Metoprolol 100 Stada/Metoprolol 200 Stada Retard

Metoprolol 100 Stada/Metoprolol 200 Stada Retard

metoprolol

Manufacturer:

Stada

Distributor:

HK Medical Supplies
/
Health Express
Full Prescribing Info
Contents
Metoprolol tartrate.
Description
Metoprolol 100 Stada: 1 tablet contains: Metoprolol Tartrate 100 mg.
Metoprolol 200 Stada Retard: 1 sustained release tablet contains: Metoprolol Tartrate 200 mg.
Excipients/Inactive Ingredients: Metoprolol 100 Stada: Lactose, Poly (1-vinyl-2-pyrrolidone), Croscarmellose sodium, Magnesium stearate, Talcum, Microdispersed Silicon Dioxide.
Metoprolol 200 Stada Retard: Lactose 1 H2O, Maize Starch, Ammonio Methacrylate Copolymer, Talc, Magnesium stearate, Colloidal anhydrous silica, Acetone, Methylhydroxypropylcellulose, Macrogol, Titanium dioxide E171.
Action
Pharmacotherapeutic group: Beta Blockers.
Indications/Uses
High blood pressure (arterial hypertension); Coronary heart disease (angina pectoris); Functional cardiovascular symptoms (hyperkinetic heart syndrome); Rapid forms of cardiac irregularity (tachycardiac arrhythmia); Prophylactic migraine therapy.
Metoprolol 100 Stada: Acute and long-term therapy during and after myocardial infarction.
Metoprolol 200 Stada Retard: Long-term therapy myocardial infarction.
Dosage/Direction for Use
The dosage should be individually determined, based mainly on the pulse rate or on the therapeutical effectiveness and may not be modified without the permission of the doctor.
The following dosage guidelines apply unless otherwise directed.
High blood pressure (hypertension): Once daily 1 tablet Metoprolol 100 Stada; or once daily 1/2-1 modified release tablet Metoprolol 200 Stada Retard.
Coronary heat disease (angina pectoris): Once daily 1 tablet Metoprolol 100 Stada; or once daily 1/2-1 modified release tablet Metoprolol 200 Stada Retard. In the event of night-time angina pectoris, a further 1/2-1 modified release tablet may be given in the evening.
Functional angiocardiopathy (hyperkinetic heart syndrome): Once daily 1/2 - 1 tablet Metoprolol 100 Stada; or once daily 1/2-1 modified release tablet Metoprolol 200 Stada Retard.
Rapid forms of cardiovascular irregularities (tachycardiac arrhythmia), Prophylactic migraine therapy: Once or twice daily 1 tablet Metoprolol 100 Stada; or once daily 1 modified release tablet Metoprolol 200 Stada Retard.
Acute and long-term therapy during and after myocardial infarction: a) Acute therapy (Metoprolol 100 Stada only): In the event of acute myocardial infarction, treatment should be initiated as soon as possible after in-patient admittance with 5 mg Metoprolol i.v. with continuous monitoring of cardiovascular and circulatory parameters (blood pressure, pulse, ECG). Under suitable tolerance conditions, further single doses of 5 mg Metoprolol tartrate should be administered at 2 minute intervals up to a total dose of 15 mg.
If the full dose of 15 mg Metoprolol tartrate i.v. is well tolerated, 25 - 50 mg oral is then administered every 6 hours over 48 hours, starting 15 minutes after the last injection.
b) Maintenance dose (long-term therapy): For subsequent maintenance therapy 1/2 - 1 tablet Metoprolol 100 Stada taken twice daily in 2 single dose; or 1/2-1 modified release tablet Metoprolol 200 Stada Retard taken once daily.
The duration of therapy must be individually established by the physician. Available clinical results would suggest a minimum therapy period of 3 months: the continuation of therapy for 1-3 years is recommended.
In the event of severely restricted hepatic function, the dose should be reduced according to individual circumstances.
Type of administration: The tablets should be taken with some liquid without chewing after a meal.
Frequency and time of administration: With a single daily dose, Metoprolol should be taken in the morning unless otherwise directed, with two doses, in the morning and the evening. Interruption or modification of the dose should only be at the direction of the physician.
Duration of administration: The physician in charge decides the duration of therapy. Any abrupt discontinuation of the therapy must be avoided. This applies in particular to coronary heart disease, as a particular, after longer periods of administration, there exists a possibility of acute deterioration.
If necessary, the metoprolol dose should be reduced by stages during the last 10 days, with the dose in the last 6 days being 25 mg. The patient must be closely monitored during this phase.
Overdosage
An overdose may lead to severe hypotension, cardiac insufficiency, cardiogenic shock or bradycardia up to cardiac arrest. In addition, breathing difficulties, bronchial spasms, vomiting, disturbance of consciousness and generalised spasmodic fits may occur.
In the event of an overdose or critical drop in pulse rate and/or blood pressure, therapy with metoprolol must be discontinued. Consult the physician in charge without delay in case of overdose.
Metoprolol 200 Stada Retard: Therapy of intoxication: In the event of an overdose or critical drop in pulse rate and/or blood pressure, therapy with Metoprolol must be discontinued. Aside from general measures, the vital parameters must be monitored and corrected as necessary under intensive care conditions. The following may be administered as antidotes:
Atropine: 0.5-2 mg intravenous, bolus.
Glucagon: Initially 1-10 mg intravenous, then 2-2.5 mg per hour as sustained perfusion.
Sympathomimetic agents depending on body weight and effect: dobutamine, orciprenaline, adrenaline.
In the event of bradycardia not responding to therapy, a pace-maker therapy should be initiated.
In the event of bronchial spasms, b-sympathomimetic agents may be administered by aerosol (or intravenously in the event of insufficient effect), or aminophylline i.v.
In the event of spasmodic fits, the slow i.v. administration of diazepam is recommended.
Contraindications
Metoprolol should not be used in the event of: Stimulus conduction disorders from the atria to the ventricles (2nd and 3rd degree AV block); sick sinus syndrome; disordered stimulus conduction between sinus nodes and atria (high-grade SA blocks); shock; (manifest) myocardial insufficiency; a resting pulse rate before therapy of less than 50 beats per minute (bradycardia); pathologically low blood pressure (hypotension); superacidity of the blood (acidosis); late stages of peripheral circulatory disturbances; tendency to bronchial spasms (bronchial hyper-reactivity); concurrent administration of MAO inhibitors (except MAO-B-inhibitors); known hypersensitivity to Metoprolol and related derivatives.
Special Precautions
Particularly close medical supervision is imperative in the following cases: Diabetic patients with heavily fluctuating blood-sugar values and in strict fasting; Patients with a hormone-produced tumour of the adrenal medulla (phaeochromocytoma, prior therapy with alpha-blockers necessary); Patients with restricted hepatic function.
With patients who have psoriasis in their personal or family history, beta-receptor blockers should only be prescribed after careful weighing of the benefits versus the risks.
Effect on ability to drive and use machines: Reactions differing from individual to individual may affect the ability to drive motor vehicles or operate machinery. This applies to a stronger degree at the start of therapy, when switching medications as well as in combination with alcohol.
Use In Pregnancy & Lactation
Metoprolol should be used during pregnancy (in particular during the first three months) only after very accurate diagnosis and after evaluation of the benefits and possible risks, as insufficient experience has been gathered to date about such application, particularly in the first weeks of pregnancy. Due to the possibility of the occurrence of bradycardia, hypotension and hypoglycaemia in the newborn, the therapy should be discontinued 48 - 72 hours before the expected date of birth. If this is not possible, the newborn must be carefully monitored for 48 to 72 hours after delivery.
Metoprolol passes over to the breast milk. Although the amount of the active substance ingested with the milk probably represents no risk to the child, infants should be monitored for symptoms of a beta blockade.
Adverse Reactions
Especially at the start of therapy, CNS disturbances such as fatigue, dizziness, depressive moods, lightheadedness, light headache, sweating, sleep disturbances, increased dream activity and hallucinations may occur. These symptoms are normally mild and reversible.
Occasionally temporary gastro-intestinal problems such as nausea, vomiting, abdominal pains, constipation or diarrhoea may occur. Dyspnoea may occur on exertion, rarely bronchial spasms (see Contraindications).
Occasionally, there might be a tingling sensation and a feeling of coldness in the extremities, and rarely, muscle weakness of muscle cramps. Increased discomfort has been observed in patients with intermittent claudication or with angiospasms in toes and fingers (Raynaud's disease).
In rare cases, there may be an increased fall in blood pressure, including on transition from prone to standing positions (orthostatic hypotension) occasionally with unconsciousness, drop in pulse rate, atrioventricular conduction disturbances, increased myocardial insufficiency with peripheral oedema (fluid collection), cardialgia and palpitations.
Rarely to be reckoned with are dryness of the mouth, conjunctivitis, and lessened tear flow (contact lens wearers should pay attention to this).
In individual cases there may be libido and potency disturbances, weight gain, sensitivity to light with the appearance of skin rashes after exposure to light, as well as hair loss, impaired vision, or tinnitus.
In addition, hypersensitivity reactions such as itching, reddening of the skin, skin rash (e.g. dystrophic skin lesions) may occur, and in individual cases changes in hepatic function values, hepatitis, arthritis, a drop on blood platelets (thrombocytopenia) or in leucocytes (leucopenia), allergic coryza or plastic induration of the penis (Peyronie's disease).
An increase (up to gangrenous stages) of existing peripheral circulatory disturbances as well as personality changes (such as mood swings, short-term memory loss) have been described.
In individual cases, beta-receptor blockers can release a psoriasis, make the symptoms of the illness worse or lead to psoriasiform skin eruptions.
Notes: In rare cases, latent diabetes mellitus may appear or an existing condition may worsen; symptoms of lowered blood sugar (e.g. rapid pulse) may be masked.
Patients receiving beta-blockers display a severe form of anaphylactic shock. Treatment of hypertension with this medicine requires regular medical control.
Drug Interactions
The following interactions between the metoprolol and other substances should be noted.
With concurrent administration of metoprolol and insulin or oral hypoglycemic agents, their effect may be intensified; the symptoms of reduced blood sugar concentration (hypoglycaemia), in particular accelerated pulse (tachycardia) are masked or moderated. Regular blood sugar checks are therefore necessary.
Metoprolol can intensify the effect of concurrently administered anti-hypertensive medications (particular caution advised with prazosin). With concurrent administration of nitroglycerine of nifedipine-type calcium antagonists, a stronger drop in blood pressure may occur. With concurrent administration of verapamil or diltiazem-type calcium antagonists or other anti-arrhythmic agents, careful monitoring of the patient is indicated, as fall in blood pressure (hypotension), slowing of the pulse rate (bradycardia) or other cardiac irregularities may occur. During therapy with metoprolol, the intravenous administration of calcium antagonists or other anti-arrhythmic agents should therefore be avoided.
With concurrent administration of adrenaline or other substances with a sympathomimetic action (e.g. contained in cough mixtures, nasal and eye drops), cardioselective beta-blockers in therapeutic doses result in lower hypertensive reactions than non-selective beta-blockers.
With concurrent administration of metoprolol and reserpine, alpha-methyldopa, clonidine, guanfacine or cardiac glycosides, there may be a stronger drop in cardiac frequency or a delay in stimulus conduction in the heart.
With concurrent therapy with clonidine, clonidine may not be discontinued until several days after the discontinuation of the administration of Metoprolol.
Rifampicin lowers and cimetidine increases the plasma concentration of metoprolol.
Indomethacin may reduce the hypotensive effect of metoprolol.
The elimination of other medications may be reduced by Metoprolol (e.g. lidocaine).
The sedative effects of metoprolol and alcohol may be reciprocally intensified.
The effect of metoprolol and an anaesthetic in reducing the force of myocardial contraction may be compounded. For this reason, the anesthetist should be notified of therapy with Metoprolol 100 Stada/Metoprolol 200 Stada Retard.
Storage
Store below 25°C. Keep dry.
MIMS Class
ATC Classification
C07AB02 - metoprolol ; Belongs to the class of selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Metoprolol 100 Stada: Tab 100 mg x 100's.
Metoprolol 200 Stada Retard: Retard tab 200 mg x 100's.
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