"The US Food and Drug Administration (FDA) has approved an extended-release (ER) hydrocodone bitartrate product (Vantrela ER, Teva Pharmaceutical Industries Ltd) for pain management, the company has announced.
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IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
IBUPROFEN/OXYCODONE 400 MG/5 MG - ORAL
COMMON BRAND NAME(S): Combunox
WARNING: One ingredient in this medication, ibuprofen, may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. Also, related drugs rarely have caused blood clots to form, resulting in heart attacks and strokes. Ibuprofen might also rarely cause similar problems. 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), or with longer use. 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 taking this medication and seek immediate medical attention: black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, weakness on one side of the body, sudden vision changes, or slurred speech.
USES: This medication is used for the short-term treatment of moderate to severe pain. It contains 2 pain relievers: oxycodone and ibuprofen. Oxycodone is a narcotic pain reliever (opiate-type) that acts on certain parts of the brain to relieve pain. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that works by blocking a certain natural substance in your body to reduce pain and swelling.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid.
Dosage and duration are based on your medical condition and response to therapy. Take this medication exactly as directed by your doctor. To minimize the risk of side effects (such as stomach bleeding), the manufacturer recommends using no more than 4 tablets per day for the shortest possible time (usually no more than 7 days). If you are instructed to take this medication for more than 7 days, discuss the risks and benefits with your doctor. Also follow your doctor's or pharmacist's instructions for the safe use of other non-narcotic pain relievers (such as acetaminophen). Consult your doctor or pharmacist if you have any questions regarding your treatment.
If you are taking this medication as needed, remember to take it as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
If this medication has been taken regularly for a long time or in high doses, withdrawal symptoms (such as runny nose, irritability, trouble sleeping, sweating, stomach cramps, diarrhea) may occur if you suddenly stop taking this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
When this medication is taken for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
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