Atropa Belladonna And Opium (Belladonna And Opium)

Trade Name : Belladonna and Opium

Paddock Laboratories, LLC

SUPPOSITORY

Strength 16.260 mg/1mg/1

ATROPA BELLADONNA; OPIUM

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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 Atropa Belladonna And Opium (Belladonna And Opium) which is also known as Belladonna and Opium and Manufactured by Paddock Laboratories, LLC. It is available in strength of 16.2; 60 mg/1; mg/1 per ml. Read more

Atropa Belladonna And Opium (Belladonna And Opium) 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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About GNH

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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  • No data
  • Arrayn- Addiction, Abuse, and Misuse
  • Belladonna and opium suppositories expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing belladonna and opium suppositories, and monitor all patients regularly for the development of these behaviors or conditions [].
  • Arrayn- Life-Threatening Respiratory Depression
  • Serious, life-threatening, or fatal respiratory depression may occur with use of belladonna and opium suppositories. Monitor for respiratory depression, especially during initiation of belladonna and opium suppositories or following a dose increase [].
  • Arrayn- Accidental Exposure
  • Accidental exposure of even one dose of belladonna and opium suppositories, especially by children, can result in a fatal overdose of opium [].
  • Arrayn- Neonatal Opioid Withdrawal Syndrome
  • Prolonged use of belladonna and opium suppositories during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [].
  • Arrayn- Risks From Concomitant Use With Alcohol, Benzodiazepines Or Other CNS Depressants
  • 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 [].
  • WARNING: ADDICTION, ABOUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOD WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH ALCOHOL, BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
  • See full prescribing information for complete boxed warning.
  • Belladonna and opium suppositories expose users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor regularly for these behaviors or conditions. (5.1)
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2)
  • Accidental exposure of belladonna and opium suppositories, especially by children, can result in a fatal overdose of opium. (5.2)
  • Prolonged use of belladonna and opium suppositories 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. (5.3)
  • 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. (5.4, 7)
  • No data
  • Belladonna and opium suppositories are indicated for the management of ureteral spasm 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 belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • Belladonna and opium suppositories are an opioid agonist indicated for the management of ureteral spasm 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 [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
  • No data
  • Belladonna and Opium Suppositories are available in two strengths.
  • Suppositories:
  • No data
  • These preparations are not recommended for use in children.
  • 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:
  • Belladonna may cause drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision. Opium usage may result in constipation, nausea or vomiting. Pruritis and urticaria may occasionally occur. Hypersensitivity to opium or belladonna may occur.
  • The following serious adverse reactions are described, or described in greater detail, in other sections:
  • The following adverse reactions have been identified during post-approval use of opioids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
  • Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
  • Anaphylaxis: Anaphylaxis has been reported with products containing opioids.
  • Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids
  • Most common adverse reactions are drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision, constipation, nausea and vomiting. (6)
  • Table 1 includes clinically significant drug interactions with belladonna and opium suppositories.
  • Table 1: Clinically Significant Drug Interactions with Belladonna and Opium Suppositories
  • Pregnancy
  • Revised: 12/2017
  • No data
  • Clinical Presentation
  • Acute overdose with belladonna and opium suppositories 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 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 opium overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to opium overdose.
  • Because the duration of opioid reversal is expected to be less than the duration of action of opium in belladonna and opium suppositories, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
  • Each belladonna and opium suppository contains (in a water-soluble base consisting of polyethylene glycol 400, 1450, 8000 and polysorbate 60):
  • Belladonna (16.2 mg) and Opium (30 mg):
  • Powdered belladonna extract 16.2 mg and powdered opium 30 mg (Warning: May be habit forming).
  • Belladonna (16.2 mg) and Opium (60 mg):
  • Powdered belladonna extract 16.2 mg and powdered opium 60 mg (Warning: May be habit forming).
  • This drug falls into the pharmacological/therapeutic class of narcotic analgesic/antispasmotic agents.
  • The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are:
  • Established Name:
  • Chemical Name:
  • Established Name:
  • Chemical Name:
  • Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is:
  • Name:
  • Chemical Name:
  • No data
  • No data
  • Belladonna (16.2 mg) and Opium (30 mg) suppositories are brown, bullet shaped suppositories. NDC 0574-7045-04: Carton of 4 suppositoriesNDC 0574-7045-12: Carton of 12 suppositories
  • Belladonna (16.2 mg) and Opium (60 mg) suppositories are brown, bullet shaped suppositories.NDC 0574-7040-04: Carton of 4 suppositories NDC 0574-7040-12: Carton of 12 suppositories
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE. PROTECT FROM MOISTURE DURING STORAGE.
  • Rx Only
  • Addiction, Abuse, and Misuse
  • Inform patients that the use of belladonna and opium suppositories, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death []. Instruct patients not to share belladonna and opium suppositories with others and to take steps to protect belladonna and opium suppositories 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 belladonna and opium suppositories 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 Exposure
  • Inform patients that accidental exposure (including ingestion), especially by children, may result in respiratory depression or death []. Instruct patients to take steps to store belladonna and opium suppositories securely and to dispose of unused belladonna and opium suppositories by returning to the pharmacy or delivering to an accredited disposal site.
  • Interactions with Alcohol and Other CNS Depressants
  • Inform patients that potentially serious additive effects may occur if belladonna and opium suppositories is used with alcohol or other CNS depressants and not to use such drugs unless supervised by a health care provider [].
  • Serotonin Syndrome
  • Inform patients that belladonna and opium suppositories 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 physicians if they are taking, or plan to take serotonergic medications. [].
  • Adrenal Insufficiency
  • Inform patients that belladonna and opium suppositories 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 [].
  • Pregnancy
  • Neonatal Opioid Withdrawal Syndrome
  • Inform patients that prolonged use of belladonna and opium suppositories during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [].
  • Embryo-Fetal Toxicity
  • Inform female patients of reproductive potential that belladonna and opium suppositories can (or may) cause fetal harm and to inform the prescriber of a known or suspected pregnancy [].
  • 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 [].
  • Disposal of Unused Belladonna and Opium Suppositories
  • Advise patients to return unused suppositories to the pharmacy or deliver to an accredited disposal site.
  • Medication Guide
  • Belladonnan- and Opiumn- Suppositories, CII
  • Belladonna and Opium Suppositories are:
  • Important information about Belladonna and Opium Suppositories:
  • Do not take Belladonna and Opium Suppositories if you have:
  • Before taking Belladonna and Opium Suppositories, tell your healthcare provider if you have a history of:
  • Tell your healthcare provider if you are:
  • When taking Belladonna and Opium Suppositories:
  • While taking Belladonna and Opium Suppositories DO NOT:
  • The possible side effects of Belladonna and Opium Suppositories:
  • Get emergency medical help if you have:
  • These are not all the possible side effects of belladonna and opium suppositories. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
  • Manufactured by: Perrigo Minneapolis, MN, or call 1-866-634-9120
  • Issued: 12/2017
  • Rx Only
  • NDC 0574--12
  • Belladonna and Opium Suppositories
  • CII
  • 16.2 mg/30 mg
  • Each suppository contains: Powdered Opium 30 mg
  • (Warning u2013 May be habit forming)
  • Powdered Belladonna Extract 16.2 mg
  • 12 Suppositories
  • UNIT DOSE
  • FOR RECTAL USE ONLY
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.
  • Rx Only
  • 0574-12
  • Belladonna and Opium Suppositories
  • CII
  • 16.2 mg/60 mg
  • Each suppository contains: Powdered Opium 60 mg
  • (Warning u2013 May be habit forming)
  • Powdered Belladonna Extract 16.2 mg
  • 12 Suppositories
  • UNIT DOSE
  • FOR RECTAL USE ONLY
  • The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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