ADONIS 5 mg Tablets/Film-coated

What is ADONIS 5 mg

ADONIS 5 mg is a prescription medication that contains the active ingredient Tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor. It is commonly used to treat:

• Erectile Dysfunction (ED): Helps men achieve and maintain an erection sufficient for satisfactory sexual performance.
• Benign Prostatic Hyperplasia (BPH): Reduces urinary symptoms such as difficulty in urination or frequent urge to urinate.
• Pulmonary Arterial Hypertension (PAH): Lowers blood pressure in the lungs and improves exercise ability (though higher doses are typically used).

ADONIS 5 mg tablets are film-coated and come in blister packs of 4 tablets. This dose is often used for daily therapy in men with both ED and BPH, offering continuous effect without the need to plan sexual activity around medication timing.

Key Features:

• Contains 5 mg of Tadalafil per tablet.
• Designed for once-daily oral use.
• Provides a more spontaneous approach to managing ED and/or BPH.

Tadalafil, the generic name of ADONIS, has a longer half-life (around 17.5 hours) compared to other PDE5 inhibitors, allowing it to remain effective for up to 36 hours in some cases. However, at a 5 mg dose, it is usually taken daily to maintain consistent levels in the bloodstream.

This medication is part of a class of drugs that work by increasing blood flow, either to the penis (in ED) or by relaxing smooth muscles in the bladder and prostate (in BPH), thus improving symptoms and quality of life. Always use ADONIS under the supervision of a qualified healthcare provider to ensure safe and effective treatment.

How to use ADONIS 5 mg

ADONIS 5 mg tablets should be taken exactly as prescribed by your healthcare provider. Here’s how to use them effectively and safely:

• Route of Administration: Oral, with or without food.
• Dose Frequency: Once daily, preferably at the same time each day.
• Swallow Whole: Do not chew, crush, or break the tablet. Swallow it with a full glass of water.

Instructions for Specific Conditions:

• For Erectile Dysfunction (ED): Take one tablet daily. Daily use allows for spontaneous sexual activity without the need for timing the dose before intercourse.
• For Benign Prostatic Hyperplasia (BPH): Take once daily to alleviate urinary symptoms.
• For Both ED and BPH: A daily 5 mg dose is typically effective in managing both conditions concurrently.

General Usage Tips:

• Consistency is key. Take the medication at the same time each day for best results.
• If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose. Do not double up.
• Avoid excessive alcohol, as it can reduce the effectiveness of the medication and increase side effects like dizziness.
• Inform your doctor about all other medications you are taking to prevent interactions.

Consult your doctor before starting, stopping, or changing the dosage. Self-medication or misuse can lead to serious complications.

Mode of Action ADONIS 5 mg

ADONIS 5 mg (Tadalafil) exerts its therapeutic effects through a well-defined mechanism targeting vascular and smooth muscle tissues.

Pharmacological Class: Phosphodiesterase Type 5 (PDE5) Inhibitor

Mechanism of Action:

• Tadalafil selectively inhibits the PDE5 enzyme, which is found predominantly in the smooth muscle of the corpus cavernosum (penis), bladder, and pulmonary vasculature.
• During sexual stimulation, nitric oxide (NO) is released in the penis. NO activates the enzyme guanylate cyclase, leading to increased levels of cyclic guanosine monophosphate (cGMP).
• cGMP causes smooth muscle relaxation and vasodilation, allowing increased blood flow to the penis, resulting in an erection.
• PDE5 normally breaks down cGMP. By inhibiting PDE5, Tadalafil prolongs the effects of cGMP, enhancing and sustaining erectile function.

In BPH:

• Tadalafil helps relax smooth muscle in the prostate and bladder neck, reducing urinary symptoms such as difficulty in starting urination or incomplete emptying.

In PAH (higher doses):

• Improves exercise capacity by relaxing pulmonary blood vessels, thereby lowering pulmonary arterial pressure.

The prolonged half-life of Tadalafil (~17.5 hours) allows for once-daily dosing and a more sustained effect compared to shorter-acting PDE5 inhibitors like Sildenafil. This also contributes to the nickname “the weekend pill” due to its longer duration of action.

ADONIS 5 mg Interactions ADONIS 5 mg

Tadalafil (ADONIS 5 mg) can interact with various medications, substances, and even certain foods. These interactions can increase the risk of side effects or reduce the drug's effectiveness.

Major Drug Interactions:

• Nitrates (e.g., Nitroglycerin): Severe hypotension may occur. This combination is absolutely contraindicated.
• Alpha-blockers (e.g., Doxazosin): May cause additive blood pressure lowering effects, leading to dizziness or fainting.
• Antihypertensives: May increase the risk of low blood pressure, especially when combined with multiple medications.

Moderate Interactions:

• Ritonavir, Saquinavir, Ketoconazole (CYP3A4 inhibitors): Can increase blood levels of Tadalafil, raising the risk of side effects. Dose adjustment may be required.
• Rifampicin, Carbamazepine (CYP3A4 inducers): May reduce Tadalafil levels, making it less effective.

Other Considerations:

• Alcohol: Excessive alcohol use may enhance the risk of dizziness, headache, or fainting.
• Grapefruit juice: Can increase serum concentration of Tadalafil and enhance effects and side effects.
• Herbal supplements (e.g., St. John’s Wort): May affect Tadalafil metabolism.

Always disclose all medications and supplements to your healthcare provider before starting ADONIS. This helps prevent harmful interactions and ensures the medication works safely and effectively.

Dosage of ADONIS 5 mg

Standard Dosage: One tablet (5 mg) taken orally once daily, at approximately the same time each day.

This dose is typically used for:

• Daily treatment of Erectile Dysfunction (ED)
• Benign Prostatic Hyperplasia (BPH)
• Concurrent ED and BPH

Dosage Guidelines:

• Take with or without food.
• Do not exceed 5 mg in 24 hours.
• If you miss a dose, take it as soon as you remember. Do not double the next dose.

Adjustment in Special Populations:

• Renal Impairment: Use with caution. In moderate to severe cases, lower or alternate-day dosing may be necessary.
• Hepatic Impairment: Not recommended in severe liver dysfunction; caution in mild to moderate cases.
• Elderly Patients: Generally no dosage adjustment needed, but monitor for increased sensitivity.

Always follow your doctor’s instructions carefully. Never self-adjust the dose or frequency without medical advice.

Possible side effects of ADONIS 5 mg

ADONIS 5 mg (Tadalafil) is generally well tolerated, but like any medication, it can cause side effects. These may vary in intensity and frequency among individuals.

Common Side Effects: (usually mild and temporary)

• Headache
• Flushing (warmth or redness of the face)
• Indigestion (dyspepsia)
• Back pain
• Muscle aches
• Stuffy or runny nose

Less Common but Notable Side Effects:

• Dizziness or lightheadedness
• Blurred vision
• Prolonged erection (priapism) — requires immediate medical attention
• Changes in hearing (rare)

Severe (Rare) Side Effects:

• Chest pain or palpitations
• Sudden vision loss (non-arteritic anterior ischemic optic neuropathy - NAION)
• Severe allergic reactions (rash, itching, swelling, difficulty breathing)

If you experience any unusual or persistent symptoms, discontinue the medication and consult your healthcare provider immediately. Emergency care is required for symptoms like chest pain, shortness of breath, or an erection lasting more than 4 hours.

ADONIS 5 mg Contraindications ADONIS 5 mg

ADONIS 5 mg is contraindicated in certain medical situations and patient populations. It should not be used if any of the following apply:

• Use of Nitrates: Concurrent use with any nitrate medication (e.g., for angina) can lead to dangerous hypotension.
• Severe Cardiovascular Conditions: Recent history of heart attack, stroke, or life-threatening arrhythmias.
• Uncontrolled Hypertension or Hypotension: Especially systolic BP below 90 mmHg or diastolic BP above 170 mmHg.
• Severe Liver Impairment: Tadalafil clearance is significantly reduced, increasing toxicity risk.
• Severe Renal Impairment: May lead to drug accumulation and heightened adverse effects.
• Allergy to Tadalafil: Known hypersensitivity to Tadalafil or any component of the formulation.

Use With Caution In:

• Patients with anatomical deformation of the penis (e.g., Peyronie’s disease)
• Patients with bleeding disorders
• Patients on alpha-blockers

Prior to prescribing ADONIS 5 mg, a full medical evaluation should be conducted, especially in men with cardiovascular risks.

Storage of ADONIS 5 mg

Proper storage of ADONIS 5 mg Tablets ensures its efficacy and safety throughout the shelf life.

Recommended Storage Conditions:

• Temperature: Store at room temperature, ideally between 20°C to 25°C (68°F to 77°F).
• Protect from Moisture: Keep in the original blister until use to prevent exposure to humidity.
• Keep Away from Light: Store in a dry, shaded place. Avoid direct sunlight exposure.

Handling and Disposal:

• Keep out of reach of children and pets.
• Do not use after the expiration date stated on the blister pack.
• Do not flush down the toilet or pour into a drain unless instructed. Dispose of via local pharmacy take-back programs.

Following these storage guidelines helps maintain the tablet’s potency and protects against accidental misuse or degradation.