Composition, form of production and packaging
Capsules are opaque, No. 1, with a body from white to white with a yellowish tint of color and a green lid; the contents of the capsules are a hygroscopic powder from white to almost white with a yellowish hue of color.
piperidic acid trihydrate 235.6 mg,
which corresponds to the content of pipemidic acid 200 mg
Excipients: magnesium stearate, silicon dioxide colloid, corn starch.
Composition of the capsule body: titanium dioxide (E171), dye sunset yellow sunset (E110), gelatin.
Composition of capsule capsule: titanium dioxide (E171), dye yellow quinoline (E104), blue dye patented (E131), dye diamond black (E151), dye sunset yellow (E110), gelatin.
10 pieces. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The description of the drug was approved by the manufacturer for the 2006 print edition.
Antibacterial drug from the group of quinolones. It is bactericidal. 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.
After taking the drug inside at a dose of 400 mg C max of pipemidic acid is achieved in 70-80 min and is 3.5 Ојg / ml. Bioavailability is 30-60%.
In the kidneys, urine and liquid of the prostate, high concentrations of pipemidic acid are created.
Pipemidic acid penetrates the placental barrier. Isolated with breast milk in small amounts.
Pipemidic acid is mainly excreted in the urine unchanged. In daily urine is determined 50-85% of the administered dose of the drug. The excretion of pipemidic acid is directly dependent on the clearance of creatinine. T 1/2 is 2 hours and 15 minutes. The total clearance is 6.3 ml / min.
Pharmacokinetics in special clinical cases
Patients with impaired renal function have higher plasma concentrations of the drug than healthy volunteers.
T 1/2 is 5.7-16 hours.
Acute and chronic infectious-inflammatory diseases of the urinary tract caused by sensitive microorganisms:
- a pyelonephritis;
Prevention of infections with instrumental interventions in urological and gynecological practice.
The drug is given in a dose of 200 mg every 12 hours, morning and evening before meals.
With staphylococcal infections, the interval between doses of the drug should not be more than 8 hours (200 mg 3 times / day). 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. The duration of treatment is determined individually.
With kidney disease treatment is 3-6 weeks, with prostatitis - 6-8 weeks. During therapy, the patient is recommended to drink abundantly.
On the part of the digestive system: nausea, vomiting, diarrhea, gastralgia; rarely - pseudomembranous colitis with severe diarrhea.
From the side of the central nervous system and the peripheral nervous system: very rarely - vision disorders, headache, agitation, depression, confusion, hallucinations, tremors, convulsions, sleep disorders, sensory disturbances; very rarely - large convulsive seizures.
From the hemopoietic system: in patients with deficiency of glucose-6-phosphate dehydrogenase, hemolytic anemia can develop; there are some reports of the development of eosinophilia; In elderly patients and patients with impaired renal function, thrombocytopenia may develop.
Allergic reactions: mild skin itching, skin rash, Stevens-Johnson syndrome.
Other: photosensitization, development of resistance, superinfection.
- CNS diseases (neurological diseases with a lower convulsive threshold);
- severe renal dysfunction (CC <10 ml / min);
- pronounced violations of the liver (including cirrhosis);
- lactation (breastfeeding);
- Children and adolescence up to 14 years;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Safety of Palina application during pregnancy and lactation is not studied, therefore the drug is contraindicated for use in pregnancy. If you need to use Palin during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal dysfunction (KK <10 ml / min).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in severe violations of liver function (including cirrhosis);
APPLICATION FOR CHILDREN
The drug is contraindicated in children and adolescents under 14 years.
With caution appoint the drug to patients who have a history of impaired cerebral circulation (including cerebral hemorrhage, spasms of cerebral vessels), convulsions; with epilepsy; patients over the age of 70 (due to an increased risk of side effects in this category of patients).
During the period of taking the drug, patients should receive a copious drink (under the control of diuresis).
Due to possible photosensitization during the Palin intake, UV irradiation should be avoided.
In connection with the possibility of developing cross-sensitivity, caution should be exercised in appointing Palina to patients who have a history of allergic reactions to quinolones.
With prolonged use of the drug should monitor the overall blood count, determine the liver and kidney function and periodically determine the sensitivity of microflora to pipemidic acid.
When using the drug, a false positive urine reaction to glucose can be noted when using a Benedict reagent or a Felling solution. It is recommended to use enzymatic reactions with glucose oxidase.
Use in Pediatrics
It is not recommended to use Palin in children. Pipemidic acid accumulates in the cartilage. There are also reports of the development of muscle hypertension in newborns and children.
Impact on the ability to drive vehicles and manage mechanisms
When using the drug should refrain from engaging in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
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: 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 (diazepam) is prescribed. Excretion of the drug can be accelerated with the help of forced diuresis.
Pipemidic acid inhibits cytochrome P 450 isoenzymes, which leads to a slowing of the metabolism of theophylline and caffeine when combined with Palin.
Simultaneous administration of antacids and sucralfate may cause a decrease in the absorption of pipemidic acid, so the interval between administration of these drugs should be at least 2-3 hours.
Pipemidic acid can enhance the effects of warfarin, rifampicin, cimetidine and NSAIDs with simultaneous application.
With the simultaneous use of pipemidic acid with aminoglycosides, a synergism of bactericidal action is noted.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry place inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 5 years.