Daiichi Sankyo

Address Daiichi Sankyo, 2 Hilton Court Parsippany, NJ 07054 Contact Details Phone: 973 359 2600 Website: http://www.dsi.com/ Careers: http://www.dsi.com/careers/positions.html

Nitro-Dur 0.3

Generic Name: nitroglycerin (Transdermal route)

nye-troe-GLIS-er-in

Commonly used brand name(s)

In the U.S.

• Minitran


• Nitrek


• Nitro-Bid


• Nitro-Dur

In Canada

• Nitrodur 0.2


• Nitro-Dur 0.2


• Nitro-Dur 0.3


• Nitrodur 0.4


• Nitro-Dur 0.4


• Nitrodur 0.6


• Nitro-Dur 0.6


• Nitro-Dur 0.8


• Transderm-Nitro


• Trinipatch 0.2


• Trinipatch 0.4


• Trinipatch 0.6

Available Dosage Forms:

• Ointment


• Patch, Extended Release

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For Nitro-Dur 0.3

Nitroglycerin transdermal is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.

Nitroglycerin transdermal belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.

This medicine is available only with your doctor's prescription.

Before Using Nitro-Dur 0.3

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin transdermal in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin transdermal in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin transdermal.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Sildenafil


• Tadalafil


• Vardenafil

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alteplase, Recombinant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetylcysteine


• Aspirin


• Dihydroergotamine


• Pancuronium

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Cardioversion (medical heart procedure) or


• Defibrillation (medical heart procedure)—Use with caution. The patch should be removed before having these procedures.

• Congestive heart failure or


• Heart attack, recent or


• Hypertrophic cardiomyopathy (a heart disease) or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood)—Use with caution. May make these conditions worse.

Proper Use of nitroglycerin

This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitro-Dur 0.3. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.

This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.

You should use this medicine first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

For patients using the ointment:

• Before applying a new dose of ointment, remove any ointment remaining on the skin from a previous dose. This will allow the fresh ointment to release the nitroglycerin properly.


• This medicine comes with papers to help measure the dose. Use them to measure the length of ointment squeezed from the tube and to apply the ointment to the skin. Do not rub or massage the ointment into the skin. Spread it in a thin, even layer, and cover an area of skin that is the same size each time it is applied.


• Apply the ointment to skin with little or no hair that is free of scars, cuts, or irritation.


• Apply each dose of ointment to a different area of skin to prevent irritation.


• If your doctor has ordered an airtight covering or dressing (such as plastic kitchen wrap) be placed over this medicine, make sure you know how to apply it. Airtight dressings will increase the amount of medicine absorbed through the skin and may cause more side effects. Use them only as directed and check with your doctor if you have any questions about this.

For patients using the patch system:

• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.


• Do not try to trim or cut the adhesive patch to adjust the dosage. Check with your doctor if you think the medicine is not working as it should.


• Apply the patch to a clean, dry skin area with little or no hair that is free of scars, cuts, or irritation.


• Always remove a previous patch before applying a new one.


• Apply a new patch if the first one becomes loose or falls off.


• Apply each patch to a different area to prevent skin irritation.

Dosing

The dose of this medicine 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 this medicine. 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 angina prevention:
  
  • For transdermal dosage form (ointment):
    
    • Adults—At first, 7.5 milligrams (mg), one-half inch of ointment, two times a day. Apply the first dose in the morning right after you wake up, and the second dose 6 hours later. Your doctor may increase your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For transdermal dosage form (skin patch):
    
    • Adults—Apply one patch once a day in the morning. Leave the patch in place for a total of 12 to 14 hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Precautions While Using Nitro-Dur 0.3

If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Do not stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.

Nitro-Dur 0.3 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 immediately if any of the following side effects occur:

More common

• Lightheadedness

Less common

• Arm, back, or jaw pain


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• confusion


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• fainting


• fast or irregular heartbeat


• nausea


• shortness of breath


• sweating


• unusual tiredness or weakness

Rare

• Bluish-colored lips, fingernails, or palms


• dark urine


• difficulty with breathing


• fever


• headache


• pale skin


• rapid heart rate


• sore throat


• unusual bleeding or bruising

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• cough


• difficulty with swallowing


• hives


• itching, scaling, severe redness, soreness, or swelling of the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• skin rash


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred or loss of vision


• bulging soft spot on the head of an infant


• change in consciousness


• change in the ability to see colors, especially blue or yellow


• cold, clammy skin


• disturbed color perception


• double vision


• feeling of constant movement of self or surroundings


• halos around lights


• headache, severe and throbbing


• loss of consciousness


• night blindness


• overbright appearance of lights


• paralysis


• sensation of spinning


• tunnel vision

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:

Rare

• Burning, itching, redness, skin rash, swelling, or soreness at the application site

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: Nitro-Dur 0.3 side effects (in more detail)

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More Nitro-Dur 0.3 resources

• Nitro-Dur 0.3 Side Effects (in more detail)
• Nitro-Dur 0.3 Use in Pregnancy & Breastfeeding
• Nitro-Dur 0.3 Drug Interactions
• Nitro-Dur 0.3 Support Group
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• Angina
• Angina Pectoris Prophylaxis
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Clonidine Extended-Release Tablets

Pronunciation: KLOE-ni-deen
Generic Name: Clonidine
Brand Name: Kapvay

Clonidine Extended-Release Tablets are used for:

Treating attention deficit hyperactivity disorder (ADHD). It may be used alone or with other medicines. Clonidine Extended-Release Tablets should be used as part of an ADHD treatment program that includes a variety of treatment measures (eg, psychological, educational, social). It may also be used for other conditions as determined by your doctor.

Clonidine Extended-Release Tablets are an alpha-2 receptor agonist. Exactly how it works to treat ADHD is not known.

Do NOT use Clonidine Extended-Release Tablets if:

• you are allergic to any ingredient in Clonidine Extended-Release Tablets


• you are taking another medicine that contains clonidine

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

Before using Clonidine Extended-Release Tablets:

Some medical conditions may interact with Clonidine Extended-Release Tablets. 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 had a skin reaction to the patch form of Clonidine Extended-Release Tablets


• if you have kidney problems, problems with the blood vessels in your heart or brain, or the blood disease porphyria; you are dehydrated; or you will be having surgery


• if you have a history of a stroke; a recent heart attack; low blood pressure; dizziness or fainting; or fast, slow, or irregular heartbeat or other heart problems (eg, heart block)


• if you are taking a medicine for high blood pressure

Some MEDICINES MAY INTERACT with Clonidine Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), calcium channel blockers (eg, verapamil), digoxin, or phenothiazines (eg, chlorpromazine) because they may increase the risk of Clonidine Extended-Release Tablets's side effects


• Tricyclic antidepressants (eg, amitriptyline) because they may decrease Clonidine Extended-Release Tablets's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clonidine Extended-Release Tablets 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 Clonidine Extended-Release Tablets:

Use Clonidine Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Clonidine Extended-Release Tablets. Talk to your pharmacist if you have questions about this information.


• Swallow Clonidine Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.


• Take Clonidine Extended-Release Tablets by mouth with or without food.


• Take Clonidine Extended-Release Tablets on a regular schedule to get the most benefit from it.


• Continue to take Clonidine Extended-Release Tablets even if you feel well. Do not miss any doses.


• If you miss a dose of Clonidine Extended-Release Tablets, 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 Clonidine Extended-Release Tablets.

Important safety information:

• Clonidine Extended-Release Tablets may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Clonidine Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Clonidine Extended-Release Tablets 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. Avoid becoming dehydrated or overheated.


• Do not drink alcohol while you are using Clonidine Extended-Release Tablets. Talk to your doctor before using medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Clonidine Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not switch between types of Clonidine Extended-Release Tablets without checking with your doctor. Different types may not work the same way in your body.


• Tell your doctor or dentist that you take Clonidine Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• Do not suddenly stop taking Clonidine Extended-Release Tablets without talking to your doctor. Side effects may occur, including nervousness, agitation, confusion, tremor, and headache. These may be followed by a rapid, severe rise in blood pressure. If you need to stop taking Clonidine Extended-Release Tablets, follow your doctor's instructions for slowly decreasing your dose.


• Talk with your doctor if you will be using Clonidine Extended-Release Tablets long-term (more than 5 weeks). Your doctor may periodically evaluate your condition if you will be using Clonidine Extended-Release Tablets long-term.


• Lab tests, including blood pressure and heart rate, may be performed while you take Clonidine Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Clonidine Extended-Release Tablets should be used with extreme caution in ADULTS; safety and effectiveness in adults have not been confirmed.


• Clonidine Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these 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 Clonidine Extended-Release Tablets while you are pregnant. Clonidine Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Clonidine Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Clonidine Extended-Release Tablets suddenly, you may have WITHDRAWAL symptoms. These may include nervousness, agitation, anxiety, headache, tremor, flushing, fast heartbeat, nausea, lightheadedness, warm feeling, chest tightness, and rapid increase in blood pressure. Do not suddenly stop taking Clonidine Extended-Release Tablets without checking with your doctor.

Possible side effects of Clonidine Extended-Release Tablets:

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; drowsiness; dry mouth; headache; increased thirst; nausea; stuffy or runny nose; tiredness; trouble sleeping.

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); ear or throat pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; mental or mood changes (eg, aggression, anxiety, irritability); nightmares; nosebleeds; severe or persistent headache, drowsiness, or dizziness; shortness of breath or wheezing; stomach pain; tremor; urinary problems (eg, frequent urination, uncontrolled bladder).

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: Clonidine 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 coma; decreased body temperature (feeling very cold); decreased or absent reflexes; difficult or slow breathing; fainting; irritability; pinpoint pupils; seizures; severe or persistent headache, dizziness, or drowsiness; slow or irregular heartbeat; weakness.

Proper storage of Clonidine Extended-Release Tablets:

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

General information:

• If you have any questions about Clonidine Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Clonidine Extended-Release Tablets 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 Clonidine Extended-Release Tablets. 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.

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Havrix Pediatric

Generic Name: hepatitis A pediatric vaccine (HEP a TYE tis)

Brand Names: Havrix Pediatric, Vaqta Pediatric

What is Havrix Pediatric (hepatitis A pediatric vaccine)?

Hepatitis is a serious disease caused by a virus. Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis A pediatric vaccine is used to help prevent this disease in children. The vaccine works by exposing your child to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis A pediatric vaccine is recommended for all children between the ages of 12 months and 23 months, and in children and adults who travel in certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis in children include: receiving treatment for hemophilia or other bleeding disorders, or being in an area where there has been an outbreak of hepatitis A.

Like any vaccine, the hepatitis A pediatric vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

Hepatitis A pediatric vaccine will not protect your child against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect a child from hepatitis A if the child is already infected with the virus, even if the child does not yet show symptoms.

The hepatitis A pediatric vaccine is given in a series of 2 shots. The first shot is usually given when the child is between 12 and 23 months old. The booster shot is then given 6 months later. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Vaccination with hepatitis A vaccine is recommended for all children between the ages of 12 months and 23 months, and in children who travel in certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis in children include: receiving treatment for hemophilia or other bleeding disorders, or being in an area where there has been an outbreak of hepatitis A.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

Hepatitis A pediatric vaccine will not protect your child against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect against hepatitis A if the child is already infected with the virus, even if he or she does not yet show symptoms.

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if the child has received cancer chemotherapy or radiation treatment in the past 3 months.

Before receiving this vaccine, tell the doctor if your child has:

• 
  

  a bleeding or blood clotting disorder such as hemophilia or easy bruising;

  
  


• 
  

  a history of seizures;

  
  


• 
  

  a neurologic disorder or disease affecting the brain;

  
  


• 
  

  an allergy to latex rubber;

  
  


• 
  

  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or

  
  


• 
  

  if the child is taking a blood thinner such as warfarin (Coumadin).

  
  

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

How is this vaccine given?

This vaccine is given as an injection (shot) into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.

The hepatitis A pediatric vaccine is given in a series of 2 shots. The first shot is usually given when the child is between 12 and 23 months old. The booster shot is then given 6 months later. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

To prevent hepatitis A while traveling, the child should receive this vaccine at least 2 weeks before the trip. Your child's doctor will determine the best dosing schedule for your situation.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

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

Havrix Pediatric (hepatitis A pediatric vaccine) side effects

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with hepatitis A is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has 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 the child has any of these serious side effects:

• 
  

  extreme drowsiness, fainting;

  
  


• 
  

  fussiness, irritability, crying for an hour or longer;

  
  


• 
  

  seizure (black-out or convulsions); or

  
  


• 
  

  high fever (within a few hours or a few days after the vaccine).

  
  

Less serious side effects include:

• 
  

  mild fever;

  
  


• 
  

  mild fussiness or crying;

  
  


• 
  

  headache;

  
  


• 
  

  dizziness, tired feeling;

  
  


• 
  

  nausea, vomiting, stomach pain, diarrhea, loss of appetite;

  
  


• 
  

  joint pain;

  
  


• 
  

  sore throat; or

  
  


• 
  

  swelling, redness, or a hard lump where the shot was given.

  
  

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What other drugs will affect Havrix Pediatric (hepatitis A pediatric vaccine)?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has received drugs or treatments in the past 2 weeks that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

If your child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and other drugs may interact with this vaccine. Tell your doctor about all medications your child receives. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Havrix Pediatric resources

• Havrix Pediatric Drug Interactions
• Havrix Pediatric Support Group
• 0 Reviews for Havrix Pediatric - Add your own review/rating

• Havrix Pediatric Advanced Consumer (Micromedex) - Includes Dosage Information

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• Hepatitis A Prophylaxis

Where can I get more information?

• Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Indican

Indican may be available in the countries listed below.

Ingredient matches for Indican

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Indican in the following countries:

• Argentina

International Drug Name Search

Laryngesic Lozenges

Pronunciation: BEN-zoe-kane
Generic Name: Benzocaine
Brand Name: Examples include Trocaine Throat and Laryngesic

Laryngesic Lozenges are used for:

Temporarily relieving minor mouth or gum irritation or minor sore throat.

Laryngesic Lozenges are a topical anesthetic. It works by numbing the affected area.

Do NOT use Laryngesic Lozenges if:

• you are allergic to any ingredient in Laryngesic Lozenges or to other similar local anesthetics (eg, lidocaine)

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

Before using Laryngesic Lozenges:

Some medical conditions may interact with Laryngesic Lozenges. 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

Some MEDICINES MAY INTERACT with Laryngesic Lozenges. Because little, if any, of Laryngesic Lozenges are absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Laryngesic Lozenges 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 Laryngesic Lozenges:

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

• Dissolve Laryngesic Lozenges slowly in your mouth as directed on the package labeling or by your doctor.


• Do not chew Laryngesic Lozenges.


• If you miss a dose of Laryngesic Lozenges and you are taking it regularly, take it as soon as you remember. Continue to take Laryngesic Lozenges as directed. Do not take 2 doses at once.

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

Important safety information:

• Do not exceed the recommended dose or use Laryngesic Lozenges for longer than 2 days without checking with your doctor.


• Severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting may be serious. Check with your doctor immediately if you experience these symptoms.


• Diabetes patients - Some of these products may contain sugar. Read the labeling carefully. If you are unsure if this product contains sugar, check with your doctor or pharmacist.


• Laryngesic Lozenges are not recommended for use in CHILDREN younger than 5 years of age. Safety and effectiveness in this age group have not been confirmed.


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

Possible side effects of Laryngesic Lozenges:

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:

Numbness of the mouth or throat.

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).

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: Laryngesic 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. Laryngesic Lozenges may be harmful if swallowed.

Proper storage of Laryngesic Lozenges:

Store Laryngesic Lozenges between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Laryngesic Lozenges out of the reach of children and away from pets.

General information:

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


• Laryngesic Lozenges 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 Laryngesic Lozenges. 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 Laryngesic resources

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

Compare Laryngesic with other medications

• Tonsillitis/Pharyngitis

Curatrem

Dosage Form: FOR ANIMAL USE ONLY
Curatrem®

(clorsulon)

8.5% Liver Fluke Drench for Cattle (85 mg/mL)

FOR ORAL USE IN CATTLE ONLY - NOT FOR HUMAN USE

INDICATIONS

For the treatment of immature and adult liver fluke (Fasciola hepatica) in cattle.

DIRECTIONS FOR USE AND DOSAGE

Dose

The recommended dose of Curatrem Suspension is 1/4 fl oz per 200 lb body weight (7-1/2 mL per 200 lb or 91 kg). This equals 7 mg clorsulon per kg body weight (approximately 3.2 mg per lb).

ADMINISTRATION

(1) Shake container vigorously before using. (2) Use automatic or single-dose drenching equipment. (3) Set equipment gauge at the required dose. (4) Insert the nozzle of the syringe into the corner of the mouth. (5) Deposit the suspension over the back of the tongue.

Timing of the retreatment for cattle is based on geographic, climatic, and husbandry considerations.

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

RESIDUE INFORMATION

Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. Do not treat cattle within 8 days of slaughter.

Keep this and all drugs out of the reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Merial at 1-888-637-4251. Restricted Drug - Use only as directed (California).

Product No.: 24411GL

Marketed by Merial Limited, Operational Headquarters, 3239 Satellite Blvd., Duluth, GA 30096-4640

Curatrem is a registered trademark of Merial Limited.

©2006 Merial Limited. All Rights Reserved.

Merial Limited, a company limited by shares registered in England and Wales (registered number 3332751) with a registered office at PO Box 327, Sandringham House, Sandringham Avenue, Harlow Business Park, Harlow, Essex CM19 5QA, England, and domesticated in Delaware, USA as Merial LLC.

Lot No. & Exp. Date

1022-1996-01

Rev. 07-2006

24411

NADA 136-742, Approved by the FDA

PRINCIPAL DISPLAY PANEL - 85 mg/mL Bottle Label

Curatrem®

(clorsulon)

8.5% Liver Fluke Drench for Cattle

85 mg/mL

128 Fl Oz (1 Gal)(3.785 L)

Product No.: 24411 GL

MERIAL

Curatrem  DRENCH clorsulon  solution

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 50604-2242 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength clorsulon (clorsulon) clorsulon 85 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50604-2242-1 3785 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA136742	01/29/1985	05/09/2011

Labeler - Merial Limited (034393582)

Revised: 08/2010Merial Limited

Monsels Solution

Generic Name: ferric subsulfate

Dosage Form: topical liquid
Monsels Solution

Light-resistant 2 ml  bottles.

Used as a styptic in its undiluted form.

It should not be used in vesicular, bullous, or exudative (oozing) dermatoses because it may then cause permanent pigmentation on the  skin.  May be harmful  if swallowed. For  external use only.  If  swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention immediately. Keep out of reach of children. 

Restricted to use by or on the order of a licensed Physician. Store at room temperature. Keep cap tightly sealed and protect from light.

Monsels Solution  ferric subsulfate  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10481-0112 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERRIC SUBSULFATE (FERRIC SUBSULFATE) FERRIC SUBSULFATE .21 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10481-0112-2 59 g In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/07/2011

Labeler - Gordon Laboratories (002333847)

Registrant - Gordon Laboratories (002333847)

Establishment
Name	Address	ID/FEI	Operations
Gordon Laboratories		002333847	manufacture

Revised: 12/2011Gordon Laboratories

More Monsels Solution resources

• Monsels Solution Support Group
• 0 Reviews · Be the first to review/rate this drug

Amlodipine Besylate

Class: Dihydropyridines
VA Class: CV200
CAS Number: 111470-99-6
Brands: Azor (combination), Caduet, Exforge (combination), Lotrel, Norvasc

Introduction

Amlodipine is a calcium-channel blocking agent; a dihydropyridine derivative with an intrinsically long duration of action.^{1 2 3}

Uses for Amlodipine Besylate

Hypertension

Amlodipine is used for management of hypertension (alone or in combination with other classes of antihypertensive agents);^{1 2 3 4 5 6 12 21 49 112 113} may be used in fixed combination with benazepril, olmesartan, or valsartan when such combined therapy is indicated.^{21 112 113}

Calcium-channel blocking agents are one of several preferred initial therapies in hypertensive patients with a high risk of developing CAD, including those with diabetes mellitus;⁸² in geriatric patients with isolated systolic hypertension;^{49 53} and in patients with coexisting angina.^{12 49}

Amlodipine can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁸²

Amlodipine should not be used for acute management of hypertensive crises.^{1 7 8 12 49}

Addition of benazepril to amlodipine usually does not provide additional antihypertensive effects in blacks but appears to reduce development of amlodipine-associated edema regardless of race.²¹

May use amlodipine/atorvastatin fixed-combination preparation when treatment with both amlodipine (for hypertension) and atorvastatin (for dyslipidemias and prevention of cardiovascular events) is appropriate.¹⁰⁷

CAD

Amlodipine is used for management of Prinzmetal variant angina and chronic stable angina pectoris;^{1 2 3 4 7 8 9} has been used alone or in combination with other antianginal agents.^{1 2 3 4 9} Calcium-channel blockers are considered the drugs of choice in management of Prinzmetal variant angina.^b

Amlodipine is used in patients with recently documented CAD (by angiography) and without heart failure or an ejection fraction <40% to reduce the risk of coronary revascularization procedure and hospitalization due to angina.¹

May use amlodipine/atorvastatin fixed-combination preparation when treatment with both amlodipine (for CAD) and atorvastatin (for dyslipidemias and prevention of cardiovascular events) is appropriate.¹⁰⁷

Amlodipine Besylate Dosage and Administration

General

Hypertension

• 
  

  Manufacturers state that amlodipine/benazepril and amlodipine/olmesartan fixed-combination preparations should not be used for initial treatment of hypertension.^{21 112}

  
  


• 
  

  Fixed-combination amlodipine/valsartan tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP.¹¹³ Consider potential benefits and risks of initiating therapy with the fixed combination of amlodipine and valsartan, including whether the patient is likely to tolerate the lowest available dosage of the combined drugs.¹¹³

  
  


• 
  

  If the patient's baseline BP is 160/100 mm Hg, the estimated probability of achieving SBP control (SBP <140 mm Hg) is 47, 67, or 80% and of achieving DBP control (DBP <90 mm Hg) is 62, 80, or 85% with valsartan alone, amlodipine alone, or amlodipine combined with valsartan, respectively.¹¹³

  
  

Administration

Oral Administration

Administer amlodipine orally without regard to meals.^{1 2 3 5}

Dosage

Amlodipine is available as amlodipine besylate; dosage expressed in terms of amlodipine.¹

Pediatric Patients

Hypertension

Amlodipine Therapy for Hypertension

Oral

Children ≥6 years of age: Usual effective amlodipine dosage is 2.5–5 mg once daily.^{1 105}

Adults

Hypertension

Amlodipine Therapy for Hypertension

Oral

Initially as monotherapy, amlodipine 2.5–5 mg once daily.^{1 2 4 6 49} In small or frail individuals, initiate therapy with 2.5 mg once daily.¹

When adding amlodipine to an existing antihypertensive regimen, use initial dosage of 2.5 mg once daily.¹

Increase amlodipine dosage gradually over 7–14 days until optimum control of BP is obtained (up to a maximum dosage of 10 mg daily).¹ May increase more rapidly if symptoms so warrant and patient’s tolerance and response are frequently assessed.¹

Usual maintenance dosage of amlodipine is 5–10 mg once daily.^{1 2 6 12 49}

Amlodipine/Benazepril Fixed-combination Therapy for Hypertension

Oral

In studies using amlodipine/benazepril fixed combination in dosages of amlodipine 2.5–10 mg daily and benazepril hydrochloride 10–40 mg daily, BP response increased with increasing amlodipine dosage in all patient groups and increased with increasing benazepril dosage in nonblack patient groups.²¹

If BP is not adequately controlled by monotherapy with amlodipine (or another dihydropyridine-derivative calcium-channel blocker) or benazepril (or another ACE inhibitor), can switch to amlodipine/benazepril fixed combination.²¹

If BP is adequately controlled by monotherapy with amlodipine, but edema has developed, can switch to amlodipine/benazepril fixed combination to achieve similar or better BP control without edema.²¹ May be prudent to reduce amlodipine dosage, especially in nonblack patients, when benazepril is initiated to avoid excessive antihypertensive response.²¹

If BP is controlled with amlodipine and benazepril (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.²¹

Adjust dosage of amlodipine/benazepril fixed combination according to patient's response; consider that steady-state plasma concentrations of amlodipine and benazepril are reached after 7 and 2 days, respectively.²¹

In small or frail patients, initial amlodipine dosage of 2.5 mg (available in fixed combination with benazepril hydrochloride 10 mg) once daily.²¹

Amlodipine/Olmesartan Fixed-combination Therapy for Hypertension

Oral

If BP is not adequately controlled by monotherapy with amlodipine (or another dihydropyridine-derivative calcium-channel blocker) or olmesartan (or another angiotensin II receptor antagonist), can switch to the fixed-combination preparation containing amlodipine 5 mg and olmesartan medoxomil 20 or 40 mg or, alternatively, amlodipine 10 mg and olmesartan medoxomil 20 or 40 mg.¹¹²

Can use the fixed combination as a substitute for the individually titrated drugs.¹¹² Can switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and olmesartan; alternatively, can increase the dosage of one or both components for additional antihypertensive effects.¹¹²

Adjust dosage of amlodipine/olmesartan fixed combination, up to a maximum dosage of amlodipine 10 mg daily and olmesartan medoxomil 40 mg daily, according to patient's response after ≥2 weeks at the current dosage.¹¹²

Amlodipine/Valsartan Fixed-combination Therapy for Hypertension

Oral

In studies using amlodipine/valsartan fixed combination in dosages of amlodipine 5–10 mg daily and valsartan 160–320 mg daily, BP response increased with increasing dosages of the drugs.¹¹³

If BP is not adequately controlled by monotherapy with amlodipine (or another dihydropyridine-derivative calcium-channel blocker) or valsartan (or another angiotensin II receptor antagonist), can switch to the fixed-combination preparation containing amlodipine 5 mg and valsartan 160 or 320 mg or, alternatively, amlodipine 10 mg and valsartan 160 or 320 mg.¹¹³

If dose-limiting adverse effects have developed during monotherapy with amlodipine or valsartan, can switch to a fixed-combination preparation containing a lower dose of that drug to achieve similar BP control; adjust dosage according to patient's response after 3–4 weeks of therapy.¹¹³

If BP is controlled with amlodipine and valsartan (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.¹¹³

When used for initial therapy of hypertension in patients likely to require combination therapy with multiple antihypertensive agents, recommended initial dosage is amlodipine 5 mg and valsartan 160 mg daily in those who are not volume depleted.¹¹³

Increase to maximum dosage of amlodipine 10 mg and valsartan 320 mg daily, if needed, to control BP.¹¹³ May adjust dosage at intervals of 1–2 weeks, since most of the antihypertensive effect of a given dosage is achieved within 2 weeks after a change in dosage.¹¹³

Amlodipine/Atorvastatin Fixed-combination Therapy for Hypertension (Amlodipine) and for Dyslipidemias and Prevention of Cardiovascular Events (Atorvastatin)

Oral

Use the fixed combination as a substitute for the individually titrated drugs.¹⁰⁷ Can switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and atorvastatin; alternatively, can increase the dosage of one or both components for additional antihypertensive and/or antilipemic effects.¹⁰⁷

Use the fixed combination to provide additional therapy for patients currently receiving one component of the preparation.¹⁰⁷ Select initial dosage of the fixed combination based on the current dosage of the component being used and the recommended initial dosage for the added monotherapy.¹⁰⁷

Use the fixed combination to initiate treatment in patients requiring therapy for hypertension and dyslipidemias.¹⁰⁷ Select initial dosage of the fixed combination based on recommended dosages of the individual components.¹⁰⁷

CAD

Amlodipine Therapy for Angina

Oral

Usual amlodipine dosage is 5–10 mg once daily;^{1 2} adequate control usually requires a maintenance dosage of 10 mg daily.¹

Amlodipine Therapy for Angiographically Documented CAD

Oral

Recommended amlodipine dosage is 5–10 mg once daily;¹ adequate control usually requires a maintenance dosage of 10 mg daily.¹

Amlodipine/Atorvastatin Fixed-combination Therapy for CAD (Amlodipine) and for Dyslipidemias and Prevention of Cardiovascular Events (Atorvastatin)

Oral

Use the fixed combination as a substitute for the individually titrated drugs.¹⁰⁷ Can switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and atorvastatin; alternatively, can increase the dosage of one or both components for additional antianginal and/or antilipemic effects.¹⁰⁷

Use the fixed combination to provide additional therapy for patients currently receiving one component of the preparation.¹⁰⁷ Select initial dosage of the fixed combination based on the current dosage of the component being used and the recommended initial dosage for the added monotherapy.¹⁰⁷

Use the fixed combination to initiate treatment in patients requiring therapy for angina and dyslipidemias.¹⁰⁷ Select initial dosage of the fixed combination based on recommended dosages of the individual components.¹⁰⁷

Prescribing Limits

Pediatric Patients

Hypertension

Oral

Children ≥6 years of age: Safety and efficacy of amlodipine dosages >5 mg daily not established.¹

Adults

Hypertension

Oral

Maximum 10 mg of amlodipine once daily.^{1 107 112 113}

Special Populations

The following information addresses dosage of amlodipine in special populations. Dosages of drugs administered in fixed combination with amlodipine also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.^{21 107 112 113}

Hepatic Impairment

Hypertension

Initially, amlodipine 2.5 mg daily (as initial or add-on therapy).^{1 21 107 112}

Angina

Initially, amlodipine 5 mg daily.^{1 107}

Renal Impairment

Amlodipine dosage modification not necessary.^{1 2 3 5 112 113}

Preparations containing amlodipine in fixed combination with benazepril are not recommended in patients with Cl_cr ≤30 mL/minute or S_cr >3 mg/dL.²¹

Geriatric Patients

Hypertension

Initially, amlodipine 2.5 mg daily (as initial or add-on therapy).^{1 21 107 112 113} Adjust subsequent dosage based on patient response and tolerance.¹

Angina

Initially, amlodipine 5 mg daily.^{1 107}

Cautions for Amlodipine Besylate

Contraindications

• 
  

  Known hypersensitivity to amlodipine.^{1 21 107}

  
  


• 
  

  When amlodipine is used in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan, consider contraindications associated with the concomitant agent.^{21 107 112 113}

  
  

Warnings/Precautions

Warnings

Increased Angina and/or AMI

Rarely, increased frequency, duration, and/or severity of angina or AMI, particularly in patients with severe obstructive CAD, upon initiation or dosage increase of calcium-channel blockers.¹

General Precautions

Use of Fixed Combinations

When amlodipine is used in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan, consider cautions, precautions, contraindications, and interactions associated with the concomitant agent.^{21 107 112 113} Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.^{21 107 112 113}

Hypotension

Possible acute hypotension.¹ Use amlodipine with caution, particularly in patients with severe aortic stenosis.¹

CHF

Use amlodipine with caution in patients with CHF; no adverse effects on survival, cardiac morbidity, or worsened heart failure reported in controlled studies.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether amlodipine is distributed into milk; manufacturer recommends discontinuance of nursing if amlodipine is used.¹

Pediatric Use

Safety and efficacy of amlodipine in children <6 years of age not established.¹

Safety and efficacy of amlodipine in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan not established in children.^{21 107 112 113}

Geriatric Use

Select amlodipine dosage with caution; initiate with dosage at lower end of recommended range.^{1 21 112 113} (See Geriatric Patients under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Amlodipine in fixed combination with benazepril, olmesartan, or valsartan: No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.^{21 112 113}

Amlodipine in fixed combination with atorvastatin: Safety and efficacy not established in geriatric patients.¹⁰⁷

Hepatic Impairment

Use amlodipine with caution and consider dosage reduction in patients with severe hepatic impairment.^{1 21 112 113} (See Hepatic Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Common Adverse Effects

Amlodipine: Headache, edema.¹ Edema may be less frequent with concomitant benazepril or olmesartan therapy.^{21 112}

Interactions for Amlodipine Besylate

The following information addresses potential interactions with amlodipine. When amlodipine is used in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan, consider interactions associated with the concomitant agent.^{21 107 112 113}

Specific Drugs and Food

Drug or Food	Interaction
Alcohol	No change in alcohol pharmacokinetics1
Antacids (e.g., aluminum hydroxide and magnesium hydroxide)	Pharmacokinetic interaction unlikely1
Atorvastatin	No clinically important change in atorvastatin pharmacokinetics1
Cimetidine	Pharmacokinetic interaction unlikely1
Digoxin	No effects on serum digoxin concentrations or clearance1
Grapefruit juice	Altered bioavailability possible;64 65 74 75 no clinically important changes in another study1
Sildenafil	Pharmacokinetic interaction unlikely; additional reduction of BP possible1
Warfarin	No change in PT1

Amlodipine Besylate Pharmacokinetics

Absorption

Bioavailability

Peak plasma amlodipine concentrations attained 6–12 hours after oral administration.¹ Absolute bioavailability ranges from 64–90%.¹

Duration

Antihypertensive effects of amlodipine persist for at least 24 hours after administration.¹

Food

Food does not affect bioavailability of amlodipine besylate tablets.¹

Distribution

Extent

Not known whether amlodipine is distributed into milk.¹

Plasma Protein Binding

Amlodipine: Approximately 93%.¹

Elimination

Metabolism

Amlodipine is extensively metabolized to inactive metabolites in the liver.¹

Elimination Route

Amlodipine is excreted in urine as metabolites (60%) and unchanged drug (10%).¹

Half-life

Terminal elimination half-life of amlodipine is 30–50 hours.¹

Special Populations

In geriatric patients, amlodipine clearance decreased and AUC increased about 40–60%.¹

In patients with hepatic impairment, amlodipine clearance decreased and AUC increased about 40–60%.¹

In patients with moderate to severe heart failure, amlodipine clearance decreased and AUC increased about 40–60%.¹

Stability

Storage

Oral

Tablets

Amlodipine: Tight, light-resistant containers at 15–30°C.¹

Amlodipine/atorvastatin, amlodipine/olmesartan, and amlodipine/valsartan fixed combinations: 25°C (may be exposed to 15–30°C).^{107 112 113}

Capsules

Amlodipine/benazepril fixed combination: Tight container at 25ºC (may be exposed to 15–30ºC).²¹

ActionsActions

• 
  

  Amlodipine inhibits transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations.¹

  
  


• 
  

  Amlodipine is a peripheral arterial vasodilator; acts directly on vascular smooth muscle causing reduction in peripheral vascular resistance and BP.¹

  
  


• 
  

  Amlodipine reduces total peripheral resistance (afterload) and rate pressure product and thus myocardial oxygen demand at any given level of exercise in patients with exertional angina.¹

  
  


• 
  

  Amlodipine blocks constriction and restores blood flow in coronary arteries in response to calcium, potassium, epinephrine, serotonin, and thromboxane A₂ analog in animal studies and human vessels in vitro.¹

  
  

Advice to Patients

• 
  

  When amlodipine is used in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan, importance of informing patients of important cautionary information about the concomitant agent.^{21 107 112 113}

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  Importance of advising 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.

Amlodipine Besylate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	2.5 mg (of amlodipine)*	Amlodipine Besylate Tablets
			Norvasc	Pfizer
		5 mg (of amlodipine)*	Amlodipine Besylate Tablets
			Norvasc	Pfizer
		10 mg (of amlodipine)*	Amlodipine Besylate Tablets
			Norvasc	Pfizer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Amlodipine Besylate Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	2.5 mg (of amlodipine) with Benazepril Hydrochloride 10 mg*	Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)
			Lotrel	Novartis
		5 mg (of amlodipine) with Benazepril Hydrochloride 10 mg*	Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)
			Lotrel	Novartis
		5 mg (of amlodipine) with Benazepril Hydrochloride 20 mg*	Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)
			Lotrel	Novartis
		5 mg (of amlodipine) with Benazepril Hydrochloride 40 mg	Lotrel	Novartis
		10 mg (of amlodipine) with Benazepril Hydrochloride 20 mg*	Amlodipine Besylate and Benazepril Hydrochloride Capsule (combination)
			Lotrel	Novartis
		10 mg (of amlodipine) with Benazepril Hydrochloride 40 mg	Lotrel	Novartis
	Tablets	5 mg (of amlodipine) with Olmesartan Medoxomil 20 mg	Azor	Daiichi-Sankyo
		5 mg (of amlodipine) with Olmesartan Medoxomil 40 mg	Azor	Daiichi-Sankyo
		10 mg (of amlodipine) with Olmesartan Medoxomil 20 mg	Azor	Daiichi-Sankyo
		10 mg (of amlodipine) with Olmesartan Medoxomil 40 mg	Azor	Daiichi-Sankyo
	Tablets, film-coated	2.5 mg (of amlodipine) with Atorvastatin Calcium 10 mg (of atorvastatin)	Caduet	Pfizer
		2.5 mg (of amlodipine) with Atorvastatin Calcium 20 mg (of atorvastatin)	Caduet	Pfizer
		2.5 mg (of amlodipine) with Atorvastatin Calcium 40 mg (of atorvastatin)	Caduet	Pfizer
		5 mg (of amlodipine) with Atorvastatin Calcium 10 mg (of atorvastatin)	Caduet	Pfizer
		5 mg (of amlodipine) with Atorvastatin Calcium 20 mg (of atorvastatin)	Caduet	Pfizer
		5 mg (of amlodipine) with Atorvastatin Calcium 40 mg (of atorvastatin)	Caduet	Pfizer
		5 mg (of amlodipine) with Atorvastatin Calcium 80 mg (of atorvastatin)	Caduet	Pfizer
		5 mg (of amlodipine) with Valsartan 160 mg	Exforge	Novartis
		5 mg (of amlodipine) with Valsartan 320 mg	Exforge	Novartis
		10 mg (of amlodipine) with Atorvastatin Calcium 10 mg (of atorvastatin)	Caduet	Pfizer
		10 mg (of amlodipine) with Atorvastatin Calcium 20 mg (of atorvastatin)	Caduet	Pfizer
		10 mg (of amlodipine) with Atorvastatin Calcium 40 mg (of atorvastatin)	Caduet	Pfizer
		10 mg (of amlodipine) with Atorvastatin Calcium 80 mg (of atorvastatin)	Caduet	Pfizer
		10 mg (of amlodipine) with Valsartan 160 mg	Exforge	Novartis
		10 mg (of amlodipine) with Valsartan 320 mg	Exforge	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.

Amlodipine Besy-Benazepril HCl 2.5-10MG Capsules (TEVA PHARMACEUTICALS USA): 30/$69.99 or 90/$199.96

Amlodipine Besy-Benazepril HCl 5-20MG Capsules (SANDOZ): 30/$69.99 or 90/$195.97

AmLODIPine Besylate 10MG Tablets (GREENSTONE): 90/$23.99 or 180/$36.97

AmLODIPine Besylate 2.5MG Tablets (MYLAN): 90/$16.99 or 100/$17.77

AmLODIPine Besylate 5MG Tablets (GREENSTONE): 90/$22.99 or 180/$39.98

Caduet 10-10MG Tablets (PFIZER U.S.): 30/$150.98 or 90/$425.98

Caduet 10-20MG Tablets (PFIZER U.S.): 30/$203.99 or 90/$587.94

Caduet 10-40MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95

Caduet 10-80MG Tablets (PFIZER U.S.): 30/$214.99 or 90/$584.95

Caduet 2.5-10MG Tablets (PFIZER U.S.): 30/$153.25 or 90/$443.91

Caduet 2.5-20MG Tablets (PFIZER U.S.): 30/$205.98 or 90/$589.96

Caduet 2.5-40MG Tablets (PFIZER U.S.): 30/$186 or 90/$532.75

Caduet 5-10MG Tablets (PFIZER U.S.): 30/$155 or 90/$434.97

Caduet 5-20MG Tablets (PFIZER U.S.): 30/$205.98 or 90/$584.95

Caduet 5-40MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95

Caduet 5-80MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95

Lotrel 10-20MG Capsules (NOVARTIS): 30/$158.99 or 90/$461.99

Lotrel 10-40MG Capsules (NOVARTIS): 30/$164.85 or 90/$469.19

Lotrel 2.5-10MG Capsules (NOVARTIS): 30/$123.99 or 90/$345.98

Lotrel 5-10MG Capsules (NOVARTIS): 30/$123.99 or 90/$340.97

Lotrel 5-20MG Capsules (NOVARTIS): 30/$128.99 or 90/$360.95

Lotrel 5-40MG Capsules (NOVARTIS): 30/$123 or 90/$348.73

Norvasc 10MG Tablets (PFIZER U.S.): 30/$99.55 or 90/$272

Norvasc 2.5MG Tablets (PFIZER U.S.): 30/$76.06 or 90/$199.51

Norvasc 5MG Tablets (PFIZER U.S.): 30/$76.06 or 90/$205.02

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 April 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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