Covera-HS Sustained-Release Tablets (Controlled Onset)

Pronunciation: ver-AP-a-mil
Generic Name: Verapamil
Brand Name: Covera-HS

Covera-HS Sustained-Release Tablets (Controlled Onset) is used for:

Treating high blood pressure and chest pain. It may be used alone or with other medicines. It may also be used for certain conditions as determined by your doctor.

Covera-HS Sustained-Release Tablets (Controlled Onset) is a calcium channel blocker. It works by relaxing (dilating) your blood vessels, lowering blood pressure, and decreasing heart rate, which lowers the workload on the heart. It also dilates coronary arteries, which increases blood flow to the heart.

Do NOT use Covera-HS Sustained-Release Tablets (Controlled Onset) if:

• you are allergic to any ingredient in Covera-HS Sustained-Release Tablets (Controlled Onset)


• you have certain heart problems (eg, left ventricular dysfunction, sick sinus syndrome, second- or third-degree heart block and do not have a pacemaker), very low blood pressure, or moderate to severe congestive heart failure (CHF)


• you have atrial fibrillation or flutter and a pre-excitation syndrome (extra conduction pathway in the heart), such as Wolff-Parkinson-White (WPW) syndrome or Lown-Ganong-Levine (LGL) syndrome


• you have shock caused by serious heart problems


• you are taking dofetilide, or you have taken disopyramide within the past 48 hours

Contact your doctor or health care provider right away if any of these apply to you.

Before using Covera-HS Sustained-Release Tablets (Controlled Onset):

Some medical conditions may interact with Covera-HS Sustained-Release Tablets (Controlled Onset). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have heart failure or a recent heart attack with lung congestion, low blood pressure, or heart problems (eg, a very slow heart rate, heart block, heart valve disease)


• if you have kidney or liver problems, muscular dystrophy, or a neuromuscular disease


• if you are taking another blood pressure medicine or you are being treated for cancer

Some MEDICINES MAY INTERACT with Covera-HS Sustained-Release Tablets (Controlled Onset). Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), clonidine, disopyramide, ketolides (eg, telithromycin), macrolides (eg, erythromycin), or ritonavir because they may increase the risk of Covera-HS Sustained-Release Tablets (Controlled Onset)'s side effects


• Phenobarbital, rifampin, or St. John's wort because they may decrease Covera-HS Sustained-Release Tablets (Controlled Onset)'s effectiveness


• Aldosterone blockers (eg, eplerenone), aspirin, carbamazepine, colchicine, cyclosporine, digoxin, dofetilide, doxorubicin, dronedarone, eletriptan, erythromycin, everolimus, flecainide, HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), lithium, narcotic pain relievers (eg, fentanyl), paclitaxel, quinazolines (eg, terazosin), quinidine, ranolazine, theophyllines, or tolvaptan because the risk of their side effects may be increased by Covera-HS Sustained-Release Tablets (Controlled Onset)

This may not be a complete list of all interactions that may occur. Ask your health care provider if Covera-HS Sustained-Release Tablets (Controlled Onset) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Covera-HS Sustained-Release Tablets (Controlled Onset):

Use Covera-HS Sustained-Release Tablets (Controlled Onset) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Covera-HS Sustained-Release Tablets (Controlled Onset) by mouth with or without food.


• Check with your doctor before you eat grapefruit or drink grapefruit juice while you use Covera-HS Sustained-Release Tablets (Controlled Onset).


• Swallow Covera-HS Sustained-Release Tablets (Controlled Onset) whole. Do not break, crush, or chew before swallowing.


• If you miss a dose of Covera-HS Sustained-Release Tablets (Controlled Onset), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Covera-HS Sustained-Release Tablets (Controlled Onset).

Important safety information:

• Covera-HS Sustained-Release Tablets (Controlled Onset) may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Covera-HS Sustained-Release Tablets (Controlled Onset) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Covera-HS Sustained-Release Tablets (Controlled Onset); it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Covera-HS Sustained-Release Tablets (Controlled Onset) may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Tell your doctor or dentist that you take Covera-HS Sustained-Release Tablets (Controlled Onset) before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver function, kidney function, complete blood cell counts, and blood pressure, may be performed while you use Covera-HS Sustained-Release Tablets (Controlled Onset). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Covera-HS Sustained-Release Tablets (Controlled Onset) with caution in the ELDERLY; they may be more sensitive to its effects.


• Covera-HS Sustained-Release Tablets (Controlled Onset) should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Covera-HS Sustained-Release Tablets (Controlled Onset) while you are pregnant. Covera-HS Sustained-Release Tablets (Controlled Onset) is found in breast milk. If you are or will be breast-feeding while you use Covera-HS Sustained-Release Tablets (Controlled Onset), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Covera-HS Sustained-Release Tablets (Controlled Onset):

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; fatigue; headache; lightheadedness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; lightheadedness, especially when standing; severe dizziness; shortness of breath; swelling of the feet or hands; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, severe or persistent stomach pain, fever, general feeling of being unwell); unusually fast, slow, or irregular heartbeat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Covera-HS (Controlled Onset) side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased mental status; dizziness; loss of consciousness; shortness of breath; slow or irregular heartbeat.

Proper storage of Covera-HS Sustained-Release Tablets (Controlled Onset):

Store Covera-HS Sustained-Release Tablets (Controlled Onset) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Covera-HS Sustained-Release Tablets (Controlled Onset) out of the reach of children and away from pets.

General information:

• If you have any questions about Covera-HS Sustained-Release Tablets (Controlled Onset), please talk with your doctor, pharmacist, or other health care provider.


• Covera-HS Sustained-Release Tablets (Controlled Onset) is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Covera-HS Sustained-Release Tablets (Controlled Onset). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Covera-HS Sustained-Release Tablets (Controlled Onset) resources

• Covera-HS Sustained-Release Tablets (Controlled Onset) Side Effects (in more detail)
• Covera-HS Sustained-Release Tablets (Controlled Onset) Use in Pregnancy & Breastfeeding
• Drug Images
• Covera-HS Sustained-Release Tablets (Controlled Onset) Drug Interactions
• Covera-HS Sustained-Release Tablets (Controlled Onset) Support Group
• 0 Reviews for Covera-HS (Controlled Onset) - Add your own review/rating

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• Angina
• Arrhythmia
• Bipolar Disorder
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• High Blood Pressure
• Idiopathic Hypertrophic Subaortic Stenosis
• Migraine Prevention
• Nocturnal Leg Cramps
• Supraventricular Tachycardia

Alteplase

Pronunciation: AL-teh-PLACE
Generic Name: Alteplase
Brand Name: Cathflo Activase

Alteplase is used for:

Restoring function to central venous access devices that have become clogged with clotted blood. It may also be used for other conditions as determined by your doctor.

Alteplase is a tissue plasminogen activator (tPA). It works by helping to break down unwanted blood clots.

Do NOT use Alteplase if:

• you are allergic to any ingredient in Alteplase

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alteplase:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have active internal bleeding


• if you have had any type of surgery or medical procedure or have undergone childbirth within the past 48 hours


• if you have blood problems (eg, thrombocytopenia, blood clotting problems) or severe liver or kidney disease


• if you have an increased risk for complications due to clotting (eg, blood clot near the catheter)


• if you have a known or suspected infection at the catheter site

Some MEDICINES MAY INTERACT with Alteplase. Tell your health care provider if you are taking any of the following medicines.

• Abciximab, anticoagulants (eg, warfarin, heparin), aspirin, or dipyridamole because the risk of serious side effects, such as bleeding, may be increased


• Nitrates (eg, nitroglycerin, isosorbide dinitrate) because the effectiveness of Alteplase may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alteplase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alteplase:

Use Alteplase as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Alteplase is usually administered at your doctor's office, hospital, or clinic. If you are using Alteplase at home, carefully follow the procedures taught to you by your health care provider.


• If Alteplase contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Mix Alteplase by swirling gently. Do not shake.


• Throw away any unused medicine left in the vial.


• Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.


• If you miss a dose of Alteplase, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Alteplase.

Important safety information:

• Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Alteplase. Using Alteplase alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Be sure you know why the catheter is not functioning before using Alteplase. If the catheter is not functioning due to a reason other than clotted blood, contact your doctor before using Alteplase.


• Contact your doctor if the catheter remains blocked after using this product as directed.


• If redness, swelling, or pain develops at the catheter site, contact your doctor immediately.


• Alteplase may reduce the number of cells in your blood that help your blood clot (platelets). To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• If serious bleeding occurs while you are using Alteplase, contact your doctor immediately.


• Additional monitoring of your dose or condition may be needed if you are taking warfarin or aspirin.


• Use Alteplase with caution in the ELDERLY because they may be more sensitive to its effects.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using this product during pregnancy. It is unknown if Alteplase is excreted in breast milk. If you are or will be breast-feeding while you are using Alteplase, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Alteplase:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; bloody vomit; calf pain or tenderness; changes in vision; chest pain; chills; coughing up blood; difficulty breathing or sudden shortness of breath; fast, slow, or irregular heartbeat; fever; one-sided weakness; redness, swelling, or pain at the catheter site; severe bleeding; severe stomach pain; speech problems or changes; unusual or easy bleeding or bruising.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Alteplase side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include unusual bleeding.

Proper storage of Alteplase:

Store Alteplase in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Store away from heat, moisture, and light. Keep Alteplase, as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Alteplase, please talk with your doctor, pharmacist, or other health care provider.


• Alteplase is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Alteplase. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Alteplase resources

• Alteplase Side Effects (in more detail)
• Alteplase Use in Pregnancy & Breastfeeding
• Alteplase Drug Interactions
• Alteplase Support Group
• 0 Reviews for Alteplase - Add your own review/rating

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• Heart Attack
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• IV Catheter Clot
• Pulmonary Embolism
• Thrombotic/Thromboembolic Disorder

pyrantel

pi-RAN-tel

Commonly used brand name(s)

In the U.S.

• Ascarel


• Pamix


• Pinworm


• Pin-X

Available Dosage Forms:

• Tablet, Chewable


• Suspension


• Tablet

Therapeutic Class: Anthelmintic

Uses For pyrantel

Pyrantel belongs to the family of medicines called anthelmintics. Anthelmintics are used in the treatment of worm infections.

Pyrantel is used to treat pinworms (enterobiasis; oxyuriasis).

pyrantel may also be used for other worm infections as determined by your doctor.

Pyrantel works by paralyzing the worms. They are then passed in the stool.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, pyrantel is used in certain patients with the following medical condition:

• Common roundworm infection


• Hookworm infection


• More than one worm infection at a time

For patients taking pyrantel for hookworm infection :

• Anemia (iron-poor blood) may occur in patients with hookworm infections. Therefore, your doctor may want you to take iron supplements to help clear up the anemia. If so, it is important to take iron every day while you are being treated for hookworms. Do not miss any doses. Your doctor may also want you to keep taking iron supplements for up to 6 months after you stop taking pyrantel. If you have any questions about this, check with your doctor.

Before Using pyrantel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pyrantel, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pyrantel or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

pyrantel has been tested in a limited number of children 2 years of age or older and, in effective doses, has not been reported to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pyrantel in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pyrantel. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease

Proper Use of pyrantel

No special preparations (for example, special diets, fasting, other medicines, laxatives, or enemas) are necessary before, during, or immediately after you take pyrantel.

For patients taking pyrantel oral suspension :

• Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.


• Shake the bottle well before using.

To help clear up your infection completely, take pyrantel exactly as directed by your doctor. In some infections a second dose of pyrantel may be required to clear up the infection completely.

For patients taking pyrantel for pinworms:

• Pinworms may be easily passed from one person to another, especially among persons in the same household. Therefore, all household members may have to be treated at the same time to prevent their infection or reinfection. Also, all household members may have to be treated again in 2 to 3 weeks to clear up the infection completely.

Dosing

The dose of pyrantel will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pyrantel. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (oral suspension or tablets):
  
  • Adults and children 2 years of age and older: Dose is based on body weight and will be determined by your doctor. It is taken as a single dose and may need to be repeated in two to three weeks.
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using pyrantel

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

pyrantel may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to pyrantel before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

For patients taking pyrantel for pinworms:

• In some patients, pinworms may return after treatment with pyrantel. The following may help to prevent this:
  
  • Avoiding scratching the area around the buttocks.
  
  
  • Washing hands and fingernails with soap often during the day, especially before eating and after using the toilet.
  
  
  • Wearing tight underpants both day and night. Changing them daily.
  
  
  • Cleaning the bedroom floor by vacuuming or damp mopping for several days after treatment. Avoiding dry sweeping that may stir up dust.
  
  
  • Keeping the toilet seat clean.
  
  
  • Washing (not shaking) all bedding and nightclothes (pajamas) after treatment.
  
  


• Some doctors may also recommend other measures to help keep your infection from returning. If you have any questions about this, check with your doctor.

pyrantel Side Effects

Along with its needed effects, a medicine 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 as soon as possible if any of the following side effects occur:

Rare

• Skin rash

Some side effects 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:

Less common

• Abdominal or stomach cramps or pain


• diarrhea


• dizziness


• drowsiness


• headache


• irritability


• loss of appetite


• nausea or vomiting


• trouble in sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pyrantel side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More pyrantel resources

• Pyrantel Side Effects (in more detail)
• Pyrantel Use in Pregnancy & Breastfeeding
• Pyrantel Drug Interactions
• Pyrantel Support Group
• 0 Reviews for Pyrantel - Add your own review/rating

• pyrantel Concise Consumer Information (Cerner Multum)


• Pyrantel Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Pyrantel Pamoate Monograph (AHFS DI)

Compare pyrantel with other medications

• Ascariasis
• Enterobiasis
• Hookworm Infection, Necator or Ancylostoma
• Moniliformis Infection
• Pinworm Infection, Enterobius vermicularis
• Trichostrongylosis

Slo-Niacin nicotinic acid

Generic Name: niacin (nicotinic acid) (NYE a sin (NIK oh TIN ik AS id))

Brand Names: B-3-50, B3-500-Gr, Niacin SR, Niacor, Niaspan ER, Slo-Niacin

What is niacin?

Niacin, also called nicotinic acid, is a B vitamin (vitamin B3). It occurs naturally in plants and animals, and is also added to many foods as a vitamin supplement. Niacin is also present in many multiple vitamins and nutritional supplements.

Niacin is used to treat and prevent a lack of natural niacin in the body, and to lower cholesterol and triglycerides (types of fat) in the blood. It is also used to lower the risk of heart attack in people with high cholesterol who have already had a heart attack. Niacin is sometimes used to treat coronary artery disease (also called atherosclerosis).

Niacin may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about niacin?

Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

What should I discuss with my healthcare provider before taking niacin ?

Do not take this medication if you are allergic to niacin, or if you have severe liver disease, a stomach ulcer, or active bleeding.

Before taking niacin, tell your doctor if you are allergic to any drugs, or if you have:

• liver or kidney disease;


• 
  

  heart disease or uncontrolled angina (chest pain);

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  diabetes;

  
  


• 
  

  gout; or

  
  


• 
  

  a muscle disorder such as myasthenia gravis.

  
  

If you have any of these conditions, you may not be able to use niacin, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. Niacin may be harmful to an unborn baby when the medication is taken at doses to treat high cholesterol or other conditions. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Niacin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take niacin ?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Niacin is sometimes taken at bedtime with a low-fat snack. Follow your doctor's instructions.

Niacin can cause certain side effects, such as flushing (warmth, itching, redness, or tingly feeling under your skin). These effects can be made worse if you drink alcohol or hot beverages shortly after you take niacin. These effects should disappear over time as you keep taking the medication.

Take niacin with a full glass of cold or cool water. Taking the medication with a hot drink may increase your risk of side effects such as flushing. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Niacin extended-release tablets and capsules contain higher strengths of the medicine than the regular niacin tablets. Take only the dose that is correct for the type of niacin tablet or capsule you are using.

Niacin can cause you to have unusual results with certain medical tests (urine tests). Tell any doctor who treats you that you are using niacin.

If you stop taking niacin for any length of time, talk with your doctor before starting the medication again. You may need to restart the medication at a lower dose.

Niacin is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

Store niacin at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Be sure to take the missed dose with food if you normally take your niacin dose with a meal or snack.

If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, dizziness, itching, vomiting, upset stomach, and flushing.

What should I avoid while taking niacin ?

Avoid drinking hot beverages shortly after taking niacin. Hot drinks can worsen niacin's flushing effect (warmth, itching, redness, or tingly feeling under your skin).

Avoid drinking alcohol while taking niacin. Alcohol may increase your risk of liver damage, and can also worsen the flushing effects of niacin.

Avoid taking colestipol (Colestid) or cholestyramine (Locholest, Prevalite, Questran) at the same time you take niacin. If you take either of these other medications, take them at least 4 to 6 hours before or after you take niacin.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Niacin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  feeling light-headed, fainting;

  
  


• 
  

  fast, pounding, or uneven heart beats;

  
  


• 
  

  feeling short of breath;

  
  


• 
  

  swelling;

  
  


• 
  

  jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

  
  

If you are diabetic, tell your doctor about any changes in your blood sugar levels.

Less serious side effects of niacin include:

• 
  

  mild dizziness;

  
  


• 
  

  warmth, redness, or tingly feeling under your skin;

  
  


• 
  

  itching, dry skin;

  
  


• 
  

  sweating or chills;

  
  


• 
  

  nausea, diarrhea, belching, gas;

  
  


• 
  

  muscle pain, leg cramps; or

  
  


• 
  

  sleep problems (insomnia).

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect niacin ?

Tell your doctor about all other cholesterol-lowering drugs you are taking with niacin, especially atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor).

Before taking niacin, tell your doctor if you are also using any of the following drugs:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  multivitamins or mineral supplements that contain niacin;

  
  


• 
  

  blood pressure or heart medications such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), or verapamil (Calan, Covera, Isoptin, Verelan); or

  
  


• 
  

  heart medications such as doxazosin (Cardura), isosorbide (Dilatrate, Imdur, Isordil, Monoket, Sorbitrate), nitroglycerin (Nitro-Bid, Nitro-Dur, Nitrostat), prazosin (Minipress), or terazosin (Hytrin).

  
  

This list is not complete and there may be other drugs that can interact with niacin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Slo-Niacin resources

• Slo-Niacin Side Effects (in more detail)
• Slo-Niacin Use in Pregnancy & Breastfeeding
• Drug Images
• Slo-Niacin Drug Interactions
• Slo-Niacin Support Group
• 1 Review for Slo-Niacin - Add your own review/rating

Compare Slo-Niacin with other medications

• High Cholesterol
• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IV, Elevated VLDL
• Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
• Niacin Deficiency
• Pellagra

Where can I get more information?

• Your pharmacist can provide more information about niacin.

See also: Slo-Niacin side effects (in more detail)

Fer-Gen-Sol Drops

Pronunciation: FER-us SUL-fate
Generic Name: Ferrous Sulfate
Brand Name: Examples include Fer-Gen-Sol and Fer-In-Sol

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years old. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Fer-Gen-Sol Drops are used for:

Preventing or treating low levels of iron in the blood. It also may be used for other conditions as determined by your doctor.

Fer-Gen-Sol Drops are an essential body mineral. It works by replacing iron in your body if your body does not produce enough on its own.

Do NOT use Fer-Gen-Sol Drops if:

• you are allergic to any ingredient in Fer-Gen-Sol Drops


• you have high levels of iron in your blood


• you are taking disulfiram

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fer-Gen-Sol Drops:

Some medical conditions may interact with Fer-Gen-Sol Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have inflammation of the intestines, Crohn disease, digestive problems, ulcers, anemia, or a blood disease (eg, porphyria, thalassemia)


• if you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Fer-Gen-Sol Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cephalosporins (eg, cefotetan), disulfiram, fluorouracil, furazolidone, metronidazole, or sulfonylureas (eg, glipizide) because the risk of side effects, such as flushing, headache, fast or irregular heartbeat, nausea, or vomiting, may be increased


• Doxycycline, mycophenolate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Fer-Gen-Sol Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fer-Gen-Sol Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fer-Gen-Sol Drops:

Use Fer-Gen-Sol Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Fer-Gen-Sol Drops by mouth immediately after a meal.


• Take Fer-Gen-Sol Drops with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Fer-Gen-Sol Drops.


• Use the dropper that comes with Fer-Gen-Sol Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Fer-Gen-Sol Drops may be squeezed directly from the dropper into the mouth, or may be mixed in water or fruit juice. Be sure to drink the entire dose.


• If you are also taking antacids, a bisphosphonate (eg, alendronate), cephalosporin (eg, cephalexin), methyldopa, penicillamine, quinolone (eg, ciprofloxacin), or tetracycline (eg, minocycline) along with Fer-Gen-Sol Drops, you may need to space the doses several hours apart. Ask your doctor or pharmacist how much time is needed between doses of Fer-Gen-Sol Drops and your other medicines.


• Certain foods and drinks may decrease the amount of Fer-Gen-Sol Drops that works in your body. Ask your doctor or pharmacist how you should take Fer-Gen-Sol Drops if you consume whole grain breads or cereal, dairy products, coffee, or tea.


• If you miss a dose of Fer-Gen-Sol Drops, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fer-Gen-Sol Drops.

Important safety information:

• Do not take large doses of vitamins while you use Fer-Gen-Sol Drops unless your doctor tells you to.


• Do NOT take more than the recommended dose or take for longer than 6 months without checking with your doctor.


• Fer-Gen-Sol Drops has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.


• Fer-Gen-Sol Drops may discolor the stool. This is normal and not a cause for concern.


• Fer-Gen-Sol Drops may temporarily stain the teeth. Mixing Fer-Gen-Sol Drops with water or fruit juice or drinking it through a straw may help to decrease this effect. If staining occurs, it may be removed by rubbing teeth once a week with a little baking soda on a small cloth.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.


• Lab tests, including complete blood cell counts and blood iron levels, may be performed while you use Fer-Gen-Sol Drops. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fer-Gen-Sol Drops while you are pregnant. Fer-Gen-Sol Drops are found in breast milk. If you are or will be breast-feeding while you use Fer-Gen-Sol Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fer-Gen-Sol Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; darkened or green stools; diarrhea; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stool; fever; vomiting with continuing sharp stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fer-Gen-Sol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficulty breathing; loss of consciousness; seizures; severe nausea; stomach pain; tarry stools; unusual tiredness; vomiting; weak, fast heartbeat.

Proper storage of Fer-Gen-Sol Drops:

Store Fer-Gen-Sol Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Protect from freezing. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fer-Gen-Sol Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Fer-Gen-Sol Drops, please talk with your doctor, pharmacist, or other health care provider.


• Fer-Gen-Sol Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fer-Gen-Sol Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fer-Gen-Sol resources

• Fer-Gen-Sol Side Effects (in more detail)
• Fer-Gen-Sol Use in Pregnancy & Breastfeeding
• Fer-Gen-Sol Drug Interactions
• Fer-Gen-Sol Support Group
• 0 Reviews for Fer-Gen-Sol - Add your own review/rating

Compare Fer-Gen-Sol with other medications

• Anemia Associated with Chronic Renal Failure
• Iron Deficiency Anemia
• Vitamin/Mineral Supplementation and Deficiency
• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Viokase

Generic Name: pancrelipase (oral) (pan kre LYE pace)

Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

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

What is the most important information I should know about pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking pancrelipase?

You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

• kidney disease;


• 
  

  gout;

  
  


• 
  

  a history of blockage in your intestines;

  
  


• 
  

  a sudden onset of pancreatitis; or

  
  


• 
  

  worsening of chronic pancreatic disease.

  
  

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

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.

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  mild stomach pain or upset;

  
  


• 
  

  diarrhea or constipation;

  
  


• 
  

  bloating or gas.

  
  


• 
  

  greasy stools;

  
  


• 
  

  rectal irritation;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  cough; or

  
  


• 
  

  weight loss.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Viokase resources

• Viokase Side Effects (in more detail)
• Viokase Use in Pregnancy & Breastfeeding
• Viokase Drug Interactions
• Viokase Support Group
• 0 Reviews for Viokase - Add your own review/rating

• Viokase Advanced Consumer (Micromedex) - Includes Dosage Information


• Viokase MedFacts Consumer Leaflet (Wolters Kluwer)


• Pancrelipase Professional Patient Advice (Wolters Kluwer)


• Pancrelipase Prescribing Information (FDA)


• Pancrelipase Monograph (AHFS DI)


• Creon Prescribing Information (FDA)


• Creon Consumer Overview


• Creon MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Dygase MedFacts Consumer Leaflet (Wolters Kluwer)


• Pancreaze Prescribing Information (FDA)


• Pancreaze Consumer Overview


• Zenpep Prescribing Information (FDA)


• Zenpep Consumer Overview

Compare Viokase with other medications

• Chronic Pancreatitis
• Cystic Fibrosis
• Pancreatic Exocrine Dysfunction

Where can I get more information?

• Your pharmacist can provide more information about pancrelipase.

See also: Viokase side effects (in more detail)

Entacapone

Class: Catechol-O-Methyltransferase (COMT) Inhibitors
VA Class: CN500
Chemical Name: (E)-α-Cyano-N,N-diethyl-1,3,4-dihydroxy-5-nitrocinnamamide
Molecular Formula: C₁₄H₁₅N₃O₅
CAS Number: 130929-57-6
Brands: Comtan, Stalevo

Introduction

Selective, reversible inhibitor of catechol-O-methyltransferase (COMT).^{1 2 3 7}

Uses for Entacapone

Parkinsonian Syndrome

Adjunct to levodopa-carbidopa in the symptomatic treatment of idiopathic parkinsonian syndrome in patients with manifestations of end-of-dose “wearing-off.”^{1 4}

Not evaluated systematically in patients without manifestations of end-of-dose “wearing-off.”¹

Entacapone Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.¹

Administer in conjunction with levodopa-carbidopa (conventional tablets, orally disintegrating tablets, or extended-release preparations) or as a fixed-combination preparation containing levodopa, carbidopa, and entacapone (Stalevo).^{1 8}

Administer one tablet of the fixed-combination preparation (Stalevo) per dosing interval; do not divide the tablets.⁸

Dosage

Adults

Parkinsonian Syndrome

Oral

200 mg with each levodopa-carbidopa dose.¹

May need to reduce daily levodopa dosage or administration frequency to optimize patient response.¹ In clinical studies, most patients receiving ≥800 mg of levodopa daily or experiencing moderate or severe dyskinesias before initiating entacapone therapy required a reduction (average 25%) in levodopa dosage.¹

Transferring to the Fixed-combination Preparation (Stalevo)

Oral

Patients receiving levodopa-carbidopa conventional tablets containing a 1:4 ratio of carbidopa to levodopa: Switch to the corresponding strength of Stalevo.⁸

No information on transferring patients receiving extended-release levodopa-carbidopa preparation or levodopa-carbidopa preparations containing a 1:10 ratio of carbidopa to levodopa.⁸

Initiating Entacapone Using the Fixed-combination Preparation (Stalevo)

Oral

Patients receiving levodopa >600 mg daily or with history of moderate or severe dyskinesias: Administer levodopa-carbidopa (1:4 ratio) and entacapone as separate preparations to determine optimum maintenance dosage and then switch to corresponding strength of Stalevo.⁸

Patients receiving levodopa <600 mg daily (conventional tablet, 1:4 ratio) with no dyskinesias: Switch to the strength of Stalevo that corresponds to the dosage of levodopa-carbidopa being taken.⁸ Further adjustment may be needed.⁸

Prescribing Limits

Adults

Parkinsonian Syndrome

Oral

Entacapone: Maximum of 8 doses (1.6 g) daily; clinical experience with dosages >1.6 g daily is limited.^{1 8}

Fixed-combination preparations containing levodopa 50–150 mg, carbidopa 12.5–37.5 mg, and entacapone 200 mg (Stalevo 50, 75, 100, 125, and 150): Maximum of 8 tablets daily; clinical experience with entacapone dosages >1.6 g daily is limited.⁸

Fixed-combination preparation containing levodopa 200 mg, carbidopa 50 mg, and entacapone 200 mg (Stalevo 200): Maximum of 6 tablets daily; clinical experience with carbidopa dosages >300 mg daily is limited.⁸

Cautions for Entacapone

Contraindications

• 
  

  Known hypersensitivity to entacapone or any ingredient in the formulation.¹

  
  


• 
  

  When entacapone is used in fixed combination with levodopa-carbidopa, consider the contraindications associated with levodopa-carbidopa.⁸

  
  

Warnings/Precautions

Warnings

Concomitant Use with MAO Inhibitors

Possible inhibition of principal pathways involved in the metabolism of catecholamines if used concomitantly with a nonselective MAO inhibitor (e.g., phenelzine, tranylcypromine); concomitant use not recommended.¹ (See Specific Drugs under Interactions.)

Concomitant Use with Drugs Metabolized by Catechol-O-methyltransferase

Possible increased heart rate, arrhythmias, and excessive changes in BP when used concomitantly with drugs metabolized by catechol-O-methyltransferase (COMT).¹ (See Specific Drugs under Interactions.)

Potential Risk of Prostate Cancer

Higher incidence of prostate cancer was observed in one long-term, randomized, controlled study in patients initiating levodopa therapy with levodopa, carbidopa, and entacapone (Stalevo) compared with those initiating therapy with conventional levodopa-carbidopa formulation.^{11 13} Increased risk of prostate cancer not observed in other shorter-term controlled studies evaluating entacapone as an adjunct to levodopa-carbidopa.^{11 13} FDA is continuing to review available data related to this safety concern.¹¹

FDA advises patients receiving entacapone as an adjunct to levodopa-carbidopa (either separately or as a fixed-combination preparation) to continue taking the drugs as prescribed unless otherwise instructed by a clinician.¹¹ Men receiving such therapy should continue to be monitored for development of prostate cancer according to current prostate cancer screening guidelines.¹¹

Major Toxicities

Cardiovascular Effects

Enhances levodopa availability; possible increased occurrence of orthostatic hypotension or syncope when administered with levodopa-carbidopa.¹

Findings from an FDA-conducted meta-analysis suggest that patients receiving combined therapy with levodopa, carbidopa, and entacapone may be at increased risk of adverse cardiovascular events (i.e., MI, stroke, cardiovascular death) compared with those receiving levodopa-carbidopa.¹² However, several limitations of the meta-analysis preclude definite conclusions.¹² FDA is continuing to review available data related to this safety concern.¹² FDA advises patients receiving entacapone as an adjunct to levodopa-carbidopa (either separately or as a fixed-combination preparation) to continue taking the drugs as prescribed unless otherwise instructed by a clinician.¹² Clinicians should monitor cardiac function regularly, particularly in patients with a history of cardiovascular disease.¹²

GI Effects

Possible mild to moderate diarrhea; rarely may be severe.¹ Generally occurs during first 4–12 weeks of therapy; may occur as early as first week or as late as several months following initiation and resolves following discontinuance.¹

Hallucinations

Possible hallucinations, sometimes resulting in hospitalization.¹

Dyskinesia

May potentiate adverse dopaminergic effects of levodopa and may cause or exacerbate dyskinesias.^{1 3 4}

Reduction of levodopa dosage may ameliorate dyskinesias; however, many patients in clinical studies continued to experience frequent dyskinesias.¹ Discontinuance of therapy may be required.¹

Rhabdomyolysis

Severe rhabdomyolysis reported rarely.^{1 4 7}

Nervous System and Muscular Effects

Symptom complex resembling neuroleptic malignant syndrome (NMS) (elevated temperature, muscular rigidity, altered consciousness, elevated CPK) reported in association with abrupt withdrawal or dosage lowering of other dopaminergic agents.¹ Similar episodes possible with entacapone.^{1 4 7} (See Withdrawal of Therapy under Cautions.)

Respiratory Effects

Retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, and thickening of the pleura reported with ergot-derivative dopamine receptor agonists (e.g., bromocriptine, pergolide); possibility exists that nonergot-derived drugs that increase dopaminergic activity (e.g., entacapone) may induce similar pulmonary changes.¹

General Precautions

Use of Fixed Combination

When the fixed combination containing levodopa, carbidopa, and entacapone (Stalevo) is used, observe the usual precautions and contraindications associated with all the drugs in the preparation.⁸

Withdrawal of Therapy

Slow withdrawal is recommended.¹

If entacapone therapy is discontinued, closely monitor patient and adjust dosage of dopaminergic therapy accordingly.¹

If hyperpyrexia or severe rigidity occurs, consider possibility of symptom complex resembling NMS.¹

Melanoma

Epidemiologic studies indicate patients with parkinsonian syndrome have a twofold to approximately sixfold higher risk of developing melanoma than the general population.^{1 8} Unclear whether increased risk is due to parkinsonian syndrome or other factors (e.g., drugs used to treat the disease).^{1 8}

Monitor for melanoma on a frequent and regular basis.^{1 8} Manufacturer recommends periodic skin examinations performed by appropriately qualified individuals (e.g., dermatologists).^{1 8}

Intense Urges

Intense urges (e.g., urge to gamble, increased sexual urges, other intense urges) and inability to control these urges reported in some patients receiving antiparkinsonian agents that increase central dopaminergic tone (including entacapone).^{1 8} Although causal relationship not established, urges stopped in some cases when dosage was reduced or drug was discontinued.^{1 8}

Consider reducing dosage or discontinuing entacapone if a patient develops such urges.^{1 8}

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ Caution if used in nursing women.¹

Pediatric Use

Not indicated.¹

Geriatric Use

No substantial differences in safety or pharmacokinetics relative to younger adults.^{1 3 7}

Hepatic Impairment

Use with caution.¹ (See Special Populations under Pharmacokinetics.)

Biliary Obstruction

Use with caution.¹

Common Adverse Effects

Dyskinesia, nausea, hyperkinesia, diarrhea, urine discoloration, hypokinesia, dizziness, abdominal pain, constipation, fatigue.¹

Interactions for Entacapone

Inhibits CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A only at very high concentrations.¹ Inhibition of these isoenzymes not expected during clinical use.¹

Drugs Metabolized by Catechol-O-methyltransferase

Possible increased heart rate, arrhythmias, and excessive changes in BP.¹

Drugs Interfering with Biliary Excretion, Glucuronidation, and Intestinal β-Glucuronidase

Decreased entacapone excretion.^{1 7}

Protein-bound Drugs

No binding displacement between entacapone and other highly protein bound drugs (e.g., warfarin, salicylic acid, phenylbutazone, diazepam).¹

Specific Drugs

Drug	Interaction	Comments
Anti-infective agents (e.g., ampicillin, chloramphenicol, erythromycin, rifampin)	Possible decreased entacapone excretion1 7	Use with caution1
Apomorphine	Possible increased heart rate, arrhythmias, and excessive changes in BP1
Cholestyramine	Possible decreased entacapone excretion1	Use with caution1
CNS depressants	Additive sedative effects1
Imipramine	Pharmacologic interaction unlikely1
Levodopa	Increased plasma levodopa concentrations, resulting in enhanced therapeutic effects1 Increased risk of levodopa-induced cardiovascular effects and dyskinesia1
MAO inhibitors	Potential inhibition of catecholamine metabolism when used concomitantly with nonselective MAO inhibitors (e.g., phenelzine, tranylcypromine)1 Pharmacologic interaction unlikely with selective MAO-B inhibitors (e.g., selegiline)1	Avoid concomitant use with nonselective MAO inhibitors1
Methyldopa	Possible increased heart rate, arrhythmias, and excessive changes in BP1
Probenecid	Possible decreased entacapone excretion1	Use with caution1
Sympathomimetic (adrenergic) agents (e.g., dobutamine, dopamine, epinephrine, isoetharine, isoproterenol, norepinephrine)	Possible increased heart rate, arrhythmias, and excessive changes in BP1

Entacapone Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration, with peak plasma concentrations attained within approximately 1 hour.¹

Absolute bioavailability is 35%.^{1 a}

Food

Food does not affect pharmacokinetics.¹

Special Populations

Increased peak plasma concentrations and AUC in patients with mild to moderate hepatic impairment.¹

Distribution

Extent

Does not distribute widely into tissues.¹

Distributed into milk in rats; not known whether distributed into human milk.¹

Plasma Protein Binding

98% (mainly albumin).¹

Elimination

Metabolism

Almost completely metabolized, principally by isomerization followed by glucuronidation to an inactive conjugate.¹

Elimination Route

Entacapone and its metabolites are eliminated principally in feces (90%) via biliary excretion and to a lesser extent in urine (10%).^{1 3 4}

Half-life

Approximately 2.4 hours.^{1 a}

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Structurally and pharmacologically related to tolcapone;^{1 3 7} however, unlike tolcapone, not associated with hepatotoxicity (e.g., drug-induced hepatitis, fatal liver failure).^{1 3 4 7}

  
  


• 
  

  Inhibits catechol-O-methyltransferase (COMT) enzyme in peripheral tissues;^{1 3 4} effects on central COMT activity in humans not studied.¹

  
  


• 
  

  Concomitant administration with levodopa and a decarboxylase inhibitor (e.g., carbidopa) results in increased and more sustained plasma levodopa concentrations compared with administration of levodopa and a decarboxylase inhibitor.^{1 3 4}

  
  


• 
  

  Lacks antiparkinsonian activity when administered alone.¹

  
  

Advice to Patients

• 
  

  Importance of taking entacapone as prescribed and not discontinuing abruptly.¹

  
  


• 
  

  Necessity of exercising caution when driving or operating machinery when entacapone is initiated.¹ Caution when taking other CNS depressants.¹

  
  


• 
  

  Advise that entacapone may cause brownish orange discoloration of urine; not clinically important.¹

  
  


• 
  

  Advise that hallucinations, nausea, and increased dyskinesia can occur.¹

  
  


• 
  

  Advise patients not to rise rapidly after prolonged sitting or lying down, especially during first few weeks of therapy.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of asking patients whether they have developed any new or increased gambling urges, sexual urges, or other urges while receiving entacapone and of advising them of the importance of reporting such urges.^{1 8}

  
  


• 
  

  Importance of frequent monitoring for melanoma and periodic dermatologic examinations by a dermatologist.^{1 8}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Entacapone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	200 mg	Comtan	Novartis

Entacapone Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	200 mg with Carbidopa 12.5 mg (of anhydrous carbidopa) and Levodopa 50 mg	Stalevo	Novartis
		200 mg with Carbidopa 18.75 mg (of anhydrous carbidopa) and Levodopa 75 mg	Stalevo	Novartis
		200 mg with Carbidopa 25 mg (of anhydrous carbidopa) and Levodopa 100 mg	Stalevo	Novartis
		200 mg with Carbidopa 31.25 mg (of anhydrous carbidopa) and Levodopa 125 mg	Stalevo	Novartis
		200 mg with Carbidopa 37.5 mg (of anhydrous carbidopa) and Levodopa 150 mg	Stalevo	Novartis
		200 mg with Carbidopa 50 mg (of anhydrous carbidopa) and Levodopa 200 mg	Stalevo	Novartis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Comtan 200MG Tablets (NOVARTIS): 30/$112.99 or 90/$310.97

Stalevo 100 25-100-200MG Tablets (NOVARTIS): 90/$318 or 270/$898.92

Stalevo 150 37.5-150-200MG Tablets (NOVARTIS): 30/$113.99 or 90/$334.97

Stalevo 200 50-200-200MG Tablets (NOVARTIS): 100/$363.99 or 300/$1043.97

Stalevo 50 12.5-50-200MG Tablets (NOVARTIS): 30/$110.98 or 90/$317.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis Pharmaceuticals Corporation. Comtan (entacapone) tablets prescribing information. East Hanover, NJ; 2009 Mar.

2. LeWitt PA. New drugs for the treatment of Parkinson’s disease. Pharmacotherapy. 2000; 20:26S-32S.

3. Holm KJ, Spencer CM. Entacapone: a review of its use in Parkinson’s disease. Drugs. 1999; 58:159-77.

4. Anon. Entacapone for Parkinson’s disease. Med Lett Drugs Ther. 2000; 42:7-8.

5. Rinne UK, Larsen JP, Siden A et al. Entacapone enhances the response to levodopa in parkinsonian patients with motor fluctuations. Neurology. 1998; 51:1309-14.

6. Parkinson Study Group. Entacapone improves motor fluctuations in levodopa-treated Parkinson’s disease patients. Ann Neurol. 1997; 42:747-55.

7. Novartis, East Hanover, NJ: Personal communication.

8. Novartis. Stalevo 50, Stalevo 75, Stalevo 100, Stalevo 125, Stalevo 150, Stalevo 200 (carbidopa, levodopa, and entacapone) tablets prescribing information. East Hanover, NJ; 2009 Mar.

9. Mylan Bertek Pharmaceuticals Inc. Apokyn (apomorphine hydrochloride) injection prescribing information. Research Triangle Park, NC; 2004 Apr.

10. van der Geest R, van Laar T, Kruger PP et al. Pharmacokinetics, enantiomer interconversion, and metabolism of R-apomorphine in patients with idiopathic Parkinson’s disease. Clin Neuropharmacol. 1998; 21:159-68. [PubMed 9617507]

11. Food and Drug Administration. FDA drug safety communication: ongoing safety review of Stalevo (entacapone/carbidopa/levodopa) and possible development of prostate cancer. Rockville, MD; 2010 Mar 31. From FDA website ().

12. Food and Drug Administration. FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. Rockville, MD; 2010 Aug 20. From FDA website ().

13. Stocchi F, Rascol O, Kieburtz K et al. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010; 68:18-27. [PubMed 20582993]

a. Heikkinen H, Saraheimo M, Antila S et al. Pharmacokinetics of entacapone, a peripherally acting catechol-O-methyltransferase inhibitor, in man. A study using a stable isotope technique. Eur J Clin Pharmacol. 2001; 56: 821-6. [PubMed 11294372]

More Entacapone resources

• Entacapone Side Effects (in more detail)
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• Entacapone Professional Patient Advice (Wolters Kluwer)


• Entacapone MedFacts Consumer Leaflet (Wolters Kluwer)


• entacapone Concise Consumer Information (Cerner Multum)


• entacapone Advanced Consumer (Micromedex) - Includes Dosage Information


• Comtan Prescribing Information (FDA)

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