URIKS [Pipemidic acid] 200 mg Film-coated tablets
instructions for the medical use of
the medicinal product
URIKS
Tradename
Uriks, Урикс
International non-proprietary name
or generic name
Pipemidic acid, Пипемидовая кислота
Composition
Each
film-coated tablet contains:
active
substance: pipemidic acid 200 mg,
excipients: pregelatinized starch,
hydroxypropyl cellulose, 8% K-30, silicon dioxide, magnesium stearate, sodium
carboxymethyl starch, talc.
Dosage form
Tablets.
Pharmacotherapeutic
group
Antibacterial agent of the quinolone group.
Pharmacological properties
Pharmacodynamics
An antibacterial drug from the group of
quinolones. Acts 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.
Pharmacokinetics
After oral
administration, Cmax in plasma is reached after 2 hours. Bioavailability is
30%-60%, plasma protein binding is 15%. T1 / 2 - 3 hours. 50-70% is excreted in
the urine.
Indications for use
Acute and chronic infectious
and inflammatory diseases of the urinary tract caused by susceptible
microorganisms:
• pyelonephritis;
• urethritis;
• cystitis;
• prostatitis.
Prevention of infections
during instrumental interventions in urological and gynecological practice.
Contraindications
• diseases of the central nervous system (neurological
diseases with a reduced convulsive threshold);
• severe renal dysfunction (CC<10 ml/min);
• severe liver dysfunction (including cirrhosis);
• pregnancy;
• lactation (breastfeeding);
• children's and adolescence up to 18 years;
• hypersensitivity to the components of the drug.
Method of administration and dosage
The drug is taken orally,
after a meal. The tablets should be swallowed whole with plenty of liquid.
The dose and duration of
treatment is determined individually by the doctor, depending on the severity
of the disease. Usually adults are prescribed 400 mg 2 times a day. In some
cases, a single dose can be increased to 600 mg.
The prophylactic dose for the
prevention of infections during instrumental interventions in urological and
gynecological practice is 200 mg 1 time per day.
Special instructions and precautions
Before using the drug,
consult a doctor.
With caution, the drug is prescribed to patients
with a history of cerebrovascular accident (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 plenty of fluids (under the control of diuresis).
With prolonged use of the drug, it is necessary
to monitor the general blood counts, determine the functions of the liver and
kidneys, and periodically determine the sensitivity of the microflora to
pipemidic acid.
During treatment, ultraviolet radiation should be
avoided due to the high risk of photosensitivity.
When using the drug, there may be a false
positive reaction of urine for glucose when using Benedict's reagent or
Felling's solution. It is recommended to use enzymatic reactions with glucose
oxidase.
It is not recommended to use the drug in children
as pipemidic acid accumulates in cartilage.
Influence on the ability to drive vehicles and
mechanisms
When using the drug, one
should refrain from engaging in potentially hazardous activities that require
increased concentration of attention and speed of psychomotor reactions.
Interaction with
other medicinal products
Pipemidic acid causes inhibition of the cytochrome enzyme (P450). The
half-life of theophylline increases, and creatinine clearance decreases with
simultaneous use with pipemidic acid, and therefore it is necessary to monitor
the concentration of theophylline in the blood serum. Pipemidic acid increases
the concentration of caffeine in the blood serum by 2-4 times. Antacids and
sucralfate significantly reduce the absorption of pipemidic acid, so they
should not be administered simultaneously. The interval between injections of
these drugs should be 2-3 hours. Pipemidic acid can enhance the effects of
warfarin, rifampicin, cimetidine and NSAIDs when used simultaneously. The
combination with aminoglycosides has a synergistic bactericidal effect.
Side effect
From the digestive system: anorexia,
epigastric pain, heartburn, nausea, vomiting, flatulence, abdominal pain,
diarrhea or constipation, pseudomembranous colitis.
From the nervous system: headaches,
dizziness, agitation, depression, confusion, hallucinations, tremors, sleep
disturbance, sensory disturbances.
On the part of the organ of
vision: blurred vision.
From the side of the blood
and lymphatic system: hemolytic anemia, in elderly patients and
patients
with impaired renal function may develop thrombocytopenia.
From the skin and
subcutaneous tissues: rash, itching, photosensitivity, Stevens-Johnson
syndrome.
From the musculoskeletal
system: acute arthropathy, tendinitis.
Others: weakness,
development of resistance, superinfection.
If any of the side effects
listed in the instructions get worse, or if you notice any other side effects
not listed in the instructions, tell your doctor.
Symptoms: nausea, vomiting, diarrhea.
Treatment: it is necessary to stop taking the drug. The
excretion of pipemidic acid from the body can be accelerated by forced diuresis.
Pipemidic acid is well excreted from blood plasma during hemodialysis. There is
no specific antidote.
Storage conditions
Store in a cool and
dry place, at a temperature not exceeding 30°C.
Keep out of the reach
of children!
Shelf life
3 years. Do not use
after the expiry date stated on the packaging.
Vacation
conditions
Dispensed by
prescription.
Release
form
10 tablets in an aluminum foil blister. 2 blisters with instructions for use in a cardboard box.