Presentation and Status in Health Basket
Presentation | Basket | Yarpa | Pharmasoft |
---|---|---|---|
Slow-Release Tablets 14 X 200 mg |
6872 | 12099 |
Related information
Dosage
The dosage should be adapted to the requirements of the individual patient. The following dosage recommendations may be taken as a guide:
Arrhythmias: 100 to 300 mg daily, given in one to three divided doses.
Hypertension: The daily oral dose is 100 to 200 mg. 1 of the Divitabs early in the morning; if necessary, another antihypertensive can be prescribed in addition. In mild hypertension, ½ of one of the Divitabs taken early in the morning may suffice.
Angina pectoris: The daily oral dose is 100 to 200 mg; if necessary, the daily dose can be increased to 400 mg. ½ or 1 of the Divitabs early in the morning; if necessary, this dose can be repeated in the evening.
Myocardial infarction
Maintenance treatment: The oral maintenance dose is 200 mg daily. The treatment should be continued for at least 3 months. The 200 mg of slow-release preparations (Divitabs) should be taken once daily in the morning. The recommended dosage can be reduced depending on the hemodynamic status of the patient.
Prevention of migraine: The daily oral dose is 100 mg, given as a single dose in the morning; if necessary, the daily dose can be increased to 200 mg. ½ of one of the Divitabs daily, given in the morning; if necessary, the daily dosage can be raised to 1 of the Divitabs, to be taken also as a single dose in the morning.
Paediatric patients: No pediatric studies have been performed. The safety and efficacy of Lopresor Divitabs in paediatric patients have not been established.
Hepatic impairment: Lopresor Divitabs blood levels are likely to increase substantially in patients with hepatic impairment. Therefore, Lopresor Divitabs should be initiated at low doses with cautious gradual dose titration according to clinical response.
Geriatric patients (>65 years): No dose adjustment of Lopresor Divitabs is required in geriatric patients but it should be given with caution due to increased likelihood of adverse events.
Indications
Hypertension, angina pectoris, arrhythmia, prophylaxis of migraine, prophylaxis of reinfarction.
Contra-Indications
Hypersensitivity to metoprolol and related derivatives, or to any of the excipients; hypersensitivity to other beta-blockers (cross-sensitivity between beta-blockers can occur). Atrioventricular block of second or third degree. Decompensated heart failure. Clinically relevant sinus bradycardia (heart rate less than 45 to 50 beats/min). Sick-sinus syndrome. Severe peripheral arterial circulatory disorders. Cardiogenic shock. Untreated phaechromocytoma. Hypotension. Severe bronchial asthma or history of severe bronchospasm. myocardial infarction who have a heart rate of less than 45 to 50 beats/min, P-R interval of greater than 0.24 sec, a systolic blood pressure of less than 100 mmHg, and/or severe heart failure.
Special Precautions
Adverse drug reactions (or constellations of reactions)
Bronchospastic diseases: In general, patients with bronchospastic diseases should not be given beta-blockers, including Lopressor. However, because of its relative cardioselectivity, oral Lopresor divitabs may be administered with caution to patients with mild or moderate bronchospastic diseases who do not respond to, or cannot tolerate, other suitable treatments. Since beta1-selectivity is not absolute, a beta2-agonist should be administered concomitantly, and the lowest possible dose of Lopresor divitabs should be used. Diabetic patients Lopresor divitabs should be used with caution in patients with diabetes mellitus, especially those who are receiving insulin or oral hypoglycemic agents
Diabetic patients: should be warned that beta-blockers including Lopresor divitabs, may mask the tachycardia occurring with hypoglycemia; however, other manifestations of hypoglycemia such as dizziness and sweating may not be significantly suppressed, and sweating may be increased.
Cardiovascular system: Beta-blockers, including Lopresor divitabs, should not be used in patients with untreated congestive heart failure. This condition should first be stabilized. Because of their negative effect on atrioventricular conduction, beta-blockers, including Lopresor divitabs, should be given only with caution to patients with first degree atrioventricular block. If the patient develops increasing bradycardia (heart rate less than 50 to 55 beats/min), the dosage should be gradually reduced or treatment gradually withdrawn.
Myocardial infarction: In patients with myocardial infarction, if significant hypotension occurs, Lopresor divitabs should be discontinued, and the hemodynamic status of the patient and the extent of myocardial ischemia carefully assessed. Intensive hemodynamic monitoring may be required and appropriate treatment modalities should be instituted. If hypotension is associated with significant bradycardia or atrioventricular block, treatment should be directed at reversing these.
Peripheral circulatory disorders: Lopresor divitabs should be used with caution in patients with peripheral arterial circulatory disorders (for example, Raynaud’s disease or phenomenon, intermittent claudication), because beta-blocker treatment may aggravate such conditions.
Pheochromocytoma: In patients known to have, or suspected of having, a pheochromocytoma, Lopresor divitabs should always be given in combination with an alpha-blocker and only after the alpha-blocker has been initiated.
Anesthesia and surgery: Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery. The impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. If a patient treated with Lopresor divitabs needs general anesthesia, the anesthetist should be informed that the patient is receiving a beta-blocker. An anesthetic agent with as little cardio depressant effect as possible should be used. If it is thought necessary to withdraw betablocker, including Lopresor divitabs, therapy before surgery, this should be done gradually and completed about 48 hours before the general anesthetic.
Abrupt withdrawal: Lopresor divitabs treatment should not be stopped suddenly, especially in patients with ischemic heart disease. To prevent exacerbation of angina pectoris, the dosage should be gradually reduced over 1 to 3 weeks and, if necessary, replacement therapy should be initiated at the same time.
Anaphylactic reactions: Anaphylactic reactions precipitated by other agents may be particularly severe in patients taking beta-blockers, and may be resistant to normal doses of adrenaline. Whenever possible, beta-blockers, including Lopressor, should be avoided for patients who are at increased risk of anaphylaxis.
Prinzmetal’s angina: Beta-blockers may increase the number and duration of angina attacks in patients with Prinzmetal’s angina (variant angina pectoris). Relatively selective beta1-receptor blockers, such as Lopresor divitabs, can be used in such patients, but only with the utmost care.
Thyrotoxicosis: Beta-blockers mask some of the clinical signs of thyrotoxicosis. Therefore, where Lopresor divitabs is administered to patients having, or suspected of developing, thyrotoxicosis, both thyroid and cardiac function should be monitored closely.
Oculomucocutaneous syndrome: The full oculomucocutaneous syndrome, has not been reported with Lopresor divitabs. However, part of this syndrome (dry eyes either alone or, occasionally, with skin rashes) has occurred. In most cases the symptoms cleared when Lopresor divitabs treatment was withdrawn. Patients should be observed carefully for potential ocular effects. If such effects occur, gradual discontinuation of Lopresor divitabs should be considered.
Interactions: Calcium channel blocker of the verapamil (phenylalkylamine) type should not be given intravenously to patients receiving Lopresor divitabs because there is a risk of cardiac arrest in this situation.
Special populations
Hepatic impairment: Metoprolol undergoes substantial hepatic first-pass metabolism, and is mainly eliminated by means of hepatic metabolism. Therefore, hepatic impairment may increase the systemic bioavailability of metoprolol and reduce its total clearance, leading to increased plasma concentrations.
Geriatric patients: Elderly patients should be treated cautiously. An excessive decrease in blood pressure or pulse rate may reduce the blood supply to vital organs to inadequate levels.
Driving and using machines: Dizziness, fatigue or visual impairment may occur during treatment with Lopresor divitabs, and may adversely affect the patient’s ability to drive or use machines.
For full details see prescribing information.
Side Effects
Common: dizziness, headache, bradycardia, orthostatic hypotension (occasionally with syncope), exertional dyspnoea, nausea and vomiting, abdominal pain, fatigue.
For full details see prescribing information.
Drug interactions
Observed interactions resulting in concomitant use not being recommended: Calcium channel blockers (IV use), Other antihypertensive drugs, Calcium channel blockers (oral use), Anti-arrhythmic drugs, Nitroglycerin, General anaesthetics, CYP2D6 inhibitors, Hydralazine, Digitalis glycosides, Sympathomimetics, Non-steroidal anti-inflammatory drugs, Hepatic enzyme inducers.
Interactions resulting in effects on other drugs: Anti-adrenergic agents, Antidiabetic drugs and insulin, Lidocaine (xylocaine), Prazosin, Ergot alkaloid, Dipyridamole, Alcohol.
Other drugs causing decrease in heart rate: Concomitant administration of beta-blockers with other drugs known to decrease heart rate such as sphingosine-1-phosphate receptor modulators (e.g. fingolimod) may result in additive heart rate lowering effects.
Other drugs causing decrease in blood pressure: Concomitant administration of beta-blockers with other drugs known to decrease blood pressure such as aldesleukin may result in an enhanced hypotensive effect.
Pregnancy and Lactation
Pregnancy: In general, no drug should be taken during the first 3 months of pregnancy, and the relative benefits and risks of treatment should be carefully considered throughout pregnancy.
Lactation: Small quantities of metoprolol are secreted into breast milk: with therapeutic doses, an infant consuming 1 L of breast milk daily would receive a dose of less than 1 mg of metoprolol. Nevertheless, breast-fed infants should be closely observed for signs of beta-blockade.
See prescribing information for full details.
Overdose
Signs and symptoms: An overdose of Lopresor divitabs may lead to severe hypotension, sinus bradycardia, atrioventricular block, myocardial infarction, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness (or even coma), convulsions, nausea, vomiting, cyanosis and death. Concomitant ingestion of alcohol, antihypertensives, quinidine, or barbiturates aggravates the signs and symptoms. The first manifestations of overdose appear 20 minutes to 2 hours after ingestion of Lopresor divitabs. The effects of massive overdose may persist for several days, despite declining plasma concentrations.
Management: Patients should be admitted to hospital and, generally, should be managed in an intensive care setting, with continuous monitoring of cardiac function, blood gases, and blood biochemistry. Emergency supportive measures such as artificial ventilation or cardiac pacing should be instituted if appropriate. Even apparently well patients who have taken a small overdose should be closely observed for signs of poisoning for at least 4 hours. In the event of a potentially life-threatening oral overdose, use induction of vomiting or gastric lavage (if within 4 hours after ingestion of Lopresor divitabs) and/or activated charcoal to remove the drug from the gastrointestinal tract. Hemodialysis is unlikely to make a useful contribution to metoprolol elimination. Other clinical manifestations of overdose should be managed symptomatically based on modern methods of intensive care. The beta-blocker withdrawal phenomenon may occur after overdose.
For advice on the management of overdose please contact the Poisons Centre.
Important notes
Storage: Store below 30°C.