
Sildenafil 100 mg Blue Pill - Comprehensive Overview and Usage Information









About Sildenafil 100 mg
Medical services icon Prescription Only Medicine
1. Name of the medicinal product
Sildenafil 100 mg film-coated tablets, widely recognized as the blue pill.
2. Qualitative and quantitative composition
Each film-coated tablet contains 100 mg of sildenafil (as citrate), which is essential for its therapeutic action. Additional excipients are detailed in section 6.1 of the package insert.
3. Pharmaceutical form
Film-coated tablet - the Sildenafil 100 mg tablet is a blue, round, biconvex tablet approximately 12.00 mm in diameter, featuring a score line on one side and debossed with '126' on one side and 'J' on the other. The score line allows for easy splitting but should not be used for dose division.
4.1 Therapeutic indications
Sildenafil 100 mg is indicated for the treatment of erectile dysfunction in adult males, defined as the inability to achieve or maintain a satisfactory penile erection during sexual activity. Effective treatment requires sexual stimulation.
4.2 Posology and method of administration
Adult Use: The recommended starting dose is 50 mg, administered approximately one hour before anticipated sexual activity. Based on individual efficacy and tolerability, the dose may either be increased to 100 mg or decreased to 25 mg. Do not exceed 100 mg nor take more than once within a 24-hour period. Note that food intake, particularly fatty meals, can delay the onset of action when taking sildenafil.
4.3 Contraindications
Patients with known hypersensitivity to sildenafil or any of its excipients should not use this medication. Co-administration with nitrates or nitric oxide donors is contraindicated due to the risk of severe hypotension. Those with significant cardiovascular disorders or a history of non-arteritic anterior ischemic optic neuropathy (NAION) should avoid sildenafil.
4.4 Special warnings and precautions for use
A thorough medical assessment is necessary to confirm a diagnosis of erectile dysfunction prior to treatment initiation. Cardiovascular Assessment: Given the potential for cardiac strain during sexual activities, it is critical to evaluate a patient’s cardiovascular health before prescribing sildenafil. The medication may induce a mild temporary drop in blood pressure; thus, caution is advised for patients with pre-existing heart conditions.
4.5 Interaction with other medicinal products
Sildenafil is primarily metabolized by the cytochrome P450 enzymes 3A4 and 2C9. Co-administration with potent CYP3A4 inhibitors (e.g., ritonavir) is discouraged as it may elevate sildenafil concentrations. Patients on alpha-blockers should be stable on their therapy prior to initiating sildenafil to mitigate hypotension risks.
4.6 Fertility, pregnancy, and lactation
Sildenafil is not approved for use in women. Limited data exist regarding its safety in pregnancy and lactation, though animal studies have shown no adverse effects. Consultation with a healthcare provider is advised.
4.8 Undesirable effects
Common adverse effects include headache, facial flushing, dyspepsia, nasal congestion, and dizziness. Serious side effects may involve visual disturbances and prolonged erections (priapism), necessitating immediate medical attention if an erection exceeds four hours.
4.9 Overdose
In the event of an overdose, standard medical interventions should be implemented. Renal dialysis is unlikely to expedite clearance due to sildenafil's extensive protein binding.
5.1 Pharmacodynamic properties
Sildenafil selectively inhibits phosphodiesterase type 5 (PDE5), enhancing nitric oxide effects and promoting increased blood flow to the penis during sexual stimulation.
5.2 Pharmacokinetic properties
Circulating levels of sildenafil peak within 30-120 minutes post-oral administration, with an average bioavailability of about 41%, exhibiting considerable variability among individuals.
6. Pharmaceutical particulars
Excipients: These include microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, magnesium stearate, and a coating composed of polyvinyl alcohol and titanium dioxide.
6.4 Special precautions for storage
Store this medication at room temperature, away from moisture and heat; no special storage conditions are required.
7. Marketing authorisation holder
Amarox Limited, United Kingdom.