Oxymetazoline Hydrochloride and Tramadol and acetaminophen

• Generic Name: oxymetazoline ophthalmic
• Dosage Forms: n.a.
• Other Brand Names: Visine LR, Visine Long Lasting, Ocuclear

Self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies.

As effective as other topical vasoconstrictors.

Labeled and has been used for self-medication for temporary relief of nasal congestion associated with sinusitis; however, efficacy data are lacking and/or controversial. In October 2005, FDA issued final rule to remove this indication from labeling of OTC nasal decongestants. Compliance date for preparations with annual sales <$25,000 is October 11, 2007; compliance date for all other preparations is April 11, 2007.

Self-medication for temporary relief of ocular redness due to minor irritation.

Has been used for self-medication for symptomatic prevention of otitic barotrauma (aerotitis [barotitis] media); however, no more effective than placebo.

• Generic Name: acetaminophen / tramadol
• Dosage Forms: n.a.
• Other Brand Names: Ultracet

Tramadol and acetaminophen combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

Tramadol belongs to the group of medicines called opioid analgesics (narcotics). It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to side effects when you suddenly stop taking the medicine. Since tramadol and acetaminophen is only used for short-term relief of pain, mental and physical dependence will probably not occur.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

Tramadol and acetaminophen is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.