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Selopres Zok 95mg/12.5mg 20 Tabs, Metroprolol, Hydrochlorothiazi

Selopres Zok 95mg/12.5mg 20 Tabs, Metroprolol, Hydrochlorothiazi
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Selopres Zok 95mg/12.5mg 20 Tabs, Metroprolol, Hydrochlorothiazide

THIS IS A BRAND MEDICATION

DOSAGE AND ADMINISTRATION: SELOPRES® ZOK is a treatment administered once daily, preferably with breakfast. The tablet should be swallowed with liquid and should not be chewed or crushed.

Hypertension: The recommended dose is one tablet SELOPRES® ZOK once daily. In patients who do not meet the recommended dose may need to increase the dose to two tablets once a day or add a vasodilator.

Impaired renal function: SELOPRES® ZOK treatment should be discontinued if renal impairment (see Contraindications and Precautions) becomes apparent.

Impaired liver function: SELOPRES® ZOK should not be given to patients with severe hepatic impairment, since hydrochlorothiazide is contraindicated in these patients.

Elderly: No dose adjustment is necessary in the elderly.

Children: Experience SELOPRES® ZOK therapy in children is limited.




RECOMMENDED STORAGE: Store at room temperature to no more than 30 ° C and dry temperature.




CHANGES IN RESULTS OF LABORATORY TESTS: Metoprolol acts against the increase in renin, which occurs during treatment with diuretics alone. It also counteracts the decrease in serum potassium, which occurs during treatment with diuretics.

SELOPRES® ZOK has been associated in rare occasions thrombocytopenia, leukopenia, agranulocytosis and aplastic anemia.

CONTRAINDICATIONS:

Metoprolol: atrioventricular block second or third degree, decompensated heart failure (pulmonary edema, hypoperfusion or hypotension), and patients receiving continuous or intermittent treatment with inotropic agents acting through beta-receptor agonism, sinus bradycardia clinically important , sick sinus syndrome, cardiogenic shock, severe alterations of peripheral arterial circulation. Metoprolol should not be given to patients with suspected acute myocardial infarction while your heart rate is <45 beats / min, the PQ interval is> 0.24 sec or the systolic blood pressure is <100 mm Hg.

Hydrochlorothiazide: severe liver or renal insufficiency. Hypokalemia and hyponatremia resistant to treatment, hypercalcemia, symptomatic hyperuricaemia, anuria.

SELOPRES® ZOK is contraindicated in patients who have shown hypersensitivity to any component of the product or products.




ADVERSE REACTIONS: In general, SELOPRES® ZOK is well tolerated and adverse reactions reported were mild and reversible. The following events have been reported as adverse events, either in clinical trials or during routine use. In many cases it has not established a relationship with metoprolol, hydrochlorothiazide or metoprolol + hydrochlorothiazide. The following definitions of frequency are used: Very common (³10%), common (1-9.9%), rare (0.1-0.9%), rare (from 0.01 to 0.09%), very rare (less than 0.01%) and unknown (can not be estimated starting from the available data).

metoprolol:

Cardiovascular system:

Common: bradycardia, (very rarely with syncope), cold hands and feet, palpitations, postural disorders.

Uncommon: deterioration of symptoms of heart failure, cardiogenic shock in patients with acute myocardial infarction *, first degree AV block, edema, pericardial pain.

* In a study of 46,000 patients with acute myocardial infarction a difference of 0.4% of cardiogenic shock between the metoprolol group (2.3%) and placebo (1.9%) in a subset of patients group was observed with low level of risk of collision cardiogenic. The risk index is based on the absolute risk of shock in each individual when age was considered, sex, time delay, Killip class, blood pressure, heart rate, abnormal electrocardiogram and history of hypertension. The group of patients with low risk index corresponded to patients who Metoprolol was recommended for use in acute myocardial infarction.

Rare: cardiac conduction disorders, cardiac arrhythmias.

Very rare: Gangrene in patients with pre-existing severe peripheral circulatory disorders.

CNS:

Very common: fatigue.

Common: dizziness, headache.

Uncommon: paresthesia, muscle cramps.

gastrointestinal:

Common: nausea, abdominal pain, diarrhea, constipation.

Uncommon: vomiting.

Rare: dry mouth.

hematologic:

Very rare: thrombocytopenia.

hepatic:

Rare: abnormal liver function tests.

Very rare: hepatitis.

metabolism:

Uncommon: weight gain.

musculoskeletal:

Very rare: arthralgia.

psychiatric:

Uncommon: depression, impaired concentration, drowsiness or insomnia, nightmares.

Rare: nervousness, anxiety, dysfunction / impotence.

Very rare: amnesia / memory impairment, confusion, hallucinations.

respiratory:

Common: dyspnea with exertion.

Uncommon: bronchospasm.

Rare: rhinitis.

Special Senses:

Rare: abnormal vision, dry eyes and / or irritated eyes, conjunctivitis.

Very rare: tinnitus, taste disturbances.

skin:

Uncommon: erythema (in the form of urticaria psoriasiform and dystrophic skin lesions), increased sweating.

Rare: hair loss.

Very rare: photosensitivity reactions, exacerbation of psoriasis.

Hydrochlorothiazide: Generally, the dose of 12.5 mg hydrochlorothiazide used in combination is well tolerated. However, a list of possible undesirable effects that occur with higher doses given.

Cardiovascular system:

Uncommon: orthostatic hypotension.

CNS:

Common: headache, dizziness, vertigo.

Rare: paresthesia.

gastrointestinal:

Uncommon: anorexia, gastric irritation, nausea, vomiting, cramps, diarrhea, constipation.

Rare: pancreatitis.

hematologic:

Rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia.

hepatic:

Rare: intrahepatic cholestasis or jaundice.

metabolism:

Common: hyperuricemia, hyperglycemia, glycosuria, hypokalemia.

psychiatric:

Rare: sleep disturbances, impotence, depression.

Special Senses:

Unknown: Acute myopia and acute angle-closure glaucoma.

skin:

Uncommon: urticaria, erythema, photosensitivity.

Rare: necrotizing angiitis.

other:

Rare: idiosyncrasy.

Use in Pregnancy and Lactation: Because hydrochlorothiazide is not recommended during pregnancy or lactation, fixed combinations should not be used unless there is a clear need.

Metoprolol Metoprolol should not be used during pregnancy and lactation unless its use is considered essential. As with all antihypertensive agents, beta-blockers can cause side effects; eg bradycardia in both the fetus and the newborn or infant.

If the mother is treated with metoprolol in therapeutic doses, the amount ingested through breast milk seems to be negligible in relation to its ß-blocker effect on the infant.

Hydrochlorothiazide like other thiazide diuretics may decrease the plasma volume and plasma uteroplacental circulation. During pregnancy, especially during the first trimester, hydrochlorothiazide only justified by overriding reasons.

Since hydrochlorothiazide seeps into breast milk, should be considered if the medication is stopped, if replaced with metoprolol monotherapy or whether to discontinue nursing.

metoprolol:

Absorption and Distribution Metoprolol is completely absorbed orally. Due to an extensive first pass, the systemic bioavailability of metoprolol from a single oral dose is approximately 50%. Compared with the conventional tablets, the bioavailability is reduced by approximately 20 to 30% for release preparations, however, has not shown any effect on the clinical efficacy as the Area Under the Curve (AUC) effect for heart rate is the same as for conventional tablets. Metoprolol affinity for plasma proteins is low, between 5-10%.

Metabolism and Elimination: Metoprolol passes through an oxidative metabolism in the liver primarily by CYP2D6. We have identified three major metabolites but none of them have beta blockers effects (beta-blockers) of clinical importance.

As a rule, more than 95% of the oral dose may be recovered in urine. Approximately 5% of the administered dose is excreted unchanged in urine, in isolated cases, this excretion can be up to 30%. The elimination half-life of metoprolol is on average 3.5 hours (range one nine hours). The total clearance rate is 1 L / min.

No significant changes in the pharmacokinetics of metoprolol between an old man and a young person. Systemic bioavailability of metoprolol removal and remain unchanged in patients with impaired renal function. However, excretion of metabolites is reduced. In patients with a GFR of less than 5 ml / min was observed significant accumulation of metabolites; However, this accumulation does not increase the effect of ß-blocker.

The pharmacokinetics of metoprolol is little affected during decreased liver function; however, in patients with severe liver cirrhosis and porto-caval shunt may increase the bioavailability of metoprolol and reduce its total clearance. Patients with porto-cava anastomosis had a total clearance of approximately 0.3 L / min and AUC values for plasma concentration over time were six times higher than in healthy subjects.

Hydrochlorothiazide is rapidly absorbed from the gastrointestinal tract with a bioavailability ranging between 60 and 80%. Hydrochlorothiazide is not metabolized and is excreted almost entirely as a medication without changes by the kidney. Hydrochlorothiazide is eliminated from plasma in a biphasic manner with a terminal half-lives ranging from 9-14 hours.

Controlled release metoprolol plus hydrochlorothiazide: Not found no pharmacokinetic interaction between metoprolol and hydrochlorothiazide, or when administered in combination, either conventional or controlled release form.

After being ingested, the tablet rapidly disintegrates allowing spheres disperse in the gastrointestinal tract and release metoprolol continuously for a period of approximately 20 hours.

On average, the elimination half-life of metoprolol is 3.5 hours. Thus, uniform plasma concentration of metoprolol is achieved with a dose interval of 24 hours. The release rate is independent of physiological factors such as pH, food and peristalsis.

After the disintegration of the tablet, hydrochlorothiazide is rapidly absorbed. The plasma concentration profile is similar to other immediate release preparations, reaching peak plasma concentrations after a period of approximately two hours.

pharmacodynamics

Metoprolol Metoprolol is a selective beta1 blocker: blocks beta1 receptors at doses much lower than those required beta2 receptor blockers.

Metoprolol has a negligible effect as membrane stabilizer and shows no partial agonist or stimulant activity.

Metoprolol agonist reduces or inhibits the effect of catecholamines on the heart (such as those released during physical or mental stress). This means that the stimulating effect of acute catecholamine release on the frequency, output and cardiac contractility, as well as on blood pressure is decreased by metoprolol. Metoprolol interferes less with the control that nonselective beta-blockers for the elevated levels of endogenous adrenaline blood pressure.

When so indicated, metoprolol controlled release may be administered to patients with symptoms of obstructive pulmonary disease, provided in conjunction with a beta2 agonist. When controlled-release metoprolol is administered together with a beta2 agonist, at therapeutic doses interferes less with the bronchodilation caused by which beta-blockers nonselective beta2 agonist.

Controlled release Metoprolol interferes less with insulin release and carbohydrate metabolism than non-selective beta-blockers. It also interferes much less in the cardiovascular response to hypoglycaemia than non-selective beta-blockers.

Short term studies have demonstrated that controlled release metoprolol can cause a slight increase in triglyceride and a decrease in free fatty acids in the blood. In some cases, there has been a slight decrease in the fraction of high density lipoproteins, provided the magnitude lower following the use of non-selective beta-blockers; However, in follow-up study for several years, a significant reduction in serum cholesterol levels after treatment with metoprolol was demonstrated.

During treatment with metoprolol controlled release is improved or quality of life is maintained. After treatment with metoprolol, there has been an improvement in the quality of life in patients who have suffered a myocardial infarction.

Effect on Hypertension: Metoprolol controlled release reduces high blood pressure, both standing and lying.

When initiating treatment with metoprolol can be observed a transient effect (hours) and clinically insignificant increase in peripheral resistance.

During long-term treatment, can reduce peripheral resistance due to regression of hypertrophy in arterial resistance vessels.

It has also been shown that antihypertensive treatment with metoprolol long term, there is a reduction in hypertrophy and improvement of left ventricular diastolic function and left ventricular filling.

It has been shown that in men with mild to moderate hypertension, metoprolol reduces the risk of death from cardiovascular diseases, mainly cardiovascular sudden death, as it reduces the risk of both myocardial fatal MI and nonfatal such as cerebral vascular disease.

Hydrochlorothiazide inhibits the reabsorption of sodium, mainly in the distal renal tubule and promotes the excretion of sodium, chloride and water. Renal excretion of potassium and magnesium increases according to the dose, whereas on the other hand suffers greater calcium absorption. It has been shown that a dose of 12.5 mg hydrochlorothiazide is sufficient for diuresis.

Hydrochlorothiazide reduces cardiac output and decreases plasma volume and extracellular fluid. During long-term treatment is reduced peripheral resistance.

Controlled release metoprolol plus hydrochlorothiazide: When adding hydrochlorothiazide 12.5 mg dose of 100 mg metoprolol has been demonstrated that there is an additive antihypertensive effect.

Metoprolol offsetting increased renin, which is known to occur with the use of diuretics as monotherapy. It also counteracts the decrease in serum potassium, which is known to occur during treatment with diuretics.

Controlled release metoprolol provides an effect and a time profile similar to plasma concentration over 24 hours (blocking beta1), which is also achieved during treatment with controlled release metoprolol plus hydrochlorothiazide.

Due to the absence of sharp peaks in plasma concentration, SS1 clinical improvement selectivity formulating controlled release metoprolol as compared to the conventional tablet. In addition, the potential for adverse effects related to peak plasma concentration, as bradycardia and leg fatigue risk is reduced.

Dosage form:

Each tablet contains:

95 mg metoprolol succinate

Hydrochlorothiazide 12.5 mg

Excipient c.b.p. 1 tablet.

INDICATIONS: Hypertension.

DRUG INTERACTIONS:

Metoprolol Metoprolol is a metabolic substrate for the cytochrome P450 isoenzyme CYP2D6. Drugs that act as inducers or inhibitors of enzymes may influence the plasma level of metoprolol. Metoprolol plasma levels can be elevated by co-administration of compounds metabolized by CYP2D6, for example, antiarrhythmic agents, antihistamines, histamine receptor-2, antidepressants, antipsychotics and COX-2 inhibitors. The plasma concentration of metoprolol decreases with rifampicin and can rise with alcohol and hydralazine. Patients receiving concomitant treatment with sympathetic ganglion blocking agents, other beta-blockers (eye drops) or inhibitors of monoamine oxidase (MAO) must keep close watch.

If it were to suspend any concomitant treatment with clonidine, ß-blocker medication should be withdrawn several days before clonidine.

When metoprolol is administered together with calcium antagonists of the verapamil or diltiazem type should be monitored for possible occurrence of negative inotropic and chronotropic. When a patient being treated with beta-blockers, calcium antagonists using the type of verapamil should be avoided by IV The ß-blockers may increase the negative inotropic effects and dromotropic caused by antiarrhythmic agents (quinidine type or amiodarone).

Digitalis glycosides in association with beta-blockers, may increase atrioventricular conduction time and may induce bradycardia.

In patients treated with beta-blockers, use of inhaled anesthetics increase the cardiodepressant effect.

Concomitant treatment with indomethacin or other drugs inhibiting prostaglandin synthetase may diminish the antihypertensive effect of beta-blockers. Under certain circumstances, when used beta-blockers and adrenaline together in some patients using cardioselective ß-blockers interfere much less control, that non-selective beta-blockers blood pressure.

The dose of oral hypoglycemic agents may require adjustment in patients receiving beta-blockers.

Hydrochlorothiazide: Generally, the interactions listed below are only relevant hydrochlorothiazide doses greater than those used in fixed combinations of SELOPRES® ZOK.

Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effects of digitalis (eg, increased ventricular irritability). Hypokalemia may develop during concomitant use of steroids or adrenocorticotropic hormone (ACTH).

Insulin requirements in diabetic patients may increase, decrease or stay.

Thiazides may decrease arterial responsiveness to norepinephrine, but not enough to achieve efficiency of the pressor agent for therapeutic purposes. Thiazides may increase the responsiveness to tubocurarine. The renal clearance of lithium is reduced by thiazides, increasing the risk of lithium toxicity.

LEGENDS OF PROTECTION:

The use of this drug during pregnancy is the responsibility of the physician. Keep out of reach of children. Its sale requires a prescription. Exclusively for medical literature.

DOSAGE AND ADMINISTRATION: SELOPRES® ZOK is a treatment administered once daily, preferably with breakfast. The tablet should be swallowed with liquid and should not be chewed or crushed.
Hypertension: The recommended dose is one tablet SELOPRES® ZOK once daily. In patients who do not meet the recommended dose may need to increase the dose to two tablets once a day or add a vasodilator.
Impaired renal function: SELOPRES® ZOK treatment should be discontinued if renal impairment (see Contraindications and Precautions) becomes apparent.

Impaired liver function: SELOPRES® ZOK should not be given to patients with severe hepatic impairment, since hydrochlorothiazide is contraindicated in these patients.
Elderly: No dose adjustment is necessary in the elderly.
Children: Experience SELOPRES® ZOK therapy in children is limited.

RECOMMENDED STORAGE: Store at room temperature to no more than 30 ° C and dry temperature.

CONTRAINDICATIONS:
Metoprolol: atrioventricular block second or third degree, decompensated heart failure (pulmonary edema, hypoperfusion or hypotension), and patients receiving continuous or intermittent treatment with inotropic agents acting through beta-receptor agonism, sinus bradycardia clinically important , sick sinus syndrome, cardiogenic shock, severe alterations of peripheral arterial circulation. Metoprolol should not be given to patients with suspected acute myocardial infarction while your heart rate is <45 beats / min, the PQ interval is> 0.24 sec or the systolic blood pressure is <100 mm Hg.
Hydrochlorothiazide: severe liver or renal insufficiency. Hypokalemia and hyponatremia resistant to treatment, hypercalcemia, symptomatic hyperuricaemia, anuria.

   
   
   
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