Comprehensive Product Information Report
Tadalis SX (Tadalafil)
1. Product Overview
- Brand Name: Tadalis SX
- Generic Name: Tadalafil
- Manufacturer: Ajanta Pharma Ltd.
- Drug Class: Phosphodiesterase Type 5 (PDE5) Inhibitor
- Formulation: Oral Tablets
- Available Strengths: 10 mg, 20 mg
- Primary Indication: Treatment of Erectile Dysfunction (ED) in adult males
2. Therapeutic Indication
Tadalis SX is indicated for the management of erectile dysfunction, a condition characterized by the inability to achieve or sustain an erection sufficient for satisfactory sexual performance. Tadalafil does not induce an erection without sexual stimulation.
3. Mechanism of Action
Tadalafil selectively inhibits the phosphodiesterase type 5 (PDE5) enzyme, which is responsible for the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. By increasing cGMP levels, the drug facilitates smooth muscle relaxation and increased blood flow to the penis, enabling erection during sexual arousal.
4. Dosage and Administration
- Standard Dose: 10 mg or 20 mg, taken as needed, approximately 30 to 60 minutes prior to sexual activity
- Maximum Frequency: Once per day
- Route: Oral
- Administration: With or without food
- Note: Not intended for continuous daily use in the as-needed form
5. Pharmacological Profile
Property | Details |
---|---|
Absorption | Rapidly absorbed; Tmax ≈ 2 hours |
Bioavailability | Not significantly affected by food |
Half-life | ~17.5 hours |
Duration of Action | Up to 36 hours |
Metabolism | Hepatic (CYP3A4 pathway) |
Excretion | Primarily fecal; minor urinary elimination |
6. Safety and Side Effects
Common Adverse Reactions
- Headache
- Indigestion (dyspepsia)
- Back pain
- Muscle aches
- Nasal congestion
- Facial flushing
Less Common / Rare
- Dizziness
- Vision disturbances (e.g., color tinge, blurred vision)
- Hearing impairment
- Skin rash
Serious Adverse Events (Require Immediate Medical Attention)
- Priapism (erection > 4 hours)
- Sudden loss of vision or hearing
- Chest pain, shortness of breath
7. Contraindications
- Concurrent use of nitrates or nitric oxide donors
- Known hypersensitivity to tadalafil or any excipients
- Severe hepatic impairment
- Recent history of myocardial infarction, stroke, or life-threatening arrhythmia
- Uncontrolled hypotension or hypertension
8. Drug Interactions
Contraindicated Interactions
- Nitrates (e.g., nitroglycerin): Risk of profound hypotension
- Guanylate cyclase stimulators (e.g., riociguat)
Use with Caution
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase tadalafil plasma levels
- Alpha-blockers: Additive hypotensive effects
- Antihypertensives: Monitor blood pressure closely
- Alcohol: May potentiate hypotensive effects and increase dizziness
9. Precautions and Warnings
- Not intended for use in women or individuals under 18 years of age
- Use cautiously in patients with cardiovascular disease, renal/hepatic impairment, or anatomical penile deformities
- Avoid combination with other ED therapies unless advised by a physician
- Evaluate cardiovascular risk before initiating therapy
10. Storage and Handling
- Storage Temperature: Below 30°C (86°F)
- Conditions: Store in original packaging, protected from moisture and light
- Shelf Life: Refer to packaging
- Keep out of reach of children
11. Packaging and Presentation
- Supplied in blister packs containing 4 or more tablets
- Each pack clearly labeled with dose strength, batch number, expiry date, and manufacturer information
12. Regulatory and Legal Status
- Legal Classification: Prescription-only (Rx)
- Regulatory Status: Approved generic equivalent of Cialis® in multiple markets
- Intellectual Property: Marketed post-expiry of original tadalafil patent
13. Market Position and Competitors
- Key Competitors: Cialis, Vidalista, Tadarise, Sildalis, Kamagra
- Market Niche: Cost-effective generic alternative for ED treatment with prolonged efficacy
- Consumer Appeal: Known as the “weekend pill” due to its extended duration of action
14. Patient Counseling Information
- Take only as prescribed by a healthcare provider
- Sexual stimulation is required for the drug to be effective
- Do not consume more than one tablet in 24 hours
- Seek immediate care for painful or prolonged erections
- Avoid excessive alcohol consumption before use