| Tramadol Hydrochloride |
Tramal |
4.6. Fertility, pregnancy and lactation |
Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.6 times the maximum recommended human daily dosage. Tramadol decreased pup body weight and increased pup mortality at 1.2 and 1.9 times the recommended human daily dosage. Based on animal data, advise pregnant women of the potential risk to a fetus. 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. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported with tramadol during post-approval use of tramadol immediate-release products. |
Sep,2022 |
| Levothyroxine |
Euthyrox |
4.4 Special warnings and precautions for use 4.8 Undesirable effects |
In pediatric patients with congenital and acquired hypothyroidism, undertreatment may adversely affect cognitive development and linear growth, and overtreatment is associated with craniosynostosis and acceleration of bone age . Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in pediatric patients receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants who have not undergone complete closure of the fontanelles, and in premature closure of the epiphyses in pediatric patients still experiencing growth with resultant compromised adult height. |
Sep,2022 |
| Allopurinol |
Loric |
4.6. Fertility, pregnancy and lactation |
Based on findings in animals, Allopurinol may cause fetal harm when administered to a pregnant woman. Allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol. Available limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse developmental outcomes. Among approximately 50 pregnancies described in published literature, 2 infants with major congenital malformations have been reported with following maternal allopurinol exposure. Advise pregnant women of the potential risk to a fetus. |
Sep,2022 |
| Pneumococcal conjugate vaccine |
Prevenar |
4.4. Special warnings and precautions for use |
The potential risk of apnoea when adminster |
Mar,2024 |
| Telotristat Ethyl |
Xermelo |
4.8 Undesirable effects |
Angioedema, pruritis, rash |
Sep,2022 |
| Alemtuzumab |
Lemtrada |
4.8 Undesirable effects 4.4. Special warnings and precautions for use |
Autoimmune Encephalitis, myasthenia gravis, Lambert-Eaton myasthenic syndrome,Autoimmune Encephalitis |
Sep,2022 |
