ketorolac Nasal

kee-toe-ROLE-ak

Nasal route(Spray)

For short term use only (up to 5 days in adults). Not for use in pediatric patients and not indicated for minor or chronic pain. Contraindicated in patients with peptic ulcer disease, history of gastrointestinal (GI) bleeding or perforation, peri-operative pain in the setting of CABG surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, and high risk of bleeding. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors for cardiovascular disease .

Commonly used brand name(s)

In the U.S.

• Sprix

Available Dosage Forms:

• Spray

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For ketorolac

Ketorolac nasal spray is used to relieve moderate to moderately severe pain, such as pain that occurs after an operation or other painful procedure. It is a nonsteroidal anti-inflammatory drug (NSAID) that will reduce pain and inflammation.

Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the amount that is used and the length of time it is used. Ketorolac should not be used for more than 5 days in a row. Before using ketorolac, you should discuss with your doctor the good that ketorolac can do as well as the risks of using it.

ketorolac is available only with your doctor's prescription.

Before Using ketorolac

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 ketorolac, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketorolac 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 ketorolac nasal spray 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 ketorolac nasal spray in the elderly. However, because of ketorolac's toxicity, it should be used with caution in the elderly, after less toxic alternatives have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment. In addition, elderly patients are more likely to have age-related heart, kidney, liver, stomach, or bowel problems, which may require caution and an adjustment in the dose for patients receiving ketorolac nasal spray.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	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.
2nd Trimester	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.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 ketorolac, 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 ketorolac 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.

• Aceclofenac


• Acemetacin


• Alclofenac


• Apazone


• Aspirin


• Benoxaprofen


• Bufexamac


• Carprofen


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pentoxifylline


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Probenecid


• Propyphenazone


• Proquazone


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Zomepirac

Using ketorolac 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.

• Abciximab


• Ardeparin


• Argatroban


• Beclamide


• Beta Glucan


• Bivalirudin


• Caramiphen


• Carbamazepine


• Certoparin


• Chlormethiazole


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Diazepam


• Dipyridamole


• Enoxaparin


• Escitalopram


• Ethotoin


• Felbamate


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Fosphenytoin


• Gabapentin


• Ginkgo


• Heparin


• Lacosamide


• Lepirudin


• Levetiracetam


• Mephenytoin


• Mephobarbital


• Methotrexate


• Nadroparin


• Nefazodone


• Oxcarbazepine


• Paraldehyde


• Paramethadione


• Parnaparin


• Paroxetine


• Pemetrexed


• Phenacemide


• Phenobarbital


• Phenytoin


• Piracetam


• Pregabalin


• Protein C


• Reviparin


• Rivaroxaban


• Rufinamide


• Sertraline


• Sibutramine


• Stiripentol


• Tacrolimus


• Tiagabine


• Ticlopidine


• Tinzaparin


• Tirofiban


• Topiramate


• Trimethadione


• Valproic Acid


• Vigabatrin


• Vilazodone


• Zimeldine


• Zonisamide

Using ketorolac 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


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Anemia or


• Congestive heart failure or


• Crohn's disease, history of or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease or


• Hypertension (high blood pressure) or


• Kidney disease, or history of or


• Liver disease, or history of or


• Stroke, history of or


• Ulcerative colitis, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or


• Aspirin sensitivity, history of or


• Bleeding problems or


• Kidney disease, severe or


• Major surgery, prior to or


• Stomach ulcers or bleeding, or history of—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of ketorolac

Take ketorolac only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not use it for more than 5 days in a row. The total number of days also includes any doses of ketorolac that may be given in a hospital or clinic setting. Using too much of ketorolac increases the chance of side effects, especially in elderly patients.

ketorolac should come with a medication guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

ketorolac is only used in the nose. Do not get any of it in your eyes. If it does get in the eyes, rinse them with water right away and call your doctor.

Drink extra fluids while you are using ketorolac. This will keep your kidneys working well and help prevent kidney problems.

To use:

• If you are using the nasal spray for the first time, you will need to prime the spray. To do this, pump the bottle five times until some of the medicine sprays out. Now it is ready to use.


• Gently blow your nose to clear the nostrils.


• Sit or stand up straight and tilt your head slightly forward.


• Insert the tip of the bottle into your right nostril. Point the bottle away from the center of your nose.


• Spray once into your right nostril. If your dose is 2 sprays, spray once into your left nostril the same way.


• After using the spray, wipe the tip of the bottle with a clean tissue and put the clear plastic cover back on.


• Do not use the bottle for more than 24 hours after your first dose. Throw the bottle away after 24 hours even if it still has liquid in it.

Dosing

The dose of ketorolac 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 ketorolac. 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 nasal dosage form (spray):
  
  • For pain:
    
    • Adults weighing 50 kilograms (kg) or more—31.5 milligrams (mg) or 1 spray in each nostril every 6 to 8 hours. Your doctor may adjust your dose if needed. However, the dose is usually not more than 126 mg (a total of 8 sprays) per day.
    
    
    • Older adults and adults weighing less than 50 kg—15.75 mg or 1 spray in only one nostril every 6 to 8 hours. However, the dose is usually not more than 63 mg (a total of 4 sprays) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of ketorolac, 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

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.

Keep the unopened bottle in the refrigerator. Protect it from light and freezing. Once opened, store the bottle at room temperature, away from heat and direct sunlight. Throw away any unused medicine 24 hours after you opened the bottle and used your first dose.

Precautions While Using ketorolac

It is very important that your doctor check your progress while you are using ketorolac. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Do not use any other form of ketorolac (such as injection or tablets) or other NSAIDs unless your doctor says it is okay. Some examples of NSAIDs are aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, or Voltaren®. Also, you should not use ketorolac together with pentoxifylline (Trental®) or probenecid (Benemid®).

Ketorolac may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). Stop using ketorolac and call your doctor right away if you have bloody or black, tarry stools; severe stomach pain or heartburn; or vomiting of blood or material that looks like coffee grounds.

ketorolac may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using ketorolac.

Ketorolac may increase your risk of having a heart attack. This is more likely in people who already have heart disease. Stop using ketorolac and call your doctor right away if you have chest pain or discomfort; an irregular or fast heart beat; severe indigestion or heartburn; nausea; sweating; or troubled breathing with exertion.

Serious skin reactions can occur during treatment with ketorolac. Stop using ketorolac and check with your doctor right away if you have any of the following symptoms while you are using ketorolac: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

ketorolac Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain, cramping, or burning


• bloody or black, tarry stools


• blurred vision


• constipation


• diarrhea


• dizziness


• fast, irregular, pounding, or racing heartbeat or pulse


• headache


• heartburn


• indigestion


• nausea


• nervousness


• pale skin


• pounding in the ears


• severe stomach pain


• sweating


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds

Less common

• Burning feeling in the chest or stomach


• chest pain or discomfort


• decrease in amount or frequency of urine


• difficult or labored breathing


• frequent urge to urinate


• frequent urination


• increased amount of pale, dilute urine


• lightheadedness, dizziness, or fainting


• rapid, shallow breathing


• shortness of breath


• troubled breathing with exertion

Rare

• Bleeding gums


• bloody or cloudy urine


• blue lips and fingernails


• chills


• clay-colored stools


• confusion


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• dark urine


• difficult, burning, or painful urination


• difficulty with swallowing


• dilated neck veins


• extreme fatigue


• general tiredness and weakness


• increased blood pressure


• increased sweating


• increased thirst


• itching or hives


• light-colored stools


• lower back or side pain


• nosebleeds


• pain or burning in the throat


• pinpoint red spots on the skin


• rash


• rectal bleeding


• sores, ulcers, or white spots on the lips or tongue or inside the mouth


• stomach upset


• swelling of the face, fingers, feet, or lower legs


• swollen glands


• tenderness in the stomach area


• tightness in the chest


• unpleasant breath odor


• upper right abdominal pain


• vomiting


• weight gain or loss


• wheezing


• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin


• bloating


• change in consciousness


• convulsions


• difficulty with moving


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


• feeling of warmth


• feeling that others are watching you or controlling your behavior


• feeling, seeing, or hearing things that are not there


• fever with or without chills


• general body swelling


• joint or muscle pain


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


• loss of consciousness


• muscle aching or cramping


• muscle pains or stiffness


• pain or discomfort in the arms, jaw, back, or neck


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale or blue lips, fingernails, or skin


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


• red skin lesions, often with a purple center


• red, irritated eyes


• redness of the face, neck, arms, and occasionally, upper chest


• redness, soreness, or itching skin


• severe mood or mental changes


• sneezing


• sores, welting, or blisters


• swollen joints


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• weakness or heaviness of the legs

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:

More common

• Acid or sour stomach


• belching


• continuing ringing or buzzing or other unexplained noise in the ears


• drowsiness


• excess air or gas in the stomach or intestines


• full feeling


• hearing loss


• nasal discomfort


• passing gas


• swelling or inflammation of the mouth

Less common

• Runny nose


• stuffy nose


• watering of the eyes

Rare

• Abnormal dreams


• abnormal taste


• appetite changes


• bloody nose


• bruising


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• decreased awareness or responsiveness


• delusions


• dementia


• difficulty with speaking


• drooling


• excessive thirst


• false or unusual sense of well-being


• feeling of constant movement of self or surroundings


• feeling sad or empty


• general feeling of discomfort or illness


• inability to concentrate


• increase in body movements


• irritability


• lack or loss of strength


• large, flat, blue, or purplish patches in the skin


• loss of balance control


• loss of interest or pleasure


• muscle trembling, jerking, or stiffness


• redness, swelling, or soreness of the tongue


• restlessness


• seeing, hearing, or feeling things that are not there


• sensation of spinning


• shakiness in the legs, arms, hands, or feet


• shuffling walk


• sleepiness or unusual drowsiness


• sleeplessness


• tiredness


• trouble concentrating


• trouble sleeping


• uncontrolled movements, especially of the face, neck, and back


• weight loss

Incidence not known

• Burning, dry, or itching eyes


• eye discharge or excessive tearing


• flushed, dry skin


• fruit-like breath odor


• increased hunger


• increased urination


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• stiff neck or back


• unexplained weight loss

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.

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

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

More ketorolac Nasal resources

• Ketorolac Nasal Use in Pregnancy & Breastfeeding
• Drug Images
• Ketorolac Nasal Drug Interactions
• Ketorolac Nasal Support Group
• 74 Reviews for Ketorolac Nasal - Add your own review/rating

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Fucidin Cream

Fucidin Cream

fusidic acid

Please read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects become serious, or you notice any side effects not listed in this
  leaflet please tell your doctor or pharmacist.

In this leaflet:

• 1. What Fucidin Cream is and what it is used for


• 2. Before you use Fucidin Cream


• 3. How to use Fucidin Cream


• 4. Possible side effects


• 5. How to store Fucidin Cream


• 6. Further information

What Fucidin Cream Is And What It Is Used For

Fucidin Cream contains fusidic acid. It is a type of antibiotic.

Fucidin Cream works by killing germs (bacteria) that cause infections.

Fucidin Cream is used to treat conditions where the skin is infected by germs (bacteria), such as:

• Impetigo (a weeping, crusty and swollen patch of skin)


• Infected dermatitis (inflammation of the skin) and spots


• Infected cuts and grazes.

Before You Use Fucidin Cream

Do not use Fucidin Cream

• If you are allergic (hypersensitive) to fusidic acid.


• If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.

Take special care with Fucidin Cream

• Take special care if you are going to use this medicine near your eyes or the eyes of a child.


• If you use the cream over a long time or in large amounts it may make the chance of getting any side effects higher. Also your skin may get more sensitive to this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before using Fucidin Cream:

• If you are pregnant, or think you are pregnant. You must not use your medicine for a long time or in large amounts. You must ask your doctor for advice.


• If you are breast-feeding.

Tell your doctor if you become pregnant while using this medicine.

Driving and using machines

Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Fucidin Cream

Fucidin Cream contains:

• Butylhydroxyanisole (E320). This may give you an itchy rash and inflammation on your skin where your medicine is used. This may also cause irritation to the eyes and mucous membranes (such as lips or genital area).


• Cetyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.


• Potassium sorbate. This may give you an itchy rash and inflammation on your skin where your medicine is used.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

How To Use Fucidin Cream

Always use Fucidin Cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to put on Fucidin Cream

This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body.

Remove the cap. Check the seal is not broken before you first use the cream. Then push the spike in the cap through the seal on the tube.

Always wash your hands before using Fucidin Cream. Rub the medicine gently on the skin. If you use it on your face be careful to avoid your eyes.

Unless you are using the cream to treat your hands, always wash your hands after using Fucidin Cream.

If you accidentally get any medicine in your eye, wash it out with cold water straight away. Then bathe your eye with eyewash if possible. Your eye may sting. If you start to have any problems with your sight or your eye is sore, contact your doctor immediately.

How much Fucidin Cream to use

Your doctor will tell you how much Fucidin Cream to use.

Usually, you should use this medicine three or four times each day.

If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.

If you forget to use Fucidin Cream

If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual time.

If you have any further questions about using this medicine, please ask your doctor or pharmacist.

Fucidin Cream Side Effects

Like all medicines, Fucidin Cream can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

• You have difficulty breathing


• Your face or throat swell


• Your skin develops a severe rash.

Other possible side effects:

Skin problems

• Rash


• Stinging and irritation


• Itchy rash and skin inflammation in the area where the medicine is used.

If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How To Store Fucidin Cream

• Keep out of the reach and the sight of children.


• Do not use Fucidin Cream after the expiry date on the carton. The expiry date is the last day of that month.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need any more. If you do this you will help protect the environment.

Further Information

What Fucidin Cream contains

• The active ingredient is fusidic acid 2%.


• The other ingredients are butylhydroxyanisole (E320), cetyl alcohol, glycerol, liquid paraffin, polysorbate 60, potassium sorbate, purified water and white soft paraffin.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

What Fucidin Cream looks like and contents of the pack

Fucidin Cream is a white to off-white cream.

Fucidin Cream comes in tubes of 15 g and 30 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited

Princes Risborough

Bucks.

HP27 9RR

UK

Manufacturer:

LEO Laboratories Limited

Dublin 12

Ireland

This leaflet was last revised in March 2008.

Registered Trade Mark

LEO

014158-01

Toposar

etoposide

Dosage Form: injection
Toposar™ (Etoposide Injection, USP)

Rx only

Toposar (etoposide injection, USP) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Severe myelosuppression with resulting infection or bleeding may occur.

Toposar Description

Toposar (etoposide injection, USP) (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-0-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents. It has a molecular weight of 588.58 and a molecular formula of C29H32O13.

Toposar is available for intravenous use as a sterile 20 mg/mL solution in 100 mg (5 mL), 500 mg (25 mL), or 1 g (50 mL) sterile multiple dose vials. The pH of the clear, yellow liquid is 3.0 to 4.0.

Each mL contains: 20 mg etoposide, 2 mg citric acid anhydrous, 80 mg polysorbate 80, 650 mg polyethylene glycol 300, dehydrated alcohol 33.2% (v/v).

The structural formula is:

Toposar - Clinical Pharmacology

Etoposide has been shown to cause metaphase arrest in chick fibroblasts. Its main effect, however, appears to be at the G2 portion of the cell cycle in mammalian cells. Two different dose-dependent responses are seen. At high concentrations (10 mcg/mL or more), lysis of cells entering mitosis is observed. At low concentrations (0.3 to 10 mcg/mL), cells are inhibited from entering prophase. It does not interfere with microtubular assembly. The predominant macromolecular effect of etoposide appears to be the induction of DNA strand breaks by an interaction with DNA topoisomerase II or the formation of free radicals.

Pharmacokinetics

On intravenous administration, the disposition of etoposide is best described as a biphasic process with a distribution half-life of about 1.5 hours and terminal elimination half-life ranging from 4 to 11 hours. Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over a range 100-600 mg/m2. Over the same dose range, the areas under the plasma concentration vs time curves (AUC) and the maximum plasma concentration (Cmax) values increase linearly with dose. Etoposide does not accumulate in the plasma following daily administration of 100 mg/m2 for 4 to 5 days.

The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m2. Etoposide enters the CSF poorly. Although it is detectable in CSF and intracerebral tumors, the concentrations are lower than in extracerebral tumors and in plasma. Etoposide concentrations are higher in normal lung than in lung metastases and are similar in primary tumors and normal tissues of the myometrium. In vitro, etoposide is highly protein bound (97%) to human plasma proteins. An inverse relationship between plasma albumin levels and etoposide renal clearance is found in children. In a study determining the effect of other therapeutic agents on the in vitro binding of carbon-14 labeled etoposide to human serum proteins, only phenylbutazone, sodium salicylate, and aspirin displaced protein-bound etoposide at concentrations achieved in vivo.

Etoposide binding ratio correlates directly with serum albumin in patients with cancer and in normal volunteers. The unbound fraction of etoposide significantly correlated with bilirubin in a population of cancer patients. Data have suggested a significant inverse correlation between serum albumin concentration and free fraction of etoposide. (See PRECAUTIONS section.)

After intravenous administration of 14C-etoposide (100-124 mg/m2), mean recovery of radioactivity in the urine was 56% of the dose at 120 hours, 45% of which was excreted as etoposide; fecal recovery of radioactivity was 44% of the dose at 120 hours.

In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours. The mean renal clearance of etoposide is 7 to 10 mL/min/m2 or about 35% of the total body clearance over a dose range of 80 to 600 mg/m2. Etoposide, therefore, is cleared by both renal and nonrenal processes, i.e., metabolism and biliary excretion. The effect of renal disease on plasma etoposide clearance is not known.

Biliary excretion of unchanged drug and/or metabolites is an important route of etoposide elimination as fecal recovery of radioactivity is 44% of the intravenous dose. The hydroxy acid metabolite [4'-demethylepipodophyllic acid-9-(4,6-O-(R)-ethylidene-β-D-glucopyranoside)], formed by opening of the lactone ring, is found in the urine of adults and children. It is also present in human plasma, presumably as the trans isomer. Glucuronide and/or sulfate conjugates of etoposide are also excreted in human urine. Only 8% or less of an intravenous dose is excreted in the urine as radiolabeled metabolites of 14C-etoposide. In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol.

After either intravenous infusion or oral capsule administration, the Cmax and AUC values exhibit marked intra- and inter-subject variability.

In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration, and nonrenal clearance. Patients with impaired renal function receiving etoposide have exhibited reduced total body clearance, increased AUC and a lower volume of distribution at steady state. (See PRECAUTIONS section.) Use of cisplatin therapy is associated with reduced total body clearance. In children, elevated serum SGPT levels are associated with reduced drug total body clearance. Prior use of cisplatin may also result in a decrease of etoposide total body clearance in children.

Although some minor differences in pharmacokinetic parameters between age and gender have been observed, these differences were not considered clinically significant.

Indications and Usage for Toposar

Toposar is indicated in the management of the following neoplasms:

Refractory Testicular Tumors

Toposar in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.

Small Cell Lung Cancer

Etoposide injection and/or capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

Contraindications

Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to etoposide or any component of the formulation.

Warnings

Patients being treated with Toposar must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported. Dose-limiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of Toposar: platelet count, hemoglobin, white blood cell count, and differential. The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil count below 500/mm3 is an indication to withhold further therapy until the blood counts have sufficiently recovered.

Physicians should be aware of the possible occurrence of an anaphylactic reaction manifested by chills, fever, tachycardia, bronchospasm, dyspnea, and hypotension. Higher rates of anaphylactic-like reactions have been reported in children who received infusions at concentrations higher than those recommended. The role that concentration of infusion (or rate of infusion) plays in the development of anaphylactic-like reactions is uncertain. (See ADVERSE REACTIONS section.) Treatment is symptomatic. The infusion should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician.

For parenteral administration, Toposar should be given only by slow intravenous infusion (usually over a 30- to 60-minute period) since hypotension has been reported as a possible side effect of rapid intravenous injection.

Pregnancy

Etoposide can cause fetal harm when administered to a pregnant woman. Etoposide has been shown to be teratogenic in mice and rats.

In rats, an intravenous etoposide dose of 0.4 mg/kg/day (about 1/20th of the human dose on a mg/m2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele, and anophthalmia); higher doses of 1.2 and 3.6 mg/kg/day (about 1/7th and 1/2 of human dose on a mg/m2 basis) resulted in 90 and 100% embryonic resorptions. In mice, a single 1.0 mg/kg (1/16th of human dose on a mg/m2 basis) dose of etoposide administered intraperitoneally on days 6, 7, or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An I.P. dose of 1.5 mg/kg (about 1/10th of human dose on a mg/m2 basis) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight.

Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus.

Etoposide should be considered a potential carcinogen in humans. The occurrence of acute leukemia with or without a preleukemic phase has been reported in rare instances in patients treated with etoposide alone or in association with other neoplastic agents. The risk of development of a preleukemic or leukemic syndrome is unclear. Carcinogenicity tests with etoposide have not been conducted in laboratory animals.

Precautions

General

In all instances where the use of etoposide is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions. Most such adverse reactions are reversible if detected early. If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician. Reinstitution of Toposar therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity.

Patients with low serum albumin may be at an increased risk for etoposide associated toxicities.

Drug Interactions

High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral etoposide has led to an 80% increase in etoposide exposure with a 38% decrease in total body clearance of etoposide compared to etoposide alone.

Laboratory Tests

Periodic complete blood counts should be done during the course of etoposide treatment. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. At least one determination should be done prior to each dose of etoposide.

Renal Impairment

In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance:

Measured Creatinine Clearance	>50 mL/min	15-50 mL/min
etoposide	100% of dose	75% of dose

Subsequent etoposide dosing should be based on patient tolerance and clinical effect.

Data are not available in patients with creatinine clearances <15 mL/min and further dose reduction should be considered in these patients.

Carcinogenesis, Mutagenesis, Impairment of Fertility

(see WARNINGS section)

Etoposide has been shown to be mutagenic in Ames assay.

Treatment of Swiss-Albino mice with 1.5 mg/kg I.P. of etoposide on day 7 of gestation increased the incidence of intrauterine death and fetal malformations as well as significantly decreased the average fetal body weight. Maternal weight gain was not affected.

Irreversible testicular atrophy was present in rats treated with etoposide intravenously for 30 days at 0.5 mg/kg/day (about 1/16th of the human dose on a mg/m2 basis).

Pregnancy

Teratogenic Effects

Pregnancy "Category D."

(See WARNINGS section.)

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from etoposide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Toposar contains polysorbate 80. In premature infants, a life-threatening syndrome consisting of liver and renal failure, pulmonary deterioration, thrombocytopenia, and ascites has been associated with an injectable vitamin E product containing polysorbate 80. Anaphylactic reactions have been reported in pediatric patients. (See WARNINGS section.)

Geriatric Use

Clinical studies of etoposide for the treatment of refractory testicular tumors did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Of more than 600 patients in four clinical studies in the NDA databases who received etoposide or etoposide phosphate in combination with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC), about one third were older than 65 years. When advanced age was determined to be a prognostic factor for response or survival in these studies, comparisons between treatment groups were performed for the elderly subset. In the one study (etoposide in combination with cyclophosphamide and vincristine compared with cyclophosphamide and vincristine or cyclophosphamide, vincristine, and doxorubicin) where age was a significant prognostic factor for survival, a survival benefit for elderly patients was observed for the etoposide regimen compared with the control regimens. No differences in myelosuppression were seen between elderly and younger patients in these studies except for an increased frequency of WHO Grade III or IV leukopenia among elderly patients in a study of etoposide phosphate or etoposide in combination with cisplatin. Elderly patients in this study also had more anorexia, mucositis, dehydration, somnolence, and elevated BUN levels than younger patients.

In five single-agent studies of etoposide phosphate in patients with a variety of tumor types, 34% of patients were age 65 years or more. WHO Grade III or IV leukopenia, granulocytopenia, and asthenia were more frequent among elderly patients.

Postmarketing experience also suggests that elderly patients may be more sensitive to some of the known adverse effects of etoposide, including myelosuppression, gastrointestinal effects, infectious complications, and alopecia.

Although some minor differences in pharmacokinetic parameters between elderly and nonelderly patients have been observed, these differences were not considered clinically significant.

Etoposide and its metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see PRECAUTIONS: Renal Impairment for recommended dosing adjustments in patients with renal impairment).

Adverse Reactions

The following data on adverse reactions are based on both oral and intravenous administration of etoposide as a single agent, using several different dose schedules for treatment of a wide variety of malignancies.

Hematologic Toxicity

Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported.

The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with etoposide in association with other antineoplastic agents. (See WARNINGS section.)

Gastrointestinal Toxicity

Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion.

Hypotension

Transient hypotension following rapid intravenous administration has been reported in 1% to 2% of patients. It has not been associated with cardiac toxicity or electrocardiographic changes. No delayed hypotension has been noted. To prevent this rare occurrence, it is recommended that etoposide injection be administered by slow intravenous infusion over a 30- to 60-minute period. If hypotension occurs, it usually responds to cessation of the infusion and administration of fluids or other supportive therapy as appropriate. When restarting the infusion, a slower administration rate should be used.

Allergic Reactions

Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea, and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous etoposide and in less than 1% of the patients treated with the oral capsules. These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Blood pressure usually normalizes within a few hours after cessation of the infusion. Anaphylactic-like reactions have occurred during the initial infusion of etoposide.

Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain, and/or loss of consciousness have sometimes occurred in association with the above reactions. In addition, an apparent hypersensitivity-associated apnea has been reported rarely.

Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported.

Alopecia

Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients.

Other Toxicities

The following adverse reactions have been infrequently reported: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis.

Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with etoposide. Metabolic acidosis has also been reported in patients receiving higher doses.

Reports of extravasation with swelling have been received postmarketing. Rarely extravasation has been associated with necrosis and venous induration.

The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2,081 patients when etoposide was used either orally or by injection as a single agent.

ADVERSE DRUG EFFECT	PERCENT RANGE OF REPORTED INCIDENCE
Hematologic toxicity
Leukopenia (less than 1,000 WBC/mm3)	3-17
Leukopenia (less than 4,000 WBC/mm3)	60-91
Thrombocytopenia (less than 50,000 platelets/mm3)	1-20
Thrombocytopenia (less than 100,000 platelets/mm3)	22-41
Anemia	0-33
Gastrointestinal toxicity
Nausea and vomiting	31-43
Abdominal pain	0-2
Anorexia	10-13
Diarrhea	1-13
Stomatitis	1-6
Hepatic	0-3
Alopecia	8-66
Peripheral neurotoxicity	1-2
Hypotension	1-2
Allergic reaction	1-2

Overdosage

No proven antidotes have been established for etoposide overdosage.

Toposar Dosage and Administration

Note: Plastic devices made of acrylic or ABS (a polymer composed of acrylonitrile, butadiene, and styrene) have been reported to crack and leak when used withundiluted etoposide injection.

Toposar

The usual dose of Toposar in testicular cancer in combination with other approved chemotherapeutic agents ranges from 50 to 100 mg/m2/day on days 1 through 5 to 100 mg/m2/day on days 1, 3, and 5.

In small cell lung cancer, the Toposar dose in combination with other approved chemotherapeutic drugs ranges from 35 mg/m2/day for 4 days to 50 mg/m2/day for 5 days.

For recommended dosing adjustments in patients with renal impairment see PRECAUTIONS section.

Chemotherapy courses are repeated at 3- to 4-week intervals after adequate recovery from any toxicity.

The dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve.

Administration Precautions

As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of Toposar. Skin reactions associated with accidental exposure to etoposide may occur. The use of gloves is recommended. If Toposar solution contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water and flush the mucosa with water.

Preparation for Intravenous Administration

Toposar must be diluted prior to use with either 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, to give a final concentration of 0.2 to 0.4 mg/mL. If solutions are prepared at concentrations above 0.4 mg/mL, precipitation may occur. Hypotension following rapid intravenous administration has been reported, hence, it is recommended that the Toposar solution be administered over a 30- to 60-minute period. A longer duration of administration may be used if the volume of fluid to be infused is a concern. Toposar should not be given by rapid intravenous injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration (see DESCRIPTION section) prior to administration whenever solution and container permit.

Stability

Unopened vials of Toposar are stable until the date indicated on the package at room temperature (25°C). Vials diluted as recommended to a concentration of 0.2 to 0.4 mg/mL are stable for 96 and 24 hours, respectively, at room temperature (25°C) under normal room fluorescent light in both glass and plastic containers.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

How is Toposar Supplied

Toposar (etoposide injection, USP) 20 mg/mL is supplied as follows:

NDC Number	Contents	Size
0703-5653-01	100 mg	5 mL Multiple Dose Vials
0703-5656-01	500 mg	25 mL Multiple Dose Vials
0703-5657-01	1 gram	50 mL Multiple Dose Vials

All are available individually packaged.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

DO NOT FREEZE.

REFERENCES

1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.


2. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC: Division of Safety, National Institutes of Health; 1983. US Dept of Health and Human Services, Public Health Service publication NIH 83-2621.


3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1591.


4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.


5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia. 1983;1:426-428.


6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA-A Cancer J for Clin. 1983;33:258-263.


7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm. 1990;47:1033-1049.


8. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work-Practice Guidelines.). Am J Health-SystPharm. 1996;53:1669-1685.

Manufactured by:

Teva Parenteral Medicines, Inc.

Irvine, CA 92618

Rev. A 9/2011

PRINCIPAL DISPLAY PANEL

Toposar (etoposide injection, USP) 20 mg/mL (100 mg/5 mL) Vial Carton Text

NDC 0703-5653-01

Rx only

Toposar™

(etoposide

injection, USP)

20 mg/mL

(100 mg/5 mL)

Warning: Cytotoxic Agent

Must Be Diluted Before IV Infusion

5 mL Multiple Dose Vial

TEVA

PRINCIPAL DISPLAY PANEL

Toposar (etoposide injection, USP) 20 mg/mL (500 mg/25 mL) Vial Carton Text

NDC 0703-5656-01

Rx only

Toposar™

(etoposide

injection, USP)

20 mg/mL

(500 mg/25 mL)

Warning: Cytotoxic Agent

Must Be Diluted Before IV Infusion

25 mL Multiple Dose Vial

TEVA

PRINCIPAL DISPLAY PANEL

Toposar (etoposide injection, USP) 20 mg/mL (1 gram/ 50 mL)Vial Carton Text

NDC 0703-5657-01

Rx only

Toposar™

(etoposide

injection, USP)

20 mg/mL

(1 gram/50 mL)

Warning: Cytotoxic Agent

Must Be Diluted Before IV Infusion

50 mL Multiple Dose Vial

TEVA

Toposar  etoposide  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0703-5653 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETOPOSIDE (ETOPOSIDE) ETOPOSIDE 20 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID   POLYSORBATE 80   POLYETHYLENE GLYCOL 300   ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0703-5653-01 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE 1 5 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0703-5653-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074529	10/06/2011

Toposar  etoposide  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0703-5656 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETOPOSIDE (ETOPOSIDE) ETOPOSIDE 20 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID   POLYSORBATE 80   POLYETHYLENE GLYCOL 300   ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0703-5656-01 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE 1 25 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0703-5656-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074529	10/06/2011

Toposar  etoposide  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0703-5657 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETOPOSIDE (ETOPOSIDE) ETOPOSIDE 20 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID   POLYSORBATE 80   POLYETHYLENE GLYCOL 300   ALCOHOL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0703-5657-01 1 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE 1 50 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0703-5657-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074529	10/06/2011

Labeler - Teva Parenteral Medicines, Inc (794362533)

Revised: 10/2011Teva Parenteral Medicines, Inc

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Lotrimin AF Lotion

Pronunciation: kloe-TRIM-uh-zole
Generic Name: Clotrimazole
Brand Name: Lotrimin AF

Lotrimin AF Lotion is used for:

Treating athlete's foot, jock itch, and ringworm. It may also be used for other conditions as determined by your doctor.

Lotrimin AF Lotion is an antifungal agent. It kills sensitive fungi by binding to the fungal cell membrane and weakening it. This allows the cell contents to leak out and results in the death of the fungus.

Do NOT use Lotrimin AF Lotion if:

• you are allergic to any ingredient in Lotrimin AF Lotion

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

Before using Lotrimin AF Lotion:

Some medical conditions may interact with Lotrimin AF Lotion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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

Some MEDICINES MAY INTERACT with Lotrimin AF Lotion. Because little, if any, of Lotrimin AF Lotion is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Lotrimin AF Lotion 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 Lotrimin AF Lotion:

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

• Lotrimin AF Lotion is for topical use on the skin only.


• Clean the affected area with soap and water and dry thoroughly.


• Shake well before each use.


• Apply a thin layer of medicine to the affected area. Rub it in gently. Do not cover unless directed to by your doctor.


• Wash your hands immediately after using Lotrimin AF Lotion, unless your hands are part of the treated area.


• To clear up your infection completely, use Lotrimin AF Lotion for the full course of treatment. Keep using it even if you feel better in a few days. Do not miss any doses.


• If you miss a dose of Lotrimin AF Lotion, 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 Lotrimin AF Lotion.

Important safety information:

• Lotrimin AF Lotion is for external use only. If you get Lotrimin AF Lotion in your eyes, immediately flush them with cool tap water.


• Be sure to use Lotrimin AF Lotion for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


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

Possible side effects of Lotrimin AF Lotion:

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:

Mild stinging.

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); reddening, blistering, peeling, itching, or burning of the skin.

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: Lotrimin AF 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. Lotrimin AF Lotion may be harmful if swallowed.

Proper storage of Lotrimin AF Lotion:

Store Lotrimin AF Lotion at room temperature, 59 to 86 degrees F (15 to 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lotrimin AF Lotion out of the reach of children and away from pets.

General information:

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


• Lotrimin AF Lotion 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 Lotrimin AF Lotion. 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 Lotrimin AF resources

• Lotrimin AF Side Effects (in more detail)
• Lotrimin AF Use in Pregnancy & Breastfeeding
• Lotrimin AF Support Group
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