Levifil 20 Vardenafil Hydrochloride Tablets

Product Name

Levifil 20

English Name

Vardenafil Hydrochloride Tablets

Specification

20mg × 30 tablets/box

Ingredients

Active Ingredient:
Vardenafil Hydrochloride

Description

This product is a light orange to dark orange film-coated tablet. After removal of the film coating, the tablet appears white.

Indications

Levifil 20 is indicated for the treatment of male erectile dysfunction (ED).

Dosage and Administration

Recommended Dose:
The recommended initial dose is 10mg, taken approximately 25–60 minutes before sexual activity.

Clinical studies have shown that vardenafil may remain effective when taken 4–5 hours before intercourse.

The maximum recommended dosing frequency is once daily.

Vardenafil may be taken with or without food.

Sexual stimulation is required for vardenafil to produce its effect. It does not cause an automatic erection without sexual arousal.

Adverse Reactions

In worldwide clinical trials, more than 9,500 patients have received vardenafil treatment.

Vardenafil is generally well tolerated. Reported adverse reactions are usually temporary and mild to moderate in severity.

Contraindications

1. Patients who are allergic or hypersensitive to vardenafil or any other active or inactive ingredients should not use this product.

2. PDE5 inhibitors, including vardenafil, have the same mechanism of action in the nitric oxide (NO)/cGMP pathway and may enhance the blood pressure-lowering effects of nitrate medications. Therefore, patients using nitrates or nitric oxide donors should avoid taking vardenafil.

3. Concomitant use of vardenafil with HIV protease inhibitors such as indinavir or ritonavir should be avoided because these drugs are strong CYP3A4 inhibitors.

Precautions

Because sexual activity may place a certain level of stress on the heart, doctors should evaluate a patient's cardiovascular condition before prescribing any erectile dysfunction treatment.

Due to the vasodilatory effects of vardenafil, temporary mild decreases in blood pressure may occur.

Patients with left ventricular outflow obstruction, such as:

• Aortic stenosis

• Idiopathic hypertrophic subaortic stenosis

may be particularly sensitive to vasodilators, including PDE5 inhibitors.

Patients with serious heart conditions for whom sexual activity is not recommended should generally avoid erectile dysfunction medications.

A study involving 59 healthy male subjects evaluated the effect of vardenafil on QT interval prolongation. Both therapeutic doses (10mg) and higher doses (80mg) were associated with QTc interval prolongation.

Patients with:

• Congenital long QT syndrome

• Use of Class IA antiarrhythmics (such as quinidine and procainamide)

• Use of Class III antiarrhythmics (such as amiodarone and sotalol)

should avoid using vardenafil.

Patients with anatomical deformation of the penis, including:

• Penile angulation

• Cavernosal fibrosis

• Peyronie's disease

should use vardenafil cautiously.

Patients with conditions that may cause prolonged erections, including:

• Sickle cell disease

• Multiple myeloma

• Leukemia

should also use this medication carefully.

The safety and effectiveness of combining vardenafil with other erectile dysfunction treatments have not been established.

Pediatric Use

Vardenafil is not indicated for children or adolescents under 16 years of age.

Elderly Patients

For elderly patients aged 65 years or older, vardenafil clearance may be reduced.

An initial dose of 5mg should be considered.

Pregnancy and Breastfeeding

Not applicable.

Vardenafil is not intended for use in women.

Drug Interactions

CYP Enzyme Inhibitors

Vardenafil is mainly metabolized in the liver through the cytochrome P450 enzyme system, primarily via:

• CYP3A4

• CYP3A5

• CYP2C isoenzymes

Inhibitors of these enzymes may reduce vardenafil clearance and increase drug exposure.

Overdose

In single-dose clinical studies, the highest tested dose was 80mg once daily.

This dose was generally well tolerated without serious adverse reactions.

Similar results were observed in clinical studies where patients received:

40mg once daily for 4 weeks

When vardenafil was administered at:

40mg twice daily

some cases of severe back pain were observed, but no evidence of muscle or neurological toxicity was confirmed.

In cases of overdose, general supportive treatment should be provided as necessary.

Because vardenafil has a high plasma protein binding rate and is not primarily eliminated through urine, hemodialysis is unlikely to significantly increase clearance.

Pharmacology and Toxicology

Pharmacological Action

Penile erection is a hemodynamic process involving relaxation of smooth muscle in the corpus cavernosum and associated penile arteries.

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).

The increase in cGMP causes smooth muscle relaxation, increasing blood flow into the penis and producing an erection.

The level of cGMP is regulated by the balance between its production and degradation by phosphodiesterase enzymes (PDEs).

PDE5 is the primary enzyme responsible for cGMP degradation in human penile tissue.

Vardenafil works by selectively inhibiting phosphodiesterase type 5 (PDE5), preventing cGMP breakdown. This enhances the natural erectile response triggered by sexual stimulation by increasing blood flow within the corpus cavernosum.

Enzyme purification studies demonstrate that vardenafil is a highly potent and selective PDE5 inhibitor.

Its inhibitory activity against PDE5 is significantly stronger than against other PDE enzymes:

• Approximately 15 times stronger than PDE6

• Approximately 130 times stronger than PDE1

• Approximately 300 times stronger than PDE11

• More than 1,000 times stronger than PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, and PDE10

Erectile Response Study

A placebo-controlled Rigiscan study showed that some patients achieved sufficient penile rigidity for penetration approximately 15 minutes after taking vardenafil 20mg.

Compared with placebo, erectile response was significantly improved 25 minutes after administration.

Toxicology Studies

Acute Toxicity

The LD50 in rats was approximately 190mg/kg.

Microscopic, electron microscopic, and visual examinations showed no drug-related effects on vision.

Long-Term Toxicity

The maximum no-observed-effect level (NOEL) in male rats and dogs was 3mg/kg.

Animal studies showed cardiovascular effects associated with PDE5 activity. Pancreatic exocrine gland and thyroid effects were observed in rats but not in mice or dogs.

Genetic Toxicity

No evidence of genetic toxicity or mutagenicity was found in:

• Ames bacterial reverse mutation tests

• Mammalian cell HPRT mutation tests

• Chromosomal aberration tests

• Mouse micronucleus tests

Reproductive Toxicity

Oral administration studies in rats and rabbits showed no adverse effects of vardenafil on fertility or embryo development.

Pharmacokinetics

After oral administration, vardenafil is rapidly absorbed.

Under fasting conditions:

• Maximum plasma concentration (Cmax) may be reached as early as 15 minutes.

• Tmax occurs approximately 30–120 minutes after administration (average about 60 minutes).

Due to significant first-pass metabolism, the average absolute bioavailability of oral vardenafil is approximately 15%.

Within the recommended dose range of 5–20mg, both AUC and Cmax increase approximately proportionally with dose.

When taken with a high-fat meal (57% fat content):

• Absorption rate decreases

• Tmax is delayed by approximately 60 minutes

• Cmax decreases by about 20%

• AUC remains unchanged

When taken with a normal meal (30% fat content), pharmacokinetic parameters are not significantly affected.

Therefore, vardenafil may be taken with or without food.

Storage

Store below 25°C in a sealed container.

Packaging

20mg × 30 tablets/box

Shelf Life

36 months

Important Information Before Purchasing Sexual Health Products

Male oral erectile dysfunction medications require sexual stimulation to work and will not automatically cause an erection.

When using medications containing:

• Sildenafil

• Vardenafil

• Tadalafil

• Avanafil

• Dapoxetine

many users are concerned about whether the medication will achieve the expected results.

Clinical data and real-world experiences show that individual responses vary:

A reduced response does not necessarily indicate a product quality issue. It is usually related to differences in:

• Individual metabolism

• Physical condition

• Underlying diseases

• Psychological factors

• Drug sensitivity

Even original branded medications may not work effectively for every user.

For example, some men may not respond adequately to sildenafil (Viagra), while another person may respond well to the same medication.

Therefore:

This store guarantees product authenticity but cannot guarantee that every individual will achieve the same expected results.

Users should carefully consider personal health conditions before purchasing.

Factors Affecting Effectiveness

Sildenafil / Vardenafil / Avanafil

These medications improve erectile function mainly through vascular relaxation.

Effectiveness may be affected by:

• Liver and kidney metabolism

• Diabetes

• Hypertension-related vascular damage

• Alcohol consumption

• High-fat meals delaying absorption

Patients with severe vascular disease may experience limited effectiveness.

Tadalafil

Although tadalafil works through a similar mechanism, its longer half-life provides a longer duration of action.

However, effectiveness may still vary depending on:

• Individual sensitivity

• Severe prostate disorders

• Spinal cord injuries

• Receptor response differences

Dapoxetine

Dapoxetine improves ejaculation control by affecting neurotransmitter reuptake.

Its effectiveness may depend on:

• Nervous system sensitivity

• Psychological factors such as anxiety or stress

• Correct dosage selection

• Severity of premature ejaculation

If any medication or dual-action tablet does not produce the expected effect:

Do not increase the dose, switch medications, or continue long-term self-medication without medical advice.

Consult a urologist or qualified healthcare professional for evaluation and treatment adjustment.

Product Information

Product Name: Levifil-20 Generic Name: Vardenafil Hydrochloride Tablets Active Ingredient: Vardenafil Hydrochloride 20mg per tablet Dosage Form: Light orange to dark orange film-coated tablets Strength: 20mg Pack Size: 30 tablets/box Manufacturer: Radicon Laboratories Limited Indication: Treatment of male erectile dysfunction

Recommended Dosage:
Initial recommended dose: 10mg, taken approximately 25–60 minutes before sexual activity.

Maximum recommended frequency: once daily.

May be taken with or without food.

Sexual stimulation is required for effectiveness.