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Sodium hydrocarbonate (Solution, Powder) Instructions for Use

ATC Code

B05CB04 (Sodium bicarbonate)

Active Substance

Sodium bicarbonate (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Acidosis correction preparation for parenteral use

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; solutions for intravenous administration; solutions affecting water-electrolyte balance

Pharmacological Action

Antacid agent, regulates acid-base balance. It has alkaline properties, increases the alkaline reserve of the blood. When taken orally, it quickly neutralizes hydrochloric acid of gastric juice and has a rapid but short-lived antacid effect. It irritates the receptors of the gastric mucosa, increases the release of gastrin with secondary activation of secretion, and may cause discomfort in the stomach (due to its distension) and belching.

It has an expectorant effect by reducing the viscosity of sputum due to a shift in the reaction of bronchial mucus to the alkaline side.

When absorbed, it leads to the development of alkalosis. Urine alkalinization prevents the precipitation of uric acid in the urinary tract.

It alleviates the symptoms of seasickness and airsickness.

Indications

Metabolic acidosis (including in diabetes mellitus, infections, intoxications, kidney diseases, anesthesia, in the postoperative period); as a symptomatic agent for the relief of heartburn, discomfort in the epigastrium associated with increased acidity of gastric juice; symptomatic treatment of cough with viscous and difficult-to-expectorate sputum in various respiratory tract diseases; seasickness and airsickness.

For topical application: inflammatory diseases of the oral cavity, eyes, upper respiratory tract, for softening earwax.

ICD codes

ICD-10 code Indication
E87.2 Acidosis
H01.0 Blepharitis
H10 Conjunctivitis
H15 Diseases of sclera
H16 Keratitis
H61.2 Impacted cerumen
J00 Acute nasopharyngitis (common cold)
J01 Acute sinusitis
J02 Acute pharyngitis
J03 Acute tonsillitis
J04 Acute laryngitis and tracheitis
J06.9 Acute upper respiratory infection, unspecified
J15 Bacterial pneumonia, not elsewhere classified
J20 Acute bronchitis
J31.0 Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J31.2 Chronic pharyngitis
J32 Chronic sinusitis
J35.0 Chronic tonsillitis
J37 Chronic laryngitis and laryngotracheitis
J42 Unspecified chronic bronchitis
K04 Diseases of pulp and periapical tissues (including periodontitis)
K05 Gingivitis and periodontal diseases
K12 Stomatitis and related lesions
K29 Gastritis and duodenitis
R05 Cough
R09.3 Sputum
R10.1 Pain localized to the upper abdomen
R12 Heartburn
T75.3 Motion sickness
ICD-11 code Indication
5C73.Z Acidosis, unspecified
9A01.3 Infectious blepharitis
9A02.Z Inflammatory disorders of eyelid, unspecified
9A60.Z Conjunctivitis, unspecified
9A71 Infectious keratitis
9A7Z Diseases of the cornea, unspecified
9B5Z Disorders of sclera, unspecified
AA42 Impacted cerumen
CA00 Acute nasopharyngitis
CA01 Acute rhinosinusitis
CA02.Z Acute pharyngitis, unspecified
CA03.Z Acute tonsillitis, unspecified
CA05 Acute laryngitis or tracheitis
CA07.0 Acute upper respiratory tract infection of unspecified site
CA09.0 Chronic rhinitis
CA09.2 Chronic pharyngitis
CA0A.Z Chronic rhinosinusitis, unspecified
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
CA0G Chronic laryngitis or laryngotracheitis
CA20.1Z Chronic bronchitis, unspecified
CA40.0Z Bacterial pneumonia, unspecified
CA42.Z Acute bronchitis, unspecified
DA01.Z Diseases of the oral mucosa, unspecified
DA09.Z Diseases of pulp and periapical tissues, unspecified
DA0B.Z Gingival diseases, unspecified
DA0C.Z Periodontal diseases, unspecified
DA0Z Diseases or disorders of the orofacial complex, unspecified
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
MD10 Abnormal sputum
MD12 Cough
MD81.10 Pain localized in the upper abdomen
MD95 Heartburn
NF08.3 Motion sickness

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 metabolic acidosis, administer intravenously. The required dose is calculated based on base deficit and body weight. Do not exceed a maximum infusion rate of 50 mL of a 5% solution over 10 minutes. For severe acidosis, administer under strict laboratory control of acid-base balance.

For oral use as an antacid, dissolve 1/2 to 1 teaspoon of powder in 1/2 glass of water. Take symptomatically for heartburn or epigastric pain. Do not use continuously for more than two weeks without medical supervision.

As an expectorant for cough with viscous sputum, use an oral solution. Inhale a 0.5-2% solution via a nebulizer for respiratory tract conditions. Follow specific device instructions for inhalation.

For inflammatory diseases of the oral cavity (gingivitis, stomatitis), use a 1-2% solution for rinsing. Apply 2-3 times daily after meals.

For conjunctivitis and eye diseases, use a 1-2% solution for irrigation. For impacted cerumen, instill a 3-5% warm solution into the external auditory canal.

For motion sickness, take orally as a powder or solution at the first sign of symptoms. Dosage depends on individual tolerance and severity.

Adjust dosage in patients with renal impairment or heart failure due to sodium content. Monitor for signs of hypernatremia or alkalosis, especially with prolonged use.

Adverse Reactions

With prolonged use, the development of alkalosis (sometimes uncompensated) is possible, accompanied by loss of appetite, nausea, vomiting, pain in the epigastric region, anxiety, headaches, and in some severe cases, tetanic convulsions; increased blood pressure, flatulence (when taken orally).

Contraindications

Conditions accompanied by the development of metabolic alkalosis, hypernatremia, hypokalemia.

Use in Pregnancy and Lactation

It should be used with caution during pregnancy and breastfeeding.

Use in Renal Impairment

In patients with concomitant kidney diseases, excessive sodium intake causes edema and heart failure.

Special Precautions

It is not recommended for systematic use because when neutralizing hydrochloric acid of the stomach with sodium bicarbonate, carbon dioxide is released, which has an excitatory effect on the receptors of the gastric mucosa, increases the release of gastrin, and can cause a secondary increase in secretion. Furthermore, with prolonged regular use, urine alkalinization and an increased risk of phosphate stone formation are possible.

Intensive release of CO2 can provoke perforation of the gastrointestinal tract walls.

In patients with concomitant heart or kidney diseases, excessive sodium intake causes edema and heart failure.

Drug Interactions

With simultaneous use, the excretion of amphetamine in the urine decreases due to an increase in urine pH under the influence of sodium bicarbonate.

When sodium bicarbonate is taken orally against the background of the use of lithium carbonate in established maintenance doses, a decrease in the plasma concentration of lithium is possible, which is due to the influence of sodium ions.

With simultaneous use with methotrexate, the excretion of methotrexate in the urine increases and its toxic effect on the kidneys decreases due to an increase in urine pH under the influence of sodium bicarbonate.

With simultaneous oral administration, the absorption of tetracyclines decreases.

Due to an increase in urine pH under the influence of sodium bicarbonate, a delay in the excretion of ephedrine from the body is observed and the risk of side effects (tremor, anxiety, sleep disorders, tachycardia) increases.

With intravenous drip administration of sodium bicarbonate, an enhancement of the antihypertensive effect of reserpine is possible.

Storage Conditions

Store at 15°C (59°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 Disclaimer

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

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Sodium bicarbonate Solution for infusion 5%: 200 ml bottle 1 or 24 pcs., 400 ml bottle 1 or 12 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 4% 100 ml
Sodium bicarbonate 4 g

Excipients : water for injections up to 100 ml.

100 ml – Glass bottles with a capacity of 100 ml (1) – cardboard packs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Sodium bicarbonate Infusion solution 40 mg/1 ml: bot. 100 ml, 200 ml or 400 ml

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

1 ml
Sodium bicarbonate 40 mg

Ionic composition (per 1 liter): sodium ion – 476 mmol, bicarbonate ion – 476 mmol.

Excipients : disodium edetate (disodium salt of ethylenediaminetetraacetic acid) – 0.2 mg, water for injections – up to 1 ml.
Theoretical osmolarity: 952 mOsm/l.

100 ml – bottles (1) – cardboard packs.
200 ml – bottles (1) – cardboard packs.
400 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Dosage Form

Bottle OTC Icon Sodium bicarbonate Powder for preparation of oral solution and topical application 10 g: pkg. 10 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for oral administration and topical application white, crystalline, odorless, salty-alkaline taste; aqueous solutions have an alkaline reaction.

1 sachet
Sodium bicarbonate 10 g

10 g – sachets (5) – cardboard packs.
10 g – sachets (10) – cardboard packs.

Marketing Authorization Holder

Mosfarm LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium bicarbonate Infusion solution 5%: 100 ml, 200 ml or 400 ml bot.

Dosage Form, Packaging, and Composition

Solution for infusion transparent, colorless.

1 l
Sodium bicarbonate 50 g

Excipients : water for injections up to 1 l.

Theoretical osmolarity 1190 mOsm/l.

100 ml – glass bottles (1) – cardboard packs.
200 ml – glass bottles (1) – cardboard packs.
400 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (36) – cardboard boxes (for hospitals).
250 ml – glass bottles (15) – cardboard boxes (for hospitals).
250 ml – glass bottles (28) – cardboard boxes (for hospitals).
450 ml – glass bottles (15) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Yaroslavl Pharmaceutical Factory, CJSC (Russia)

Dosage Form

Bottle OTC Icon Sodium bicarbonate Powder for solution for oral and topical use 25 g: jars

Dosage Form, Packaging, and Composition

Powder for preparation of solution for oral administration and topical application 1 jar
Sodium bicarbonate 25 g

25 g – dark glass jars.

Marketing Authorization Holder

Yaroslavl Pharmaceutical Factory, CJSC (Russia)

Dosage Form

Bottle OTC Icon Sodium bicarbonate Powder for preparation of solution for oral and topical administration 10 g: sachets 5 pcs.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for oral administration and topical application 1 sachet
Sodium bicarbonate 10 g

10 g – sachets made of combined heat-sealable material (5) – cardboard packs.

Marketing Authorization Holder

Liquor, LLC (Armenia)

Dosage Form

Bottle Rx Icon Sodium bicarbonate Infusion solution 8.4%: bottle 200 ml 30 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 8.4% 1 l
Sodium bicarbonate 84 g

200 ml – bottles (30) – cardboard boxes.

Marketing Authorization Holder

Liquor, LLC (Armenia)

Dosage Form

Bottle Rx Icon Sodium bicarbonate Infusion solution 8.4%: vial 20 ml 30 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion 8.4% 1 l
Sodium bicarbonate 84 g

20 ml – vials (30) – cardboard boxes.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium bicarbonate-Eskom Infusion solution 5%: 100 mL, 200 mL, or 400 mL bottle

Dosage Form, Packaging, and Composition

Solution for infusion 5% 1 l
Sodium bicarbonate 50 g

100 ml – bottles.
200 ml – bottles.
400 ml – bottles.
100 ml – bottles (28) – cardboard boxes.
200 ml – bottles (28) – cardboard boxes.
400 ml – bottles (15) – cardboard boxes.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium bicarbonate-Eskom Infusion solution 42 mg/mL: 100 mL or 200 mL bottle, 1 or 28 pcs., 400 mL bottle, 1 or 15 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 1 ml
Sodium bicarbonate 42 mg

100 ml – bottles.
200 ml – bottles.
400 ml – bottles.
100 ml – bottles (28) – cardboard boxes.
200 ml – bottles (28) – cardboard boxes.
400 ml – bottles (15) – cardboard boxes.

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Dosage Form

Bottle Rx Icon Sodium bicarbonate-Eskom Infusion solution 84 mg/mL: 100 mL or 200 mL bottle, 1 or 28 pcs., 400 mL bottle, 1 or 15 pcs.

Dosage Form, Packaging, and Composition

Infusion solution 1 ml
Sodium bicarbonate 84 mg

100 ml – bottles.
200 ml – bottles.
400 ml – bottles.
100 ml – bottles (28) – cardboard boxes.
200 ml – bottles (28) – cardboard boxes.
400 ml – bottles (15) – cardboard boxes.

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