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:

Padagis US LLC

INN (International Name):

ATROPA BELLADONNA

Composition:

ATROPA BELLADONNA 16.2 mg

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. 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]: Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no available data with belladonna and opium suppositories in pregnant women to inform a drug associated risk for major birth defects and miscarriage. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated bac

Product summary:

Belladonna (16.2 mg) and Opium (30 mg) suppositories are brown, bullet shaped suppositories. NDC 0574-7045-04: Carton of 4 suppositories NDC 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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE. PROTECT FROM MOISTURE DURING STORAGE. Rx Only

Authorization status:

unapproved drug other

Patient Information leaflet

BELLADONNA AND OPIUM- ATROPA BELLADONNA AND OPIUM SUPPOSITORY
Padagis US LLC
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.
----------
MEDICATION GUIDE
Medication Guide
Belladonna (bell ah DON ah) and Opium (OH pee um) Suppositories, CII
Belladonna and opium suppositories are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage ureteral
spasm pain severe enough to require an opioid analgesic, when other
pain treatments such as non-
opioid pain medicines do not treat your pain well enough or you cannot
tolerate them.
•
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 or call 911 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. Talk to your healthcare provider about
naloxone, a medicine for the
emergency treatment of an opioid overdose.
•
Taking belladonna and opium suppositories 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 belladonna and opium suppositories. They
could die from taking them.
Selling or giving away belladonna and opium suppositories is against
the law.
•
Store belladonna and opium suppositories securely, out of sight and
reach of children, and in a location
not accessible by others, including visitors to the home.
Do not take belladonna and opium supp

Summary of Product characteristics

BELLADONNA AND OPIUM- ATROPA BELLADONNA AND OPIUM SUPPOSITORY
PADAGIS US LLC
_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: 1938
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME;
AND RISKS FROM CONCOMITANT USE WITH 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)
• 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 ALTERNATI