Proflosin, 30 pcs., 0.4 mg, long-acting enteric capsules
At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down.
Before starting therapy with Proflosin®, the patient should exclude the presence of diseases and conditions that could cause symptoms similar to those of benign prostatic hyperplasia.
Before starting treatment and regularly during therapy, a digital rectal examination and, if necessary, determination of the concentration of prostate specific antigen (PSA) should be performed.
The use of tamsulosin in patients with severe renal impairment (creatinine clearance less than 10 ml/min) requires caution, since no studies have been conducted in this patient population.
During surgical interventions for cataracts or glaucoma while taking the drug or with its previous use, some patients may develop intraoperative instability syndrome of the iris (narrow pupil syndrome), which must be taken into account during the preoperative preparation of the patient and during the operation. It is recommended to stop taking tamsulosin 1–2 weeks before surgery for cataracts or glaucoma, but the benefit of stopping tamsulosin therapy has not yet been proven. Small pupil syndrome may also develop in patients who took tamsulosin for a longer period of time before surgery.
The use of tamsulosin in patients undergoing surgery for cataracts or glaucoma is not recommended.
During preoperative preparation, the ophthalmic surgeon should clarify whether the patient is currently or previously using tamsulosin in order to take appropriate measures, if necessary, to prevent small pupil syndrome.
In short-term and long-term clinical studies, cases of ejaculation disorders were observed in patients taking tamsulosin. In the post-registration period, cases of ejaculation disorders, retrograde ejaculation, and anejaculation were noted.
There have been cases of the development of prolonged erection and priapism during the use of α1-blockers. If an erection persists for more than 4 hours, you should immediately seek medical help. Treatment of priapism should be carried out immediately to avoid damage to penile tissue and irreversible loss of potency.
Impact on the ability to drive vehicles and other mechanisms
No studies have been conducted on the effect of tamsulosin on the ability to drive vehicles and operate machinery. But, given the possibility of dizziness, caution must be exercised when driving vehicles and other machinery, as well as when engaging in other potentially hazardous activities.
Proflosin®
Manufacturer: BERLIN-PHARMA CJSC (Russia)
caps. enteric-soluble long-acting valid 400 mcg: 10, 30 or 100 pcs. Reg. No.: LP-000832
Clinical and pharmacological group:
A drug used for urinary disorders associated with benign prostatic hyperplasia. Alpha1-blocker
Release form, composition and packaging
Long-acting enteric capsules
gelatin; size No. 2; opaque, with a light orange body and a gray-green cap; one black line is marked on the body and cap, “TSLO.4” is printed on the cap; The contents of the capsules are pellets from white to almost white.
| 1 caps. | |
| tamsulosin hydrochloride | 400 mcg |
Excipients:
microcrystalline cellulose - 276.9 mg, copolymer of methacrylic acid and ethyl acrylate (1:1) - 16.5 mg, triethyl citrate - 1.65 mg, talc - 16.5 mg.
Pellet shell composition:
copolymer of methacrylic acid and ethyl acrylate (1:1) - 21.63 mg, talc - 8.65 mg, triethyl citrate - 2.16 mg.
Composition of the capsule body:
red iron oxide dye - 0.0239 mg, titanium dioxide - 0.53 mg, yellow iron oxide dye - 0.258 mg, gelatin - 38.938 mg.
Composition of the capsule cap:
indigo carmine - 0.00152 mg, black iron oxide dye - 0.0107 mg, titanium dioxide - 0.356 mg, yellow iron oxide dye - 0.114 mg, gelatin - 23.889 mg.
10 pieces. - blisters (1) - cardboard packs. 10 pieces. - blisters (3) - cardboard packs. 10 pieces. - blisters (10) - cardboard packs.
Description of the active components of the drug "Proflosin®"
pharmachologic effect
Tamsulosin selectively and competitively blocks postsynaptic α1A-adrenergic receptors located in the smooth muscles of the prostate gland, bladder neck and prostatic urethra. This leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck, prostatic urethra and improved urine outflow.
α-adrenergic blockers may reduce blood pressure (BP) by reducing peripheral vascular resistance. However, during clinical trials of tamsulosin, in patients with normal blood pressure levels, no clinically significant decrease in blood pressure was observed.
Indications
- benign prostatic hyperplasia (treatment of dysuric disorders).
Dosage regimen
Orally, 1 capsule 1 time per day after breakfast or the first meal. The capsule should be swallowed whole, without chewing, with a sufficient amount of water. The capsule should not be divided into parts or broken, as this may affect the rate of release of the active substance. The duration of use is not limited.
Side effect
Possible side effects when using the drug are listed below in descending frequency of occurrence: often (< 1/10, > 1/100), infrequently (< 1/100, > 1/1000), rarely (< 1/1000, > 1/10000 ), very rare (< 1/10000), including isolated reports.
Nervous system disorders:
often - dizziness; infrequently - headache; rarely - fainting.
Violations by the SSS:
infrequently - tachycardia, orthostatic hypotension.
Gastrointestinal disorders:
uncommon - constipation, diarrhea, nausea, vomiting.
Reproductive system disorders:
infrequently - ejaculation disorders; very rarely - priapism.
Disorders of the skin and subcutaneous tissues:
uncommon - rash, itchy skin, urticaria; rarely - angioedema.
Other:
in some cases - the development of atonic iris syndrome (narrow pupil syndrome) during cataract surgery, asthenia, rhinitis.
Contraindications
- hypersensitivity to tamsulosin or other components of the drug;
- orthostatic hypotension (including history);
- severe liver failure.
Carefully
— chronic renal failure (creatinine clearance less than 10 ml/min);
- arterial hypotension.
Pregnancy and lactation
The drug is prescribed only to men.
Use for liver dysfunction
Contraindicated in severe liver failure.
Use for renal impairment
Use the drug with caution in chronic liver diseases (creatinine clearance less than 10 ml/min)
special instructions
At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down.
Before starting therapy with Proflosin®, the patient should exclude the presence of diseases and conditions that could cause symptoms similar to those of benign prostatic hyperplasia.
Before starting treatment and regularly during therapy, a digital rectal examination and, if necessary, determination of the concentration of prostate specific antigen (PSA) should be performed.
If angioedema develops, therapy with Proflosin should be stopped immediately. Repeated administration of the drug is contraindicated. During surgery for cataracts while taking the drug, the development of atonic iris syndrome is possible, which must be taken into account by the surgeon for the preoperative preparation of the patient and during the operation.
Impact on the ability to drive a vehicle and other complex mechanisms
Care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, due to the fact that dizziness may develop.
Overdose
There have been no cases of overdose while taking the drug to date. However, theoretically, there is a possibility of a sharp decrease in blood pressure and tachycardia, which may require appropriate measures. To restore blood pressure (including orthostatic hypotension) and heart rate to normal values, the patient must be laid down. Hemodialysis is not advisable because tamsulosin has a high affinity for plasma proteins.
To prevent further absorption of tamsulosin, it is advisable to lavage the stomach, take activated charcoal or an osmotic laxative (for example, sodium sulfate).
Drug interactions
Tamsulosin does not interact with atenolol, enalapril, nifedipine and theophylline.
When used simultaneously with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was observed; with furosemide - a decrease in concentration, but this does not require adjustment of the dose of the drug Proflosin®, since the concentration of the drug remains within the normal range.
Diclofenac and warfarin may increase the elimination rate of tamsulosin.
The simultaneous administration of tamsulosin with other ai-adrenergic receptor blockers can lead to a decrease in blood pressure.
Conditions for dispensing from pharmacies
On prescription.
Storage conditions and periods
At a temperature not higher than 30°C. Keep out of the reach of children! Shelf life: 3 years.
Drug interactions
Tamsulosin does not interact with atenolol, enalapril, nifedipine and theophylline.
When used simultaneously with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was observed; with furosemide - a decrease in concentration, but this does not require adjustment of the dose of the drug Proflosin®, since the concentration of the drug remains within the normal range.
Diclofenac and warfarin may increase the elimination rate of tamsulosin.
The simultaneous administration of tamsulosin with other ai-adrenergic receptor blockers can lead to a decrease in blood pressure.
Proflosin capsules enteric acid prolong 0.4 mg No. 30
Compound
Active substance: tamsulosin hydrochloride 400 mcg.
Excipients: microcrystalline cellulose - 276.9 mg, copolymer of methacrylic acid and ethyl acrylate (1:1) - 16.5 mg, triethyl citrate - 1.65 mg, talc - 16.5 mg.
Pellet shell composition: copolymer of methacrylic acid and ethyl acrylate (1:1) - 21.63 mg, talc - 8.65 mg, triethyl citrate - 2.16 mg.
Composition of the capsule body: red iron oxide dye - 0.0239 mg, titanium dioxide - 0.53 mg, yellow iron oxide dye - 0.258 mg, gelatin - 38.938 mg.
Composition of the capsule cap: indigo carmine - 0.00152 mg, black iron oxide dye - 0.0107 mg, titanium dioxide - 0.356 mg, yellow iron oxide dye - 0.114 mg, gelatin - 23.889 mg.
Pharmacokinetics
After oral administration, tamsulosin is quickly and almost completely absorbed from the gastrointestinal tract. After a single oral dose of 400 mcg, the Cmax of the active substance in plasma is achieved after 6 hours.
Plasma protein binding - 99%. Vd is insignificant and amounts to 0.2 l/kg.
Tamsulosin is slowly metabolized in the liver to form pharmacologically active metabolites that retain high selectivity for α1A-adrenergic receptors. Most of the active substance is present in the blood unchanged.
T1/2 of tamsulosin with a single dose is 10 hours, terminal T1/2 is 22 hours. It is excreted by the kidneys, 9% unchanged.
Indications for use
Treatment of dysuric disorders in benign prostatic hyperplasia.
Contraindications
- Hypersensitivity to tamsulosin;
- orthostatic hypotension (including a history), severe liver failure;
- children and adolescents up to 18 years of age.
With caution: severe renal failure (creatinine clearance less than 10 ml/min); arterial hypotension.
Directions for use and doses
Orally, 1 capsule 1 time per day after breakfast or the first meal. The capsule should be swallowed whole, without chewing, with a sufficient amount of water. The capsule should not be divided into parts or broken, as this may affect the rate of release of the active substance.
The duration of use is not limited.
Storage conditions
At a temperature not higher than 30°C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiration date stated on the package.
special instructions
At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down.
Before starting therapy with Proflosin, the patient should exclude the presence of diseases and conditions that could cause symptoms similar to those of benign prostatic hyperplasia.
Before starting treatment and regularly during therapy, a digital rectal examination and, if necessary, determination of the concentration of prostate specific antigen (PSA) should be performed.
If angioedema develops, therapy with Proflosin should be stopped immediately. Repeated administration of the drug is contraindicated.
During surgery for cataracts while taking the drug, the development of atonic iris syndrome is possible, which must be taken into account by the surgeon for the preoperative preparation of the patient and during the operation.
Description
Alpha1 is an adrenergic blocker.
Use in children
Contraindicated for use in children and adolescents under 18 years of age.
Pharmacodynamics
α1-adrenergic receptor blocker; a drug for the symptomatic treatment of benign prostatic hyperplasia.
Selectively blocks postsynaptic α1A-adrenergic receptors of smooth muscles of the prostate gland, bladder neck, prostatic urethra. As a result, the tone of the smooth muscles of these formations decreases, and the outflow of urine is facilitated. At the same time, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia are reduced. The therapeutic effect appears approximately 2 weeks from the start of treatment.
Tamsulosin's ability to block α1B-adrenergic receptors of vascular smooth muscles is much less pronounced, so the effect on systemic blood pressure is insignificant.
Side effects
Possible side effects when using the drug are listed below in descending frequency of occurrence: often (< 1/10, > 1/100), infrequently (< 1/100, > 1/1000), rarely (< 1/1000, > 1/10000 ), very rare (< 1/10000), including isolated reports.
Nervous system disorders: often - dizziness; infrequently - headache; rarely - fainting.
Disorders of the cardiovascular system: infrequently - tachycardia, orthostatic hypotension.
Gastrointestinal disorders: uncommon - constipation, diarrhea, nausea, vomiting.
Reproductive system disorders: uncommon - ejaculation disorders; very rarely - priapism.
Disorders of the skin and subcutaneous tissues: infrequently - rash, itching, urticaria; rarely - angioedema.
Other: in some cases - development of atonic iris syndrome (narrow pupil syndrome) during cataract surgery, asthenia, rhinitis.
Use during pregnancy and breastfeeding
Not applicable.
Interaction
With simultaneous use of tamsulosin with cimetidine, a slight increase in the concentration of tamsulosin in the blood plasma was noted, and with furosemide - a decrease in concentration; with other α1-blockers - a pronounced increase in the hypotensive effect is possible.
Diclofenac and indirect anticoagulants slightly increase the rate of elimination of tamsulosin.
Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.
In vitro studies showed no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride.
Other α1-blockers, acetylcholinesterase inhibitors, alprostadil, anesthetics, diuretics, levodopa, antidepressants, beta-blockers, slow calcium channel blockers, muscle relaxants, nitrates and ethanol may increase the severity of the hypotensive effect.
Co-administration of tamsulosin with potent inhibitors of the CYP3A4 isoenzyme may lead to an increase in tamsulosin concentrations. Co-administration with ketoconazole resulted in an increase in the AUC and Cmax of tamsulosin by 2.8 and 2.2 times, respectively.
Tamsulosin should not be used in combination with strong CYP3A4 inhibitors in patients with impaired metabolism of the CYP2D6 isoenzyme. Tamsulosin should be used with caution in combination with strong and moderate CYP3A4 inhibitors.
Overdose
There have been no cases of overdose while taking the drug to date.
However, theoretically, there is a possibility of a sharp decrease in blood pressure and tachycardia, which may require appropriate measures. To restore blood pressure (including orthostatic hypotension) and heart rate to normal values, the patient must be laid down. Hemodialysis is not advisable because tamsulosin has a high affinity for plasma proteins.
To prevent further absorption of tamsulosin, it is advisable to lavage the stomach, take activated charcoal or an osmotic laxative (for example, sodium sulfate).
Release form
Long-acting enteric capsules, 0.4 mg.
Impact on the ability to drive vehicles and operate machinery
Care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, due to the fact that dizziness may develop.
