Midodrine Hydrochloride and Tylenol w/Codeine #3

• Generic Name: midodrine
• Dosage Forms: n.a.
• Other Brand Names: Proamatine, Orvaten

Treatment of symptomatic orthostatic hypotension (designated an orphan drug by FDA for this use). Indication is based on effect on increases in 1-minute standing systolic BP, a surrogate marker; clinical benefits (principally improved ability to perform life activities) not established. Continue the drug only in patients who report substantial symptomatic improvement.

Use recommended only in patients whose lives are considerably impaired despite standard clinical care; use only after nondrug therapies (e.g., support hose, increased sodium intake, life-style modifications) and fluid expansion have failed. May be more effective than comparative drugs (e.g., ephedrine) in managing postural symptoms.

In August 2010, FDA proposed to withdraw approval of midodrine because required postapproval studies verifying the clinical benefit of the drug had not been done. FDA stated that neither the original manufacturer (Shire) nor any generic manufacturer had demonstrated clinical benefit (e.g., performance of life activities); data submitted had not verified expected clinical benefit. In September 2010, FDA clarified that its proposal was part of the regulatory process and that midodrine could remain on the market as that process moves forward. Subsequently, FDA and Shire reached an agreement that Shire would conduct 2 additional clinical studies to verify the clinical benefit of midodrine in patients with symptomatic orthostatic hypotension. In February 2012, FDA announced that the proposal to withdraw approval of midodrine will be deferred until these studies have been conducted; meanwhile, the drug remains approved and available on the US market. In September 2014, FDA extended the deadline to March 31, 2015 for final submission of study results and analyses for FDA review.

• Generic Name: acetaminophen / codeine
• Dosage Forms: n.a.
• Other Brand Names: Tylenol with Codeine #3, Tylenol with Codeine #4, EZ III, Phenaphen with Codeine, Tylenol with Codeine, Capital and Codeine Suspension, Tylenol with Codeine #2, Vopac, Cocet, Cocet Plus, Capital w/Codeine, Tylenol w/ Codeine

Acetaminophen and codeine combination is used to relieve mild to moderate pain.

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 serious 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.

Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

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