Zygra

Zygra

sildenafil

Manufacturer:

DongKoo

Distributor:

SB Pharma
Full Prescribing Info
Contents
Sildenafil.
Description
Each tablet contains Sildenafil (as citrate) 100mg.
Indications/Uses
Zygra is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Zygra to be effective, sexual stimulation is required.
Dosage/Direction for Use
Posology: Use in adults: The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If Zygra is taken with food, the onset of activity may be delayed compared to the fasted state.
Special populations: Elderly: Dosage adjustments are not required in elderly patients (≥ 65 years old).
Renal impairment: The dosing recommendations described previously in "Use in adults" apply to patients with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 mL/min) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Hepatic impairment: Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Paediatric population: Zygra is not indicated for individuals below 18 years of age.
Use in patients taking other medicinal products: With the exception of ritonavir for which co-administration with sildenafil is not advised a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors.
In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered.
Please note that only Zygra Tablets 100mg are available. Please consider other suitable oral preparation for recommended dosages other than 100mg.
Method of administration: For oral use.
Overdosage
In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
Adverse Reactions
Summary of the safety profile: The safety profile of Zygra is based on 9,570 patients in 74 double blind placebo-controlled clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and blurred vision.
Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years. Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Tabulated list of adverse reactions: In the table as follows all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See table.)

Click on icon to see table/diagram/image
Storage
Shelf life: 36 months from manufactured date.
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Tab 100 mg (blue, hexagon, film-coated, engraved with D|C on one side and "100" on the other side) x 30's.
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