Rezira

Generic name:hydrocodone and pseudoephedrine
Drug class:Upper respiratory combinations
Approval date: June 8, 2011
Company: Cypress Pharmaceutical, Inc.
Treatment for: Cough and Nasal Congestion

FDA Approves Rezira

The U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for Rezira (hydrocodone bitartrate and pseudoephedrine hydrochloride) Oral Solution (CIII) for the relief of cough and symptoms associated with the common cold.

What is Rezira used for?

Rezira is used for:

• Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

What is Rezira?

Rezira is a decongestant and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. This allows you to breathe more easily. The cough suppressant works in the brain to decrease the cough reflex to help decrease a dry cough.

Do NOT use Rezira if:

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rezira:

Some medical conditions may interact with Rezira. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an abnormal heartbeat or other heart problems
• if you have a history of adrenal gland problems (eg, tumor), high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, seizures or epilepsy, or an overactive thyroid
• if you have or recently have had any head or brain injury, brain tumor, increased pressure in the brain, or infection of the brain or nervous system
• if you have a history of any lung or breathing problems, asthma, stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), gallbladder problems (eg, gallstones), an enlarged prostate gland or other prostate problems, or you have had recent abdominal surgery
• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Rezira. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Naltrexone because it may decrease Rezira's effectiveness
• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Rezira's side effects
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