Sild enafil Citrate Powder

Silden afil Citrate Powder

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Sild enafil Citrate is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), primarily used to treat ere ctile dy sfunction and pulmonary arterial hypertension.

Chemical Properties:

Chemical Name: 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate

Molecular Formula: CHNOSCHO

Molecular Weight: 666.7 g/mol

CAS Number: 171599-83-0

Appearance: White to off-white crystalline powder

Solubility:In DMSO: 23 mg/mL (34.49 mM) In water and ethanol: Insoluble

In chloroform: Insoluble

Mechanism of Action:

Sild enafil Citrate inhibits PDE5, preventing the degradation of cGMP in the corpus cavernosum. Elevated cGMP levels lead to smooth muscle relaxation and increased blood flow, facilitating erection.

Pharmacokinetics:

Absorption: Rapid, with peak plasma concentrations reached within 30 to 120 minutes after oral administration.

Metabolism: Primarily hepatic via cytochrome P450 enzymes, mainly CYP3A4.

Elimination Half-Life: Approximately 4 hours.

Excretion: Mainly as metabolites in feces (approximately 80%) and urine (approximately 13%).

Indications:

Ere ctile Dysf unction (ED): To improve the ability to achieve and maintain an erection.

Pulmonary Arterial Hypertension (PAH): To improve exercise capacity and delay clinical worsening.

Starting dose: 50 mg orally, as needed, approximately 1 hour before sexual activity.

Adjustable between 25 mg to 100 mg based on efficacy and tolerability.

Maximum recommended frequency: Once daily.

For PAH: 20 mg three times a day, taken 4 to 6 hours apart.

Adverse Effects: Common:Headache,Flushing,Dyspepsia,Nasal congestion

Dizziness:Visual disturbances (e.g., changes in color vision)

Serious: Sudden hearing loss

Non-arteritic anterior ischemic optic neuropathy (NAION)

Priapism (prolonged erection)

Hypotension

Contraindications:

Concurrent use with nitrates or nitric oxide donors.

Known hypersensitivity to Silde nafil or any component of the formulation.

Drug Interactions:

Nitrates: Potentiation of hypotensive effects; concurrent use is contraindicated.

Alpha-blockers: May lead to symptomatic hypotension; initiate Sild enafil at the lowest dose.

CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir): May increase Sild enafil exposure; dose adjustments may be necessary.

Storage:

Powder Form: Store below 30C (86F) in the original package to protect from moisture.

Reconstituted Oral Suspension: Store below 30C (86F) or in a refrigerator at 2C to 8C (36F to 46F); do not freeze. The shelf-life of the reconstituted suspension is 60 days; discard any remaining suspension after this period