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Ultracet |
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Ultracet 37.5/325mg
30 tablets |
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Ultracet
37.5/325mg 60 tablets |
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Ultracet
37.5/325mg 90 tablets |
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Precautions on using Ultracet Medication
Before taking
Ultracet, tell your doctor and pharmacist
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 Ultracet,
the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or
allergic reaction to tramadol, other opioid analgesics or acetaminophen.
Also tell your health care professional if you are allergic to any other
substances, such as foods, preservatives, or dyes.
Pregnancy—Ultracet
has not been
studied in pregnant women. However, studies in animals have shown that
tramadol and acetaminophen causes birth defects and other problems.
Before taking this medicine, make sure your doctor knows if you are
pregnant or if you may become pregnant.
Too much use of an opioid during pregnancy may cause the fetus to become
dependent on the medicine. This may lead to withdrawal side effects in
the newborn baby. Newborn seizures, symptoms of withdrawal from opioids,
death of the fetus and still birth have been reported.
Breast-feeding—Ultracet
pass into breast milk and may cause unwanted side effects in nursing
babies. It may be necessary for you to take another medicine or to stop
breast-feeding during treatment. Be sure you have discussed the risks
and benefits of the medicine with your doctor.
Children—Studies on this medicine have been done only in adult
patients, and there is no specific information comparing use of tramadol
and acetaminophen in children up to 16 years of age with use in other
age groups.
Older adults—Ultracet
medicine has been tested and has not been shown to cause different side
effects or problems in older people than it does in younger adults.
Other 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 Ultracet,
it is especially important that your health care professional know if
you are taking any of the following:
MedWorm: Ultracet
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Amneal Receives FDA Approval For Tramadol/APAP Tablets
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Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal's generic is an AB-rated, therapeutically equivalent alternative to Ultracet® (a licensed trademark of Ortho-McNeil Janssen). U.S. sales of Tramadol/APAP were $61 MM according to June 2009 IMS Health market data. Tramadol/APAP is a centrally-acting analgesic indicated for the short-term management of moderately severe acute pain... (Source: Health News from Medical News Today)
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FDA Safety Changes: Ultram, Ultracet, Sustiva, Kayexalate
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The FDA has approved safety labeling revisions for tramadol HCl tablets, tramadol plus acetaminophen tablets, efavirenz capsules and tablets, and sodium polystyrene sulfonate powder. Medscape Medical News (Source: Medscape Today Headlines)
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