Vardenafil Levifil 20mg

[Drug Name]

Generic Name: Vardenafil Hydrochloride Tablets

English Name: Vardenafil Hydrochloride Tablets

Pinyin: Yansuan Fadinafei Pian

Specification: 20mg × 30 tablets/box

[Composition] Main ingredient: Vardenafil hydrochloride.

[Description] This product consists of light orange to dark orange film-coated tablets; the core appears white after the film coating is removed.

[Indications] Treatment of erectile dysfunction in men.

[Dosage and Administration] Recommended dose: The recommended starting dose is 10 mg, taken approximately 25–60 minutes before sexual activity. In clinical trials, efficacy was demonstrated even when taken 4–5 hours prior to sexual activity. The maximum recommended dosing frequency is once daily. Vardenafil may be taken with or without food. Sexual stimulation is required for the drug to be effective.

[Adverse Reactions] More than 9,500 patients received vardenafil in global clinical trials. Vardenafil was well tolerated, and adverse events were generally transient and mild to moderate in severity.

[Contraindications]

1. Contraindicated in patients with hypersensitivity to any component (active or inactive) of the drug.

2. PDE5 inhibitors may potentiate the hypotensive effects of nitrates, as they share the same mechanism of action within the NO/cGMP pathway. Therefore, concomitant use of vardenafil with nitrates or nitric oxide donors should be avoided.

3. Concomitant use of vardenafil with the HIV protease inhibitors indinavir or ritonavir should be avoided, as these are potent CYP3A4 inhibitors.

[Precautions] Since sexual activity carries a certain degree of cardiac risk, physicians should assess the patient's cardiovascular status before initiating any treatment for erectile dysfunction. The vasodilatory properties of vardenafil may result in a transient, mild decrease in blood pressure. Patients with left ventricular outflow obstruction (e.g., aortic stenosis or idiopathic hypertrophic subaortic stenosis) may be sensitive to vasodilators, including PDE5 inhibitors. Due to potential cardiac risks associated with sexual activity, patients with heart disease are generally advised against sexual intercourse; consequently, medications for erectile dysfunction are typically not indicated for them.

A study involving 59 healthy male subjects investigating the effect of vardenafil on the QT interval demonstrated that both therapeutic doses (10 mg) and supratherapeutic doses (80 mg) caused prolongation of the QTc interval. Post-marketing data indicate that co-administration of vardenafil with other drugs known to affect the QT interval results in a greater effect on the QT interval compared to the use of either drug alone; this factor should be considered during clinical use. Vardenafil should be avoided in patients with congenital QT prolongation or in those taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs.

Caution should be exercised when treating erectile dysfunction in patients with anatomical penile deformities (e.g., angulation, cavernosal fibrosis, Peyronie’s disease) or conditions that predispose them to priapism (e.g., sickle cell disease, multiple myeloma, leukemia).

The safety and efficacy of vardenafil when used in combination with other treatments for erectile dysfunction have not been studied.

[Use in Children] Children (birth to 16 years): Vardenafil is not indicated for use in children.

[Use in Elderly Patients] Elderly patients (≥65 years) exhibit reduced clearance of vardenafil; a starting dose of 5 mg should be considered.

[Use in Pregnant and Lactating Women] Not applicable.

[Drug Interactions] CYP Inhibitors: Vardenafil is primarily metabolized by hepatic enzymes via the cytochrome P450 (CYP) isoform 3A4, with CYP3A5 and CYP2C isoforms also playing a role. Consequently, inhibitors of these enzymes may reduce the clearance of vardenafil.

[Overdose] In single-dose studies involving human subjects, the maximum dose tested was 80 mg. This maximum dose (80 mg) was well tolerated, with no serious adverse drug reactions reported. Similar results were confirmed in another clinical trial involving the administration of 40 mg of vardenafil once daily for four weeks. When vardenafil was administered at a dosage of 40 mg twice daily, a few cases of severe back pain were observed; however, no muscular or neurotoxic effects were confirmed. In the event of overdose, general supportive measures should be administered as clinically indicated. Since vardenafil is highly bound to plasma proteins and is not primarily excreted via urine, renal dialysis does not enhance its clearance from the body.

[Pharmacology and Toxicology] Pharmacological Action: Penile erection is a hemodynamic process involving the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nerve endings in the corpus cavernosum release nitric oxide (NO). NO activates guanylate cyclase in smooth muscle cells, increasing intracellular cyclic guanosine monophosphate (cGMP) levels; this ultimately leads to smooth muscle relaxation and increased blood flow to the penis. The actual level of cGMP is regulated by the balance between the rate of synthesis by guanylate cyclase and the rate of degradation by phosphodiesterases (PDEs). cGMP-specific phosphodiesterase type 5 (PDE5) is the predominant PDE found in the human corpus cavernosum. Vardenafil enhances the natural response to sexual stimulation by inhibiting PDE5—the enzyme responsible for degrading cGMP in the corpus cavernosum—thereby potentiating the effects of locally released endogenous nitric oxide, relaxing smooth muscle, and increasing blood flow to the corpus cavernosum. Enzyme purification studies demonstrate that vardenafil is a potent and highly selective PDE5 inhibitor, with an IC50 of 0.7 nM for human PDE5. Vardenafil's inhibitory effect on PDE5 is far greater than its effect on other PDEs (being 15 times more potent than against PDE6, 130 times more than PDE1, 300 times more than PDE11, and 1,000 times more than PDEs 2, 3, 4, 7, 8, 9, and 10). In *in vitro* studies, vardenafil relaxes smooth muscle by increasing cGMP levels in isolated human penile corpus cavernosum tissue. In studies involving conscious rabbits, vardenafil-induced penile erection depends on endogenous nitric oxide synthase levels and is potentiated by nitric oxide donors. Erectile response: A placebo-controlled Rigiscan study demonstrated that some subjects achieved sufficient penile erection for penetration (≥60% rigidity) within 15 minutes of taking a 20 mg dose of vardenafil. Compared to the placebo group, subjects taking vardenafil showed a statistically significant erectile response 25 minutes after administration. Toxicology studies: Acute toxicity: The LD50 in rats is 190 mg/kg; light microscopy, electron microscopy, and visual examinations revealed no adverse effects on vision. Long-term toxicity: The maximum no-observed-effect level (NOEL) was 3 mg/kg in both male rats and dogs. Additionally, the animals exhibited cardiovascular toxicity associated with PDE5 inhibition; rats also showed PDE-related toxicity affecting the pancreas, exocrine glands, and thyroid, which was not observed in mice or dogs. Genotoxicity: *In vitro* *Salmonella typhimurium* reverse mutation assays, mammalian cell HPRT mutation assays, chromosomal aberration assays, and *in vivo* mouse micronucleus tests showed no evidence of genotoxicity or mutagenicity. Reproductive toxicity: Oral administration of vardenafil to rats and rabbits showed no adverse effects on fertility or embryonic development.

[Pharmacokinetics] Vardenafil is rapidly absorbed following oral administration; maximum plasma concentration (Cmax) can be reached as early as 15 minutes post-dose, with the time to peak concentration (Tmax) typically ranging from 30 to 120 minutes (mean: 60 minutes). Due to a significant first-pass effect, the mean absolute bioavailability of oral vardenafil is approximately 15%. Within the recommended dosage range of 5–20 mg, the increase in AUC (area under the plasma concentration-time curve) and Cmax following oral administration of vardenafil is approximately proportional to the dose increase. When vardenafil is taken with a high-fat meal (57% fat content), the rate of absorption decreases, Tmax is delayed by 60 minutes, and Cmax is reduced by an average of 20%, although the AUC remains unaffected. When taken with a standard meal (30% fat content), the pharmacokinetic parameters (Cmax, Tmax, and AUC) remain unchanged. Therefore, vardenafil may be taken with or without food.

[Storage] Store in a sealed container below 25°C.

[Packaging] 20 mg × 30 tablets/box.

[Shelf Life] 36 months.

Important Information for Purchasing Sexual Health Products:

Note: Oral medications for erectile dysfunction in men require sexual stimulation to be effective; they do not induce erections automatically.

When using drugs containing sildenafil, vardenafil, tadalafil, avanafil, or Priligy (dapoxetine), many users are concerned about potential lack of efficacy.

Based on clinical data and real-world user feedback, there are slight differences in the proportion of non-responders among the various drugs:

Sildenafil: Approximately 15%–20% of users do not achieve the expected results;

Vardenafil: The proportion of non-responders is similar to that of sildenafil, at approximately 15%–22%;

Tadalafil: Due to its longer half-life and broader suitability, the proportion of non-responders is slightly lower, at approximately 12%–18%;

Avanafil: Characterized by rapid onset and metabolism; the proportion of non-responders is approximately 14%–19%;

Priligy (dapoxetine): Targeted at premature ejaculation; efficacy is significantly influenced by individual nerve sensitivity and psychological state, resulting in a relatively higher proportion of non-responders, at approximately 20%–25%. It must be clearly understood that for some individuals, a lack of efficacy after use is by no means an indication of a product quality issue; rather, it is the result of the interplay between the drug's mechanism of action and the individual's unique physiological and pathological conditions. Even with original, patented products—such as Pfizer's Viagra (sildenafil)—a significant proportion of users may experience no effect. For instance, approximately 20% of men do not respond to Viagra, a phenomenon unrelated to product quality. With many male enhancement products, it is common to encounter situations where the exact same box of medication works for one person but not another; conversely, switching to a different product might prove effective for the second person while failing to work for the first. This store guarantees that all sexual health products sold are 100% authentic; however, we cannot guarantee that 100% of users will achieve their desired results. Please ensure you have carefully considered these factors before placing an order.

The specific reasons for varying efficacy differ depending on the medication:

Sildenafil / Vardenafil / Avanafil: All three function by promoting vasodilation. Their efficacy is influenced by individual metabolic capacity (specifically, how liver and kidney function affect the rate at which the drug is broken down), underlying medical conditions (such as diabetes or hypertension, which can damage blood vessels and reduce drug efficiency), and usage context (e.g., consuming alcohol concurrently can inhibit the drug's effects, while a high-fat meal may delay the absorption of sildenafil and vardenafil). If severe arterial vascular disease is present, the medication may struggle to facilitate blood flow, and its efficacy will naturally be limited.

Tadalafil: Although its mechanism of action is similar to the three drugs mentioned above, it remains in the body for a longer duration. Nevertheless, its efficacy is still influenced by factors such as individual sensitivity to the drug, and the presence of severe prostate conditions or spinal cord injuries. For some individuals with weaker receptor binding capabilities, the results may be less than ideal.

Priligy: This medication improves ejaculatory control by inhibiting neurotransmitter reuptake. Its efficacy is closely correlated with the individual's neural conduction efficiency, psychological state (anxiety or stress can counteract the drug's effects), and whether the dosage is appropriately matched to the user's body weight and the severity of their condition. If there is abnormal neural sensitivity or a history of long-term psychogenic premature ejaculation, the drug's regulatory effect may be diminished.

If you have used any of the aforementioned medications—or combination tablets—and the results did not meet your expectations, you must strictly avoid self-medicating by increasing the dosage, switching medications, or continuing to take the drug blindly over the long term. We strongly recommend consulting a urologist or a specialist in men's health as soon as possible. A doctor will assess your physical condition through a detailed consultation and adjust your medication regimen based on test results (e.g., optimizing dosage or switching medication types). They may also incorporate psychological interventions or behavioral training to create a treatment plan best suited to your needs.

Specifications

Product Name: Vardenafil Hydrochloride Tablets (Levitra) 20mg x 30 tablets

Common Name: Levitra

Ingredients: Each tablet contains 20mg of vardenafil hydrochloride.

Dosage Form: Light orange to dark orange film-coated tablets; white inside after removing the coating.

Quantity: 30 tablets

Manufacturer: Radicon Laboratories Limited

Indication: Treatment of erectile dysfunction in men.

Dosage and Administration: Recommended dose: The recommended starting dose is 10mg, taken approximately 25–60 minutes before sexual intercourse. Clinical trials have shown efficacy even when taken 4–5 hours prior to intercourse. The maximum recommended frequency of use is once daily. Vardenafil may be taken with or without food. Sexual stimulation is required for the medication to be effective.