Voltaren

Generic Name: diclofenac (Oral route)

dye-KLOE-fen-ak

Oral route(Tablet, Enteric Coated;Tablet, Extended Release)

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. Diclofenac is contraindicated for the treatment of peri-operative pain in the setting of 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 .

Oral route(Tablet;Capsule, Liquid Filled;Powder for Solution)

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. Diclofenac is contraindicated for the treatment of perioperative 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.

• Cambia


• Cataflam


• Voltaren


• Voltaren-XR


• Zipsor

Available Dosage Forms:

• Tablet, Enteric Coated


• Tablet, Extended Release


• Capsule


• Powder for Solution


• Capsule, Liquid Filled


• Tablet

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For Voltaren

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

This medicine is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine, and other painful conditions such as menstrual cramps.

Diclofenac is also used to treat acute migraine attacks, with or without aura, in adults. It will not prevent or lessen the number of migraine attacks.

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

Before Using Voltaren

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 diclofenac 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 diclofenac in the elderly. However, elderly patients are more likely to have age-related kidney or stomach problems, which may require caution for patients receiving diclofenac.

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 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


• 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


• Cholestyramine


• Cilazapril


• Ciprofloxacin


• Clopamide


• Colestipol


• 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


• 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


• Heart attack, history of or


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


• Hepatitis, history of or


• Hypertension (high blood pressure) or


• Kidney disease or


• Porphyria (blood disorder) or


• Stomach ulcers or bleeding, history of or


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

• Aspirin-sensitive asthma, history of—This medicine should not be used in patients with this condition.

• 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.

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

• Phenylketonuria (PKU)—The oral powder for solution contains phenylalanine, which can make this condition worse.

Proper Use of diclofenac

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

For the 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 your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.

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

When used for severe or continuing arthritis, this medicine must be taken every day 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 longer may pass before you begin to feel better. Several weeks may pass before you feel the full effects of this medicine.

You may take this medicine with or without food.

To use the oral solution:

• Open the packet of medicine right before you use it.


• Empty the contents of the packet into a cup with 1 to 2 ounces (30 to 60 milliliters [mL]) of water. Do not use any liquid other than water for mixing the medicine.


• Mix well and drink it immediately on an empty stomach.

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

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (delayed-release tablets, enteric-coated tablets):
  
  • For ankylosing spondylitis:
    
    • Adults—25 milligrams (mg) four times a day, with an extra 25 mg dose at bedtime if necessary.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For osteoarthritis:
    
    • Adults—50 milligrams (mg) two or three times a day, or 75 mg two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For rheumatoid arthritis:
    
    • Adults—50 milligrams (mg) three or four times a day, or 75 mg two times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (immediate-release tablets):
  
  • For osteoarthritis:
    
    • Adults—50 milligrams (mg) two or three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For pain or menstrual cramps:
    
    • Adults—50 milligrams (mg) three times a day. Your doctor may direct you to take 100 mg for the first dose only.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For rheumatoid arthritis:
    
    • Adults—50 milligrams (mg) three or four times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (solution):
  
  • For migraine headaches:
    
    • Adults—One packet (50 milligrams) as a single, one time dose.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Voltaren

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, are over 60 years of age, are in poor health, or are using certain medicines (such as a steroid medicine 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 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.

Some possible warning signs of serious side effects that can occur with this medicine may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, and/or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow skin or eyes; . Also, signs of serious heart problems could occur, such as chest pain, fast or irregular heartbeat, tightness in the chest, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor right away 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 more often in patients who are allergic to aspirin or nonsteroidal antiinflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and 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 color of the skin 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.

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

Call your doctor right away if you have confusion, drowsiness, fever, general feeling of illness, headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of meningitis.

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 awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.

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.

Voltaren 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 bloating, burning, cramping, or pain


• belching


• bloody or black, tarry stools


• cloudy urine


• constipation


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


• diarrhea


• dizziness


• feeling of indigestion


• headache


• increased bleeding time


• itching skin


• loss of appetite


• nausea and vomiting


• pain in the chest below the breastbone


• pale skin


• rash


• severe stomach pain


• swelling


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• weight loss

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

Symptoms of overdose

• Agitation


• blurred vision


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


• change in consciousness


• confusion


• depression


• difficult or troubled breathing


• hives


• hostility


• insomnia


• irregular, fast or slow, or shallow breathing


• irritability


• loss of consciousness


• muscle twitching


• nervousness


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


• pale or blue lips, fingernails, or skin


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


• rapid weight gain


• seizures


• shortness of breath


• sleepiness


• slow or fast heartbeat


• stupor


• swelling of the face, ankles, or hands


• tightness in the chest


• unusual drowsiness, dullness, or feeling of sluggishness


• wheezing

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

• Bloated, full feeling


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


• excess air or gas in stomach or intestines


• hearing loss


• lack or loss of strength


• passing gas

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: Voltaren side effects (in more detail)

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More Voltaren resources

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

• Voltaren Prescribing Information (FDA)


• Voltaren Consumer Overview


• Voltaren Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Diclofenac Professional Patient Advice (Wolters Kluwer)


• Diclofenac Prescribing Information (FDA)


• Diclofenac MedFacts Consumer Leaflet (Wolters Kluwer)


• Cambia Prescribing Information (FDA)


• Cambia Consumer Overview


• Cambia Powder Packets MedFacts Consumer Leaflet (Wolters Kluwer)


• Cataflam Prescribing Information (FDA)


• Cataflam Immediate-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Cataflam Consumer Overview


• Zipsor Consumer Overview


• Zipsor Prescribing Information (FDA)


• diclofenac epolamine Monograph (AHFS DI)

Compare Voltaren with other medications

• Ankylosing Spondylitis
• Aseptic Necrosis
• Back Pain
• Frozen Shoulder
• Muscle Pain
• Osteoarthritis
• Pain
• Period Pain
• Rheumatoid Arthritis
• Sciatica

Almotriptan

Pronunciation: AL-moe-TRIP-tan
Generic Name: Almotriptan
Brand Name: Axert

Almotriptan is used for:

Treating acute migraine headaches with or without aura (eg, dark spots, flashing lights, wavy lines). It may also be used for other conditions as determined by your doctor.

Almotriptan is a serotonin 5-HT₁ receptor agonist "triptan." It works by narrowing the blood vessels in the brain and thereby reducing pressure and pain in the brain. A migraine headache is thought to be caused by widened blood vessels exerting pressure on the brain.

Do NOT use Almotriptan if:

• you are allergic to any ingredient in Almotriptan


• you have a history of ischemic heart disease (eg, angina, heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease (eg, stroke, transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)


• you have uncontrolled high blood pressure or ischemic heart disease


• you have hemiplegic or basilar migraine headaches


• you have used certain other migraine medicines within the past 24 hours (eg, an ergot alkaloid [eg, ergotamine], another serotonin 5-HT₁ receptor agonist [eg, eletriptan, rizatriptan])


• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days


• you are taking sibutramine

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

Before using Almotriptan:

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

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


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


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


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• if you have history of liver or kidney problems, seizures (eg, epilepsy), other types of headaches (eg, cluster headaches), or heart problems, or if a family member has had heart disease


• if you have shortness of breath, chest pain, or a history of high blood pressure, heart attack, stroke, high cholesterol, diabetes, or smoking


• if you are a woman who is past menopause or you have had a hysterectomy


• if you are a man who is over 40 years old


• if you are very overweight

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

• Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), or sibutramine because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea


• Azole antifungals (eg, ketoconazole), ergot alkaloids (eg, ergotamine), HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin), MAOIs (eg, phenelzine), verapamil, or another serotonin 5-HT₁ receptor agonist [eg, eletriptan, rizatriptan]) because they may increase the risk of Almotriptan's side effects

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

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

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


• Take Almotriptan by mouth with or without food.


• Take Almotriptan with a full glass of water (8 oz/240 mL).


• Swallow Almotriptan whole. Do not break, crush, or chew before swallowing.


• It is best to take a dose of Almotriptan as soon as you notice symptoms of a migraine attack.


• If your headache returns, a second dose may be taken. Allow at least 2 hours between doses of Almotriptan.


• If your pain continues after the first dose, do not take a second dose without talking with your health care provider. Do not take more than 2 tablets in a 24-hour period.


• If you miss a dose of Almotriptan and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are not sure what to do if you miss a dose. Do not take Almotriptan more often than prescribed. Do not take 2 doses at once.

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

Important safety information:

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


• If Almotriptan does not stop or decrease the severity of your migraine attack or if your symptoms become worse, check with your doctor.


• Almotriptan is intended to relieve acute migraine headaches. Do not use it to prevent or reduce the number of attacks you experience. Use Almotriptan only to treat an actual migraine attack. If you have a headache that is different from your usual migraine attacks, check with your doctor before using Almotriptan.


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


• Rarely, serious heart problems (eg, heart attack, irregular heartbeat) have been reported within a few hours of using Almotriptan. Contact your doctor at once if fast or irregular heartbeat; chest, jaw, or neck pain or numbness; numbness of an arm or leg; severe stomach pain, dizziness, or vomiting; fainting; or vision changes occur. Discuss any questions or concerns with your doctor.


• Serotonin syndrome is a possibly fatal syndrome that can be caused by Almotriptan. Your risk may be greater if you take Almotriptan with certain other medicines (eg, SSRIs, SNRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.


• Lab tests, including heart function tests, may be performed while you use Almotriptan. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• Almotriptan should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in children have not been confirmed.


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

Possible side effects of Almotriptan:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth; headache; nausea; sleepiness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; changes in vision; chest pain; cold, pale, or blue-colored fingers or toes; confusion; fainting; fast or irregular heartbeat; numbness and tingling of hands or feet; one-sided weakness; seizures; severe headache, dizziness, or vomiting; severe stomach pain; shortness of breath; slurred speech; tightness, pain, or pressure in the jaw, neck, or chest; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Almotriptan 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin; clumsiness; enlarged pupils; inactivity; incoordination; redness in the arms and legs; seizure; slowed breathing; slow, fast, or irregular heartbeat; unusual dizziness or drowsiness.

Proper storage of Almotriptan:

Store Almotriptan at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Almotriptan out of the reach of children and away from pets.

General information:

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


• Almotriptan 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 Almotriptan. 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 Almotriptan resources

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

• almotriptan Advanced Consumer (Micromedex) - Includes Dosage Information


• almotriptan Concise Consumer Information (Cerner Multum)


• Almotriptan Malate Monograph (AHFS DI)


• Axert Prescribing Information (FDA)

Compare Almotriptan with other medications

• Migraine

Boots Thrush 1% w / w Cream

Boots Thrush 1% w/w Cream

(Clotrimazole)

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

This medicine is available without prescription to treat the external symptoms of thrush. However, you still need to use it 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

What this medicine is for

This medicine contains Clotrimazole which belongs to a group of medicines called antifungals, which act to treat infections caused by fungi.

It can be used to treat the external symptoms of thrush (vulval candidiasis). It may also be used by the woman’s sexual partner to treat associated penile thrush (candidal balanitis).

Thrush is a common infection caused by a yeast (or fungus), which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances, it may develop into an infection in the vagina and symptoms may spread to the surrounding area. These symptoms may include one or more of the following:

• Itching of the vagina and surrounding area (the vulva)


• Redness and swelling of the tissues of the vagina and vulva


• Soreness of the vagina and vulva


• A white non-smelling discharge from the vagina

Thrush may be aggravated by sexual intercourse, but is not a sexually transmitted disease. Sometimes however, thrush can be passed to your partner through sexual intercourse.

If your partner has penile thrush he may have one or more of the following symptoms:

• Soreness and redness of the penis


• Tightness of the foreskin


• An abnormal penile discharge

Before you use this medicine

This medicine can be used by adults between the ages of 16 and 60 years. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

Do not use:

• 
  If you are allergic to any of the ingredients in the medicine or any other antifungal medicine


• 
  If you are pregnant or breastfeeding, unless your doctor or midwife tells you to

Talk to your pharmacist or doctor:

• If this is the first time you have had these symptoms


• If you are under 16 years, or 61 years or older


• If you have had thrush more than twice in the last 6 months


• If you or your partner have been exposed to a sexually transmitted disease


• If you have lower stomach pain, or pain or a burning sensation on passing urine


• If you are a woman and:
  
  
  • You have abnormal or irregular vaginal bleeding, or a blood-stained discharge
  • You have sores, ulcers or blisters on your vulva or vagina


• If you are a man and:
  
  
  • Your sexual partner does not have thrush
  • You have an abnormal discharge or leakage from your penis
  • You have sores, ulcers or blisters on your penis

Other important information

The ingredients in the cream may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using the cream.

Cetyl alcohol and stearyl alcohol in the cream may cause local skin reactions (e.g. contact dermatitis).

You can help the treatment to work if you follow these simple self-help tips:

• Although the infected area will itch, do not scratch as this will damage the surface of the skin and cause the infection to spread further


• Keep the affected areas of skin clean


• Pay particular attention to drying the skin but avoid excessive rubbing

To help prevent thrush from coming back once you have treated it, follow these simple steps:

• Wash daily


• Wear cotton underwear and loose fitting clothing


• Try to avoid wearing tights, nylon underwear and tight fitting clothing


• After going to the toilet, wipe yourself from the front to the back, as a thrush infection may be transferred from the bowel


• Try to avoid washing with perfumed soaps or using vaginal deodorants


• Do not rub hard with sponges or flannels and avoid hot baths with strong perfumed oils


• Change your sanitary protection regularly

If you take other medicines

Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time. If you are unsure about interactions with any medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream. Pierce tube seal with end of cap.

Adults ages 16 to 60 years: Apply to the affected area two or three times a day for 2 weeks.

For use on the skin only. For women, apply the cream to the vulva and surrounding area. For men, apply the cream to the penis.

Do not use on children under 16 years, or if you are an adult of 61 years or older, unless your doctor tells you to.

Do not use more than the amount recommended above.

If symptoms do not go away within 7 days talk to your doctor.

If you have thrush more than twice in six months you must see your doctor.

If anyone accidentally swallows some of the cream: Talk to a doctor or go to your nearest hospital casualty department straight away. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop using the cream. See a doctor at once:

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

These other effects are less serious. If they bother you talk to a pharmacist:

• Mild burning or irritation of the skin immediately after applying the cream


• Skin rash, red or itchy skin (may be an allergic reaction)


• Pain

The symptoms of allergic reactions are very similar to the symptoms of thrush. If the pain, itching and burning get worse see your doctor.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

This cream contains Clotrimazole 1% w/w which is the active ingredient.

As well as the active ingredient, the cream also contains sorbitan stearate, polysorbate 60, cetyl palmitate, stearyl alcohol, cetyl alcohol, 2-octyldodecanol, benzyl alcohol, purified water

The pack contains 20 g of white cream.

Who makes this medicine

Manufactured for

The Boots Company PLC

Nottingham

NG2 3AA

by

Thornton and Ross Ltd

Linthwaite

Huddersfield

South Yorkshire

HD7 5QH

Marketing Authorisation held by

PLIVA Pharma Ltd

Vision House

Bedford Road

Petersfield

Hampshire

GU32 3QB

Leaflet prepared May 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Thrush Cream 1%

Reference number: 10622/0230

This is a service provided by the Royal National Institute of the Blind.

3349XPil

Estrostep Fe

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Estrostep Fe (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Estrostep Fe (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Estrostep Fe (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Estrostep Fe (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Estrostep Fe (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Estrostep Fe (ethinyl estradiol and norethindrone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Estrostep Fe (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Estrostep Fe resources

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

• Estrostep Fe Prescribing Information (FDA)


• Aranelle Prescribing Information (FDA)


• Balziva Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Estrostep Fe with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms
• Prevention of Osteoporosis

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Estrostep Fe side effects (in more detail)

Equioxx Injection

Dosage Form: FOR ANIMAL USE ONLY
Equioxx®

Injection (firocoxib)

Non-steroidal anti-inflammatory drug for intravenous use in horses only.

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

EQUIOXX (firocoxib) belongs to the coxib class of non-narcotic, non-steroidal anti-inflammatory drugs (NSAID). Firocoxib is a white crystalline compound described chemically as 3-(cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)-5, 5-dimethylfuranone. The empirical formula is C17H20O5S, and the molecular weight is 336.4. The structural formula is shown below:

Equioxx Injection is a colorless to pale yellow solution. Each mL of Equioxx Injection for Horses contains 20 mg of firocoxib as a free base, 550 mg of polyethylene glycol (PEG 400) and 600 mg of glycerol formal.

Indications

Equioxx Injection is administered for up to 5 days for the control of pain and inflammation associated with osteoarthritis in horses.

Dosage and Administration

Always provide the Client Information Sheet with the prescription. The recommended dosage of Equioxx Injection for intravenous administration in horses is 0.04 mg/lb (0.09 mg/kg) of body weight once daily for up to 5 days. If further treatment is needed, EQUIOXX (firocoxib) Oral Paste for horses can be used at a dosage of 0.045 mg/lb (0.1 mg/kg) body weight for up to an additional 9 days of treatment. The overall duration of treatment with Equioxx Injection and EQUIOXX Oral Paste will be dependent on the response observed, but should not exceed 14 days. See EQUIOXX Oral Paste for horses package insert for dosage and administration. Equioxx Injection is a non-aqueous solution, and therefore should not be added to an aqueous solution (such as intravenous infusion lines).

Contraindications

Horses with hypersensitivity to firocoxib should not receive Equioxx Injection.

Warnings

For intravenous use in horses only. Do not use in horses intended for human consumption.

Human Warnings

Not for use in humans. Keep this and all medications out of the reach of children. Consult a physician in case of accidental human exposure.

Animal Safety

Clients should be advised to observe for signs of potential drug toxicity and be give a Client Information Sheet with each prescription.

For technical assistance or to report suspected adverse events, call 1-877-217-3543.

Precautions

Horses should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data before and periodically during administration of any NSAID. Clients should be advised to observe for signs of potential drug toxicity and be given a Client Information Sheet with each prescription. See Information for Owner or Person Treating Horse section of this package insert.

Treatment with EQUIOXX should be terminated if signs such as inappetance, colic, abnormal feces, or lethargy are observed.

As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Horses that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached or avoided. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since many NSAIDs possess the potential to produce gastrointestinal ulcerations and/or gastrointestinal perforation, concomitant use of Equioxx Injection with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided.

The concomitant use of protein bound drugs with Equioxx Injection for horses has not been studied in horses. The influence of concomitant drugs that may inhibit the metabolism of firocoxib Injection has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

The safe use of Equioxx Injection for horses has not been evaluated in horses less than one year of age, horses used for breeding, or in pregnant or lactating mares.

Consider appropriate washout times when switching from one NSAID to another NSAID or corticosteroid.

Adverse Reactions

The effectiveness of Equioxx Injection was established in a biocomparability study demonstrating that EQUIOXX Oral Paste is bioequivalent to Equioxx Injection. Thus, additional field studies were not performed to support the effectiveness of Equioxx Injection.

In controlled field studies, 127 horses (ages 3 to 37 years) were evaluated for safety when given EQUIOXX® (firocoxib) Oral Paste for Horses at a dose of 0.045 mg/lb (0.1 mg/kg) orally once daily for up to 14 days. The following adverse reactions were observed. Horses may have experienced more than one of the observed adverse reactions during the study.

Adverse Reactions Seen in U.S. Field Studies with EQUIOXX Oral Paste

Adverse Reactions	EQUIOXX® n=127	Active Control n=125
Abdominal pain	0	1
Diarrhea	2	0
Excitation	1	0
Lethargy	0	1
Loose stool	1	0
Polydipsia	0	1
Urticaria	0	1

EQUIOXX Oral Paste was safely used concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics, during the field studies.

The material safety data sheet (MSDS) contains more detailed occupational safety information. To obtain a material safety data sheet, please call 1-877-217-3543.

Information for Owner or Person Treating Horse

You should give a Client Information Sheet to the person treating the horse and advise them of the potential for adverse reactions and the clinical signs associated with NSAID intolerance. Adverse reactions may include erosions and ulcers of the gums, tongue, lips and face, weight loss, colic, diarrhea, or icterus. Serious adverse reactions associated with this drug class can occur without warning and, in some situations, result in death. Clients should be advised to discontinue NSAID therapy and contact their veterinarian immediately if any of these signs of intolerance are observed. The majority of patients with drug-related adverse reactions recover when the signs are recognized, drug administration is stopped, and veterinary care is initiated.

Clinical Pharmacokinetics/Pharmacodynamics

Based on the comparison data between the intravenous and oral administration, the area under the curve (AUC) for both routes of administration was the same. The average AUC ratio of injectable to the oral product was 103%. The average peak plasma concentration observed one minute following firocoxib intravenous administration was approximately 3.7 fold greater than the observed average peak plasma concentration reached after administration of the oral paste (oral Tmax = 2.02 hours). The average plasma concentrations following IV injection and oral administration were similar by 2 hours post-dose, after which the concentrations proceeded to decline in parallel. The terminal elimination half-life (T ½ el) values were not significantly different (p>0.05), with values ranging from 14.6 to 68.0 hrs (mean = 31.5 hours) for the oral paste and from 12.6 to 66.3 (mean = 33.0 hours) for the intravenous solution.

The major metabolism mechanism of firocoxib in the horse is decyclopropylmethylation followed by glucuronidation of that metabolite. Based upon radiolabel studies, the majority of firocoxib is eliminated in the urine as the glucuronide conjugate of the decyclopropylmethylated metabolite. Despite a high rate of plasma protein binding (98%), firocoxib exhibits a large volume of distribution (mean Vd (ss) = 1652 mL/kg). The drug accumulation occurs with repeated dose administrations and steady state concentrations are achieved beyond 6-8 daily oral doses in the horse. Dose linearity exists from 1X-2X of 0.1 mg/kg/day after oral administration. Little drug amount distributes into blood cells.

Steady-state plasma firocoxib concentrations at 4 and 24 hours post administration were the same following intravenous or oral administration at each dose in the range of 1X to 5X.

Mode of action

Firocoxib is a cyclooxygenase-inhibiting (coxib) class, non-narcotic, non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic activity1 in animal models. Based on in vitro horse data, firocoxib is a selective inhibitor of prostaglandin biosynthesis through inhibition of the inducible cyclooxygenase-2 isoenzyme (COX-2)2,3. Firocoxib selectivity for the constitutive isoenzyme, cyclooxygenase-1 (COX-1), is relatively low. However, the clinical significance of these in vitro selectivity findings has not been established.

Effectiveness

The effectiveness of Equioxx Injection was established in a biocomparability study evaluating EQUIOXX Oral Paste and Equioxx Injection. Thus, additional field studies were not performed to support the effectiveness of Equioxx Injection. Two hundred fifty-three client-owned horses of various breeds, ranging in age from 2 to 37 years and weighing from 595 to 1638 lbs, were randomly administered EQUIOXX Oral Paste or an active control drug in multi-center field studies. Two hundred forty horses were evaluated for effectiveness and 252 horses were evaluated for safety. Horses were assessed for lameness, pain on manipulation, range of motion, joint swelling, and overall clinical improvement in a non-inferiority evaluation of EQUIOXX Oral Paste compared to an active control. At study's end, 84.4% of horses treated with EQUIOXX Oral Paste were judged improved on veterinarians' clinical assessment, and 73.8% were also rated improved by owners. Horses treated with EQUIOXX Oral Paste showed improvement in veterinarian-assessed lameness, pain on manipulation, range of motion, and joint swelling that was comparable to the active control.

Animal Safety

A target animal safety study was conducted to assess the safety of Equioxx Injection followed by EQUIOXX Oral Paste in the horse. Thirty-two clinically healthy adult horses received Equioxx Injection intravenously once daily for five days at doses of either 0 mg/kg (control group); 0.09 mg/kg (1X); 0.27 mg/kg (3X); or 0.45 mg/kg (5X the recommended dose). This was followed by once daily oral administration of EQUIOXX Oral paste for nine days at doses of either 0 mg/kg (control group); 0.1 mg/kg (1X); 0.3 mg/kg (3X); or 0.5 mg/kg (5X the recommended dose). This sequence (five days of Equioxx Injection followed by nine days EQUIOXX Oral Paste, for a total of 14 days) was repeated three times for a total treatment duration of 42 days (3X the recommended treatment duration of 14 days).

Two male 5X horses demonstrated a white focus in the renal cortex which correlated with tubulointerstitial nephropathy microscopically. The presence of tubulointerstitial nephropathy was considered treatment-related.

One horse from the control group and two horses from the 5X group had injection site swellings during treatment. Injection site changes characterized by inflammatory cell influx and rarely tissue necrosis were seen in all study groups including the control group.

There was a dose-dependent increase in the incidence of oral ulcers and erosions.

Elevated hepatic enzymes (GGT or AST) were noted in all study groups at one or more timepoints. One male 5X horse with an elevated GGT value on Day 42 was noted to have tubulointerstitial nephropathy at the time of necropsy. For all horses, these hepatic enzyme elevations generally returned to the reference range by the next time point.

Storage

Store at 20-25°C with excursions between 15-30°C.

How Supplied

EQUIOXX (firocoxib) Injection for Horses will be supplied in sterile, 25 mL amber glass vials for multi-dose use.

1

McCann ME, Rickes EL, Hora DF, Cunningham PK et al. In vitro effects and In vivo efficacy of a novel cyclooxygenase-2 inhibitor in cats with lipopolysaccharide-induced pyrexia. Am J Vet Res. 2005 Jul;66 (7):1278-84

2

McCann ME, Anderson DR, Brideau C et al. In vitro activity and in vivo efficacy of a novel COX-2 inhibitor in the horse. Proceedings of the Academy of Veterinary Internal Medicine. 2002. Abstract 114, p.789.

3

Data on file.

Manufactured for:

Merial Limited

Duluth, GA 30096-4640, U.S.A.

1-877-217-3543

Made in Germany

U.S. Patent No. 5,981,576

NADA 141-313, Approved by FDA

®EQUIOXX is a registered trademark of Merial Limited.

©2010 Merial Limited. All Rights Reserved.

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

Rev. 07-2010

721462

Non-steroidal anti-inflammatory drug for intravenous use in horses only.

Information for Horse Owners

Indication: Equioxx Injection is administered for up to 5 days for the control of pain and inflammation associated with osteoarthritis in horses. If further treatment is needed, EQUIOXX Oral Paste can be used for up to an additional 9 days of treatment. The overall duration of treatment with Equioxx Injection and EQUIOXX Oral Paste will be dependent on the response observed, but should not exceed 14 days.

This summary contains important information about EQUIOXX. You should read this information before you start giving your horse EQUIOXX and review it each time your prescription is refilled. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or you want to know more about EQUIOXX.

What is EQUIOXX?

EQUIOXX is a veterinary prescription non-steroidal anti-inflammatory drug (NSAID) of the coxib class used to control pain and inflammation associated with osteoarthritis in horses. Osteoarthritis (OA) is a painful condition caused by progressive "wear and tear" of cartilage and other parts of the joints that may result in the following changes or signs in your horse:

• Limping or lameness.


• Decreased activity or exercise (reluctance to stand, walk, trot or run, or difficulty in performing these activities).


• Stiffness or decreased movement of joints.

How to give EQUIOXX to your horse?

EQUIOXX should be given according to your veterinarian's instructions. Do not change the way you give EQUIOXX to your horse without first speaking with your veterinarian. Do not exceed 14 days of treatment. The recommended dosage of Equioxx Injection for intravenous administration in horses is 0.04 mg/lb (0.09 mg/kg) of body weight once daily for up to 5 days. If further treatment is needed, EQUIOXX (firocoxib) Oral Paste for horses can be used at a dosage of 0.045 mg/lb (0.1 mg/kg) bodyweight for up to an additional 9 days of treatment. The overall duration of treatment with Equioxx Injection and EQUIOXX Oral Paste will be dependent on the response observed, but should not exceed 14 days.

What kind of results can I expect when my horse is on EQUIOXX for OA?

While EQUIOXX is not a cure for osteoarthritis, it can control the pain and inflammation associated with OA and can improve your horse's mobility.

• Response varies from horse to horse, but improvement can be quite dramatic.


• Improvement can be seen in just a few hours in most horses.

Which horses should not receive EQUIOXX?

Your horse should not be given EQUIOXX if he/she:

• Has an allergic reaction to firocoxib, the active ingredient in EQUIOXX.


• Has previously had an allergic reaction (such as hives, facial or lower limb swelling, or red or itchy skin) to aspirin or other NSAIDs.


• Is presently taking aspirin, phenylbutazone, flunixin meglumine, diclofenac, ketoprofen, or other NSAIDs or corticosteroids.


• The safety of EQUIOXX has not been determined in horses less than one year of age or in breeding horses, pregnant or lactating mares.

Equioxx Injection should only be given intravenously to horses.

• EQUIOXX is not for use in horses intended for human food consumption.


• People should not take EQUIOXX. Keep EQUIOXX and all medications out of the reach of children. Consult a physician in case of accidental ingestion by humans.

What to tell/ask your veterinarian before giving EQUIOXX.

Talk to your veterinarian about:

• The signs of OA you have observed in your horse, such as limping or stiffness.


• If any tests, such as X-rays, will be done before EQUIOXX is prescribed.


• How often your horse may need to be examined by your veterinarian.


• The risks and benefits of using EQUIOXX.

Tell your veterinarian if your horse has ever had the following medical problems:

• Any side effects from taking EQUIOXX or other NSAIDs, such as aspirin or phenylbutazone.


• Any kidney disease.


• Any liver disease.


• Any gastrointestinal ulcers.

Tell your veterinarian about:

• Other medical problems or allergies that your horse has now, or has had in the past.


• All medicines that you are giving or plan to give to your horse, including those you can get without a prescription and any dietary supplements.

Tell your veterinarian if you plan to breed your horse, or if your mare is pregnant or nursing a foal.

What are the possible side effects that may occur in my horse during EQUIOXX therapy?

EQUIOXX, like other NSAIDS, may cause some side effects. Serious side effects associated with NSAID therapy in horses can occur with or without warning. The most common side effects associated with EQUIOXX therapy involve the tongue, lips and skin of the mouth and face (erosions and ulcers of the mucosa and skin) and the kidney. Gastrointestinal, kidney and liver problems have also been reported with other NSAIDs. Look for the following side effects that may indicate your horse is having a problem with EQUIOXX or may have another medical problem:

• Sores or ulcers on the tongue and inside of mouth.


• Sores, scabs, redness, or rubbing of the facial skin, particularly around the mouth.


• Change in eating or drinking habits (frequency or amount consumed).


• Change in urination habits (frequency or color).


• Yellowing of gums, skin, or whites of the eyes (jaundice).


• Unexpected weight loss.


• Change in behavior (such as increased or decreased activity level).

It is important to stop therapy and contact your veterinarian if you think your horse has a medical problem or side effect while taking EQUIOXX. If you have additional questions about possible side effects, talk with your veterinarian or call 1-877-217-3543.

Can EQUIOXX be given with other medications?

EQUIOXX should not be given with other NSAIDs (for example, aspirin, phenylbutazone, diclofenac, ketoprofen or flunixin) or systemic corticosteroids (for example, prednisone, cortisone, dexamethasone, or triamcinolone).

Tell your veterinarian about all medications that you have given your horse in the past, and any medications you are planning to give with EQUIOXX. This should include other medicines that you can get without a prescription or any dietary supplements. Your veterinarian may want to check that all of your horse's medicines can be given together.

What do I do in case my horse receives more than the prescribed amount of EQUIOXX?

• Consult your veterinarian if your horse receives more than the prescribed amount of EQUIOXX.

What else should I know about EQUIOXX?

• This sheet provides a summary of information about EQUIOXX paste and general information about NSAIDs. If you have any questions or concerns about EQUIOXX or osteoarthritis pain, talk with your veterinarian.


• As with all prescribed medicines, EQUIOXX should only be given to the horse for which it is prescribed. It should be given to your horse only for the condition for which it is prescribed, at the labeled dose and duration.


• It is important to periodically discuss your horse's response to EQUIOXX. Your veterinarian will determine if your horse is responding as expected and if your horse should continue receiving EQUIOXX.

Manufactured for:

Merial Limited

Duluth, GA 30096-4640, U.S.A.

1-877-217-3543

Made in Germany

U.S. Patent No. 5,981,576

NADA 141-313, Approved by FDA

®EQUIOXX is a registered trademark of Merial Limited.

©2010 Merial Limited. All Rights Reserved.

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

Rev. 06-2010

721941

PRINCIPAL DISPLAY PANEL

NADA 141-313,

Approved by FDA

Equioxx®

Injection (firocoxib)

20 mg/ml

Non-steroidal

anti-inflammatory drug

For intravenous use

in Horses only

Caution: Federal law

restricts this drug to use

by or on the order of a

licensed veterinarian.

25 ml

MERIAL

EQUIOXX  firocoxib  injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 50604-7209 Route of Administration INTRAVENOUS DEA Schedule

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

Inactive Ingredients Ingredient Name Strength Polyethylene Glycol 400   glycerol formal

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50604-7209-1 1 VIAL In 1 CARTON contains a VIAL, GLASS 1 25 mL In 1 VIAL, GLASS This package is contained within the CARTON (50604-7209-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141313	09/20/2010

Labeler - Merial Limited (034393582)

Revised: 09/2010Merial Limited