Adalat OROS 30 mg. 28 tablets

BAYER
Adalat OROS 30 mg. 28 tablets
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Active substance: nifedipine antianginal / antihypertensive drug Prolonged-release tablet

ADALAT OROS 30
1 prolonged-release tablet contains 30 nig nifedipine
 
Nifedipine is a calcium antagonist of the dihydropyridine type 1.4. Calcium antagonists reduce the transmembranal influx of calcium ions through the slow calcium channel in the cell. Nifedipine acts particularly on the cells of the myocardium and smooth muscle cells in the coronary arteries and peripheral resistance of nifedipine sadovete.V heart expands the coronary arteries, especially large vessels, even in the vacant portions of the partially stenosed fields. Nifedipine reduces the tone of vascular smooth muscle in the coronary arteries and prevents vasospasm. The end result is an increase in blood flow poststenotic and increased oxygen supply. Parallel to this, nifedipine reduces oxygen demand by reducing peripheral resistance (afterload). After prolonged use nifedipine can also prevent the formation of new atherosclerotic lesions in the coronary arterii.Nifedipine reduces the tonus of the smooth muscle in the arterioles, thereby decreasing the increased peripheral resistance and consequently the blood pressure. At the beginning of treatment with nifedipine may be transient reflex increase in heart rate and cardiac output. This speed is not enough to compensate for vasodilatation. Additional nifedipine increases excretion of sodium and water in short and long term use. Lowering effect on blood pressure of nifedipine is especially well developed in patients with arterial hipertoniya.V multinational, randomized, double-blind, prospective study in which recruited 6321 patients presenting with at least one risk factor for 3 to 4.8 years, Adalat (Nifedipin GITS) is proven to reduce cardiovascular and cerebral events in comparative like standard diuretic combination. The composition of the tablets Adalat OROS 30 is intended to release the nifedipine at an approximately constant rate over 24 hours. Nifedipine! is released from the tablet at a speed of zero order controlled by the membrane, an osmotic push-pull process. The release rate is independent otstomashno-intestinal pH or peristalsis. After uptake the biologically inert components of the tablet remain intact during passage through the gastrointestinal tract and is eliminated in the feces as an insoluble shell.
 
indications
1. Treatment of coronary heart disease
-Hronichna Stable angina (angina on exertion)
 
2. Treatment of arterial hypertension
Treatment of 6321 patients presenting with at least one risk factor in a multinational, randomized, double-blind, prospective study, which recruited for 3 to 4.8 years. It has been shown that Adalat (Nifedipin GITS) reduce cardiovascular and cerebrovascular accidents in comparable degree with a standard combination of diuretics.
 
Dosage (dose interval)
As far as possible, treatment should be tailored to the needs of patsienta.V depending on the clinical condition of the main dose should be gradually introduced in each case. In patients with impaired hepatic function should be carefully monitored and in severe cases, a dose reduction.
 
Duration of treatment
Your doctor will determine the duration of treatment.
 
application
  As a rule, the tablets should be swallowed whole with some liquid, regardless of effort)
2. To treat hypertension: 1 tablet once daily (1 x 30 mg / day) diet.
 
Contraindications
Tablets should not be chewed or crushed!
Adalat OROS should not be used in patients with known hypersensitivity to nifedipine.Nifedipine should not be used during pregnancy and karmene.Nifedipine should not be used in case of cardiovascular shok.Nifedipine should not be used in combination with rifampicin, due to receipt of ineffective plasma levels of nifedipine, due to enzyme induction.
 
Special warnings and precautions for use
Be used with caution in patients with very low blood pressure (severe hypotension with systolic blood pressure lower than 90 mm Hg), in cases of overt heart failure and in cases of severe aortic stenosis. As with other non-fissile materials (see instructions for use) Adalat OROS 30 should be used with caution in patients with pre-existing severe gastrointestinal narrowing, due to possible occurrence of obstructive symptoms. In very rare cases can form stones and surgicsl interventsiya.V single cases described symptoms of obstructive symptoms with no history of gastrointestinal narusheniya.Adalat OROS 30 should not be used in patients with Kock pouch (ileostomy after proctocolectomy) .For contrast x-ray with barium Adalat OROS may cause falshivopolozhitelni effects (eg. filling defects interpreted as polyp) .Vnimatelno not be used in pregnant women when used in combination with nifedipine magnesium sulfate iv (see Contraindications). In patients with impaired liver function should be carefully monitored and in severe cases it may be necessary to reduce the dose.
 
Effects on ability to drive and use machines
Reactions to the drug, which vary in intensity in different individuals may impair ability to drive or operate machinery. This applies especially to the beginning of the treatment, on changing the medication and in combination with alcohol.
 
Drug Interactions Interactions with other drugs
The effect of lowering the blood pressure of nifedipine can be enhanced by other antihypertensives lekarstva.Kogato nifedipine is administered simultaneously with the beta-blockers. the patient should be carefully monitored, as can be seen quite heavy hipotonii. It is also known worsening heart failure in some cases.
Nifedipine is metabolized by cytochrome P450 ZA4. located in the intestinal mucosa and in the liver. Drugs which are known to inhibit or induce this enzyme system may therefore alter the first pass (after oral administration) or the clearance of nifedipine.
digoxin
Co-administration of nifedipine and digoxin may lead to reduced digoxin clearance and hence an increase in plasma concentrations of digoxin. Therefore, as a precaution, the patient should be examined for symptoms of digoxin overdose and, if necessary glycoside dose should be reduced by taking the plasma kontsentratsiya.indutsira cytochrome P450 ZA4. When co-administered with phenytoin, the bioavailability of nifedipine is reduced and thus its efficacy weakened. When two drugs are administered at the same time must be monitored clinical response to nifedipine and if necessary to increase the dose of nifedipine. If the dose of nifedipine is increased during co-administration of both drugs, the dose of nifedipine should be reduced when phenytoin is prekasva.Kogato nifedipine and quinidine are administered simultaneously, the concentration of quinidine is reduced or after discontinuation of nifedipine, in some cases there was a significant increase in the plasma concentration of quinidine. For this reason, when nifedipine is included additionally or withdrawn it is recommended to monitor the plasma concentration of quinidine, and if necessary, adjust the dosage of quinidine. Some authors reported increased plasma concentrations of nifedipine during concomitant administration of both drugs, while others did not observe changes in the pharmacokinetics of nifedipine. Therefore, blood pressure should be carefully monitored if quinidine is added to an existing therapy with nifedipine. If necessary, the dose of nifedipine should be decreased.
Quinupristin / Dalfopristin
Co-administration of quinupristin / dalfopristin and nifedipine may lead to increased plasma concentrations of nifedipine. Simultaneous administration of both drugs, blood pressure should be monitored and, if necessary to reduce the dose of nifedipine.
Pimetidin
Due to its inhibition of cytochrome P450 ZA4, cimetidine increases the plasma concentrations of nifedipine and may potentiate the antihypertensive effect.
rifampicin
Rifampicin strongly accelerates the cytochrome P450 ZA4. When co-administered with rifampicin, the bioavailability of nifedipine is distinctly reduced and thus its efficacy weakened. Accordingly, the use of nifedipine in combination with rifampicin is contraindicated.
diltiazem
Diltiazem decreases the clearance of nifedipine. The combination of both drugs should be used with caution and may be given to decreasing the dose of nifedipine.
Grapefruit juice
Grapefruit juice inhibits cytochrome P450 ZA4. The administration of nifedipine together with grapefruit juice results in increased plasma concentrations of nifedipine, due to decreased first-pass metabolism. Subsequently can be enhanced effect of lowering blood pressure. After regular intake of grapefruit juice this effect may last for at least three days after the last intake of grapefruit juice.
cisapride
Co-administration of cisapride and nifedipine may lead to elevated plasma concentrations of nifedipine. Simultaneous administration of both drugs should be monitored blood pressure and if necessary to reduce the dose of nifedipine.
 
Theoretically potential interactions
erythromycin
No studies on the interaction of nifedipine and erythromycin. It is known that erythromycin inhibits cytochrome P450 ZA4 mediated metabolism of other drugs. It can not therefore exclude a potential for increasing plasma concentrations of nifedipine during concomitant administration of both drugs.
fluoxetine
Not yet conducted a clinical trial to study the potential interaction between nifedipine and fluoxetine. It has been shown that fluoxetine inhibits in vitro the cytochrome P450-mediated metabolism of ZA4 nifedipine. It can not therefore be ruled increase plasma concentrations of nifedipine during concomitant administration of both drugs. When fluoxetine is administered with nifedipine, blood pressure should be monitored and, if necessary to reduce the dose of nifedipine.
Amprenavir. indinavir. nelfinavir. ritonavir. sagvinavir not yet conducted a clinical study to investigate the potential interaction between nifedipine and amprenavir indanavir, nelfinavir, ritonavir, sagvinavir. It is known that drugs of this class inhibit cytochrome P450 ZA4. Additionally, it is known that indinavir and ritonavir to inhibit in vitro the cytochrome P450-mediated metabolism of ZA4 nifedipine. When administered together with nifedipine, may not be a significant increase in plasma concentrations of nifedipine, due to decreased first-pass metabolism and decreased elimination. When co-administered blood pressure should be monitored and, if necessary to reduce the dose of nifedipine.
 
nefazodone
Not yet conducted a clinical trial to study the potential interaction between nifedipine and nefazodone. It is known that nefazodone inhibits in vitro the cytochrome P450 ZA4 mediated metabolism of other drugs. It can not therefore be ruled increase plasma concentrations of nifedipine during concomitant administration of both drugs. Nefazodone when administered with nifedipine, blood pressure should be monitored and, if necessary to reduce the dose of nifedipine.
Ketoconazole. itraconazole. fluconazole
Not yet conducted a formal clinical study to investigate the potential interaction between nifedipine and ketoconazole. itraconazole. fluconazole. Drugs of this class are known to inhibit the cytochrome P450 system, ZA4. When administered orally together with nifedipine, may not be a significant increase in the systemic bioavailability of nifedipine, due to decreased first-pass metabolism. When co-administered blood pressure should be monitored and, if necessary to reduce the dose of nifedipine.
tacrolimus
Tacrolimus is metabolized by cytochrome P450 ZA4. Published recent data suggest that the dose of tacrolimus administered simultaneously with nifedipine may be reduced in some cases. Upon co-administration of both drugs the plasma concentrations of tacrolimus should be monitored and if necessary to reduce the dose of tacrolimus.
 
carbamazepine
Not conducted a formal clinical study to investigate the potential interaction between nifedipine and carbamazepine. It has been shown that carbamazepine reduces plasma concentrations of the calcium channel blocker nimodipine due to enzyme induction, decreased plasma concentrations of nifedipine, and can not therefore be ruled out lowering efficacy.
phenobarbitone
Not conducted a formal clinical study to investigate the potential interaction between nifedipine and phenobarbitone. It has been shown that phenobarbitone reduced plasma concentrations of the calcium channel blocker nimodipine due to enzyme induction, decreased plasma concentrations of nifedipine, and can not therefore be ruled out lowering efficacy.
valproic acid
Not conducted a formal clinical study to investigate the potential interaction between nifedipine and valproic acid. It has been shown that valproic acid increases the plasma concentrations of the calcium channel blocker nimodipine due to enzyme induction, therefore, can not be ruled out in elevated plasma concentrations of nifedipine and increased efficiency.
Interactions that do not exist
Co-administration of nifedipine with ajmaline. benazepril. debrisokvin. doxazosin. irbesartan. omeprazole. orlistat. pantoprazole. ranitidine. rosiglitazone. talinolol triamterene and hydrochlorothiazide has no effect on the pharmacokinetics of nifedipine.
aspirin
Co-administration of nifedipine and aspirin 100 mg had no effect on the pharmacokinetics of nifedipine. Coadministration strength nifedipine did not alter the effect of aspirin 100 mg on platelet aggregation, and bleeding time.
candesartan cilexetil
Co-administration of nifedipine and candesartan cilexetil has no effect on the pharmacokinetics of the drug.
 
Other forms of interaction
Nifedipine may cause falsely elevated values of vanilla-almond acid in urine reported by spectrophotometry. HPLC measurement is not applicable.
 
Pregnancy and breast-feeding and fertility .Bremennost
Nifedipine is contraindicated during pregnancy sang.
It has been shown that nifedipine causes damage teratogenic in rats or rabbits, including digital anomalies. Anomalies are due to impaired uterine circulation. Administration of nifedipine in animals is associated with embryotoxic, placentotoxic and fetotoxic effects, including stunted fetuses (rats, mice, rabbits), stunted (small) part developed placentas and chorionic villus sampling (monkeys), death of the embryo and fetus (rats , mice, rabbits) and prolonged pregnancy / decreased neonatal survival (rats, other species have been studied). Each dose of teratogenic, embryotoxic or fetotoxic effects in animals were maternally toxic and several times higher than the recommended maximum dose in humans. There are no adequate and well-controlled studies in pregnant women. In single cases of in vitro fertilization calcium antagonists such as nifedipine have been associated with reversible biochemical changes in the head of the sperm, which may lead to damage of the sperm function. In men with repeated unsuccessful IVF and if no other explanation, calcium channel blockers (nifedipine) may be accepted as a possible cause.
 
breastfeeding
Nifedipine passes into breast milk. Despite the lack of data on possible effects on infants, breastfeeding should be discontinued if necessary treatment with nifedipine during karmene.Efekti on ability to drive and use mashiniReaktsiite to the drug, ranging in intensity from one individual can impair the ability to drive or operate machinery. This applies especially to the beginning of treatment, in case of treatment in combination with alkohol.Nezhelani reaktsiiNay common adverse reactions based on clinical studies with Adalat OROS, ranked based on the criteria of CIOMS P1 frequency iCOSTART body system (5- edition of Bayer)
The most common adverse reactions based on spontaneous reports sorted based on the criteria of CIOMS III frequency and COSTART body system (5th edition of Bayer) (n = 2886 patients 15/09/1998)
overdose
The following symptoms are observed in cases of severe nifedipine intoxication: Disturbances in consciousness to coma, lowering blood pressure, cardiac arrhythmias tachycardia / bradycardia, hyperglycemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary edema.
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