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Afeditab
Overview
What is Afeditab?
Afeditab CR 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.
Afeditab CR tablets contain either 30 mg or 60 mg of nifedipine for once-a-day oral administration.
Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate (60 mg), magnesium stearate, and microcrystalline cellulose (30 mg). The inert ingredients in the film coating are: hypromellose, iron oxide, polyethylene glycol, and titanium dioxide. The ingredients of the printing ink are: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac.
Does not meet USP Drug Release Test.
What does Afeditab look like?
What are the available doses of Afeditab?
Sorry No records found.
What should I talk to my health care provider before I take Afeditab?
Sorry No records found
How should I use Afeditab?
Afeditab CR 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 nifedipine extended-release tablets be administered orally once daily on an empty stomach. Afeditab CR 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 Afeditab CR 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 Afeditab CR to assure that the extended-release dosage form has been prescribed.
What interacts with Afeditab?
Known hypersensitivity to nifedipine.
What are the warnings of Afeditab?
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Excessive Hypotension:
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:
Beta-Blocker Withdrawal:
Congestive Heart Failure:
What are the precautions of Afeditab?
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General - Hypotension:
Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of Afeditab CR is suggested. Close observation is especially recommended for patients already taking medications that are known to lower blood pressure (See ).
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Peripheral Edema:
Mild to moderate peripheral edema occurs in a dose-dependent manner with Afeditab CR. 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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Information for Patients:
Afeditab CR 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.
Patients should be advised that empty matrix “ghosts” (tablets) may pass via colostomy or in the stool, and that this is of no concern since the active medication has already been absorbed.
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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.
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Drug Interactions:
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Flecainide:
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Verapamil:
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Candesartan:
Beta-blockers
Timolol:
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Tirofiban:
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Pantoprazole:
Ranitidine:
Cimetidine:
In normotensive subjects receiving single doses of 10 mg or multiple doses of up to 20 mg nifedipine t.i.d. alone or together with cimetidine up to 1000 mg/day, the AUC values of nifedipine in the presence of cimetidine were between 1.52 and 2.01 times those in the absence of cimetidine. The C values of nifedipine in the presence of cimetidine were increased by factors ranging between 1.60 and 2.02. The increase in exposure to nifedipine by cimetidine was accompanied by relevant changes in blood pressure or heart rate in normotensive subjects. Hypertensive subjects receiving 10 mg q.d. nifedipine alone or in combination with cimetidine 1000 mg q.d. also experienced relevant changes in blood pressure when cimetidine was added to nifedipine. The interaction between cimetidine and nifedipine is of clinical relevance and blood pressure should be monitored and a reduction of the dose of nifedipine considered.
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Erythromycin:
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Rifapentine:
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Valproic acid
Phenytoin:
Phenobarbitone and carbamazepine
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Sirolimus:
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Rosiglitazone:
Metformin:
Miglitol:
Repaglinide:
Acarbose:
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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.
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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 exposure to phenytoin.
There are no adequate and well-controlled studies in pregnant women. Nifedipine should generally be avoided during pregnancy and used only if the potential benefit justifies the potential risk to the fetus.
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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.
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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 Afeditab?
Sorry No records found
What should I look out for while using Afeditab?
Known hypersensitivity to nifedipine.
Excessive Hypotension:
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:
Beta-Blocker Withdrawal:
Congestive Heart Failure:
What might happen if I take too much Afeditab?
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 Afeditab?
Afeditab CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.Afeditab CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF.Manufactured by:Alkermes Pharma Ireland LimitedAthlone, Co. Westmeath, IrelandDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: September 201440-9252Afeditab CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.Afeditab CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF.Manufactured by:Alkermes Pharma Ireland LimitedAthlone, Co. Westmeath, IrelandDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: September 201440-9252Afeditab CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.Afeditab CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF.Manufactured by:Alkermes Pharma Ireland LimitedAthlone, Co. Westmeath, IrelandDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: September 201440-9252Afeditab CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.Afeditab CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF.Manufactured by:Alkermes Pharma Ireland LimitedAthlone, Co. Westmeath, IrelandDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: September 201440-9252Afeditab CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.Afeditab CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF.Manufactured by:Alkermes Pharma Ireland LimitedAthlone, Co. Westmeath, IrelandDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: September 201440-9252Afeditab CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.Afeditab CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF.Manufactured by:Alkermes Pharma Ireland LimitedAthlone, Co. Westmeath, IrelandDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: September 201440-9252Afeditab CR, 30 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.Afeditab CR, 60 mg, is available as round, brownish-red, film-coated, unscored tablets, imprinted with , and are supplied in bottles of 100 and 500.The tablets should be protected from light and moisture and stored below 30°C (86°F). Dispense in tight, light resistant containers as defined in USP/NF.Manufactured by:Alkermes Pharma Ireland LimitedAthlone, Co. Westmeath, IrelandDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARevised: September 201440-9252
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.Excessive Hypotension:
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:
Beta-Blocker Withdrawal:
Congestive Heart Failure:
Because nifedipine decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of Afeditab CR is suggested. Close observation is especially recommended for patients already taking medications that are known to lower blood pressure (See ).
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 tablets 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: chest pain, leg pain paresthesia, vertigo rash constipation leg cramps epistaxis, rhinitis impotence, urinary frequency
Other adverse events reported with an incidence of less than 1.0% were: allergic reaction, asthenia, cellulitis, substernal chest pain, chills, facial edema, lab test abnormal, malaise, neck pain, pelvic pain, pain, photosensitivity reaction atrial fibrillation, bradycardia, cardiac arrest, extrasystole, hypotension, migraine, palpitations, phlebitis, postural hypotension, tachycardia, cutaneous angiectases anxiety, confusion, decreased libido, depression, hypertonia, hypesthesia, insomnia, somnolence angioedema, petechial rash, pruritus, sweating abdominal pain, diarrhea, dry mouth, dysphagia, dyspepsia, eructation, esophagitis, flatulence, gastrointestinal disorder, gastrointestinal hemorrhage, GGT increased, gum disorder, gum hemorrhage, vomiting eosinophilia, lymphadenopathy gout, weight loss arthralgia, arthritis, joint disorder, myalgia, myasthenia dyspnea, increased cough, rales, pharyngitis, stridor abnormal vision, amblyopia, conjunctivitis, diplopia, eye disorder, eye hemorrhage, tinnitus dysuria, kidney calculus, nocturia, breast engorgement, polyuria, urogenital disorder
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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Interactions
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