March 30, 2017
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Rezira

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Rezira

PATIENT INFORMATION

REZIRA®
(re-zear-uh)
(hydrocodone bitartrate and pseudoephedrine hydrochloride) Oral Solution

What is the most important information I should know about REZIRA?

  • Taking REZIRA with benzodiazepines, or other central nervous system depressants, including alcohol can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
  • REZIRA can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with REZIRA.
  • Women who breastfeed should talk to their healthcare provider before taking REZIRA.
  • Call your healthcare provider or get emergency medical help right away if anyone taking REZIRA has any of the symptoms below:
    • increased sleepiness
    • shallow breathing
    • confusion
    • limpness
    • difficulty breathing
    • your baby has difficulty breastfeeding
  • Keep REZIRA in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes REZIRA, get emergency medical help right away.
  • REZIRA can cause serious side effects, including death.
  • Take REZIRA exactly as prescribed by your healthcare provider. If you take the wrong dose of REZIRA, you could overdose and die.
  • REZIRA is not for children under 18 years of age.

What is REZIRA?

  • REZIRA is a prescription medicine used to treat a cough and nasal congestion that you can have with the common cold. REZIRA contains 2 medicines, hydrocodone and pseudoephedrine. Hydrocodone is a narcotic cough suppressant. Pseudoephedrine is a decongestant.
  • REZIRA is a federal controlled substance (C-II) because it contains hydrocodone that can be abused or lead to dependence. Keep REZIRA in a safe place to prevent misuse and abuse. Selling or giving away REZIRA may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.
  • REZIRA is not for children under 18 years of age. It is not known if REZIRA is safe and effective in children.

Who should not take REZIRA?

  • Do not take REZIRA if you are allergic to any of the ingredients in REZIRA. See the end of this Medication Guide for a complete list of ingredients. You may have an increased risk of having an allergic reaction to REZIRA if you are allergic to certain other opioid medicines.
  • Do not take REZIRA if you take a medicine for depression called a Monoamine Oxidase Inhibitor (MAOI).
    • Do not take an MAOI within 14 days after you stop taking REZIRA.
    • Do not start REZIRA if you stopped taking an MAOI in the last 14 days.
  • Do not take REZIRA if you have a type of glaucoma called “narrow angle glaucoma”.
  • Do not take REZIRA if you have problems emptying your bladder (urinary retention).
  • Do not take REZIRA if you have severe high blood pressure or certain heart problems (severe coronary artery disease).

Before you take REZIRA, tell your healthcare provider about all of your medical conditions, including if you:

  • have a drug dependence
  • plan to have surgery
  • have lung or breathing problems
  • drink alcohol
  • have had a head injury
  • have pain in your stomach-area (abdomen)
  • have a history of severe or persistent cough
  • have prostate problems
  • have problems with your urinary tract (urethral stricture)
  • have kidney or liver problems
  • have diabetes
  • have thyroid problems, such as hypothyroidism
  • have Addison's disease
  • are pregnant or plan to become pregnant. It is not known if REZIRA will harm your unborn baby. You and your healthcare provider should decide if you should take REZIRA while you are pregnant.
  • are breastfeeding or plan to breastfeed. Hydrocodone and pseudoephedrine pass into your breast milk. You and your healthcare provider should decide if you will take REZIRA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking REZIRA with certain other medicines can cause side effects or affect how well REZIRA or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

  • take pain medicines such as narcotics
  • take cold or allergy medicines that contain antihistamines or cough suppressants
  • take medicines for mental illness (anti-psychotics, anti-anxiety)
  • drink alcohol
  • take medicines for depression, including monoamine oxidase inhibitors (MAOIs) and tricyclics
  • take medicines for stomach or intestine problems. Ask your healthcare provider if you are not sure if you take one of these medicines.

How should I take REZIRA?

  • Take REZIRA exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much REZIRA to take and when to take it. Do not change your dose without talking to your healthcare provider.
  • Take REZIRA by mouth only.
  • REZIRA should be taken using an accurate milliliter measuring device.
  • Ask your pharmacist to give you a measuring device to help you measure the correct amount of REZIRA. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
  • If you take too much REZIRA, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking REZIRA?

  • REZIRA can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with REZIRA.
  • Avoid drinking alcohol while taking REZIRA. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of REZIRA?

REZIRA may cause serious side effects, including:

  • See “What is the most important information I should know about REZIRA?”
  • Breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you are sleeping more than usual, have shallow or slow breathing, or confusion.
  • Physical dependence or abuse. Take REZIRA exactly as your healthcare provider tells you to take it. Stopping REZIRA suddenly could cause withdrawal symptoms.
  • Bowel problems including constipation or stomach pain.
  • Heart and blood vessel (cardiovascular), and central nervous system (CNS) effects. Cardiovascular and CNS effects can happen in some people during treatment with REZIRA, including trouble sleeping (insomnia), dizziness, weakness, tremors abnormal heart beats (arrhythmias), seizures, and feeling faint. Severe heart and blood vessel problems can also happen and cause you to have low blood pressure. Call your healthcare provider right away if you have any of these symptoms.

The most common side effects of REZIRA include:

  • sleepiness
  • confusion
  • nausea and vomiting
  • difficulty urinating
  • trouble breathing
  • mood changes, including anxiety, fear, nervousness, and feeling low (dysphoria)
  • dizziness

These are not all the possible side effects of REZIRA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store REZIRA?

  • Store REZIRA at room temperature between 68°F to 77°F (20°C to 25°C).
  • Safely throw away medicine that is out of date or no longer needed.
  • Keep REZIRA Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of REZIRA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REZIRA for a condition for which it was not prescribed. Do not give REZIRA to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about REZIRA that is written for health professionals.

What are the ingredients in REZIRA?

Active ingredients: hydrocodone bitartrate and pseudoephedrine hydrochloride

Inactive ingredients: citric acid anhydrous, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin, and sucrose.

REZIRA is manufactured for Hawthorn Pharmaceuticals, Inc., Morristown, NJ 07960. REZIRA is a registered trademark of Hawthorn Pharmaceuticals, Inc. For more information, go to www.REZIRA.com or call 1-800-793-2145.Issued: January 2017

Last reviewed on RxList: 3/27/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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