Active ingredients: pipemidic acid
UROTRACTIN 20 hard capsules 400 mg
UROTRACTIN 20 hard capsules 200 mg
Why is Urotractin used? What is it for?
Pharmacotherapeutic group
Antibacterial
THERAPEUTIC INDICATIONS
Infections of the urinary tract (cystitis, pyelitis, cystopyelitis, pyelonephritis, urethritis, prostatitis, etc.) sustained by germs sensitive to pipemidic acid.
Contraindications When Urotractin should not be used
In childhood and in case of individual hypersensitivity to the product.
Precautions for use What you need to know before taking Urotractin
During therapy with Urotractin it is recommended to reduce the time of exposure to the sun due to the risk of photosensitization, with consequent bullous dermatitis
Use in case of pregnancy and lactation:
In pregnant women, the product should be administered in cases of real need and under direct medical supervision.
Interactions Which drugs or foods can modify the effect of Urotractin
No interactions with other medicinal products have been reported, except that with erythromycin, which may be responsible for thrombocytopenic purpura.
Warnings It is important to know that:
The product does not interfere with driving and using machines.
KEEP OUT OF REACH OF CHILDREN
Dose, Method and Time of Administration How to use Urotractin: Posology
The recommended dosage is 400 mg (1 capsule of 400 mg or 2 capsules of 200 mg) twice a day 12 hours apart, preferably after meals.
As with all treatments for urinary tract infections, if you want to avoid the risk of relapse, it is preferable to continue treatment with Urotractin for at least 10 days.
In case of chronic or relapsing infections, Urotractin can also be taken for a long time without problems.
Side Effects What are the side effects of Urotractin
Nausea, gastralgia which does not normally require the suspension of treatment. They occur in less than 2% of treated subjects and are attenuated by administering the drug on a full stomach.
Exanthematic or urticarial rashes are even rarer.
Exceptionally, neurosensory and psychic manifestations with dizziness and balance disturbances in elderly subjects.
Notify the attending physician or pharmacist of any onset of undesirable effects not described in this leaflet.
Expiry and Retention
The expiry date shown on the package refers to the product in intact packaging, correctly stored
Warning
Warning: do not use the medicine after the expiry date shown on the package.
Composition
Urotractin - 400 mg capsules
Each capsule contains:
Active principle:
Pipemidic acid 400 mg
Excipients:
talc, sodium carboxymethyl starch, magnesium stearate, starch, gelatin, titanium dioxide, indigo carmine, yellow iron oxide
Urotractin - 200 mg capsules
Each capsule contains:
Active principle:
Pipemidic acid 200 mg
Excipients:
talc, sodium carboxymethyl starch, magnesium stearate, starch, gelatin, titanium dioxide, indigo carmine, yellow iron oxide, black iron oxide
Pharmaceutical form and content for each presentation
20 hard capsules of 400 mg
20 hard capsules of 200 mg
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
UROTRACTIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Urotractin 400 mg
Urotractin 200 mg
Active ingredient: pipemidic acid 400 mg 200 mg (contained in the form of trihydrate 471.25 mg 235.63 mg).
03.0 PHARMACEUTICAL FORM
Hard capsules.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Infections of the urinary tract (cystitis, pyelitis, cystopyelitis, pyelonephritis, urethritis, prostatitis, etc.) sustained by germs sensitive to pipemidic acid.
04.2 Posology and method of administration
Adults: the recommended dosage is 400 mg (1 capsule of 400 mg or 2 capsules of 200 mg) twice a day 12 hours apart, preferably after meals.
As with all treatments for urinary tract infections, if you want to avoid the risk of relapse, it is preferable to continue treatment with Urotractin for at least 10 days.
In case of chronic or relapsing infections, Urotractin can also be taken for a long time without problems.
04.3 Contraindications
In childhood and in cases of individual hypersensitivity to the product.
04.4 Special warnings and appropriate precautions for use
During therapy with Urotractin it is recommended to reduce the time of exposure to the sun due to the risk of photosensitization with consequent bullous dermatitis.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions with other medicinal products have been reported, except that with erythromycin, which may be responsible for thrombocytopenic purpura.
04.6 Pregnancy and breastfeeding
In pregnant women, the product should be administered in cases of real need and under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
The product does not affect these capabilities.
04.8 Undesirable effects
Nausea, gastralgia which does not normally require the suspension of treatment. They occur in less than 2% of treated subjects and are attenuated by administering the drug on a full stomach.
Skin rashes of the exanthematic or urticarial type are even rarer.
Exceptionally, neurosensory and psychic manifestations with dizziness and balance disorders in elderly subjects.
04.9 Overdose
No symptoms of overdose in humans have been described so far.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Urotractin is a chemotherapy for the treatment of urinary tract infections belonging to the quinolone group. It acts in a bactericidal sense, by inhibiting the duplication of chromosomal DNA, on Gram-negative germs, including Pseudomonas, and on the Gram-positive ones most frequently found in urinary infections. Urotractin, also inhibiting the duplication of plasmid DNA, does not cause the onset and transmission of resistances.
The clinical case history in which Urotractin has been used includes all the possible manifestations of the infectious pathology of the urinary tract, both of the upper excretory tract (pyelonephritis, pyelitis) and of the lower urinary tract (cystitis, urethritis, prostatitis). The greatest efficacy was obtained in the acute forms: 91% of positive results with urine sterilization in the 4th-5th day. In the chronic and complicated forms, 65/70% of definitive recoveries were obtained.
In the remaining cases, mostly represented by obstructive uropathies (sustained by stenosis, stones, neoformations, etc.), alongside the disappearance of clinical symptoms, a strong reduction in the urinary bacterial load has always been obtained.
05.2 "Pharmacokinetic properties
Urotractin carries out its activity within the widest variations of the urinary pH (pH 5 - pH 9); it is optimally absorbed orally even in the presence of food, rapidly reaches and maintains high concentrations in the urine, kidney, prostate and intestine for a long time.
It is eliminated in active form by glomerular filtration and partly by proximal tubular excretion (65-83%). A small part is eliminated through the intestine with the faeces. In case of reduced renal excretion the amount eliminated with the faeces increases proportionally. It can therefore also be administered to elderly patients or patients with renal insufficiency, without causing accumulation phenomena.
05.3 Preclinical safety data
Toxicology studies show a practical absence of acute (mouse, rat), subacute (rat) and chronic (rat and mini-pig) toxicity for pipemidic acid. For example: LD50 in mice and rats per os> 5000 mg / kg Other studies also excluded negative effects on reproductive function and fetal development (rat and rabbit) as well as of a teratogenic nature (rat and rabbit).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Urotractin 400 mg
talc, sodium carboxymethyl starch, magnesium stearate, starch
Casing:
gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172)
Urotractin 200 mg
Talc, Sodium Carboxymethyl Starch, Magnesium Stearate, Starch
Casing:
gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172), black iron oxide (E172).
06.2 Incompatibility
No incompatibilities with other therapies have been reported.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
None under normal storage conditions.
06.5 Nature of the immediate packaging and contents of the package
Box of 20 hard capsules of 400 mg in blister.
Box of 20 hard capsules of 200 mg in blister.
06.6 Instructions for use and handling
07.0 MARKETING AUTHORIZATION HOLDER
Teofarma S.r.l. - Via F.lli Cervi, 8 - Salimbene Valley (PV)
08.0 MARKETING AUTHORIZATION NUMBER
Urotractin 400 mg hard capsules AIC n. 023869023
Urotractin 200 mg hard capsules AIC n. 023869011
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
hard capsules 400 mg November 1978 / June 2010
hard capsules 200 mg November 1978 / June 2010
10.0 DATE OF REVISION OF THE TEXT
June 2010
