Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), OPIUM (UNII: 37M3MZ001L) (OPIUM - UNII:37M3MZ001L)
Padagis US LLC
ATROPA BELLADONNA
ATROPA BELLADONNA 16.2 mg
RECTAL
PRESCRIPTION DRUG
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
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
unapproved drug other
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 Preberite celoten dokument
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 Preberite celoten dokument