Hysingla ER

Generic name: hydrocodone (oral)
Drug class: Narcotic analgesics

Medically reviewed by A Ras MD.

What is Hysingla ER?

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.

Description

HYSINGLA ER (hydrocodone bitartrate) extended-release tablets are supplied in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg film-coated tablets for oral administration. The tablet strengths describe the amount of hydrocodone per tablet as the bitartrate salt.

Hydrocodone bitartrate is an opioid agonist. Its chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its structural formula is:

Empirical formula: C18H21NO3•C4H6O6•2½H2O; Molecular weight: 494.49.

Hydrocodone bitartrate exists as fine white crystals or a crystalline powder. It is affected by light. It is soluble in water, slightly soluble in alcohol, and insoluble in ether and chloroform.

The 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg tablets contain the following inactive ingredients: Butylated Hydroxytoluene (BHT, an additive in Polyethylene Oxide), Hydroxypropyl Cellulose, Macrogol/PEG 3350, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Oxide, Polysorbate 80, Polyvinyl Alcohol, Talc, Titanium Dioxide, and Black Ink.

The 20 mg tablets also contain Iron Oxide Yellow and FD&C Blue #2 Aluminum Lake/Indigo Carmine Aluminum Lake.
The 30 mg tablets also contain Iron Oxide Yellow.
The 40 mg tablets also contain Iron Oxide Yellow, Iron Oxide Red, and Iron Oxide Black.
The 60 mg tablets also contain Iron Oxide Yellow and Iron Oxide Red.
The 80 mg tablets also contain Iron Oxide Red.
The 100 mg tablets also contain FD&C Blue #2 Aluminum Lake.

Black Ink Contains: Shellac Glaze (in Ethanol), Isopropyl Alcohol, Iron Oxide Black, N-Butyl Alcohol, Propylene Glycol and Ammonium Hydroxide.

Mechanism of Action

Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

What is the most important information I should know 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. Selling or giving away Hysingla ER is against the law.
Store Hysingla ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Who should not take Hysingla ER?

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.

What should I tell my healthcare provider before taking Hysingla ER?

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.

How should I take Hysingla ER?

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.
Dispose of expired, unwanted, or unused Hysingla ER, by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

What should I avoid while taking Hysingla ER?

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.

What are the possible side effects of Hysingla ER?

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.

How should I store Hysingla ER?

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

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

Store Hysingla ER securely and dispose of properly

What are the ingredients in Hysingla ER?

Active ingredients: hydrocodone bitartrate

Inactive ingredients:

Green 20mg tablets: polyethylene glycol 3350, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, ferric oxide yellow, FD&C blue no. 2, aluminum oxide, magnesium stearate, butylated hydroxytoluene, cochineal, hydroxypropyl cellulose (1600000 wamw), unspecified polyethylene glycol.

Yellow 30mg tablets: polyethylene glycol 3350, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, ferric oxide yellow, magnesium stearate, butylated hydroxytoluene, hydroxypropyl cellulose (1600000 wamw), unspecified polyethylene glycol.

Gray 40mg tablets: polyethylene glycol 3350, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, ferric oxide yellow, ferric oxide red, ferrosoferric oxide, magnesium stearate, butylated hydroxytoluene, hydroxypropyl cellulose (1600000 wamw), unspecified polyethylene glycol.

White (Beige) 60mg tablets: polyethylene glycol 3350, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, ferric oxide yellow, ferric oxide red, magnesium stearate, butylated hydroxytoluene, hydroxypropyl cellulose (1600000 wamw), unspecified polyethylene glycol.

Pink 60mg tablets: polyethylene glycol 3350, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, ferric oxide red, magnesium stearate, butylated hydroxytoluene, hydroxypropyl cellulose (1600000 wamw), unspecified polyethylene glycol.

Blue 100mg tablets: polyethylene glycol 3350, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue no. 2, aluminium oxide, magnesium stearate, butylated hydroxytoluene, hydroxypropyl cellulose (1600000 wamw), unspecified polyethylene glycol.

White 120mg tablets: polyethylene glycol 3350, microcrystalline cellulose, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, magnesium stearate, butylated hydroxytoluene, hydroxypropyl cellulose (1600000 wamw), unspecified polyethylene glycol.