METOPROLOL TARTRATE DAWA

Posology The dose must always be adjusted to the individual requirements of the patient.

The following are guidelines:

Cardiac arrhythmias Initially up to 5 mg injected intravenously at a rate of 1-2 mg per minute. The injection can be repeated at 5 minute intervals until a satisfactory response has been obtained. A total dose of 10-15 mg generally proves sufficient.

V. administration of Metoprolol Tartrate Injection to patients with a systolic blood pressure below 100 mmHg should only be given with special care. V. at induction is usually sufficient to prevent the development of arrhythmias during anaesthesia.

The same dosage can also be used to control arrhythmias developing during anaesthesia. Further injections of 2 mg may be given as required to a maximum overall dose of 10 mg. Myocardial infarction Early intervention. To achieve optimal benefits from intravenous Metoprolol Tartrate Injection, suitable patients should present within 12 hours of the onset of chest pain.

Intravenous Metoprolol Tartrate Injection should be initiated in a coronary care or similar unit when the patient’s haemodynamic condition has stabilised. V. every 2 minutes to a maximum of 15 mg total as determined by blood pressure and heart rate.

26 seconds, or if there is any aggravation of dyspnoea or cold sweating. Oral therapy should commence 15 minutes after the last injection with 50 mg every 6 hours for 48 hours. Patients who fail to tolerate the full intravenous dose should be given half the suggested oral dose.

Renal impairment Dose adjustment is generally not needed in patients with impaired renal function. Hepatic Impairment Dose adjustment is normally not needed in patients suffering from liver cirrhosis because metoprolol has a low protein binding (5 – 10 %).

However, in patients with severe hepatic dysfunction a reduction in dosage may be necessary. Elderly Several studies indicate that age related physiological changes have negligible effects on the pharmacokinetics of metoprolol. Dose adjustment is not needed in the elderly, but careful dose titration is important in all patients.

Paediatric population:

The safety and efficacy of metoprolol in children has not been established.

Metoprolol is well tolerated and adverse reactions have generally been mild and reversible. The following events have been reported as adverse events in clinical trials or reported from routine use.

The following definitions of frequencies are used:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). System Organ Class Frequency Undesirable Effect Infections and infestations Very rare Gangrene in patients with pre-existing severe peripheral circulatory disorders Blood and lymphatic system disorders Very rare Thrombocytopenia Uncommon Depression, insomnia, nightmares Rare Nervousness, anxiety Psychiatric disorders Very rare Confusion, hallucinations Common Dizziness, headache Uncommon Concentration impairment, somnolence, paraesthesia Nervous system disorders Very rare Amnesia/memory impairment, taste disturbances Eye disorders Rare Disturbances of vision, dry and/or irritated eyes, conjunctivitis Ear and labyrinth disorders Very rare Tinnitus Common Bradycardia, palpitations Uncommon Deterioration of heart failure symptoms, cardiogenic shock in patients with acute myocardial infarction*, first degree heart block Cardiac disorders Rare Disturbances of cardiac conduction, cardiac arrhythmias, increased existing AV block Common Postural disorders (very rarely with syncope) Rare Raynaud’s phenomenon Vascular disorders Very rare Increase of pre-existing intermittent claudication Common Dyspnoea on exertion Uncommon Bronchospasm Respiratory, thoracic and mediastinal disorders Rare Rhinitis Common Nausea, abdominal pain, diarrhoea, constipation Uncommon Vomiting Gastrointestinal disorders Rare Dry mouth Hepatobiliary disorders Very rare Hepatitis Uncommon Rash (in the form of psoriasiform urticaria and dystrophic skin lesions), increased sweating Rare Loss of hair Skin and subcutaneous tissue disorders Very rare Photosensitivity reactions, aggravated psoriasis Very rare ArthralgiaMusculoskeletal and connective tissue disorders Uncommon Muscle cramps Reproductive system and breast disorders Rare Impotence/sexual dysfunction Very common Fatigue Common Cold hands and feet General disorders and administration site disorders Uncommon Precordial pain, oedema Uncommon Weight gainInvestigations Rare Liver function test abnormalities, positive anti-nuclear antibodies (not associated with SLE).

When treating patients with suspected or definite myocardial infarction the haemodynamic status of the patient should be carefully monitored after each of the three 5 mg intravenous doses. 26 sec, or if there is any aggravation of dyspnoea or cold sweating Metoprolol Tartrate Injection, as with other beta blockers: • Should not be withdrawn abruptly during oral treatment.

V. should be withdrawn gradually over a period of 10 – 14 days, in diminishing doses to 25 mg daily for the last 6 days. During its withdrawal patients should be kept under close surveillance, especially those with known ischaemic heart disease.

The risk for coronary events, including sudden death, may increase during the withdrawal of beta-blockade. • Must be reported to the anaesthetist prior to general anaesthesia. V. treatment in patients undergoing surgery. If withdrawal of metoprolol is considered desirable, this should, if possible, be completed at least 48 hours before general anaesthesia.

Routine initiation of high-dose metoprolol to patients undergoing non-cardiac surgery should be avoided, since it has been associated with bradycardia, hypotension, stroke and increased mortality in patients with cardiovascular risk factors.

However, in some patients it may be desirable to employ a beta- blocker as premedication. In such cases an anaesthetic with little negative inotropic activity should be selected to minimise the risk of myocardial depression. 3), may also aggravate less severe peripheral arterial circulatory disorders.

• May be administered when heart failure has been controlled. Digitalisation and/or diuretic therapy should also be considered for patients with a history of heart failure, or patients known to have a poor cardiac reserve. V. should be used with caution in patients where cardiac reserve is poor.

V. dosage should be reduced or gradually withdrawn. • Due to the negative effect on conduction time, should only be given with caution to patients with first-degree heart block. • May increase the number and duration of angina attacks in patients with Prinzmetal’s angina, due to unopposed alpha-receptor mediated coronary artery vasoconstriction.

1. • Hypotension. • AV block of second- or third-degree. • Unstable decompensated cardiac failure (pulmonary oedema, hypoperfusion or hypotension). • Continuous or intermittent inotropic therapy acting through beta receptor agonism. • Bradycardia (<45 bpm).

• Sick sinus syndrome (unless a permanent pacemaker is in place). • Cardiogenic shock. • Severe peripheral arterial circulatory disorder. • Untreated phaeochromocytoma. • Metabolic acidosis. Known hypersensitivity to any component of Metoprolol Tartrate Injection or other beta-blockers.

24 sec) or systolic blood pressure <100 mmHg and/or severe heart failure.