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Sulfadimethoxine (Tablets) Instructions for Use

ATC Code

J01ED01 (Sulfadimethoxine)

Active Substance

Sulfadimethoxine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibacterial sulfonamide drug

Pharmacotherapeutic Group

Antimicrobial agent, sulfonamide

Pharmacological Action

An antibacterial agent, a sulfonamide derivative. It has a prolonged action when taken orally. The mechanism of action is associated with competitive antagonism with PABA and competitive inhibition of dihydropteroate synthase, which leads to a disruption in the synthesis of tetrahydrofolic acid, necessary for the synthesis of purines and pyrimidines.

It is active against gram-positive bacteria: Staphylococcus spp., Streptococcus spp. (including Streptococcus pneumoniae); gram-negative bacteria: Klebsiella pneumoniae, Escherichia coli, Shigella spp.

It is active against Chlamydia trachomatis.

Pharmacokinetics

After oral administration, it is detected in the blood within 30 minutes, Cmax is reached within 8-12 hours. It poorly penetrates the blood-brain barrier. A therapeutic concentration in adults is noted when taking 1-2 g on the first day and 0.5-1 g on subsequent days.

Unlike other sulfonamides, the predominant metabolism occurs via the pathway of microsomal glucuronidation, associated with CYP450 isoenzymes and NADPH-dependent.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to sulfadimethoxine, including tonsillitis, sinusitis, otitis media, bronchitis, pneumonia, dysentery, pyoderma, inflammatory diseases of the biliary and urinary tracts, erysipelas, wound infections, trachoma; malaria (as part of combination therapy).

ICD codes

ICD-10 code Indication
A03 Shigellosis
A46 Erysipelas
A71 Trachoma
B54 Unspecified malaria
H66 Suppurative and unspecified otitis media
J01 Acute sinusitis
J02 Acute pharyngitis
J03 Acute tonsillitis
J04 Acute laryngitis and tracheitis
J15 Bacterial pneumonia, not elsewhere classified
J20 Acute bronchitis
J31.2 Chronic pharyngitis
J35.0 Chronic tonsillitis
J37 Chronic laryngitis and laryngotracheitis
K81.0 Acute cholecystitis
K81.1 Chronic cholecystitis
K83.0 Cholangitis
L08.0 Pyoderma
N10 Acute tubulointerstitial nephritis (acute pyelonephritis)
N11 Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N30 Cystitis
N34 Urethritis and urethral syndrome
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
1A02 Intestinal infections due to Shigella
1B70.0Z Erysipelas, unspecified
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1C23.Z Trachoma, unspecified
1F45 Malaria without parasitological confirmation
1F4Z Malaria, unspecified
AA9Z Unspecified suppurative otitis media
CA01 Acute rhinosinusitis
CA02.Z Acute pharyngitis, unspecified
CA03.Z Acute tonsillitis, unspecified
CA05 Acute laryngitis or tracheitis
CA09.2 Chronic pharyngitis
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
CA0G Chronic laryngitis or laryngotracheitis
CA40.0Z Bacterial pneumonia, unspecified
CA42.Z Acute bronchitis, unspecified
DC12.0Z Acute cholecystitis, unspecified
DC12.1 Chronic cholecystitis
DC13 Cholangitis
EB21 Pyoderma gangrenosum
GB50 Acute tubulo-interstitial nephritis
GB51 Acute pyelonephritis
GB55.Z Chronic tubulo-interstitial nephritis, unspecified
GB5Z Renal tubulo-interstitial diseases, unspecified
GC00.Z Cystitis, unspecified
GC02.Z Urethritis and urethral syndrome, unspecified
NF0A.3 Posttraumatic wound infection, not elsewhere classified

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.

Administer orally once daily after a meal to minimize gastrointestinal discomfort.

For adult patients, the initial loading dose is 1 gram (1000 mg) on the first day of treatment.

On all subsequent days, administer a maintenance dose of 500 mg daily.

In severe infections, the maintenance dose may be increased as determined by the prescribing physician based on clinical severity and patient response.

For pediatric patients, calculate the dose based on body weight.

The initial loading dose is 25 mg per kilogram of body weight on the first day.

The daily maintenance dose thereafter is 12.5 mg per kilogram of body weight.

Do not exceed the maximum recommended adult doses in pediatric patients.

The typical treatment course is 7 to 10 days.

Continue therapy for a minimum of 72 hours after the patient becomes asymptomatic to prevent relapse.

Ensure adequate fluid intake during treatment to maintain urine output and prevent crystalluria.

Adhere strictly to the prescribed regimen; do not discontinue therapy prematurely.

Adverse Reactions

From the CNS headache is possible.

From the digestive system dyspepsia (including nausea, vomiting), cholestatic hepatitis.

Allergic reactions skin rash, drug fever.

From the hematopoietic system rarely – leukopenia, agranulocytosis.

Contraindications

Hypersensitivity to sulfonamides; bone marrow depression, renal and/or hepatic insufficiency, chronic heart failure, congenital glucose-6-phosphate dehydrogenase deficiency, porphyria, azotemia; pregnancy, breastfeeding period; pediatric age – depending on the dosage form.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated for use in hepatic insufficiency.

Use in Renal Impairment

Contraindicated for use in renal insufficiency.

Pediatric Use

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

Special Precautions

During treatment, copious alkaline fluid intake, monitoring of blood and urine parameters is recommended.

It is used externally as part of combination drugs.

Effect on ability to drive vehicles and machinery

During the use of sulfadimethoxine, patients should exercise caution when driving vehicles and machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

The effect of sulfadimethoxine is enhanced with simultaneous use with diaminopyrimidine derivatives (trimethoprim, tetroxoprim, pyrimethamine).

With simultaneous use, Sulfadimethoxine reduces the effectiveness of bactericidal antibiotics that act only on dividing microorganisms (including penicillins, cephalosporins).

With simultaneous use, methotrexate and other folic acid antagonists increase the risk of folic acid deficiency.

With simultaneous use, procaine, benzocaine, and tetracaine reduce the antibacterial activity of sulfadimethoxine.

With simultaneous use, PAS and barbiturates enhance the antimicrobial effect of sulfadimethoxine.

With simultaneous use, salicylates increase the activity and toxicity of sulfadimethoxine.

With simultaneous use, methoxsalen promotes the development of photosensitization.

With simultaneous use, NSAIDs, thioacetazone, chloramphenicol enhance the toxic effect of sulfadimethoxine on the blood (leukopenia, agranulocytosis).

With simultaneous use, Sulfadimethoxine enhances the effect of indirect anticoagulants, phenytoin, sulfonamides with hypoglycemic action.

With simultaneous use, pyrazolone derivatives, indomethacin, and salicylates increase the free fraction of sulfadimethoxine in the blood.

With simultaneous use with sulfadimethoxine, the effectiveness of oral contraceptives is reduced.

With simultaneous use, Sulfadimethoxine enhances the metabolism of cyclosporine.

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 Disclaimer

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

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Sulfadimethoxine Tablets 500 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Sulfadimethoxine 500 mg

10 pcs. – non-cell contour packaging.
10 pcs. – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Sulfadimethoxine Tablets 200 mg: 10, 15, 20, or 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Sulfadimethoxine 200 mg

10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – non-cell contour packaging (1) – cardboard packs.
10 pcs. – non-cell contour packaging.
10 pcs. – non-cell contour packaging (100) – cardboard packs.
15 pcs. – plastic cases.

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Bottle Rx Icon Sulfadimethoxine 500 mg tablets: 10, 20 or 1000 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Sulfadimethoxine 500 mg

10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – non-cell contour packaging (1) – cardboard packs.
10 pcs. – non-cell contour packaging (100) – cardboard packs.
10 pcs. – non-cell contour packaging.
10 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – dark glass jars (1) – cardboard packs.
20 pcs. – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Dosage Form

Bottle Rx Icon Sulfadimethoxine Tablets 200 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Sulfadimethoxine 200 mg

10 pcs. – contour cell packaging (2) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Dosage Form

Bottle Rx Icon Sulfadimethoxine Tablets 500 mg: 10, 20, or 2000 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Sulfadimethoxine 500 mg

10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (PVC/paper).
10 pcs. – contour cell packaging (200) – cardboard boxes.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle Rx Icon Sulfadimethoxine Tablets 200 mg: 10, 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Sulfadimethoxine 200 mg

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle Rx Icon Sulfadimethoxine Tablets 500 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Sulfadimethoxine 500 mg

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

Bottle Rx Icon Sulfadimethoxine tablets Tablets 200 mg: 10 or 15 pcs.
Tablets 500 mg: 10 or 15 pcs.

Dosage Form, Packaging, and Composition

Tablets 1 tab.
Sulfadimethoxine 200 mg

10 pcs. – non-cell contour packaging.
10 pcs. – contour cell packaging.
10 pcs. – polymer jars.
15 pcs. – polyethylene cases.

Tablets 1 tab.
Sulfadimethoxine 500 mg

10 pcs. – non-cell contour packaging.
10 pcs. – contour cell packaging.
10 pcs. – polymer jars.
15 pcs. – polyethylene cases.

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