Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
nifedipine
Overview
What is NifedicalXL?
Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, CHNO, and has the structural formula:
Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Each extended-release tablet, formulated as a once-a-day controlled release tablet for oral administration, delivers 30 or 60 mg of nifedipine.
In addition, each extended-release tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type A, methacrylic acid copolymer type B, microcrystalline cellulose, polyethylene glycol, red ferric oxide, sodium lauryl sulfate, talc and titanium dioxide.
Nifedipine Extended-release Tablets meet USP Dissolution Test 3.
What does NifedicalXL look like?
What are the available doses of NifedicalXL?
Sorry No records found.
What should I talk to my health care provider before I take NifedicalXL?
Sorry No records found
How should I use NifedicalXL?
Nifedical XL tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedical XL tablets 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 in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers.
Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedical XL Extended-release tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7 to 14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. 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. Titration to doses above 120 mg are not recommended.
Angina patients controlled on nifedipine capsules alone or in combination with other antianginal medications may be safely switched to Nifedical XL Extended-release tablets at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted.
No "rebound effect" has been observed upon discontinuation of nifedipine extended-release tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.
Care should be taken when dispensing Nifedical XL Extended-release Tablets to assure that the extended-release dosage form has been prescribed.
What interacts with NifedicalXL?
Known hypersensitivity reaction to nifedipine.
What are the warnings of NifedicalXL?
Excessive Hypotension
Although in most angina patients the hypotensive effect of nifedipine is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment, and may be more likely in patients on concomitant beta-blockers.
Severe hypotension and/or increased fluid volume requirements have been reported in patients receiving nifedipine together with a beta-blocking agent who underwent coronary artery bypass surgery using high-dose fentanyl anesthesia. 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. 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.
The following information should be taken into account in those patients who are being treated for hypertension as well as angina:
Array
Beta-Blocker Withdrawal
It is important to taper beta-blockers if possible, rather than stopping them abruptly before beginning nifedipine. Patients recently withdrawn from beta-blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines. Initiation of nifedipine treatment will not prevent this occurrence and on occasion has been reported to increase it.
Congestive Heart Failure
Rarely, patients, usually receiving a beta blocker, have developed heart failure after beginning 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, owing to the fixed impedance to flow across the aortic valve in these patients.
Gastrointestinal Obstruction Requiring Surgery
There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of nifedipine. Bezoars can occur in very rare cases and may require surgical intervention.
Cases of serious gastrointestinal obstruction have been identified in patients with no known gastrointestinal disease, including the need for hospitalization and surgical intervention.
Risk factors for gastrointestinal obstruction identified from post-marketing reports of nifedipine extended-release tablets include alteration in gastrointestinal anatomy (severe gastrointestinal narrowing, colon cancer, small bowel obstruction, bowel resection, gastric bypass, vertical banded gastroplasty, and colostomy), hypomotility disorders (constipation, gastroesophageal reflux disease, ileus, obesity, hypothyroidism, and diabetes) and concomitant medications (H2-histamine blockers, nonsteroidal anti-inflammatory drugs, laxatives, anticholinergic agents, and levothyroxine).
What are the precautions of NifedicalXL?
Array
General - Hypotension:
WARNINGS
Array
Peripheral Edema:
Array
Information for Patients:
®
Array
Array
Array
Array
Long-acting Nitrates: Nifedipine may be safely coadministered with nitrates, but there have been no controlled studies to evaluate the antianginal effectiveness of this combination.
Array
Digitalis: Administration of nifedipine with digoxin increased digoxin levels in nine of twelve normal volunteers. The average increase was 45%. Another investigator found no increase in digoxin levels in thirteen patients with coronary artery disease. In an uncontrolled study of over two hundred patients with congestive heart failure during which digoxin blood levels were not measured, digitalis toxicity was not observed. Since there have been isolated reports of patients with elevated digoxin levels, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing nifedipine to avoid possible over- or under-digitalization.
Array
Coumarin Anticoagulants: There have been rare reports of increased prothrombin time in patients taking coumarin anticoagulants to whom nifedipine was administered. However, the relationship to nifedipine therapy is uncertain.
Array
Cimetidine: A study in six healthy volunteers has shown a significant increase in peak nifedipine plasma levels (80%) and area-under-the-curve (74%), after a one-week course of cimetidine at 1000 mg per day and nifedipine at 40 mg per day. Ranitidine produced smaller, non-significant increases. The effect may be mediated by the known inhibition of cimetidine on hepatic cytochrome P-450, the enzyme system probably responsible for the first-pass metabolism of nifedipine. If nifedipine therapy is initiated in a patient currently receiving cimetidine, cautious titration is advised.
Array
Carcinogenesis, Mutagenesis, Impairment of Fertility:
in vitro
In vivo
Array
Pregnancy:
There are no adequate and well-controlled studies in pregnant women. Nifedical XL Extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Array
Pediatric Use:
What are the side effects of NifedicalXL?
Over 1000 patients from both controlled and open trials with nifedipine extended-release tablets in hypertension and angina were included in the evaluation of adverse experiences. All side effects reported during nifedipine extended-release tablet therapy were tabulated independent of the causal relation to medication. The most common side effect reported with nifedipine extended-release tablet was edema which was dose related and ranged in frequency from approximately 10% to about 30% at the highest dose studied (180 mg). Other common adverse experiences reported in placebo-controlled trials include:
Of these, only edema and headache were more common in patients given nifedipine extended-release tablets than placebo patients.
The following adverse reactions occurred with an incidence of less than 3.0%. With the exception of leg cramps, the incidence of these side effects was similar to that of placebo alone.
Body as a Whole/Systemic:
Cardiovascular:
Central Nervous System:
Dermatologic:
Gastrointestinal:
Musculoskeletal:
Respiratory:
Urogenital:
Other adverse reactions were reported sporadically with an incidence of 1.0% or less. These include:
Body as a Whole/Systemic:
Cardiovascular:
Central Nervous System:
Dermatologic:
Gastrointestinal:
Musculoskeletal:
Respiratory:
Special Senses:
Urogenital/Reproductive:
Adverse experiences which occurred in less than 1 in 1000 patients cannot be distinguished from concurrent disease states or medications.
The following adverse experiences, reported in less than 1% of patients, occurred under conditions (e.g., open trials, marketing experiences) where a causal relationship is uncertain: gastrointestinal irritation, gastrointestinal bleeding, gynecomastia.
Gastrointestinal obstruction resulting in hospitalization and surgery, including the need for bezoar removal, has occurred in association with nifedipine extended-release tablets, even in patients with no prior history of gastrointestinal disease.
In multiple-dose U.S. and foreign controlled studies with nifedipine capsules in which adverse reactions were reported spontaneously, adverse effects were frequent but generally not serious and rarely required discontinuation of therapy or dosage adjustment. Most were expected consequences of the vasodilator effects of nifedipine.
There is also a large uncontrolled experience in over 2100 patients in the United States. Most of the patients had vasospastic or resistant angina pectoris, and about half had concomitant treatment with beta-adrenergic blocking agents. The relatively common adverse events were similar in nature to those seen with nifedipine extended-release tablets.
In addition, more serious adverse events were observed, not readily distinguishable from the natural history of the disease in these patients. It remains possible, however, that some or many of these events were drug related. Myocardial infarction occurred in about 4% of patients and congestive heart failure or pulmonary edema in about 2%. Ventricular arrhythmias or conduction disturbances each occurred in fewer than 0.5% of patients.
In a subgroup of over 1000 patients receiving nifedipine with concomitant beta-blocker therapy, the pattern and incidence of adverse experiences was not different from that of the entire group of nifedipine treated patients (see ).
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. Hypotension occurred in about one in 20 patients. Syncope occurred in approximately one patient in 250. Myocardial infarction or symptoms of congestive heart failure each occurred in about one patient in 15. Atrial or ventricular dysrhythmias each occurred in about one patient in 150.
In post-marketing experience, there have been rare reports of exfoliative dermatitis caused by nifedipine. There have been rare reports of exfoliative or bullous skin adverse events (such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) and photosensitivity reactions.
| Adverse Event | NIFEDIPINEEXTENDED-RELEASE TABLETS (%)(n=707) | PLACEBO (%)(n=266) |
| Headache | 15.8 | 9.8 |
| Fatigue | 5.9 | 4.1 |
| Dizziness | 4.1 | 4.5 |
| Constipation | 3.3 | 2.3 |
| Nausea | 3.3 | 1.9 | Adverse Event | NIFEDIPINE Capsule (%)(n=226) | PLACEBO (%)(n=235) |
| Dizziness/lightheadedness giddiness | 27 | 15 |
| Flushing/heat sensation | 25 | 8 |
| Headache | 23 | 20 |
| Weakness | 12 | 10 |
| Nausea, heartburn | 11 | 8 |
| Muscle cramps, tremor | 8 | 3 |
| Peripheral Edema | 7 | 1 |
| Nervousness, mood changes | 7 | 4 |
| Palpitations | 7 | 5 |
| Dyspnea, cough, wheezing | 6 | 3 |
| Nasal congestion/sore throat | 6 | 8 |
What should I look out for while using NifedicalXL?
Known hypersensitivity reaction to nifedipine.
What might happen if I take too much NifedicalXL?
Experience with nifedipine overdosage is limited. 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. Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function. Since nifedipine is highly protein-bound, dialysis is not likely to be of any benefit.
There has been one reported case of massive overdosage with nifedipine extended-release tablets. The main effects of ingestion of approximately 4800 mg of nifedipine extended-release tablets in a young man attempting suicide as a result of cocaine-induced depression was initial dizziness, palpitations, flushing, and nervousness. Within several hours of ingestion, nausea, vomiting, and generalized edema developed. No significant hypotension was apparent at presentation, 18 hours post-ingestion. Electrolyte abnormalities consisted of a mild, transient elevation of serum creatinine, and modest elevations of LDH and CPK, but normal SGOT. Vital signs remained stable, no electrocardiographic abnormalities were noted and renal function returned to normal within 24 to 48 hours with routine supportive measures alone. No prolonged sequelae were observed.
The effect of a single 900 mg ingestion of nifedipine capsules in a depressed anginal patient also on tricyclic antidepressants was loss of consciousness within 30 minutes of ingestion, and profound hypotension, which responded to calcium infusion, pressor agents, and fluid replacement. 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. These dictated the prophylactic placement of a temporary ventricular pacemaker, but otherwise resolved spontaneously. Significant hyperglycemia was seen initially in this patient, but plasma glucose levels rapidly normalized without further treatment.
A young hypertensive patient with advanced renal failure ingested 280 mg of nifedipine capsules at one time, with resulting marked hypotension responding to calcium infusion and fluids. No AV conduction abnormalities, arrhythmias, or pronounced changes in heart rate were noted, nor was there any further deterioration in renal function.
How should I store and handle NifedicalXL?
Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Nifedical XL Extended-release Tablets, USP, are supplied as 60 mg reddish brown, unscored, film-coated, round tablets, debossed with "B" on one side and "60" on the other.Nifedical XL Extended-release Tablets, USP, are supplied in:Nifedical XL Extended-release Tablets, USP, are supplied as 60 mg reddish brown, unscored, film-coated, round tablets, debossed with "B" on one side and "60" on the other.Nifedical XL Extended-release Tablets, USP, are supplied in:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action
Non-Clinical Toxicology
Known hypersensitivity reaction to nifedipine.General - Hypotension:
WARNINGS
Over 1000 patients from both controlled and open trials with nifedipine extended-release tablets in hypertension and angina were included in the evaluation of adverse experiences. All side effects reported during nifedipine extended-release tablet therapy were tabulated independent of the causal relation to medication. The most common side effect reported with nifedipine extended-release tablet was edema which was dose related and ranged in frequency from approximately 10% to about 30% at the highest dose studied (180 mg). Other common adverse experiences reported in placebo-controlled trials include:
Of these, only edema and headache were more common in patients given nifedipine extended-release tablets than placebo patients.
The following adverse reactions occurred with an incidence of less than 3.0%. With the exception of leg cramps, the incidence of these side effects was similar to that of placebo alone.
Body as a Whole/Systemic:
Cardiovascular:
Central Nervous System:
Dermatologic:
Gastrointestinal:
Musculoskeletal:
Respiratory:
Urogenital:
Other adverse reactions were reported sporadically with an incidence of 1.0% or less. These include:
Body as a Whole/Systemic:
Cardiovascular:
Central Nervous System:
Dermatologic:
Gastrointestinal:
Musculoskeletal:
Respiratory:
Special Senses:
Urogenital/Reproductive:
Adverse experiences which occurred in less than 1 in 1000 patients cannot be distinguished from concurrent disease states or medications.
The following adverse experiences, reported in less than 1% of patients, occurred under conditions (e.g., open trials, marketing experiences) where a causal relationship is uncertain: gastrointestinal irritation, gastrointestinal bleeding, gynecomastia.
Gastrointestinal obstruction resulting in hospitalization and surgery, including the need for bezoar removal, has occurred in association with nifedipine extended-release tablets, even in patients with no prior history of gastrointestinal disease.
In multiple-dose U.S. and foreign controlled studies with nifedipine capsules in which adverse reactions were reported spontaneously, adverse effects were frequent but generally not serious and rarely required discontinuation of therapy or dosage adjustment. Most were expected consequences of the vasodilator effects of nifedipine.
There is also a large uncontrolled experience in over 2100 patients in the United States. Most of the patients had vasospastic or resistant angina pectoris, and about half had concomitant treatment with beta-adrenergic blocking agents. The relatively common adverse events were similar in nature to those seen with nifedipine extended-release tablets.
In addition, more serious adverse events were observed, not readily distinguishable from the natural history of the disease in these patients. It remains possible, however, that some or many of these events were drug related. Myocardial infarction occurred in about 4% of patients and congestive heart failure or pulmonary edema in about 2%. Ventricular arrhythmias or conduction disturbances each occurred in fewer than 0.5% of patients.
In a subgroup of over 1000 patients receiving nifedipine with concomitant beta-blocker therapy, the pattern and incidence of adverse experiences was not different from that of the entire group of nifedipine treated patients (see ).
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. Hypotension occurred in about one in 20 patients. Syncope occurred in approximately one patient in 250. Myocardial infarction or symptoms of congestive heart failure each occurred in about one patient in 15. Atrial or ventricular dysrhythmias each occurred in about one patient in 150.
In post-marketing experience, there have been rare reports of exfoliative dermatitis caused by nifedipine. There have been rare reports of exfoliative or bullous skin adverse events (such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) and photosensitivity reactions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
516Total User Reviews
User Reviews
Learn about
User Reviews
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).