascular disorder Very rarely Worsening of the symptoms of Raynaud’s syndrome Common Nasal congestionRespiratory, thoracic, and mediastinal disorders Rarely Bronchospasm Hepato-biliary disorders Common Raised liver function tests Very rarely Hepatitis, hepatocellular jaundice cholestatic jaundice, hepatic necrosis Common Erectile dysfunctionReproductive system and breast disorders Frequency not known Nipple pain, Raynaud's phenomenon of the nipple Description of some undesired effects: Blood and the lymphatic system disorders Rare reports of positive antinuclear antibodies unassociated with disease, hyperkalaemia, particularly in patients who may have impaired renal excretion of potassium, thrombocytopenia.
Psychiatric disorders Depressed mood and lethargy, hallucinations, psychoses, confusion, sleep disturbances, nightmares. Nervous system disorders Headache, tiredness, dizziness, tremor has been reported in the treatment of hypertension of pregnancy.
Eye disorders Impaired vision, dry eyes. Respiratory, thoracic and mediastinal disorders Bronchospasm (in patients with asthma or a history of asthma), nasal congestion, interstitial lung disease. Gastrointestinal disorders Epigastric pain, nausea, vomiting, diarrhoea.
Liver Disease There have been rare reports of severe hepatocellular injury with labetalol therapy. The hepatic injury is usually reversible and has occurred after both short and long term treatment. There have been reports of fatal hepatic necrosis.
Appropriate laboratory testing should be done at the first sign or symptom of liver dysfunction. If there is laboratory evidence of liver injury or the patient is jaundiced, labetalol therapy should be stopped and not re-started. Extra caution needs to be taken when labetalol is used in patients with liver dysfunction, as these patients metabolize labetalol slower than patients without liver dysfunction.
Peripheral circulatory disorders In patients with peripheral circulatory disorders (Raynaud’s disease or syndrome, intermittent claudication), beta-blockers should be used with great caution as aggravation of these disorders may occur.
Symptomatic Bradycardia Beta-blockers may induce bradycardia. If the pulse rate decreases to less than 50-55 beats per minute at rest and if the patient experiences symptoms related to bradycardia, the dosage of Labetalol should be reduced.
First degree atrioventricular block Due to the negative effect of beta-adrenergic blocking agents on the atrioventricular conduction time, labetalol needs to be administered with caution to patients with first degree atrioventricular block.
Patients with liver or kidney insufficiency may need a lower dosage, depending on the pharmacokinetic profile of the compound. The elderly should be treated with caution, starting with a lower dosage but tolerance is usually good in the elderly.
Hypersensitivity to beta-blockers Risk of anaphylactic reaction:
While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
1 • History of wheezing or asthma. • Second or third degree heart block. • Cardiogenic shock. • Hypotension. • Bradycardia (<45-50bpm). • Uncontrolled, incipient or digitalis refractory heart failure. • Sick sinus syndrome (including sino-atrial block).
• Prinzmetal’s angina. • Untreated phaechromocytoma • Metabolic acidosis • Severe peripheral circulatory disturbances. Where peripheral vasoconstriction suggests low cardiac output, the use of labetalol to control hypertensive episodes following acute myocardial infarction is contra-indicated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The blood pressure and pulse rate should be monitored throughout the infusion. It is desirable to monitor the heart rate after injection and during infusion. In most patients, there is a small decrease in the heart rate; severe bradycardia is unusual but may be controlled by injecting atropine 1-2 mg intravenously.
Respiratory function should be observed particularly in patients with any known impairment. Once the blood pressure has been adequately reduced, maintenance therapy with labetalol tablets should be instituted with a starting dose of one 100 mg tablet twice daily (see labetalol tablet SmPC for further details).
Labetalol Injection has been administered to patients with uncontrolled hypertension already receiving other hypotensive Indication Dosage agents, including beta-blocking drugs, without adverse effects.
In the hypertension of pregnancy:
In severe cases of hypertension of pregnancy a lower, increasing infusion rate needs to be administered. The infusion needs to be started at the rate of 20mg/ hour, and this dose may be doubled every 30 minutes until a satisfactory result has been obtained, or a dosage of 160mg/hour is reached.
Occasionally, higher doses may be necessary.
In hypertensive episodes following acute myocardial infarction:
The infusion should be commenced at 15mg per hour and gradually increased to a maximum of 120mg per hour depending on the control of blood pressure. g. sodium thiopentone) and anaesthesia maintained with nitrous oxide and oxygen with or without halothane.
The recommended starting dose of Labetalol injection is 10-20mg intravenously, depending on the age and condition of the patient. Patients for whom halothane is contraindicated usually require a higher initial dose of labetalol hydrochloride (25-30 mg).
If satisfactory hypotension is not achieved after five minutes, increments of 5-10mg should be given until the desired level of blood pressure is attained. 5% as profound falls in blood pressure may be precipitated. Following labetalol injection the blood pressure can be quickly and easily adjusted by altering the halothane concentration and/or adjusting table tilt.
The mean duration of hypotension following 20 to 25mg of labetalol is 50 minutes. 6 mg and discontinuation of halothane. Tubocurarine and pancuronium may be used when assisted or controlled ventilation is required. Intermittent Positive Pressure Ventilation (IPPV) may further increase the hypotension resulting from labetalol injection and/or halothane.
Paediatric population:
The safety and efficacy of Labetalol administered to children from 0 to 18 years of age have not been established. No data are available.
Skin and subcutaneous tissue disorders Sweating, tingling sensation in the scalp, usually transient, may occur in a few patients early in treatment, reversible lichenoid rash, systemic lupus erythematosus, exacerbation of psoriasis.
Musculoskeletal, connective tissue and bone disorders:
Cramps, toxic myopathy. Renal and urinary disorders Acute retention of urine, difficulty in micturition. General disorders and administration site conditions Drug fever, masking of the symptoms of thyrotoxicosis or hypoglycaemia, reversible alopecia.
Immune system disorder:
Reports of hypersensitivity include rash, pruritus, angioedema and dyspnea.
Vascular disorders:
Ankle oedema, increase of an existing intermittent claudication, cold or cyanotic extremities, Raynaud’s phenomenon, paraesthesia of the extremities. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions through the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Skin rashes and/or dry eyes There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenoceptor blocking drugs. The reported incidence is small and in most cases the symptoms have cleared when the treatment was withdrawn.
Gradual discontinuation of the drug should be considered if any such reaction is not otherwise explicable. Intraoperative floppy iris syndrome The occurrence of intraoperative floppy iris syndrome (IFIS, a variation of Horner’s syndrome) has been observed during cataract surgeries in some patients who were being treated with tamsulosine, or have been treated with tamsulosine in the past.
IFIS has also been reported when other alpha- 1- blockers were being used, and the possibility of a class effect cannot be excluded. Since IFIS can lead to a higher chance of complications during cataract surgeries, the ophthalmologist needs to be informed if alpha-1- blockers are currently being used, or have been used in the past.
Heart failure or ischemic heart disease Due to negative inotropic effects, special care should be taken with patients whose cardiac reserve is poor and heart failure should be controlled before starting labetalol therapy. Patients, particularly those with ischemic heart disease, should not interrupt or discontinue abruptly labetalol therapy.
e. over 1-2 weeks, if necessary at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris. In addition, hypertension and arrhythmias may develop. Anaesthetics It is not necessary to discontinue labetalol therapy in patients requiring anaesthesia, but the anaesthetist must be informed and the patient should be given intravenous atropine prior to induction.
During anaesthesia labetalol may mask the compensatory physiological responses to sudden haemorrhage (tachycardia and vasoconstriction). Close attention must therefore be paid to blood loss, and the blood volume maintained. g. cyclopropane, trichloroethylene) should be avoided.
Labetalol may enhance the hypotensive effects of halothane. Asthma and obstructive airways disease Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with asthma or a history of obstructive airways disease unless no alternative treatment is available.
In such cases the risk of inducing bronchospasm should be appreciated and appropriate precautions taken. g. salbutamol (the dose of which may need to be greater than the usual in asthma) and, if necessary, intravenous atropine 1mg. Psoriasis Patients with a history of psoriasis should take beta-blockers only after careful consideration.
Sodium This medicinal product contains less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium-free’.