Hysingla ER - Dosage hydrocodone bitartrate

HYSINGLA ER (hydrocodone bitartrate tablet, extended release) comes in different strengths and amounts, which is referred to as the dosing of Hysingla ER. The appearance of Hysingla ER can differ based on the dosing. Your doctor may change the dosage and prescription of Hysingla ER to get you the best results possible.

Dosage & Administration

important dosageand administration information

HYSINGLA ER should be prescribed only byhealthcare professionals who are knowledgeable in the use of potentopioids for the management of chronic pain.

Daily doses of HYSINGLA ER greater than orequal to 80 mg are only for use in patients in whom tolerance to anopioid of comparable potency has been established. Patients who areopioid tolerant are those receiving, for one week or longer, at least60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour,30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or anequianalgesic dose of another opioid.

  • Use the lowest effective dosage for the shortest durationconsistent with individual patient treatment goals [see Warningsand Precautions (5)].
  • 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 (5.1)].
  • Monitor patients closely for respiratory depression, especiallywithin the first 24-72 hours of initiating therapy and following dosageincreases with HYSINGLA ER and adjust the dosage accordingly [see Warnings and Precautions (5.3)].

Instruct patients toswallow HYSINGLA ER tablets whole, one tablet at a time, with enoughwater to ensure complete swallowing immediately after placing in themouth [see Patient Counseling Information (17)]. Instruct patients not topre-soak, lick, or otherwise wet the tablet prior to placing in themouth [see Warnings and Precautions (5.12)]. Crushing, chewing, or dissolving HYSINGLAER tablets will result in uncontrolled delivery of hydrocodone andcan lead to overdose or death [see Warnings and Precautions(5.1)].

HYSINGLA ER is administered orally once daily(every 24 hours). Multiple tablets of lower dose strengths that providethe desired total daily dose can be taken as a once daily dose.

initial dosage

Use of HYSINGLA ERas the First Opioid Analgesic (opioid-naïve patients)

Initiate therapy with HYSINGLAER 20 mg orally every 24 hours.

Use of HYSINGLA ER in Patientswho are not Opioid Tolerant (opioid non-tolerant patients)
The starting dose for patients who are not opioid tolerant is HYSINGLAER 20 mg orally every 24 hours.

Use of higher starting doses in patients whoare not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions (5.3)].

Conversion from Oral Hydrocodone Formulations to HYSINGLA ER
Patients receiving other oral hydrocodone-containingformulations may be converted to HYSINGLA ER by administering thepatient's total daily oral hydrocodone dose as HYSINGLA ER once daily.

Conversion fromOther Oral Opioids to HYSINGLA ER
Discontinueall other around-the-clock opioid drugs when HYSINGLA ER therapy isinitiated.

Thereis inter-patient variability in the relative potency of opioid drugsand formulations. Therefore, a conservative approach is advised whendetermining the total daily dosage of HYSINGLA ER. It is safer tounderestimate a patient’s 24-hour oral hydrocodone dosage and providerescue medication (e.g., immediate-release opioid) than to overestimatethe 24-hour oral hydrocodone dosage and manage an adverse reactiondue 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 usingTable 1 as a guide for the initial HYSINGLA ER dose. To obtain theinitial HYSINGLA ER dose, first use Table 1 to convert the prior oralopioids to a total hydrocodone daily dose and then reduce the calculateddaily hydrocodone dose by 25% to account for interpatient variabilityin relative potency of different opioids.

Consider the following when using theinformation found in Table 1.

  • This is not a tableof equianalgesic doses.
  • The conversion factors in this table are only for the conversion from one of the listed oral opioidanalgesics to HYSINGLA ER.
  • The table cannot beused to convert from HYSINGLAER to another opioid. Doing so will result in an over-estimation ofthe dose of the new opioid and may result in fatal overdose
Table 1. Conversion factors to HYSINGLA ER (Not EquianalgesicDoses)
Opioid Oral dose (mg) Approximate oral conversion factor
Codeine 133 0.15
Hydromorphone 5 4
Methadone 13.3 1.5
Morphine 40 0.5
Oxycodone 20 1
Oxymorphone 10 2
Tramadol 200 0.1

To calculate the estimatedtotal hydrocodone daily dose using Table 1:

  • For patients on a single opioid, sum the current total dailydose of the opioid and then multiply the total daily dose by the approximateoral conversion factor to calculate the approximate oral hydrocodonedaily dose.
  • For patients on a regimen of more than one opioid, calculatethe approximate oral hydrocodone dose for each opioid and sum thetotals to obtain the approximate oral hydrocodone daily dose.
  • For patients on a regimen of fixed-ratio opioid/non-opioidanalgesic products, use only the opioid component of these productsin the conversion.
  • Reduce the calculated daily oral hydrocodone dose by 25%

Always round the dosedown, if necessary, to the nearest HYSINGLA ER tablet strength availableand initiate therapy with that dose. If the converted HYSINGLA ERdose using Table 1 is less than 20 mg, initiate therapy with HYSINGLAER 20 mg.

Exampleconversion from a single opioid to HYSINGLA ER:
For example,a total daily dose of oxycodone 50 mg would be converted to hydrocodone50 mg based on the table above, and then multiplied by 0.75 (ie, takea 25 % reduction) resulting in a dose of 37.5 mg hydrocodone. Roundthis down to the nearest dose strength available, HYSINGLA ER 30 mg,to initiate therapy.

Close observation and frequent titration are warranted until painmanagement is stable on the new opioid. Monitor patients for signsand symptoms of opioid withdrawal or for signs of over-sedation/toxicityafter converting patients to HYSINGLA ER.

Conversion from Methadone toHYSINGLA ER
Close monitoring is of particularimportance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widelyas a function of previous dose exposure. Methadone has a long half-lifeand can accumulate in the plasma.

Conversion from Transdermal Fentanylto HYSINGLA ER
Eighteen hours following theremoval of the transdermal fentanyl patch, HYSINGLA ER treatment canbe initiated. For each 25 mcg/hr fentanyl transdermal patch, a doseof HYSINGLA ER 20 mg every 24 hours represents a conservative initialdose. Follow the patient closely during conversion from transdermalfentanyl to HYSINGLA ER, as there is limited experience with thisconversion.

Conversion from Transdermal Buprenorphine to HYSINGLA ER
All patients receiving transdermal buprenorphine (≤ 20mcg/hr) should initiate therapy with HYSINGLA ER 20 mg every 24 hours. Follow the patient closely during conversion from transdermal buprenorphineto HYSINGLA ER, as there is limited experience with this conversion.

titration & maintenanceof therapy

Individually titrate HYSINGLA ER to a dose that provides adequateanalgesia and minimizes adverse reactions. Continually reevaluatepatients receiving HYSINGLA ER to assess the maintenance of pain controland the relative incidence of adverse reactions, as well as monitoringfor the development of addiction, abuse, or misuse [see Warningsand Precautions (5.1). Frequentcommunication is important among the prescriber, other members ofthe healthcare team, the patient, and the caregiver/family duringperiods of changing analgesic requirements, including initial titration.During chronic therapy, periodically reassess the continued need forthe use of opioid analgesics.

Patients who experience breakthrough painmay require a dosage adjustment of HYSINGLA ER, or may need rescuemedication with an appropriate dose of an immediate-release analgesic.If the level of pain increases after dose stabilization, attempt toidentify the source of increased pain before increasing the HYSINGLAER dosage. Adjust the dose of HYSINGLA ER in increments of 10 mgto 20 mg every 3 to 5 days as needed to achieve adequate analgesia.

If unacceptable opioid-relatedadverse reactions are observed, consider reducing the dosage. Adjustthe dosage to obtain an appropriate balance between management ofpain and opioid-related adverse reactions.

dosage modificationsin patients with severe hepatic impairment

Patients with severe hepatic impairment mayhave higher plasma concentrations of hydrocodone than those with normalfunction. Initiate therapy with one half the initial dose of HYSINGLAER in these patients and monitor closely for respiratory depression,sedation, and hypotension [see Clinical Pharmacology (12.3)].

dosage modificationsin patients with moderate to severe renal impairment

Patients with moderate to severerenal impairment, and end-stage renal disease may have higher plasmaconcentrations than those with normal function. Initiate therapy withone half the initial dose of HYSINGLA ER in these patients and monitorclosely for respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3)].

discontinuation ofhysingla er

Do not abruptly discontinue HYSINGLA ER. When the patient no longerrequires therapy with HYSINGLA ER, taper the dose gradually by 25%to 50% every 2 to 4 days, while monitoring carefully for signs andsymptoms of withdrawal. If the patients develop these signs or symptoms,raise the dose to the previous level and taper more slowly, eitherby increasing the interval between decreases, decreasing the amountof change in dose, or both. The dose may be reduced every 2 to 4days. The next dose should be at least 50% of the prior dose. Afterreaching HYSINGLA ER 20 mg dose for 2 to 4 days, HYSINGLA ER can bediscontinued.

Dosage Form & 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”)

Overdosage

Clinical Presentation

Acute overdosage with HYSINGLA ER can bemanifested by respiratory depression, somnolence progressing to stuporor coma, skeletal muscle flaccidity, cold and clammy skin, constrictedpupils, and, in some cases, pulmonary edema, bradycardia, hypotension,partial or complete airway obstruction, atypical snoring, and death.Marked mydriasis rather than miosis may be seen with hypoxia in overdosesituations [see Clinical Pharmacology (12.2)].

Treatment of Overdose

In case of overdose,priorities are the re-establishment of a patent airway and institutionof assisted or controlled ventilation, if needed. Employ other supportivemeasures (including oxygen and vasopressors) in the management ofcirculatory shock and pulmonary edema accompanying overdose as indicated.Cardiac arrest or arrhythmias will require advanced life support techniques.

The opioid antagonists, naloxoneor nalmefene, are specific antidotes to respiratory depression resultingfrom opioid overdosage. For clinically significant respiratory orcirculatory depression secondary to hydrocodone overdose, administeran opioid antagonist. Opioid antagonists should not be administeredin the absence of clinically significant respiratory or circulatorydepression secondary to hydrocodone overdose.

Because the duration of opioid reversalis expected to be less than the duration of action of hydrocodonein HYSINGLA ER, carefully monitor the patient until spontaneous respirationis reliably reestablished. HYSINGLA ER will continue to release hydrocodoneand add to the hydrocodone load for 24 to 48 hours or longer followingingestion, necessitating prolonged monitoring. If the response toan opioid antagonist is suboptimal or only brief in nature, administeradditional antagonist as directed by the product’s prescribing information.

In an individual physicallydependent on opioids, administration of the recommended dose of theantagonist will precipitate an acute withdrawal syndrome. The severityof the withdrawal syndrome produced will depend on the degree of physicaldependence and the dose of the antagonist administered. If a decisionis made to treat serious respiratory depression in the physicallydependent patient, administration of the antagonist should be initiatedwith care and by titration with smaller than usual doses of the antagonist.

Storage & Handling

HYSINGLA ER (hydrocodonebitartrate) extended-release tablets 20 mg are round, green-colored,bi-convex tablets printed with “HYD 20” and are supplied in child-resistantclosure, opaque plastic bottles of 60 (NDC 59011-271-60).

HYSINGLA ER (hydrocodone bitartrate)extended-release tablets 30 mg are round, yellow-colored, bi-convextablets printed with “HYD 30” and are supplied in child-resistantclosure, opaque plastic bottles of 60 (NDC 59011-272-60).

HYSINGLA ER (hydrocodone bitartrate)extended-release tablets 40 mg are round, grey-colored, bi-convextablets printed with “HYD 40” and are supplied in child-resistantclosure, opaque plastic bottles of 60 (NDC 59011-273-60).

HYSINGLA ER (hydrocodone bitartrate)extended-release tablets 60 mg are round, beige-colored, bi-convextablets printed with “HYD 60” and are supplied in child-resistantclosure, opaque plastic bottles of 60 (NDC 59011-274-60).

HYSINGLA ER (hydrocodone bitartrate)extended-release tablets 80 mg are round, pink-colored, bi-convextablets printed with “HYD 80” and are supplied in child-resistantclosure, opaque plastic bottles of 60 (NDC 59011-275-60).

HYSINGLA ER (hydrocodone bitartrate)extended-release tablets 100 mg are round, blue-colored, bi-convextablets printed with “HYD 100” and are supplied in child-resistantclosure, opaque plastic bottles of 60 (NDC 59011-276-60).

HYSINGLA ER (hydrocodone bitartrate)extended-release tablets 120 mg are round, white-colored, bi-convextablets printed with “HYD 120” and are supplied in child-resistantclosure, opaque plastic bottles of 60 (NDC 59011-277-60).

Store at 25°C (77°F); excursionspermitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistantcontainer, as defined by the USP.

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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