Infants' Motrin

Generic Name: ibuprofen (Oral route)

eye-bue-PROE-fen

Oral route(Tablet;Suspension;Capsule, Liquid Filled;Tablet, Chewable)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Addaprin


• Advil


• A-G Profen


• Bufen


• Genpril


• Haltran


• I-Prin


• Midol


• Motrin


• Nuprin


• Proprinal


• Q-Profen

In Canada

• Actiprofen


• Advil Children's


• Advil Pediatric


• Children's Motrin


• Children's Motrin Berry Flavor


• Children's Motrin Bubble Gum Flavor


• Children's Motrin Grape Flavor


• Equate Children's Ibuprofen - Berry - Dye Free


• Infants' Motrin


• Teddy's Choice Children's Ibuprofen - Berry


• Teddy's Choice Children's Ibuprofen - Bubble Gum


• Teddy's Choice Children's Ibuprofen - Grape

Available Dosage Forms:

• Suspension


• Tablet


• Capsule, Liquid Filled


• Tablet, Chewable


• Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Infants' Motrin

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor .

This medicine is available both over-the-counter (OTC) and with your doctor's prescription .

Before Using Infants' Motrin

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 ibuprofen in children below 6 months of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ibuprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ibuprofen .

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

• Ketorolac


• Pentoxifylline

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.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

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


• Acetohexamide


• Alacepril


• Alprenolol


• Amikacin


• Amiloride


• Arotinolol


• Aspirin


• 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


• Desipramine


• 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


• Phenytoin


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Tacrine


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Voriconazole


• 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Asthma or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• High blood pressure or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding or


• Stroke, history of—Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition .

• Diabetes—Use with caution. The suspension form of this medicine contains sugar .

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

Proper Use of ibuprofen

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

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine .

To lessen stomach upset, you may take this medicine with food or milk .

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 oral dosage form (tablets and suspension):
  
  • For fever:
    
    • Children over 2 years of age—Use and dose must be determined by your doctor.
    
    
    • Children 6 months of age up to 2 years—Dose is based on body weight and body temperature, and must be determined by your doctor. For fever lower than 102.5 °F (39.2 °C), the dose usually is 5 milligrams (mg) per kilogram (kg) (about 2.2 mg per pound) of body weight. For higher fever, the dose usually is 10 mg per kg (about 4.5 mg per pound) of body weight. The medicine may be given every six to eight hours, as needed, up to 40 mg per kg per day.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For menstrual cramps:
    
    • Adults—400 milligrams (mg) every four hours, as needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For mild to moderate pain:
    
    • Adults and teenagers—400 milligrams (mg) every four to six hours, as needed.
    
    
    • Children over 6 months of age—Dose is based on body weight and must be determined by your doctor. The dose usually is 10 milligrams (mg) per kilogram (kg) of body weight every six to eight hours, as needed, up to 40 mg per kg per day.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults and teenagers—1200 milligrams (mg) up to 3200 mg per day divided into three or four equal doses.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The dose usually is 30 milligrams (mg) to 40 mg per kilogram (kg) of body weight per day, divided into three or four doses.
    
    
    • Infants younger than 6 months of age—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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Infants' Motrin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems 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 old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

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

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Some people who have used this medicine had symptoms of meningitis. If you have fever, headache, nausea, vomiting, and stiff neck or back while using this medicine, check with your doctor right away .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) .

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .

Infants' Motrin 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 pain


• acid or sour stomach


• belching


• bloating


• cloudy urine


• decrease in amount of urine


• decrease in urine output or decrease in urine-concentrating ability


• diarrhea


• difficulty having a bowel movement (stool)


• excess air or gas in stomach or intestines


• full feeling


• heartburn


• indigestion


• itching skin


• pain or discomfort in chest, upper stomach, or throat


• pale skin


• passing gas


• nausea


• noisy, rattling breathing


• rash with flat lesions or small raised lesions on the skin


• shortness of breath


• swelling of face, fingers, hands, feet, lower legs, or ankles


• troubled breathing at rest


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Abdominal cramps


• stomach soreness or discomfort

Rare

• Agitation


• back, leg, or stomach pains


• bleeding gums


• blistering, peeling, loosening of skin


• blood in urine or stools


• bloody, black, or tarry stools


• blurred vision


• burning feeling in chest or stomach


• change in vision


• chest pain


• chills


• clay-colored stools


• coma


• confusion


• constipation


• cough or hoarseness


• dark urine


• decreased urine output


• depression


• difficulty breathing


• difficulty swallowing


• dilated neck veins


• dizziness


• dry mouth


• extreme fatigue


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


• fever with or without chills


• frequent urination


• general body swelling


• general feeling of tiredness or weakness


• hair loss, thinning of hair


• headache


• hives or welts


• hostility


• impaired vision


• increased blood pressure


• increased volume of pale, dilute urine


• irregular breathing


• irritability


• itching


• joint or muscle pain


• lab results that show problems with liver


• lethargy


• light-colored stools


• loss of appetite


• lower back or side pain


• muscle twitching


• nosebleeds


• painful or difficult urination


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


• pinpoint red spots on skin


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


• rash


• red skin lesions, often with a purple center


• red, irritated eyes


• redness of skin


• seizures


• severe abdominal pain, cramping, burning


• severe and continuing nausea


• sore throat


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


• stiff neck or back


• stomach upset


• stupor


• swollen or painful glands


• tenderness in stomach area


• thirst


• tightness in chest


• unpleasant breath odor


• upper right abdominal pain


• vomiting of blood


• vomiting of material that looks like coffee grounds


• wheezing


• yellow eyes and skin

Symptoms of overdose

• Bluish lips or skin


• difficulty sleeping


• disorientation


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


• drowsiness to profound coma


• hallucination


• lightheadedness or fainting


• mood or other mental changes


• muscle tremors


• not breathing


• rapid, deep breathing


• restlessness


• slow or irregular heartbeat


• stomach cramps


• sudden fainting


• sweating

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

• Continuing ringing or buzzing or other unexplained noise in ears


• hearing loss


• nervousness

Rare

• Crying


• depersonalization


• discouragement


• dry eyes


• dysphoria


• euphoria


• feeling sad or empty


• lack of appetite


• loss of interest or pleasure


• mental depression


• paranoia


• quick to react or overreact


• rapidly changing moods


• runny nose


• sleepiness or unusual drowsiness


• sleeplessness


• sneezing


• stuffy nose


• trouble concentrating


• trouble sleeping


• unable to sleep

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: Infants' Motrin side effects (in more detail)

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

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

More Infants' Motrin resources

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

Compare Infants' Motrin with other medications

• Fever
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Brolene Eye Ointment

Brolene 0.15% w/w Eye Ointment

dibropropamidine isetionate

Is this leaflet hard to see or read?

Phone 01483 505515 for help

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription.

However, you still need to use Brolene Eye Ointment carefully to get the best results from it.

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


• Ask your pharmacist if you need more information or advice


• You must contact a doctor if your symptoms worsen or do not improve after 2 days


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

In this leaflet:

• 1. What Brolene Eye Ointment is and what it is used for


• 2. Before you use Brolene Eye Ointment


• 3. How to use Brolene Eye Ointment


• 4. Possible side effects


• 5. How to store Brolene Eye Ointment


• 6. Further information

What Brolene Eye Ointment is and what it is used for

Brolene Eye Ointment contains a medicine called dibrompropamidine isetionate. This belongs to a group of medicines called disinfectants and antifungals. It works by stopping the growth of bacteria, allowing your body to fight off the infection.

It is used for minor infections of the eye or eyelid.

Signs include sore, red or inflamed eyes, stickiness or a crust on the eyelids.

Before you use Brolene Eye Ointment

Do not use this medicine and tell your doctor or pharmacist if:

• You are allergic (hypersensitive) to dibrompropamidine isetionate or any of the other ingredients of Brolene Eye Ointment (listed in Section 6 below)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid

Do not use this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist before using Brolene Eye Ointment.

Take special care with Brolene Eye Ointment

Check with your doctor or pharmacist before taking your medicine if:

• You wear contact lenses. You should not wear contact lenses while using the ointment.

If you are not sure, talk to your doctor or pharmacist before using Brolene Eye Ointment.

Pregnancy and breast-feeding

Talk to your doctor before using this medicine if you are pregnant, might become pregnant, or think you may be pregnant.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking or using any medicine.

Driving and using machines

You may have blurred eyesight straight after using this medicine. If this happens, do not drive or use any tools or machines until you can see clearly.

Important information about some of the ingredients of Brolene Eye Ointment

Brolene Eye Ointment contains lanolin. This may cause local skin reactions (e.g. contact dermatitis).

How to use Brolene Eye Ointment

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

How to use this medicine

• Wash your hands


• Remove the cap from the tube


• Tilt your head back


• Squeeze 1cm of the ointment inside the lower lid without touching your eye with the tube


• Close your eye


• Wipe away any excess ointment with a clean tissue


• Always put the cap back on the tube as soon as you have used it

How much to use

• Apply the ointment in the affected eye once or twice each day


• Use for at least 2 days


• If your symptoms worsen or do not improve after 2 days, talk to your doctor or pharmacist

If you forget to use Brolene Eye Ointment

If you forget a dose, use your Ointment as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Brolene Eye Ointment can cause side effects, although not everybody gets them.

Stop using Brolene Eye Ointment and see a doctor if:

• You get any kind of skin problem, such as a rash or itching around your eyes or they become more red

Talk to your doctor or pharmacist if you get any of the side effects or if you notice any side effects not listed in this leaflet.

How to store Brolene Eye Ointment

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Brolene Eye Ointment after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.

Store below 25ºC.

Brolene Eye Ointment is sterile when you buy it, so you must not keep it for more than four weeks after opening the container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Brolene Eye Ointment contains

• The ointment contains 0.15%w/w of the active substance, dibrompropamidine isetionate


• The other ingredients are soft yellow paraffin, liquid paraffin, anhydrous lanolin, phenylethanol and water for injections

What Brolene Eye Ointment looks like and contents of the pack

Brolene Eye Ointment is yellow to pale golden brown, smooth and almost translucent. It is supplied in 5g aluminium collapsible tubes fitted with a screw capped nozzle and a polythene cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Patheon UK Limited

Covingham

Swindon

Wiltshire

SN3 5BZ

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 08/2007

© Sanofi-aventis, 2007

BNE 90270

Ibuprofen Oral Suspension

Dosage Form: oral suspension
Ibuprofen Suspension

100 mg/5 mL

Rx Only

Cardiovascular Risk

• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).


• Ibuprofen suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

Ibuprofen Oral Suspension Description

The active ingredient in ibuprofen suspension is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74° to 77°C. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular weight of ibuprofen is 206.28. Its molecular formula is C13H1802 and it has the following structural formula:

Ibuprofen suspension is a sweetened, orange colored, berry flavored suspension containing 100 mg of ibuprofen in 5 mL (20 mg/mL). Inactive ingredients include: anhydrous citric acid, artificial berry flavor, butylparaben, , D&C red #33, FD&C yellow #6, glycerin, high fructose corn syrup, hypromellose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, xanthan gum.

Ibuprofen Oral Suspension - Clinical Pharmacology

Pharmacodynamics

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that possesses anti-inflammatory, analgesic and antipyretic activity. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. After absorption of the racemic ibuprofen, the [-]R-enantiomer undergoes interconversion to the [+]S-form. The biological activities of ibuprofen are associated with the [+]S-enantiomer.

Pharmacokinetics

Ibuprofen is a racemic mixture of [-]R-and [+]S-isomers. In vivo and in vitro studies indicate that the [+]S-isomer is responsible for clinical activity. The [-]R-form, while thought to be pharmacologically inactive, is slowly and incompletely (~60%) interconverted into the active [+]S species in adults. The degree of interconversion in children is unknown, but is thought to be similar. The [-]R-isomer serves as a circulating reservoir to maintain levels of active drug. Ibuprofen is well absorbed orally, with less than 1% being excreted in the urine unchanged. It has a biphasic elimination time curve with a plasma half-life of approximately 2 hours. Studies in febrile children have established the dose-proportionality of 5 and 10 mg/kg doses of ibuprofen. Studies in adults have established the dose-proportionality of ibuprofen as a single oral dose from 50 to 600 mg for total drug and up to 1200 mg for free drug.

Absorption

In vivo studies indicate that ibuprofen is well absorbed orally from the suspension formulation, with peak plasma levels usually occurring within 1 to 2 hours (see Table 1).

Table 1 Pharmacokinetic Parameters of Ibuprofen Suspension [Mean values (% coefficient of variation)]

Dose	200mg (2.8mg/kg) in Adults	10mg/kg in Febrile Children
Formulation	Suspension	Suspension
Legend: AUCinf = Area-under-the-curve to infinity Tmax = Time-to-peak plasma concentration Cmax = Peak plasma concentration CI/F = Clearance divided by fraction at drug absorbed
Number of Patients	24	18
AUCinf (µg•h/mL)	64 (27%)	155 (24%)
Cmax (µg/mL)	19 (22%)	55 (23%)
Tmax (h)	0.79 (69%)	0.97 (57%)
CI/F(mL/h/kg)	45.6 (22%)	68.6 (22%)

Antacids

A bioavailability study in adults has shown that there was no interference with the absorption of ibuprofen when given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide.

H-2 Antagonists

In studies with human volunteers, coadministration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

Food Effects

Absorption is most rapid when ibuprofen is given under fasting conditions. Administration of ibuprofen suspension with food affects the rate but not the extent of absorption. When taken with food, Tmax is delayed by approximately 30 to 60 minutes, and peak levels are reduced by approximately 30 to 50%.

Distribution

Ibuprofen, like most drugs of its class, is highly protein bound (>99% bound at 20 µg/mL). Protein binding is saturable and at concentrations >20 µg/mL binding is non-linear. Based on oral dosing data there is an age- or fever-related change in volume of distribution for ibuprofen. Febrile children <11 years old have a volume of approximately 0.2 L/kg while adults have a volume of approximately 0.12 L/kg. The clinical significance of these findings is unknown.

Metabolism

Following oral administration, the majority of the dose was recovered in the urine within 24 hours as the hydroxy-(25%) and carboxypropyl-(37%) phenylpropionic acid metabolites. The percentages of free and conjugated ibuprofen found in the urine were approximately 1% and 14%, respectively. The remainder of the drug was found in the stool as both metabolites and unabsorbed drug.

Elimination

Ibuprofen is rapidly metabolized and eliminated in the urine. The excretion of ibuprofen is virtually complete 24 hours after the last dose. It has a biphasic plasma elimination time curve with a half-life of approximately 2.0 hours. There is no difference in the observed terminal elimination rate or half-life between children and adults, however, there is an age-or fever-related change in total clearance. This suggests that the observed change in clearance is due to changes in the volume of distribution of ibuprofen (see Table 1 for CI/F values).

Clinical Studies

Controlled clinical trials comparing doses of 5 and 10 mg/kg ibuprofen suspension and 10-15 mg/kg of acetaminophen elixir have been conducted in children 6 months to 12 years of age with fever primarily due to viral illnesses. In these studies there were no differences between treatments in fever reduction for the first hour and maximum fever reduction occurred between 2 and 4 hours. Response after 1 hour was dependent on both the level of temperature elevation as well as the treatment. In children with baseline temperatures at or below 102.5°F both ibuprofen doses and acetaminophen were equally effective in their maximum effect. In children with temperatures above 102.5°F, the ibuprofen 10 mg/kg dose was more effective. By 6 hours, children treated with ibuprofen 5mg/kg tended to have recurrence of fever, whereas children treated with ibuprofen 10 mg/kg still had significant fever reduction at 8 hours. In control groups treated with 10 mg/kg acetaminophen, fever reduction resembled that seen in children treated with 5 mg/kg of ibuprofen, with the exception that temperature elevation tended to return 1-2 hours earlier.

In patients with primary dysmenorrhea, ibuprofen has been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce testing and active intrauterine pressure, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia.

Indications and Usage for Ibuprofen Oral Suspension

Carefully consider the potential benefits and risks of ibuprofen suspension and other treatment options before deciding to use ibuprofen suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

In Pediatric Patients, ibuprofen suspension is indicated:

• For reduction of fever in patients aged 6 months up to 2 years of age.


• For relief of mild to moderate pain in patients aged 6 months up to 2 years of age.


• For relief of signs and symptoms of juvenile arthritis.

In Adults, ibuprofen is indicated:

• For treatment of primary dysmenorrhea.


• For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended. (See PRECAUTIONS - Drug Interactions).

Contraindications

Ibuprofen suspension is contraindicated in patients with known hypersensitivity to ibuprofen.

Ibuprofen suspension should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDS have been reported in such patients (see WARNINGS - Anaphylactoid Reactions and PRECAUTIONS - Preexisting Asthma).

Ibuprofen suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Warnings

CARDIOVASCULAR EFFECTS

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms.

Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).

Hypertension

NSAIDs, including ibuprofen suspension, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen suspension, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Ibuprofen suspension should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including ibuprofen suspension, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of ibuprofen suspension in patients with advanced renal disease. Therefore, treatment with ibuprofen suspension is not recommended in these patients with advanced renal disease. If ibuprofen suspension therapy must be initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to ibuprofen suspension. Ibuprofen suspension should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS – Preexisting Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

NSAIDs, including ibuprofen suspension, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, as with other NSAIDs, ibuprofen should be avoided because it may cause premature closure of the ductus arteriosus.

Precautions

General

Ibuprofen suspension cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of ibuprofen suspension in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Hepatic Effects

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including ibuprofen suspension. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.

A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ibuprofen suspension. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen suspension should be discontinued.

Hematological Effects

Anemia is sometimes seen in patients receiving NSAIDs, including ibuprofen suspension. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including ibuprofen suspension, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

In two postmarketing clinical studies the incidence of a decreased hemoglobin level was greater than previously reported. Decrease in hemoglobin of 1 gram or more was observed in 17.1% of 193 patients on 1600 mg ibuprofen daily (osteoarthritis), and in 22.8% of 189 patients taking 2400 mg of ibuprofen daily (rheumatoid arthritis). Positive stool occult blood tests and elevated serum creatinine levels were also observed in these studies.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving ibuprofen suspension who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Preexisting Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, ibuprofen suspension should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Aseptic Meningitis

Aseptic meningitis, with fever and coma, has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease.

Diabetics

Ibuprofen suspension contains 270 mg high fructose corn syrup and 2.43 calories per mL, or 1350 mg high fructose corn syrup and 12.15 calories per teaspoonful, which should be taken into consideration when treating diabetic patients with this product.

Information for Patients

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

1. Ibuprofen suspension, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization, and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS - Cardiovascular Effects).


2. Ibuprofen suspension, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization or even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS - Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation).


3. Ibuprofen suspension, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash or contact their physicians as soon as possible.


4. Patients should promptly report signs and symptoms of unexplained weight gain or edema to their physicians.


5. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritis, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.


6. Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS).


7. In late pregnancy, as with other NSAIDs, ibuprofen suspension should be avoided because it may cause premature closure of the ductus arteriosus.

Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, ibuprofen suspension should be discontinued.

Drug Interactions

ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

Aspirin

As with other NSAIDs, concomitant administration of IBUPROFEN and aspirin is not generally recommended because of the potential of increased adverse effects.

Diuretics

Clinical studies, as well as post marketing observations, have shown that ibuprofen suspension can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS - Renal Effects), as well as to assure diuretic efficacy.

Lithium

Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.)

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Warfarin

Several short-term controlled studies failed to show that ibuprofen significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on warfarin-type anticoagulants. However, because bleeding has been reported when ibuprofen and other NSAIDs have been administered to patients on warfarin-type anticoagulants, the physician should be cautious when administering ibuprofen to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Ibuprofen should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.

Labor and Delivery

In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of ibuprofen suspension on labor and delivery in pregnant women are unknown. Therefore, administration of ibuprofen suspension is not recommended during labor and delivery.

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 ibuprofen suspension, 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 of ibuprofen suspension in pediatric patients below the age of 6 months have not been established (see CLINICAL PHARMACOLOGY - Clinical Studies). Dosing of ibuprofen suspension in children 6 months or older should be guided by their body weight (see DOSAGE AND ADMINISTRATION).

Geriatric Use

As with any NSAID, caution should be exercised in treating the elderly (65 years and older).

Adverse Reactions

In patients taking ibuprofen or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are: Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, fluid retention, gastrointestinal experiences (including abdominal pain, bloating, constipation, diarrhea, dyspepsia, epigastric pain, flatulence, heartburn, nausea, vomiting), headaches, increased bleeding time, nervousness, pruritus, rashes (including maculopapular) and tinnitus.

Additional adverse experiences reported occasionally include:

Body as a whole -	fever, infection, sepsis
Cardiovascular system -	congestive heart failure in patients with marginal cardiac function, hypertension, tachycardia, syncope
Digestive system -	dry mouth, duodenitits, esophagitis, gastric or duodenal ulcer with bleeding and/or perforation, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding
Hemic and lymphatic system -	ecchymosis, eosinophilia, leukopenia, purpura, stomatitis, thrombocytopenia
Metabolic and nutritional -	weight changes
Nervous system -	anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, paresthesia, somnolence, tremors, vertigo
Respiratory system -	asthma, dyspnea
Skin and appendages -	alopecia, photosensitivity, sweat
Special senses -	blurred vision
Urogenital system -	cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, acute renal failure in patients with pre-existing significantly impaired renal function

Other adverse reactions, which occur rarely are:

Body as a whole -	anaphylactic reactions, anaphylactoid reactions, appetite changes
Cardiovascular system -	arrhythmia, cerebrovascular accident, hypotension, myocardial infarction, palpitations, vasculitis
Digestive system -	eructation, gingival ulcer, hepatorenal syndrome, liver necrosis, liver failure, pancreatitis
Hemic and lymphatic system -	agranulocystosis, hemolytic anemia, aplastic anemia, lymphadenopathy, neutropenia, pancytopenia
Metabolic and nutritional -	hyperglycemia
Nervous system -	convulsions, coma, emotional lability, hallucinations, aseptic meningitis
Respiratory -	apnea, respiratory depression, pneumonia, rhinitis
Skin and appendages -	angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens Johnson syndrome, urticaria, vesiculobullous eruptions
Special senses -	amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision), conjunctivitis, dry eyes, hearing impairment
Urogenital -	azotemia, decreased creatinine clearance, glomerulitis, renal papillary necrosis, tubular necrosis

Overdosage

The toxicity of ibuprofen overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate each case individually. Although uncommon, serious toxicity and death have been reported in the medical literature with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other central nervous system symptoms include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure and apnea (primarily in very young children) may rarely occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation, also have been reported.

The treatment of acute ibuprofen overdose is primarily supportive. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary. In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or lavage. Emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption and reabsorption of ibuprofen.

In children, the estimated amount of ibuprofen ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated. Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Children ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of four hours. Children ingesting 200 to 400 mg/kg of ibuprofen should have immediate gastric emptying and at least four hours observation in a health care facility. Children ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Ipecac-induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk for convulsions and the potential for aspiration of gastric contents.

In adult patients the history of the dose reportedly ingested does not appear to be predictive of toxicity. The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be carefully evaluated, observed and supported.

Ibuprofen Oral Suspension Dosage and Administration

Carefully consider the potential benefits and risks of ibuprofen suspension and other treatment options before deciding to use ibuprofen suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with ibuprofen suspension, the dose and frequency should be adjusted to suit an individual patient's needs.

PEDIATRIC PATIENTS

Fever Reduction

For reduction of fever in children, 6 months up to 2 years of age, the dosage should be adjusted on the basis of the initial temperature level (see CLINICAL PHARMACOLOGY). The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5°F, or 10 mg/kg if the baseline temperature is 102.5°F or greater. The duration of fever reduction is generally 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg.

Analgesia

For relief of mild to moderate pain in children 6 months up to 2 years of age, the recommended dosage is 10 mg/kg, every 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. Doses should be given so as not to disturb the child's sleep pattern.

Juvenile Arthritis

The recommended dose is 30 to 40 mg/kg/day divided into three to four doses (see Individualization of Dosage). Patients with milder disease may be adequately treated with 20 mg/kg/day.

In patients with juvenile arthritis, doses above 50 mg/kg/day are not recommended because they have not been studied and doses exceeding the upper recommended dose of 40 mg/kg/day may increase the risk of causing serious adverse events. The therapeutic response may require from a few days to several weeks to be achieved. Once a clinical effect is obtained, the dosage should be lowered to the smallest dose of ibuprofen needed to maintain adequate control of symptoms.

Pediatric patients receiving doses above 30 mg/kg/day or if abnormal liver function tests have occurred with previous NSAID treatments should be carefully followed for signs and symptoms of early liver dysfunction.

ADULTS

Primary Dysmenorrhea

For the treatment of primary dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen suspension should be given in a dose of 400 mg every 4 hours, as necessary, for the relief of pain.

Rheumatoid Arthritis and Osteoarthritis

Suggested dosage: 1200-3200 mg daily (300 mg q.i.d. or 400 mg, 600 mg or 800 mg t.i.d. or q.i.d.). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.

Individualization of Dosage

The dose of ibuprofen suspension should be tailored to each patient, and may be lowered or raised from the suggested doses depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

One fever study showed that, after the initial dose of ibuprofen suspension, subsequent doses may be lowered and still provide adequate fever control.

In a situation when low fever would require the ibuprofen suspension 5 mg/kg dose in a child with pain, the dose that will effectively treat the predominant symptom should be chosen.

In chronic conditions, a therapeutic response to ibuprofen suspension therapy is sometimes seen in a few days to a week, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

Patients with rheumatoid arthritis seem to require higher doses than do patients with osteoarthritis. The smallest dose of ibuprofen suspension that yields acceptable control should be employed.

Ibuprofen suspension may be used in combination with gold salts and/or corticosteroids.

How is Ibuprofen Oral Suspension Supplied

Ibuprofen Suspension, 100 mg/5 mL is available as follows:

Orange-colored, berry-flavored suspension

Bottle of 120 mL (NDC 45802-952-26)

Bottle of 473 mL (NDC 45802-952-43)

Shake well before using. Store at 20-25°C (68-77°F)

[see USP Controlled Room Temperature].

MANUFACTURED AND DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Revised 09/08

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAlDs)

(See the end of this Medication Guide for a list of pres

Zinc Sulfate Injection

CONCENTRATED Zinc Sulfate Injection, USP

Rx Only

STERILE, NONPYROGENIC TRACE ELEMENT ADDITIVE FOR

INTRAVENOUS USE AFTER DILUTION

(Zinc 5 mg/mL)

DESCRIPTION

Concentrated Zinc Sulfate Injection, USP is a sterile, non-pyrogenic solution intended for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Zinc Sulfate (Anhydrous) 12.32 mg, Water for Injection q.s.  pH adjusted with Sulfuric Acid. It contains no preservatives. Discard unused portion. It delivers elemental zinc 5 mg per mL.

CLINICAL PHARMACOLOGY

Zinc has been identified as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and the senses of taste and smell.

Providing zinc during TPN prevents development of the following deficiency symptoms: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly. At plasma levels below 20 mcg zinc/100 mL, dermatitis followed by alopecia has been reported for TPN patients.

INDICATIONS AND USAGE

Concentrated Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain plasma levels and to prevent depletion of endogenous stores.

CONTRAINDICATIONS

Concentrated Zinc Sulfate Injection, USP should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential to increase renal loss of zinc from a bolus injection.

WARNINGS

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.  Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

Administration of zinc in the absence of copper may cause a decrease in serum copper levels. Periodic determination of serum copper as well as zinc are suggested as a guideline for subsequent zinc administration. Zinc is eliminated via the intestine and kidneys. The possibility of retention should be considered in patients with malfunctioning excretory routes.

ADVERSE REACTIONS

The amount of zinc present in Concentrated Zinc Sulfate Injection, USP is very small, symptoms of toxicity from zinc are considered unlikely to occur.

Pregnancy

Safety for use in pregnancy has not been established. Use of zinc in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

DOSAGE AND ADMINISTRATION

Concentrated Zinc Sulfate Injection, USP provides 5 mg zinc/mL. For metabolically stable adults receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/day is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost, or an additional 17.1 mg zinc/kg of stool or ileostomy output is recommended. Frequent monitoring of zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc.

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested.

Aseptic addition of Concentrated Zinc Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Zinc is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN.

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

OVERDOSAGE

Symptoms of zinc overdosage resulting from oral ingestion of zinc sulfate in large amounts (30 and 44 grams, respectively) have resulted in death. Symptoms included nausea, vomiting, dehydration, electrolyte imbalances, dizziness, abdominal pain, lethargy and incoordination. Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. Normal plasma levels for zinc vary from approximately 88 to 112 mcg/100 mL. Plasma levels sufficient to produce symptoms of toxic manifestations in humans are not known. Calcium supplements may confer a protective effect against zinc toxicity.

HOW SUPPLIED

Concentrated Zinc Sulfate Injection, USP, 5 mg zinc/mL

NDC 0517-8105-25     5 mL Vials     Packed in a box of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)

(See USP Controlled Room Temperature).

AMERICAN

REGENT, INC.

SHIRLEY, NY 11967

IN8105

Rev. 1/09

MG #14229

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISLAY PANEL – 5 mL Carton

CONCENTRATED ZINC SULFATE

INJECTION, USP

Zinc 25 mg/5 mL (5 mg/mL)

Trace Element Additive

NDC 0517-8105-25

25 x 5 mL SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION

PRESERVATIVE FREE

Rx Only

Each mL contains: Zinc Sulfate (Anhydrous) 12.32 mg, Water for Injection q.s.

pH adjusted with Sulfuric Acid, if necessary. Sterile, nonpyrogenic.

WARNING: DISCARD UNUSED PORTION.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP

Controlled Room Temperature).

Directions for Use: See Package Insert.

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Rev. 11/05

ZINC SULFATE  zinc sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0517-8105 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC SULFATE ANHYDROUS (ZINC) ZINC SULFATE ANHYDROUS 12.32 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength SULFURIC ACID   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0517-8105-25 25 VIAL In 1 TRAY contains a VIAL, SINGLE-DOSE 1 5 mL In 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-8105-25)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/30/1990

Labeler - American Regent, Inc. (622781813)

Revised: 09/2011American Regent, Inc.

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