Sephpotek - instructions for use, dose, side effects, contraindications

Active substanceCefpodoximeCefpodoxime

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Doxef

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Lupine Co., Ltd. India

Sephpotek®

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Nobel Ilach Sanayi Ve Tidjaret A.Sh. Turkey

Dosage form: & nbsp

Film-coated tablets.

Composition:

one tablet, film-coated, contains active substance: cefpodoxime proxetil, in terms of cefpodoxime 200 mg;

Excipients: Avicel RC 591 (microcrystalline cellulose, carmellose sodium) 152.52 mg, sodium lauryl sulfate 14.00 mg, giprolose 7.22 mg, silicon dioxide colloid 1.76 mg, magnesium stearate 3.60 mg;

film sheath: Sepifilm LP761 Blanc (E464) 45-55%, microcrystalline cellulose (E460) 5-15%, stearic acid (E570) 18-22%, titanium dioxide (E171) 15-25%.

Description:

Oblong film-coated tablets are white with a risk on one side. On the cross section, the core is cream colored.

Pharmacotherapeutic group:Antibiotic-cephalosporin.

ATX: & nbsp

J.01.D.D.13 Cefpodoxime

Pharmacodynamics:

The antibiotic from the group of cephalosporins of the third generation, acts bactericidal, disrupts the synthesis of the bacterial cell wall. Resistant to beta-lactamases.

It is active against gram-positive bacteria: Streptococcus pyogenes, Streptococcus pneumoniae (excluding penicillin-resistant strains), Staphylococcus aureus (including strains producing penicillinase); 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 protea species, including Proteus vulgaris; Providencia, Enterobacter (including Enterobacter cloacae and Enterobacter aerogenes), Salmonella spp., Shigella spp; is active in vitro against most strains: Brucella, Neisseria, Aeromonas hydrophila, Yersinia enterocolitica, Providencia rettgeri, Providencia stuartii and strains of Citrobacter, Morganella and Serratia.

Inactive with 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 a weak activity against anaerobes, including most species of Bacteroides, Campylobacter, Yersinia. Destroyed by cephalosporinases of chromosomal origin of Citrobacter, Enterobacter, Bacteroides.

Pharmacokinetics:Cefpodoxime proxetil refers to prodrugs, which in the body (in the small intestine) are deesterified, becoming an active metabolite cefpodoxime. After a single and multiple administration of 100 to 400 mg of the drug after 1.9-3.1 hours, a therapeutic concentration of 1.0-4.5 mg / l is achieved. Absolute bioavailability is 50%. It binds to blood proteins (20-30%). About 30-35% of the dose is excreted in the urine unchanged for 12 hours. The half-life period (T1 / 2) varies from 2.1 to 2.8 hours. If the renal function is impaired, the excretion decreases: with KK 50-80 ml / min , then T1 / 2 is 3.5 h, 30-49 ml / min - 5.9 h, 5-29 ml / min - 9.8 h. In the elderly, including with broncho-pulmonary.there is a slight T1 / 2 elongation and a concentration in the blood, but not requiring a dose adjustment.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to cephodoxim:

Infections of the upper and lower respiratory tract: tonsillitis, pharyngitis, acute sinusitis, acute bronchitis, pneumonia; exacerbation of chronic bronchitis (in people who abuse alcohol, smokers and in people older than 65 years); uncomplicated urinary tract infections (cystitis): uncomplicated gonorrhea, uncomplicated anorectal infection in women caused by Neisseria gonorrhoeae, skin and soft tissue infections, other infections caused by microorganisms susceptible to the drug (gastrointestinal infections, oral infections).

Contraindications:Hypersensitivity to cefpodoxime, components of the drug, other cephalosporins; children's age (up to 12 years).

Carefully:Hypersensitivity to penicillins, pregnancy, lactation, chronic colitis, renal failure, a combination with "loop" diuretics and other nephrotoxic drugs.

Pregnancy and lactation:

Precautiously prescribe during pregnancy, comparing the potential benefit to the mother and the possible risk to the fetus.

If you need to use the drug during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Inside, with food

Adults and children over 12 years of age:

Infections of the upper and lower respiratory tract	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 infection in women caused by Neisseria gonorrhoeae	200 mg	Single Reception
Infections of the skin and soft tissues	400 mg every 12 hours	7-14 days
Uncomplicated urinary tract infections (cystitis)	100 mg every 12 hours	7 days

Patients with severe renal dysfunction (CC below 30 ml / min) single dose reduced by half.

Side effects:

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

From the nervous system: dizziness, headaches, irritability, fatigue, insomnia, "nightmarish" dreams.

From the genitourinary system: violation of the menstrual cycle.

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

From the respiratory system: cough.

From the CAS side: a decrease in blood pressure.

From the hematopoiesis: thrombocytosis, thrombocytopenia, leukocytosis, leukopenia, lymphocytosis, granulocytosis, basophilia, monocytosis, neutropenia, lymphocytopenia, nasal bleeding.

Laboratory indicators: an increase in the activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia, LDH, GGT, urea, creatinine, hyper- or hypoglycemia, hypoproteinemia and hypoalbuminemia, a decrease in Hb, a positive Coombs reaction, an increase in prothrombin time. Pain in the chest, increased sweating, weakness.

Overdose:

Symptoms: nausea, vomiting, epigastric discomfort, diarrhea.

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

Interaction:

Diuretics, aminoglycosides, polymyxin AT, ethacrynic acid block the secretion of cephalosporins, increase their concentration in serum, prolong the half-life (T1 / 2),increase nephrotoxicity.

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

The blockers of H2-histamine receptors reduce bioavailability due to changes in the pH of the stomach.

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

Antacids in high doses (sodium hydrogen carbonate, aluminum hydroxide) reduce the absorption.

With a simultaneous appointment with bactericidal antibiotics, synergism is manifested, with bacteriostatic (macrolides, chloramphenicol, tetracyclines) - antagonism, enhances the nephrotoxicity of aminoglycosides.

Special instructions:Perhaps the appearance of a positive Coombs reaction.

Form release / dosage:

Tablets coated with a film coating of 200 mg.

Packaging:

For 5 and 7 tablets, covered with a film sheath in a foil blister aluminum printed.

10 tablets, film-coated / 2 blisters / 1 package (5 tablets / 1 blister).

14 tablets, film-coated / 2 blisters / 1 pack (7 tablets / 1 blister).

20 tablets, film-coated / 4 blisters / 1 pack (5 tablets / 1 blister).

Together with the instructions for use are placed in a cardboard box.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001006

Date of registration:18.10.2011

The owner of the registration certificate:Nobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh. Turkey

Manufacturer: & nbsp

NOBELPHARMA ILAC SANAYII VE TICARET, A.S. Turkey

Representation: & nbspNobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh.Russia

Information update date: & nbsp07.11.2015

Illustrated instructions

Instructions

Sephpotek® (Sefpotek®)