This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. Also, nonsteroidal anti-inflammatory drugs (including ibuprofen) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while using this drug but is more likely if you use it for a long time. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not use ibuprofen right before or after heart bypass surgery (CABG). Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other possible medication choices.
If you notice any of the following rare but very serious side effects, stop using ibuprofen and seek immediate medical attention: black/tarry/bloody stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, weakness on one side of the body, sudden vision changes, slurred speech.Who should not take Caldolor Vial?
Ibuprofen is used for the short-term treatment of mild to moderate pain in adults. When used with a narcotic (such as morphine) it may be used to treat moderate to severe pain. It is also used to reduce fever. This medication is a nonsteroidal anti-inflammatory drug (NSAID).
If you are using this medication at home, read and learn all preparation and usage instructions from the manufacturer or from your health care professional. If you have any questions about using this medication properly, consult your doctor or pharmacist.
Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.
Follow your doctor's directions carefully. This medication is diluted and then given by injection into a vein for 30 minutes. When used to treat pain, it is usually injected every 6 hours as needed. When used to reduce fever, this drug may be injected every 4 to 6 hours as needed.
Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.
Drink plenty of fluids while using this medication unless your doctor tells you otherwise.
To reduce your risk of stomach bleeding and other side effects, use this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, use it more frequently, or use it for a longer time than prescribed.
Tell your doctor if your pain or fever persists or worsens.
See also Warning section.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: swelling of ankles/feet/hands, sudden/unexplained weight gain, ringing in the ears, mental/mood changes, fast/pounding heartbeat, persistent/severe headache, fainting, vision changes, unusual tiredness.
This drug may rarely cause serious (rarely fatal) liver disease. If you notice any of the following rare but very seriousside effects, stop using ibuprofen and consult your doctor or pharmacist right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.
Stop using ibuprofen and tell your doctor right away if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), very stiff neck, signs of kidney problems (such as change in the amount of urine), seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using ibuprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent heart bypass surgery (CABG), liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (such as bleeding, ulcers, recurring heartburn), heart disease (such as history of heart attack), high blood pressure, stroke, swelling (edema, fluid retention), blood disorders (such as anemia), bleeding/clotting problems, asthma (especially aspirin-sensitive type which means a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps).
Kidney problems can sometimes occur with the use of NSAID medications, including ibuprofen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.
This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana.
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.
Older adults may be more sensitive to the side effects of this drug, especially stomach bleeding and kidney problems.
Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some of the products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), other medications for arthritis (such as aspirin, methotrexate), cidofovir, corticosteroids (such as prednisone), lithium, "water pills" (diuretics such as furosemide).
This medication may increase the risk of bleeding when used with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.
Check all prescription and nonprescription medicine labels carefully for other pain/fever drugs (aspirin, NSAIDs such as celecoxib, ketorolac, or naproxen). These drugs are similar to ibuprofen, so taking one of these drugs while also using ibuprofen may increase your risk of side effects. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise.
Daily use of ibuprofen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you must use ibuprofen, talk to your doctor about possibly taking immediate-release aspirin (not enteric-coated/EC) while using ibuprofen. Use ibuprofen at least 8 hours before or at least 30 minutes after your aspirin dose. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, vomit that looks like coffee grounds, extreme drowsiness/dizziness.
Laboratory and/or medical tests (such as blood counts, liver function tests, kidney function tests, blood pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised June 2017. Copyright(c) 2017 First Databank, Inc.
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