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Hysingla ER
Overview
What is Hysingla ER?
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: CHNO CHO 2½HO; 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.
What does Hysingla ER look like?
What are the available doses of Hysingla ER?
Extended-release tablets: 20,
30, 40, 60, 80, 100, and 120 mg ()
What should I talk to my health care provider before I take Hysingla ER?
How should I use 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
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.
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 . Instruct patients not to
pre-soak, lick, or otherwise wet the tablet prior to placing in the
mouth Crushing, chewing, or dissolving HYSINGLA
ER tablets will result in uncontrolled delivery of hydrocodone and
can lead to overdose or death .
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.
What interacts with Hysingla ER?
Sorry No Records found
What are the warnings of Hysingla ER?
Sorry No Records found
What are the precautions of Hysingla ER?
Sorry No Records found
What are the side effects of Hysingla ER?
Sorry No records found
What should I look out for while using Hysingla ER?
P8
HYSINGLA ER is contraindicated in patients with:
What might happen if I take too much Hysingla ER?
Clinical Presentation
Acute overdosage with HYSINGLA ER can be
manifested by respiratory depression, somnolence progressing to stupor
or coma, skeletal muscle flaccidity, cold and clammy skin, constricted
pupils, 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 overdose
situations .
Treatment of Overdose
In case of overdose,
priorities are the re-establishment of a patent airway and institution
of assisted or controlled ventilation, if needed. Employ other supportive
measures (including oxygen and vasopressors) in the management of
circulatory shock and pulmonary edema accompanying overdose as indicated.
Cardiac arrest or arrhythmias will require advanced life support techniques.
The opioid antagonists, naloxone
or nalmefene, are specific antidotes to respiratory depression resulting
from opioid overdosage. For clinically significant respiratory or
circulatory depression secondary to hydrocodone overdose, administer
an opioid antagonist. Opioid antagonists should not be administered
in the absence of clinically significant respiratory or circulatory
depression secondary to hydrocodone overdose.
Because the duration of opioid reversal
is expected to be less than the duration of action of hydrocodone
in HYSINGLA ER, carefully monitor the patient until spontaneous respiration
is reliably reestablished. HYSINGLA ER will continue to release hydrocodone
and add to the hydrocodone load for 24 to 48 hours or longer following
ingestion, necessitating prolonged monitoring. If the response to
an opioid antagonist is suboptimal or only brief in nature, administer
additional antagonist as directed by the product’s prescribing information.
In an individual physically
dependent on opioids, administration of the recommended dose of the
antagonist will precipitate an acute withdrawal syndrome. The severity
of the withdrawal syndrome produced will depend on the degree of physical
dependence and the dose of the antagonist administered. If a decision
is made to treat serious respiratory depression in the physically
dependent patient, administration of the antagonist should be initiated
with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle Hysingla ER?
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)Protect TOBI Podhaler from moisture.Keep this and all drugs out of the reach of children.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)Protect TOBI Podhaler from moisture.Keep this and all drugs out of the reach of children.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)Protect TOBI Podhaler from moisture.Keep this and all drugs out of the reach of children.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.HYSINGLA ER (hydrocodone bitartrate) extended-release tablets 20 mg are round, green-colored, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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, bi-convex 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].Dispense in tight, light-resistant container, as defined by the USP.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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.
Non-Clinical Toxicology
P8HYSINGLA ER is contraindicated in patients with:
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
The benzodiazepines, including Ativan (lorazepam), produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.
Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.
Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with valproate.
Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid.
The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation.
Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.
HYSINGLA ER contains hydrocodone, a Schedule II controlled substance. As an opioid, HYSINGLA ER exposes users to the risks of addiction, abuse, and misuse. Because extended-release products such as HYSINGLA ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present .
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed HYSINGLA ER. Addiction can occur at recommended doses and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing HYSINGLA ER, and monitor all patients receiving HYSINGLA ER for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol addiction or abuse) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of HYSINGLA ER for the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as HYSINGLA ER, but use in such patients necessitates intensive counseling about the risks and proper use of HYSINGLA ER along with intensive monitoring for signs of addiction, abuse, and misuse.
Abuse or misuse of HYSINGLA ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the hydrocodone and can result in overdose and death .
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing HYSINGLA ER. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug . Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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