"Nov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.
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Roxanol Side Effects Center
Pharmacy Editor: Melissa Conrad Stöppler, MD
Roxanol (Morphine sulfate) is a highly concentrated solution of the narcotic analgesic morphine sulfate for oral administration. It is used for the treatment of severe, chronic pain. Side effects can include constipation, nausea, vomiting, diarrhea, dizziness, anxiety, or sleep problems. Other side effects may also occur.
It is not known whether morphine can cause fetal harm when administered to a pregnant woman, so morphine should be given to a pregnant woman only if clearly needed. Morphine readily crosses the placental barrier and if administered during labor, may lead to respiratory depression in the neonate. Morphine has been detected in human milk. For this reason, caution should be exercised when morphine is administered to a nursing woman.
Our Roxanol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Roxanol in Detail - Patient Information: 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.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- seizure (convulsions);
- cold, clammy skin;
- severe weakness or dizziness; or
- feeling light-headed, fainting.
Less serious side effects are more likely to occur, such as:
- warmth, tingling, or redness under your skin;
- nausea, vomiting, stomach pain, diarrhea, loss of appetite;
- dizziness, headache, anxiety;
- memory problems; or
- sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Roxanol (Morphine Sulfate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Roxanol Overview - Patient Information: Side Effects
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
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 immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, fainting, mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, vision changes, slow/fast heartbeat.
Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, 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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Roxanol (Morphine Sulfate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Roxanol FDA Prescribing Information: Side Effects
THE MAJOR HAZARDS OF MORPHINE, AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRA-TORY DEPRESSION AND, TO A LESSER DEGREE, CIRCULATORY DEPRESSION, RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURRED.
The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are suffering severe pain. In such individuals, lower doses are available. Some adverse reactions may be alleviated in the ambulatory patient if he lies down.
Other adverse reactions include the following
Treatment of the most frequent adverse reactions
Ample intake of water or other liquids should be encouraged. Concomitant administration of a stool softener and a peristaltic stimulant with the narcotic analgesic can be an effective preventive measure for those patients in need of therapeutics. If elimination does not occur for two days, an enema should be administered to prevent impaction.
Nausea and Vomiting
Phenothiazines and antihistamines can be effective treatments of nausea of the medullary and vestibular sources respectively. However, these drugs may potentiate the side effects of the narcotic or the antinauseant.
Once pain control is achieved, undesirable sedation can be minimized by titrating the dosage to a level that just maintains a tolerable pain or pain free state.
Drug Abuse And Dependence
Morphine Sulfate, a narcotic, is a Schedule II controlled substance under the Federal Controlled Substance Act. As with other narcotics, some patients may develop a physical and psychological dependence on morphine. They may increase dosage without consulting a physician and subsequently may develop a physical dependence on the drug. In such cases, abrupt discontinuance may precipitate typical withdrawal symptoms, including convulsions. Therefore the drug should be withdrawn gradually from any patient known to be taking excessive dosages over a long period of time.
In treating the terminally ill patient the benefit of pain relief may outweigh the possibility of drug dependence. The chance of drug dependence is substantially reduced when the patient is placed on scheduled narcotic programs instead of a “pain to relief-of-pain” cycle typical of a PRN regimen.
Read the entire FDA prescribing information for Roxanol (Morphine Sulfate) »
Additional Roxanol Information
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Roxanol User Reviews
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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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