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Adalat CC
Overview
What is Adalat CC?
Adalat CC is an extended release tablet dosage form of the calcium channel blocker nifedipine. 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. Adalat CC tablets consist of an external coat and an internal core. Both contain nifedipine, the coat as a slow release formulation and the core as a fast release formulation. Adalat CC tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration.
Inert ingredients in the formulation are: hydroxypropylcellulose, lactose, corn starch, crospovidone, microcrystalline cellulose, silicon dioxide, and magnesium stearate. The inert ingredients in the film coating for Adalat CC 30 and 60 are: hypromellose, polyethylene glycol, ferric oxide, and titanium dioxide. The inert ingredients in the film coating for Adalat CC 90 are: hypromellose, polyethylene glycol and ferric oxide
What does Adalat CC look like?
What are the available doses of Adalat CC?
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What should I talk to my health care provider before I take Adalat CC?
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How should I use Adalat CC?
Adalat CC is 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 Adalat CC be administered orally once daily on an empty stomach. Adalat CC is an extended release dosage form and tablets should be swallowed whole, not bitten or divided. In general, titration should proceed over a 7-14 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 Adalat CC is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision.
Co-administration of nifedipine with grapefruit juice is to be avoided (See and ).
Care should be taken when dispensing Adalat CC to assure that the extended release dosage form has been prescribed.
What interacts with Adalat CC?
Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See.)
Nifedipine must not be used in cases of cardiogenic shock.
Adalat is contraindicated in patients with a known hypersensitivity to any component of the tablet.
What are the warnings of Adalat 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 Adalat CC?
General
Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of Adalat CC is suggested. Close observation is especially recommended for patients already taking medications that are known to lower blood pressure (See ).
Mild to moderate peripheral edema occurs in a dose-dependent manner with Adalat CC. 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.
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Use in Cirrhotic Patients
Clearance of nifedipine is reduced and systemic exposure increased in patients with cirrhosis. It is unknown how systemic exposure may be altered in patients with moderate or severe liver impairment. Careful monitoring and dose reduction may be necessary; consider initiating therapy with the lowest dose available.
Information for Patients
Adalat CC is 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 Adalat CC. 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, Adalat CC 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
Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and co-administration of other drugs affecting blood pressure may result in pharmacodynamic interactions.
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CYP3A inhibitors such as ketoconazole, fluconazole, itraconazole, clarithromycin, erythromycin (Azithromycin, although structurally related to the class of macrolide antibiotic is void of clinically relevant CYP3A4 inhibition), grapefruit, nefazodone, fluoxetine, saquinavir, indinavir, nelfinavir, and ritonavir may result in increased exposure to nifedipine when co-administered. Careful monitoring and dose adjustment may be necessary; consider initiating nifedipine at the lowest dose available if given concomitantly with these medications.
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Strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St. John’s Wort reduce the bioavailability and efficacy of nifedipine; therefore nifedipine should not be used in combination with strong CYP3A inducers such as rifampin (See ).
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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
In rodents, rabbits and monkeys, nifedipine has been shown to have a variety of embryotoxic, placentotoxic, teratogenic 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 exposure to phenytoin.
From the clinical evidence available, a specific prenatal risk has not been identified. However, an increase in perinatal asphyxia, caesarean delivery, prematurity and intrauterine growth retardation have been reported.
Careful monitoring of blood pressure must be exercised in pregnant women, when administering nifedipine in combination with IV magnesium sulfate due to the possibility of an excessive fall in blood pressure which could harm the mother and fetus.
There are no adequate and well-controlled studies in pregnant women.
Nursing Mothers
Nifedipine is excreted in human milk. Nursing mothers are advised not to breastfeed their babies when taking the drug.
Pediatric Use
The safety and effectiveness of Adalat CC in pediatric patients have not been established.
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.
Patients with Galactose Intolerance
Since this medicinal product contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
What are the side effects of Adalat CC?
Sorry No records found
What should I look out for while using Adalat CC?
Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See.)
Nifedipine must not be used in cases of cardiogenic shock.
Adalat is contraindicated in patients with a known hypersensitivity to any component of the tablet.
What might happen if I take too much Adalat 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. After oral ingestion, thorough gastric lavage is indicated, if necessary in combination with irrigation of the small intestine. 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.
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.
Bradycardiac heart rhythm disturbances may be treated symptomatically with ß-sympathomimetics, and in life-threatening bradycardiac disturbances of heart rhythm temporary pacemaker therapy can be advisable.
How should I store and handle Adalat CC?
Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:Adalat CC Tablets are supplied in:The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.Manufactured for:Almatica Pharma, Inc. Pine Brook, NJ 07058 USAAdalat is a registered trademark of Alvogen Group Holdings LLCRx OnlyPI494-00 Rev. 05/2016 P
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, 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
Concomitant administration with strong P450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (See.)Nifedipine must not be used in cases of cardiogenic shock.
Adalat is contraindicated in patients with a known hypersensitivity to any component of the tablet.
Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and co-administration of other drugs affecting blood pressure may result in pharmacodynamic interactions.
The incidence of adverse events during treatment with Adalat CC 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 Adalat CC and in 64 of the 126 patients on placebo. All adverse events reported during Adalat CC therapy were tabulated independently of their causal relationship to medication.
The most common adverse event reported with Adalat CC was peripheral edema. This was dose related and the frequency was 18% on Adalat CC 30 mg daily, 22% on Adalat CC 60 mg daily and 29% on Adalat CC 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 Adalat CC 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 1.0% 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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