Nifcal tablets

Nifcal

  • Active Ingredient: Nifedipine
  • 30 mg, 20 mg
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What is Nifcal?

The active ingredient of Nifcal brand is nifedipine. Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels. Nifedipine, USP is a yellow powder, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.33. Nifedipine Extended-Release Tablets, USP are formulated as a once-a-day controlled-release tablet for oral administration designed to deliver 30 mg, 60 mg or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide, cellulose acetate, ferric oxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, propylene glycol, red iron oxide, sodium chloride, talc, titanium dioxide and yellow iron oxide. Meets USP Dissolution Test 8.

Used for

Nifcal is used to treat diseases such as: Angina Pectoris Prophylaxis, Heart Failure, High Blood Pressure, Hypertensive Emergency, Hypertrophic Cardiomyopathy, Migraine Prevention, Premature Labor, Raynaud's Syndrome.

Side Effect

Possible side effects of Nifcal include: redness of the face, neck, arms, and occasionally, upper chest; discouragement; blood in the urine or stools; tiredness; Belching; troubled breathing; shakiness and unsteady walk.

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Before taking Nifcal,

  • tell your doctor and pharmacist if you are allergic to Nifcal, any other medications, or any of the ingredients in Nifcal. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, you are taking or plan to take. Be sure to mention any of the following: acarbose (Precose); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), propranolol (Inderal, Innopran, in Inderide), and timolol ); carbamazepine (Carbatrol, Epitol, Tegretol); cimetidine (Tagamet); digoxin (Lanoxin); diltiazem (Cardizem); doxazosin (Cardura); erythromycin (E.E.S., E-Mycin, Erythrocin); fentanyl (Actiq, Duragesic, Fentora); flecainide (Tambocor); HIV protease inhibitors including amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); metformin (Glucophage); nefazodone; phenobarbital; phenytoin (Dilantin, Phenytek); quinidine (in Nuedexta); quinupristin and dalfopristin (Synercid); rifampin (Rifadin, in Rifamate, in Rifater, Rimactane); rifapentine (Priftin); tacrolimus (Astagraf SL,Prograf); valproic acid (Depakene); and verapamil (Calan, Covera, Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John's wort.
  • tell your doctor if you have or have ever had a narrowing or blockage of your digestive system or any other condition that causes food to move through your digestive system more slowly; or heart, liver, or kidney disease. Also tell your doctor if you have had a myocardial infarction (MI) within the last 2 weeks.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Nifcal, call your doctor.
  • talk to your doctor about the safe use of Nifcal capsules if you are 65 years of age or older. Older adults should not usually take Nifcal capsules because they are not as safe as other medications that can be used to treat the same condition.
  • if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking Nifcal.
  • ask your doctor about the safe use of alcoholic beverages while you are taking Nifcal. Alcohol can make the side effects from Nifcal worse.

Missed Dose of Nifcal

If you miss a dose of Nifcal, take it as soon as you remember.

However, if it’s almost time for your next dose, skip the missed dose and continue on your regular medication schedule.

Don’t double up on doses to make up for a missed one.

Severe Hypotension

Nifcal is widely used as a tocolytic, since it is well tolerated and inexpensive, nonetheless it should be considered that it can cause severe hypotension. A 18-year-old woman presented with risk of preterm delivery at 24 weeks of gestation; she was given a loading dose of 10 mg of oral Nifcal every 15 minutes, four times. After 2.5 hours her heart rate was 135 bpm and pressure 88/43 mmHg. The hypotension and tachycardia worsened constantly up to 7 hours after the first dose of Nifcal, when emergency caesarean section for delivery was performed, with rapid complete resolution of the clinical condition .

Case 1. Acute hepatitis-like syndrome attributed to amlopidine.

A 76 year old man with diabetes and end stage renal disease developed jaundice while on long term Nifcal therapy (60 mg daily for

3 years) for hypertension. He was taking insulin, but no other medications. He had no risk factors for viral hepatitis and did not drink alcohol. Serum bilirubin was 2.5 mg/dL and rose over the next few months to 6.2 mg/dL. Tests for acute hepatitis A, B and C were negative and abdominal ultrasonography showed a normal liver and gallbladder. Nifcal was stopped and he recovered rapidly. Several months later, amlodipine was started (10 mg daily) and within 6 weeks, he developed jaundice and a cholestatic pattern of serum enzyme elevations. Once amlodipine was stopped, liver tests improved and were normal three weeks later.

How it works

Nifcal belongs to a class of drugs called calcium channel blockers. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Calcium channel blockers help lower blood pressure by relaxing the blood vessels throughout your body. As a result, less pressure is built up and your heart does not have to work as hard to pump blood.

Calcium channel blockers help to prevent angina in two ways. First, they lower pressure in the coronary arteries (the arteries that supply blood to your heart). As a result, your heart receives more blood and oxygen. Second, they help prevent spasm of the coronary arteries. (A spasm is a temporary, sudden narrowing of these arteries.)

Nifcal oral tablet doesn’t cause drowsiness. However, it may cause other side effects.

16.6.1 Influence of API solubility on IVIVC

Nifcal is practically insoluble. Its in vivo apparent absorption from the osmotic pump or matrix systems consists of sequential steps of release or metering of drug particles followed by particle dissolution and permeation across the intestinal membrane. This is indirectly supported by the known dependency of bioavailability on the drug particle size discussed previously. Conventional USP tests using a large volume of test medium containing a solubilizer to create sink conditions are incapable of separating the particle dissolution from the drug release. In investigating the IVIVC of Push-Pull osmotic pump of Nifcal, Grundy et al. 103 designed a two-phase test to measure the rate of drug transfer from an aqueous phase into an organic phase, that is, the processes of release of suspension from the device, particle dissolution, and subsequent partitioning into the organic phase ( Fig. 16.14a ). The authors demonstrated that a zero-order rate of drug transfer (0.96 mg/h) obtained from such a test system closely matched the estimated in vivo absorption rate of 1.03 mg/h (30-mg strength) as compared to a rate of 1.7 mg/h based on the conventional test. As a result, an improved 1:1 Level A IVIVC was obtained for all strengths (R 2 >0.99). Similarly, the impact of the drug’s solubility on IVIVR was also evaluated in studies comparing ER hydrophilic matrix formulations containing crystalline and amorphous compound with high dose-to-solubility ratio. 85,169 Three tablet formulations containing crystalline API and 10–30% hydroxypropyl methylcellulose (HPMC) exhibited different dissolution rates in a conventional USP method using 900 mL of test medium. However, the in vivo performance of the three formulations is similar, likely a result of a nonsink condition for the in vivo drug release. When the more soluble amorphous drug was used in the same type of ER matrices to improve the particle dissolution, a rank order relationship between the in vitro and in vivo data was observed in the same in vitro test.

Q: I have had terrible stomach nausea and aching pain in my upper abdomen since I increased my medication from 30 to 60 mg of Procardia. Could that be a side effect?

A: Procardia (Nifcal) is a calcium channel blocker used to treat high blood pressure and other heart conditions, such as angina (chest pain), as directed by your doctor. Procardia works by increasing the supply of oxygen and blood to the heart, and relaxing the blood vessels, so the heart does not have to work as hard. The most common side effects with Procardia are flushing, edema (swelling), dizziness, headache, and nausea. Other side effects with Procardia include abdominal cramps, diarrhea and constipation. This is not a complete list of the side effects associated with Procardia. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Laura Cable, PharmD

By Lynn Marks | Medically Reviewed by Robert Jasmer, MD

Latest Update: 2015-06-22 Copyright © 2014 Everyday Health Media, LLC

Warnings

This medication contains Nifcal. Do not take Procardia, Procardia XL, Adalat CC, Nifedical XL, Adalat, Afeditab CR, or Nifediac CC if you are allergic to Nifcal or any ingredients contained in this drug.

This medication contains Nifcal. Do not take ProAmatine or Orvaten if you are allergic to Nifcal or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Urgent advice: Call your doctor or go to A&E straight away if you take too much Nifcal

If you need to go to hospital, do not drive yourself - get someone else to drive you or call for an ambulance.

Take the Nifcal packet or leaflet inside it plus any remaining medicine with you.

Like all medicines, Nifcal can cause side effects, although not everyone gets them. Side effects often improve as your body gets used to the medicine.

Serious Side Effects of Nifcal

Tell your doctor right away if you experience any of the following serious side effects:

  • More intense or more frequent chest pain
  • Fainting
  • Difficulty breathing or swallowing
  • Swelling of the eyes, face, lips, tongue, hands, arms, feet, ankles, or lower legs
  • Rash
  • Yellowing of the skin or eyes (jaundice)

Introduction

Nifcal is a first generation calcium channel blocker used to treat hypertension and angina pectoris. Nifcal therapy is associated with a low rate of serum enzyme elevations and has been linked to several instances of clinically apparent acute liver injury.

Why is Nifcal prescribed to patients?

Nifcal is used for the treatment and prevention of angina resulting from either an increased workload on the heart (as with exercise) or spasm of the coronary arteries. It is used in the treatment of high blood pressure, to treat abnormally fast heart rhythms such as atrial fibrillation, and in the prevention of episodes of rapid heart rhythm originating from the atria of the heart.

It also is used to dilate blood vessels that go into spasm such as those causing Raynaud's phenomenon, a painful condition of the hands caused by spasm of the arteries supplying blood to the hands.

Non-FDA approved uses include:

  • anal fissures (applied to the fissures),
  • prevention of migraineheadaches in adults,
  • ureteral stones (as secondary therapy) and
  • wound healing (applied to the skin).

What is Nifcal?

Nifcal belongs to a class of medications called calcium channel blockers (CCBs) that are used to treat angina (heart pain), high blood pressure, and abnormal heart rhythms.

Nifcal Interactions

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you’re taking, especially:

  • Acarbose (Prandase, Precose)
  • Anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven)
  • Antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
  • Beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), propranolol (Inderal), and timolol (Blocadren)
  • Carbamazepine (Carbatrol, Epitol, Tegretol)
  • Cimetidine (Tagamet)
  • Digoxin (Lanoxin, Lanoxicaps)
  • Diltiazem (Cardizem)
  • Doxazosin (Cardura)
  • Erythromycin (E.E.S., E-Mycin, Erythrocin)
  • Fentanyl (Actiq, Duragesic, Fentora, Sublimaze)
  • Flecainide (Tambocor)
  • HIV protease inhibitors including amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra)
  • Metformin (Glucophage)
  • Nefazodone (Serzone)
  • Phenobarbital (Luminal)
  • Phenytoin (Dilantin)
  • Quinidine (Quinidex)
  • Quinupristin and dalfopristin (Synercid)
  • Rifampin (Rifadin, Rifamate, Rifater, Rimactane)
  • Rifapentine (Priftin)
  • St. John’s wort
  • Tacrolimus (Prograf)
  • Valproic acid (Depakene, Depakote)
  • Verapamil (Calan, Covera, Isoptin, Verelan)

What is Nifcal?

Nifcal may also be used for purposes not listed in this medication guide.

Before taking Nifcal

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Nifcal it is important that your doctor knows:

  • If you have any heart problems (other than angina or high blood pressure).
  • If you are pregnant or breast-feeding.
  • If you have sugar diabetes.
  • If you have problems with the way your liver works.
  • If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to a medicine.

Nifcal and breastfeeding

Small amounts of Nifcal may get into breast milk, but it's generally considered safe for breastfeeding mothers and babies. Talk to your doctor if you have any concerns about taking Nifcal while you're breastfeeding.


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