SAGACEFPO 100 DT, 200 DT

INSTRUCTIONS FOR MEDICAL USE

SAGACEFPO 100 DT, 200 DT

Trade name of the drug: Sagacefpo 100 DT, 200 DT

Active ingredient (INN): cefpodoxime proxetil

Dosage form : dispersible tablets

Compound:

Each tablet contains:

active substance : cefpodoxime (in the form of proxetil) – 100 mg or 200 mg;

excipients : beta cyclodextrin, lactose, mannitol, soluble starch, sodium chloride, sodium lauryl sulfate, magnesium stearate, purified talc, colloidal anhydrous silicon, potassium polacriline (Kyron T 314), dry pineapple flavor, aspartame, sodium benzoate.

Pharmacotherapeutic group: III generation cephalosporin

ATX code: J01DD13

Pharmacological properties

An antibiotic from the group of third-generation cephalosporins, it acts bactericidal and disrupts the synthesis of bacterial cell walls. Resistant to beta-lactamases.

Active against gram-positive bacteria: Streptococcus pyogenes, Streptococcus pneumoniae (except for penicillin-resistant strains), Staphylococcus aureus (including penicillinase-producing strains); gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae (beta-lactamase-positive and negative strains), Moraxella (Branhaemella) catarrhalis, Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae and Klebsiella oxytoca), Neisseria gonorrhoeae, indole-positive Proteus, other Proteus species, including Proteus vulgaris; Providencia, Enterobacter (including Enterobacter cloacae and Enterobacter aerogenes). Salmonella spp., Shigella spp; active in vitro against most strains: Brucella, Neisseria, Aeromonas hydrophila, Yersinia enterocolitica, Providencia rettgeri, Providencia stuartii and strains of Citrobacter, Morganella and Serratia.

Inactive against Streptococcus spp. (group D), methicillin-resistant strains of Staphylococcus spp., Corynebacterium spp. (groups J and K), Pseudomonas spp. (including Pseudomonas aeruginosa), Listeria monocytogenes, Acinetobacter baumannii, Clostridium difficile, Bacteroides spp.. Has weak activity against anaerobes, including most species of Bacteroides, Campylobacter, Yersinia. It is destroyed by cephalosporinases of chromosomal origin Citrobacter, Enterobacter, Bacteroides.

Pharmacokinetics

Cefpodoxime proxetil is a prodrug that is deesterified in the body (in the small intestine), turning into the active metabolite cefpodoxime.

After a single or multiple dose of 100 to 400 mg of the drug, a therapeutic concentration of 1.0-4.5 mg/l is achieved in 1.9-3.1 hours. Absolute bioavailability — 50%.

Binds to blood proteins (20-30%).

About 30-35% of the dose is excreted unchanged in the urine within 12 hours. T1 _/2 ranges from 2.1 to 2.8 hours.

If renal function is impaired, excretion decreases: with CC 50-80 ml/min, then T1 _/2 is 3.5 hours, 30-49 ml/min — 5.9 hours, 5-29 ml/min — 9.8 hours .

In elderly people, including those with bronchopulmonary infection, there is a slight increase in T1 _/2 and blood concentrations, but this does not require dose adjustment.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to cefpodoxime:

• infections of the upper and lower respiratory tract: tonsillitis, pharyngitis, acute sinusitis, acute bronchitis, pneumonia; exacerbation of chronic bronchitis (in persons who abuse alcohol, smokers and in persons over 65 years of age);

— uncomplicated urinary tract infections (cystitis);

— uncomplicated gonorrhea;

— uncomplicated infections of the anorectal area in women caused by Neisseria gonorrhoeae;

— infections of the skin and soft tissues;

— other infections caused by microorganisms sensitive to the drug (gastrointestinal infections, oral infections).

Directions for use and doses

Inside, during meals

Adults and children over 12 years of age:

Upper and lower respiratory tract infections	100 mg every 12 hours	5-10 days
Acute community-acquired pneumonia	200 mg every 12 hours	14 days
Acute maxillary sinusitis Exacerbation of chronic bronchitis	200 mg every 12 hours	10 days
Uncomplicated gonorrhea, uncomplicated anorectal infections in women caused by Neisseria gonorrhoeae	200 mg	Single dose
Skin and soft tissue infections	400 mg every 12 hours	7-14 days
Uncomplicated urinary tract infections (cystitis)	100 mg every 12 hours	7 days

For patients with severe renal impairment (creatinine clearance below 30 ml/min), the single dose is halved.

Side effects

Allergic reactions: skin rash, itching, eosinophilia, urticaria, angioedema, fever, anaphylactic shock.

From the nervous system: dizziness, headaches, irritability, increased fatigue, insomnia, nightmares.

From the genitourinary system: menstrual irregularities.

From the digestive system: nausea, persistent diarrhea, stool retention, gastritis, vomiting, abdominal pain, dysbacteriosis (growth of Clostridium difficile), pseudomembranous colitis, salivation, flatulence, decreased appetite.

From the respiratory system: cough.

From the cardiovascular system: decreased blood pressure.

From the hematopoietic organs: thrombocytosis, thrombocytopenia, leukocytosis, leukopenia, lymphocytosis, granulocytosis, basophilia, monocytosis, neutropenia, lymphocytopenia, nosebleeds.

Laboratory indicators: increased activity of “liver” transaminases and alkaline phosphatase, hyperbilirubinemia, LDH, GGT, urea, creatinine, hyper- or hypoglycemia, hypoproteinemia and hypoalbuminemia, decreased Hb, positive Coombs test, increased prothrombin time. Chest pain, increased sweating, weakness.

Contraindications for use

— children’s age (up to 12 years);

— hypersensitivity to cefpodoxime, components of the drug, and other cephalosporins.

With caution: hypersensitivity to penicillins, pregnancy, lactation, chronic colitis, renal failure, combination with loop diuretics and other nephrotoxic drugs.

Use for renal impairment

With caution in case of renal failure. For patients with severe renal impairment (creatinine clearance below 30 ml/min), the single dose is halved.

special instructions

When using cefpodoxime proxetil, like other cephalosporins, even with a careful history taking, the possibility of anaphylactic shock cannot be excluded. In patients with hypersensitivity to penicillin, the possibility of cross-allergic reactions should be remembered.

In the presence of severe persistent diarrhea, the possibility of developing pseudomembranous colitis associated with antibiotic therapy should be considered. Since this condition can be life-threatening, treatment with cefazolin should be stopped immediately and appropriate treatment should be instituted. The use of drugs that affect peristalsis is contraindicated.

In patients with impaired renal function (creatinine clearance below 30 ml/min), the single dose is halved.

Rare cases of changes in prothrombin time have been described in patients receiving cefpodoxime proxetil. Patients with vitamin K deficiency (impaired synthesis, malnutrition) may require monitoring of prothrombin time during therapy and administration of vitamin K (10 mg/week) if the prothrombin time increases before or during therapy.

After the use of cefpodoxime proxetil, usually in doses exceeding the standard recommended, ultrasound of the gallbladder revealed shadows that were mistaken for stones. They are precipitates of the calcium salt of cefpodoxime proxetil, which disappear after completion or discontinuation of cefpodoxime proxetil therapy. Such changes rarely give any symptoms, but even in such cases only conservative treatment is recommended. If these phenomena

are accompanied by clinical symptoms, the decision to discontinue the drug is made by the attending physician.

In patients receiving cefpodoxime proxetil, rare cases of pancreatitis, possibly due to bile duct obstruction, have been described. Most of these patients already had risk factors for biliary congestion, such as previous therapy, severe illness, and total parenteral nutrition. At the same time, it is impossible to exclude the triggering role of precipitates formed under the influence of cefpodoxime proxetil in the biliary tract in the development of pancreatitis.

Caution should be exercised when prescribing cefpodoxime proxetil to neonates with hyperbilirubinemia. Cefpodoxime proxetil should not be used in newborns, especially premature infants, who are at risk of developing bilirubin encephalopathy.

During long-term treatment, blood counts should be regularly monitored.

In rare cases, when treating cefpodoxime proxetil, patients may experience false-positive Coombs test results. Like other antibiotics, cefpodoxime proxetil may give a false-positive test result for galactosemia. False-positive results can also be obtained when determining glucose in urine, therefore, during therapy with cefpodoxime proxetil, glucosuria, if necessary, should be determined only by the enzyme method.

Use during pregnancy and breastfeeding

Use with caution during pregnancy, weighing the potential benefit to the mother against the possible risk to the fetus.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Use in children

Contraindicated for children under 12 years of age.

Drug interactions

Diuretics, aminoglycosides, polymyxin B, ethacrynic acid block the secretion of cephalosporins, increase their concentration in the blood serum, prolong T1 _/2 , and increase nephrotoxicity.

NSAIDs slow down the excretion of cephalosporins by the kidneys, increasing the risk of bleeding.

_H2 -histamine receptor blockers reduce bioavailability due to changes in gastric pH.

Increases the effect of indirect anticoagulants (suppressing intestinal microflora, reduces the prothrombin index).

Antacids in high doses (sodium bicarbonate, aluminum hydroxide) reduce absorption.

When administered simultaneously with bactericidal antibiotics, synergism appears, with bacteriostatic ones (macrolides, chloramphenicol, tetracyclines) — antagonism, enhancing the nephrotoxicity of aminoglycosides.

Overdose

Symptoms: nausea, vomiting, epigastric discomfort, diarrhea.

Treatment: hemodialysis or peritoneal dialysis, especially in cases of impaired renal function, is effective.

Release form

10 tablets in blisters. 1 blister in a cardboard box along with instructions for medical use.

Storage conditions

Store in a cool, dry place, protected from light, at a temperature not exceeding 30 ^° C.

Keep out of the reach of children.

Best before date

2 years.

Do not use after the expiration date.

Conditions for dispensing from pharmacies

On prescription.

Registration Certificate Holder

Saga Laboratories

Survey no. 198/2 & 198/3, Chachrawadi Vasna,

Tal.: Sanand, Dist.: Ahmedabad 382 210, India.

E-mail: viranchi.shah@sagalabs.com

Name and address of the organization accepting claims (proposals)

on the quality of the medicinal product in the territory of the Republic of Uzbekistan

SHAYANA FARM LLC

700057, Republic of Uzbekistan, Tashkent, st. Usta Shirin, house 117.

Tel.: 99(871) 2281692(93/94)

Fax: 99 (871) 2281695