Staficin^® (Capsules) Instructions for Use

Marketing Authorization Holder

Nts-Bio, LLC (Russia)

Manufactured By

Pharmproekt, JSC (Russia)

ATC Code

J01XX (Other antibacterial drugs)

Active Substance

Staphycin (Grouping name)

Dosage Form

Staphycin®

Capsules 250 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 0, opaque, yellow in color; the capsule contents are a powder ranging from light yellow to yellow-brown in color.

Excipients: microcrystalline cellulose, potato starch, magnesium stearate.

Composition of the hard gelatin capsule: gelatin, titanium dioxide (E171), quinoline yellow dye (E104), sunset yellow FCF dye (E110).

10 pcs. – blister packs (5) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug

Pharmacotherapeutic Group

Other systemic antibacterial agents

Pharmacological Action

Synthetic antimicrobial agent, a derivative of benzopyranopyrimidine.

It is active in vitro against Gram-positive bacteria of the genera: Staphylococcus (S. aureus, S. epidermidis, S. haemolyticus, S. capitis), Streptococcus (S. pyogenes), Enterobacter cloacae, Enterococcus faecalis. In vivo, Staphycin exhibits high activity against Staphylococcus aureus and Streptococcus pyogenes. The antibacterial effect of Staphycin is associated with the suppression of bacterial DNA synthesis.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. Staphycin is detected in blood plasma after 30 minutes. C_max after a single dose of 1000 mg is observed after 2 hours and reaches 8.6 mg/L. T_1/2 is 4.8 hours, the total mean residence time (MRT) of Staphycin in the body is approximately 6 hours. The high value of V_d at steady state suggests that Staphycin is significantly redistributed into body tissues. The concentration in blood plasma is linearly dependent on the dose.

It is metabolized primarily in the blood by hydrolysis and oxidation to form low-activity metabolites – barbituric acid and dibromosalicylic acid; the involvement of hepatic enzymes in metabolism is insignificant. It is excreted mainly by the kidneys in the form of metabolites. The C_max of the main metabolite of Staphycin – barbituric acid in urine is observed 5-7 hours after administration.

Indications

Exacerbation of chronic tonsillitis caused by susceptible microorganisms.

ICD codes

Dosage Regimen

Administer orally with a sufficient amount of water.

On the first day of treatment, take a single dose of 2000 mg (equivalent to eight 250 mg capsules).

From the second day onward, take 1000 mg (four capsules) in the morning and 500 mg (two capsules) in the evening.

Maintain a consistent interval between doses, approximately 12 hours for the twice-daily regimen.

The total duration of therapy is 6 days. Complete the entire course as prescribed, even if symptoms improve.

Do not exceed the recommended daily dosage. If a dose is missed, take it as soon as remembered unless it is almost time for the next dose; in that case, continue with the regular schedule. Do not take a double dose to make up for a missed one.

Adverse Reactions

Nervous system disorders: decreased performance, headache, general weakness.

Gastrointestinal disorders: abdominal pain and discomfort, loose stools, diarrhea, nausea, decreased appetite, dry mouth.

Urinary system disorders: nephropathy, hematuria, painful urination, pain in the lumbar region.

Contraindications

Hypersensitivity to Staphycin, children and adolescents under 18 years of age (efficacy and safety have not been established), pregnancy, breastfeeding period, renal failure, hepatic failure.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated for use in hepatic failure.

Use in Renal Impairment

Contraindicated for use in renal failure.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Effect on the ability to drive vehicles and operate machinery

Since the use of Staphycin may cause weakness, decreased performance, and headache, if such phenomena occur, patients should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

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.