Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: RPH Pharmaceuticals AB, Lagervägen 7, 136 50 Haninge, Sweden
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 The reported incidence is small and in most cases the symptoms have cleared when the treatment was withdrawn.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.
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.
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. 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.
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 Trandate therapy.
Patients particularly those with ischemic heart disease, should not interrupt/discontinue abruptly Trandate therapy. The dosage should gradually be reduced, i.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.
It is not necessary to discontinue Trandate therapy in patients requiring anaesthesia but the anaesthetist must be informed and the patient should be given intravenous atropine prior to induction. During anaesthesia Trandate 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. If beta-blockade is interrupted in preparation for surgery, therapy should be discontinued for at least 24 hours. Anaesthetic agents causing myocardial depression (e.g. cyclopropane, trichloroethylene) should be avoided. Trandate may enhance the hypotensive effects of halothane.
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.
Beta-blockers may induce bradycardia. If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to the bradycardia, the dosage should be reduced.
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. If bronchospasm should occur after the use of Trandate it can be treated with a beta2-agonist by inhalation, e.g. salbutamol (the dose of which may need to be greater than the usual in asthma) and, if necessary, intravenous atropine 1mg.
Due to a negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart 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.
Patients with a history of psoriasis should take beta-blockers only after careful consideration.
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 reaction.
The label will state "Do not take Trandate if you have a history of wheezing or asthma as it can make your breathing worse."
Trandate Tablets contain sodium benzoate which is a mild irritant to the eyes, nose and mucous membranes. It may increase the risk of jaundice in newborn babies.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Labetalol interferes with laboratory tests for catecholamines.
Concomitant use not recommended:
Use with caution:
Take into account:
Although no teratogenic effects have been demonstrated in animals, Trandate should only be used during the first trimester of pregnancy if the potential benefit outweighs the potential risk. Trandate crosses the placental barrier and the possible consequences of alpha- and beta-adrenoceptor blockade in the foetus and neonate should be borne in mind. Perinatal and neonatal distress (bradycardia, hypotension, respiratory depression, hypoglycaemia, hypothermia) has been rarely reported. Sometimes these symptoms have developed a day or two after birth. Response to supportive measures (e.g. intravenous fluids and glucose) is usually prompt but with severe preeclampsia, particularly after prolonged intravenous labetalol, recovery may be slower. This may be related to diminished liver metabolism in premature babies.
Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period. Intra-uterine and neonatal deaths have been reported with Trandate but other drugs (e.g. vasodilators, respiratory depressants) and the effects of preeclampsia, intra-uterine growth retardation and prematurity were implicated.
Such clinical experience warns against unduly prolonging high dose labetalol and delaying delivery and against co-administration of hydralazine.
Trandate is excreted in breast milk. Breast-feeding is therefore not recommended.
There are no studies on the effect of this medicine on the ability to drive. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.
Most side-effects are transient and occur during the first few weeks of treatment with Trandate. They include:
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.
Cardiac disorders: Bradycardia, heart block, heart failure, hypotension.
Vascular disorders: Ankle oedema, increase of an existing intermittent claudication, postural hypotension, cold or cyanotic extremities, Raynaud’s phenomenon, paraesthesia of the extremities.
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.
Hepato-biliary disorders: Raised liver function tests, jaundice (both hepatocellular and cholestatic), hepatitis and hepatic necrosis.
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.
Reproductive system and breast disorders: Ejaculatory failure.
General disorders and administration site conditions: Hypersensitivity (rash, pruritus, angioedema and dyspnoea), drug fever, masking of the symptoms of thyrotoxicosis or hypoglycaemia, reversible alopecia.
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 via Yellow Card Scheme on the MHRA website (www.mhra.gov.uk/yellowcard).
None stated.
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