Tetralgin Pregnancy

• Pregnancy of Tetralgin in details
• Tetralgin breastfeeding
• Tetralgin reviews

Pregnancy of Tetralgin in details

Tetralgin ophthalmic has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of teratogenicity with doses up to 312 times higher than the normal human dose. There are no controlled data in human pregnancy. Very small amounts of Tetralgin were detected in umbilical vein samples after its intramuscular administration during labor and delivery. Tetralgin ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.

Tetralgin is known to cross the placenta. In one study, 32 women received Tetralgin 10 mg one time by intramuscular injection to relieve pain during labor. Tetralgin levels were obtained from maternal plasma and from the umbilical cord at the time of delivery, with sample times ranging from 0.5 to 6.5 hours post-dose. Tetralgin concentrations ranged from 0.02 to 0.12 mcg/mL in cord blood and from 0.2 to 0.9 mcg/mL in maternal plasma. The mean cord blood to maternal plasma concentration ratio was 0.12. In another study, 18 women were randomly assigned to receive Tetralgin 10 mg or meperidine 50 mg or 100 mg one time by intramuscular injection to relieve pain during labor. An analysis of platelet aggregation in whole blood obtained from the neonates revealed a significant inhibition of arachidonic acid and collagen-induced platelet aggregation in those infants whose mothers received Tetralgin. ADP-induced aggregation was not affected. The clinical significance of this finding remains to be determined. Data on the use of Tetralgin during pregnancy, other than for the management of labor pain, are lacking.

Tetralgin breastfeeding

A peri/postnatal study in rats showed reduction in postnatal growth and survival of the offspring when Tetralgin trometamol was administered to lactating rats at oral dose levels greater than 4.8 mg/kg/day. In human breast milk, limited data suggests milk levels of Tetralgin are low with usual oral doses, however, milk levels have not been measured after higher injectable doses. Available evidence has not shown any specific adverse events in nursing infants.

Use is contraindicated Excreted into human milk: Yes

See references

References for pregnancy information

1. "Product Information. Sprix (Tetralgin)." American Regent Laboratories Inc, Shirley, NY.
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. Cerner Multum, Inc. "Australian Product Information." O 0
4. "Product Information. Tetralgin Tromethamine (Tetralgin)." Hospira Inc, Lake Forest, IL.
5. "Product Information. Toradol (Tetralgin)." Roche Laboratories, Nutley, NJ.

References for breastfeeding information

1. "Product Information. Toradol (Tetralgin)." Roche Laboratories, Nutley, NJ.
2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
3. "Product Information. Sprix (Tetralgin)." American Regent Laboratories Inc, Shirley, NY.
4. "Product Information. Tetralgin Tromethamine (Tetralgin)." Hospira Inc, Lake Forest, IL.
5. 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 -]):
6. Cerner Multum, Inc. "Australian Product Information." O 0

References

1. DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: 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).
2. DailyMed. "CAFFEINE; ERGOTAMINE TARTRATE: 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).
3. PubMed Health. "Reglan: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology