Do not use the extended-release form of hydrocodone to relieve pain that is mild or that will go away in a few days. This medication is not for occasional (“as needed”) use.
How to use Hysingla ER
Take this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain. Take this medication by mouth as directed by your doctor, usually once daily (24 hours apart). Do not pre-soak, lick, or otherwise wet the tablet before placing it in your mouth, since it may make it harder to swallow the tablet. If your dose is for more than one tablet, you should take one tablet at a time. Take each tablet with enough water to make sure you completely swallow it right after placing it in your mouth.
Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).
The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Properly stop the medication when so directed.
Before you start using this medication, ask your doctor or pharmacist if you should stop or change how you use your other opioid medication(s). Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using hydrocodone safely with other drugs.
Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
See also Warning section.
Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
Get medical help right away if you have any very serious side effects, including: fainting, fast/irregular heartbeat, severe dizziness, seizure, slow/shallow breathing, severe drowsiness/difficulty waking up.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Before taking hydrocodone, tell your doctor or pharmacist if you are allergic to it; or to other opioids (such as benzhydrocodone, codeine, hydromorphone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease–COPD), gallbladder disease, kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), disease of the pancreas (pancreatitis), difficulty urinating (such as due to enlarged prostate), trouble swallowing.
Hydrocodone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using hydrocodone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills“) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using hydrocodone safely.
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)
This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Other medications can affect the removal of hydrocodone from your body, which may affect how hydrocodone works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), mifepristone, HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, oxycodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
DOSAGE AND ADMINISTRATION
Important Dosage And Administration Information
HYSINGLA ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Daily doses of HYSINGLA ER greater than or equal to 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS ANDPRECAUTIONS].
- Initiate the dosing regimen for each patient individually; taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS].
- Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with HYSINGLA ER and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].
Instruct patients to swallow HYSINGLA ER tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in the mouth [see PATIENT INFORMATION]. Instruct patients not to pre-soak, lick, or otherwise wet the tablet prior to placing in the mouth [see WARNINGS AND PRECAUTIONS]. Crushing, chewing, or dissolving HYSINGLA ER tablets will result in uncontrolled delivery of hydrocodone and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].
HYSINGLA ER is administered orally once daily (every 24 hours). Multiple tablets of lower dose strengths that provide the desired total daily dose can be taken as a once daily dose.
Use Of HYSINGLA ER As The First Opioid Analgesic (opioid-naÃ¯ve patients)
Initiate therapy with HYSINGLA ER 20 mg orally every 24 hours.
Use Of HYSINGLA ER In Patients Who Are Not Opioid Tolerant (opioid non-tolerant patients)
The starting dose for patients who are not opioid tolerant is HYSINGLA ER 20 mg orally every 24 hours.
Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see WARNINGS AND PRECAUTIONS].
Conversion From Oral Hydrocodone Formulations To HYSINGLA ER
Patients receiving other oral hydrocodone-containing formulations may be converted to HYSINGLA ER by administering the patient’s total daily oral hydrocodone dose as HYSINGLA ER once daily.
Conversion From Other Oral Opioids To HYSINGLA ER
Discontinue all other around-the-clock opioid drugs when HYSINGLA ER therapy is initiated.
There is inter-patient variability in the relative potency of opioid drugs and formulations. Therefore, a conservative approach is advised when determining the total daily dosage of HYSINGLA ER. It is safer to underestimate a patient’s 24-hour oral hydrocodone dosage and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral hydrocodone dosage and manage an adverse reaction due to an overdose.
In a HYSINGLA ER clinical trial with an open-label titration period, patients were converted from their prior opioid to HYSINGLA ER using Table 1 as a guide for the initial HYSINGLA ER dose. To obtain the initial HYSINGLA ER dose, first use Table 1 to convert the prior oral opioids to a total hydrocodone daily dose and then reduce the calculated daily hydrocodone dose by 25% to account for interpatient variability in relative potency of different opioids.
Consider the following when using the information found in Table 1.
- This is not a table of equianalgesic doses.
- The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to HYSINGLA ER.
- The table cannot be used to convert from HYSINGLA ER to another opioid. Doing so will result in an over-estimation of the dose of the new opioid and may result in fatal overdose
Table 1: Conversion factors to HYSINGLA ER (Not Equianalgesic Doses)
|Opioid||Oral dose (mg)||Approximate oral conversion factor|
To calculate the estimated total hydrocodone daily dose using Table 1:
- For patients on a single opioid, sum the current total daily dose of the opioid and then multiply the total daily dose by the approximate oral conversion factor to calculate the approximate oral hydrocodone daily dose.
- For patients on a regimen of more than one opioid, calculate the approximate oral hydrocodone dose for each opioid and sum the totals to obtain the approximate oral hydrocodone daily dose.
- For patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion.
- Reduce the calculated daily oral hydrocodone dose by 25%
Always round the dose down, if necessary, to the nearest HYSINGLA ER tablet strength available and initiate therapy with that dose. If the converted HYSINGLA ER dose using Table 1 is less than 20 mg, initiate therapy with HYSINGLA ER 20 mg.
Example conversion from a single opioid to HYSINGLA ER: For example, a total daily dose of oxycodone 50 mg would be converted to hydrocodone 50 mg based on the table above, and then multiplied by 0.75 (ie, take a 25 % reduction) resulting in a dose of 37.5 mg hydrocodone. Round this down to the nearest dose strength available, HYSINGLA ER 30 mg, to initiate therapy.
Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of over-sedation/toxicity after converting patients to HYSINGLA ER.
Conversion From Methadone To HYSINGLA ER
Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.
Conversion from Transdermal Fentanyl to HYSINGLA ER
Eighteen hours following the removal of the transdermal fentanyl patch, HYSINGLA ER treatment can be initiated. For each 25 mcg/hr fentanyl transdermal patch, a dose of HYSINGLA ER 20 mg every 24 hours represents a conservative initial dose. Follow the patient closely during conversion from transdermal fentanyl to HYSINGLA ER, as there is limited experience with this conversion.
Conversion from Transdermal Buprenorphine to HYSINGLA ER
All patients receiving transdermal buprenorphine ( ≤ 20 mcg/hr) should initiate therapy with HYSINGLA ER 20 mg every 24 hours. Follow the patient closely during conversion from transdermal buprenorphine to HYSINGLA ER, as there is limited experience with this conversion.
Titration And Maintenance Of Therapy
Individually titrate HYSINGLA ER to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving HYSINGLA ER to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS AND PRECAUTIONS.] Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.
Patients who experience breakthrough pain may require a dosage adjustment of HYSINGLA ER, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the HYSINGLA ER dosage. Adjust the dose of HYSINGLA ER in increments of 10 mg to 20 mg every 3 to 5 days as needed to achieve adequate analgesia.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Dosage Modifications In Patients With Severe Hepatic Impairment
Patients with severe hepatic impairment may have higher plasma concentrations of hydrocodone than those with normal function. Initiate therapy with one half the initial dose of HYSINGLA ER in these patients and monitor closely for respiratory depression, sedation, and hypotension [see CLINICAL PHARMACOLOGY].
Dosage Modifications In Patients With Moderate To Severe Renal Impairment
Patients with moderate to severe renal impairment, and end-stage renal disease may have higher plasma concentrations than those with normal function. Initiate therapy with one half the initial dose of HYSINGLA ER in these patients and monitor closely for respiratory depression, sedation, and hypotension [see CLINICAL PHARMACOLOGY].
Discontinuation Of HYSINGLA ER
Do not abruptly discontinue HYSINGLA ER. When the patient no longer requires therapy with HYSINGLA ER, taper the dose gradually by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patients develop these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. The dose may be reduced every 2-4 days. The next dose should be at least 50% of the prior dose. After reaching HYSINGLA ER 20 mg dose for 2 to 4 days, HYSINGLA ER can be discontinued.
Dosage Forms And Strengths
- 20 mg film-coated extended-release tablets (round, green-colored, bi-convex tablets printed with “HYD 20”)
- 30 mg film-coated extended-release tablets (round, yellow-colored, bi-convex tablets printed with “HYD 30”)
- 40 mg film-coated extended-release tablets (round, grey-colored, bi-convex tablets printed with “HYD 40”)
- 60 mg film-coated extended-release tablets (round, beige-colored, bi-convex tablets printed with “HYD 60”)
- 80 mg film-coated extended-release tablets (round, pink-colored, bi-convex tablets printed with “HYD 80”)
- 100 mg film-coated extended-release tablets (round, blue-colored, bi-convex tablets printed with “HYD 100”)
- 120 mg film-coated extended-release tablets (round, white-colored, bi-convex tablets printed with “HYD 120”)
Storage And Handling
HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, biconvex tablets printed with “HYD 20” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-271-60).
HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 30 mg are round, yellow-colored, biconvex tablets printed with “HYD 30” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-272-60).
HYSINGLA ER (hydrocodone bitartrate )extended-release tablets 40 mg are round, grey-colored, biconvex tablets printed with “HYD 40” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-273-60).
HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 60 mg are round, beige-colored, biconvex tablets printed with “HYD 60” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-274-60).
HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 80 mg are round, pink-colored, biconvex tablets printed with “HYD 80” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-275-60).
HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 100 mg are round, blue-colored, biconvex tablets printed with “HYD 100” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-276-60).
HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 120 mg are round, white-colored, biconvex tablets printed with “HYD 120” and are supplied in child-resistant closure, opaque plastic bottles of 60 (NDC 59011-277-60).
Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].