Vantrela ER (Oral)

Hydrocodone is used to relieve pain in patients who are tolerant to opioids and have severe pain that needs constant relief for a long time. It should not be used if you need pain relief for only a short time, like after surgery. Do not use this medicine for mild pain. This medicine should not be used for pain that happens occasionally or "as needed."

Hydrocodone is part of a group of medicines called narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain.

Using hydrocodone for a long time may lead to habit-forming behavior, causing mental or physical dependence. However, people with ongoing pain should not avoid narcotics due to fear of dependence. Mental dependence (addiction) is unlikely when narcotics are used for pain relief. Physical dependence can cause withdrawal side effects if treatment is stopped suddenly. Severe withdrawal side effects can usually be avoided by slowly reducing the dose over time before stopping treatment completely.

This medicine is available only with a doctor's prescription. Hysingla® and Zohydro® are only available through a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important for your doctor to monitor your progress while you are taking this medicine, especially during the first 24 to 72 hours of treatment. This will help your doctor determine if the medicine is effective and if you should keep taking it. Blood and urine tests may be necessary to check for side effects.

This medicine can cause a serious allergic reaction known as anaphylaxis, which can be life-threatening and requires immediate medical help. Contact your doctor right away if you experience a rash, itching, hoarseness, difficulty breathing, trouble swallowing, or swelling of your hands, face, or mouth while using this medicine.

Do not use this medicine if you have taken an MAO inhibitor (MAOI) (e.g., isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) in the past 14 days.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not exceed your prescribed dose. Contact your doctor for guidance.

This medicine will enhance the effects of alcohol and other CNS depressants. CNS depressants are medications that slow down the nervous system, which may cause drowsiness or reduced alertness. Examples of CNS depressants include antihistamines or medicines for allergies or colds, sedatives, tranquilizers, sleeping medications, other prescription pain medications or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may persist for a few days after you stop taking this medicine. Consult your doctor before taking any of these medications while using this medicine.

This medicine may cause dizziness, drowsiness, or lightheadedness. Do not drive or engage in any activities that could be dangerous until you know how this medicine affects you.

Taking too much hydrocodone can lead to an overdose, which can be life-threatening. Signs of an overdose include: changes in consciousness, cold and clammy skin, dark urine, difficulty breathing, irregular, fast or slow, or shallow breathing, loss of consciousness, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils, excessive sleepiness or unusual drowsiness, or yellowing of the eyes or skin. In the event of an overdose, contact your doctor immediately. Your doctor may also administer naloxone to treat the overdose.

This medicine may cause problems with your adrenal glands. Contact your doctor right away if you notice darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur when you stand up quickly from a lying or sitting position. Getting up slowly may help reduce this issue. Lying down for a while may also relieve dizziness or lightheadedness.

Long-term use of narcotics can lead to severe constipation. To prevent this, your doctor may recommend laxatives, drinking plenty of fluids, or increasing fiber in your diet. Follow these directions carefully, as ongoing constipation can lead to more serious issues.

Contact your doctor immediately if you notice any changes in your heart rhythm. You may feel dizzy or faint, or experience a fast, pounding, or uneven heartbeat. Make sure your doctor is aware if you or anyone in your family has had a heart rhythm problem, including QT prolongation.

Do not stop or change your dose suddenly without consulting your doctor first. You may be advised to gradually reduce your dosage before stopping treatment completely or to take another narcotic for a while to reduce the risk of withdrawal symptoms (e.g., anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or difficulty sleeping).

Contact your doctor right away if you experience anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not real. These may be signs of a serious condition called serotonin syndrome. Your risk is higher if you are taking certain other medications that affect serotonin levels in your body.

Using this medicine during pregnancy may lead to neonatal withdrawal syndrome in newborns. Inform your doctor immediately if your baby exhibits an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, tremors, weight loss, vomiting, or does not gain weight.

For nursing mothers:

• Consult your doctor if you have any questions about taking hydrocodone or how this medicine may affect your baby.
• Contact your doctor if you become extremely tired and find it hard to care for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Seek immediate medical help if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, trouble breathing, or limpness. These may indicate an overdose and require urgent attention.

Using too much of this medicine may lead to infertility (the inability to have children). Speak with your doctor before using this medicine if you plan to conceive.

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

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

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other medicines. As well inform 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 serious sleepiness and age-related liver, kidney, heart, or lung issues, which may require caution and an adjustment in the dose for patients receiving hydrocodone.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medication while breastfeeding.

Interactions with Medications

Although certain medications 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 physician may want to change the dose, or other precautions may be necessary. When you are taking this drug, it is especially critical 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 advised. Your clinician may decide not to treat you with this medicine or change some of the other drugs you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this medication with any of the following medicines is typically not advised, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medications.

• Abametapir
• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Daridorexant
• Darunavir
• Dasabuvir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Lenacapavir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paritaprevir
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Piperacetazine
• Pipotiazine
• Piritramide
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

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 medications may as well 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 typically not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Other Medical Issues

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

• Addison disease (adrenal gland problem) or
• Alcohol abuse or
• Brain tumor, history of or
• Breathing or lung issues (eg, apnea, low oxygen levels) or
• Chronic obstructive pulmonary disease (COPD) or
• Congestive heart failure or
• Cor pulmonale (severe heart condition) or
• Depression, history of or
• Drug dependence, especially with narcotics abuse or dependence, history of or
• Electrolyte imbalance or
• Gallbladder problems or
• Head injury, history of or
• Heart rhythm problems (eg, congenital long QT syndrome, slow heartbeat) or
• Increased pressure in the head or
• Mental health issues, history of or
• Stomach or bowel problems or
• Trouble swallowing or
• Weakened immune system—Use with caution. May increase chance for more severe side effects.

• Asthma, acute or severe or
• Lung or breathing issues (eg, asthma, respiratory depression), severe or
• Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or
• Pancreatitis (swelling of the pancreas) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medication from the body.

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

• Bladder pain
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody or cloudy urine
• Body aches or pain
• Chills
• Cough
• Depression
• Difficult or labored breathing
• Difficult, burning, or painful urination
• Ear congestion
• Fear or nervousness
• Fever
• Frequent urge to urinate
• Headache
• Loss of voice
• Lower back or side pain
• Rapid weight gain
• Runny or stuffy nose
• Sneezing
• Sore throat
• Tightness in the chest
• Tingling of the hands or feet
• Unusual tiredness or weakness
• Unusual weight gain or loss

Incidence not known

• Agitation
• Darkening of the skin
• Diarrhea
• Difficulty swallowing
• Fast heartbeat
• Hives, itching, skin rash
• Loss of appetite
• Mental depression
• Nausea
• Overactive reflexes
• Poor coordination
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Restlessness
• Shivering
• Talking or acting with excitement you cannot control
• Trembling or shaking
• Twitching
• Vomiting

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
• 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
• Pale skin
• Sleepiness or unusual drowsiness
• Slow or irregular heartbeat
• Weak muscle tone

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

Less common

• Back pain
• Dry mouth
• Heartburn
• Muscle spasms
• Stomach pain or discomfort

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.

In the U.S.

• Hysingla ER
• Vantrela ER
• Zohydro ER

In Canada

• Hycodan
• pdp-HYDROcodone
• Robidone

Available Dosage Forms:

• Tablet, Extended Release
• Capsule, Extended Release

Therapeutic Class: Analgesic

Chemical Class: Hydrocodone

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.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

If you are using the extended-release capsules or extended-release tablets:

• Hydrocodone extended-release capsules or extended-release tablets are for use in opioid-tolerant patients only. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.
• Take this medicine at the same time each day, with or without food.
• Swallow the extended-release tablet whole. Do not crush, break, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth, or take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.

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 severe pain: For oral dosage form (extended-release capsules): Patients who are not taking narcotic medicines: 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. Patients switching from other narcotic medicines: Adults—The capsule is given every 12 hours. Your doctor will determine your dose and adjust the dose as needed. Children—Use and dose must be determined by your doctor. For oral dosage form (extended-release tablets): Patients who are not taking narcotic medicines: Adults— Hysingla® ER: At first, 20 milligrams (mg) every 24 hours. Your doctor may adjust your dose as needed. Vantrela™: At first, 15 mg every 12 hours. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. Patients switching from other narcotic medicines: Adults— Hysingla® ER: The tablet is given every 24 hours. Your doctor will determine your dose and adjust the dose as needed. Vantrela™: The tablet is given every 12 hours. Your doctor will determine your dose and adjust the 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.

If you miss a dose of Hysingla® ER, skip the missed dose and go back to your regular dosing schedule.

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.

Hydrocodone can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

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