Found inside – Page 1-104... er Nitrostati Nitecore Umg 11/2009 NIFEDIPINE 30 mg WENGUALDAS BAREDAS MAJUCE - DAMS 30 0.3 mg 0.4 mg Nimotop® Capsules Bayer Corporation Pharmaceutical ... of nifedipine immediate-release capsules may be changed to 90 mg once daily of Nifedipine Extended-release Tablets). For subsequent doses, relatively constant plasma concentrations at this plateau are maintained with minimal fluctuations over the 24-hour dosing interval. for 4 days to male and female volunteers resulted in least square mean (90% CI) values for unchanged nifedipine of 0.83 (0.73 to 0.95) for Cmax and 0.88 (0.80 to 0.96) for AUC relative to nifedipine monotherapy. Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. It has a molecular weight of 346.3. Two 30 mg nifedipine extended-release tablets may be interchanged with a 60 mg nifedipine extended-release tablet. Two studies investigated the impact of coadministered cimetidine on blood pressure in hypertensive subjects on nifedipine. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. Patients with hepatic impairment (liver cirrhosis) have a longer disposition half-life and higher bioavailability of nifedipine than healthy volunteers. This property increases myocardial oxygen delivery in patients with coronary artery spasm, and is responsible for the effectiveness of nifedipine in vasospastic (Prinzmetal's or variant) angina. In formal electrophysiologic studies, predominantly in patients with normal conduction systems, nifedipine has had no tendency to prolong atrioventricular conduction or sinus node recovery time, or to slow sinus rate. Hypotension occurred in about one in 20 patients. This was an isolated finding not associated with clinical symptoms and it rarely resulted in values which fell outside the normal range. Generally, overdosage with nifedipine leading to pronounced hypotension calls for active cardiovascular support including monitoring of cardiovascular and respiratory function, elevation of extremities, judicious use of calcium infusion, pressor agents and fluids. This suggests that, in general, relief of spasm or dilation of coronary arteries is not an important factor in classical angina. Although, like other members of its class, nifedipine causes a slight depression of sinoatrial node function and atrioventricular conduction in isolated myocardial preparations, such effects have not been seen in studies in intact animals or in man. There are no adequate and well-controlled studies in pregnant women. These laboratory abnormalities have rarely been associated with clinical symptoms; however, cholestasis with or without jaundice has been reported. The increased peripheral vascular resistance that is an underlying cause of hypertension results from an increase in active tension in the vascular smooth muscle. In patients with impaired ventricular function, most acute studies have shown some increase in ejection fraction and reduction in left ventricular filling pressure. Positive direct Coombs test with/without hemolytic anemia has been reported, but a causal relationship between nifedipine administration and positivity of this laboratory test, including hemolysis, could not be determined. Description ; Reviews (0) In view of the high variability of nifedipine pharmacokinetics, the clinical significance of this finding is unknown. The following information should be taken into account in those patients who are being treated for hypertension as well as angina: Rarely, patients, particularly those who have severe obstructive coronary artery disease, have developed well documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting nifedipine or at the time of dosage increase. Rarely, patients, usually receiving a beta blocker, have developed heart failure after beginning nifedipine. Upon swallowing, the biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell. and repaglinide 2 mg t.i.d.) Two studies investigated the impact of coadministered ranitidine on blood pressure in hypertensive subjects on nifedipine. Nifedipine Extended-Release Tablets USP are supplied as 30 mg round, biconvex, rose-pink, film-coated tablets with " T011" in black ink on one side and plain on the other side: Bottles of 100: (NDC 10370-390-01) Bottles of 300: (NDC 10370-390-30) Nifedipine extended-release tablets USP are supplied as 60 mg round, biconvex, rose-pink, film . Myocardial infarction occurred in about 4% of patients and congestive heart failure or pulmonary edema in about 2%. Since nifedipine is highly protein-bound, dialysis is not likely to be of any benefit. Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. showed that all three 30 mg mg nifedipine SR brands (28.6 %) (75 %) 30 mg and four (50 %) 20 mg nifedipine SR brands exhibited appropriate drug release profiles based on the USP acceptance criteria. For Tablets labeled to contain 30 mg of nifedipine: Phase 2 Medium: 0.5% sodium lauryl sulfate in simulated gastric fluid without enzyme, pH 1.2; 900 mL Apparatus 2: 100 rpm Times: 1, 4, 8, and 12 h Standard solution: 0.034 mg/mL of USP Nifedipine RS in Medium. About a fourfold higher fluctuation index (ratio of peak to trough plasma concentration) was observed with the conventional immediate-release nifedipine capsule at t.i.d. Although nifedipine has been used safely in patients with renal dysfunction and has been reported to exert a beneficial effect in certain cases, rare reversible elevations in BUN and serum creatinine have been reported in patients with pre-existing chronic renal insufficiency. Cases of serious gastrointestinal obstruction have been identified in patients with no known gastrointestinal disease, including the need for hospitalization and surgical intervention. There was no evidence of dose dumping either in the presence or absence of food for over 150 subjects in pharmacokinetic studies. Nifedipine Extended-release Tablet is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta-blockers and/or organic nitrates or who cannot tolerate those agents. Phenytoin, Phenobarbital, and Carbamazepine: There is a literature report of reversible reduction in the ability of human sperm obtained from a limited number of infertile men taking recommended doses of nifedipine to bind to and fertilize an ovum in vitro. nifedipine cream uses. Urogenital: impotence, polyuria. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely, since severe hypotension can occur from the combined effects of the drugs (see WARNINGS). The contractile processes of vascular smooth muscle and cardiac muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Thus, it is improbable that nifedipine inhibits in vivo the metabolism of other drugs that are substrates of CYP2D6. MORRISTOWN, N.J., May 30, 2012 /PRNewswire/ -- Actavis Group, an international generic pharmaceuticals company, today announced that it received US FDA approval of Nifedipine Extended-Release Tablets, USP, 90mg, a generic equivalent to Bayer's Adalat® CC. Upon coadministration of quinupristin/dalfopristin with nifedipine, blood pressure should be monitored and a reduction of the dose of nifedipine considered. In a subgroup of approximately 250 patients with a diagnosis of congestive heart failure as well as angina, dizziness or lightheadedness, peripheral edema, headache or flushing each occurred in one in eight patients. Musculoskeletal: back pain, gout, myalgias Although nifedipine has been used safely in patients with renal dysfunction and has been reported to exert a beneficial effect, in certain cases, rare, reversible elevations in BUN and serum creatinine have been reported in patients with pre-existing chronic renal insufficiency. Alternative antihypertensive therapy should be considered in patients taking phenytoin, phenobarbital, and carbamazepine. Because nifedipine is metabolized via the cytochrome P450 3A4 system, its pharmacokinetics may be altered in patients with chronic liver disease. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. Found inside – Page 116... PARASYMPATHOMIMETIC AGENTS 36-56 DIAGNOSTIC AGENTS - MYASTHENIA GRAVIS INJECTION U.S.P. , 1 MG . ... TABLETS , SUSTAINED RELEASE , FILM COATED , 30 MG . No AV conduction abnormalities, arrhythmias, or pronounced changes in heart rate were noted, nor was there any further deterioration in renal function. With patients whose angina or hypertension is complicated by congestive heart failure, care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction. Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of nifedipine extended-release tablets is suggested. With the exception of leg cramps, the incidence of these side effects was similar to that of placebo alone. Tell your doctor if you are breast-feeding a baby. However, an increase in perinatal asphyxia, caesarean delivery, prematurity, and intrauterine growth retardation have been reported. In Nifedipine Extended-release Tablet, the medication is contained within a nonabsorbable shell that has been specially designed to slowly release the drug for your body to absorb. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. Co-administration of nifedipine with phenytoin, an inducer of CYP3A4, lowers the systemic exposure to nifedipine by approximately 70%. Nifedipine Extended-release Tablets should be swallowed whole and should not be bitten or divided. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. Rebel Distributors Corp. Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. The most common side effect reported with Nifedipine Extended-release Tablets was edema which was dose related and ranged in frequency from approximately 10% to about 30% at the highest dose studied (180 mg). They are supplied as: NDC 50268-597-15 (10 tablets per card, 5 cards per carton) Nifedipine Extended-release Tablets 60 mg are round, biconvex, pink coated tablets imprinted with "KU 261" in black ink. Electrolyte abnormalities consisted of a mild, transient elevation of serum creatinine, and modest elevations of LDH and CPK, but normal SGOT. Found inside – Page 1049JAMA 100 Years Ago TESSALON PERLES ( benzonatate USP ). once. -. a. -. day. PROCARDIAXL. (. nifedipine. ) extended. release. Tablets. 30mg. Coumarins: There have been rare reports of increased prothrombin time in patients taking coumarin anticoagulants to whom nifedipine was administered. Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of nifedipine is suggested. Nifedipine Extended-release Tablet is similar in appearance to a conventional tablet. This is thought to be a function of inhibition of calcium transport across the platelet membrane. No significant hypotension was apparent at presentation, 18 hours post-ingestion. The binding of nifedipine to voltage-dependent and possibly receptor-operated channels in vascular smooth muscle results in an inhibition of calcium influx through these channels. Nifedipine may be safely co-administered with nitrates, but there have been no controlled studies to evaluate the antianginal effectiveness of this combination. Angina patients controlled on Nifedipine alone or in combination with other antianginal medications may be safely switched to Nifedipine Extended Release Tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. The mean peak plasma concentration of nifedipine following a 90 mg nifedipine extended-release tablet, administered under fasting conditions, is approximately 115 ng/mL. No AV conduction abnormalities, arrhythmias, or pronounced changes in heart rate were noted, nor was there any further deterioration in renal function. Inert ingredients are: colloidal silicon dioxide . In addition, more serious adverse events were observed, not readily distinguishable from the natural history of the disease in these patients. Do not be concerned if you occasionally notice in your stool something that looks like a tablet. In general, titration should proceed over a 7 to 14 day period starting with 30 mg once daily. No prolonged sequelae were observed. This is rarely, if ever, seen in intact animals or man, probably because of reflex responses to its vasodilating effects. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. nifedipine extended release usp 5 mg/10 mg/20mg & 30 mg . Nifedipine extended-release tablets are indicated for the treatment of hypertension. In vitro and in vivo data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. After administration of nifedipine extended-release tablets to healthy elderly men and women (age >60 years), the mean Cmax is 36% higher and the average plasma concentration is 70% greater than in younger patients. CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism, 100 in 1 BOTTLE; Type 0: Not a Combination Product, 300 in 1 BOTTLE; Type 0: Not a Combination Product. Careful monitoring and dose adjustment may be necessary; consider initiating nifedipine at the lowest dose available if given concomitantly with these medications. They are supplied as follows: Nifedipine Extended-release Tablets 60 mg are round, biconvex, pink coated tablets imprinted with "KU 261" in black ink. Significant hyperglycemia was seen initially in this patient, but plasma glucose levels rapidly normalized without further treatment. Nifedipine Extended-release Tablet is formulated as a once-a-day extended-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. If nifedipine therapy is initiated in a patient currently receiving cimetidine, cautious titration is advised. The usual maintenance dose is 30 mg to 60 mg . Since steady-state plasma levels are achieved on the second day of dosing, if symptoms so warrant, titration may proceed more rapidly provided the patient is assessed frequently. Inert ingredients are: colloidal silicon dioxide . Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C17H18N2O6, and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. Cardiovascular: palpitations (See PRECAUTIONS: Drug Interactions.). It is not known whether nifedipine will harm an unborn baby. Rare, usually transient, but occasionally significant elevations of enzymes such as alkaline phosphatase, CPK, LDH, SGOT and SGPT have been noted. nifedipine extended-release tablets * Certain Material Origins (i.e. for 8 days were 1.26 and 0.87 times those after pretreatment with placebo. The following adverse events were reported with an incidence of 3% or less in daily doses up to 90 mg: Body as a Whole/Systemic: chest pain, leg pain, Central Nervous System: paresthesia, vertigo. They may be used alone or in combination with other antihypertensive agents. Like other slow-channel blockers, nifedipine exerts a negative inotropic effect on isolated myocardial tissue. Experience with nifedipine overdosage is limited. Nifedipine administration was associated with a variety of embryotoxic, placentotoxic, and fetotoxic effects, including stunted fetuses (rats, mice, rabbits), rib deformities (mice), cleft palate (mice), small placentas and underdeveloped chorionic villi (monkeys), embryonic and fetal deaths (rats, mice, rabbits), and prolonged pregnancy/decreased neonatal survival (rats; not evaluated in other species). These dictated the prophylactic placement of a temporary ventricular pacemaker, but otherwise resolved spontaneously. diltiazem p.o. Transplant patients on tacrolimus and nifedipine required from 26% to 38% smaller doses than patients not receiving nifedipine. Repaglinide: Coadministration of 10 mg nifedipine with a single dose of 2 mg repaglinide (after 4 days nifedipine 10 mg t.i.d. In the first study, nifedipine extended-release tablet was given as monotherapy and in the second study, nifedipine extended-release tablet was added to a beta-blocker in patients not controlled on a beta-blocker alone. When nifedipine extended-release tablet is given immediately after a high fat meal in healthy volunteers, there is an average increase of 60% in the peak plasma nifedipine concentration, a prolongation in the time to peak concentration, but no significant change in the AUC. Found inside – Page 324In the USP monograph for Nifedipine Extended-Release Tablets, the acceptance criteria for ... Tablets containing 30, 60, and 90 mg nifedipine per tablet. 500 mg. 12 . It has a molecular weight of 346.33. Irbesartan: In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites by nifedipine. The intake of grapefruit juice should be stopped at least 3 days prior to initiating patients on nifedipine. Nifedipine Extended-release Tablet is designed to provide nifedipine at an approximately constant rate over 24 hours. Positive direct Coombs’ test, with or without hemolytic anemia, has been reported, but a causal relationship between nifedipine administration and positivity of this laboratory test, including hemolysis, could not be determined. Nifedipine is extensively metabolized to highly water soluble, inactive metabolites accounting for 60% to 80% of the dose excreted in the urine. Coadministration of multiple doses of quinidine sulfate, 200 mg t.i.d., and nifedipine, 20 mg t.i.d., increased Cmax and AUC of nifedipine in healthy volunteers by factors of 2.30 and 1.37, respectively. Dispense in tight, child-resistant containers (USP). The increase in exposure to nifedipine by cimetidine was accompanied by relevant changes in blood pressure or heart rate in normotensive subjects. Nifedipine Extended Release Tablets 20 mg, 30 mg and 60 mg USP PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Table 1 - Product Information Summary Route of Administration Dosage Form / Strength All Nonmedicinal Ingredients oral extended release tablets / 20 mg, 30 mg and 60 mg There has been one reported case of massive overdosage with tablets of another extended-release formulation of nifedipine. S are the peak Standard stock solution: 1 mg/mL of USP Nifedipine RS in responses of the corresponding related compound obtained methanol from the Test solution and the Standard solution, respectively: Standard solution: 0.1 mg/mL of USP Nifedipine RS from not more than 2.0% of dimethyl 4-(2-nitrophenyl)-2,6- the Standard stock solution in . simvasyn. Grapefruit Juice: In healthy volunteers, a single dose coadministration of 250 mL double strength grapefruit juice with 10 mg nifedipine increased AUC and Cmax by factors of 1.35 and 1.13, respectively. 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