Consists of Codeine, Metamizole, Tiemonium
Pregnancy of Codeine (Visceralgine Compositum) in details
Opioids cross the placenta.
According to some studies, maternal use of opioids may be associated with birth defects (including neural tube defects, congenital heart defects, and gastroschisis), poor fetal growth, stillbirth, and preterm delivery (CDC [Dowell 2016]).
[US Boxed Warning]: Prolonged use of Codeine (Visceralgine Compositum) 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. If chronic opioid exposure occurs in pregnancy, adverse events in the newborn (including withdrawal) may occur (Chou 2009). Symptoms of neonatal abstinence syndrome (NAS) following opioid exposure may be autonomic (eg, fever, temperature instability), gastrointestinal (eg, diarrhea, vomiting, poor feeding/weight gain), or neurologic (eg, high-pitched crying, hyperactivity, increased muscle tone, increased wakefulness/abnormal sleep pattern, irritability, sneezing, seizure, tremor, yawning) (Dow 2012; Hudak 2012). Mothers who are physically dependent on opioids may give birth to infants who are also physically dependent. Opioids may cause respiratory depression and psycho-physiologic effects in the neonate; newborns of mothers receiving opioids during labor should be monitored.
Codeine (Visceralgine Compositum) is not commonly used to treat pain during labor and immediately postpartum (ACOG 209 2019) or chronic noncancer pain in pregnant women or those who may become pregnant (CDC [Dowell 2016]; Chou 2009).
Codeine (Visceralgine Compositum) breastfeeding
UK: Use is contraindicated. AU: Use should be avoided. US: Benefit should outweigh risk; limit maternal intake Excreted into human milk: Yes Comments: -The American Academy of Pediatrics recommends that other agents are preferred over Codeine (Visceralgine Compositum) during breastfeeding. -Both the European Medicine Agency and UK's Medicines and Healthcare Products Regulatory Agency recommend that Codeine (Visceralgine Compositum) not be used in nursing mothers.
Codeine (Visceralgine Compositum) is present in breast milk and for women with normal Codeine (Visceralgine Compositum) metabolism (normal CYP450 2D6 activity) the amount of Codeine (Visceralgine Compositum) secreted is low and dose-dependent; however, in women who are ultra-rapid metabolizers of Codeine (Visceralgine Compositum) (those with a specific CYP2D6 genotype) higher-than-expected serum levels of morphine, Codeine (Visceralgine Compositum)'s active metabolite, may be present in their breast milk which may lead to dangerously high serum morphine levels in their breastfed infants. In most cases, a person's specific CYP2D6 genotype is unknown. Several small series and 1 small retrospective study suggest that Codeine (Visceralgine Compositum) may be causative in episodes of apnea, bradycardia, and cyanosis in the first week of life. A death of a breastfeed infant due to respiratory depression has been reported; the mother was found to be a CYP450 2D6 ultrarapid metabolizer. Once a mother's milk comes in, it is best to provide pain control with nonnarcotic analgesics; if Codeine (Visceralgine Compositum)-containing drugs are prescribed, it is recommended that maternal intake of oral Codeine (Visceralgine Compositum) be limited to 4 days at a low dose with close infant monitoring. If the baby shows signs of increased sleepiness, difficult breastfeeding, breathing difficulties, or limpness, medical care should be sought immediately. Excessive sedation in the mother often correlates with excess sedation in the breastfed infant. There is an FDA cleared test for determining a patient's CYP2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test can predict those that convert Codeine (Visceralgine Compositum) to morphine at a faster rate than average, resulting in higher morphine levels in the blood.
See references
References for pregnancy information
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Codeine (Visceralgine Compositum) Sulfate (Codeine (Visceralgine Compositum))." Roxane Laboratories Inc, Columbus, OH.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
- "Product Information. Codeine (Visceralgine Compositum) Sulfate (Codeine (Visceralgine Compositum))." Roxane Laboratories Inc, Columbus, OH.
- Cerner Multum, Inc. "Australian Product Information." O 0
Pregnancy of Metamizole (Visceralgine Compositum) in details
In the absence of clinical experience with omeprazole it is not recommended to use this drug during pregnancy. If necessary to use during Metamizole (Visceralgine Compositum) lactation it should been solve the issue of termination of breastfeeding.
Category effects on the fetus by FDA - C.
References
- DailyMed. "CODEINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Codeine (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Codeine: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
