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Pyridoxine (Tablets, Solution) Instructions for Use

ATC Code

A11HA02 (Pyridoxine (vitamin B6))

Active Substance

Pyridoxine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

B vitamin

Pharmacotherapeutic Group

Vitamins; other vitamin preparations

Pharmacological Action

Vitamin B6. It plays an important role in metabolism; it is necessary for the normal functioning of the central and peripheral nervous system.

In its phosphorylated form, Pyridoxine is a coenzyme for a large number of enzymes acting on the non-oxidative metabolism of amino acids (including decarboxylation and transamination processes).

Pyridoxine is involved in the metabolism of tryptophan, methionine, cysteine, glutamic acid, and other amino acids.

It plays an important role in histamine metabolism. It helps to normalize lipid metabolism.

Pharmacokinetics

It is metabolized in the liver to form pharmacologically active metabolites (pyridoxal phosphate and pyridoxamine phosphate).

Pyridoxal phosphate is 90% bound to plasma proteins. It is distributed mainly in the liver, and to a lesser extent in muscles and the CNS.

It crosses the placenta and is excreted in breast milk. The elimination half-life (T1/2) is 15-20 days.

It is excreted by the kidneys (with intravenous administration, 2% is excreted in bile) and also by hemodialysis.

Indications

For oral administration: treatment of hypo- and avitaminosis B6. As part of complex therapy for diseases of the nervous system ( neuralgia, Ménière’s syndrome); in dermatology ( dermatitis, including atopic and seborrheic; herpes zoster, neurodermatitis, psoriasis, exudative diathesis); sideroblastic anemia; acute and chronic hepatitis.

For parenteral administration: hypo- and avitaminosis B6; congenital pyridoxine-dependent convulsive syndrome in newborns; prevention and treatment of neurotoxicity caused by isoniazid and other derivatives of isonicotinic acid hydrazide. As part of complex therapy for diseases of the nervous system: parkinsonism, central or peripheral paralysis, Little’s disease, Ménière’s disease and syndrome, seasickness and airsickness, radiculitis, neuralgia, neuritis.

ICD codes

ICD-10 code Indication
B02 Zoster [herpes zoster]
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
D64.3 Other sideroblastic anemias
E53.1 Pyridoxine deficiency
G20 Parkinson's disease
G21 Secondary parkinsonism
G80 Cerebral palsy
G81 Hemiplegia
G82 Paraplegia and tetraplegia
G83 Other paralytic syndromes
H81.0 Ménière's disease
K73 Chronic hepatitis, not elsewhere classified
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L21 Seborrheic dermatitis
L28.0 Lichen simplex chronicus (circumscribed neurodermatitis)
L40 Psoriasis
M54.1 Radiculopathy
M54.3 Sciatica
M54.4 Lumbago with sciatica
M79.2 Neuralgia and neuritis, unspecified
P90 Convulsions of newborn
T75.3 Motion sickness
Y41.1 Antimycobacterial drugs
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
1E91.Z Herpes zoster, unspecified
3A72.Z Sideroblastic anemia, unspecified
5B5D Vitamin B6 deficiency
8A00.0Z Parkinson's disease, unspecified
8A00.2Z Secondary parkinsonism, unspecified
8A0Y Other specified movement disorders
8B93.Z Radiculopathy, unspecified
8D2Z Cerebral palsy, unspecified
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
9A06.70 Atopic eczema of the eyelids
AB31.0 Ménière's disease
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
EA81.Z Seborrheic dermatitis, unspecified
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
FB56 Specified soft tissue diseases, not elsewhere classified
KB06 Neonatal convulsions
LD90.1 Early-onset parkinsonism-mental retardation
MB50.Z Tetraplegia, unspecified
MB53.0 Alternating hemiplegia
MB53.Z Hemiplegia, unspecified
MB56 Paraplegia
MB5Z Paralytic symptoms, unspecified
ME84.20 Lumbago with sciatica
ME84.3 Sciatica
NF08.3 Motion sickness
PL00 Drugs, medicaments or biological substances causing injury or harm in therapeutic use

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.

Tablets, Solution

It is used orally and parenterally (subcutaneously, intramuscularly, or intravenously).

The dose, method and scheme of application, and duration of therapy are determined individually, depending on the indications, clinical situation, patient’s age, and the dosage form used; when conducting combination therapy, the doses of pyridoxine also depend on the components of the combination used.

Adverse Reactions

In some cases: allergic reactions, hypersecretion of hydrochloric acid.

Possible: allergic reactions, increased acidity of gastric juice, pain in the epigastric region, sensation of pressure in the extremities – “stocking and glove” symptom, decreased lactation; with rapid administration – convulsions.

Contraindications

Hypersensitivity to pyridoxine; pediatric age – depending on the dosage form.

With caution: gastric and duodenal ulcer (due to possible increase in gastric acidity), coronary artery disease, severe liver damage.

Use in Pregnancy and Lactation

During pregnancy, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Long-term use of pyridoxine in high doses during pregnancy and breastfeeding may lead to the development of pyridoxine dependence in children. It is not recommended to exceed the physiological requirement norms for pyridoxine during pregnancy (2 mg/day).

Use in Hepatic Impairment

It should be used with caution in severe liver damage.

Pediatric Use

It can be used in children of appropriate age categories according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the pyridoxine drug leaflets regarding contraindications for the use of specific pyridoxine dosage forms in children of different ages.

Special Precautions

In severe liver damage, Pyridoxine in high doses may cause deterioration of its function.

When determining urobilinogen using Ehrlich’s reagent, Pyridoxine may distort the results.

Drug Interactions

The physiological function of vitamins B1 and B6 is to potentiate each other’s action, manifested in a positive effect on the nervous, muscular, and cardiovascular systems.

With simultaneous use with hormonal contraceptives, an increase in the concentration of pyridoxine in blood plasma is possible.

With simultaneous use, Pyridoxine potentiates the action of diuretics.

With simultaneous use with levodopa, the effects of levodopa are reduced or completely inhibited.

With simultaneous use with isonicotinyl hydrazide, penicillamine, cycloserine, a decrease in the effectiveness of pyridoxine is possible.

With simultaneous use with phenytoin, phenobarbital, a decrease in the plasma concentrations of phenytoin and phenobarbital is possible.

Pyridoxine can be used in combination with cardiac glycosides ( Pyridoxine promotes increased synthesis of contractile proteins in the myocardium), with glutamic acid, and with potassium and magnesium asparaginate.

Pyridoxine prevents or reduces toxic manifestations, including liver damage, observed when using isoniazid and other anti-tuberculosis drugs.

Simultaneous use of pyridoxine with cycloserine, ethionamide, hydralazine, azathioprine, chlorambucil, corticotropin, cyclophosphamide, cyclosporine, mercaptopurine, isoniazid, penicillamine may cause anemia and neuropathy.

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

Over-the-Counter

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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection transparent, colorless or slightly yellowish.

1 ml
Pyridoxine hydrochloride 50 mg

Excipients: water for injections – up to 1 ml.

1 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
1 ml – ampoules (5) – cardboard trays (1) – cardboard packs.
1 ml – ampoules (5) – cardboard trays (2) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 10 mg/1 ml: amp. 1 or 2 ml, 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml
Pyridoxine hydrochloride 10 mg

1 ml – ampoules (10) – cardboard packs.
2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 1 or 2 ml, 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – cardboard packs.
2 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)

Dosage Form

Bottle Rx Icon Pyridoxine Solution for injection 10 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml
Pyridoxine hydrochloride 10 mg

1 ml – ampoules (10) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Solution for injection 10 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml
Pyridoxine hydrochloride 10 mg

1 ml – ampoules (10) – cardboard packs.
1 ml – ampoules (5) – contour plastic packaging (2) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – cardboard packs.
1 ml – ampoules (5) – contour plastic packaging (2) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Solution for injection 20 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection 1 ml 1 amp.
Pyridoxine hydrochloride 10 mg 20 mg

2 ml – ampoules (10) – cardboard packs.
2 ml – ampoules (5) – contour plastic packaging (2) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 100 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml 1 amp.
Pyridoxine hydrochloride 50 mg 100 mg

2 ml – ampoules (10) – carton packs.
2 ml – ampoules (5) – plastic contour packs (2) – carton packs.

Marketing Authorization Holder

Lvivdialek State Production Association Ukrmedprom (Ukraine)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 1 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – carton packs.
1 ml – ampoules (5) – contour cell packs (2) – carton packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (5) – plastic contour packs (1) – carton packs.
1 ml – ampoules (5) – plastic contour packs (2) – carton packs.
1 ml – ampoules (10) – plastic contour packs (2) – carton packs.
1 ml – ampoules (10) – plastic contour packs (1) – carton packs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 100 mg/2 ml: amp. 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml 1 amp.
Pyridoxine hydrochloride 50 mg 100 mg

2 ml – ampoules (5) – plastic contour packs (1) – carton packs.
2 ml – ampoules (5) – plastic contour packs (2) – carton packs.
2 ml – ampoules (10) – plastic contour packs (2) – carton packs.
2 ml – ampoules (10) – plastic contour packs (1) – carton packs.

Marketing Authorization Holder

Statusfarm LLC (Russia)

Manufactured By

Yerevan Chemical And Pharmaceutical Firm, OJSC (Armenia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution as a transparent, colorless or yellowish liquid.

1 ml
Pyridoxine hydrochloride 50 mg

Excipients: water for injections – up to 1 ml.

1 ml – glass ampoules (10) – carton boxes.

Marketing Authorization Holder

Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Solution for injection 10 mg/1 ml: amp. 10, 150, or 200 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Pyridoxine hydrochloride 10 mg

1 ml – ampoules (10) – carton packs.
1 ml – ampoules (150) – carton boxes.
1 ml – ampoules (200) – carton boxes.

Marketing Authorization Holder

Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 20 mg/2 ml: amp. 10, 150, or 200 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml 1 amp.
Pyridoxine hydrochloride 10 mg 20 mg

2 ml – ampoules (10) – carton packs.
2 ml – ampoules (150) – carton packs.
2 ml – ampoules (200) – carton packs.

Marketing Authorization Holder

Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 10, 150 or 200 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – carton packs.
1 ml – ampoules (150) – carton packs.
1 ml – ampoules (200) – carton packs.

Marketing Authorization Holder

Pharmstandard-Ufimsky Vitaminny Zavod OJSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 100 mg/2 ml: amp. 10, 150 or 200 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml 1 amp.
Pyridoxine hydrochloride 50 mg 100 mg

2 ml – ampoules (10) – carton packs.
2 ml – ampoules (150) – carton packs.
2 ml – ampoules (200) – carton packs.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Manufactured By

NPC Eskom, PJSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Injection solution 50 mg/1 ml: amp. 3, 5, 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Injection solution as a transparent, colorless or slightly yellowish liquid.

1 ml
Pyridoxine hydrochloride 50 mg

Excipients: water for injections – up to 1 ml.

1 ml – colorless glass ampoules (3 or 5) – contour cell packs (1) – carton packs.
1 ml – colorless glass ampoules (5) – contour cell packs (2 or 4) – carton packs.
1 ml – colorless glass ampoules (10) – contour cell packs (1 or 2) – carton packs.
1 ml – colorless glass ampoules (5) – contour cell packs (10 or 20) – carton packs (for hospitals).
1 ml – colorless glass ampoules (10) – contour cell packs (5 or 10) – carton packs (for hospitals).

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Bufus Injection solution 50 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine Bufus Injection solution 100 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml 1 amp.
Pyridoxine hydrochloride 50 mg 100 mg

2 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Or

Ozon Pharm, LLC (Russia)

Dosage Form

Bottle OTC Icon Pyridoxine hydrochloride Tablets 10 mg: 10, 20, 30, 40, 50, 100, 150, 200, 250, or 500 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score.

1 tab.
Pyridoxine hydrochloride 10 mg

Excipients: dextrose monohydrate (glucose monohydrate) – 77.5 mg, microcrystalline cellulose (MCC-102) – 9.5 mg, povidone K17 – 1.5 mg, calcium stearate – 1 mg, colloidal silicon dioxide – 0.5 mg.

10 pcs. – contour cell packs (1) – carton packs.
10 pcs. – contour cell packs (2) – carton packs.
10 pcs. – contour cell packs (3) – carton packs.
10 pcs. – contour cell packs (4) – carton packs.
10 pcs. – contour cell packs (5) – carton packs.
10 pcs. – contour cell packs (10) – carton packs.
50 pcs. – contour cell packs (1) – carton packs.
50 pcs. – contour cell packs (2) – carton packs.
50 pcs. – contour cell packs (3) – carton packs.
50 pcs. – contour cell packs (4) – carton packs.
50 pcs. – contour cell packs (5) – carton packs.
50 pcs. – contour cell packs (10) – carton packs.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine-SOLOpharm Injection solution 50 mg/1 ml: amp. 1 ml 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution as a transparent, colorless or colored liquid.

1 ml
Pyridoxine hydrochloride 50 mg

Excipients: water for injections – up to 1 ml.

1 ml – glass ampoules (5) – contour cell packs (2) – carton packs.
1 ml – glass ampoules (10) – contour cell packs (1) – carton packs.
1 ml – glass ampoules (5) – cardboard forms (2) – carton packs.
1 ml – glass ampoules (10) – cardboard forms (1) – carton packs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

CSPC Ouyi Pharmaceutical, Co. Ltd. (China)

Dosage Form

Bottle Rx Icon Pyridoxine-Vial Injection solution 50 mg/1 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – carton packs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

CSPC Ouyi Pharmaceutical, Co. Ltd. (China)

Or

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Pyridoxine-Vial Solution for injection 50 mg/1 ml: amp. 10 or 100 pcs. (packaged by Ozon LLC)

Dosage Form, Packaging, and Composition

Injection solution 1 ml
Pyridoxine hydrochloride 50 mg

1 ml – ampoules (10) – carton packs.
1 ml – ampoules (10) – plastic contour packs (10) – carton packs.

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