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Hydromorphone Hydrochloride (Hydromorphone Hydrochloride)

Trade Name : Hydromorphone Hydrochloride

West-Ward Pharmaceuticals Corp.

TABLET

Strength 4 mg/1

HYDROMORPHONE HYDROCHLORIDE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hydromorphone Hydrochloride (Hydromorphone Hydrochloride) which is also known as Hydromorphone Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 4 mg/1 per ml. Read more

Hydromorphone Hydrochloride (Hydromorphone Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
  • See full prescribing information for complete boxed warning.
  • Ensure accuracy when prescribing, dispensing, and administering Hydromorphone Hydrochloride Oral Solution. Dosing errors due to confusion between mg and mL can result in accidental overdose and death. (, )
  • Hydromorphone Hydrochloride Tablets or Hydromorphone Hydrochloride Oral Solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor regularly for these behaviors and conditions. ()
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. ()
  • Accidental ingestion of Hydromorphone Hydrochloride Tablets or Hydromorphone Hydrochloride Oral Solution, especially by children, can result in a fatal overdose of hydromorphone. ()
  • Prolonged use of Hydromorphone Hydrochloride Tablets or Hydromorphone Hydrochloride Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ()
  • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (, )
  • Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
  • Limitations of Use
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses n- [see Warnings and Precautions ()],n- reserve Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • Hydromorphone Hydrochloride Tablets and Hydromorphone Hydrochloride Oral Solution contain hydromorphone, an opioid agonist, and are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ()
  • Limitations of Use ()
  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Hydromorphone Hydrochloride Tablets or Hydromorphone Hydrochloride Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • No data
  • Hepatic Impairment:
  • Renal Impairment:
  • Hydromorphone Hydrochloride Oral Solution USP
  • Hydromorphone Hydrochloride Tablets USP
  • Hydromorphone Hydrochloride Oral Solution and Hydromorphone Hydrochloride Tablets are contraindicated in patients with:
  • No data
  • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients:
  • Adrenal Insufficiency
  • Severe Hypotension
  • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness:
  • The following serious adverse reactions are described, or described in greater detail, in other sections:
  • Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. ()
  • Table 1 includes clinically significant drug interactions with Hydromorphone Hydrochloride.
  • Table 1: Clinically Significant Drug Interactions with Hydromorphone Hydrochloride
  • Serotonergic Drugs
  • Monoamine Oxidase Inhibitors (MAOIs):
  • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
  • No data
  • u2022
  • 8.1
  • No data
  • Clinical Presentation
  • Acute overdose with Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets 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 n
  • Treatment of Overdose
  • In case of overdose, priorities are the reestablishment of a patent and protected 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 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 overdose. For clinically significant respiratory or circulatory depression secondary to hydromorphone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdose.
  • Because the duration of opioid reversal is expected to be less than the duration of action of hydromorphone in Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
  • In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced 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.
  • Hydromorphone hydrochloride, a hydrogenated ketone of morphine, is an opioid analgesic. Hydromorphone hydrochloride USP is a white to off-white powder. It is soluble in water and sparingly soluble in alcohol. The chemical name of hydromorphone hydrochloride is 4,5-Epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The structural formula is:
  • CHNO u25cfHCl M.W. 321.80
  • Each Hydromorphone Hydrochloride Tablet USP for oral administration, contains 4 mg or 8 mg hydromorphone hydrochloride USP. In addition, the tablets include lactose anhydrous and magnesium stearate. Hydromorphone Hydrochloride Tablets USP may contain traces of sodium metabisulfite.
  • Each 5 mL (1 teaspoonful) of Hydromorphone Hydrochloride Oral Solution USP contains 5 mg of hydromorphone hydrochloride USP. In addition, other ingredients include FD&C Red No. 40, methyl paraben, propylene glycol, propylparaben, purified water, raspberry blend, saccharin sodium and sorbitol solution. Hydromorphone Hydrochloride Oral Solution USP may contain traces of sodium metabisulfite.
  • No data
  • Carcinogenesis
  • Long term studies in animals to evaluate the carcinogenic potential of hydromorphone have not been conducted.
  • Mutagenesis
  • Hydromorphone was positive in the mouse lymphoma assay in the presence of metabolic activation, but was negative in the mouse lymphoma assay in the absence of metabolic activation. Hydromorphone was not mutagenic in the bacterial reverse mutation assay (Ames assay). Hydromorphone was not clastogenic in either the human lymphocyte chromosome aberration assay or the mouse micronucleus assay.
  • Impairment of Fertility
  • Reduced implantation sites and viable fetuses were noted at 2.1 times the human daily dose of 32 mg/day in a study in which female rats were treated orally with 1.75, 3.5, or 7 mg/kg/day hydromorphone hydrochloride (0.5, 1.1, or 2.1 times a human daily dose of 24 mg/day (HDD) based on body surface area) beginning 14 days prior to mating through Gestation Day 7 and male rats were treated with the same hydromorphone hydrochloride doses beginning 28 days prior to and throughout mating.
  • Analgesic effects of single doses of Hydromorphone Hydrochloride Oral Solution administered to patients with post-surgical pain have been studied in double-blind controlled trials. In one study, both 5 mg and 10 mg of Hydromorphone Hydrochloride Oral Solution provided significantly more analgesia than placebo. In another trial, 5 mg and 10 mg of Hydromorphone Hydrochloride Oral Solution were compared to 30 mg and 60 mg of morphine sulfate oral liquid. The pain relief provided by 5 mg and 10 mg Hydromorphone Hydrochloride Oral Solution was comparable to 30 mg and 60 mg oral morphine sulfate, respectively.
  • Hydromorphone Hydrochloride Tablets USP
  • 4 mg tablet is supplied as a white to off-white, round, flat-faced tablet with beveled edges; debossed with u201c4u201d on one side and u201c54 196u201d debossed on the other side.
  • NDC 0054-0264-24: 4 x 25 Reverse Numbered Unit Dose
  • NDC 0054-0264-25: Bottle of 100 Tablets
  • 8 mg tablet is supplied as a white to off-white, round, flat-faced tablet with beveled edges; scored on one side and u201c54 425u201d debossed on the other side.
  • NDC 0054-0265-25: Bottle of 100 Tablets
  • Hydromorphone Hydrochloride Oral Solution USP
  • 1 mg/mL oral solution is supplied as a clear, red solution.
  • NDC 0054-0386-63: Bottle of 473 mL
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Medication Errors
  • Instruct patients how to measure and take the correct dose of Hydromorphone Hydrochloride, and to always use the enclosed cup when administering Hydromorphone Hydrochloride Oral Solution to ensure the dose is measured and administered accurately n
  • If the prescribed concentration is changed, instruct patients on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death.
  • Addiction, Abuse, and Misuse
  • Inform patients that the use of Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death Instruct patients not to share Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets with others and to take steps to protect Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets 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 Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets or when the dosage is increased, and that it can occur even at recommended dosages 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 Instruct patients to take steps to store Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets securely and to dispose of unused Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets. When Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets are no longer needed, the unused medication should be destroyed by flushing it down the toilet.
  • Interactions with Benzodiazepines and Other CNS Depressants
  • Inform patients and caregivers that potentially fatal additive effects may occur if Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a health care provider n
  • Serotonin Syndrome
  • Inform patients that Hydromorphone Hydrochloride 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. n
  • MAOI Interaction
  • Inform patients to avoid taking Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets n
  • 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 n
  • Important Administration Instructions
  • Instruct patients how to properly take Hydromorphone Hydrochloride.
  • Hypotension
  • Inform patients that Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets 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) n
  • Anaphylaxis
  • Inform patients that anaphylaxis has been reported with ingredients contained in Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets. Advise patients how to recognize such a reaction and when to seek medical attention n
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndromen- [see Warnings and Precautions (), Use in Specific Populations ()].
  • Embryo-Fetal Toxicityn- [see Use in Specific Populations (), Warnings and Precautions ()]
  • Lactation
  • Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs n
  • Infertility
  • Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible n
  • Driving or Operating Heavy Machinery
  • Inform patients that Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication n
  • Constipation
  • Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention n
  • Disposal of Unused Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets
  • Advise patients to flush unused Hydromorphone Hydrochloride Oral Solution or Hydromorphone Hydrochloride Tablets down the toilet.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10007362/03
  • Revised March 2017
  • 10007362/03
  • Revised March 2017
  • No data
  • No data
  • No data

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