Midodrine Hydrochloride and Motrin PM

• 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: diphenhydramine / ibuprofen
• Dosage Forms: tablet, coated
• Other Brand Names: Advil PM, Advil PM Liqui-Gels, Ibuprofen PM, Motrin PM

Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Antihistamines can cause drowsiness, which can aid in the treatment of occasional sleep problems (insomnia).

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.

Motrin PM is a combination medicine used to treat occasional insomnia associated with minor aches and pains.

Motrin PM is not for use in treating sleeplessness without pain, or sleep problems that occur often.

Motrin PM may also be used for purposes not listed in this medication guide.