Active Ingredient: Tadalafil 40mg per tablet
Therapeutic Class: Phosphodiesterase type 5 (PDE5) inhibitor
Description:
Cialis 40mg is a high-dose formulation of tadalafil, a potent and selective PDE5 inhibitor. This dosage is specifically designed for men requiring stronger treatment for erectile dysfunction (ED). The 40mg strength offers enhanced efficacy while maintaining tadalafil’s characteristic 36-hour duration of action.
Indications:
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Treatment of erectile dysfunction in adult men
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Management of benign prostatic hyperplasia (BPH) symptoms
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Combined treatment of ED and BPH (when clinically indicated)
Dosage & Administration:
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Recommended starting dose: 10mg or 20mg (40mg reserved for special cases)
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Maximum recommended frequency: Once daily
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Administration: Take orally with water, at least 30 minutes before anticipated sexual activity
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May be taken with or without food (avoid high-fat meals)
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Not for use in women or pediatric populations
Pharmacokinetics:
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Time to peak plasma concentration: 2 hours (range 0.5-6 hours)
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Terminal half-life: 17.5 hours
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Duration of effect: Up to 36 hours
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Protein binding: Approximately 94%
Clinical Advantages:
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Extended therapeutic window allows for more spontaneous sexual activity
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Demonstrated efficacy in men with diabetes mellitus
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Effective in difficult-to-treat ED cases
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Maintains efficacy with alcohol consumption (within moderate limits)
Safety Information:
[Black Box Warning]
CONTRAINDICATED WITH NITRATES – Concomitant use with organic nitrates in any form is strictly prohibited due to risk of life-threatening hypotension.
Common Adverse Reactions (≥2%):
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Headache (15%)
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Dyspepsia (10%)
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Back pain (6%)
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Myalgia (5%)
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Nasal congestion (4%)
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Flushing (3%)
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Limb pain (3%)
Serious Adverse Reactions:
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Priapism (prolonged erection >4 hours)
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Sudden hearing loss
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Non-arteritic anterior ischemic optic neuropathy (NAION)
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Cardiovascular events in predisposed patients
Drug Interactions:
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Absolute contraindication with nitrates
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Caution with alpha-blockers (risk of hypotension)
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Moderate CYP3A4 inhibitors may increase tadalafil exposure
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Rifampin significantly decreases tadalafil exposure
Special Populations:
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Renal impairment: Not recommended in severe cases (CrCl <30 mL/min)
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Hepatic impairment: Maximum 10mg dose in moderate-severe cases
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Elderly: Consider lower starting dose
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CYP3A4 inducers: May require dose adjustment
Storage Conditions:
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Store below 30°C (86°F)
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Protect from moisture and light
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Keep in original packaging until use
Packaging Options:
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1 tablet blister pack (sample)
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4 tablet treatment pack
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8 tablet value pack
Legal Status:
Prescription-only medication (Schedule H/Schedule IV depending on country)
Manufacturer:
[Insert Pharmaceutical Company Information]
Prescribing Considerations:
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Complete cardiovascular assessment recommended prior to prescription
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Individualize dosage based on patient needs and tolerability
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Consider lower starting dose in elderly or patients with comorbidities
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Counsel patients on proper use and potential adverse effects
Patient Counseling Information:
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Explain proper dosing and administration
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Review contraindications and warnings
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Discuss what to do if adverse effects occur
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Emphasize that sexual stimulation is required for effect
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Advise to seek immediate medical attention for erections >4 hours
