Hysingla ER

Name: Hysingla ER

Side Effects of Hysingla ER

Serious side effects have been reported with Hysingla ER. See the Hysingla ER Precautions” section.

Common side effects of Hysingla ER include the following:

  • Nausea
  • Vomiting
  • Constipation
  • Drowsiness
  • Dizziness
  • Lightheadedness
  • Headache
  • Fuzzy thinking
  • Anxiety
  • Abnormally happy or abnormally sad mood
  • Dry throat
  • Difficulty urinating
  • Rash
  • Itching
  • Narrowing of the pupils
  • Upper respiratory tract infection

This is not a complete list of Hysingla ER side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Hysingla ER Interactions

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • Antidepressants
  • Antihistamines
  • Antipsychotics (medications for mental illness)
  • Ipratropium (Atrovent)
  • Medications for irritable bowel disease, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
  • Monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
  • Sedatives
  • Sleeping pills
  • Tranquilizers

This is not a complete list of Hysingla ER drug interactions. Ask your doctor or pharmacist for more information.

Hysingla ER Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Hysingla ER, there are no specific foods that you must exclude from your diet when receiving this medication.

Do not drink alcohol or take products containing alcohol while taking Hysingla ER.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Commonly used brand name(s)

In the U.S.

  • Hysingla ER
  • Vantrela ER
  • Zohydro ER

In Canada

  • Hycodan
  • Robidone

Available Dosage Forms:

  • Tablet, Extended Release
  • Capsule, Extended Release
  • Liquid
  • Syrup
  • Tablet

Therapeutic Class: Analgesic

Chemical Class: Hydrocodone

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Very bad dizziness or passing out.
  • Chest pain or pressure.
  • Trouble breathing, slow breathing, or shallow breathing.
  • Swelling in the arms or legs.
  • A burning, numbness, or tingling feeling that is not normal.
  • A fast heartbeat.
  • Feeling confused.
  • Very hard stools (constipation).
  • Very bad belly pain.
  • Feeling very tired or weak.
  • Mood changes.
  • Very bad headache.
  • Memory problems or loss.
  • Pain when passing urine.
  • Seizures.
  • Choking.
  • Trouble swallowing.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this medicine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Taking an opioid drug like Hysingla ER may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.
  • Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Hysingla ER is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Hysingla ER or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Hysingla ER. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Indications and Usage for Hysingla ER

Hysingla ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use


  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve Hysingla ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Hysingla ER is not indicated as an as-needed (prn) analgesic.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

Addiction, Abuse, and Misuse
Inform patients that the use of Hysingla ER, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose or death [see Warnings and Precautions (5.1)]. Instruct patients not to share Hysingla ER with others and to take steps to protect HYSINGLA ER from theft or misuse.

Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting HYSINGLA ER or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.2)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.2)]. Instruct patients to take steps to store Hysingla ER securely and to dispose of unused Hysingla ER by flushing the tablets down the toilet.

Interaction with Benzodiazepines and other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if Hysingla ER is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.5), Drug Interactions (7)].

Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications[see Drug Interactions (7)].

MAOI Interaction
Inform patients to avoid taking Hysingla ER while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Hysingla ER [see Drug Interactions (7)].

Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.7)].

Important Administration Instructions
Instruct patients how to properly take Hysingla ER, including the following:

  • Use Hysingla ER exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression) [see Warnings and Precautions (5.2)].
  • Swallow tablets whole, one tablet at a time, with enough water to ensure swallowing immediately after placing in the mouth [see Dosage and Administration (2.1)].
  • Do not pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth [see Dosage and Administration (2.1)].
  • Do not chew, crush, or dissolve the tablets [see Dosage and Administration (2.1)].
  • Do not discontinue Hysingla ER without first discussing the need for a tapering regimen with the prescriber [see Dosage and Administration (2.6)].

Hypotension
Inform patients that Hysingla ER may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.8)].

QTc interval prolongation
Inform patients that QT prolongation has been observed with Hysingla ER [see Clinical Pharmacology (12.2)]. Hysingla ER should be avoided in patients with congenital long QT syndrome. Instruct patients with a history of congestive heart failure or bradyarrhythmias, and patients at risk for electrolyte abnormalities or who are taking other medications known to prolong the QT interval, that periodic monitoring of electrocardiograms and electrolytes may be necessary during therapy with Hysingla ER [see Warnings and Precautions (5.9)].

Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in Hysingla ER. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindication (4), Adverse Reactions (6)].

Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of HYSINGLA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)].

Embryo-Fetal Toxicity
Inform female patients of reproductive potential that Hysingla ER can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Lactation
Advise patients that breastfeeding is not recommended during treatment with Hysingla ER [see Use in Specific Populations (8.2)]

Infertility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2) Use in Specific Populations (8.3)].

Driving or Operating Heavy Machinery
Inform patients that Hysingla ER may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Blood levels of hydrocodone, in some patients, may be high at the end of 24 hours after repeated dose administration. Advise patients not to perform such tasks until they know how they will react to the medication [see Warnings and Precautions (5.15)].

Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention. Instruct patients to monitor their analgesic response following the use of strong laxatives and to contact the prescriber if changes are noted [see Adverse Reactions (6), Clinical Pharmacology (12.2)].

Disposal of unused Hysingla ER
Advise patients to dispose of any unused tablets from a prescription as soon as they are no longer needed by flushing down the toilet.

Healthcare professionals can telephone Purdue Pharma’s Medical Services Department (1-888-726-7535) for information on this product.

Purdue Pharma L.P.
Stamford, CT 06901-3431

©2016, Purdue Pharma L.P.

U.S. Patent Numbers: 6,488,963; 6,733,783; 8,309,060; 8,361,499; 8,529,948; 8,551,520; 8,647,667 and 8,808,740. 9,023,401;9,056,052;9,060,940;9,084,816;9,101,661;9,095,614;9,095,615;9,198,863;9,205,055;9,205,056;9,289,391;9,393,206;9,486,412;9,486,413;9,492,389;9,492,390; and 9,492,391

Medication Guide
HYSINGLA™ ER (hye-SING-luh)
(hydrocodone bitartrate) extended-release tablets, CII
Hysingla ER is:
  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not for use to treat pain that is not around-the-clock.
Important information about Hysingla ER:
  • Get emergency help right away if you take too much Hysingla ER (overdose). When you first start taking HYSINGLA ER, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
  • Taking Hysingla ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
  • Never give anyone else your Hysingla ER. They could die from taking it. Store Hysingla ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away HYSINGLA ER is against the law.
Do not take Hysingla ER if you have:
  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.
Before taking HYSINGLA ER, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • heart rhythm problems (long QT syndrome)
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems
Tell your healthcare provider if you are:
  • pregnant or planning to become pregnant. Prolonged use of Hysingla ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. Not recommended during treatment with Hysingla ER. It may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Hysingla ER with certain other medicines can cause serious side effects and could lead to death.
When taking Hysingla ER:
  • Do not change your dose. Take Hysingla ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 24 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time the next day.
  • Swallow Hysingla ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject Hysingla ER because this may cause you to overdose and die.
  • Hysingla ER should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing it in your mouth to avoid choking on the tablet..
Call your healthcare provider if the dose you are taking does not control your pain.
  • Do not stop taking Hysingla ER without talking to your healthcare provider.
  • After you stop taking Hysingla ER, flush any unused tablets down the toilet.
While taking HYSINGLA ER, DO NOT:
  • Drive or operate heavy machinery until you know how HYSINGLA ER affects you. Hysingla ER can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Hysingla ER may cause you to overdose and die.
The possible side effects of Hysingla ER are:
  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Hysingla ER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Manufactured by: Purdue Pharma L.P., Stamford, CT 06901-3431, www.purduepharma.com or call 1-888-726-7535


This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issue: 12/2016

HYSINGLA ER 20 mg

HYSINGLA ER 30 mg

HYSINGLA ER 40 mg

HYSINGLA ER 60 mg

HYSINGLA ER 80 mg

HYSINGLA ER 100 mg

HYSINGLA ER 120 mg

Hysingla ER 
hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-272
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 30 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)  
POLYETHYLENE GLYCOL 3350  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
POLYETHYLENE GLYCOLS  
MAGNESIUM STEARATE  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;30
Contains     
Packaging
# Item Code Package Description
1 NDC:59011-272-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
Hysingla ER 
hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-271
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 20 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)  
POLYETHYLENE GLYCOL 3350  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
BUTYLATED HYDROXYTOLUENE  
COCHINEAL  
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;20
Contains     
Packaging
# Item Code Package Description
1 NDC:59011-271-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
Hysingla ER 
hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-273
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 40 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)  
POLYETHYLENE GLYCOL 3350  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
FERRIC OXIDE RED  
FERROSOFERRIC OXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color GRAY Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;40
Contains     
Packaging
# Item Code Package Description
1 NDC:59011-273-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
Hysingla ER 
hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-274
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 60 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)  
POLYETHYLENE GLYCOL 3350  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
FERRIC OXIDE YELLOW  
FERRIC OXIDE RED  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color WHITE (Beige) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;60
Contains     
Packaging
# Item Code Package Description
1 NDC:59011-274-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
Hysingla ER 
hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-275
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 80 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)  
POLYETHYLENE GLYCOL 3350  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
FERRIC OXIDE RED  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;80
Contains     
Packaging
# Item Code Package Description
1 NDC:59011-275-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
Hysingla ER 
hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-276
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 100 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)  
POLYETHYLENE GLYCOL 3350  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;100
Contains     
Packaging
# Item Code Package Description
1 NDC:59011-276-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
Hysingla ER 
hydrocodone bitartrate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-277
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 120 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)  
POLYETHYLENE GLYCOL 3350  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
BUTYLATED HYDROXYTOLUENE  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code HYD;120
Contains     
Packaging
# Item Code Package Description
1 NDC:59011-277-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA206627 01/15/2015
Labeler - Purdue Pharma LP (932323652)
Registrant - Purdue Pharma LP (932323652)
Establishment
Name Address ID/FEI Operations
Purdue Pharmaceuticals L.P. 132080875 MANUFACTURE(59011-276, 59011-277, 59011-273, 59011-275, 59011-271, 59011-274, 59011-272)
Revised: 12/2016   Purdue Pharma LP

Hysingla ER dosing information

Usual Adult Dose for Pain:

Hysingla ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Initial dose: 10 mg orally every 12 hours

Titration: The dose should be increased in increments of 10 mg orally every 12 hours every 3 to 7 days as needed to achieve adequate analgesia. Hysingla ER should be titrated to a dose that provides adequate analgesia and minimizes adverse reactions. Patients should be monitored routinely to assess the maintenance of pain control and incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Patients who experience breakthrough pain may require a dose increase, or may need a rescue medication with an appropriate dose of an immediate-release analgesic.
-If unacceptable adverse reactions are observed, the dose may be reduced. The dose should be adjusted to obtain an appropriate balance between management of pain and adverse reactions.

Maximum dose: A single dose of Hysingla ER greater than 40 or 50 mg, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established.

Approved indication: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

What should I avoid while taking Hysingla ER?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with hydrocodone. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Hysingla ER will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

For the Consumer

Applies to hydrocodone: oral capsule extended release, oral liquid, oral syrup, oral tablet, oral tablet extended release

Along with its needed effects, hydrocodone (the active ingredient contained in Hysingla ER) 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 while taking hydrocodone:

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 while taking hydrocodone:

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
  • pale skin
  • sleepiness or unusual drowsiness
  • slow or irregular heartbeat
  • weak muscle tone

Some side effects of hydrocodone 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

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