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LABETALOL is a brand name for Labetalol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Labetalol is a combined alpha and beta-adrenoceptor blocker indicated for: - Hypertension, including hypertension in pregnancy. - Angina pectoris with existing hypertension.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration only. Labetalol tablets should be taken with food.
Adults:
Hypertension: Initially, 100 mg twice daily. In patients already being treated with antihypertensives and in those of low body weight this may be sufficient to control blood pressure. In others, increases in dose of 100 mg twice daily should be made at intervals of 14 days.
Many patients blood pressure is controlled by 200 mg twice daily. If necessary up to 800 mg daily may be given, as a twice daily regimen. In severe refractory hypertension, daily doses of up to 2400 mg have been given, divided into three or four times a day regimens.
Hypertension in Pregnancy:
An initial dosage of 100 mg twice daily may be increased, if necessary at weekly intervals by 100 mg twice daily. During the second and third trimesters, the severity of hypertension may necessitate a further dose titration to a three times daily regimen ranging from 100 mg – 400 mg three times a day.
The total daily dosage should not exceed 2400 mg. Hospital in-patients with severe hypertension, particularly in pregnancy, may have daily increases in dosage.
Angina Co-Existing with Hypertension:
The recommended dose is that which is necessary to control the hypertension.
Paediatric population:
Labetalol is not recommended for use in children due to a lack of data on safety and efficacy.
Elderly:
An initial dose of 50 mg twice daily is recommended and this has been sufficient in some cases to control hypertension. g. diuretics, methyldopa etc. When transferring patients from such agents, Labetalol tablets should be introduced with a dosage of 100 mg twice daily and the previous therapy gradually decreased.
Abrupt withdrawal of clonidine or beta-blocking agents is undesirable.
Most side effects are transient and occur during the first few weeks of treatment with Labetalol.
They include:
Immune system disorders Very common: Positive antinuclear antibodies unassociated with disease.
Common:
Hypersensitivity (rash, pruritus, angioedema and dyspnoea).
Blood and the lymphatic system disorders Not known:
Hyperkalaemia, particularly in patients who may have impaired renal excretion of potassium, thrombocytopenia.
Psychiatric disorders Not known:
Depressed mood and lethargy, hallucinations, psychoses, confusion, sleep disturbances, nightmares.
Nervous system disorders Common:
Dizziness.
Very rare:
Tremor has been reported in the treatment of hypertension of pregnancy.
Not known:
Headache, tiredness.
Eye disorders Not known:
Impaired vision, dry eyes.
Cardiac disorders Common:
Heart failure.
Rare:
Bradycardia.
Very rare:
Heart block Not known: Hypotension.
Vascular disorders Very rare:
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 discontinuance of the drug should be considered if any such reaction is not otherwise explicable.
There have been reports of severe hepatocellular injury with Labetalol therapy which has occurred after both short-term and long-term treatment and is usually reversible upon withdrawal of the drug. At the first sign or symptom of liver dysfunction appropriate laboratory testing should be carried out.
If there is laboratory evidence of liver injury or the patient is jaundiced, Labetalol should be stopped and not re-started. Particular care should be taken when labetalol is used in patients with hepatic impairment as these patients metabolise labetalol more slowly than patients without hepatic impairment.
Lower doses may be required. The occurrence of Intraoperative Floppy Iris Syndrome (IFIS, a variation of Small Pupil Syndrome) has been observed during cataract surgery in some patients on, or previously treated with, tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded.
As IFIS may lead to increased procedural complications during the cataract operation, current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery. Beta-adrenoceptor blocking drugs reduce cardiac output through their negative inotropic and negative chronotropic effects.
Beta-blockers may therefore cause worsening systolic heart failure or the development of heart failure in patients who depend on high sympathetic drive to maintain cardiac output. Especially in patients with ischaemic heart disease, sudden withdrawal of beta- adrenoceptor blocking drugs may result in anginal attacks of increased frequency or severity.
g. in some diabetics).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Exacerbation of the symptoms of Raynaud’s Syndrome.
Not known:
Ankle oedema, increase of an existing intermittent claudication, postural hypotension is uncommon except at very high doses, or if the initial dose is too high or doses are increased too rapidly. Cold or cyanotic extremities.
Respiratory, thoracic and mediastinal disorders Uncommon:
Bronchospasm (in patients with asthma or a history of asthma).
Not known:
Nasal congestion, interstitial lung disease.
Gastrointestinal disorders Not known:
Epigastric pain, nausea, vomiting, diarrhoea.
Hepatobiliary disorders Common:
Raised liver function tests.
Very rare:
Jaundice (both hepatocellular and cholestatic), hepatitis and hepatic necrosis. When mild, hepatotoxicity is usually reversible on withdrawal of the drug.
Skin and subcutaneous tissue disorders Common:
Tingling sensation in scalp usually transient may occur in a few patients early in treatment.
Not known:
Sweating, reversible lichenoid rash, paraesthesia of the extremities, photosensitivity reactions, systemic lupus erythematous, exacerbation of psoriasis, reversible alopecia.
Musculoskeletal and connective tissue disorders:
Very rare: toxic myopathy, systemic lupus erythematous.
Not known:
Cramps, toxic myopathy.
Renal and urinary disorders Common:
Difficulty in micturition.
Not known:
Acute retention of urine.
Reproductive system and breast disorders Common:
Ejaculatory failure, erectile dysfunction.
Frequency ‘not known’:
Nipple pain, Raynaud's phenomenon of the nipple.
General disorders and administration site conditions Common:
Drug fever.
Not known:
Masking of the symptoms of thyrotoxicosis or hypoglycaemia. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continual monitoring of the benefit/risk balance of the medicinal product.
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e. over 1-2 weeks, and if necessary at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris. In addition, hypertension and arrhythmias may develop. Particular care is required with patients whose cardiac reserve is poor.
Beta- adrenoceptor blocking drugs should be avoided in overt heart failure or poor left ventricular systolic function, although they may be used when cardiac failure has been controlled. A reduction in heart rate (bradycardia) is a pharmacological effect of Labetalol.
In rare cases where symptoms may be attributable to the heart rate decreasing to less than 50-55 beats per minute at rest, the dose should be reduced. Airway obstructions may be aggravated in patients with chronic obstructive pulmonary disorders.
Non-selective beta-blockers, such as Labetalol, should not be used for these patients 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 1 mg. Labetalol should only be given with caution to patients with first-degree heart block due to its negative effect on conduction time.
Patients with liver or kidney insufficiency may need a lower dosage, depending on the pharmacokinetic profile of the compound. Tolerance to Labetalol is usually good in the elderly, however, they should be treated with caution and with a lower starting dose.
Beta adrenoceptor blocking drugs may increase the number and duration of anginal attacks in patients with Prinzmetal’s angina, due to unopposed alpha- receptor mediated coronary artery vasoconstriction. Non-selective beta- blockers, such as Labetalol, should not be used for these patients.
Patients with a history of psoriasis should only be administered beta adrenoceptor blockers after careful consideration. There have been reports of increased sensitivity towards allergens and the seriousness of anaphylactic reactions with the use of beta adrenoceptor blocking drugs.
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 reaction.
Labetalol modifies the tachycardia of hypoglycaemia and it may prolong the hypoglycaemic response to insulin. Care should be exercised during concomitant use of Labetalol and hypoglycaemic therapy in patients with diabetes mellitus.
As with other beta-adrenoceptor blocking drugs, labetalol may mask the symptoms of hypoglycaemia in diabetic patients and thyrotoxicosis. Care is required when transferring patients from clonidine to a beta- adrenoceptor blocking drug.
Labetalol should be introduced with a dosage of 100 mg twice daily and clonidine gradually decreased. Labetalol may prove useful in preventing rebound hypertension following clonidine withdrawal. Because of negative inotropic effects, care is required when prescribing a beta- adrenoceptor blocking drug with class 1 antidysrhythmic agents such as disopyramide.
Beta-adrenoceptor blocking drugs should be used with caution in combination with verapamil where ventricular function is impaired. The combination should not be given to patients with conduction abnormalities, nor should either drug be administered intravenously within 48 hours of discontinuing the other.
Care is required during parenteral administration of preparations containing adrenaline to patients receiving beta-adrenoceptor blocking drugs, as in rare instances vasoconstriction, hypertension and bradycardia may occur. A reduced dosage of adrenaline should be used.
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