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CALAN SR
Overview
What is CALAN SR?
CALAN SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist). CALAN SR is available for oral administration as light green, capsule-shaped, scored, film-coated tablets (caplets) containing 240 mg of verapamil hydrochloride; as light pink, oval, scored, film-coated tablets (caplets) containing 180 mg of verapamil hydrochloride; and as light violet, oval, film-coated tablets (caplets) containing 120 mg of verapamil hydrochloride. The caplets are designed for sustained release of the drug in the gastrointestinal tract; sustained-release characteristics are not altered when the caplet is divided in half.
The structural formula of verapamil HCl is:
Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil HCl is not chemically related to other cardioactive drugs.
Inactive ingredients include alginate, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, talc, titanium dioxide, and coloring agents: 240 mg—D&C Yellow No. 10 Lake and FD&C Blue No. 2 Lake; 120 and 180 mg—iron oxide.
What does CALAN SR look like?
What are the available doses of CALAN SR?
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What should I talk to my health care provider before I take CALAN SR?
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How should I use CALAN SR?
CALAN SR is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
What interacts with CALAN SR?
- Verapamil HCl caplets are contraindicated in:
- Severe left ventricular dysfunction (see )
- Hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock
- Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)
- Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker)
- Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (eg, Wolff-Parkinson-White, Lown-Ganong-Levine syndromes) (see )
- Patients with known hypersensitivity to verapamil hydrochloride
What are the warnings of CALAN SR?
Heart failure
Verapamil has a negative inotropic effect, which in most patients is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In clinical experience with 4,954 patients, 87 (1.8%) developed congestive heart failure or pulmonary edema.
Verapamil should be avoided in patients with severe left ventricular dysfunction (eg, ejection fraction less than 30%) or moderate to severe symptoms of cardiac failure and in patients with any degree of ventricular dysfunction if they are receiving a beta-adrenergic blocker (see ). Patients with milder ventricular dysfunction should, if possible, be controlled with optimum doses of digitalis and/or diuretics before verapamil treatment.
Hypotension
Occasionally, the pharmacologic action of verapamil may produce a decrease in blood pressure below normal levels, which may result in dizziness or symptomatic hypotension. The incidence of hypotension observed in 4,954 patients enrolled in clinical trials was 2.5%. In hypertensive patients, decreases in blood pressure below normal are unusual. Tilt-table testing (60 degrees) was not able to induce orthostatic hypotension.
Elevated liver enzymes
Elevations of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported. Such elevations have sometimes been transient and may disappear even in the face of continued verapamil treatment. Several cases of hepatocellular injury related to verapamil have been proven by rechallenge; half of these had clinical symptoms (malaise, fever, and/or right upper quadrant pain) in addition to elevation of SGOT, SGPT, and alkaline phosphatase. Periodic monitoring of liver function in patients receiving verapamil is therefore prudent.
Accessory bypass tract (Wolff-Parkinson-White or Lown-Ganong-Levine)
Some patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, producing a very rapid ventricular response or ventricular fibrillation after receiving intravenous verapamil (or digitalis). Although a risk of this occurring with oral verapamil has not been established, such patients receiving oral verapamil may be at risk and its use in these patients is contraindicated (see ). Treatment is usually DC-cardioversion. Cardioversion has been used safely and effectively after oral CALAN.
Atrioventricular block
The effect of verapamil on AV conduction and the SA node may cause asymptomatic first-degree AV block and transient bradycardia, sometimes accompanied by nodal escape rhythms. PR-interval prolongation is correlated with verapamil plasma concentrations, especially during the early titration phase of therapy. Higher degrees of AV block, however, were infrequently (0.8%) observed. Marked first-degree block or progressive development to second- or third-degree AV block, requires a reduction in dosage or, in rare instances, discontinuation of verapamil HCl and institution of appropriate therapy, depending upon the clinical situation.
Patients with hypertrophic cardiomyopathy (IHSS)
In 120 patients with hypertrophic cardiomyopathy (most of them refractory or intolerant to propranolol) who received therapy with verapamil at doses up to 720 mg/day, a variety of serious adverse effects were seen. Three patients died in pulmonary edema; all had severe left ventricular outflow obstruction and a past history of left ventricular dysfunction. Eight other patients had pulmonary edema and/or severe hypotension; abnormally high (greater than 20 mm Hg) pulmonary wedge pressure and a marked left ventricular outflow obstruction were present in most of these patients. Concomitant administration of quinidine (see ) preceded the severe hypotension in 3 of the 8 patients (2 of whom developed pulmonary edema). Sinus bradycardia occurred in 11% of the patients, second-degree AV block in 4%, and sinus arrest in 2%. It must be appreciated that this group of patients had a serious disease with a high mortality rate. Most adverse effects responded well to dose reduction, and only rarely did verapamil use have to be discontinued.
What are the precautions of CALAN SR?
General
Use in patients with impaired hepatic function
Since verapamil is highly metabolized by the liver, it should be administered cautiously to patients with impaired hepatic function. Severe liver dysfunction prolongs the elimination half-life of immediate-release verapamil to about 14 to 16 hours; hence, approximately 30% of the dose given to patients with normal liver function should be administered to these patients. Careful monitoring for abnormal prolongation of the PR interval or other signs of excessive pharmacologic effects (see ) should be carried out.
Use in patients with attenuated (decreased) neuromuscular transmission
It has been reported that verapamil decreases neuromuscular transmission in patients with Duchenne's muscular dystrophy, and that verapamil prolongs recovery from the neuromuscular blocking agent vecuronium. It may be necessary to decrease the dosage of verapamil when it is administered to patients with attenuated neuromuscular transmission.
Use in patients with impaired renal function
About 70% of an administered dose of verapamil is excreted as metabolites in the urine. Verapamil is not removed by hemodialysis. Until further data are available, verapamil should be administered cautiously to patients with impaired renal function. These patients should be carefully monitored for abnormal prolongation of the PR interval or other signs of overdosage (see ).
Drug interactions
HMG-CoA reductase inhibitors
The use of HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with verapamil has been associated with reports of myopathy/rhabdomyolysis.
Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.
Ivabradine
Concurrent use of verapamil increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Avoid co-administration of verapamil and ivabradine.
Beta-blockers
Concomitant therapy with beta-adrenergic blockers and verapamil may result in additive negative effects on heart rate, atrioventricular conduction and/or cardiac contractility. The combination of sustained-release verapamil and beta-adrenergic blocking agents has not been studied. However, there have been reports of excessive bradycardia and AV block, including complete heart block, when the combination has been used for the treatment of hypertension. For hypertensive patients, the risks of combined therapy may outweigh the potential benefits. The combination should be used only with caution and close monitoring.
Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.
A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together.
Digitalis
Clinical use of verapamil in digitalized patients has shown the combination to be well tolerated if digoxin doses are properly adjusted. However, chronic verapamil treatment can increase serum digoxin levels by 50% to 75% during the first week of therapy, and this can result in digitalis toxicity. In patients with hepatic cirrhosis the influence of verapamil on digoxin kinetics is magnified. Verapamil may reduce total body clearance and extrarenal clearance of digitoxin by 27% and 29%, respectively. Maintenance and digitalization doses should be reduced when verapamil is administered, and the patient should be carefully monitored to avoid over- or under-digitalization. Whenever over-digitalization is suspected, the daily dose of digitalis should be reduced or temporarily discontinued. On discontinuation of CALAN use, the patient should be reassessed to avoid under-digitalization.
Antihypertensive agents
Verapamil administered concomitantly with oral antihypertensive agents (eg, vasodilators, angiotensin-converting enzyme inhibitors, diuretics, beta-blockers) will usually have an additive effect on lowering blood pressure. Patients receiving these combinations should be appropriately monitored. Concomitant use of agents that attenuate alpha-adrenergic function with verapamil may result in a reduction in blood pressure that is excessive in some patients. Such an effect was observed in one study following the concomitant administration of verapamil and prazosin.
Antiarrhythmic agents
Other agents
Carcinogenesis, mutagenesis, impairment of fertility
An 18-month toxicity study in rats, at a low multiple (6-fold) of the maximum recommended human dose, and not the maximum tolerated dose, did not suggest a tumorigenic potential. There was no evidence of a carcinogenic potential of verapamil administered in the diet of rats for two years at doses of 10, 35, and 120 mg/kg/day or approximately 1, 3.5, and 12 times, respectively, the maximum recommended human daily dose (480 mg/day or 9.6 mg/kg/day).
Verapamil was not mutagenic in the Ames test in 5 test strains at 3 mg per plate with or without metabolic activation.
Studies in female rats at daily dietary doses up to 5.5 times (55 mg/kg/day) the maximum recommended human dose did not show impaired fertility. Effects on male fertility have not been determined.
Pregnancy
Reproduction studies have been performed in rabbits and rats at oral doses up to 1.5 (15 mg/kg/day) and 6 (60 mg/kg/day) times the human oral daily dose, respectively, and have revealed no evidence of teratogenicity. In the rat, however, this multiple of the human dose was embryocidal and retarded fetal growth and development, probably because of adverse maternal effects reflected in reduced weight gains of the dams. This oral dose has also been shown to cause hypotension in rats. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Verapamil crosses the placental barrier and can be detected in umbilical vein blood at delivery.
Labor and delivery
It is not known whether the use of verapamil during labor or delivery has immediate or delayed adverse effects on the fetus, or whether it prolongs the duration of labor or increases the need for forceps delivery or other obstetric intervention. Such adverse experiences have not been reported in the literature, despite a long history of use of verapamil in Europe in the treatment of cardiac side effects of beta-adrenergic agonist agents used to treat premature labor.
Nursing mothers
Verapamil is excreted in human milk. Because of the potential for adverse reactions in nursing infants from verapamil, nursing should be discontinued while verapamil is administered.
Pediatric use
Safety and efficacy of CALAN SR in pediatric patients below the age of 18 years have not been established.
Animal pharmacology and/or animal toxicology
In chronic animal toxicology studies, verapamil caused lenticular and/or suture line changes at 30 mg/kg/day or greater, and frank cataracts at 62.5 mg/kg/day or greater in the beagle dog but not in the rat. Development of cataracts due to verapamil has not been reported in man.
What are the side effects of CALAN SR?
Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil. The following reactions to orally administered verapamil occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug-related in clinical trials in 4,954 patients:
Elevated liver enzymes (see )
In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or flutter, ventricular rates below 50/min at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.
The following reactions, reported in 1% or less of patients, occurred under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Cardiovascular:
Digestive system:
Hemic and lymphatic:
Nervous system:
Skin:
Special senses:
Urogenital:
| Constipation | 7.3% | Dyspnea | 1.4% |
| Dizziness | 3.3% | Bradycardia | |
| Nausea | 2.7% | (HR <50/min) | 1.4% |
| Hypotension | 2.5% | AV block | |
| Headache | 2.2% | (total 1°, 2°, 3°) | 1.2% |
| Edema | 1.9% | (2° and 3°) | 0.8% |
| CHF, Pulmonary | Rash | 1.2% | |
| edema | 1.8% | Flushing | 0.6% |
| Fatigue | 1.7% |
What should I look out for while using CALAN SR?
Verapamil HCl caplets are contraindicated in:
What might happen if I take too much CALAN SR?
Overdose with verapamil may lead to pronounced hypotension, bradycardia, and conduction system abnormalities (eg, junctional rhythm with AV dissociation and high degree AV block, including asystole). Other symptoms secondary to hypoperfusion (eg, metabolic acidosis, hyperglycemia, hyperkalemia, renal dysfunction, and convulsions) may be evident.
Treat all verapamil overdoses as serious and maintain observation for at least 48 hours (especially CALAN SR), preferably under continuous hospital care. Delayed pharmacodynamic consequences may occur with the sustained-release formulation. Verapamil is known to decrease gastrointestinal transit time.
In overdose, caplets of CALAN SR have occasionally been reported to form concretions within the stomach or intestines. These concretions have not been visible on plain radiographs of the abdomen, and no medical means of gastrointestinal emptying is of proven efficacy in removing them. Endoscopy might reasonably be considered in cases of massive overdose when symptoms are unusually prolonged.
Treatment of overdosage should be supportive. Beta-adrenergic stimulation or parenteral administration of calcium solutions may increase calcium ion flux across the slow channel and have been used effectively in treatment of deliberate overdosage with verapamil. Continued treatment with large doses of calcium may produce a response. In a few reported cases, overdose with calcium channel blockers that was initially refractory to atropine became more responsive to this treatment when the patients received large doses (close to 1 g/hr for more than 24 hr) of calcium chloride. Verapamil cannot be removed by hemodialysis. Clinically significant hypotensive reactions or high degree AV block should be treated with vasopressor agents or cardiac pacing, respectively. Asystole should be handled by the usual measures including cardiopulmonary resuscitation.
How should I store and handle CALAN SR?
Dispense in a well-closed container as defined in the USP.Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015Dispense in a well-closed container as defined in the USP.Keep container tightly closed. Protect from light, moisture, and freezing, -20°C (-4°F).Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USAMarketed/ Packaged by: Camarillo, CA 93012 USA40-9176Revised — November 2015CALAN SR 120 mg caplets are light violet, oval, film coated, with CALAN debossed on one side and SR 120 on the other, supplied as:CALAN SR 180 mg caplets are light pink, oval, scored, film coated, with CALAN debossed on one side and SR 180 on the other, supplied as:CALAN SR 240 mg caplets are light green, capsule shaped, scored, film coated, with CALAN debossed on one side and SR 240 on the other, supplied as:CALAN SR 120 mg caplets are light violet, oval, film coated, with CALAN debossed on one side and SR 120 on the other, supplied as:CALAN SR 180 mg caplets are light pink, oval, scored, film coated, with CALAN debossed on one side and SR 180 on the other, supplied as:CALAN SR 240 mg caplets are light green, capsule shaped, scored, film coated, with CALAN debossed on one side and SR 240 on the other, supplied as:CALAN SR 120 mg caplets are light violet, oval, film coated, with CALAN debossed on one side and SR 120 on the other, supplied as:CALAN SR 180 mg caplets are light pink, oval, scored, film coated, with CALAN debossed on one side and SR 180 on the other, supplied as:CALAN SR 240 mg caplets are light green, capsule shaped, scored, film coated, with CALAN debossed on one side and SR 240 on the other, supplied as:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CALAN (verapamil HCl) is a calcium ion influx inhibitor (slow-channel blocker or calcium ion antagonist) that exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells.
Non-Clinical Toxicology
Verapamil HCl caplets are contraindicated in:Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See for discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil. The following reactions to orally administered verapamil occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug-related in clinical trials in 4,954 patients:
Elevated liver enzymes (see )
In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or flutter, ventricular rates below 50/min at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.
The following reactions, reported in 1% or less of patients, occurred under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Cardiovascular:
Digestive system:
Hemic and lymphatic:
Nervous system:
Skin:
Special senses:
Urogenital:
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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