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Silatio

Silatio

sildenafil

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma
Concise Prescribing Info
Contents
Sildenafil citrate
Indications/Uses
Pulmonary arterial HTN in adults to improve exercise ability & delay clinical worsening.
Dosage/Direction for Use
Adult 20 mg tid administered 4-6 hr apart. May increase to max of 80 mg tid in patients who do not achieve adequate response.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ organic nitrates in any form (eg, nitroglycerin, isosorbide dinitrate); riociguat.
Special Precautions
Discontinue therapy if sudden vision loss occurs. Not recommended to use in patients w/ pulmonary veno-occlusive disease. Avoid abrupt discontinuation, especially if used as monotherapy in pulmonary arterial HTN. Decreased BP; sudden decrease or loss of hearing accompanied by tinnitus & dizziness; vision loss; dose-related impairment of color discrimination. Increased risk of non-arteritic anterior ischemia optic neuropathy in patients w/ history of vision loss; CAD, diabetes, HTN, hyperlipidemia, smoking, >50 yr. Patients w/ left ventricular outflow obstruction (aortic stenosis or hypertrophic obstructive cardiomyopathy), on antihypertensive therapy, w/ resting hypotension (BP <90/50 mmHg), fluid depletion or autonomic dysfunction; uncontrolled HTN (>170/110 mmHg), life-threatening arrhythmias, stroke or MI w/in last 6 mth; cardiac failure or CAD causing unstable angina; retinitis pigmentosa; bleeding disorders or w/ active PUD. Pulmonary HTN associated w/ sickle cell disease. Renal impairment. Severe hepatic impairment (Child-Pugh class C). Pregnancy & lactation. Elderly >65 yr.
Adverse Reactions
Flushing; dizziness, headache, insomnia, paresthesia; erythema, skin rash; diarrhea, dyspepsia, gastritis, nausea; UTI; increased liver enzymes; back pain, myalgia; visual disturbance including vision color change, blurred vision & photophobia; epistaxis, exacerbation of dyspnea, nasal congestion, rhinitis, sinusitis; fever. Abnormal hepatic function tests, absent reflexes, transient global amnesia, anemia, anorgasmia, anterior chamber eye hemorrhage, anterior ischemic optic neuropathy, arthritis, auditory impairment, basal cell carcinoma, breast hypertrophy, burning sensation of eyes, cardiac failure, cataract, cerebrovascular hemorrhage, colitis, cystitis, depression, diaphoresis, diplopia, dry eye syndrome, dysphagia, ECG abnormality, ejaculatory disorder, exfoliative dermatitis, falling, gastroenteritis, genital edema, gingivitis, glossitis, gout, herpes simplex infection, hyperglycemia, hypernatremia, hypersensitivity reaction, HTN, hypertonia, hypoglycemia, increased bronchial secretions, increased IOP, ischemic heart disease, laryngitis, leukopenia, malignant melanoma, migraine, myasthenia, mydriasis, MI, neuralgia, neuropathy, orthostatic hypotension, otalgia, peripheral edema, pharyngitis, photophobia, priapism, prolonged erection, pulmonary & rectal hemorrhage, retinal edema, hemorrhage & vascular disease, tendon rupture, seizure, severe sickle cell crisis (vaso-occlusive crisis in patients w/ pulmonary HTN associated w/ sickle cell disease), skin photosensitivity, stomatitis, syncope, synovitis, tachycardia, transient ischemic attacks, unstable diabetes, urinary incontinence, ventricular arrhythmia, vitreous detachment & traction.
Drug Interactions
Concomitant use w/ alprostadil, amyl nitrate; boceprevir; conivaptan; dapoxetine; systemic fusidic acid; idelalisib; molsidomine; phosphodiesterase-5 inhibitors; riociguat; telaprevir; vasodilators (organic nitrates). May increase levels/effects of α-1 blockers, alprostadil, amyl nitrile; BP lowering agents; bosentan; phosphodiesterase-5 inhibitors, riociguat, vasodilators (organic nitrates). Increased levels/effects w/ ethyl alcohol; aprepitant; boceprevir; clarithromycin; conivaptan; strong & moderate CYP3A4 inhibitors; dapoxetine; dasatinib; systemic erythromycin; fluconazole; fosaprepitant; systemic fusidic acid; idelalisib; itraconazole; ivacaftor; systemic ketoconazole; lorcaserin; mifepristone; molsidomine; nefazodone; netupitant; palbociclib; posaconazole; PIs; sapropterin; saquinavir; simeprevir; stiripentol; telaprevir; telithromycin; voriconazole. Decreased level/effects w/ bosentan; strong & moderate CYP3A4 inducers; dabrafenib; deferasirox; enzalutamide; etravirine; mitotane; siltuximab; St. John's wort, tocilizumab. Increase serum levels/toxicity w/ grapefruit juice.
MIMS Class
Other Antihypertensives
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
C02KX - Antihypertensives for pulmonary arterial hypertension ; Used in the treatment of pulmonary arterial hypertension.
Presentation/Packing
Form
Silatio FC tab 20 mg
Packing/Price
10 × 10's
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