BELLADONNA AND OPIUM- atropa belladonna and opium suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)

Available from:

Legacy Pharma Inc.

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Belladonna and Opium Suppositories are used for relief of moderate to severe pain associated with ureteral spasm not responsive to non-narcotic analgesics and to space intervals between injections of opiates.  Belladonna and Opium Suppositories are for rectal use only. 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]: - Have not been tolerated, or are not expected to be tolerated - Have not provided adequate analgesia, or are not expected to provide adequate analgesic Not recommended for use in children 12 years of age and under Belladonna and Opium Suppositor

Product summary:

Belladonna (16.2 mg) and Opium (30 mg) Suppositories are brown, bullet shaped suppositories. NDC 73577-030-12: Carton of 12 suppositories Belladonna (16.2 mg) and Opium (60 mg) Suppositories are brown, bullet shaped suppositories. NDC 73577-060-12: Carton of 12 suppositories Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE. PROTECT FROM MOISTURE DURING STORAGE. Rx Only CII

Authorization status:

unapproved drug other

Patient Information leaflet

BELLADONNA AND OPIUM- ATROPA BELLADONNA AND OPIUM SUPPOSITORY
Legacy Pharma Inc.
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
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MEDICATION GUIDE
Belladonna (bell ah DON ah) and Opium (OH pee um) Suppositories, CII
Belladonna and Opium Suppositories are:
An 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.
Important information about Belladonna and Opium Suppositories:
•
Get emergency help right away if you take too much Belladonna and
Opium Suppositories
(overdose). When you first start taking Belladonna and Opium
Suppositories, 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.
•
Never give anyone else your Belladonna and Opium Suppositories. They
could die from taking it.
Store Belladonna and Opium Suppositories away from children and in a
safe place to prevent stealing
or abuse. Selling or giving away Belladonna and Opium Suppositories is
against the law.
Do not take Belladonna and Opium Suppositories if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
•
A history of hypersensitivity to belladonna or opium.
Before taking Belladonna and Opium Suppositories, tell your healthcare
provider if you have a history of:
•
Head injury, seizures
•
Liver, kidney, thyroid problems
•
Problems urinating
•
Pancreas or gallbladder problems
•
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 Belladonna
and Opium Suppositories
during pregnancy can cause withdrawal symptoms in your newborn baby
that could

Summary of Product characteristics

BELLADONNA AND OPIUM- ATROPA BELLADONNA AND OPIUM SUPPOSITORY
LEGACY PHARMA INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BELLADONNA AND OPIUM SUPPOSITORIES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BELLADONNA AND OPIUM SUPPOSITORIES.
BELLADONNA AND OPIUM SUPPOSITORIES, FOR RECTAL USE, CII
INITIAL U.S. APPROVAL: 193
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL EXPOSURE; NEONATAL OPIOID 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 PATIENT’S RISK BEFORE PRESCRIBING
AND MONITOR REGULARLY FOR THESE
BEHAVIORS OR CONDITIONS. (5.1)
_BELLADONNA AND OPIUM SUPPOSITORIES_ ARE FOR RECTAL USE ONLY AND MUST
BE INSERTED WHOLE. CUTTING, BREAKING,
CRUSHING, CHEWING, OR DISSOLVING_ BELLADONNA AND OPIUM SUPPOSITORIES_
CAN LEAD TO DANGEROUS ADVERSE EVENTS
INCLUDING DEATH. FURTHER, INSTRUCT PATIENTS OF THE HAZARDS RELATED TO
TAKING OPIOIDS INCLUDING FATAL
OVERDOSE [_SEE WARNINGS AND PRECAUTIONS (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 B_ELLADONNA AND OPIUM SUPPOSITORIES_,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL
OVERDOSE OF OPIUM. (5.2)
PROLONGED USE OF B_ELLADONNA 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