【Ingredients】

The main ingredient of this product is riboflavin sodium phosphate, chemically known as riboflavin 5'-dihydrogen phosphate monosodium salt dihydrate.

Molecular formula: C17H20N4NaO9P·2H2O

Molecular weight: 514.36

The excipient of this product is mannitol.

【Characteristics】

This product is a yellow or orange-yellow loose granular substance or powder.

【Indications】

Riboflavin supplement. Used for the treatment of diseases caused by riboflavin deficiency, such as angular stomatitis, cheilitis, glossitis, conjunctivitis, and balanitis.

【Specifications】

Calculated as riboflavin (C17H20N4O6): (1) 5mg (2) 10mg

【Dosage and Administration】

Subcutaneous, intramuscular, or intravenous injection. 5-30mg once daily.

【Adverse Reactions】

1. When renal function is normal, this drug is almost non-toxic.

2. Occasional allergic reactions.

【Contraindications】

Hypersensitivity to this drug.

【Precautions】

After using this drug in large quantities, urine may turn yellow (or yellow-green), and it may also cause symptoms similar to hyperthyroidism.

【Use in Pregnant and Lactating Women】

1. The effect of this drug on pregnancy is not yet clear.

2. This drug can be secreted into breast milk, but breastfeeding is safe.

【Use in Children】

Not yet clear.

【Use in the Elderly】

Not yet clear.

【Drug Interactions】

Metoclopramide can reduce the absorption of this drug. Therefore, they should not be used together.

【Overdose】

Not yet clear.

【Pharmacology and Toxicology】

Pharmacological Actions: This product is a vitamin-class drug. Riboflavin (vitamin B2) is an important nutrient in the human body and plays a key role in energy metabolism. This drug is a precursor of flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD), which are important cofactors of flavin enzymes. Flavin enzymes catalyze many biochemical reactions, the most typical of which are oxidation-reduction reactions that are key factors in cellular respiration. FAD and FMN transfer hydrogen in the mitochondrial respiratory chain, producing cellular energy in the process. Deficiency can affect the body's oxidative metabolism, leading to metabolic disorders, with symptoms manifesting as inflammation in the mouth, eyes, and external genitalia.

【Pharmacokinetics】

No pharmacokinetic data available for injectable administration of this drug. According to literature, riboflavin is mainly absorbed in the proximal small intestine after oral administration, and absorption is enhanced by food and accelerated by bile salts. Within the dose range of 2-25mg, its bioavailability is 50-60%, with a maximum absorption of 27mg after a single oral dose. The excess amount is excreted in feces. Flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD) are absorbed to a lesser extent. This drug enters the bloodstream through the portal vein into the liver and then reaches the tissues. Most of the serum riboflavin is transported by albumin or immunoglobulin, diffusing into cells through concentration gradients. Inside the cells, riboflavin is converted to FMN by riboflavin kinase, and FMN is further converted to FAD by FAD synthetase. FAD is the main form of riboflavin in tissues. Excess riboflavin beyond the body's needs is mainly excreted by the kidneys, and some metabolites are also excreted by the kidneys. The half-life of this drug after oral or intramuscular administration is 66-84 minutes.

【Storage】Avoid light, tightly sealed (10-30°C).

【Packaging】

(1) Antibiotic bottle (amber). 10 bottles per box.

(2) Antibiotic bottle (amber). 10 bottles per box, with pre-filled syringes (pre-filled).

(3) Antibiotic bottle (amber). 1 bottle per box, with 1 disposable pre-filled injection drug disposer (with needle).

【Shelf Life】24 months.

【Executive Standard】YBH01752006-2015Z

【Approval Number】

(1) 5mg: National Drug Approval H20060077

(2) 10mg: National Drug Approval H20060078