Claritin-D

Generic Name: loratadine and pseudoephedrine (lor AT a deen and SOO doe ee FED rin)

Brand Names: Alavert D-12, Claritin-D, Claritin-D 24 Hour, Leader Allergy Relief D-24, Loratadine-D 24 Hour

What is loratadine and pseudoephedrine?

Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of loratadine and pseudoephedrine is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Loratadine and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about loratadine and pseudoephedrine?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use loratadine and pseudoephedrine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use loratadine and pseudoephedrine before the MAO inhibitor has cleared from your body. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant. This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of loratadine and pseudoephedrine.

What should I discuss with my healthcare provider before taking loratadine and pseudoephedrine?

Do not use this medication if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use loratadine and pseudoephedrine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  thyroid disorder;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

FDA pregnancy category B. This medication is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether loratadine and pseudoephedrine 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 loratadine and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have surgery, tell the surgeon ahead of time if you have taken a cold or allergy medicine within the past few days.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking loratadine and pseudoephedrine?

This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Loratadine and pseudoephedrine 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. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


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  confusion, hallucinations, unusual thoughts or behavior;

  
  


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  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


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  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats, seizure);

  
  


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  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


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  urinating less than usual or not at all.

  
  

Less serious side effects may include:

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  blurred vision;

  
  


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  dry mouth;

  
  


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  nausea, stomach pain, constipation;

  
  


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  mild loss of appetite, stomach upset;

  
  


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  warmth, redness, or tingly feeling under your skin;

  
  


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  sleep problems (insomnia);

  
  


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  restless or excitability (especially in children);

  
  


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  skin rash or itching;

  
  


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  dizziness, drowsiness;

  
  


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  problems with memory or concentration; or

  
  


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  mild ringing in your ears.

  
  

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 loratadine and pseudoephedrine?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by loratadine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medicine.

Tell your doctor about all other medicines you use, especially:

• 
  

  blood pressure medications;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


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  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with loratadine and pseudoephedrine. 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 Claritin-D resources

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

• Claritin-D Consumer Overview


• Claritin-D 24 Hour 24-Hour Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Claritin-D with other medications

• Hay Fever
• Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about loratadine and pseudoephedrine.

See also: Claritin-D side effects (in more detail)

Jodetten

Jodetten may be available in the countries listed below.

Ingredient matches for Jodetten

Potassium Iodide

Potassium Iodide is reported as an ingredient of Jodetten in the following countries:

• Germany

International Drug Name Search

Nicorette Gum

Pronunciation: NIK-oh-teen
Generic Name: Nicotine
Brand Name: Nicorette

Nicorette Gum is used for:

Helping you to quit smoking.

Nicorette Gum is a smoking deterrent. It works by providing low levels of nicotine, which may help you to quit smoking by lessening the physical signs of withdrawal symptoms.

Do NOT use Nicorette Gum if:

• you are allergic to any ingredient in Nicorette Gum


• you have had a recent heart attack


• you have severe or worsening chest pain or a severely irregular heartbeat


• you continue to smoke, chew tobacco, use snuff, or any other nicotine-containing products

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

Before using Nicorette Gum:

Some medical conditions may interact with Nicorette Gum. 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 chest pain (eg, angina), heart problems (eg, coronary artery disease, irregular heartbeat), a history of heart attack, high blood pressure, an overactive thyroid, an ulcer, a tumor on your adrenal gland (pheochromocytoma), diabetes, a jaw problem (temporomandibular joint disorder [TMJ]), or blood vessel problems (eg, Buerger disease, Raynaud phenomena)


• if you take medicine for asthma or depression, or if you are using another medicine to stop smoking

Some MEDICINES MAY INTERACT with Nicorette Gum. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acetaminophen, adrenergic antagonists (eg, prazosin), asthma medicines (eg, theophylline), beta-blockers (eg, labetalol, propranolol), caffeine, insulin, oxazepam, pentazocine, or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased when you stop smoking


• Adrenergic agonists (eg, isoproterenol, phenylephrine) because their effectiveness may be decreased when you stop smoking

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

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

• Do not eat or drink for 15 minutes before using Nicorette Gum or while chewing a piece of Nicorette Gum.


• Do not swallow the gum.


• Carry this gum with you at all times. Whenever you have the urge to smoke, chew 1 piece of gum. Chew the gum slowly. Bite 1 or 2 times until the gum tingles, then keep it between your cheek and gum. Wait until the tingle is gone and then repeat by chewing until the tingle returns and placing it between your cheek and gum. Continue until you cannot feel the tingle anymore (about 30 minutes).


• Continue using the gum until your urge to smoke fades or until 1 to 2 pieces of gum per day satisfies your craving.


• To improve your chances of quitting smoking, use at least 9 pieces of gum per day for the first 6 weeks unless your doctor tells you otherwise.


• If you miss a dose of Nicorette Gum, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

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

Important safety information:

• Nicorette Gum may cause dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nicorette Gum with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Tell your doctor or dentist that you take Nicorette Gum before you receive any medical or dental care, emergency care, or surgery.


• This gum may stick to dental work and damage it. If this occurs, stop using the gum and contact your dentist.


• Dispose of used pieces by wrapping and placing in the trash out of the reach of children and away from pets.


• Do NOT use Nicorette Gum for longer than 12 weeks. If you still feel the need to use Nicorette Gum after 12 weeks, check with your doctor.


• Do not smoke or use tobacco products while you are using Nicorette Gum.


• Do not chew more than 24 pieces of gum a day unless advised to do so by your doctor.


• Nicorette Gum should be used as part of a larger program to help you stop smoking. If you need help choosing a program, talk with your health care provider.


• Use Nicorette Gum with caution in the ELDERLY; they may be more sensitive to its effects.


• Nicorette Gum should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Nicorette Gum may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nicorette Gum while you are pregnant. Nicorette Gum is found in breast milk. If you are or will be breast-feeding while you use Nicorette Gum, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Nicorette Gum. This is known as DEPENDENCE or addiction.

Do not suddenly stop taking Nicorette Gum without your doctor's approval. Stopping Nicorette Gum suddenly may cause serious WITHDRAWAL symptoms. These may include: anxiety, craving, impaired concentration, increased appetite, irritability, nervousness, sleep disturbances, and weight gain.

Possible side effects of Nicorette Gum:

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:

Abnormal dreams; diarrhea; difficulty sleeping; dry mouth; joint pain; muscle pain; nervousness; sweating; weakness.

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); fast or irregular heartbeat; mouth, teeth, or jaw problems; pounding in the chest; severe diarrhea, dizziness, nausea, vomiting, or weakness.

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: Nicorette 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 cold and clammy skin; confusion; diarrhea; difficulty breathing; dizziness; excessive saliva; fainting; headache; hearing and vision problems; nausea; rapid, weak, or irregular heartbeat; seizures; stomach pain; sweating; tremor; vomiting; weakness.

Proper storage of Nicorette Gum:

Store Nicorette Gum at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store Nicorette Gum in the original blister pack. Once removed from the blister, use immediately. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nicorette Gum out of the reach of children and away from pets.

General information:

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


• Nicorette Gum 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 Nicorette Gum. 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 Nicorette resources

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

Compare Nicorette with other medications

• Smoking Cessation

Hydrocodone/Phenylephrine/Pyrilamine Liquid

Generic Name: Hydrocodone/Phenylephrine/Pyrilamine (hye-droe-KOE-done/fen-ill-EF-rin/peer-IL-a-meen)
Brand Name: Examples include Codimal DH and Poly Hist HC

Hydrocodone/Phenylephrine/Pyrilamine Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Hydrocodone/Phenylephrine/Pyrilamine Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Hydrocodone/Phenylephrine/Pyrilamine Liquid if:

• you are allergic to any ingredient in Hydrocodone/Phenylephrine/Pyrilamine Liquid or any other codeine- or morphine-related medicine (eg, codeine)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Hydrocodone/Phenylephrine/Pyrilamine Liquid:

Some medical conditions may interact with Hydrocodone/Phenylephrine/Pyrilamine Liquid. 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 a fast, slow, or irregular heartbeat, heart blood vessel problems, or other heart problems


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have or recently have had any head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Hydrocodone/Phenylephrine/Pyrilamine Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hydrocodone/Phenylephrine/Pyrilamine Liquid's side effects


• Cimetidine, digoxin, or droxidopa because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone because it may decrease Hydrocodone/Phenylephrine/Pyrilamine Liquid's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Hydrocodone/Phenylephrine/Pyrilamine Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Hydrocodone/Phenylephrine/Pyrilamine Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydrocodone/Phenylephrine/Pyrilamine Liquid 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 Hydrocodone/Phenylephrine/Pyrilamine Liquid:

Use Hydrocodone/Phenylephrine/Pyrilamine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Hydrocodone/Phenylephrine/Pyrilamine Liquid by mouth with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Hydrocodone/Phenylephrine/Pyrilamine Liquid, 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 Hydrocodone/Phenylephrine/Pyrilamine Liquid.

Important safety information:

• Hydrocodone/Phenylephrine/Pyrilamine Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Hydrocodone/Phenylephrine/Pyrilamine Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you take Hydrocodone/Phenylephrine/Pyrilamine Liquid without checking with your doctor.


• Hydrocodone/Phenylephrine/Pyrilamine Liquid has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


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


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Hydrocodone/Phenylephrine/Pyrilamine Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Hydrocodone/Phenylephrine/Pyrilamine Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Hydrocodone/Phenylephrine/Pyrilamine Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Hydrocodone/Phenylephrine/Pyrilamine Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Hydrocodone/Phenylephrine/Pyrilamine Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Hydrocodone/Phenylephrine/Pyrilamine Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Hydrocodone/Phenylephrine/Pyrilamine Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocodone/Phenylephrine/Pyrilamine Liquid while you are pregnant. It is not known if Hydrocodone/Phenylephrine/Pyrilamine Liquid is found in breast milk. Do not breast-feed while taking Hydrocodone/Phenylephrine/Pyrilamine Liquid.

When used for long periods of time or at high doses, Hydrocodone/Phenylephrine/Pyrilamine Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Hydrocodone/Phenylephrine/Pyrilamine Liquid stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Hydrocodone/Phenylephrine/Pyrilamine Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Hydrocodone/Phenylephrine/Pyrilamine Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Hydrocodone/Phenylephrine/Pyrilamine Liquid:

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; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble sleeping; vision changes.

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: Hydrocodone/Phenylephrine/Pyrilamine 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Hydrocodone/Phenylephrine/Pyrilamine Liquid:

Store Hydrocodone/Phenylephrine/Pyrilamine Liquid at room temperature, 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 Hydrocodone/Phenylephrine/Pyrilamine Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Hydrocodone/Phenylephrine/Pyrilamine Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Hydrocodone/Phenylephrine/Pyrilamine Liquid 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.

This information is a summary only. It does not contain all information about Hydrocodone/Phenylephrine/Pyrilamine Liquid. 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 Hydrocodone/Phenylephrine/Pyrilamine resources

• Hydrocodone/Phenylephrine/Pyrilamine Side Effects (in more detail)
• Hydrocodone/Phenylephrine/Pyrilamine Use in Pregnancy & Breastfeeding
• Hydrocodone/Phenylephrine/Pyrilamine Drug Interactions
• Hydrocodone/Phenylephrine/Pyrilamine Support Group
• 0 Reviews · Be the first to review/rate this drug

Nastrosa 1mg film-coated tablets

1. Name Of The Medicinal Product

Nastrosa 1mg film-coated tablets

2. Qualitative And Quantitative Composition

Each tablet contains 1 mg anastrozole as active substance.

Excipients: Each tablet contains 90.3 mg lactose (as lactose monohydrate).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White, round, biconvex, film-coated tablets. Debossed with '1' on one side and plain on the reverse side.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of advanced breast cancer in postmenopausal women.

Efficacy has not been demonstrated in oestrogen receptor-negative patients unless they had a previous positive clinical response to tamoxifen.

4.2 Posology And Method Of Administration

Adults including the elderly:	One 1 mg tablet to be taken orally once a day.
Children:	Not recommended for use in children.
Renal impairment:	No dose change is recommended in patients with mild or moderate renal impairment.
Hepatic impairment:	No dose change is recommended in patients with mild hepatic disease.

4.3 Contraindications

Anastrozole is contraindicated in:

- premenopausal women.

- pregnant or lactating women.

- patients with severe renal impairment (creatinine clearance less than 20 ml / min)

- patients with moderate or severe hepatic disease

- patients with hypersensitivity to anastrozole or to any of the excipients as referenced in section 6.1.

Oestrogen-containing therapies should not be co-administered with anastrozole as they would negate its pharmacological action.

Concurrent tamoxifen therapy (see section 4.5)

4.4 Special Warnings And Precautions For Use

Anastrozole is not recommended for use in children as safety and efficacy have not been established in this group of patients.

The menopause should be defined biochemically in any patient where there is doubt about hormonal status.

There are no data to support the safe use of anastrozole in patients with moderate or severe hepatic impairment, or patients with severe impairment of renal function (creatinine clearance less than 20 ml/min).

Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed by bone densitometry e.g. DEXA scanning at the commencement of treatment and at regular intervals thereafter. Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.

There are no data available for the use of anastrozole with LHRH analogues. This combination should not be used outside clinical trials.

As anastrozole lowers circulating oestrogen levels it may cause a reduction in bone mineral density. Adequate data to show the effect of bisphosphonates on bone mineral density loss caused by anastrozole, or their utility when used prophylactically, are not currently available.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Anastrozole inhibited cytochrome P450 1A2, 2C8/9 and 3A4 in vitro. A clinical interaction study indicated that anastrozole at a 1 mg dose does not significantly alter the pharmacokinetics of warfarin, a CYP2C9 substrate.

No clinically significant interactions between anastrozole and bisphosphonates have been identified.

Antipyrine and cimetidine clinical interaction studies indicate that co-administration of anastrozole with other drugs is unlikely to result in clinically significant drug interactions mediated by cytochrome P450.

A review of the clinical trial safety datatbase did not reveal evidence of clinically significant interaction in patients treated with anastrozole who also received other commonly prescribed drugs.

Tamoxifen should not be co-administered with anastrozole, as this may diminish its pharmacological action (see section 4.3).

4.6 Pregnancy And Lactation

Anastrozole is contraindicated in pregnant or lactating women.

Pregnancy

There are no data on the use of anastrozole in pregnant patients. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Anastrozole 1mg should not be used in pregnancy.

Lactation

It is unknown whether anastrozole is excreted in human milk. Anastrozole 1mg should nor be used during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Anastrozole is unlikely to impair the ability of patients to drive and operate machinery. However, asthenia and somnolence have been reported with the use of anastrozole and caution should be observed when driving or operating machinery while such symptoms persist.

4.8 Undesirable Effects

The assessment of the side effects is based on the following frequencies:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Nervous system disorders

Common: Headache, mainly mild or moderate in nature

Carpal Tunnel Syndrome

Uncommon: Somnolence, mainly mild or moderate in nature

Gastrointestinal disorders

Common: Nausea, mainly mild or moderate in nature, diarrhoea, mainly mild or moderate

Uncommon: Vomiting, mainly mild or moderate in nature

Skin and subcutaneous tissue disorders

Common: Hair thinning, mainly mild or moderate in nature, Rash, mainly mild or moderate in nature

Very rare: Erythema multiforme, Stevens-Johnson syndrome, allergic reactions including angiooedema, urticaria and anaphylaxis

Musculoskeletal and connective tissue disorders

Common: Joint pain/stiffness, mainly mild or moderate in nature

Metabolism and nutrition disorders

Uncommon: Anorexia, mainly mild in nature, hypercholesterolaemia, mainly mild or moderate in nature

Vascular disorders

Very common: Hot flushes, mainly mild or moderate in nature

General disorders and administration site conditions

Common: Asthenia, mainly mild or moderate in nature

Hepatobiliary disorders

Common: Increases in alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase

Uncommon: Increases in gamma-GT and bilirubin, hepatitis

Reproductive system and breast disorders

Common: Vaginal dryness, mainly mild or moderate in nature

Uncommon: Vaginal bleeding, mainly mild or moderate in nature*

*Vaginal bleeding has been reported uncommonly, mainly in patients with advanced breast cancer during the first few weeks after changing from existing hormonal therapy to treatment with anastrozole. If bleeding persists, further evaluation should be considered.

As anastrozole lowers circulating oestrogen levels, it may cause a reduction in bone mineral density placing some patients at a higher risk of fracture (see section 4.4).

Elevated gamma-GT has been reported uncommonly (

The table below presents the frequency of pre-specified adverse events in the ATAC study, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.

Adverse effects	Anastrozole (N=3092)	Tamoxifen (N=3094)
Hot flushes	1104 (35.7%)	1264 (40.9%)
Joint pain/stiffness	1100 (35.6%)	911 (29.4%)
Mood disturbances	597 (19.3%)	554 (17.9%)
Fatigue/asthenia	575 (18.6%)	544 (17.6%)
Nausea and vomiting	393 (12.7%)	384 (12.4%)
Fractures	315 (10.2%)	209 (6.8%)
Fractures of the spine, hip, or wrist/Colles	133 (4.3%)	91 (2.9%)
Wrist/Colles fractures	67 (2.2%)	50 (1.6%)
Spine fractures	43 (1.4%)	22 (0.7%)
Hip fractures	28 (0.9%)	26 (0.8%)
Cataracts	182 (5.9%)	213 (6.9%)
Vaginal bleeding	167 (5.4%)	317 (10.2%)
Ischaemic cardiovascular disease	127 (4.1%)	104 (3.4%)
Angina pectoris	71 (2.3%)	51 (1.6%)
Myocardial infarct	37 (1.2%)	34 (1.1%)
Coronary artery disorder	25 (0.8%)	23 (0.7%)
Myocardial ischaemia	22 (0.7%)	14 (0.5%)
Vaginal discharge	109 (3.5%)	408 (13.2%)
Any venous thromboembolic event	87 (2.8%)	140 (4.5%)
Deep venous thromboembolic events including PE	48 (1.6%)	74 (2.4%)
Ischaemic cerebrovascular events	62 (2.0%)	88 (2.8%)
Endometrial cancer	4 (0.2%)	13 (0.6%)

Fracture rates of 22 per 1000 patient-years and 15 per 1000 patient-years were observed for the anastrozole and tamoxifen groups, respectively, after a median follow-up of 68 months. The observed fracture rate for anastrozole is similar to the range reported in age-matched postmenopausal populations. It has not been determined whether the rates of fracture and osteoporosis seen in ATAC in patients on anastrozole treatment reflect a protective effect of tamoxifen, a specific effect of anastrozole, or both. The incidence of osteoporosis was 10.5% in patients treated with anastrozole and 7.3% in patients treated with tamoxifen.

4.9 Overdose

There is limited clinical experience of accidental overdosage. In animal studies, anastrozole demonstrated low acute toxicity. Clinical trials have been conducted with various dosages of anastrozole, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated. A single dose of anastrozole that results in life-threatening symptoms has not been established. There is no specific antidote to overdosage and treatment must be symptomatic.

In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because anastrozole is not highly protein bound. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antineoplastic and immunomodulating agents – Endocrine therapy – Hormone antagonists and related agents – Enzyme inhibitors.

ATC code: L02B G03

Anastrozole is a potent and highly selective non-steroidal aromatase inhibitor. In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues. Estrone is subsequently converted to estradiol. Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer. In postmenopausal women, anastrozole at a daily dose of 1 mg produced estradiol suppression of greater than 80% using a highly sensitive assay.

Anastrozole does not possess any progestogenic, androgenic or oestrogenic activity. Daily doses of anastrozole up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard ACTH challenge testing. Corticoid supplements are therefore not needed.

An extensive phase III clinical study programme showed that anastrozole is an effective treatment of hormone-receptor positive breast cancer in post menopausal women.

5.2 Pharmacokinetic Properties

Absorption of anastrozole is rapid and maximum plasma concentrations typically occur within two hours of dosing (under fasted conditions). Anastrozole is eliminated slowly with a plasma elimination half-life of 40 to 50 hours. Food slightly decreases the rate but not the extent of absorption. The small change in the rate of absorption is not expected to result in a clinically significant effect on steady-state plasma concentrations during once daily dosing of anastrozole. Approximately 90 to 95% of plasma anastrozole steady-state concentrations are attained after 7 daily doses. There is no evidence of time or dose-dependency of anastrozole pharmacokinetic parameters.

Anastrozole pharmacokinetics are independent of age in postmenopausal women.

Pharmacokinetics have not been studied in children.

Anastrozole is only 40% bound to plasma proteins.

Anastrozole is extensively metabolised by postmenopausal women with less than 10% of the dose excreted in the urine unchanged within 72 hours of dosing. Metabolism of anastrozole occurs by N-dealkylation, hydroxylation and glucuronidation. The metabolites are excreted primarily via the urine. Triazole, the major metabolite in plasma, does not inhibit aromatase.

The apparent oral clearance of anastrozole in volunteers with stable hepatic cirrhosis or renal impairment was in the range observed in healthy volunteers.

5.3 Preclinical Safety Data

Acute toxicity

In acute toxicity studies in rodents, the median lethal dose of anastrozole was greater than 100 mg/kg/day by the oral route and greater than 50 mg/kg/day by the intraperitoneal route. In an oral acute toxicity study in the dog, the median lethal dose was greater than 45 mg/kg/day.

Chronic toxicity

Multiple dose toxicity studies utilized rats and dogs. No no-effect levels were established for anastrozole in the toxicity studies, but those effects that were observed at the low doses (1 mg/kg/day) and mid doses (dog 3 mg/kg/day; rat 5 mg/kg/day) were related to either the pharmacological or enzyme-inducing properties of anastrozole and were unaccompanied by significant toxic or degenerative changes.

Mutagenicity

Genetic toxicology studies with anastrozole show that it is not a mutagen or a clastogen.

Reproductive toxicology

Oral administration of anastrozole to female rats produced a high incidence of infertility at 1 mg/kg/day and increased pre-implantation loss at 0.02 mg/kg/day. These effects occurred at clinically relevant doses. An effect in man cannot be excluded. These effects were related to the pharmacology of the compound and were completely reversed after a 5-week compound withdrawal period.

Oral administration of anastrozole to pregnant rats and rabbits caused no teratogenic effects at doses up to 1.0 and 0.2 mg/kg/day respectively. Those effects that were seen (placental enlargement in rats and pregnancy failure in rabbits) were related to the pharmacology of the compound.

The survival of litters born to rats given anastrozole at 0.02 mg/kg/day and above (from day 17 of pregnancy to day 22 post-partum) was compromised. These effects were related to the pharmacological effects of the compound on parturition. There were no adverse effects on behaviour or reproductive performance of the first generation offspring attributable to maternal treatment with anastrozole.

Carcinogenicity

A two year rat oncogenicity study resulted in an increase in incidence of hepatic neoplasms and uterine stromal polyps in females and thyroid adenomas in males at the high dose (25 mg/kg/day) only. These changes occurred at a dose which represents 100-fold greater exposure than occurs at human therapeutic doses, and are considered not to be clinically relevant to the treatment of patients with anastrozole.

A two year mouse oncogenicity study resulted in the induction of benign ovarian tumours and a disturbance in the incidence of lymphoreticular neoplasms (fewer histiocytic sarcomas in females and more deaths as a result of lymphomas). These changes are considered to be mouse-specific effects of aromatase inhibition and not clinically relevant to the treatment of patients with anastrozole.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Lactose monohydrate

Sodium starch glycolate (Type A)

Magnesium stearate

Film coating:

Opadry II white 85F18422 consisting of

Poly (vinyl alcohol) –partially hydrolysed

Titanium dioxide

Macrogol 3350

Talc

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions

6.5 Nature And Contents Of Container

PVC/PVDC aluminium blisters.

Pack sizes :

20, 28, 30. 84, 98, 100 and 300 film-coated tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Niche Generics Limited,

1 The Cam Centre,

Wilbury Way,

Hitchin,

Hertfordshire,

SG4 0TW,

United Kingdom.

8. Marketing Authorisation Number(S)

PL 19611/0157.

9. Date Of First Authorisation/Renewal Of The Authorisation

3^rd December 2009.

10. Date Of Revision Of The Text

January 2011

Symmetrel

Generic Name: amantadine (a MAN ta deen)

Brand Names: Symmetrel

What is Symmetrel (amantadine)?

Amantadine is an antiviral medication. It blocks the actions of viruses in your body.

Amantadine is used to treat and to prevent influenza A (a viral infection). There may be some flu seasons during which amantadine is not recommended because certain flu strains may be resistant to this drug.

Amantadine is also used to treat Parkinson's disease and "Parkinson-like" symptoms such as stiffness and shaking that may be caused by the use of certain drugs.

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

What is the most important information I should know about Symmetrel (amantadine)?

Do not use FluMist nasal influenza "live vaccine" while you are being treated with amantadine and for at least 48 hours after you stop taking amantadine. The nasal vaccine may not be as effective if you receive it while you are taking amantadine. Before taking amantadine, tell your doctor if you have received a nasal flu vaccine within the past 14 days.

Before taking amantadine, tell your doctor if you have epilepsy or other seizure disorder, congestive heart failure, kidney or liver disease, low blood pressure, eczema, glaucoma, or a history of mental illness, suicide attempt, or drug/alcohol addiction.

Amantadine can cause side effects that may impair your thinking, vision, or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. If you are taking amantadine to treat influenza A, take the medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. If you are taking amantadine to treat Parkinson symptoms, do not stop taking the medication without first talking to your doctor. If you stop taking amantadine suddenly, your condition may become worse.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking amantadine.

What should I discuss with my healthcare provider before taking Symmetrel (amantadine)?

You should not use this medication if you are allergic to amantadine, or if you have received a nasal flu vaccine (FluMist) within the past 14 days.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take amantadine:

• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  congestive heart failure;

  
  


• kidney disease;


• liver disease;


• 
  

  low blood pressure or fainting;

  
  


• 
  

  eczema;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  a history of mental illness, suicide attempt, or drug/alcohol addiction.

  
  

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking amantadine. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking amantadine.

Some people taking medicines for Parkinson's disease have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk than most people for developing melanoma. Talk to your doctor about your specific risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking amantadine, tell your doctor if you are pregnant or plan to become pregnant during treatment. Amantadine 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 Symmetrel (amantadine)?

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.

Take this medicine with a full glass of water.

Measure the liquid form of amantadine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you are taking amantadine to treat influenza A, start taking the medication within 24 to 48 hours after flu symptoms begin. Keep taking the medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. If you are taking amantadine to treat Parkinson symptoms, do not stop taking the medication without first talking to your doctor. If you stop taking amantadine suddenly, your condition may become worse. Store amantadine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. 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. An overdose of amantadine can be fatal.

Overdose symptoms may include fever, anxiety, severe headache, confusion, hallucinations, agitation, aggression, personality changes, tremor, problems with balance or walking, fast or uneven heart rate, urinating less than usual or not at all, trouble breathing, seizure (convulsion), or fainting.

What should I avoid while taking Symmetrel (amantadine)?

Do not use FluMist nasal influenza "live vaccine" while you are being treated with amantadine and for at least 48 hours after you stop taking amantadine. The nasal vaccine may not be as effective if you receive it while you are taking amantadine. Before taking amantadine, tell your doctor if you have received a nasal flu vaccine within the past 14 days. Amantadine can cause side effects that may impair your vision, thinking, or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

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 drinking alcohol. It can increase some of the side effects of amantadine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with amantadine can increase your risk of unpleasant side effects.

Symmetrel (amantadine) 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 short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  feeling depressed, agitated, or aggressive;

  
  


• 
  

  behavior changes, hallucinations, thoughts of hurting yourself;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, feeling like you might pass out;

  
  


• 
  

  restless muscle movements in your eyes, tongue, jaw, or neck; or

  
  


• 
  

  tremor (uncontrolled shaking).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, headache;

  
  


• 
  

  sleep problems (insomnia), strange dreams;

  
  


• 
  

  feeling nervous;

  
  


• 
  

  nausea, diarrhea, constipation, loss of appetite;

  
  


• 
  

  dry mouth, dry nose; or

  
  


• 
  

  loss of balance or coordination.

  
  

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 Symmetrel (amantadine)?

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

• 
  

  atropine (Atreza, Sal-Tropine, and others);

  
  


• 
  

  dicyclomine (Bentyl);

  
  


• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  hyoscyamine (Anaspaz, Levbid, Levsin, Nulev, and others);

  
  


• 
  

  mepenzolate (Cantil);

  
  


• 
  

  methscopolamine (Pamine);

  
  


• 
  

  propantheline (Pro-Banthine);

  
  


• 
  

  scopolamine (Maldemar, Scopace, Transderm-Scop).

  
  


• 
  

  quinine (Qualaquin);

  
  


• 
  

  quinidine (Cardioquin, Quinaglute);

  
  


• 
  

  a diuretic (water pill) such as triamterene (Dyrenium), hydrochlorothiazide (HCTZ, Dyazide, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), and others; or

  
  


• 
  

  phenothiazines such as prochlorperazine (Compazine), thioridazine (Mellaril), and others.

  
  

This list is not complete and there may be other drugs that can interact with amantadine. 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 Symmetrel resources

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

• Symmetrel Prescribing Information (FDA)


• Symmetrel Monograph (AHFS DI)


• Symmetrel Advanced Consumer (Micromedex) - Includes Dosage Information


• Amantadine Prescribing Information (FDA)


• Amantadine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Symmetrel with other medications

• Extrapyramidal Reaction
• Influenza
• Influenza Prophylaxis
• Parkinson's Disease

Where can I get more information?

• Your pharmacist can provide more information about amantadine.

See also: Symmetrel side effects (in more detail)

Hydrocortisone/Urea

Pronunciation: hye-droe-KOR-ti-sone/yoor-EE-ah
Generic Name: Hydrocortisone/Urea
Brand Name: Examples include Carmol HC and U-cort

Hydrocortisone/Urea is used for:

Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor.

Hydrocortisone/Urea is a topical adrenocortical steroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation) in a way that is not clearly understood.

Do NOT use Hydrocortisone/Urea if:

• you are allergic to any ingredient in Hydrocortisone/Urea

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

Before using Hydrocortisone/Urea:

Some medical conditions may interact with Hydrocortisone/Urea. 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 any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test


• if you have asthma


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Hydrocortisone/Urea. Because little, if any, of Hydrocortisone/Urea is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Hydrocortisone/Urea 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 Hydrocortisone/Urea:

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

• Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Hydrocortisone/Urea, unless your hands are part of the treated area.


• Do not bandage or cover the treated skin area unless directed by your doctor.


• If you miss a dose of Hydrocortisone/Urea, apply 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 apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydrocortisone/Urea.

Important safety information:

• Hydrocortisone/Urea is for external use only. Do not get Hydrocortisone/Urea in your eyes. If contact is made with the eyes, flush them immediately with tap water.


• If Hydrocortisone/Urea is applied to the diaper area, apply a very small amount and do not use tight-fitting diapers or plastic pants.


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


• Check with your doctor before having vaccinations while using Hydrocortisone/Urea.


• Do not use Hydrocortisone/Urea for other skin conditions at a later time.


• Hydrocortisone/Urea has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• 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.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Hydrocortisone/Urea.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocortisone/Urea while you are pregnant. It is not known if Hydrocortisone/Urea is found in breast milk after topical use. If you are or will be breast-feeding while you use Hydrocortisone/Urea, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hydrocortisone/Urea:

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:

Dryness; itching.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Hydrocortisone/Urea; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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: Hydrocortisone/Urea 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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Hydrocortisone/Urea:

Store Hydrocortisone/Urea at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Hydrocortisone/Urea out of the reach of children and away from pets.

General information:

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


• Hydrocortisone/Urea 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 Hydrocortisone/Urea. 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 Hydrocortisone/Urea resources

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

Compare Hydrocortisone/Urea with other medications

• Dermatological Disorders

Cardioplegic

Dosage Form: solution
Cardioplegic SOLUTION

FOR CARDIAC PERFUSION

NOT FOR INTRAVENOUS INJECTION

(PL 146 Plastic)

Rx only

Cardioplegic Description

Baxter Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in Water for Injection, USP. It is a “core solution” intended for use only after addition of sodium bicarbonate to adjust pH prior to administration. After buffering with sodium bicarbonate it is suitable for cardiac instillation (usually with hypothermia) to induce arrest during open heart surgery. Other agents may be added to the solution prior to instillation. (See INSTRUCTIONS FOR USE.)

Each 100 mL of solution contains Calcium Chloride Dihydrate USP 17.6 mg, Magnesium Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg, and Sodium Chloride USP 643 mg, in Water for Injection, USP. May contain HCl and/or NaOH for pH adjustment. Electrolyte content per liter (not including ions for pH adjustment): Sodium (Na+) 110 mEq; Magnesium (Mg++) 32 mEq; Potassium (K+) 16 mEq; Calcium (Ca++) 2.4 mEq; Chloride (Cl-) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH 3.8 (3.5 to 3.9) prior to sodium bicarbonate addition.

It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of Cardioplegic solution to adjust pH. Use 10 mL of Hospira1 List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be stored under refrigeration and be used within 24 hours. The buffered admixture contains the following electrolytes (per liter): Na+ 120 mEq, Mg++ 32 mEq, K+ 16 mEq, Ca++ 2.4 mEq, Cl- 160 mEq and bicarbonate (HCO3-) 10 mEq; osmolar concentration, 324 mOsmol/liter (calc.); pH 7.8 (approx.). If other agents are added, these values may be altered. The solution contains no bacteriostat, or antimicrobial agent and is intended only for use (after adjusting pH with sodium bicarbonate) in a single operative procedure. When smaller amounts are required, the unused portion should be discarded. Cardioplegic solution with added sodium bicarbonate used as a coronary artery infusate induces cardiac arrest, combats ischemic ionic disturbances, buffers ischemic acidosis and protects energy sources for functional recovery after ischemia.

Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 • 2 H2O), white fragments or granules freely soluble in water.

Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 • 6 H2O), deliquescent flakes or crystals very soluble in water.

Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Cardioplegic - Clinical Pharmacology

Cardioplegic solution with added sodium bicarbonate when cooled and instilled into the coronary artery vasculature, causes prompt arrest of cardiac electromechanical activity, combats intracellular ion losses and buffers ischemic acidosis. When used with hypothermia and ischemia, the action may be characterized as cold ischemic potassium-induced cardioplegia.

This is conducive to providing the surgeon with a quiet, relaxed heart and bloodless field of operation.

Calcium (Ca++) ion in low concentration is included in the solution to maintain integrity of cell membrane to ensure that there is no likelihood of calcium paradox during reperfusion.

Magnesium (Mg++) ion may help stabilize the myocardial membrane by inhibiting a myosin phosphorylase, which protects adenosine triphosphate (ATP) reserves for postischemic activity. The protective effects of magnesium and potassium have been shown to be additive.

Potassium (K+) ion concentration is responsible for prompt cessation of mechanical myocardial contractile activity. The immediacy of the arrest thus preserves energy supplies for postischemic contractile activity in diastole.

The chloride (Cl-) and sodium (Na+) ions have no specific role in the production of cardiac arrest. Sodium is essential to maintain ionic integrity of myocardial tissue. The chloride ions are present to maintain the electroneutrality of the solution.

Added bicarbonate (HCO3-) anion is included as a buffer to render the solution slightly alkaline and compensate for the metabolic acidosis that accompanies ischemia.

Extemporaneous alternative buffering to the described formulation of this solution is not recommended.

Indications and Usage for Cardioplegic

Baxter Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.

Contraindications

Baxter Cardioplegic Solution must not be administered without the addition of 8.4% Sodium Bicarbonate Injection, USP, Hospira1 List 4900.

NOT FOR INTRAVENOUS INJECTION.

This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate.

Warnings

This solution should be used only by those trained to perform open heart surgery. This solution is intended only for use during cardiopulmonary bypass when the coronary circulation is isolated from the systemic circulation. (See INDICATIONS AND USAGE.)

Do not instill the solution into the coronary vasculature unless sodium bicarbonate has been added. If large volumes of Cardioplegic solution are infused and allowed to return to the heart lung machine without any venting from the right heart, then plasma magnesium and potassium levels may rise. Development of severe hypotension and metabolic acidosis while on bypass has been reported when large volumes (8 to 10 liters) of solution are instilled and allowed to enter the pump and then the systemic circulation. Right heart venting is therefore recommended. The buffered solution with added sodium bicarbonate should be cooled to 4°C prior to administration and used within 24 hours of mixing.

Precautions

Myocardial temperature should be monitored during surgery to maintain hypothermia.

Continuous electrocardiogram monitoring is essential to detect changes in myocardial activity during the procedure.

Appropriate equipment to defibrillate the heart following cardioplegia should be readily available.

Inotropic support drugs should be available during postoperative recovery.

Do not administer unless solution is clear and container is undamaged.

Discard unused portion.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. (See INSTRUCTIONS FOR USE.)

Pregnancy

Category C

Animal reproduction studies have not been conducted with Cardioplegic Solution. It is also not known whether this solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Cardioplegic Solution should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because of differences in structure, function, and metabolism, clinical myocardial protection strategies and Cardioplegia solutions that are effective in adult hearts may be less effective in the immature heart.

Geriatric Use

Clinical studies of Cardioplegic solution did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between older and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.

This product is unique in that there is no hepatic or renal excretion and specific adjustments for dosing in the elderly are not known.

Adverse Reactions

Intraoperative and perioperative potential hazards of open heart surgery include myocardial infarction, electrocardiographic abnormalities, and arrhythmias, including ventricular fibrillation. Spontaneous recovery after Cardioplegic cardiac arrest may be delayed or absent when circulation is restored. Defibrillation by electric shock may be required to restore normal cardiac function.

Overdosage

Overzealous instillation of the solution may result in unnecessary dilatation of the myocardial vasculature and leakage into the perivascular myocardium, possibly causing tissue edema. (See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.)

Cardioplegic Dosage and Administration

The following information is suggested as a guide and is subject to variation according to the preference and experience of the surgeon. It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate) be added aseptically and thoroughly mixed with each 1000 mL of Cardioplegic solution to adjust pH. Use 10 mL of Hospira1 List 4900, 8.4% Sodium Bicarbonate Injection, USP, to achieve the approximate pH of 7.8 when measured at room temperature. Use of any other Sodium Bicarbonate Injection may not achieve this pH due to the varying pH’s of Sodium Bicarbonate Injections. Due to its inherent instability with other components, sodium bicarbonate must be added just prior to administration. After this addition, the solution must be used within 24 hours. The solution should be cooled to 4°C prior to use. Following institution of cardiopulmonary bypass at perfusate temperatures of 28° to 30°C, and after cross-clamping of the ascending aorta, the buffered solution is administered by rapid infusion into the aortic root. The initial rate of infusion may be 300 mL/m2/minute (about 540 mL/min in a 5’ 8”, 70 kg adult with 1.8 square meters of surface area) given for a period of two to four minutes. Concurrent external cooling (regional hypothermia of the pericardium) may be accomplished by instilling a refrigerated (4°C) physiologic solution such as a Normosol®2 -R  (balanced electrolyte replacement solution) or Ringer's Injection into the chest cavity.

Should myocardial electromechanical activity persist or recur, the solution may be reinfused at a rate of 300 mL/m2/min for a period of two minutes. Reinfusion of the solution may be repeated every 20 to 30 minutes or sooner if myocardial temperature rises above 15° to 20°C or returning cardiac activity is observed. The regional hypothermia solution around the heart also may be replenished continuously or periodically in order to maintain adequate hypothermia. Suction may be used to remove warmed infusates. An implanted thermistor probe may be used to monitor myocardial temperature.

The volumes of solution instilled into the aortic root may vary depending on the duration or type of open heart surgical procedure.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS.)

INSTRUCTIONS FOR USE

To Open

Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To add 10 mL of 8.4% Sodium Bicarbonate Injection, USP, Hospira1 List 4900, and other supplemental medication, follow directions below before preparing for administration.

To Add Medication

1. Prepare additive port.


2. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.


3. The additive port may be protected by covering with an additive cap.


4. Mix container contents thoroughly.

Preparation for Administration

(Use aseptic technique)

1. Close flow control clamp of administration set.


2. Remove cover from outlet port at bottom of container.


3. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.


4. Suspend container from hanger.


5. Squeeze and release drip chamber to establish proper fluid level in chamber.


6. Attach aortic infusion device to set.


7. Open flow control clamp to expel air from set and aortic infusion device. Close clamp.


8. Position aortic infusion device to introduce solution into aortic root.


9. Regulate rate of administration with flow control clamp.

How is Cardioplegic Supplied

Baxter Cardioplegic Solution is supplied (without sodium bicarbonate) in a single-dose 1000 mL flexible plastic container as follows:

2B1462 NDC 0338-0341-04

WARNING: Do not use flexible container in series connections.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

For Product Information

Call 1-800-933-0303

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

*Bar Code Position Only

071961243

07-19-61-243

Rev. April 2011

 Baxter and PL146 are trademarks of Baxter International Inc.

1Hospira, Inc., Lake Forest, IL 60045 USA

2Normosol® is a trademark of Hospira, Inc.

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

Container Label

LOT

EXP

2B1462

NDC 0338-0341-04

Cardioplegic Solution

FOR CARDIAC PERFUSION

W A R N I N G :

NOT FOR INTRAVENOUS

INJECTION

CAUTION USE ASEPTIC TECHNIQUE ADDITION OF 10 ML OF

8.4% SODIUM BICARBONATE INJECTION USP

ABBOTT LIST 4900 IS REQUIRED PRIOR TO USAGE TO

ADJUST THE pH TO APPROXIMATELY 7.8 AT ROOM

TEMPERATURE (SEE INSERT) MIX THOROUGHLY

AFFIX ADDITIVE LABEL OVER LABEL ON FLEXIBLE CONTAINER

1000 mL

EACH 100 mL CONTAINS SODIUM CHLORIDE USP 643 mg

MAGNESIUM CHLORIDE HEXAHYDRATE USP 325.3 mg

POTASSIUM CHLORIDE USP 119.3 mg CALCIUM CHLORIDE

DIHYDRATE USP 17.6 mg MAY CONTAIN HCI AND/OR NAOH FOR pH

ADJUSTMENT 304 mOsmol/L (CALC) pH 3.8 (3.5-3.9) PRIOR TO

SODIUM BICARBONATE ADDITION ELECTROLYTES PER 1000 mL (NOT

INCLUDING IONS FOR pH ADJUSTMENT) SODIUM 110 mEq

MAGNESIUM 32 mEq POTASSIUM 16 mEq CALCIUM 2.4 mEq

CHLORIDE 160 mEq STERILE NONPYROGENIC

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE

AFTER REMOVING THE OVERWRAP CHECK FOR MINUTE LEAKS BY

SQUEEZING CONTAINER FIRMLY IF LEAKS ARE FOUND DISCARD SOLUTION

AS STERILITY MAY BE IMPAIRED RECOMMENDED STORAGE ROOM

TEMPERATURE (25°C) AVOID EXCESSIVE HEAT PROTECT FROM

FREEZING STORE SOLUTION CONTAINING BICARBONATE UNDER

REFRIGERATION DO NOT STORE LONGER THAN 24 HOURS ADDITIVES

MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE

WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE

MIX THOROUGHLY AND DO NOT STORE USE ONLY IF SOLUTION IS CLEAR

AND CONTAINER IS UNDAMAGED USUAL DOSAGE SEE INSERT

MUST NOT BE USED IN SERIES CONNECTIONS

Rx ONLY

VIAFLEX CONTAINER PL 146 PLASTIC

BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS

OF BAXTER INTERNATIONAL INC

Baxter logo

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

FOR PRODUCT INFORMATION

1-800-933-0303

Carton Label

2B1462X

14-1000 ML

VIAFLEX® CONTAINER

Cardioplegic SOLUTION

PROTECT FROM FREEZING

EXP

XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT

XXXXX

PRIMARY BAR CODE

(01) 50303380341042

Cardioplegic  calcium chloride, magnesium chloride, potassium chloride and sodium chloride  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0341 Route of Administration INTRA-ARTERIAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 17.6 mg  in 100 mL MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 325.3 mg  in 100 mL POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 119.3 mg  in 100 mL SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 643 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   HYDROCHLORIC ACID   SODIUM HYDROXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0341-04 1000 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075323	08/26/2011

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Operations
Baxter Healthcare Corporation		059140764	MANUFACTURE

Revised: 08/2011Baxter Healthcare Corporation

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