Medication info

Samjin Sildenafil Citrate Tablet 20 mg

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Sildenafil Citrate›28.09mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
White round film-coated tablets
Packaging
90 tablets per bottle
Approval status
Approval withdrawn

MFDS item code 202302072 · Approved 2023.07.07

This product's status changed to Approval withdrawn on 2025.06.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of exercise capacity in patients with pulmonary arterial hypertension (WHO Group I)
Who uses it
Adults
Adult dosage
The recommended adult dose (18 years and older) is 20 mg (as sildenafil) taken three times a day. It should be taken at intervals of 4 to 6 hours, regardless of food. For elderly patients (65 years and older), the dose should be determined considering liver function, kidney function, heart function, accompanying diseases, and medications being taken. For patients with renal impairment (including severe renal impairment), dose adjustments are generally not necessary, but in cases of poor tolerability, the dosage may be adjusted to 20 mg twice a day.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of exercise capacity in patients with pulmonary arterial hypertension (WHO Group I)

View approved original text

Used to improve exercise capacity in patients with pulmonary arterial hypertension classified as WHO functional class II and III. However, this drug's effectiveness has not been evaluated in patients who are receiving bosentan. This medication helps improve the exercise capacity of patients.

Dosage and Administration

Adult dosage

The recommended adult dose (18 years and older) is 20 mg (as sildenafil) taken three times a day. It should be taken at intervals of 4 to 6 hours, regardless of food. For elderly patients (65 years and older), the dose should be determined considering liver function, kidney function, heart function, accompanying diseases, and medications being taken. For patients with renal impairment (including severe renal impairment), dose adjustments are generally not necessary, but in cases of poor tolerability, the dosage may be adjusted to 20 mg twice a day.

Precautions

This medication acts to dilate blood vessels and may temporarily lower blood pressure. Therefore, patients must inform their doctor if they are taking other medications that lower blood pressure, such as nitrates or nitric oxide donors, before taking this medication. Patients with cardiovascular diseases or a history of recent myocardial infarction, stroke, or life-threatening arrhythmias should consult a doctor before taking this drug. Caution is needed in patients with hypotension or uncontrolled hypertension as taking this medication may be risky. Additionally, it is advisable for patients with certain hereditary retinal diseases or specific heart valve diseases to avoid taking this medication. When taken in conjunction with certain HIV treatments like ritonavir, this drug's concentration in the blood can significantly increase, elevating the risk of side effects, so special caution is needed for patients taking such medications. Elderly patients aged 65 and older and patients with severely impaired liver or kidney function should consider the potential for increased concentration in the blood when taking this medication. If sudden vision loss or hearing loss occurs while taking this medication, patients should immediately consult healthcare professionals, and caution is warranted when combined with other medications that affect blood pressure, such as alpha-blockers, as symptoms of hypotension may present. Pregnant or nursing women are advised not to take this medication. Finally, this medication has been reported to increase mortality in children when used for long periods; thus, it is generally not safe to administer except in special cases.

Side effects and when to seek care immediately

Serious side effects

Death due to cardiovascular adverse reactions, severe blood pressure drop, severe arrhythmias, cerebrovascular hemorrhage, transient ischemic attack, vision impairment or loss due to non-arteritic anterior ischemic optic neuropathy (NAION), sudden hearing loss or deafness, symptomatic hypotension, orthostatic hypotension, worsening of cardiovascular disease in patients with pulmonary vein obstruction disease, severe liver failure, hypotension, hypertension, life-threatening arrhythmias, heart failure, unstable angina.

Mild side effects

  • Headache
  • flushing
  • dyspepsia
  • back pain
  • diarrhea
  • limb pain
  • insomnia
  • blurred vision
  • cough
  • fever
Show 3 more
  • nasal bleeding
  • nasal congestion
  • muscle pain

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

90 tablets per bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.