Palin Capsules 200mg N20
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Active ingredients
Pipemido acid
Release form
Capsules
Composition
Active ingredient: Pipemidic acid (Pipemidic acid) Active ingredient concentration (mg): 200
Pharmacological effect
Antibacterial drug from the group of quinolones. Bactericidal effect. The drug is active against gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Neisseria spp., Pseudomonas aeruginosa; Gram-positive bacteria: Staphylococcus aureus. The drug is not active against anaerobic microorganisms.
Pharmacokinetics
Absorption After receiving the drug inside a dose of 400 mg Cmax of pimemidic acid is achieved in 70-80 minutes and is 3.5 μg / ml. Bioavailability is 30-60%. Distribution In the kidneys, urine and fluid of the prostate gland, high concentrations of pimemidic acid are created. Pipemido acid penetrates the placental barrier. It is excreted in breast milk in small quantities. ExcretionPipemidic acid is mainly excreted in the urine unchanged. In daily urine is determined 50-85% of the administered dose of the drug. The removal of pipemidovoy acid is directly dependent on creatinine clearance. T1 / 2 is 2 h 15 min. Total clearance - 6.3 ml / min. Pharmacokinetics in special clinical situations. Patients with impaired renal function have higher plasma concentrations of the drug than healthy volunteers. T1 / 2 is 5.7-16 hours.
Indications
Acute and chronic infectious and inflammatory diseases of the urinary tract, caused by microorganisms sensitive to Palin, including: pyelonephritis, urethritis, cystitis, prostatitis, prevention of infections during instrumental interventions in urological and gynecological practice.
Contraindications
hypersensitivity to any of the components of the drug, pronounced renal dysfunction (creatinine clearance <10 ml / min), pronounced hepatic dysfunction (including cirrhosis), porphyria, diseases of the central nervous system (neurological conditions with a reduced seizure threshold), pregnancy and lactation, children up to 14 years old. With caution: a history of allergic reactions to quinolones
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
The safety of Palina during pregnancy and lactation has not been studied, therefore, the drug is contraindicated for use during pregnancy.If necessary, the use of the drug Palin during lactation should decide on the termination of breastfeeding.
Dosage and administration
Inside. The average daily dose is 800 mg, divided into two doses, i.e. 400 mg (2 capsules) every 12 hours, in the morning and evening before meals. For staphylococcal infections, the interval between doses should not be more than 8 hours (i.e., the dose can be increased to 2 capsules 3 times a day). In kidney diseases, the duration therapy ranges from 3 to 6 weeks, with prostatitis 6-8 weeks. During therapy, the patient is recommended to drink plenty of water. When acute urinary tract infections recur in women, oral administration is recommended at the same time as 1 vaginal suppository at night for 7-10 days. The average course of treatment is 10 days. If necessary, the course of treatment may be extended depending on the course of the disease. The duration of treatment is determined by the attending physician.
Side effects
Side effects in most cases are weak and transient, as a rule, do not require discontinuation of the drug. Nausea, vomiting, diarrhea, gastralgia are most frequently observed. As with other antimicrobial agents, resistance or superinfection may occur during treatment. In rare cases, pseudomembranous colitis may develop with severe diarrhea. It is rarely recorded undesirable effects of the drug from the nervous system. Visual disturbances, headache, agitation, depression, confusion, hallucinations, tremor, convulsions were noted. Very rarely, large convulsive seizures may occur. Sleep and sensory disturbances are possible. It is not recommended to use this drug in children. Like other quinolones, pipemidic acid accumulates in cartilage. Particularly mentioned is the phenomenon of muscle hypertonia in newborns and children. Allergic reactions can occur - weak skin itching, skin rashes, Stevens-Johnson syndrome, photosensitivity. Skin reactions are reversible. There are isolated reports on the development of anaphylactic reactions. Hemolytic anemia may develop in patients with glucose-6-phosphate dehydrogenase deficiency. There are separate reports on the development of eosinophilia.Elderly patients and patients with impaired renal function may develop thrombocytopenia.
Overdose
There are no reports of the development of threatening side effects or death in overdose of the drug. Symptoms: nausea, vomiting, dizziness, headache, confusion, tremor, convulsions. Treatment: there is no specific antidote. If less than 4 hours have passed since the moment of taking the drug, to decrease the absorption it is necessary to wash the stomach with the subsequent appointment of activated charcoal. With the development of side effects from the central nervous system (including epileptiform seizures), symptomatic treatment (diazepam) is prescribed. Removal of the drug can be accelerated using forced diuresis.
Interaction with other drugs
Pipemid acid inhibits cytochrome P450 isoenzymes, which leads to a slower metabolism of theophylline and caffeine when used together with Palin. Simultaneous administration of antacids and sucralfate may cause a decrease in the absorption of pimemido acid, therefore the interval between administration of these drugs should be at least 2-3 hours. Acid can enhance the effects of warfarin, rifampicin, cimetidine and NSAIDs with simultaneous use. With simultaneous use of pipemidic acid with aminoglycosides, synergism is noted m bactericidal action.
special instructions
With caution, the drug is prescribed to patients with a history of cerebral circulation disorders (including hemorrhage in the brain, spasms of cerebral vessels), convulsions; with epilepsy; patients over the age of 70 years (due to the increased risk of side effects in this category of patients). During the period of taking the drug, patients should receive plenty of drinks (under the control of diuresis). Due to possible photosensitization during the period of receiving Palin, UV exposure should be avoided. Due to the possibility of cross-sensitivity, caution should be exercised when prescribing Palin in patients with a history of allergic reactions to quinolones. With prolonged use of the drug should be monitored general blood counts, to determine liver function and kidney and periodically determine the sensitivity of microorganisms to pipemidovoy kislote.Pri applying the drug may be marked false positive reaction urine for glucose using Benedict's reagent or solution Felling. Enzymatic reactions with glucose oxidase are recommended. Use in pediatrics Palin is not recommended for use in children.Pipemid acid accumulates in cartilage. There are also reports on the development of muscle hypertonia in newborns and children. Impact on the ability to drive vehicles and control mechanisms