Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Naloxone hydrochloride dihydrate/Oxycodone Hydrochloride | Targinact | 4.4 Special Warnings and Special Precautions for Use | Opioid Use Disorder, Biliary tract disorders | May,2024 |
| Empagliflozin/ Metformin hydrochloride | Synjardy | 4.4 Special Warnings and Special Precautions for Use | Vitamin B12 decrease/deficiency | Apr,2024 |
| Diphtheria Toxoid/ Pertussis toxoid/ Tetanus Toxoid/ Filamentous haemagglutinin/ Inactivated Poliomyelitis virus type 1 (Mahoney strain)/ Inactivated Poliomyelitis virus type 2 (MEF-1 strain)/ Inactivated Poliomyelitis virus type 3 (Saukett strain) ,HAEMOPHILUS INFLUENZAE TYPE B | Pentaxim | 4.8. Undesirable effects | Screaming | Apr,2024 |
| Rosuvastatin Calcium, Ezetimibe | Roneza | 4.4 Special Warnings and Special Precautions for Use | Myasthenia gravis and ocular myasthenia | Apr,2024 |
| Carbidopa monohydrate\Levodopa | Duodopa | 4.8. Undesirable effects | Addition of Urinary tract infections (frequency: very common) | Apr,2024 |
| Methylphenidate | Ritalin | 4.8. Undesirable effects | Epistaxis | Apr,2024 |