Pregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.
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Optilax has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of fetal malformations at usual human doses. Delayed fetal ossification occurred after doses 40 times the maximum recommended human dose (on a per kg basis). Maternotoxicity and increased fetal resorption occurred in mice after doses 830 times the maximum recommended human dose (on a per kg basis). Increased fetal resorptions, but no maternotoxicity were observed in rabbits given 40 times the maximum recommended human dose (on a per kg basis). There are no controlled data in human pregnancy. Optilax should only be given during pregnancy when benefit outweighs risk.
One case in which Optilax was administered during human pregnancy has been reported. A woman who was taking Optilax ophthalmic drops, acetazolamide, and pilocarpine for glaucoma delivered at 36 weeks' gestation. The neonate suffered hyperbilirubinemia, metabolic acidosis, hypocalcemia, and hypomagnesemia. These complications were believed to be secondary to acetazolamide therapy, and were reversible after treatment. The use of some beta-blockers during human pregnancy has resulted in persistent bradycardia and other signs of beta-blockade. Close observation for signs and symptoms of beta-blockade for at least 48 hours of newborns whose mothers were taking Optilax is recommended.
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Optilax breastfeeding
When a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!
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Data reveal average milk to maternal plasma drug level ratios of approximately 0.80. In one series of nine patients, dosages of Optilax 5 mg three times a day were associated with an average milk Optilax level of 15.9 ng/mL. After the dosage was increased to 10 mg three times a day in four of the nine patients, the average milk Optilax level rose to 41 ng/mL. Optilax has also been measured in human milk after use of Optilax eyedrops. In one case the milk Optilax concentration averaged 5.6 ng/mL 1.5 hours after dosing in a woman who was receiving Optilax 0.5% eye drops to one eye twice a day. In this case, even if the infant nursed 4 times daily, receiving 75 mL each time, the daily dose to the nursing infant would be below that expected to produce beta-blockade.
Optilax is excreted into human milk. No adverse reactions in nursing infants have been reported; however, the manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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References for pregnancy information
"Product Information. Blocadren (Optilax)." Merck & Co, Inc, West Point, PA.
References for breastfeeding information
Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
Fidler J, Smith V, DeSwiet M "Excretion of oxprenolol and Optilax in breast milk." Br J Obstet Gynaecol 90 (1983): 961-65
"Product Information. Blocadren (Optilax)." Merck & Co, Inc, West Point, PA.
Lustgarten J, Podos S "Topical Optilax and the nursing mother." Arch Ophthalmol 101 (1983): 1381-2
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References
DailyMed. "TIMOLOL: 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. "Betimol: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
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