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Nifediac CC
Overview
What is Nifediac CC?
Nifediac CC Extended-release Tablets USP are an extended release tablet dosage form of the calcium channel blocker nifedipine. The product is provided as a general matrix tablet with a polymer coating. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester. The molecular formula is 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. Nifediac CC Extended-release Tablets USP contain 90 mg of nifedipine for once-a-day oral administration.
In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, ethylcellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. Contains FD&C yellow #5 (tartrazine) as a color additive.
Nifedipine Extended-release Tablets USP Dissolution Test is pending.
What does Nifediac CC look like?
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What are the available doses of Nifediac CC?
Sorry No records found.
What should I talk to my health care provider before I take Nifediac CC?
Sorry No records found
How should I use Nifediac CC?
Nifediac CC Extended-release Tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Dosage should be adjusted according to each patient's needs. It is recommended that Nifediac CCExtended-release Tablets USP be administered orally once daily on an empty stomach. Nifediac CC Extended-release Tablets USP is an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7 to 14 day period starting with 30 mg once daily. Upward titration should be based on therapeutic efficacy and safety. The usual maintenance dose is 30 mg to 60 mg once daily. Titration to doses above 90 mg daily is not recommended.
If discontinuation of Nifediac CC Extended-release Tablets USP is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.
Coadministration of nifedipine with grapefruit juice is to be avoided (see and ).
Care should be taken when dispensing Nifediac CC Extended-release Tablets USP to assure that the extended-release dosage form has been prescribed.
What interacts with Nifediac CC?
Known hypersensitivity to nifedipine.
What are the warnings of Nifediac CC?
Excessive Hypotension
Although in most 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 using concomitant beta-blockers.
Severe hypotension and/or increased fluid volume requirements have been reported in patients who received immediate-release capsules together with a beta-blocking agent and 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.
Increased Angina and/or Myocardial Infarction
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 upon starting nifedipine or at the time of dosage increase. The mechanism of this effect is not established.
Beta-Blocker Withdrawal
When discontinuing a beta-blocker, it is important to taper its dose, if possible, rather than stopping 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 while 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 to these patients, owing to their fixed impedance to flow across the aortic valve.
What are the precautions of Nifediac CC?
General Hypotension
Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of Nifediac CC Extended-release Tablets USP is suggested. Close observation is especially recommended for patients already taking medications that are known to lower blood pressure (see ).
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Peripheral Edema
Mild to moderate peripheral edema occurs in a dose-dependent manner with nifedipine extended-release tablets. The placebo subtracted rate is approximately 8% at 30 mg, 12% at 60 mg and 19% at 90 mg daily. This edema is a localized phenomenon, thought to be associated with vasodilation of dependent arterioles and small blood vessels and not due to left ventricular dysfunction or generalized fluid retention. With patients whose hypertension is complicated by congestive heart failure, care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction.
Information for Patients
Nifediac CC Extended-release Tablets USP are an extended-release tablet and should be swallowed whole and taken on an empty stomach. It should not be administered with food. Do not chew, divide, or crush tablets.
Laboratory Tests
Rare, usually transient, but occasionally significant elevations of enzymes such as alkaline phosphatase, CPK, LDH, SGOT, and SGPT have been noted. The relationship to nifedipine therapy is uncertain in most cases, but probable in some. These laboratory abnormalities have rarely been associated with clinical symptoms; however, cholestasis with or without jaundice has been reported. A small increase (<5%) in mean alkaline phosphatase was noted in patients treated with nifedipine extended-release tablets. This was an isolated finding, and it rarely resulted in values which fell outside the normal range. Rare instances of allergic hepatitis have been reported with nifedipine treatment. In controlled studies, nifedipine extended-release tablets did not adversely affect serum uric acid, glucose, cholesterol or potassium.
Nifedipine, like other calcium channel blockers, decreases platelet aggregation . Limited clinical studies have demonstrated a moderate but statistically significant decrease in platelet aggregation and increase in bleeding time in some nifedipine patients. This is thought to be a function of inhibition of calcium transport across the platelet membrane. No clinical significance for these findings has been demonstrated.
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.
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. The relationship to nifedipine therapy is uncertain in most cases but probable in some.
Drug Interactions:
Beta-adrenergic Blocking Agents
WARNINGS
In vitro
in vivo
Array
CardiovascularDrugs
Antiarrhythmics
Quinidine:
in vitro
Flecainide:
Calcium Channel Blockers
Diltiazem:
Verapamil:
ACE Inhibitors
Benazepril:
Angiotensin-II Blockers
Irbesartan: In vitro
Candesartan:
Beta-blockers
Nifedipine extended-release tablet was well tolerated when administered in combination with beta-blockers in 187 hypertensive patients in a placebo-controlled clinical trial. However, there have been occasional literature reports suggesting that the combination of nifedipine and beta-adrenergic blocking drugs may increase the likelihood of congestive heart failure, severe hypotension, or exacerbation of angina in patients with cardiovascular disease. Clinical monitoring is recommended, and a dose adjustment of nifedipine should be considered.
Timolol:
Central Alpha1-Blockers
Doxazosin:
Digitalis
Digoxin:
Antithrombotics
Coumarins:
Platelet Aggregation Inhibitors
Clopidogrel:
Tirofiban:
Array
Non-Cardiovascular Drugs
Antifungal Drugs
Ketoconazole, itraconazole and fluconazole are CYP3A inhibitors and can inhibit the metabolism of nifedipine and increase the exposure to nifedipine during concomitant therapy. Blood pressure should be monitored and a dose reduction of nifedipine considered.
Antisecretory Drugs
Omeprazole:
Pantoprazole:
Ranitidine:
Cimetidine:
Antibacterial Drugs
Quinupristin/Dalfopristin:
In vitro
Erythromycin:
Antitubercular Drugs
Rifampin:
Rifapentine:
Antiviral Drugs
Amprenavir, atanazavir, delavirine, fosamprinavir, indinavir, nelfinavir and ritonavir
CNS Drugs
Nefazodone
Valproic acid
Phenytoin:
Phenobarbitone and carbamazepine
Antiemetic Drugs
Dolasetron
Immunosuppressive Drugs
Tacrolimus:
in vitro
Sirolimus:
Glucose Lowering Drugs
Pioglitazone:
Rosiglitazone:
Metformin:
Miglitol:
Repaglinide:
Acarbose:
Drugs Interfering with Food Absorption
Orlistat:
Dietary Supplements
Grapefruit Juice:
Herbals
St. John’s Wort:
CYP2D6 Probe Drug
Debrisoquine:
in vivo
Carcinogenesis, Mutagenesis, Impairment of Fertility
Nifedipine was administered orally to rats for two years and was not shown to be carcinogenic. When given to rats prior to mating, nifedipine caused reduced fertility at a dose approximately 30 times the maximum recommended human dose.
mutagenicity studies were negative.
Pregnancy: Pregnancy Category C
In rodents, rabbits, and monkeys, nifedipine has been shown to have a variety of embryotoxic, placentotoxic, and fetotoxic effects, including stunted fetuses (rats, mice, and rabbits), digital anomalies (rats and rabbits), rib deformities (mice), cleft palate (mice), small placentas and underdeveloped chorionic villi (monkeys), embryonic and fetal deaths (rats, mice, and rabbits), prolonged pregnancy (rats; not evaluated in other species), and decreased neonatal survival (rats; not evaluated in other species). On a mg/kg or mg/m basis, some of the doses associated with these various effects are higher than the maximum recommended human dose and some are lower, but all are within an order of magnitude of it.
The digital anomalies seen in nifedipine-exposed rabbit pups are strikingly similar to those seen in pups exposed to phenytoin, and these are in turn similar to the phalangeal deformities that are the most common malformation seen in human children with in utero exposure to phenytoin.
There are no adequate and well-controlled studies in pregnant women. Nifediac CC Extended-release Tablets USP should generally be avoided during pregnancy and used only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:
Nifedipine is excreted in human milk. Therefore, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Geriatric Use:
Although small pharmacokinetic studies have identified an increased half-life and increased C and AUC (see ), clinical studies of nifedipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of Nifediac CC?
The incidence of adverse events during treatment with nifedipine extended-release tablets in doses up to 90 mg daily were derived from multi-center, placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on nifedipine extended-release tablets and in 64 of the 126 patients on placebo. All adverse events reported during nifedipine extended-release tablet therapy were tabulated independently of their causal relationship to medication.
The most common adverse event reported with nifedipine extended-release tablets was peripheral edema. This was dose related, and the frequency was 18% on nifedipine extended-release tablets 30 mg daily, 22% on nifedipine extended-release tablets 60 mg daily, and 29% on nifedipine extended-release tablets 90 mg daily versus 10% on placebo.
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.
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:
Central Nervous System:
Dermatologic:
Gastrointestinal:
Musculoskeletal:
Respiratory:
Urogenital:
Other adverse events reported with an incidence of less than 1% were:
Body as a Whole/Systemic:
Cardiovascular:
Central Nervous System:
Dermatologic:
Gastrointestinal:
Hematologic:
Metabolic:
Musculoskeletal:
Respiratory:
Special Senses:
Urogenital/Reproductive:
The following adverse events have been reported rarely in patients given nifedipine in coat core or other formulations: allergenic hepatitis, alopecia, anaphylactic reaction, anemia, arthritis with ANA (+), depression, erythromelalgia, exfoliative dermatitis, fever, gingival hyperplasia, gynecomastia, hyperglycemia, jaundice, leukopenia, mood changes, muscle cramps, nervousness, paranoid syndrome, purpura, shakiness, sleep disturbances, Stevens-Johnson syndrome, syncope, taste perversion, thrombocytopenia, toxic epidermal necrolysis, transient blindness at the peak of plasma level, tremor, and urticaria.
| Adverse Event | NIFEDIPINEEXTENDED-RELEASETABLETS (%)(n=370) | PLACEBO(%)(n=126) | |||
| Headache | 19 | 13 | |||
| Flushing/heat sensation | 4 | 0 | |||
| Dizziness | 4 | 2 | |||
| Fatigue/asthenia | 4 | 4 | |||
| Nausea | 2 | 1 | |||
| Constipation | 1 | 0 |
What should I look out for while using Nifediac CC?
Known hypersensitivity to nifedipine.
What might happen if I take too much Nifediac CC?
Experience with nifedipine overdosage is limited. Symptoms associated with severe nifedipine overdosage include loss of consciousness, drop in blood pressure, heart rhythm disturbances, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary edema. 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; however, plasmapheresis may be beneficial.
There has been one reported case of massive overdosage with tablets of another extended-release formulation of nifedipine. The main effects of ingestion of approximately 4800 mg of nifedipine 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. Blood chemistry 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 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 Nifediac CC?
StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]NIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central PharmacyNIFEDIAC CC (nifedipine) Extended-release Tablets USP are supplied as 90 mg yellow, round, film-coated tablets, unscored, and engraved with “B” on one side and “90” on the other side.They are supplied by as follows:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. PROTECT FROM MOISTURE.Manufactured In Canada By:Biovail CorporationMississauga, ON L5N 8M5 CanadaDistributed By:TEVA PHARMACEUTICALS USASellersville, PA 18960This Product was Repackaged By:State of Florida DOH Central Pharmacy
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism by which nifedipine reduces arterial blood pressure involves peripheral arterial vasodilatation and, consequently, a reduction in peripheral vascular resistance. The increased peripheral vascular resistance that is an underlying cause of hypertension results from an increase in active tension in the vascular smooth muscle. Studies have demonstrated that the increase in active tension reflects an increase in cytosolic free calcium.
Nifedipine is a peripheral arterial vasodilator which acts directly on vascular smooth muscle. 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. Stores of intracellular calcium in vascular smooth muscle are limited and thus dependent upon the influx of extracellular calcium for contraction to occur. The reduction in calcium influx by nifedipine causes arterial vasodilation and decreased peripheral vascular resistance which results in reduced arterial blood pressure.
Non-Clinical Toxicology
Known hypersensitivity to nifedipine.Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when metronidazole is prescribed for patients on this type of anticoagulant therapy.
The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported.
The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half life and decrease plasma clearance of metronidazole. In patients stabilized on relatively high doses of lithium, short term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication.
Alcoholic beverages should not be consumed during metronidazole therapy and for at least one day afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.
Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last two weeks.
Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of Nifediac CC Extended-release Tablets USP is suggested. Close observation is especially recommended for patients already taking medications that are known to lower blood pressure (see ).
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
The incidence of adverse events during treatment with nifedipine extended-release tablets in doses up to 90 mg daily were derived from multi-center, placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on nifedipine extended-release tablets and in 64 of the 126 patients on placebo. All adverse events reported during nifedipine extended-release tablet therapy were tabulated independently of their causal relationship to medication.
The most common adverse event reported with nifedipine extended-release tablets was peripheral edema. This was dose related, and the frequency was 18% on nifedipine extended-release tablets 30 mg daily, 22% on nifedipine extended-release tablets 60 mg daily, and 29% on nifedipine extended-release tablets 90 mg daily versus 10% on placebo.
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.
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:
Central Nervous System:
Dermatologic:
Gastrointestinal:
Musculoskeletal:
Respiratory:
Urogenital:
Other adverse events reported with an incidence of less than 1% were:
Body as a Whole/Systemic:
Cardiovascular:
Central Nervous System:
Dermatologic:
Gastrointestinal:
Hematologic:
Metabolic:
Musculoskeletal:
Respiratory:
Special Senses:
Urogenital/Reproductive:
The following adverse events have been reported rarely in patients given nifedipine in coat core or other formulations: allergenic hepatitis, alopecia, anaphylactic reaction, anemia, arthritis with ANA (+), depression, erythromelalgia, exfoliative dermatitis, fever, gingival hyperplasia, gynecomastia, hyperglycemia, jaundice, leukopenia, mood changes, muscle cramps, nervousness, paranoid syndrome, purpura, shakiness, sleep disturbances, Stevens-Johnson syndrome, syncope, taste perversion, thrombocytopenia, toxic epidermal necrolysis, transient blindness at the peak of plasma level, tremor, and urticaria.
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.
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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
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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).