FOLIC ACID

5 Renal Impairment 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 7

1 Adverse Reaction Overview Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Allergic reactions, including bronchospasm, erythema, fever, general malaise, skin rash or itching have been reported with folic acid administration.

g. 15 mg/day) have been associated rarely with various CNS effects such as altered sleep patterns, difficulty concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. EEG changes and convulsion have been reported with intravenous therapy.

5 Renal Impairment 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 9 8 ADVERSE REACTIONS ..................................................................................................

1 Adverse Reaction Overview ................................................................................ 10 9 DRUG INTERACTIONS.................................................................................................. 2 Drug Interactions Overview ................................................................................

3 Drug-Behavioural Interactions ............................................................................ 4 Drug-Drug Interactions ....................................................................................... 5 Drug-Food Interactions.......................................................................................

6 Drug-Herb Interactions....................................................................................... 7 Drug-Laboratory Test Interactions ...................................................................... 12 10 CLINICAL PHARMACOLOGY .........................................................................................

1 Mechanism of Action.......................................................................................... 2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics...............................................................................................

12 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 13 12 SPECIAL HANDLING INSTRUCTIONS............................................................................. 13 Product Monograph – Folic Acid Injection, USP Page 4 of 18 PART II: SCIENTIFIC INFORMATION ........................................................................................