Septrin DS 160 mg / 800 mg 10 tablets

Septrin DS 160 mg / 800 mg 10 tablets

Composition:

Active Ingredients:
Trimethoprim — 160 mg,
sulfamethoxazole — 800 mg per tablet.
Excipients:
Potato starch, talc, magnesium stearate, polyvinyl alcohol.

Product Description:

• Combined broad-spectrum antibacterial agent with bactericidal activity.
• Sulfamethoxazole, structurally similar to para-aminobenzoic acid, impairs dihydrofolic acid synthesis in bacterial cells by inhibiting the incorporation of para-aminobenzoic acid into its molecule. 
• Trimethoprim enhances the effect of sulfamethoxazole by inhibiting the reduction of dihydrofolic acid to tetrahydrofolic acid — the active form of folic acid responsible for protein metabolism and microbial cell division.
• The drug is active against Gram-positive and Gram-negative microorganisms: streptococcal species (including Streptococcus pneumoniae and hemolytic strains), staphylococcal species, Neisseria meningitidis, Neisseria gonorrhoeae, Escherichia coli (including enterotoxigenic strains), Salmonella species (including Salmonella typhi and Salmonella paratyphi), Vibrio cholerae, Bacillus anthracis, Haemophilus influenzae (including ampicillin-resistant strains), Listeria species, Nocardia asteroides, Bordetella pertussis, Enterococcus faecalis, Klebsiella species, Proteus species, Pasteurella species, Francisella tularensis, Brucella species, Mycobacterium species (including Mycobacterium leprae), Citrobacter species, Enterobacter species, Legionella pneumophila, Providencia species, certain Pseudomonas species (excluding Pseudomonas aeruginosa), Serratia marcescens, Shigella species, Yersinia species, Morganella species, Pneumocystis jirovecii, Chlamydia species; protozoa — Plasmodium species, Toxoplasma gondii; Actinomyces israelii; pathogenic fungi — Coccidioides immitis and Histoplasma capsulatum; Leishmania species.
• Resistant to the drug: Corynebacterium species, Pseudomonas aeruginosa, Mycobacterium tuberculosis, Treponema species, Leptospira species, and viruses.
• It suppresses the activity of Escherichia coli, leading to reduced intestinal synthesis of thiamine, riboflavin, nicotinic acid, and other B-complex vitamins. The duration of therapeutic effect is 7 hours.

Indications for Use:

• Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
• Respiratory tract infections (including bronchitis, pneumonia, lung abscess, and pleural empyema).
• Otitis media, sinusitis.
• Urogenital tract infections (including pyelonephritis, urethritis, salpingitis, and prostatitis).
• Gonorrhea.
• Gastrointestinal tract infections (including typhoid fever, paratyphoid, bacterial dysentery, cholera, and diarrhea).
• Skin and soft tissue infections (including furunculosis and pyoderma).

Method of Administration and Dosage:

• Administered orally after meals with an adequate amount of fluid.
• Adults and children over 12 years of age are prescribed 1 tablet (960 mg of total active ingredients) twice daily; for long-term therapy, half a tablet (480 mg) twice daily. 
• The duration of treatment ranges from 5 to 14 days. In severe cases or chronic infections, a 30–50% increase in the single dose is permissible. 
• Peripheral blood counts must be monitored during treatment exceeding 5 days or when using elevated dosages; if pathological changes occur, folic acid supplementation at a dose of 5–10 mg daily should be initiated.

Contraindications:

• Known hypersensitivity to trimethoprim, sulfamethoxazole, co-trimoxazole, sulfonamides, or any inactive excipients of the drug.
• Established diagnosis of hepatic parenchymal damage.
• Severe renal impairment in the absence of plasma concentration monitoring, as well as severe renal failure (creatinine clearance less than 15 ml/min).
• Severe hematological disorders (aplastic anemia, B12-deficiency anemia, agranulocytosis, leukopenia, megaloblastic anemia, anemia or hyperbilirubinemia in children associated with folate deficiency).
• Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis).
• Concomitant use with dofetilide, paclitaxel, amiodarone, or clozapine.
• Pregnancy.
• Lactation (breastfeeding).
• Children under 3 years of age (for this dosage form; under 12 years for whole tablet administration).

Precautions:

• The drug should be prescribed only in cases where the potential benefit of combination therapy outweighs the potential risk compared to monotherapy.
• Caution is advised in patients with folate deficiency, bronchial asthma, or thyroid disease.
• At the first appearance of skin rash or any other severe adverse reaction, the drug must be discontinued immediately.
• If cough or shortness of breath appears or worsens unexpectedly (signs of pulmonary infiltrates, eosinophilic, or allergic alveolitis), the patient should be evaluated and treatment discontinuation considered.

Adverse Reactions / Side Effects:

• Nervous System: Headache, dizziness; in isolated cases, aseptic meningitis, depression, apathy, tremor, and peripheral neuritis.
• Respiratory System: Bronchospasm, dyspnea, cough, and pulmonary infiltrates.
• Gastrointestinal System: Nausea, vomiting, loss of appetite, diarrhea, gastritis, abdominal pain, glossitis, stomatitis, cholestasis, elevated liver enzymes, hepatitis, hepatic necrosis, pseudomembranous enterocolitis, and pancreatitis.
• Hematopoietic System: Leukopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anemia, aplastic and hemolytic anemia, eosinophilia, hypoprothrombinemia, and methemoglobinemia.
• Urinary System: Polyuria, interstitial nephritis, impaired renal function, crystalluria, hematuria, elevated blood urea and creatinine levels, and toxic nephropathy with oliguria or anuria.
• Musculoskeletal System: Arthralgia and myalgia.
• Allergic Reactions: Pruritus, photosensitivity, urticaria, drug fever, rash, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, allergic myocarditis, angioedema, and scleral hyperemia.
• Metabolic Disorders: Hypoglycemia, hyperkalemia, and hyponatremia.

Pregnancy and Lactation:

The use of the drug during pregnancy and lactation is contraindicated.
If administration during lactation is necessary, breastfeeding must be discontinued.

Storage Conditions:

Store at a temperature not exceeding 30 °C in a dry place, protected from light.
Keep out of reach of children.

Packaging:

Cardboard box containing 10 tablets.