CALAPTIN SR (Verapamil) 120mg

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CALAPTIN SR (Verapamil) 120mg

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WHAT IS VERAPAMIL?
Verapamil is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.
Verapamil is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders.
Verapamil may also be used for purposes not listed in this medication guide.

IMPORTANT INFORMATION ABOUT VERAPAMIL
You should not use verapamil if you have a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), severe heart failure, slow heartbeats that have caused you to faint, or certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart).

BEFORE TAKING VERAPAMIL
You should not use verapamil if you are allergic to it, or if you have a serious heart condition such as:
-"sick sinus syndrome" or "AV block" (unless you have a pacemaker);
-severe heart failure;
-slow heartbeats that have caused you to faint; or
certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart).
To make sure verapamil is safe for you, tell your doctor if you have:
-congestive heart failure;
-low blood pressure;
-kidney disease;
-liver disease; or
-a nerve-muscle disorder such as myasthenia gravis or muscular dystrophy.
FDA pregnancy category C. It is not known whether verapamil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

HOW SHOULD I TAKE VERAPAMIL?
Take verapamil exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Do not crush, chew, or break an extended-release verapamil tablet or capsule. Swallow it whole.
If you have trouble swallowing an extended-release capsule whole, ask your doctor or pharmacist if it is safe for you to open the capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.
Your blood pressure will need to be checked often. Your kidney or liver function may also need to be checked.
If you need surgery, tell the surgeon ahead of time that you are using verapamil.
You should not stop using verapamil suddenly. Stopping suddenly may make your condition worse.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Verapamil may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your doctor's instructions very closely.
Store at room temperature away from moisture, heat, and light.

WHAT HAPPENS IF I MISS A DOSE?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

WHAT HAPPENS IF I OVERDOSE?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of verapamil can be fatal.
Generic Name Verapamil
Search Name Covera Chronovera 120mg Tab
Supply Name CALAPTIN SR
Brand Generic BRAND NAME
Presentation Foil in Box
Dosage Tab
USA Brand Covera Chronovera
Manufacture Nicolas Piramal
Strength 120mg
Search Terms Covera Chronovera ,CALAPTIN SR,Verapamil
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

FOR THE CONSUMER

Along with its needed effects, verapamil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking verapamil:

Less common:
-Blue lips and fingernails
-blurred vision
-burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
-chest pain
-confusion
-coughing that sometimes produces a pink frothy sputum
-difficult, fast, noisy breathing, sometimes with wheezing
-dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
-increased sweating
-lightheadedness, dizziness, or fainting
-pale skin
-shortness of breath
-slow or irregular heartbeat
-sore throat
-sweating
-swelling in legs and ankles
-unusual tiredness or weakness

Rare:
-Chills
-cold sweats
-feeling of warmth
-redness of the face, neck, arms and occasionally, upper chest

Some side effects of verapamil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:
-Difficulty having a bowel movement (stool)
-headache

Less common:
-Acid or sour stomach
-belching
-difficulty in moving
-heartburn
-indigestion
-joint pain
-muscle aching or cramping
-muscle pains or stiffness
-nausea
-rash
-stomach discomfort, upset, or pain
-trouble sleeping
-unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
-swollen joints
USUAL ADULT DOSE FOR HYPERTENSION
Oral: The antihypertensive effects of verapamil are evident within the first week of therapy.
Immediate release tablets (Calan (R)):
Initial dose: 80 mg orally 3 times a day; alternatively, 40 mg orally 3 times a day may be considered in patients who might respond to lower doses (e.g., small stature)
Maintenance dose: Upward titration should be based on therapeutic efficacy, assessed at the end of the dosing interval. Daily dosages of 360 and 480 mg have been used but there is no evidence that dosages beyond 360 mg provided added effect.
Sustained release tablets (Calan SR (R), Isoptin SR (R)):
Initial dose: 180 mg orally once a day in the morning with food: alternatively, 120 mg orally once a day in the morning with food may be warranted in patients who may have an increased response to verapamil (e.g., small stature)
Maintenance dose: Upward titration should be based on therapeutic efficacy and safety evaluated weekly, about 24 hours after the previous dose. If adequate response is not obtained with the initial dose, it may be titrated upward.
Sustained release capsules (Verelan (R)):
Initial dose: 240 mg orally once a day in the morning (usual dose in clinical trials); alternatively, 120 mg orally once a day in the morning may be warranted in patients who may have an increased response to verapamil (e.g., small stature)
Maintenance dose: Upward titration should be based on therapeutic efficacy and safety evaluated about 24 hours after dosing. If adequate response is not obtained with the initial dose, it may be titrated upward.
Extended release tablets (Covera HS (R)):
Initial dose: 180 mg orally once a day at bedtime
Maintenance dose: If adequate response is not obtained with the initial dose, it may be titrated upward.
Extended release capsules (Verelan PM (R)):
Initial dose: 200 mg orally once a day at bedtime (usual dose in clinical trials); in rare cases, initial doses of 100 mg orally once a day at bedtime may be warranted in patients who have an increased response to verapamil (e.g., low-weight patients)
Maintenance dose: Upward titration should be based on therapeutic efficacy and safety evaluated about 24 hours after dosing. If adequate response is not obtained with the initial dose, it may be titrated upward.

USUAL ADULT DOSE FOR SUPRAVENTRICULAR TACHYCARDIA
Manufacturer:
Initial dose: 5 to 10 mg (0.075 to 0.15 mg/kg) given as an IV bolus over at least 2 minutes
Repeat dose: 10 mg (0.15 mg/kg) 30 minutes after the first dose if the initial response is not adequate
An optimal interval for subsequent doses has not been determined and must be individualized for each patient.
ACLS guidelines:
Initial dose: 2.5 to 5 mg
If no response in 15 to 30 minutes and no side effects seen: 5 to 10 mg every 15 to 30 minutes to a maximum total dose of 20 mg
Alternative ACLS dosing regimen:
Initial dose: 5 mg
If no response in 15 minutes and no side effects seen: 5 mg every 15 minutes up to a total dose of 30 mg

USUAL ADULT DOSE FOR ANGINA PECTORIS
Oral:
Immediate release tablets:
Initial dose: 80 to 120 mg orally 3 times a day; alternatively, 40 mg orally 3 times a day may be warranted in patients who may have an increased response to verapamil
Maintenance dose: Upward titration should be based on therapeutic efficacy and safety evaluated about 8 hours after dosing. Dosage may be increased daily (e.g., patients with unstable angina) or weekly until optimum clinical response is obtained.
Extended release tablets (Covera HS (R)):
Initial dose: 180 mg orally once a day at bedtime
Maintenance dose: If adequate response is not obtained with 180 mg, the dose may be titrated upward.

USUAL ADULT DOSE FOR ARRHYTHMIAS
Oral:
Immediate release tablets:
Chronic atrial fibrillation in digitalized patients: 240 to 320 mg/day orally in 3 or 4 divided doses
Prophylaxis of PSVT (non-digitalized patients): 240 to 480 mg/day orally in 3 or 4 divided doses
In general, maximum effects for any given dosage will be apparent during the first 48 hours of therapy.

USUAL ADULT DOSE FOR CLUSTER HEADACHE
Oral:
Initial dose:
Immediate release tablets: 80 mg orally 3 to 4 times a day
Sustained release tablets or capsules: 240 mg orally once a day at bedtime
Extended release tablets (Covera HS (R)): 180 mg orally once a day
Maintenance dose: Dosage may be adjusted at weekly intervals until optimum clinical response is obtained.

USUAL ADULT DOSE FOR MIGRAINE PROPHYLAXIS
Oral:
Initial dose:
Immediate release tablets: 80 mg orally 3 to 4 times a day
Sustained release tablets or capsules: 240 mg orally once a day at bedtime
Extended release tablets (Covera HS (R)): 180 mg orally once a day
Maintenance dose: Dosage may be adjusted at weekly intervals until optimum clinical response is obtained.

USUAL ADULT DOSE FOR BIPOLAR DISORDER
Oral:
Initial dose:
Immediate release tablets: 80 mg orally 3 to 4 times a day
Sustained release tablets or capsules: 240 mg orally once a day at bedtime
Extended release tablets (Covera HS (R)): 180 mg orally once a day
Maintenance dose: Dosage may be adjusted at weekly intervals until optimum clinical response is obtained.

USUAL ADULT DOSE FOR IDIOPATHIC HYPERTROPHIC SUBAORTIC STENOSIS
Oral:
Initial dose:
Immediate release tablets: 80 mg orally 3 to 4 times a day
Sustained release tablets or capsules: 240 mg orally once a day at bedtime
Extended release tablets (Covera HS (R)): 180 mg orally once a day
Maintenance dose: Dosage may be adjusted at weekly intervals until optimum clinical response is obtained.

USUAL GERIATRIC DOSE FOR HYPERTENSION
Oral: The antihypertensive effects of verapamil are evident within the first week of therapy.
Immediate release tablets (Calan (R)):
Initial dose: 40 mg orally 3 times a day; this reduced dosage may be considered in patients who might respond to lower doses
Maintenance dose: Upward titration should be based on therapeutic efficacy, assessed at the end of the dosing interval. Daily dosages of 360 and 480 mg have been used but there is no evidence that dosages beyond 360 mg provided added effect.
Sustained release tablets (Calan SR (R), Isoptin SR (R)):
Initial dose: 120 mg orally once a day in the morning with food; this reduced dosage may be warranted in patients who may have an increased response to verapamil
Maintenance dose: Upward titration should be based on therapeutic efficacy and safety evaluated weekly, about 24 hours after the previous dose. If adequate response is not obtained with the initial dose, it may be titrated upward.
Sustained release capsules (Verelan (R)):
Initial dose: 120 mg orally once a day in the morning; this reduced dosage may be warranted in patients who may have an increased response to verapamil
Maintenance dose: Upward titration should be based on therapeutic efficacy and safety evaluated about 24 hours after dosing. If adequate response is not obtained with the initial dose, it may be titrated upward.
Extended release tablets (Covera HS (R)):
Initial dose: 180 mg orally once a day at bedtime
Maintenance dose: If adequate response is not obtained with the initial dose, it may be titrated upward.
Extended release capsules (Verelan PM (R)):
Initial dose: 100 mg orally once a day at bedtime; in rare cases, this reduced initial dosage may be warranted in patients who have an increased response to verapamil
Maintenance dose: Upward titration should be based on therapeutic efficacy and safety evaluated about 24 hours after dosing. If adequate response is not obtained with the initial dose, it may be titrated upward.

USUAL GERIATRIC DOSE FOR ANGINA PECTORIS
Oral:
Immediate release tablets:
Initial dose: 40 mg orally 3 times a day; this reduced dosage may be warranted in patients who may have an increased response to verapamil
Maintenance dose: Upward titration should be based on therapeutic efficacy and safety evaluated about 8 hours after dosing. Dosage may be increased daily (e.g., patients with unstable angina) or weekly until optimum clinical response is obtained.
Extended release tablets (Covera HS (R)):
Initial dose: 180 mg orally once a day at bedtime
Maintenance dose: If adequate response is not obtained with 180 mg, the dose may be titrated upward.

USUAL PEDIATRIC DOSE FOR SUPRAVENTRICULAR TACHYCARDIA
-Less than 1 year: Generally not recommended due to potential risk of severe apnea, bradycardia, hypotensive reactions, and cardiac arrest; IV calcium should be available at bedside
Initial dose: 0.1 to 0.2 mg/kg/dose (usual single dose range: 0.75 to 2 mg/dose) should be administered as an IV bolus over at least 2 minutes under continuous ECG monitoring
Repeat dose: 0.1 to 0.2 mg/kg/dose (usual single dose range: 0.75 to 2 mg/dose) 30 minutes after the first dose if the initial response is not adequate (under continuous ECG monitoring)
An optimal interval for subsequent doses has not been determined and must be individualized for each patient.
-1 to 15 years:
Initial dose: 0.1 to 0.3 mg/kg/dose (usual single dose range: 2 to 5 mg/dose) should be administered as an IV bolus over at least 2 minutes; doses of 5 mg should not be exceeded
Repeat dose: 0.1 to 0.3 mg/kg/dose (usual single dose range: 2 to 5 mg/dose) 30 minutes after the first dose if the initial response is not adequate; doses of 10 mg should not be exceeded
An optimal interval for subsequent doses has not been determined and must be individualized for each patient.

RENAL DOSE ADJUSTMENTS
In general, multiple doses in patients with renal failure should be avoided. If repeated injections are essential, smaller repeat doses are recommended.
Oral: The manufacturers recommend caution when administering this drug to patients with renal dysfunction.
Extended release capsules (Verelan PM (R)): 100 mg orally once a day at bedtime; in rare cases, this reduced initial dosage may be warranted in patients who have an increased response to verapamil (e.g., patients with impaired renal function)

LIVER DOSE ADJUSTMENTS
In general, multiple doses in patients with hepatic failure should be avoided. If repeated injections are essential, smaller repeat doses are recommended.
Oral: The manufacturers recommend caution when administering this drug to patients with liver dysfunction.
Immediate release tablets: 40 mg orally 3 times a day; this reduced initial dosage may be warranted in patients who may have an increased response to verapamil (e.g., patients with decreased hepatic function)
Immediate release tablets, sustained release tablets and capsules, extended release tablets:
Severe liver dysfunction: Approximately 30% of the usual dose
Extended release capsules (Verelan PM (R)): 100 mg orally once a day at bedtime; in rare cases, this reduced initial dosage may be warranted in patients who have an increased response to verapamil (e.g., patients with impaired hepatic function)

DOSE ADJUSTMENTS
Sustained release tablets (Calan SR (R), Isoptin SR (R)): If adequate response is not obtained with 120 mg, the dose may be titrated upward in the following manner:
a) 180 mg each morning
b) 240 mg each morning
c) 180 mg every 12 hours or 240 mg each morning plus 120 mg each evening
d) 240 mg every 12 hours
Sustained release capsules (Verelan (R)): If adequate response is not obtained with 120 mg, the dose may be titrated upward in the following manner:
a) 180 mg in the morning
b) 240 mg in the morning
c) 360 mg in the morning
d) 480 mg in the morning
Extended release tablets (Covera HS (R)): If adequate response is not obtained with 180 mg, the dose may be titrated upward in the following manner:
a) 240 mg each evening
b) 360 mg each evening
c) 480 mg each evening
Extended release capsules (Verelan PM (R)): If adequate response is not obtained with 100 mg, the dose may be titrated upward in the following manner:
a) 200 mg each evening
b) 300 mg each evening
c) 400 mg each evening

PRECAUTIONS
Verapamil is contraindicated in hypotension (systolic pressure less than 90 mm Hg) or cardiogenic shock, in sick sinus syndrome or second- or third-degree AV block in patients without a functioning artificial ventricular pacemaker, and in patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). In addition, oral verapamil is contraindicated in severe left ventricular dysfunction and IV verapamil is contraindicated in severe congestive heart failure (unless secondary to a supraventricular tachycardia amenable to verapamil therapy), in patients receiving IV beta-adrenergic blocking drugs, and in ventricular tachycardia.
Verapamil should be avoided in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30%) or moderate to severe symptoms of heart failure and in patients with any degree of ventricular dysfunction if they are receiving beta-blockers. Patients with milder ventricular dysfunction should, if possible, be controlled with digitalis and/or diuretics prior to initiation of verapamil.
Asymptomatic first-degree AV block and transient bradycardia (sometimes accompanied by nodal escape rhythms) may occur due to the effect of verapamil on AV conduction and the SA node. Prolonged PR interval correlates with verapamil plasma levels, especially during the early titration phase of treatment. Infrequently, higher degrees of AV block were observed. Marked first-degree or progression to second- or third-degree AV block requires a dosage reduction or, rarely, verapamil discontinuation and initiation of appropriate therapy.
In 120 patients with hypertrophic cardiomyopathy, idiopathic hypertrophic subaortic stenosis (most refractory or intolerant to propranolol) who received verapamil therapy at doses up to 720 mg/day, a variety of serious side effects were seen. Most side effects responded well to dose reduction and only rarely required discontinuation of verapamil.
Elevated transaminases with and without elevated alkaline phosphatase and bilirubin have been reported. Such elevations have sometimes been transient and may disappear with continued verapamil therapy. Several cases of hepatocellular injury related to verapamil have been proven by rechallenge; half of these had clinical symptoms in addition to elevated SGOT, SGPT, and alkaline phosphatase. Periodic monitoring of liver function is recommended in patients receiving verapamil.
Since verapamil is highly metabolized by the liver, it should be administered cautiously to patients with impaired hepatic function. When using the extended release capsule formulation (Verelan PM) in such patients, lower dosages should be considered and responses to the drug should be closely monitored. Careful monitoring for abnormal prolongation of the PR interval or other signs of excessive pharmacologic effects is recommended.
Patients with impaired renal function should be carefully monitored for abnormal prolongation of the PR interval or other signs of overdosage.
Significant hepatic and renal failure should not increase the effects of a single IV dose of verapamil but may prolong its duration. Repeated injections of IV verapamil in patients with significant hepatic and renal failure may lead to accumulation and an excessive pharmacologic effect of the drug. In general, multiple doses should be avoided in such patients. If repeated injections are essential, blood pressure and PR interval should be closely monitored and smaller repeat doses are recommended.
IV verapamil should be used with caution in patients with Duchenne's muscular dystrophy since it can precipitate respiratory muscle failure in these patients.
Patients with attenuated neuromuscular transmission may require a decreased dosage of verapamil.
Increased intracranial pressure in patients with supratentorial tumors at the time of anesthesia induction has been reported with IV verapamil. Caution and appropriate monitoring are recommended.
As with any other nondeformable dosage form, the extended release tablet formulation (Covera-HS (R)) should be used with caution in patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). In patients with extremely short gastrointestinal transit time (less than 7 hours), pharmacokinetic data are not available and dosage adjustment may be necessary.
Safety and effectiveness of oral verapamil have not been established in pediatric patients (less than 18 years of age).

DIALYSIS
Verapamil is not removed by hemodialysis.

OTHER COMMENTS
IV verapamil should be administered as a slow IV injection over at least 2 minutes under continuous ECG and blood pressure monitoring. IV doses in older patients should be administered over at least 3 minutes to minimize the risk of untoward drug effects.
The dose of oral verapamil should be individualized by titration. The maximum recommended daily dose is 480 mg.
Calan SR (R) and Isoptin SR (R) should be administered in the morning initially. Both should be administered with food.
Covera HS (R) should be administered at bedtime. Covera-HS (R) tablets should be swallowed whole and should not be broken, crushed, or chewed. Since the outer shell of Covera-HS (R) does not dissolve, patients may notice it in their stools.
Verelan (R) capsules should be administered in the morning. Verelan PM (R) capsules should be administered at bedtime. Verelan (R) and Verelan PM (R) capsules may be opened and the pellets sprinkled on a spoonful of applesauce. The applesauce should be swallowed at once without chewing and followed with a glass of cool water to ensure complete swallowing of the pellets.