"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
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.
MORPHINE - INJECTION
COMMON BRAND NAME(S): Duramorph, Infumorph
WARNING: Morphine has a high risk for abuse and severe, possibly fatal, breathing problems. The risk for harm is higher if you use the wrong dose/strength, or if you use it along with other drugs that might also affect breathing. Be sure you know how to use morphine and what other drugs you should avoid taking with it. The risk for breathing problems might also be higher when you start this medication and after a dose increase. Get immediate help if you notice unusual slow/shallow breathing.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows this drug, get emergency medical help right away.
USES: This medication is used to treat severe pain. It acts on certain centers in the brain to give you pain relief. This medication is a narcotic pain reliever (opiate-type).
HOW TO USE: Depending on your specific product, this medication is given by injection into a vein, into a muscle, or under the skin. Use this product exactly as directed by your doctor. Read and learn all of the manufacturer's instructions for preparation and use. If you have any questions about using this medication properly, consult your doctor or pharmacist.
Preservative-free morphine may also be given by a doctor as an injection into the area around the spinal cord (epidural) or into the fluid-filled space that contains the spinal cord (intrathecal). In this case, the medication is first given in the hospital where you can be monitored closely. If your doctor directs you to continue using this medication at home, it is usually given as a continuous injection using an infusion pump placed under your skin.
The dosage is based on your medical condition and response to treatment. For children, the dosage may also be based on weight. Do not increase your dose, use the medication more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.
Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. If this medication is given into a muscle or under the skin, it is important to change the location of the injection site with each dose to avoid problem areas under the skin.
Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.
If nausea occurs, consult your doctor or pharmacist for ways to decrease it (such as taking antihistamines, lying down for 1 to 2 hours with as little head movement as possible).
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur if you suddenly stop using 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 used 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. Use this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain persists or worsens.
Additional Duramorph Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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