Tamsulosin, Finasteride set
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Clinical Pharmacology
The drug Sonirid Duo is intended for the treatment and control of symptoms of benign prostatic hyperplasia (BPH) in the case of the need for combined treatment with tamsulosin and finasteride in order to:
Indications
Treatment and control of symptoms of benign prostatic hyperplasia (BPH).
Composition
pills and capsules set / in a set:
- tamsulosin (modified release capsules, 0.4 mg) - active ingredient: tamsulosin hydrochloride, 0.4 mg;
- finasteride (film-coated pills, 5 mg) - active substance: finasteride, 5 mg.
Tamsulosin, Finasteride set is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Sonirid Duo | Gedeon Richter | Hungary | capsules |
Tulosin | Egis | Hungary | capsules |
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Dosage and Administration
A drugSonirid Duo contains tamsulosin 400 mcg in modified release capsules and finasteride 5 mg in film-coated pills.
Preparations are intended for daily use.
Daily doseSonirid Duo includes 1 capsule with a modified release of tamsulosin 400 μg and 1 tablet, film-coated, finasteride 5 mg.
Tamsulosin 400 mcg, modified release capsules, must be taken at the same time of day, after meals. Capsules should be swallowed whole, do not crush or chew, because this can disrupt the sustained release of the active ingredient.
For a full therapeutic effect, long-term use of the drug is necessary.Sonirid Duo.
If adverse reactions occur, you can transfer the patient to monotherapy with finasteride; however, it is recommended to return to the combined mode with increased severity of symptoms of BPH.
Adverse reactions
Adverse reactions with tamsulosin monotherapy
From the nervous system: frequent - dizziness; infrequent - headache; rare - fainting.
Since the cardiovascular system: infrequent - postural hypotension, tachycardia.
On the part of the respiratory system: infrequent - rhinitis.
From the digestive system: infrequent - constipation, diarrhea, nausea, vomiting.
On the part of the skin and subcutaneous fat: infrequent - rash, pruritus, urticaria; rare - angioedema.
From the reproductive system: infrequent - retrograde ejaculation; rare - priapism.
Adverse Reactions Monotherapy with Finasteride
On the part of the immune system: infrequent - hypersensitivity.
On the part of the organ of vision: infrequent - clouding of the lens.
From the digestive system:frequent - pain in the abdomen.
On the part of the skin and subcutaneous fat:infrequent - rash.
From the reproductive system and mammary glands:frequent - erectile dysfunction, impaired ejaculation, decreased ejaculate volume, decreased libido; infrequent - breast tenderness, increase in mammary glands, pain in the testicles.
During post-marketing follow-up, the following additional undesirable reactions are described (data on the frequency of unwanted reactions are not): hypersensitivity reactions, including pruritus, urticaria, swelling of the lips and face.
Adverse reactions combined treatment
In patients receiving combined treatment (finasteride and α1adrenergic blocker) describes the same undesirable reactions that occur with the same frequency as with monotherapy with finasteride and α1-blocker. However, the following exceptions were identified: erectile dysfunction and impaired ejaculation were more common with combined treatment, while disease progression (including increased symptoms of BPH or the need for surgical treatment) were more common with monotherapy.
Contraindications
WITHcaution: if there is a risk of obstructive uropathy; with liver diseases; when planning surgical treatment of cataracts.
Drug interactions
In in vitro studies of hepatic microsomal fractions (model of drug metabolism by the cytochrome P450 enzyme system), it was determined that tamsulosin does not enter into a pharmacokinetic interaction with finasteride during metabolism in the liver.
Additional tamsulosin interaction with other drugs and other types of interaction
No interaction was detected with the simultaneous use of tamsulosin and atenolol, enalapril, nifedipine or theophylline.
Combined use with cimetidine can cause an increase in plasma tamsulosin concentration, while furosemide causes its decrease. However, changing the dose of the drug is not required, because tamsulosin concentration remains in the normal range.
In vitro, diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the content of the free fraction of tamsulosin in human plasma.
Also tamsulosin does not change the content of the free fraction of diazepam, propranolol, trichloromethiazide and chlormadinone.
In in vitro studies of hepatic microsomal fractions (model of drug metabolism by cytochrome P450 enzyme system), no interaction with amitriptyline, salbutamol, glibenclamide and finasteride was observed at the level of hepatic metabolism.
However, diclofenac and warfarin may increase the rate of elimination of tamsulosin.
Theoretically, there is a possibility that concomitant use with tamsulosin may enhance the antihypertensive effect of other drugs, such as general anesthesia or other drugs.1-blockers.
Additional interactions with finasteride with other drugs and other types of interactions
No clinically significant interaction was found with the combined use of finasteride with the following drugs: warfarin, ACE inhibitors, α1-adrenoblockers, theophylline, acetylsalicylic acid, paracetamol, beta-blockers, diuretics, nitrates, slow calcium channel blockers, anticonvulsants, NSAIDs, benzodiazepines, quinolones, histamine H blockers2-receptors, 3-hydroxy-3-methyl-glutaryl-coenzyme A-reductase inhibitors (HMG-CoA).
- Finasteride and tamsulosin used in benign prostatic hypertrophy: a review of the prescription-event monitoring data
- Evaluation of Male Sexual Function in Patients with Lower Urinary Tract Symptoms (LUTS) Associated with Benign Prostatic Hyperplasia (BPH) Treated with a Phytotherapeutic Agent (Permixon®), Tamsulosin or Finasteride
- HPTLC Method Validation for simultaneous determination of Tamsulosin Hydrochloride and Finasteride in Bulk and Pharmaceutical Dosage Form
- Tamsulosin versus finasteride: effect on bother and urinary flow
- Finasteride/tamsulosin: no serious, unexpected adverse events
- RETRACTED ARTICLE: Interaction Study Between Finasteride and Tamsulosin in Healthy Young Male Subjects
- Finasteride/tamsulosin: no serious, unexpected adverse events
- Validated RP-HPLC and TLC methods for simultaneous estimation of tamsulosin hydrochloride and finasteride in combined dosage forms
- SIMULTANEOUS DETERMINATION OF FINASTERIDE AND TAMSULOSIN IN COMBINED DOSAGE FORM BY USING RP-HPLC METHOD
- Pharmacokinetic Interaction of Finasteride With Tamsulosin Hydrochloride: An Open-label, Randomized, 3-period Crossover Study in Healthy Chinese Male Volunteers
- Comparison of Tamsulosin and Finasteride for Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia in Korean Patients
- Finasteride, not tamsulosin, increases severity of erectile dysfunction and decreases testosterone levels in men with benign prostatic hyperplasia
- Simultaneous quantitative analysis of tamsulosin and finasteride in pharmaceutical dosage form by U-HPLC Tandem mass spectrometry
- Re: Finasteride, Not Tamsulosin, Increases Severity of Erectile Dysfunction and Decreases Testosterone Levels in Men with Benign Prostatic Hyperplasia
- Re: Finasteride, Not Tamsulosin, Increases Severity of Erectile Dysfunction and Decreases Testosterone Levels in Men with Benign Prostatic Hyperplasia
- Additive effect of oral LDD175 to tamsulosin and finasteride in a benign prostate hyperplasia rat model
- Chromatographic methods for determination of finasteride and tamsulosin hydrochloride and in presence of finasteride degradation product