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: active ingredient: pipepidic acid trihydrate (corresponding to pipemidic acid 200.00 mg) - 235.60 mg; Excipients: magnesium stearate - 3.40 mg, silicon dioxide colloid - 0.68 mg, corn starch - 100.32 mg; composition of the capsule body: titanium dioxide (E 171) - 3.0000%, dye sunset yellow (E 110) - 0.0041%, gelatin - up to 100%; composition of the cap capsule: titanium dioxide (E 171) - 1.3331%, dye yellow quinolone (E 104) 1.147%, blue patented dye (E 131) 0.1672%, black diamond dye (E 151) 0.0958%, dye The sunset is yellow (E 110) - 0.0063%. Description:Opaque capsules No. 1, with a body from white to white with a yellowish shade of color and a green lid.Contents of capsules: hygroscopic powder from white to almost white with a yellowish tint of color. Pharmacotherapeutic group:Antimicrobial agent - quinolone. ATX: & nbspJ.01.M.B Other quinolonesJ.01.M.B.04 Pipedic acid Pharmacodynamics:Pipemid acid refers to the drugs of the quinoline series and is used in the treatment of urinary tract infections caused by pathogens sensitive to pipemidic acid. Pipemid acid suppresses bacterial DNA topoisomerase II, which leads to the disintegration of bacterial DNA.The drug has a bactericidal effect on most Gram-negative microorganisms (Proteus vulgaris, Proteus mirabilis, Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Neisseria spp., Etc.). He is active against anaerobes. Pharmacokinetics:Pipemid acid it is easily absorbed (93%) and reaches a maximum serum concentration within 1 to 2 hours after administration. After ingestion of 400 mg of pipemidic acid, the maximum concentration in the blood serum (3.5 μg / ml) is reached after 70-80 minutes. The half-life (T1 / 2) is 3.1 hours.The binding of plasma proteins to pipemidic acid is approximately 30% and depends on serum concentration. The volume of distribution is 1.7 l / kg. High concentrations of the active substance are created in the kidneys, urine and liquid of the prostate gland. Pipemid acid, like other quinolone compounds, penetrates the placenta, penetrates into breast milk in small amounts.Pipemidic acid is mostly excreted by the kidneys through glomerular filtration and tubular secretion in an unchanged form, up to 35% of pipemidic acid is excreted by the intestine.In daily urine is determined 50-85% of the administered dose of the drug. Isolation of pipemidic acid is directly dependent on the clearance of creatinine (CC). Patients with impaired renal function have higher plasma concentrations of the drug than healthy volunteers. T1 / 2 pipepidic acid from the blood plasma is somewhat elongated and is 5.7-16 hours. Indications:Acute and chronic infectious-inflammatory diseases of the urinary tract caused by microorganisms sensitive to pipemidic acid, including:- a pyelonephritis;- Cystitis;- prostatitis; Contraindications:- hypersensitivity to pipemidic acid or any of the components of the drug;- allergic reactions to quinolones in the anamnesis;- severe renal dysfunction (CC <10 ml / min);- severe violations of the liver (including cirrhosis);- porphyria;- diseases of the central nervous system (epilepsy and other neurological conditions with a lowered convulsive threshold);- pregnancy and lactation;- Children's age under 18 years (the period of formation and growth of the skeleton). Carefully:Patients with renal insufficiency (CC> 10 and <30 ml / min), elderly age (over 70 years), history of cerebral circulation, deficiency of glucose-6-phosphate dehydrogenase. Pregnancy and lactation:There is no data on the use of the drug during pregnancy. Use during pregnancy is contraindicated.Pipemidic acid is excreted in breast milk in sufficient quantities to cause unwanted effects in the newborn. The use of Palin during lactation is contraindicated. Dosing and Administration:Inside.The average daily dose is 800 mg, divided into two doses, i.e. 400 mg (2 capsules) every 12 hours, morning and evening before meals, with water.The course of treatment is an average of 10 days. If necessary, the course of treatment can be extended depending on the course of the disease, but no more than up to 4 weeks. During therapy, patients are encouraged to drink abundantly.Treatment of cystitis without complications in women lasts 3 days.In patients with severe renal failure (CC> 10 and <30 ml / min), the dose should be reduced.In elderly patients with normal renal function, as well as patients with hepatic insufficiency, dose adjustment is not required. Side effects:Side effects in most cases are mild and transient, usually not requiring withdrawal of the drug.The most frequent adverse reactions are disorders of the gastrointestinal tract, which occur in 3 to 13% of cases and, as a rule, are mild or moderate in severity and are transient.According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (> 1/10), often (> 1/100 to <1/10), infrequently (>> 1/1000 to <1/100), rarely (from> 1/10000 to <1/1000), very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.Violations of the blood and lymphatic system rarely: eosinophilia;frequency is unknown: reversible thrombocytopenia (in elderly patients and patients with renal insufficiency), hemolytic anemia (in patients with deficiency of glucose-6-phosphate dehydrogenase).Disorders of the psyche frequency is unknown: agitation, depression, confusion, hallucinations, sleep disturbances.Disturbances from the nervous systemfrequency is unknown: tremor, sensory disturbances, prolongedconvulsions associated with cerebral edema.Disturbances on the part of the organ of sight frequency is unknown: impaired vision.Hearing disorders and labyrinthine disorders frequency is unknown: vertigo, headache.Disorders from the gastrointestinal tractOften: anorexia, epigastric pain, heartburn, nausea, vomiting, bloating or abdominal pain, diarrhea, or constipation.Disturbances from the skin and subcutaneous tissuesfrequency unknown: hypersensitivity reactions (skin rash, mild itching), photosensitivity reactions, toxic epidermal necrolysis. Disturbances from the musculoskeletal and connective tissue are unknown frequency: acute arthropathy, tendonitis. Overdose:There are no reports of death or the occurrence of life-threatening side effects due to an overdose of the drug.There is no specific antidote.Clinical symptoms of an overdose include nausea, vomiting, dizziness, headache, confusion, tremors, convulsions.In case of an overdose, the patient should be under the supervision of a doctor. When there are side effects from the nervous system (including epileptiform cramps), symptomatic treatment is prescribed (diazepam).After a recent intake (less than 4 hours), remove the drug from the gastrointestinal tract (gastrointestinal tract) by rinsing the stomach, then takeActivated charcoal to reduce suction. Removal of the drug from the body can be accelerated with the help of forced diuresis. Interaction:Pipemid acid inhibits the enzyme cytochrome (P450). The half-life of theophylline increases with the simultaneous use of pipemidic acid, its concentration in the serum increases by 40-80%. It is necessary to monitor the concentration of theophylline in the blood plasma during the use of pipemidic acid.Against the background of the use of pipemidic acid, as well as other antibiotics of the quinolone series, there is an increase in the concentration of caffeine in the blood serum (by 2-4 times).Antacids (preparations of aluminum, magnesium and calcium) and sucralfate significantly slow the absorption of pipemidic acid. The interval between taking these drugs should be at least 2-3 hours. At the same time, this effect was not observed with the simultaneous use of cimetidium and ranitidine. Palin can enhance the anticoagulant effect of warfarin while taking it.With simultaneous application with NSAIDs, there may be seizures.When combined with aminoglycosides, synergism is observed with respect to bactericidal action. Special instructions:In the treatment should avoid ultraviolet radiation due to the high risk of photosensitization.With prolonged use of the drug should monitor the overall blood count, determine the liver and kidney function and repeat the definition of the sensitivity of microflora to pipemidic acid. It is necessary to increase the amount of fluid consumed (under the control of diuresis).Use with caution in patients older than 70 years (due to increased incidence of side effects in the elderly) and patients with impaired renal function (CC> 10 and <30 mL / min)(contraindicated in oliguria and anuria, CC <10 mi / min), dose adjustment and regular monitoring of the patient's condition are required. Be careful when using the drug in patients with a historydisturbance of cerebral circulation (including cerebral hemorrhage, spasms of cerebral vessels), as well as convulsions.In patients with deficiency of glucose-6-phosphate dehydrogenase, the development of hemolytic anemia is possible.As with other antibacterial agents, there is a risk of developing superinfection.With a long course of treatment, it is possible to develop pseudomembranous colitis.There may be a false positive reaction to urine glucose when using a Benedict reagent or a Felling solution. It is recommended to use enzymatic reactions with glucose oxidase.A diamond black dye (E151) can cause allergic reactions, including bronchial asthma. Allergic reactions were more common in patients with allergy to acetylsalicylic acid. Dye sunset sunset yellow (E110) can cause allergic reactions. Effect on the ability to drive transp. cf. and fur:During the period of Palin's use, dizziness and visual impairment may occur, therefore, care should be taken when driving vehicles and engaging in other activities requiring concentration of attention and speed of psychomotor reactions. Form release / dosage:Capsules 200 mg. Packaging:10 capsules are placed in a foil blister of aluminum and polyvinyl chloride film. Two blisters are placed in a cardboard box together with instructions for medical use. Storage conditions:Store at a temperature not exceeding 25 ° C.Keep out of the reach of children. Shelf life:5 years.Do not use the drug after the expiry date printed on the package. Terms of leave from pharmacies:On prescription Registration number:П N013947 / 01 Date of registration:04.07.2008 The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia Manufacturer: & nbspLEK d.d. Slovenia Representation: & nbspSANDOZ SANDOZ Switzerland Information update date: & nbsp07.07.2015 Illustrated instructions × Illustrated instructions Instructions