Fosfogard (Capsules, Lyophilisate) Instructions for Use
ATC Code
A05BA (Drugs for the treatment of liver diseases)
Active Substances
Phospholipids (Grouping name)
Glycyrrhizinic acid (BP British Pharmacopoeia)
Clinical-Pharmacological Group
Hepatoprotective agent with immunomodulatory and antiviral action
Pharmacotherapeutic Group
Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of liver diseases, lipotropic agents
Pharmacological Action
Hepatoprotective agent, also possesses antiviral activity.
Glycyrrhizinic acid suppresses virus reproduction in the liver and other organs due to its stimulating effect on interferon production, increased phagocytosis, and increased activity of natural killer cells. Due to its detergent action, it improves the emulsification of phosphatidylcholine in the intestine.
Phosphatidylcholine is the main structural component of the phospholipid layer of biological membranes (cellular and intracellular).
It restores the structure and function of damaged hepatocyte membranes, thereby preventing the loss of enzymes and other active substances by the cells, normalizes protein, lipid, and fat metabolism, restores the detoxification function of the liver, suppresses the formation of connective tissue in the liver, and reduces the risk of fibrosis and cirrhosis of the liver.
Pharmacokinetics
The components of this combination are well absorbed in the small intestine both in the form of the original molecule and as biologically active products of their hydrolysis by digestive enzymes (unsaturated fatty acids, glycerol, inorganic phosphate and choline, glycyrrhetinic acid), which are transported through the intestinal wall into the lymphatic stream and easily penetrate the liver, lungs, skin, and other organs.
Partial resynthesis of phosphatidylcholine from hydrolysis products occurs in the liver.
Indications
As part of complex therapy: acute and chronic hepatitis; fatty hepatosis and other degenerative liver lesions; drug-induced and alcoholic liver lesions; liver cirrhosis; intoxications; psoriasis; neurodermatitis; eczema.
ICD codes
| ICD-10 code | Indication |
| B15 | Acute hepatitis A |
| B16 | Acute hepatitis B |
| B17.1 | Acute hepatitis C |
| B18.0 | Chronic viral hepatitis B with delta-agent |
| B18.1 | Chronic viral hepatitis B without delta-agent |
| B18.2 | Chronic viral hepatitis C |
| K70 | Alcoholic liver disease |
| K71 | Toxic liver disease |
| K73 | Chronic hepatitis, not elsewhere classified |
| K74 | Fibrosis and cirrhosis of liver |
| K76.0 | Fatty (change of) liver, not elsewhere classified |
| L20.8 | Other atopic dermatitis (neurodermatitis, eczema) |
| L28.0 | Lichen simplex chronicus (circumscribed neurodermatitis) |
| L30.0 | Nummular eczema |
| L40 | Psoriasis |
| ICD-11 code | Indication |
| 1E50.0 | Acute hepatitis A |
| 1E50.1 | Acute hepatitis B |
| 1E50.2 | Acute hepatitis C |
| 1E51.0Z | Chronic hepatitis B, unspecified |
| 1E51.1 | Chronic viral hepatitis C |
| 1E51.2 | Chronic hepatitis D |
| 4A85.00 | Drug hypersensitivity-induced liver disease |
| 9A06.70 | Atopic eczema of the eyelids |
| DB92.0 | Non-alcoholic fatty liver disease without steatohepatitis |
| DB92.Y | Other specified non-alcoholic fatty liver disease |
| DB92.Z | Non-alcoholic fatty liver disease, unspecified |
| DB93 | Fibrosis or cirrhosis of liver |
| DB94.Z | Alcoholic liver disease, unspecified |
| DB95.Z | Drug-induced or toxic liver disease, unspecified |
| DB97.2 | Chronic hepatitis, not elsewhere classified |
| EA80.0 | Infantile atopic eczema |
| EA80.1 | Childhood atopic eczema |
| EA80.2 | Adult atopic eczema |
| EA80.Z | Atopic eczema, unspecified |
| EA82 | Nummular dermatitis |
| EA83.00 | Lichen simplex of vulva |
| EA83.01 | Lichen simplex of male genital organs |
| EA83.02 | Lichen simplex of perianal area |
| EA83.0Z | Lichen simplex of unspecified location |
| EA85.20 | Atopic hand eczema |
| EA90.Z | Psoriasis, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
For oral administration, take two capsulesthree to four times daily.
Administer capsules with meals and a small amount of water.
For intravenous administration, inject the solution slowly.
The single IV dose is administered twice daily, typically in the morning and evening.
Continue the IV regimen for 10 days.
After the initial 10-day IV course, switch to oral administration for continued therapy.
The total daily dosage and treatment duration are determined by the severity of the condition and clinical response.
Adhere strictly to the prescribed regimen for the full course of therapy.
Do not alter the dosage or frequency without medical consultation.
Adverse Reactions
Allergic reactions skin rash.
Contraindications
Hypersensitivity to the components of the combination.
Use in Hepatic Impairment
The drug is approved for use in liver function impairment
Drug Interactions
The solution for parenteral administration should not be mixed with solutions of other medicinal products.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 35 mg+65 mg: 20, 30, 50, 96, 100, 200, or 300 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
 |
Fosfogard | Capsules 35 mg+65 mg: 20, 30, 50, 96, 100, 200, or 300 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 0, capsule body orange, capsule cap black; capsule contents – a mixture of granules and powder from white with a slight yellowish tint to light yellow, with a faint characteristic odor.
| 1 cap. | |
| Sodium glycyrrhizinate (in the form of trisodium salt of glycyrrhizinic acid) | 35 mg |
| Phospholipids (Lipoid C80) [calculated as 100% substance (main component – phosphatidylcholine from 73 to 79%)] | 65 mg |
Excipients : microcrystalline cellulose, calcium carbonate, calcium stearate, talc, colloidal silicon dioxide.
Composition of the capsule body gelatin, dye iron oxide yellow (E172), dye azorubine (E122).
Composition of the capsule cap gelatin, dye iron oxide black (E172).
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
96 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
200 pcs. – polymer jars (1) – cardboard packs.
300 pcs. – polymer jars (1) – cardboard packs.
Lyophilizate for preparation of solution for intravenous administration 200 mg+500 mg: vial 1, 5 or 10 pcs.
Marketing Authorization Holder
Pharmasintez, JSC (Russia)
Dosage Form
|
Fosfogard lio | Lyophilizate for preparation of solution for intravenous administration 200 mg+500 mg: vial 1, 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for preparation of solution for intravenous administration in the form of a lyophilized mass from white to light yellow, with a faint characteristic odor; reconstituted solution: an opalescent light yellow solution, with a faint characteristic odor.
| 1 vial | |
| Sodium glycyrrhizinate (trisodium salt of glycyrrhizinic acid) | 200 mg |
| Phospholipids (Lipoid C 100) [calculated as 100% substance] | 500 mg |
Excipients : maltose monohydrate, sodium hydroxide 1M solution and/or hydrochloric acid 1M solution).
2.5 g – dark glass vials (1) – cardboard packs.
2.5 g – dark glass vials (1) complete with solvent “Water for injections” (amp. 10 ml 1 pc.) – cardboard packs.
2.5 g – dark glass vials (5) – cardboard packs with partitions.
2.5 g – dark glass vials (5) complete with solvent “Water for injections” (amp. 10 ml 5 pcs.) – cardboard packs with partitions.
2.5 g – dark glass vials (10) – cardboard packs with partitions.
![Fosfogard [Capsules, Lyophilisate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Fosfogard [Capsules, Lyophilisate] 2")