Zohydro ER

Generic Name: hydrocodone (Oral route)

hye-droe-KOE-done bye-TAR-trate

Oral route(Capsule, Extended Release)

Hydrocodone bitartrate extended-release capsules is an opioid agonist. Assess each patient’s risk for opioid abuse or addiction prior to prescribing hydrocodone bitartrate extended-release capsules. Routinely monitor for signs of misuse, abuse, and addiction during treatment. Respiratory depression, including fatal cases, may occur with use of hydrocodone bitartrate extended-release capsules. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate extended-release capsules or following a dose increase. Accidental exposure to hydrocodone bitartrate extended-release capsules, especially in children, can result in a fatal overdose of hydrocodone bitartrate extended-release capsules. Infants exposed to opioids during pregnancy may require treatment for neonatal opioid withdrawal syndrome. Prolonged maternal use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome. Patients should not consume alcohol or any products containing alcohol during treatment due to a risk of fatal plasma hydrocodone levels .

Commonly used brand name(s)

In the U.S.

  • Zohydro ER

In Canada

  • Hycodan
  • Robidone

Available Dosage Forms:

  • Capsule, Extended Release
  • Liquid
  • Syrup
  • Tablet

Therapeutic Class: Analgesic

Chemical Class: Hydrocodone

Uses For Zohydro ER

Hydrocodone is used to treat severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

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When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly.

This medicine is available only with your doctor's prescription.

Before Using Zohydro ER

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone in the elderly. However, elderly patients are more likely to have confusion and severe drowsiness and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving hydrocodone.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone Acetate
  • Acetophenazine
  • Alfentanil
  • Alprazolam
  • Amobarbital
  • Amprenavir
  • Anileridine
  • Aprepitant
  • Baclofen
  • Bosentan
  • Bromazepam
  • Brotizolam
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Ceritinib
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Ciprofloxacin
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Codeine
  • Conivaptan
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dantrolene
  • Darunavir
  • Delavirdine
  • Dexamethasone
  • Dexmedetomidine
  • Dezocine
  • Diacetylmorphine
  • Diazepam
  • Difenoxin
  • Dihydrocodeine
  • Diltiazem
  • Diphenhydramine
  • Diphenoxylate
  • Dixyrazine
  • Doxylamine
  • Efavirenz
  • Enzalutamide
  • Erythromycin
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Etravirine
  • Fentanyl
  • Fluconazole
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Fospropofol
  • Furazolidone
  • Halazepam
  • Hydromorphone
  • Hydroxyzine
  • Imatinib
  • Indinavir
  • Iproniazid
  • Isocarboxazid
  • Itraconazole
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Levorphanol
  • Linezolid
  • Lomitapide
  • Lorazepam
  • Lormetazepam
  • Loxapine
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methylene Blue
  • Metopimazine
  • Miconazole
  • Midazolam
  • Mifepristone
  • Mitotane
  • Moclobemide
  • Modafinil
  • Morphine
  • Morphine Sulfate Liposome
  • Nafcillin
  • Nalbuphine
  • Nefazodone
  • Nevirapine
  • Nicomorphine
  • Nitrazepam
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxcarbazepine
  • Oxycodone
  • Oxymorphone
  • Papaveretum
  • Paregoric
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Phenytoin
  • Piperaquine
  • Pipotiazine
  • Piritramide
  • Posaconazole
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propiomazine
  • Propofol
  • Quazepam
  • Ramelteon
  • Rasagiline
  • Regorafenib
  • Remifentanil
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Secobarbital
  • Selegiline
  • Siltuximab
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Tapentadol
  • Telithromycin
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioproperazine
  • Thioridazine
  • Ticagrelor
  • Tilidine
  • Tizanidine
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Triazolam
  • Triflupromazine
  • Trimeprazine
  • Verapamil
  • Voriconazole
  • Zaleplon
  • Zolpidem
  • Zopiclone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Escitalopram

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

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:

  • Asthma, severe or
  • Breathing problems, severe (eg, hypercarbia) or
  • Paralytic ileus (intestine stops working and may be blocked), known or suspected or
  • Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.
  • Brain tumor or
  • Head injuries or
  • Increased pressure in the head—Hydrocodone can cause serious problems in people who have these medical problems.
  • Breathing problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia) or
  • Depression, history of or
  • Drug dependence, especially with narcotics, or history of or
  • Gallbladder problems or
  • Mental illness, history of or
  • Pancreatitis (inflammation or swelling of the pancreas) or
  • Stomach or bowel problems or
  • Weakened immune system—Use with caution. May increase risk for more serious side effects.
  • Hypotension (low blood pressure)—Use with caution. May make this condition worse.
  • Kidney disease or
  • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of hydrocodone

This section provides information on the proper use of a number of products that contain hydrocodone. It may not be specific to Zohydro ER. 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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. 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 these instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release capsule whole with water. Do not crush, break, chew, or dissolve it.

Take this medicine at the same time each day.

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 (extended-release capsule):
    • For severe pain:
      • Adults—At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

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.

Flush any unused capsules down the toilet.

Precautions While Using Zohydro ER

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Stand or sit up slowly if you are dizzy.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Do not suddenly stop or change your dose without first checking with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Zohydro ER 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:

Less common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • chills
  • cough
  • depression
  • difficult or labored breathing
  • ear congestion
  • fear or nervousness
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • rapid weight gain
  • runny nose
  • sneezing
  • sore throat
  • tightness in the chest
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Blue lips and fingernails
  • blurred vision
  • change in consciousness
  • chest pain or discomfort
  • cold and clammy skin
  • confusion
  • constricted pupil (black part of the eye)
  • coughing that sometimes produces a pink frothy sputum
  • decreased awareness or responsiveness
  • difficult, fast, noisy breathing, sometimes with wheezing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • increased sweating
  • irregular, fast or slow, or shallow breathing
  • lightheadedness, dizziness, or fainting
  • loss of consciousness
  • no muscle tone or movement
  • pale skin
  • severe sleepiness
  • sleepiness or unusual drowsiness
  • slow or irregular heartbeat

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
  • Difficulty having a bowel movement (stool)
  • nausea
Less common
  • Abdominal or stomach pain or discomfort
  • back pain
  • bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • dry mouth
  • frequent urge to urinate
  • heartburn
  • itching skin
  • lower back or side pain
  • muscle spasms
  • vomiting

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.

See also: Side effects (in more detail)

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