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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tablets 500 mg: 10 or 20 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
Irbit Chemical Pharmaceutical Plant, JSC (Russia)
Dosage Form
 |
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.
Tablets 200 mg: 10, 15, 20, or 1000 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
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.
500 mg tablets: 10, 20 or 1000 pcs.
Marketing Authorization Holder
Biosintez, PJSC (Russia)
Dosage Form
|
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.
Tablets 200 mg: 20 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Dosage Form
|
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.
Tablets 500 mg: 10, 20, or 2000 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Dosage Form
|
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.
Tablets 200 mg: 10, 20 or 30 pcs.
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
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.
Tablets 500 mg: 10, 20, or 30 pcs.
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
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.
Tablets 200 mg: 10 or 15 pcs.
Tablets 500 mg: 10 or 15 pcs.
Marketing Authorization Holder
Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)
Dosage Forms
|
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.
![Sulfadimethoxine [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Sulfadimethoxine [Tablets] 2")