BELLADONNA AND OPIUM- atropa belladonna and opium suppository

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Padagis US LLC

INN (국제 이름):

ATROPA BELLADONNA

구성:

ATROPA BELLADONNA 16.2 mg

관리 경로:

RECTAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.3)] . Belladonna refers to plant alkaloids that contain anticholinergic agents such as atropine. Atropine used in human pregnancies has not been associated with birth defects or adverse fetal effects although the drug readily crosses the placenta. Use during pregnancy may increase risk of respiratory abnormalities, hypospadias, and eye or ear malformations but causal relationship is unclear. The Collaborative Perinatal Project found no relationship between first trimester use of atropine and birth defects in the offspring but found an increase in birth defects in general in the offspring of pregnancies where the mother had taken belladonna. There was no relationship to any particular syndrome of anomalies. A statistically significant (although weak) association was discovered between congenital anomalies and maternal use of belladonna. A study was conducted based on the infants of 554 women who took belladonna during the first four months of pregnancy. The study was conducted in the Collaborative Perinatal Project and showed that belladonna is unlikely to cause minor congenital abnormalities. The estimated maximum risk is most likely less than 3% if maternal belladonna is used early in pregnancy.1 Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Belladonna and opium suppositories is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including belladonna and opium suppositories, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Risk Summary The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for belladonna and opium suppositories and any potential adverse effects on the breastfed infant from belladonna and opium suppositories or from the underlying maternal condition. Clinical Considerations Infants exposed to belladonna and opium suppositories through breast milk should be monitored for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible. The safety and effectiveness of belladonna and opium suppositories in pediatric patients have not been established. Elderly patients (aged 65 years or older) may have increased sensitivity to belladonna and opium. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of belladonna and opium suppositories slowly in geriatric patients [see Warnings and Precautions (5.2)] . Belladonna and opium suppositories contains opium, a Schedule II controlled substance. Belladonna and opium suppositories contains opium, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Belladonna and opium suppositories can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.1)] . All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating health care provider(s). “Doctor shopping” (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Belladonna and opium suppositories, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Risks Specific to Abuse of Belladonna and Opium Suppositories Belladonna and opium suppositories are for rectal use only. Abuse of belladonna and opium suppositories poses a risk of overdose and death. The risk is increased with concurrent abuse of belladonna and opium suppositories with alcohol and other central nervous system depressants. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV. Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. Physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. Belladonna and opium suppositories should not be abruptly discontinued [see Dosage and Administration (2.4)] . If belladonna and opium suppositories is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Do not abruptly discontinue belladonna and opium suppositories in a patient physically dependent on opioids. Rapid tapering of belladonna and opium suppositories in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. When discontinuing belladonna and opium suppositories, gradually taper the dosage using a patient-specific plan that considers the following: the dose of belladonna and opium suppositories the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see Dosage and Administration (2.5), Warnings and Precautions (5.12)] . Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)] .

제품 요약:

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

승인 상태:

unapproved drug other

환자 정보 전단

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

제품 특성 요약

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