The sampling times were 5, 10, 20, 30, 60, 90, and 120 min after the initiation of the test. Although in most patients the hypotensive effect of nifedipine is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. Once daily dosing of nifedipine extended-release tablets under fasting conditions results in decreased fluctuations in the plasma concentration of nifedipine when compared to t.i.d. Blood pressure should be monitored and reduction of the dose of nifedipine considered. The increase in exposure to nifedipine by cimetidine was accompanied by relevant changes in blood pressure or heart rate in normotensive subjects. In view of the high variability of nifedipine pharmacokinetics, the clinical significance of this finding is unknown. There have been rare reports of an interaction between quinidine and nifedipine (with a decreased plasma level of quinidine). Physical Properties and Solubility Studies of Nifedipine-PEG 1450/HPMCAS-HF Solid Dispersions. . Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios of nifedipine and lorazepam. permission is required to reuse all or part of the article published by MDPI, including figures and tables. In healthy subjects, the elimination half-life of a different sustained release nifedipine formulation was longer in elderly subjects (6.7 h) compared to young subjects (3.8 h) following oral administration. These dictated the prophylactic placement of a temporary ventricular pacemaker, but otherwise resolved spontaneously. Since nifedipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial. MeSH ; Shah, G.A. For this purpose, physicochemical properties o Supercritical carbon dioxide solubility measurement and modelling for effective size reduction of nifedipine . Nifedipine Capsules are formulated as soft gelatin capsules for oral administration, each containing 10 mg or 20 mg nifedipine. These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment. Yang, B.; Xu, L.; Wang, Q.; Li, S. Modulation of the Wettability of Excipients by Surfactant and its Impacts on the Disintegration and Release of Tablets. The bioavailability of nifedipine from nifedipine extended-release tablets relative to immediate release tablets is in the range of 84%-89%. It has a molecular weight of 346.3. 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. However, the solubility of nifedipine in proliposomes was 176.4, 91.8, and 97.9 g/mL in artificial gastric fluid, artificial intestinal fluid, and water, respectively. These CBD candies offer a simple and flexible . You seem to have javascript disabled. Co-administration of nifedipine with grapefruit juice results in up to a 2-fold increase in AUC and Cmax, due to inhibition of CYP3A related first-pass metabolism. AAPS PharmSciTech. Epub 2013 Aug 7. The core formulation consisted of drug alone but with varying solubilities in water (chlorpheniramine maleate, pyridoxine, theophylline, felodipine, and nifedipine); these were individually loaded into the asymmetric membrane . The relationship to nifedipine therapy is uncertain in most cases but probable in some. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4 (2-nitrophenyl)-, dimethyl ester, C. 17 . Atrial or ventricular dysrhythmias each occurred in about one patient in 150. The suitable formulation contained NDP and AMCP at a ratio of 1:4 and polysorbate at a concentration of 0.1%, 0.3%, or 0.6%. A variety of ECG abnormalities were seen in this patient with a history of bundle branch block, including sinus bradycardia and varying degrees of AV block. In cases involving overdosage of a slow-release product like nifedipine, elimination must be as complete as possible, including from the small intestine, to prevent the subsequent absorption of the active substance.Additional liquid or volume must be administered with caution because of the risk of fluid overload. Co-administration of nifedipine with phenytoin, an inducer of CYP3A4, lowers the systemic exposure to nifedipine by approximately 70%. A small increase (<5%) in mean alkaline phosphatase was noted in patients treated with nifedipine extended-release tablets. It is recommended that nifedipine extended-release tablets, USP be administered orally once daily on an empty stomach. Analysis of variance and Levenes test for homogeneity of variance were performed by using SPSS version 10.0 for Windows (SPSS Inc., Chicago, IL, USA) [, Solid solutions were prepared as described in, A hot stage microscopy was used to examine the microscopic findings of the solid solutions after changing the temperature of NDP and the solid solution. Hypotension occurred in about one in 20 patients. for 5 days did not change the metabolic ratio of hydroxydebrisoquine to debrisoquine measured in urine after a single dose of 10 mg debrisoquine. However, biting through the capsule prior to swallowing does result in slightly earlier plasma concentrations (27 ng/mL 10 minutes after 10 mg) than if capsules are swallowed intact. Alqurshi, A.; Andrew Chan, K.L. Experience with nifedipine overdosage is limited. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. IVIVC were obtained for USP2, USP3 and USP4 in FaSSGFoj (Fasted State Simulated Gastric Fluid pH 3.4; orange juice administration). Doses above 120 mg daily are rarely necessary. In this study, the solubilizing effect of 4-sulphonic calix[n]arenes on the poorly water soluble drug nifedipine was investigated. Paper should be a substantial original Article that involves several techniques or approaches, provides an outlook for permission provided that the original article is clearly cited. The .gov means its official. The solubility of nifedipine was 7.1, 7.2, and 7.5 g/mL in pH 1.2, 6.8, and 7 solutions, respectively. On a mg/kg basis, all of the doses associated with the teratogenic embryotoxic or fetotoxic effects in animals were higher (5 to 50 times) than the maximum recommended human dose of 120 mg/day. Two 30 mg nifedipine extended-release tablets may be interchanged with a 60 mg nifedipine extended-release tablet. Timolol: Hypotension is more likely to occur if dihydropryridine calcium antagonists such as nifedipine are co-administered with timolol. The most common adverse events were: Central Nervous System: dizziness or lightheadedness, Systemic: headache and flushing, weakness, Respiratory: nasal and chest congestion, shortness of breath, Gastrointestinal: diarrhea, constipation, cramps, flatulence, Musculoskeletal: inflammation, joint stiffness, muscle cramps, Central Nervous System: shakiness, nervousness, jitteriness, sleep disturbances, blurred vision, difficulties in balance, Other: dermatitis, pruritus, urticaria, fever, sweating, chills, sexual difficulties, Cardiovascular: syncope (mostly with initial dosing and/or an increase in dose), erythromelalgia, Hematologic: thrombocytopenia, anemia, leukopenia, purpura, Face and Throat: angioedema (mostly oropharyngeal edema with breathing difficulty in a few patients), gingival hyperplasia, Special Senses: transient blindness at the peak of plasma level, tinnitus, Other: arthritis with ANA (+), exfoliative dermatitis, gynecomastia. NIFEDIPINE- nifedipinetablet, extended release Understanding and predicting the impact of critical dissolution variables for nifedipine immediate release capsules by multivariate data analysis. In nifedipine-treated patients where surgery using high dose fentanyl anesthesia is contemplated, the physician should be aware of these potential problems and, if the patient's condition permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washed out of the body prior to surgery. Unauthorized use of these marks is strictly prohibited. Zhang, D.; Lee, Y.-C.; Shabani, Z.; Frankenfeld Lamm, C.; Zhu, W.; Li, Y.; Templeton, A. All adverse events reported during nifedipine extendedrelease tablets therapy were tabulated independently of their causal relationship to medication. The rates of intrinsic dissolution and concentrations of drug dissolved were higher for that solid solution than for the solid dispersion. Double-sided adhesive tape was used to adhere the sample powders to a stub. 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. Minhaz, M.; Rahman, M.; Ahsan, M.; Khalipha, A.; Chowdhury, M. Dissolution Enhancement of Poorly Soluble Drug by Solvent Evaporation Method using Hydrophilic Polymer: A Solid Dispersion Technique. 0000001899 00000 n Please enable it to take advantage of the complete set of features! Large inter-patient variability in nifedipine absorption results in variable exposure among different patients. Nifedipine was administered orally to rats for two years and was not shown to be carcinogenic. and repaglinide 2 mg t.i.d.) The relationship to nifedipine therapy is uncertain in most cases but probable in some. for 8 days were 1.26 and 0.87 times those after pre-treatment with placebo. Patients with tight aortic stenosis may be at greater risk for such an event, as the unloading effect of nifedipine would be expected to be of less benefit to these patients, owing to their fixed impedance to flow across the aortic valve. In the heart, nifedipine as well as verapamil and diltiazem depress cardiac contractionsand heart rate. There has been one reported case of massive overdosage with tablets of another extended release formulation of nifedipine. nifedipine alone or in combination with cimetidine 1000 mg q.d. 1115 0 obj This unloading of the heart reduces myocardial energy consumption and oxygen requirements and probably accounts for the effectiveness of nifedipine in chronic stable angina. Its low water solubility, however, leads to poor drug absorption from oral dosage forms while commercia lly available soft capsules lead to a short half - life. Initiation of nifedipine treatment will not prevent this occurrence and on occasion has been reported to increase it. Nifedipine is completely absorbed after oral administration. 2013;19(36):6507-21. doi: 10.2174/13816128113199990406. How it works Nifedipine may be used to treat angina. 0000003722 00000 n The elimination half-life of nifedipine is approximately two hours. There are no adequate and well-controlled studies in pregnant women. Effect of 4-sulphonato-calix[n]arenes and cyclodextrins on the solubilization of niclosamide, a poorly water soluble anthelmintic. Ganesan, P.; Soundararajan, R.; Shanmugam, U.; Ramu, V. Development, Characterization and Solubility Enhancement of Comparative Dissolution Study of Second Generation of Solid Dispersions and Microspheres for Poorly Water Soluble Drug. The elimination half-life of nifedipine administered as nifedipine extended-release tablets is approximately 7 hours in contrast to the known 2 hour elimination half-life of nifedipine administered as an immediate release capsule. Women's health is once again the center of a political ping-pong match with evidence-based science on one side and anti-choice advocates on the other. Haware, R.V. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In-Situ Freeze-Drying-Forming Amorphous Solids Directly within Capsules: An Investigation of Dissolution Enhancement for A Poorly Soluble Drug. Stabilization of Omega-3 Oils and Enriched Foods using Emulsifiers. This equation is simply a statement that the solubility of organic molecules (drugs) in aqueous-organic mixtures is approximated as a geometric average, as expressed by All articles published by MDPI are made immediately available worldwide under an open access license. In nifedipine treated patients where surgery using high dose fentanyl anesthesia is contemplated, the physician should be aware of these potential problems and, if the patient's condition permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washed out of the body prior to surgery. (See PRECAUTIONS.). Photosensitive drugs: a review on their photoprotection by liposomes and cyclodextrins. In formal electrophysiologic studies, predominantly in patients with normal conduction systems, nifedipine has had no tendency to prolong atrioventricular conduction, prolong sinus node recovery time, or slow sinus rate. 9 Oral dosing leads to a C max of 82ng/mL, with a T max of 28min, and an AUC of 152ng*h/mL. Most of the patients had vasospastic or resistant angina pectoris, and about half had concomitant treatment with beta-adrenergic blocking agents. Nifedipine is rapidly and fully absorbed after oral administration. Nifedipine Capsules Prescribing Information. 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. FOIA methods, instructions or products referred to in the content. Pharm Res. In general, titration should proceed over a 7-14 day period starting with 30 mg once daily. Nifedipine has been shown to produce teratogenic findings in rats and rabbits, including digital anomalies similar to those reported for phenytoin. interesting to readers, or important in the respective research area. In, Weerapol, Y.; Tubtimsri, S.; Jansakul, C.; Sriamornsak, P. Improved Dissolution of. 0000003502 00000 n All solid solutions were stored for 3 or 6 months under accelerated (40 C/75% relative humidity) and ambient conditions (25 C) to assess the stability of NDP. Solubility experiments were performed Sublingual dosing leads to a C max of 10ng/mL, with a T max of 50min, and an AUC of 25ng*h/mL. Myocardial infarction or symptoms of congestive heart failure each occurred in about one patient in 15. Szts, A.; Lng, P.; Ambrus, R.; Kiss, L.; Deli, M.A. Al Hujran TA, Magharbeh MK, Habashneh AY, Al-Dmour RS, Aboelela A, Tawfeek HM. Improving the Dissolution Rate of Poorly Water Soluble Drug by Solid Dispersion and Solid SolutionPros and Cons. In vivo mutagenicity studies were negative. CYP3A inhibitors such as fluconazole, itraconazole, clarithromycin, erythromycin, nefazodone, fluoxetine, saquinavir, indinavir, and nelfinavir may result in increased exposure to nifedipine when co-administered. When nifedipine is co-administered with tacrolimus the blood concentrations of tacrolimus should be monitored and a reduction of the dose of tacrolimus considered. Rifampin: Strong CYP3A inducers, such as rifampin, rifapentin, and rifabutin reduce the bioavailability of nifedipine which may reduce the efficacy of nifedipine; therefore nifedipine should not be used in combination with strong CYP3A inducers such as rifampin (See CONTRAINDICATIONS). Mercuri A, Pagliari M, Baxevanis F, Fares R, Fotaki N. Int J Pharm. When given to rats prior to mating, nifedipine caused reduced fertility at a dose approximately 5 times the maximum recommended human dose. Bookshelf <>stream Rarely, patients (usually while receiving a beta-blocker) have developed heart failure after beginning nifedipine. It has a molecular weight of 346.3. Akbari, J.; Saeedi, M.; Morteza-Semnani, K.; Kelidari, H.R. Ventricular arrhythmias or conduction disturbances each occurred in fewer than 0.5% of patients. Nifedipine (NIF) is a Class II drug of the Biopharmaceutical Classification System (BCS) with low oral bioavailability, low dissolution rate and significant hepatic drug metabolism. ; Zareh, G.; Rostamkalaei, S.; Sadegh Moghanlou, F.; Zareh, G.; Rostamkalaei, S. The Effect of Tween 20, 60, and 80 on Dissolution Behavior of Sprionolactone in Solid Dispersions Prepared by PEG 6000. https://doi.org/10.3390/polym13172963, Tubtimsri, Sukannika, and Yotsanan Weerapol. PMC future research directions and describes possible research applications. The addition of a surfactant with high hydrophilicity tended to increase the dissolution of NDP, whereas this dissolution was decreased in the presence of a surfactant with low hydrophilicity (PS65). Other common adverse events reported in the above placebo-controlled trials include: Where the frequency of adverse events with nifedipine extended-release tablets and placebo is similar, causal relationship cannot be established. Irbesartan: In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites by nifedipine. This may be, in part, because nifedipine extended-release tablets are less bioavailable than the immediate release formulation. Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain). Saur, J.; Su-Negre, J.M. Both mixtures (EtOH + water and PG + water) have a maximum solubility at 313.2 K. A compensatory volume (5 mL) was added to account for the loss of volume after sampling. Coumarins: There have been rare reports of increased prothrombin time in patients taking coumarin anticoagulants to whom nifedipine was administered. An official website of the United States government. When nifedipine extended-release tablets are administered as multiples of 30 mg tablets over a dose range of 30 mg to 90 mg, the area under the curve (AUC) is dose proportional; however, the peak plasma concentration for the 90 mg dose given as 3 x 30 mg is 29% greater than predicted from the 30 mg and 60 mg doses. The degree of protein binding of nifedipine is high (92%-98%). Nifedipine Capsules should not be administered within the first week or two after myocardial infarction, and they should also be avoided in the setting of acute coronary syndrome (when infarction may be imminent). Do not chew, divide or crush tablets. 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. The interaction with high dose fentanyl appears to be due to the combination of nifedipine and a beta blocker, but the possibility that it may occur with nifedipine alone, with low doses of fentanyl, in other surgical procedures, or with other narcotic analgesics cannot be ruled out. Nifedipine should be used during breast-feeding only if the potential benefit justifies the potential risk. Transplant patients on tacrolimus and nifedipine required from 26% to 38% smaller doses than patients not receiving nifedipine. HHS Vulnerability Disclosure, Help The aim is to provide a snapshot of some of the Smoothie. The heart rate in the initial interval after drug administration was increased by up to 17.9 beats/minute. '~Eb.k]^SqdzNKqv]VY. Patients recently withdrawn from beta blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The samples were placed in an ATR crystal and scanned with a spectral resolution of 2 cm. Nifedipine has been shown to inhibit the metabolism of tacrolimus in vitro. also experienced relevant changes in blood pressure when cimetidine was added to nifedipine. Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. 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. Mantas, A.; Mihranyan, A. Immediate-Release Nifedipine Binary Dry Powder Mixtures with Nanocellulose Featuring Enhanced Solubility and Dissolution Rate. ; Jahan, Z.; Kakar, S.J. Each capsule is imprinted with "HP 194" in black ink. The dosage of nifedipine needed to suppress angina and that can be tolerated by the patient must be established by titration. Grapefruit Juice: In healthy volunteers, a single dose co-administration of 250 mL double strength grapefruit juice with 10 mg nifedipine increased AUC and Cmax by factors of 1.35 and 1.13, respectively. If discontinuation of the nifedipine extended-release tablet is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. 2013 Sep;102(9):3205-19. doi: 10.1002/jps.23611. Upon co-administration of quinupristin/dalfopristin with nifedipine, blood pressure should be monitored and a reduction of the dose of nifedipine considered. There have been rare reports of increased prothrombin time in patients taking coumarin anticoagulants to whom nifedipine was administered. However, the degree to which these forces promote the formation of nifedipine:4-sulphonic calix[n]arene complexes with increased solubility was limited by conformational changes in the 4-sulphonic calix[n]arene molecules. You are accessing a machine-readable page. Solubility experiments were performed at 30 degrees C using the Higuchi rotating bottle method. The impact of omeprazole on nifedipine is not likely to be of clinical relevance. J Pharm Pharmacol. Compared to nifedipine monotherapy, blood pressure was lower in the presence of doxazosin. Initiation of nifedipine treatment will not prevent this occurrence and might be expected to exacerbate it by provoking reflex catecholamine release. Valproic acid may increase the exposure to nifedipine during concomitant therapy. 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. No clinical significance for these findings has been demonstrated. Acute generalized exanthematous pustulosis also has been reported. Monitoring of heart rate and adjustment of the nifedipine dose, if necessary, are recommended when quinidine is added to a treatment with nifedipine. Patients with tight aortic stenosis may be at greater risk for such an event, as the unloading effect of nifedipine would be expected to be of less benefit to these patients, owing to their fixed impedance to flow across the aortic valve. Rarely, patients, usually those receiving a beta blocker, have developed heart failure after beginning nifedipine. ; Ayyala, R.S. Pharmaceutics. Nifedipine is excreted in human milk. Nifedipine is a calcium channel blocker, widely used in the treatment of angina pectoris and hypertension. There is usually a small increase in heart rate, a reflex response to vasodilation. resulted in unchanged AUC and Cmax values for both drugs. Nifedipine may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers. And hypertension highly protein bound, dialysis is not likely to be of any benefit ; however if. Potential prediction of formulation performance in paediatric patients using biopharmaceutical tools and simulation of clinically relevant administration scenarios nifedipine... Of Health and human Services ( hhs ) were performed at 30 degrees C using the Higuchi rotating bottle.! Approximately two hours findings in rats and rabbits, including figures and tables in 15 Fotaki Int. Bound, dialysis is not likely to be of clinical relevance there have been rare reports increased..., Help the aim is to provide a snapshot of some of the formation of irbesartan... 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And Enriched Foods using Emulsifiers release Understanding and predicting the impact of critical Dissolution variables for nifedipine immediate release of! Higher for that Solid solution than for the Solid dispersion and Solid SolutionPros and Cons mating! In fewer than 0.5 % of patients, Y. ; Tubtimsri, ;! Should proceed over a 7-14 day period starting with 30 mg once daily with timolol administration..., probably related to increased sensitivity to catecholamines fertility at a dose 5... It is recommended that nifedipine extended-release tablets may be, in part because., over-the-counter medicines and natural products of nifedipine and lorazepam patient must be established titration! Hhs ) exposure among different patients hypotensive effect of 4-sulphonato-calix [ n ] on. And tables S. ; Jansakul, C. ; Sriamornsak, P. Improved Dissolution of and diltiazem depress contractionsand. 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