Euglucon

Generic Name: glyburide (Oral route)

GLYE-bure-ide

Commonly used brand name(s)

In the U.S.

• Diabeta


• Glycron


• Glynase Pres-Tab


• Micronase

In Canada

• Euglucon

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 2nd Generation Sulfonylurea

Uses For Euglucon

Glyburide is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Glyburide belongs to a class of medicines called sulfonylureas. It causes your pancreas to release more insulin into the blood stream. This medicine may be used alone or with another oral medicine such as metformin.

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

Before Using Euglucon

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 glyburide 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 glyburide in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment in the dose for patients receiving glyburide.

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.

• Bosentan

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.

• Acarbose


• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Disopyramide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

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.

• Acebutolol


• Aceclofenac


• Acemetacin


• Alclofenac


• Alprenolol


• Apazone


• Aspirin


• Atenolol


• Benoxaprofen


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bromfenac


• Bucindolol


• Bufexamac


• Carprofen


• Carteolol


• Carvedilol


• Celiprolol


• Clarithromycin


• Clometacin


• Clonixin


• Clorgyline


• Colesevelam


• Cyclosporine


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dilevalol


• Dipyrone


• Droxicam


• Esmolol


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Fenugreek


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gemfibrozil


• Glucomannan


• Ibuprofen


• Indomethacin


• Indoprofen


• Iproniazid


• Isocarboxazid


• Isoxicam


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nialamide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxprenolol


• Oxyphenbutazone


• Pargyline


• Penbutolol


• Phenelzine


• Phenylbutazone


• Pindolol


• Pirazolac


• Piroxicam


• Pirprofen


• Procarbazine


• Propranolol


• Propyphenazone


• Proquazone


• Psyllium


• Rifampin


• Rifapentine


• Selegiline


• Sotalol


• Sulfamethoxazole


• Sulindac


• Suprofen


• Talinolol


• Tenidap


• Tenoxicam


• Tertatolol


• Tiaprofenic Acid


• Timolol


• Tolmetin


• Toloxatone


• Tranylcypromine


• Voriconazole


• Warfarin


• Zomepirac

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• Alcohol intoxication or


• Underactive adrenal glands or


• Underactive pituitary gland or


• Undernourished condition or


• Weakened physical condition or


• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking glyburide.

• Diabetic ketoacidosis (ketones in the blood) or


• Type I diabetes—Should not be used in patients with these conditions.

• Fever or


• Infection or


• Surgery or


• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (a blood disorder) in patients with this condition.

• Heart disease—Use with caution. May make this condition worse.

• Kidney disease or


• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of glyburide

This section provides information on the proper use of a number of products that contain glyburide. It may not be specific to Euglucon. Please read with care.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 type 2 diabetes:
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 2.5 to 5 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (micronized tablets):
    
    • Adults—At first, 1.5 to 3 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. The dose is usually not more than 12 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

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.

Precautions While Using Euglucon

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.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.

Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, including a heart attack.

Too much glyburide can cause low blood sugar (hypoglycemia) when it is used under certain conditions. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly and call someone on your health care team right away when you need advice.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Do not take this medicine if you are also using bosentan (Tracleer®). Also, make sure your doctor knows about all other medicines you are using for diabetes, including insulin.

Euglucon 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:

Less common

• Difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


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


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Rare

• Abdominal or stomach pain


• chills


• clay-colored stools


• dark urine


• diarrhea


• fever


• headache


• light-colored stools


• loss of appetite


• nausea and vomiting


• rash


• unpleasant breath odor


• upper right abdominal pain


• vomiting of blood


• yellow eyes and skin

Incidence not known

• Agitation


• back, leg, or stomach pains


• bleeding gums


• blood in the urine or stools


• bloody, black, or tarry stools


• blurred vision


• change in near or distance vision


• chest pain


• coma


• confusion


• convulsions


• cough or hoarseness


• decreased urine output


• depression


• difficulty in focusing eyes


• difficulty with breathing


• fast or irregular heartbeat


• fluid-filled skin blisters


• general body swelling


• high fever


• hostility


• increased thirst


• irritability


• itching of the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lethargy


• lower back or side pain


• muscle pain or cramps


• muscle twitching


• nosebleeds


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• rapid weight gain


• seizures


• sensitivity to the sun


• skin thinness


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stupor


• swelling of the face, ankles, or hands


• swollen or painful glands


• unusual bleeding or bruising

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

Symptoms of overdose

• Anxiety


• cold sweats


• cool, pale skin


• increased hunger


• nervousness


• nightmares


• shakiness


• slurred speech

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

Less common

• Indigestion


• passing of gas

Incidence not known

• Difficulty with moving


• itching


• joint pain


• redness or other discoloration of the skin


• severe sunburn


• swollen joints

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: Euglucon side effects (in more detail)

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More Euglucon resources

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

Compare Euglucon with other medications

• Diabetes, Type 2

Restrictive Cardiomyopathy Medications

There are currently no drugs listed for "Restrictive Cardiomyopathy".

Definition of Restrictive Cardiomyopathy:

"Restrictive cardiomyopathy" referes to a group of disorders in which the heart chambers are unable to fill properly with blood because of stiffness of the heart. In restrictive cardiomyopathy, the heart is normal in size or only slightly enlarged, but it cannot relax normally during diastole (that is, the time between heartbeats in which the blood returns from the body to the heart).

Later in the disease, the heart may not pump blood efficiently. The abnormal heart function can affect the lungs, liver, and other body systems. Restrictive cardiomyopathy may affect either or both ventricles and may or may not be associated with a disease of the heartmuscle.

More...

Learn more about Restrictive Cardiomyopathy

Micromedex Care Notes:

• Dilated Cardiomyopathy
• Restrictive Cardiomyopathy

Medical Encyclopedia:

• Restrictive cardiomyopathy

Drug List:

torsemide

Generic Name: torsemide (TORE se mide)

Brand names: Demadex, Demadex I.V.

What is torsemide?

Torsemide is a loop diuretic (water pill) that prevents your body from absorbing too much salt, allowing the salt to instead be passed in your urine.

Torsemide treats fluid retention (edema) in people with congestive heart failure, liver disease, or a kidney disorder such as nephrotic syndrome. This medication is also used to treat high blood pressure (hypertension).

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

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

Do not use this medication if you are allergic to torsemide or if you are unable to urinate

Before using this medication, tell your doctor if you have kidney disease or liver disease, or an allergy to sulfa drugs..

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Avoid becoming dehydrated. Follow your doctor's instructions about the type and amount of liquids you should drink while you are taking torsemide.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

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

Do not use this medication if you are allergic to torsemide, or if you are unable to urinate.

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

• kidney disease;


• cirrhosis or other liver disease; or


• 
  

  an allergy to sulfa drugs.

  
  

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

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.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store this medication at room temperature away from heat, light, and moisture. Do not allow the tablets to freeze.

See also: Torsemide dosage (in more detail)

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 the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include ringing in your ears, loss of appetite, weakness, dizziness, or confusion.

What should I avoid while taking torsemide?

Avoid becoming dehydrated. Follow your doctor's instructions about the type and amount of liquids you should drink while you are taking torsemide.

What are the possible side effects of torsemide

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 torsemide and call your doctor at once if you have a serious side effect such as:

• 
  

  dry mouth, thirst, nausea, vomiting;

  
  


• 
  

  feeling weak, drowsy, restless, or light-headed;

  
  


• 
  

  fast or uneven heartbeat;

  
  


• 
  

  muscle pain or weakness;

  
  


• 
  

  coughing up blood;

  
  


• 
  

  bloody or black, tarry stools; or

  
  


• 
  

  hearing loss.

  
  

Less serious side effects may include:

• 
  

  diarrhea or constipation;

  
  


• 
  

  headache;

  
  


• 
  

  dizziness; or

  
  


• 
  

  decreased sex drive, impotence, or difficulty having an orgasm.

  
  

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 torsemide?

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

• 
  

  lithium (Lithobid, Eskalith);

  
  


• 
  

  digoxin (Lanoxin);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  ethacrynic acid (Edecrin);

  
  


• 
  

  cholestyramine (Prevalite, Questran);

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  amikacin (Amikin), gentamicin (Garamycin), streptomycin, tobramycin (Nebcin, Tobi);

  
  


• 
  

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

  
  


• 
  

  indomethacin (Indocin).

  
  

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

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

• torsemide Advanced Consumer (Micromedex) - Includes Dosage Information


• Torsemide Prescribing Information (FDA)


• Torsemide Professional Patient Advice (Wolters Kluwer)


• Torsemide Monograph (AHFS DI)


• Torsemide MedFacts Consumer Leaflet (Wolters Kluwer)


• Demadex Prescribing Information (FDA)

Compare torsemide with other medications

• Ascites
• Edema
• Heart Failure
• High Blood Pressure
• Nonobstructive Oliguria
• Renal Failure

Where can I get more information?

• Your pharmacist can provide more information about torsemide.

See also: torsemide side effects (in more detail)

Adcal 1500mg chewable tablets

1. Name Of The Medicinal Product

Adcal 1500mg Chewable Tablets

2. Qualitative And Quantitative Composition

Per tablet:

Calcium carbonate: 1500mg

equivalent to 600mg of elemental calcium

3. Pharmaceutical Form

Chewable Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

Adcal is a chewable tablet recommended as a supplementary source of calcium when normal requirements are high and in the correction of calcium deficiency in the diet. They can be used in osteoporosis therapy as an adjunct to more specific conventional treatments. Adcal chewable tablets can be used as a phosphate binding agent in the management of renal failure.

4.2 Posology And Method Of Administration

Oral.

Adults, elderly and children

Dietary deficiency and as an adjunct in osteoporosis therapy; 2 chewable tablets per day, preferably one tablet each morning and evening.

For use in binding phosphate in the management of renal failure in patients on renal dialysis, the dose should be adjusted for the individual patient and is dependent on the serum phosphate level.

The tablets should be chewed, not swallowed whole and taken just prior to, during or immediately following a meal.

4.3 Contraindications

Absolute contra-indications are hypercalcaemia resulting for example from myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism and vitamin D overdosage. Severe renal failure untreated by renal dialysis. Hypersensitivity to any of the tablet ingredients.

Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.

4.4 Special Warnings And Precautions For Use

Patients with mild to moderate renal failure or mild hypercalciuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalciuria.

Urinary calcium excretion should also be measured. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalciuria.

With long-term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5mmol/24 hours.

Allowances should be made for calcium and vitamin D supplements from other sources.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The risk of hypercalcaemia should be considered in patients taking thiazide diuretics since these drugs can reduce urinary calcium excretion. Hypercalcaemia must be avoided in digitalised patients.

The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with Vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium.

Certain foods (e.g. those containing oxalic acid, phosphate or phytinic acid) may reduce the absorption of calcium

Calcium salts may reduce the absorption of thyroxine, bisphosphonates, sodium fluoride, quinolone and tetracycline antibiotics or iron. It is advisable to allow a minimum period of four hours before taking the calcium.

Calcium absorption is reduced in patients receiving systemic corticosteroid therapy. This should be taken in to account when patients are receiving concomitant therapy.

4.6 Pregnancy And Lactation

During pregnancy and lactation treatment with Adcal should be under the direction of a physician. During pregnancy and lactation, requirements for calcium are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources. If Adcal and iron supplements are both required to be administered to the patient, they should be taken at different times (see Section 4.5).

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

The use of calcium supplements has, rarely, given rise to mild gastro-intestinal disturbances, such as constipation, flatulence, nausea, gastric pain, diarrhoea.

4.9 Overdose

Overdosage may cause gastro-intestinal disturbances but would not be expected to cause hypercalcaemia except in patients treated with excessive doses of vitamin D. Treatment should be aimed at lowering serum calcium levels through a high fluid intake and low calcium diet. In severe cases treatments with corticosteroid and other specialist treatment may be necessary. Alkalosis is a potential but rare risk.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Calcium carbonate is a well established medicinal material and is used extensively for supplementation in deficiency states. Calcium carbonate is also widely used as an antacid.

5.2 Pharmacokinetic Properties

The pharmacokinetic profiles of calcium and its salts are well known. Calcium carbonate is converted to calcium chloride by gastric acid. Calcium is absorbed to the extent of about 15-25% from the gastro-intestinal tract while the remainder reverts to insoluble calcium carbonate and calcium stearate, and is excreted in the faeces.

5.3 Preclinical Safety Data

Calcium carbonate is a well known and widely used material and has been used in clinical practice for many years. As such toxicity is only likely to occur in chronic overdosage where hypercalcaemia could result.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Xylitol, polydextrose, pre-gelatinised starch, sodium saccharin, magnesium stearate, fruit flavour (contains propylene glycol and maltodextrin).

6.2 Incompatibilities

Not applicable, oral preparation.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Do not store above 25°C.

Store in the original package. Keep container in the outer carton.

6.5 Nature And Contents Of Container

PVC/PVdC aluminium foil blister packs of 10 (Physicians sample), or 100 tablets in a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

No special conditions

7. Marketing Authorisation Holder

ProStrakan Ltd.

Galabank Business Park

Galashiels

Scotland

TD1 1QH

8. Marketing Authorisation Number(S)

PL16508/0005

9. Date Of First Authorisation/Renewal Of The Authorisation

04/10/2005

10. Date Of Revision Of The Text

November 2008

11 LEGAL CATEGORY

P

Ephedrine Nasal Drops 0.5%

1. Name Of The Medicinal Product

Ephedrine Nasal Drops 0.5%

2. Qualitative And Quantitative Composition

Ephedrine Hydrochloride BP 0.5% W/V

For excipients see 6.1.

3. Pharmaceutical Form

Nasal Drops.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of nasal congestion.

4.2 Posology And Method Of Administration

Nasal, by application to the mucous membranes.

RECOMMENDED DOSE

Instil one or two drops into each nostril.

DOSAGE SCHEDULE

As required, but not more than 4 times a day.

The above dose and schedule are recommended for adults, the elderly and children over 12 years.

4.3 Contraindications

Ephedrine should not be given to patients who are being treated with monoamine oxidase inhibitors, or within two weeks of stopping such treatment (see section 4.5).

Ephedrine should not be taken with beta-blockers (see section 4.5)

It should be used with caution in patients receiving halogenated anaesthetics.

Ephedrine nasal drops should not be used concomitantly with other sympathomimetic decongestants.

It should also be avoided in patients with cardiovascular disease, cardiac arrhythmias, cardiomyopathy and peripheral vascular disease, hypertension, hyperthyroidism, hyperexcitability, phaeochromocytoma, closed-angle glaucoma and urinary retention.

Ephedrine nasal drops should not be used after nasal or sinus surgery.

Excessive and/or frequent use of a nasal decongestant should be avoided.

Children under 12 years of age.

Hypersensitivity to ephedrine or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Store below 25°C. Do not allow to freeze.

Keep all medicines away from children.

Warning: asthmatics should consult their doctor before using this product.

Ephedrine should be used with care in the elderly and in patients with prostatic hypertrophy, diabetes mellitus or renal impairment.

The product should not be used for longer than 7 days. Avoid contamination during use. Keep away from eyes.

10ml pack label states: do not share the drops with anyone.

10ml pack states: discard any unused drops 2 months after opening.

Do not give to children under 12 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Medicinal products, the use of which may be affected by ephedrine nasal drops:

MAOIs: Risk of hypertensive crisis. Sympathomimetics such as ephedrine should not be given with MAOIs or within 14 days of stopping treatment (see Section 4.3).

Anti-arrhythmics - including beta-blockers and quinidine: ephedrine may increase the risk of arrhythmias, and block the hypotensive effects of beta-blockers (see Section 4.3);

Adrenergic neurone blockers (such as guanethidine): ephedrine may block the hypotensive effects.

Cardiac glycosides (such as digoxin or digitoxin), or tricyclic antidepressants: ephedrine may increase the risk of arrythmias.

Ergotamine and methysergide: ephedrine may increase the risk of ergotism.

Oxytocin: there is increased risk of hypertension when vasoconstrictor sympathomimetics are given with oxytocin.

Doxapram: there is increased risk of hypertension when sympathomimetics are given with doxapram.

Dexamethasone: ephedrine accelerates the metabolism of dexamethasone.

MAO-B inhibitors (such as rasagiline and selegiline): risk of hypertension.

Theophylline: concomitant use with ephedrine may potentiate the adverse effects.

Volatile anaesthetics: ephedrine should be avoided in patients undergoing anaesthesia with volatile anaesthetics – risk of hazardous arrhythmias (see Section 4.3).

Thyroid hormones: Caution is required with sympathomimetics and thyroid hormones.

Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension.

Medicinal products potentially affecting the activity of ephedrine:

Antihypertensives such as guanethidine, reserpine and probably methyldopa may diminish the effects of ephedrine.

Tricyclic antidepressants may reduce the effect of sympathomimetics.

Caffeine may enhance the side effects of ephedrine.

Antipsychotics may antagonise the hypertensive effects of sympathomimetics.

4.6 Pregnancy And Lactation

This product should not be used in pregnancy or whilst breast feeding unless recommended by a doctor. Ephedrine crosses the placenta and has been associated with an increase in foetal heart rate. Ephedrine has been reported to cause irritability and disturbed sleep in infants when used during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

The following undesirable effects have been reported following use of ephedrine and may arise following use of ephedrine nasal drops. The frequency of adverse effects cannot be estimated from available data, but adverse effects may be minimised by avoiding prolonged or excessive use (see section 4.4).

Metabolism and nutrition disorders: Hyperglycaemia, hypokalaemia.

Psychiatric disorders: hallucinations, paranoia.

Nervous system disorders: Anxiety, restlessness, irritability, tremors, headache, tolerance, dependence, insomnia, dizziness and fainting.

Eye disorders: Mydriasis.

Cardiac disorders: Palpitations, arryhythmias.

Vascular disorders: Hypertension (vasoconstriction with hypertension), vasodilation with hypotension, flushing, impaired circulation to the extremities.

Respiratory, thoracic and mediastinal disorders: dyspnoea.

Gastrointestinal disorders: Nausea, thirst, dry mouth, anorexia, vomiting, increased salivation.

Skin & subcutaneous tissue disorders: Sweating, dermatitis, piloerection.

Musculoskeletal and connective tissue disorders: Muscular weakness.

Renal and Urinary disorders: Difficulty in micturition in patients with prostatic enlargement, urinary retention.

General disorders and administration site conditions: Local irritation, dryness, pain, rebound congestion and drug-induced rhinitis.

4.9 Overdose

The estimated minimal lethal dose of ephedrine in children up to 2 years of age is 200mg, and for adults 2g, but fatalities due to ephedrine overdose are rare and not likely to occur following administration of the nasal drops. Single doses of up to 400mg of ephedrine have been given without serious toxic effects. In large doses ephedrine may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tremors, anxiety, restlessness and insomnia Paranoid psychosis, delusions, and hallucinations may follow overdosage. Treatment of overdosage should include supportive and symptomatic therapy. In severe cases the stomach should be emptied by aspiration and lavage. Diazepam may be given to control central nervous system stimulation. Chlorpromazine may be given for excitement or the management of hallucinations. A beta-adrenoceptor blocking agent may be required to control cardiac arrhythmias. Acute poisoning with chlorobutanol is also highly improbable considering the concentration in the drops and the method of administration, however treatment for overdosage would be aspiration and lavage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

R01A A 03-Decongestants and other nasal preparations for topical use.

Ephedrine hydrochloride is applied locally to relieve congestion of mucous membranes in acute sinusitis and hay fever. It has a stimulant action on the respiratory centre. Ephedrine releases norepinephrine from storage sites in the sympathetic nerves to the effector organ. It exhibits tachyphylaxis; repeated infusions become less effective as the releasable stores of norepinephrine are depleted.

5.2 Pharmacokinetic Properties

Ephedrine redistributes the blood flow and causes cardiac stimulation without markedly raising the blood pressure. Sympathomimetic drugs exert their effect by vasoconstriction of the mucosal blood vessels, which in turn reduces the thickness of the nasal mucosa. However, they can give rise to a rebound phenomenon as their effects wear off, due to a secondary vasodilation with a subsequent temporary increase in nasal congestion.

5.3 Preclinical Safety Data

No data of relevance which is additional to that included to other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chlorobutanol BP

Sodium Chloride BP

Purified Water BP

6.2 Incompatibilities

None known.

6.3 Shelf Life

10 ml: 18 months unopened, 2 months after first opening.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

10 ml: amber glass, winchester bottle with 20mm R3 plastic wadded cap.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite Laboratories,

Huddersfield,

HD7 5QH.

8. Marketing Authorisation Number(S)

PL 00240/6528R

9. Date Of First Authorisation/Renewal Of The Authorisation

14/09/2005

10. Date Of Revision Of The Text

10/01/2011

Carisoma Tablets

1. Name Of The Medicinal Product

CARISOMA TABLETS

2. Qualitative And Quantitative Composition

Each tablet contains 125mg or 350mg Carisoprodol.

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

As an adjunct to the symptomatic treatment of acute musculoskeletal disorders associated with painful muscle spasm, where sedation is acceptable.

4.2 Posology And Method Of Administration

For oral administration and short term use only.

Adults:

The usual dose is 350mg three times a day.

Elderly:

Half the normal adult dose or less may be sufficient for a therapeutic response.

Children:

Not recommended.

4.3 Contraindications

Sensitivity to carisoprodol or related drugs such as meprobamate. Acute intermittent porphyrias. Breast feeding.

4.4 Special Warnings And Precautions For Use

Carisoprodol is metabolised by the liver and excreted by the kidneys. To prevent accumulation, administer with caution in renal and hepatic impairment.

The dependence potential of carisoprodol is not known. Dependence has occurred. As with other sedative drugs, dependence may possibly occur when carisoprodol is given in high dosage and for prolonged periods, especially in patients with a history of alcoholism or drug dependence or in patients with marked personality disorders. Withdrawal symptoms have been reported to occur in a study of the effects of abrupt cessation of higher than normal dosage.Safety in long term use has not been established.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In hepatic or renal insufficiency, the concurrent use of other CNS depressant drugs should be avoided. Little is known about the possibility of other drug interactions. Carisoprodol may cause hepatic enzyme induction. Therefore the availability and blood levels of drugs given concurrently that are metabolised by the liver, may be affected. These include coumarin-type anticoagulants, systemic steroids (including oral contraceptives), phenytoin, griseofulvin, rifampicin, phenothiazines and tricyclic antidepressants. The sedative effects of carisoprodol are potentiated by the use of alcohol.

4.6 Pregnancy And Lactation

Do not use during pregnancy, especially the first trimester, unless there are compelling reasons.

Carisoprodol is present in breast milk at two to four times that of maternal plasma. This factor should be taken into account when use of this drug is contemplated in breast-feeding patients.

4.7 Effects On Ability To Drive And Use Machines

Performance and alertness may be impaired. Patients should be warned of the hazard and advised not to drive or operate machines during treatment. These effects are potentiated by alcohol.

4.8 Undesirable Effects

Reported adverse effects include drowsiness, dizziness, nausea, vertigo, lassitude, weakness, flushing, headache, irritability and constipation. Skin rashes may occur.

Poor metabolisers of CYP2C19 may be at greater risk of drowsiness (see Section 5.2).

Rare reactions reported have included anaphylactic shock, syncope, tachycardia, confusion, transient quadriplegia, bronchospasm; such idiosyncratic reactions may occur after the first dose in patients not previously exposed to the drug.

4.9 Overdose

Overdosage of carisoprodol has produced stupor, coma, shock, respiratory depression and (very rarely) death. Effects can be additive with other CNS depressant drugs or alcohol taken concurrently. In cases where excessive doses have been taken, sleep ensues rapidly and blood pressure, pulse and respiratory rates are reduced to basal levels. Any drug remaining in the stomach should be removed and symptomatic therapy given.

Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously as indicated. Carisoprodol is metabolised in the liver and excreted by the kidney. Forced alkaline diuresis, peritoneal dialysis and haemodialysis have been used successfully. Careful monitoring of urinary output is necessary and caution should be taken to avoid over-hydration.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Carisoprodol is a centrally acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain.

5.2 Pharmacokinetic Properties

The onset of action is rapid and the duration of effect is 4 to 6 hours.

Carisoprodol is metabolised by the liver and excreted by the kidneys.

The metabolism of carisoprodol may be under the control of genetic polymorphism of CYP2C19 and an extended half-life has been reported in a 'poor metaboliser' phenotype. Thus, care should be exercised in known CYP2C19 'poor metabolisers' who may be at greater risk of drowsiness.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Alginic Acid

Magnesium Stearate

Methylcellulose

Corn Starch

Purified Water

6.2 Incompatibilities

None stated

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Amber glass bottle with black urea formaldehyde cap with a steran faced pulpboard wad and acid-free tissue dunnage containing 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

Forest Laboratories UK Limited

Bourne Road

Bexley

Kent DA5 1NX

8. Marketing Authorisation Number(S)

125mg: PL 0108/0082

350mg: PL 0108/0081

9. Date Of First Authorisation/Renewal Of The Authorisation

125mg: 13 April 1984 / 31 October 2000

350mg: 13 April 1984 / 17 October 2000

10. Date Of Revision Of The Text

July 2006

11. Legal Category

POM

Flonase Spray

Pronunciation: floo-TIK-a-sone
Generic Name: Fluticasone
Brand Name: Flonase

Flonase Spray is used for:

Treatment of allergic and nonallergic nasal symptoms including congestion, sneezing, itching, and runny nose.

Flonase Spray is a corticosteroid. It works by reducing inflammatory reactions in the nasal airway in response to allergens and irritants in the air.

Do NOT use Flonase Spray if:

• you are allergic to any ingredient in Flonase Spray

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

Before using Flonase Spray:

Some medical conditions may interact with Flonase Spray. 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 or other substances


• if you have recently experienced an ulcer of the nasal septum, nasal surgery, or nasal trauma


• if you have active or inactive tuberculosis or a positive skin test for tuberculosis


• if you have infections of the respiratory tract, untreated fungal or bacterial infections, parasitic or viral infections, measles, chickenpox, herpes simplex in or around the eye, or recently received a vaccination


• if you have diarrhea


• if you have glaucoma or cataracts

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

• Certain medicines that act on the liver (eg, protease inhibitors [eg, ritonavir], ketoconazole) because they may increase the actions and the risk of Flonase Spray's side effects

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

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

• An extra patient leaflet is available with Flonase Spray. Talk to your pharmacist if you have questions about this information.


• Shake gently before each use.


• If needed, prime the spray pump according to the directions in the extra patient leaflet.


• To use a nose spray, gently blow your nose. Sit down and tilt your head forward slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for 1 to 2 minutes between sprays. After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.


• Symptoms can start to improve as soon as 12 hours after you start using Flonase Spray, and should improve within a couple of days. The full benefit may not be achieved until you have used Flonase Spray for several days. If symptoms do not improve or if the condition worsens, contact your health care provider.


• Use Flonase Spray on a regular schedule to get the most benefit from it.


• Using Flonase Spray at the same time each day will help you remember to use it.


• Continue to use Flonase Spray even if you feel well. Do not miss any doses.


• If you miss a dose of Flonase Spray, use 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 use 2 doses at once.

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

Important safety information:

• Flonase Spray may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Flonase Spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Use caution if you switch from an oral steroid (eg, prednisone) to Flonase Spray. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.


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


• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.


• Avoid spraying in the eyes.


• Flonase Spray should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.


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


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

Possible side effects of Flonase Spray:

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:

Dizziness; headache; nasal irritation or burning; nausea; nosebleed; sore throat; vomiting.

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; unusual hoarseness); blurred vision or other vision changes; frequent, severe, or persistent nosebleeds or nasal irritation; loss of sense of smell or taste; shortness of breath; sores in the nose; unusual nasal discharge; voice changes; wheezing.

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: Flonase 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.

Proper storage of Flonase Spray:

Store Flonase Spray between 39 and 86 degrees F (4 and 30 degrees C). Keep Flonase Spray out of the reach of children and away from pets.

General information:

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


• Flonase Spray 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 Flonase Spray. 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 Flonase resources

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

Compare Flonase with other medications

• Hay Fever
• Nasal Polyps
• Rhinitis

Fluticasone Furoate Spray

Pronunciation: floo-TIK-a-sone
Generic Name: Fluticasone Furoate
Brand Name: Veramyst

Fluticasone Furoate Spray is used for:

Treatment of nasal allergy symptoms, including congestion, sneezing, itching, and runny nose.

Fluticasone Furoate Spray is a corticosteroid. It works by reducing inflammatory reactions in the nasal airway in response to allergens and irritants in the air.

Do NOT use Fluticasone Furoate Spray if:

• you are allergic to any ingredient in Fluticasone Furoate Spray


• you have recently had an open sore in your nose, nasal surgery, or a nasal injury and it has not healed yet


• you are taking ritonavir

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

Before using Fluticasone Furoate Spray:

Some medical conditions may interact with Fluticasone Furoate Spray. 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 active or inactive tuberculosis (TB) or you have had a positive skin test for TB


• if you have any type of infection (eg, bacterial, fungal, viral, parasitic), including measles, chickenpox, or herpes simplex, in or around the eye


• if you have diarrhea or a history of liver problems, asthma, glaucoma or increased pressure in the eye, or cataracts


• if you have recently had an open sore in your nose, nasal surgery, or a nasal injury


• if you have a medical condition requiring long-term use of corticosteroids (eg, prednisone)


• if you have recently received a vaccination

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

• Azole antifungals (eg, ketoconazole), delavirdine, or protease inhibitors (eg, boceprevir, ritonavir) because they may increase the risk of Fluticasone Furoate Spray's side effects

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

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

• An extra patient leaflet is available with Fluticasone Furoate Spray. Talk to your pharmacist if you have questions about this information.


• You will need to prime Fluticasone Furoate Spray before you use it for the first time. To prime Fluticasone Furoate Spray, shake it well then spray 6 test sprays in to the air away from your face. You will need to re-prime the medicine if it is not used for 30 days or longer or if the cap is left off the bottle for 5 days or longer


• Shake Fluticasone Furoate Spray well before each use.


• To use Fluticasone Furoate Spray, gently blow your nose. Remove the cap and hold the spray device upright. Tilt your head forward slightly and place the nozzle in one nostril. Point the end of the nozzle toward the side of your nose (away from the center of your nose). Firmly press the mist release button while breathing in gently through your nose, then remove the nozzle from your nose and breathe out through your mouth. Repeat these steps for the other nostril. After you finish your dose, wipe the nozzle with a clean, dry tissue and replace the cap.


• If the patient is a young child, an adult should help the child use Fluticasone Furoate Spray.


• Clean the inside of the cap once a week with a clean, dry tissue. Never try to clean the nozzle with a pin or anything sharp; doing so may damage the nozzle.


• This bottle contains 120 sprays (not counting the initial priming sprays). Do not use this bottle after 120 sprays have been used. It may not give the correct amount of medicine with each spray.


• Use Fluticasone Furoate Spray on a regular schedule to get the most benefit from it. Using Fluticasone Furoate Spray at the same time each day will help you remember to use it.


• Continue to use Fluticasone Furoate Spray even if you feel well. Do not miss any doses.


• If you miss a dose of Fluticasone Furoate Spray, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluticasone Furoate Spray.

Important safety information:

• Do not get Fluticasone Furoate Spray in your eyes or mouth. If you get it in either of these areas, rinse right away with cool water.


• Tell your doctor or dentist that you take Fluticasone Furoate Spray before you receive any medical or dental care, emergency care, or surgery.


• Symptoms may begin to improve within 24 hours after you start Fluticasone Furoate Spray. However, it may take several days before you notice the full benefit of Fluticasone Furoate Spray. If symptoms do not improve or if the condition worsens, contact your health care provider.


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


• If you have NOT had chickenpox or measles, avoid contact with anyone who does. Contact your doctor right away if you are exposed to anyone with these conditions.


• Serious side effects may occur if too much of Fluticasone Furoate Spray is used. These effects may also occur in certain patients at the recommended dose. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, anxiety, depression, irritability, or vision changes. Discuss any questions or concerns with your doctor.


• Fluticasone Furoate Spray should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluticasone Furoate Spray.


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

Possible side effects of Fluticasone Furoate Spray:

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:

Back pain; cough; headache; minor nosebleed; sore 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; unusual hoarseness); crusting in the nose; dizziness; redness or white patches in the mouth or throat; severe or persistent nosebleed; severe or persistent pain in the nose or throat; shortness of breath; slow wound healing; symptoms of infection (eg, fever, chills, persistent cough or sore throat); unexplained runny nose; unusual nausea or vomiting; unusual tiredness or weakness; vision changes; whistling sound when you breathe.

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.

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.

Proper storage of Fluticasone Furoate Spray:

Store Fluticasone Furoate Spray between 59 and 86 degrees F (15 and 30 degrees C). Do not refrigerate or freeze. Store in the upright position with the cap in place. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use past the expiration date on the container. Keep Fluticasone Furoate Spray out of the reach of children and away from pets.

General information:

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


• Fluticasone Furoate Spray 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 Fluticasone Furoate Spray. 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 Fluticasone Furoate resources

• Fluticasone Furoate Use in Pregnancy & Breastfeeding
• Fluticasone Furoate Drug Interactions
• Fluticasone Furoate Support Group
• 29 Reviews for Fluticasone Furoate - Add your own review/rating

Compare Fluticasone Furoate with other medications

• Hay Fever
• Nasal Polyps
• Rhinitis

A/B Otic

Generic Name: antipyrine and benzocaine otic (AN tee PYE reen and BEN zoe kane)

Brand Names: A/B Otic, Aurodex, Rx-Otic

What is A/B Otic (antipyrine and benzocaine otic)?

Antipyrine is a pain reliever.

Benzocaine is a numbing medicine.

The combination of antipyrine and benzocaine is used to treat pain, and swelling caused by ear infections.

Antipyrine and benzocaine otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about A/B Otic (antipyrine and benzocaine otic)?

Antipyrine and benzocaine otic is for use only in your ears. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Stop using this medication and call your doctor if you have ear drainage or discharge, or worsening pain, irritation, or rash.

Talk with your doctor if your symptoms do not improve after using this medication.

What should I discuss with my healthcare provider before using A/B Otic (antipyrine and benzocaine otic)?

You should not use antipyrine and benzocaine otic if you have a ruptured (torn) ear drum, or the medication could leak into the inner ear. A ruptured ear drum usually causes moderate to severe ear pain, with or without a decrease in hearing. Call your doctor if you think you have a ruptured ear drum. Your doctor will use a special scope to see any tear in your ear drum. FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before using antipyrine and benzocaine otic, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether antipyrine and benzocaine otic 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 use A/B Otic (antipyrine and benzocaine otic)?

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

Do not use the medication in your eyes or take it by mouth. Antipyrine and benzocaine otic is for use only in the ears.

For best results, remove any ear wax or other debris before using the ear drops. Ask your doctor about safe methods of ear wax removal.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. Hold the dropper upside down over your ear canal and place enough drops of the medicine in your ear to fill the ear canal.

Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, keep the ear tilted upward for about 5 minutes. Ask your doctor about using a small piece of cotton to plug the ear and keep the medicine from draining out.

Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.

Talk with your doctor if your symptoms do not improve after using this medication.

Store antipyrine and benzocaine otic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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 antipyrine and benzocaine applied into the ear is not likely to cause life-threatening symptoms.

What should I avoid while using this medication?

Do not use other ear drops during treatment with antipyrine and benzocaine otic without first talking to your doctor. Ear infections may sometimes cause dizziness or a loss of balance. Be careful if you drive, operate machinery, or do anything else hazardous if you feel dizzy or off balance. Antipyrine and benzocaine otic is for use only in your ear. Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water.

A/B Otic (antipyrine and benzocaine otic) 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 any of these serious side effects:

• 
  

  ear drainage or discharge; or

  
  


• 
  

  worsening pain, irritation, or rash.

  
  

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 A/B Otic (antipyrine and benzocaine otic)?

It is not likely that other drugs you take orally or inject will have an effect on antipyrine and benzocaine used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More A/B Otic resources

• A/B Otic Side Effects (in more detail)
• A/B Otic Use in Pregnancy & Breastfeeding
• A/B Otic Support Group
• 2 Reviews for A/B Otic - Add your own review/rating

• A/B Otic Advanced Consumer (Micromedex) - Includes Dosage Information


• Aurodex MedFacts Consumer Leaflet (Wolters Kluwer)

Compare A/B Otic with other medications

• Ear Wax Impaction
• Otitis Media

Where can I get more information?

• Your pharmacist can provide more information about antipyrine and benzocaine otic.

See also: A/B Otic side effects (in more detail)

Fluvirin

influenza virus vaccine

Dosage Form: injection
FULL PRESCRIBING INFORMATION

Indications and Usage for Fluvirin

Fluvirin® is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza virus disease caused by influenza virus subtypes A and type B contained in the vaccine. [see DOSAGE FORMS AND STRENGTHS (3)]

Fluvirin® is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group.

Fluvirin Dosage and Administration

Preparation for Administration

Inspect Fluvirin® syringes and multidose vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.

Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.

Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

A separate syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped.

It is recommended that small syringes (0.5-mL or 1-mL) should be used to minimize any product loss.

Recommended Dose and Schedule

Children (4 to 17 years of age):

Children aged 4 to 8 years should receive 2 doses of vaccine if they have not been vaccinated previously at any time with any influenza virus vaccine. Children aged 4 to 8 years who received only 1 dose in their first year of vaccination in the previous season should receive 2 doses. Fluvirin® should be given as a 0.5-mL intramuscular injection on day 1 followed by another 0.5-mL intramuscular injection at least 4 weeks later. 2 doses are required for protection in these children. (15.3)

Children aged 4 to 8 years who have been vaccinated with two doses of any influenza virus vaccine in the previous season, or with one dose in the year prior to the previous season, should receive only one dose. (15.3)

Children aged 9 years and older should receive a single 0.5-mL intramuscular injection.

The needle size may range from 7/8 to 1¼ inches, depending on the size of the child's deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

Adults (18 years and older):

Fluvirin® should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.

The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk. A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

Dosage Forms and Strengths

Fluvirin® is a sterile suspension for intramuscular injection. Each 0.5-mL dose contains 15 mcg hemagglutinin from each of the following 3 influenza virus types: A/California/7/2009, NYMC X-181 (H1N1); A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus); and B/Brisbane/60/2008. [see DESCRIPTION (11)]

Fluvirin® is available in two presentations:

1. Prefilled syringe, 0.5-mL. Thimerosal, a mercury derivative used during manufacture, is removed by subsequent purification steps to a trace amount (≤1 mcg mercury per 0.5-mL dose).


2. Multidose vial, 5-mL. Contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.

Contraindications

Hypersensitivity

Fluvirin® should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of Fluvirin®, or who has had a life-threatening reaction to previous influenza vaccinations.

Warnings and Precautions

Guillain-Barré Syndrome

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Fluvirin® should be based on careful consideration of the potential benefits and risks.

Altered Immunocompetence

If Fluvirin® is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

Preventing and Managing Allergic Reactions

Prior to administration of any dose of Fluvirin®, the healthcare provider should review the patient's prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with Fluvirin® and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

The tip caps of the Fluvirin® prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.

Limitations of Vaccine Effectiveness

Vaccination with Fluvirin® may not protect all individuals.

Adverse Reactions

Overall Adverse Reaction Profile

Serious allergic reactions, including anaphylactic shock, have been observed in individuals receiving Fluvirin® during postmarketing surveillance.

Clinical Trial Experience

Adverse event information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating the rates of these events. However, because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect rates observed in clinical practice.

Adult and Geriatric Subjects

Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age and older) who have received Fluvirin® in 29 clinical studies since 1982.

In 9 clinical studies since 1997, among 1261 recipients of Fluvirin®, 745 (59%) were women; 1211 (96%) were White, 23 (2%) Asian, 15 (1%) Black and 12 (1%) other; 370 (29%) of subjects were elderly (≥65 years of age). All studies have been conducted in the UK, apart from a study run in the US in 2005-2006 where Fluvirin® was used as a comparator for an unlicensed vaccine.

After vaccination, the subjects were observed for 30 minutes for hypersensitivity or other immediate reactions. Subjects were instructed to complete a diary card for three days following immunization (i.e. Day 1 to 4) to collect local and systemic reactions (see Tables 1 and 2). All local and systemic adverse events were considered to be at least possibly related to the vaccine. Local and systemic reactions mostly began between day 1 and day 2. The overall adverse events reported in clinical trials since 1998 in at least 5% of the subjects are summarized in Table 3.

TABLE 1 Solicited Adverse Events in the First 72-96 Hours After Administration of Fluvirin® in Adult (18-64 years of age) and Geriatric (≥65 years of age) Subjects.

	1998-1999*§			1999-2000*§			2000-2001*§
	18-64 yrs	≥ 65 yrs		18-64 yrs	≥ 65 yrs		18-64 yrs	≥ 65 yrs
	N = 66	N = 44		N = 76	N = 34		N = 75	N = 35
Results reported to the nearest whole percent; Fever defined as >38°C
– not reported
* Solicited adverse events in the first 72 hours after administration of Fluvirin®
§ Solicited adverse events reported by COSTART preferred term
^ Solicited adverse events reported by MEDDRA preferred term
Local Adverse Events
Pain	16 (24%)	4 (9%)		16 (21%)	-		9 (12%)	-
Mass	7 (11%)	1 (2%)		4 (5%)	-		8 (11%)	1 (3%)
Inflammation	5 (8%)	2 (5%)		6 (8%)	-		7 (9%)	1 (3%)
Ecchymosis	4 (6%)	1 (2%)		3 (4%)	1 (3%)		4 (5%)	-
Edema	2 (3%)	1 (2%)		1 (1%)	2 (6%)		3 (4%)	1 (3%)
Reaction	2 (3%)	-		2 (3%)	-		4 (5%)	1 (3%)
Hemorrhage	-	-		1 (1%)	-		-	-
Systemic Adverse Events
Headache	7 (11%)	1 (2%)		17 (22%)	3 (9%)		4 (5%)	-
Fatigue	3 (5%)	2 (5%)		4 (5%)	1 (3%)		3 (4%)	-
Malaise	2 (3%)	1 (2%)		2 (3%)	1 (3%)		1 (1%)	-
Myalgia	1 (2%)	-		2 (3%)	-		-	-
Fever	1 (2%)	-		1 (1%)	-		-	-
Arthralgia	-	1 (2%)		-	1 (3%)		-	-
Sweating	-	-		3 (4%)	-		1 (1%)	1 (3%)
	2001-2002*^			2002-2003*^			2004-2005*^
	18-64 yrs		≥ 65 yrs	18-64 yrs		≥ 65 yrs	18-64 yrs	≥ 65 yrs
	N = 75		N = 35	N = 107		N = 88	N = 74	N = 61
Local Adverse Events
Pain	12 (16%)		1 (3%)	14 (13%)		7 (8%)	15 (20%)	9 (15%)
Mass	4 (5%)		1 (3%)	-		-	-	-
Ecchymosis	2 (3%)		-	3 (3%)		3 (3%)	2 (3%)	1 (2%)
Edema	2 (3%)		1 (3%)	6 (6%)		2 (2%)	-	-
Erythema	5 (7%)		-	11 (10%)		5 (6%)	16 (22%)	5 (8%)
Swelling	-		-	-		-	11 (15%)	4 (7%)
Reaction	-		-	2 (2%)		-	-	-
Induration	-		-	14 (13%)		3 (3%)	11 (15%)	1 (2%)
Pruritus	-		-	1 (1%)		-	-	-
Systemic Adverse Events
Headache	8 (11%)		1 (3%)	12 (11%)		9 (10%)	14 (19%)	3 (5%)
Fatigue	1 (1%)		1 (3%)	-		-	5 (7%)	2 (3%)
Malaise	3 (4%)		-	3 (3%)		4 (5%)	1 (1%)	1 (2%)
Myalgia	3 (4%)		-	5 (5%)		3 (3%)	8 (11%)	1 (2%)
Fever	-		-	-		1 (1%)	-	-
Arthralgia	-		-	2 (2%)		-	1 (1%)	-
Sweating	3 (4%)		1 (3%)	-		2 (2%)	-	-
Shivering	-		-	-		1 (1%)	-	-

TABLE 2 Solicited Adverse Events in the First 72 Hours After Administration of Fluvirin® in Adult Subjects (18-49 years of age).

	2005-2006 US Trial
	Fluvirin®
	N = 304
Results reported to the nearest whole percent
– not reported
Local Adverse Events
Pain	168 (55%)
Erythema	48 (16%)
Ecchymosis	22 (7%)
Induration	19 (6%)
Swelling	16 (5%)
Systemic Adverse Events
Headache	91 (30%)
Myalgia	64 (21%)
Malaise	58 (19%)
Fatigue	56 (18%)
Sore throat	23 (8%)
Chills	22 (7%)
Nausea	21 (7%)
Arthralgia	20 (7%)
Sweating	17 (6%)
Cough	18 (6%)
Wheezing	4 (1%)
Chest tightness	4 (1%)
Other difficulties breathing	3 (1%)
Facial edema	-

TABLE 3 Adverse Events Reported by at least 5% of Subjects in Clinical Trials since 1998

	1998-1999§				1999-2000§			2000-2001§
	18-64 yrs	≥ 65 yrs			18-64 yrs	≥ 65 yrs		18-64 yrs	≥ 65 yrs
	N = 66	N = 44			N = 76	N = 34		N = 75	N = 35
Results reported to the nearest whole percent; Fever defined as >38°C
– not reaching the cut-off of 5%
§ Solicited adverse events reported by COSTART preferred term
^ Solicited adverse events reported by MEDDRA preferred term
Adverse Events
Fatigue	8 (12%)	2 (5%)			8 (11%)	2 (6%)		5 (7%)	-
Back pain	4 (6%)	3 (7%)			-	-		-	-
Cough increased	2 (3%)	2 (5%)			-	-		-	-
Ecchymosis	4 (6%)	1 (2%)			4 (5%)	1 (3%)		5 (7%)	-
Fever	3 (5%)	-			-	-		-	-
Headache	12 (18%)	5 (11%)			22 (29%)	5 (15%)		14 (19%)	2 (6%)
Infection	3 (5%)	2 (5%)			-	-		-	-
Malaise	4 (6%)	4 (9%)			4 (5%)	1 (3%)		-	-
Migraine	4 (6%)	1 (2%)			-	-		-	-
Myalgia	4 (6%)	1 (2%)			-	-		-	-
Sweating	5 (8%)	1 (2%)			-	-		-	-
Rhinitis	3 (5%)	1 (2%)			-	-		5 (7%)	2 (6%)
Pharingitis	6 (9%)	1 (2%)			10 (13%)	-		6 (8%)	-
Arthralgia	-	-			-	2 (6%)		-	-
Injection site pain	16 (24%)	4 (9%)			16 (21%)	-		9 (12%)	-
Injection site ecchymosis	4 (6%)	1 (2%)			-	-		4 (5%)	-
Injection site mass	7 (11%)	1 (2%)			4 (5%)	-		8 (11%)	1 (3%)
Injection site edema	-	-			1 (1%)	2 (6%)		-	-
Injection site      inflammation	5 (8%)	2 (5%)			6 (8%)	-		7 (9%)	1 (3%)
Injection site reaction	-	-			-	-		4 (5%)	1 (3%)
	2001-2002^			2002-2003^				2004-2005^
	18-64 yrs		≥ 65 yrs	18-64 yrs			≥ 65 yrs	18-64 yrs	≥ 65 yrs
	N = 75		N = 35	N = 107			N = 88	N = 74	N = 61
Adverse Events
Fatigue	5 (7%)		4 (11%)	11 (10%)			8 (9%)	4 (5%)	2 (3%)
Hypertension	-		-	1 (1%)			4 (5%)	-	-
Rinorrhea	-		-	2 (2%)			5 (6%)	-	-
Headache	20 (27%)		2 (6%)	35 (33%)			18 (20%)	12 (16%)