Active substancePipemid acidPipemid acid Similar drugsTo uncover Palin® capsules inwards Sandoz d. Slovenia Pipegal® capsules inwards Galenika ad. Serbia and Montenegro Pipemid acid capsules inwards VELFARM, LLC Republic of San Marino Dosage form: & nbspCapsules Composition:1 capsule contains:Pipemidic acid 200 mg (in the form of trihydrate 236 mg).Excipients: croscarmellose sodium 42 mg, corn starch 14 mg, talc 3 mg, magnesium stearate 5 mg.The composition of the capsule body: gelatin to 100.00%, titanium dioxide dye (E171) 2.00%. Composition of capsule capsule: gelatin up to 100.00%, titanium dioxide dye (E171) 2.00%, iron oxide pigment oxide yellow (E172) 1.00%, dye indigo carmine (E132) 0.14%. Description:Hard opaque gelatin capsules No. 1, with a white body and a green lid filled with yellowish-white to pale yellow powder. Pharmacotherapeutic group:antimicrobial agent, quinolone. ATX: & nbspJ.01.M.B Other quinolonesJ.01.M.B.04 Pipedic acid Pharmacodynamics:Pipemid acid binds to the enzyme DNA gyrase, which participates in the process of DNA replication and thus leads to inhibition of bacterial DNA replication. This effect is more pronounced with respect to microorganisms that are in the proliferation phase. High concentrations of pipemidic acid inhibit both the synthesis of RNA and the synthesis of bacterial proteins. The drug belongs to the group of quinolone preparations.The drug has a bactericidal or bacteriostatic effect, depending on the concentration of the drug at the site of infection.Conducted in conditions in vivo studies have shown the effectiveness of treatment of infectious diseases caused by gram-negative bacteria: Proteus vulgaris, Proteus mirabilis, Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Neisseria spp., Enterobacter spp., Pseudomonas aeruginosa; Gram-positive bacteria: Staphylococcus aureus. The drug is not active against anaerobic microorganisms. Pharmacokinetics:After oral administration piperidic acid quickly absorbed, the bioavailability of pipemidic acid is 30 - 50%. After oral administration at a dose of 400 mg, the maximum concentration of the drug in the plasma (Cmax) - 3.5 μg / m-is reached after 70 to 80 minutes.High concentrations of the active substance are created in the kidneys and the prostate gland. Pipemid acid, like other quinolone compounds, passes through the placenta, penetrates into the mother's milk in trace amounts.Pipemidic acid is mostly excreted from the body through the kidneys in an unmodified form. In daily urine, 50 to 85% of the dose administered is determined. The excretion of pipemidic acid is directly dependent on the clearance of creatinine.The half-life of the drug with normal kidney function is 2 hours 15 minutes, and the total clearance 6.3 ml / min.In patients with impaired renal function, slightly higher plasma concentrations of the drug are observed than in healthy volunteers. The half-life of plasma is prolonged and is 5.7 - 16 hours. In severe disorders of renal function in the urine, a therapeutic concentration is also created. Indications:Acute and chronic diseases of the urinary tract caused by microorganisms sensitive to the drug (including urethritis, cystitis, pyelonephritis, prostatitis). Contraindications:- hypersensitivity to pipemidovoy acid, other drugs from the group of fluoroquinolones and other components of the drug;- severe violations of the liver and kidneys (with a decrease in creatinine clearance below 30 ml / min, and with serum creatinine values greater than 265 μmol / l), oliguria, anuria;- porphyria;- lesions of tendons during the previous treatment with quinolones;- pregnancy and lactation;- diseases of the central nervous system (epilepsy, intracranial hypertension);- children's age till 18 years;- infections caused by drug-resistant pathogens. Carefully:Prescribe the drug elderly (over 70 years) and patients with impaired renal function; patients who have a history of cerebral hemorrhage, cerebral circulation disorder and cerebral vasospasms; patients with a deficiency of glucose-6-dihydrogenase.If you have any of these diseases, consult a doctor before taking the drug. Dosing and Administration:The drug is taken orally.The average dose for adults is 2 times 400 mg (2 capsules) per day (morning and evening) before meals. With staphylococcal infections, the interval between doses should not exceed 8 hours. The usual course of treatment is 10 days, if necessary, prolonged by a doctor. With kidney disease, the duration of therapy is 3 to 6 weeks, with prostatitis 6-8 weeks. During therapy, the patient is recommended to drink abundantly. It is not recommended to prescribe the drug in pediatric practice. Side effects:From the side of the hemostasis system: eosinophilia, reversible thrombocytopenia (in elderly patients and patients with renal insufficiency).From the digestive system: anorexia, pain in the epigastric region, heartburn, bloating or abdominal pain, nausea, vomiting, diarrhea, pseudomembranous colitis.From the central and peripheral nervous system: visual impairment, headaches, dizziness, weakness, agitation, confusion, sleep disturbance, convulsions, convulsive seizures, sensory disorders, depression, hallucinations, psychoses, peripheral disorders in the form of muscle weakness and myalgia.Hypersensitivity reactions: skin rash, itching, photosensitivity, toxic epidermal necrosis, Stevens-Johnson syndrome, anaphylaxis.In patients with a deficiency of glucose-6-dihydrogenase can cause hemolytic anemia.From the musculoskeletal system: arthralgia, tendonitis.If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor. Overdose:There are no reports of development of threatening side effects or death in overdose of the drug.Symptoms: nausea, vomiting, dizziness, headache, confusion, tremor, convulsions.Treatment: When an overdose of the drug should immediately stop taking it. There is no specific antidote. If, after taking the drug, less than 4 hours have passed, to reduce absorption, it is necessary to rinse the stomach with the subsequent administration of activated charcoal. With the development of side effects from the central nervous system (including epileptiform cramps), symptomatic treatment is prescribed (diazepam). Excretion of the drug can be accelerated with the help of forced diuresis. The drug is well excreted from the blood plasma during hemodialysis. Interaction:It should be borne in mind that this information may be relevant to medicines that you no longer accept or that you plan to take in the future. Consult your doctor if you are taking shi shortly before taking any other medicine, including drugs that are dispensed without a doctor's prescription.Pipemidic acid inhibits cytochrome P450 isoenzymes. With simultaneous use with pipemidovoy acid slows the metabolism of theophylline and caffeine.Antacids (compounds of aluminum, magnesium and calcium) and sucralfate significantly slow the absorption of pipemidic acid, so the interval between taking these drugs should be at least 2-3 hours.Pipemidic acid can enhance the effects of warfarin, rifampicin, cimetidine and non-steroidal anti-inflammatory drugs with simultaneous application.With the simultaneous use of pipemidic acid with aminoglycosides, synergism is noted with respect to bactericidal action.Pipemidic acid reduces the concentration of cyclosporine in plasma with simultaneous application. Special instructions:When allergic reactions to the drug appear, it is necessary to stop using it. In the treatment avoid exposure to sunlight and quartz due to possible photosensitization. During the period of taking the drug, patients should receive a copious drink (under the control of diuresis). With prolonged use of the drug should monitor the overall blood count, determine hepatic and renal tests and repeat the sensitivity of microflora to pipemidovoy acid. A false-positive reaction to glucose may be noted when the urine is tested with Benedict's reagent or solutionFelling. It is recommended to use enzymatic reactions with glucose oxidase. Pseudomembranous colitis can appear both on the background of long-term use, and 2-3 weeks after cessation of treatment; is manifested by diarrhea, leukocytosis, fever, abdominal pain (sometimes accompanied by discharge with blood or mucus calves). If these phenomena occur in mild cases, it is sufficient to cancel the treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin inwards or metronidazole is indicated. Do not use drugs that inhibit the intestinal motility. Effect on the ability to drive transp. cf. and fur:When using the drug should refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, due to possible side effects from the central and peripheral nervous system. Form release / dosage:Capsules of 200 mg. Packaging:10 capsules are placed in a blister of A1 / PVC film and a PVC of a solid film.For 2 blisters, together with instructions for use, are placed in a cardboard box. Storage conditions:Store in the original packaging at a temperature not exceeding 30 ° C.Keep out of the reach of children! Shelf life:3 years.Do not use at the expiration date indicated on the package. Terms of leave from pharmacies:On prescription Registration number:P N 015427/01 Date of registration:15.03.2010 The owner of the registration certificate:Galenika ad.Galenika ad. Serbia and Montenegro Manufacturer: & nbspGALENIKA, a.d. Serbia and Montenegro Information update date: & nbsp22.02.2013 Illustrated instructions × Illustrated instructions Instructions