Product Overview
Product name
Yirishuang Tadalafil Tablets 20mg*5 tablets
Product specifications
20mg*5 tablets
Expiration date
36 months
Main raw materials
The main ingredient of this product is tadalafil. Chemical name: 6-(1,3-benzodioxolane-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl, (6R,12aR)-pyrazino[1'2':1,6]pyridino[3,4-b]indole-1,4-dione Molecular formula: C22H19N3O4 Molecular weight: 389.41 (see the instructions for excipients)
Manufacturer
Hainan Zhuoli Pharmaceutical Co., Ltd.
[Usage and dosage]
Tadalafil tablets are not affected by food intake, and sexual stimulation is required for tadalafil tablets to take effect. Erectile dysfunction: Take tadalafil tablets on demand: For most patients, the recommended starting dose of tadalafil tablets taken on demand is 10mg, taken before sexual intercourse. Depending on the individual's efficacy and tolerability, the dose can be increased to 20mg or reduced to 5mg. The maximum recommended frequency of medication for most patients is once a day. Compared with placebo, taking tadalafil tablets on demand can improve erectile function for up to 36 hours. Therefore, this factor should be considered when recommending patients to take tadalafil tablets in the best way. For more details, please refer to the instructions.
[Properties]
[Pharmacological Action]
[Drug Interactions]
Possibility of pharmacokinetic interactions with tadalafil tablets: Nitrate drugs-Clinical pharmacology studies have shown that tadalafil tablets can enhance the antihypertensive effect of nitrate drugs, so patients who are taking any form of organic nitrate drugs are strictly prohibited from taking tadalafil tablets. For patients taking tadalafil tablets, nitrate drugs should only be considered for the treatment of life-threatening situations, otherwise nitrate drugs should be considered at least 48 hours after the last dose of tadalafil tablets. Even in this case, nitrates should be administered only under close medical supervision and adequate hemodynamic monitoring (see
[Special Population Use]
Pregnant and Lactating Women Use: Pregnancy: Pregnancy Category B (FDA Pregnancy Safety Category) - Tadalafil is not for use in women. There are no adequate, well-controlled studies of tadalafil tablets in pregnant women. Animal reproduction studies in rats and mice showed no evidence of fetal harm. Non-teratogenic effects - Animal reproduction studies showed that when tadalafil was administered to pregnant rats or mice during organogenesis, exposure levels reached 11 times the maximum recommended human dose (MRHD), and there was no evidence of teratogenicity, embryotoxicity, or fetotoxicity. In one of the two perinatal/postnatal studies in rats, administration of tadalafil to pregnant rats or mice was associated with teratogenicity, embryotoxicity, or fetotoxicity. When the dose of tadalafil reaches more than 10 times the MRHD based on AUC, the survival of the pups after birth is reduced. Based on AUC, symptoms of maternal toxicity occurred at doses exceeding 16 times the 4MRHD. Surviving fetuses had normal development and reproductive performance (see "Pharmacology and Toxicology"). Lactating women: Tadalafil tablets are not for use in women. It is not known whether tadalafil is secreted in breast milk in humans. Although tadalafil or certain metabolites of tadalafil are secreted in breast milk in rats, drug levels in animal milk cannot accurately predict drug levels in human milk. Pediatric use: Tadalafil tablets are not for use in pediatric patients. Safety and effectiveness have not been established in patients under 18 years of age. Geriatric use: Of the total number of subjects in tadalafil clinical studies, approximately 19% were Patients aged 65 years and over, 2% were patients aged 75 years or over. No overall differences in effectiveness or safety were observed in subjects aged 65 years and over compared with younger subjects (≤65 years). However, in all placebo-controlled clinical trials of tadalafil tablets for the treatment of erectile dysfunction, patients aged 65 years and over experienced diarrhea more frequently when taking tadalafil tablets (2.5% of patients) (see [Adverse Reactions]). No dose adjustment is required based on age. However, it should be considered that some older individuals are more sensitive to the drug (see [Pharmacology and Toxicology]).
[Precautions]
[Adverse Reactions]
Clinical research experience: Because the conditions for conducting clinical trials vary greatly, the adverse reaction rates observed in the clinical trials of one drug cannot be directly compared with the clinical trials of another drug. The incidence rates reported in the literature may not reflect the rates observed in practice. In clinical trials worldwide, more than 6,550 men have taken tadalafil. In trials of once-daily tadalafil tablets, 716, 389, and 115 patients were treated for at least 6 months, 1 year, and 2 years, respectively. For on-demand tadalafil tablets, more than 1,300 and 1,000 subjects were treated for at least 6 months and 1 year, respectively. On-demand tadalafil tablets: In the 8 main placebo-controlled Phase 3 studies lasting 12 weeks, the mean age was 59 years (range 22-88), and the percentage of patients who withdrew due to adverse events was 3.1% for patients receiving tadalafil 10 mg or 20 mg, compared with 1.4% for patients receiving placebo. The following adverse events occurred with on-demand tadalafil tablets (see Table 1) when administered as recommended in placebo-controlled clinical trials. For the rest, see the instructions.
