Rezira

Name: Rezira

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison's disease (adrenal gland problem) or
  • Asthma or
  • Diabetes or
  • Drug dependence, especially narcotic abuse or dependence, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Problems with passing urine or
  • Thyroid disease—Use with caution. May increase risk for more serious side effects.
  • Heart disease (e.g., coronary artery disease), severe or
  • Hypertension (high blood pressure), severe or
  • Narrow angle glaucoma or
  • Urinary retention—Should not be used in patients with these conditions.
  • Kidney disease, severe or
  • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Uses For Rezira

Hydrocodone and pseudoephedrine combination is used in adults to relieve cough and nasal congestion (stuffy nose) caused by the common cold.

Hydrocodone is a narcotic antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough. Pseudoephedrine is a decongestant, which decreases nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passage.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing cough and nasal congestion should not let the fear of dependence keep them from using narcotics to relieve their cough. 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 with your doctor's prescription.

Proper Use of hydrocodone and pseudoephedrine

This section provides information on the proper use of a number of products that contain hydrocodone and pseudoephedrine. It may not be specific to Rezira. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Measure the oral liquid correctly using the marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist for instructions for measuring the correct dose of this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (solution):
    • For relief of cough and nasal congestion:
      • Adults—5 milliliters (mL) every 4 to 6 hours as needed. However, the dose is usually not more than 4 doses (20 mL) in 24 hours.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Rezira Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Blurred vision
  • confusion
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, slow, or irregular heartbeat
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach cramps or pain
  • bloating
  • bulging soft spot on the head of an infant
  • change in the ability to see colors, especially blue or yellow
  • convulsions
  • decrease in the frequency of urination
  • decrease in urine volume
  • diarrhea
  • difficult or painful urination
  • difficult or troubled breathing
  • difficulty having a bowel movement (stool)
  • difficulty in passing urine (dribbling)
  • drowsiness
  • frequent urge to urinate
  • headache
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • nervousness
  • pale or blue lips, fingernails, or skin
  • pounding in the ears
  • shakiness in the legs, arms, hands, or feet
  • trembling or shaking of the hands or feet
  • trouble with sleeping
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Fear
  • mood changes
  • nausea
  • relaxed and calm
  • sleepiness
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
  • Itching or skin rash
  • weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

What are some things I need to know or do while I take Rezira?

  • Tell all of your health care providers that you take Rezira. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this medicine for longer than you were told by your doctor.
  • Avoid driving and doing other tasks or actions that call for alertness while you take Rezira. Talk with your doctor.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • This medicine may be habit-forming with long-term use.
  • If you have been taking this medicine on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking Rezira all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
  • Do not take this medicine with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
  • Keep away from children. Accidental exposure may cause death. If a child takes Rezira by accident, get medical help right away.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
  • If you are 65 or older, use Rezira (hydrocodone and pseudoephedrine) with care. You could have more side effects.
  • The use of hydrocodone in children younger than 6 years has led to deadly breathing problems. Talk with the doctor.
  • This medicine is not approved for use in children younger than 18 years of age. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Using Rezira for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
  • Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

What are some other side effects of Rezira?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Hard stools (constipation).
  • Feeling sleepy.
  • Upset stomach or throwing up.
  • Sweating a lot.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Adverse Reactions

Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following:

  • Respiratory depression [see Warnings and Precautions (5.2) and Overdosage (10)]
  • Drug dependence [see Warnings and Precautions (5.3)]
  • Increased intracranial pressure [see Warnings and Precautions (5.4) and Overdosage (10)]
  • Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.5)]
  • Paralytic ileus [see Warnings and Precautions (5.6)]

Use of pseudoephedrine, a sympathomimetic amine, may result in the following:

  • Central nervous system effects such as insomnia, dizziness, weakness, tremor, or convulsions [see Warnings and Precautions (5.9)]
  • Cardiovascular system effects such as arrhythmias, or increased blood pressure, cardiovascular collapse with accompanying hypotension [see Warnings and Precautions (5.9)]

The most common adverse reactions are central nervous system and cardiovascular reactions and include the following: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, sleeplessness, tremor or arrhythmia.

Other adverse reactions include:

Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation.

Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention.

Cardiovascular System: Fast, slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitation, shock-like state, syncope.

Dermatological System: Skin rash, pruritus.

Rezira - Clinical Pharmacology

Mechanism of Action

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone will depress respiration. Hydrocodone can produce miosis, euphoria, and physical and physiological dependence.

Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to the common cold. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.

Pharmacokinetics

Systemic exposure (in terms of peak plasma concentrations and area under plasma concentration versus time curve) of hydrocodone bitartrate and pseudoephedrine hydrochloride after single-dose administration of 5 mg hydrocodone and 60 mg pseudoephedrine are equivalent to respective reference solutions of 5 mL hydrocodone bitartrate (5 mg/5 mL) and 5 mL pseudoephedrine hydrochloride (60 mg/5 mL).

Hydrocodone had a mean (SD) peak plasma concentration of 10.6 (2.63) ng/mL at 1.4 (0.55) hours. The mean plasma half-life of hydrocodone is approximately 4.9 hours. Pseudoephedrine had a mean (SD) peak plasma concentration of 212 (46.2) ng/mL at 1.8 (0.56) hours. The mean plasma half-life of pseudoephedrine is approximately 5.6 hours.

Specific Populations

Renal Impairment

Pseudoephedrine is primarily excreted unchanged in the urine as unchanged drug with the remainder apparently being metabolized in the liver. Therefore, pseudoephedrine may accumulate in patients with renal impairment.

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.

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