Product Name: AVANDRO

Manufacturer: THE LOTUS BIOTECH Dosage Form: Tablet Strength: Each tablet contains Avanafil 100mg and Dapoxetine 60mg Packaging: 10 tablets per box

Suitable for: Adult men aged 18 years and above
Not intended for: Women and individuals under 18 years old

1. Active Ingredients and Mechanism of Action

Avanafil 100mg

Avanafil is a PDE5 inhibitor used for the treatment of erectile dysfunction (ED).

It works by increasing blood flow to the corpus cavernosum of the penis, helping men achieve and maintain an erection during sexual stimulation.

Avanafil is known for its relatively rapid onset of action, with effects potentially beginning within approximately 15 minutes for some users.

Dapoxetine 60mg

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) medication.

It works by increasing serotonin activity in the nervous system, which may help extend ejaculation latency time and improve control over ejaculation in men with premature ejaculation (PE).

Dual Action Benefits

The combination of avanafil and dapoxetine is designed to address two common male sexual health concerns:

• Erectile dysfunction (ED) — difficulty achieving or maintaining an erection

• Premature ejaculation (PE) — difficulty controlling ejaculation

2. Indications

AVANDRO is intended for the treatment of:

• Erectile dysfunction in adult men

• Symptoms associated with premature ejaculation

Use should be based on appropriate medical evaluation and professional advice.

3. Dosage and Administration

1. When to Take

• Take orally approximately 30–60 minutes before sexual activity.

• Swallow the tablet whole with water.

• Do not chew, crush, or split the tablet.

2. Recommended Dose

• Recommended dose: 1 tablet per use (Avanafil 100mg + Dapoxetine 60mg)

• Do not take more than one dose within 24 hours.

3. Food Effects

• May be taken with or without food.

• Avoid heavy high-fat meals, as they may delay the onset of action.

4. Requirement for Sexual Stimulation

Avanafil does not automatically cause an erection.

Sexual stimulation is required for the medication to work.

4. Contraindications (Do Not Use)

AVANDRO should not be used by individuals who:

• Are allergic to avanafil, dapoxetine, or any inactive ingredients

• Are taking nitrate medications, such as:

• Nitroglycerin

• Isosorbide mononitrate

Combining PDE5 inhibitors with nitrates may cause severe blood pressure reduction and potentially life-threatening complications.

Avoid use in patients with:

• Severe liver or kidney impairment

• Uncontrolled high or low blood pressure

• Recent heart attack or stroke

• Serious cardiovascular disease

• Conditions that increase the risk of abnormal prolonged erections, such as penile deformities or sickle cell anemia

5. Important Precautions

1. Medication Safety

AVANDRO is a prescription medication. Medical evaluation is recommended before use.

Do not self-medicate or misuse this medication.

2. Monitoring Side Effects

Common side effects may include:

• Headache

• Dizziness

• Facial flushing

• Nausea

• Indigestion

These reactions are usually mild to moderate and temporary.

If symptoms persist or become severe, seek medical advice.

3. Special Populations

Use caution in patients with:

• Mild liver or kidney impairment (dose adjustment may be required)

• Epilepsy

• Psychiatric disorders

• Bleeding disorders

Moderate to severe liver or kidney impairment may require avoidance of use.

4. Drug Interactions

Do not combine AVANDRO with:

• Nitrate medications

• Riociguat

• Certain alpha-blockers

When used with strong CYP3A4 inhibitors, such as:

• Ketoconazole

• Erythromycin

• HIV protease inhibitors

dose adjustment and medical monitoring may be required.

5. Alcohol and Driving

Avoid excessive alcohol consumption while using this medication.

Alcohol may increase the risk of:

• Dizziness

• Low blood pressure

• Reduced sexual performance

Avoid driving or operating machinery if dizziness or impaired alertness occurs.

6. Prolonged Erection Warning

If an erection lasts longer than 4 hours, seek immediate medical attention.

Delayed treatment may result in permanent damage to penile tissue.

6. Possible Adverse Reactions

Common Side Effects

• Headache

• Dizziness

• Facial flushing

• Nasal congestion

• Nausea

• Diarrhea

• Insomnia

Less Common Side Effects

• Palpitations

• Blood pressure changes

• Visual disturbances

• Muscle pain

• Skin rash

Rare but Serious Side Effects

• Priapism (prolonged erection)

• Severe allergic reactions

• Seizures

• Liver function abnormalities

Seek medical attention if serious symptoms occur.

7. Drug Interactions

1. Strictly Avoid Combination With:

• Nitrate medications

• Riociguat

• Certain alpha-blockers

2. Use With Caution:

Strong CYP3A4 inhibitors

Examples include:

• Ketoconazole

• Itraconazole

• Clarithromycin

• HIV protease inhibitors

These medications may significantly increase avanafil levels in the blood, requiring dose adjustment.

Serotonergic Medications

Dapoxetine should not be combined with:

• SSRIs

• SNRIs

• MAO inhibitors

• Tramadol

because of an increased risk of serotonin syndrome.

3. Other Interactions

When combined with blood pressure medications, AVANDRO may enhance blood pressure-lowering effects.

Blood pressure monitoring may be required.

8. Use in Special Populations

Pregnant or Breastfeeding Women

Not applicable. This medication is not intended for women.

Children and Adolescents

Not recommended for individuals under 18 years old.

Elderly Patients

Men over 65 years old should use caution.

Medical supervision may be recommended, including:

• Lower starting doses

• Blood pressure monitoring

• Side effect observation

Patients With Liver or Kidney Problems

• Mild impairment: Use cautiously and consider dose adjustment.

• Moderate to severe impairment: Avoid use unless specifically advised by a healthcare professional.

9. Storage and Packaging

Storage Conditions

• Store in a sealed container

• Keep in a cool, dry place

• Protect from direct sunlight

• Recommended temperature: 15–30°C

Packaging

• Aluminum blister packaging

• 10 tablets per box

Product Specifications