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Film Coated Tablets
90 x 20 mg
20 mg 3 x dailly approx. 4-6 hours apart, with/out food. Higher
than 20 mg not recommend.
Treatment of primary pulmonary hypertension (PPH), pulmonary hypertension (PH) associated with connective tissue disease (CTD), or PH following surgical repair at least 5 years previously of atrial septal defect (ASD), ventricular septal defect (VSD), patent ductus arteriosus (PDA), or aorto-pulmonary window. For adults >18 years.
Consistent with its known effects on the nitric oxide/cGMP pathway sildenafil was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated. Known hypersensitivity to any component of the tablet.
The concomitant administration of the protease inhibitor ritonavir (a highly potent CYP3A4 inhibitor) substantially increases serum concentrations of sildenafil, therefore co-administration is not recommended. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Prior to prescribing this drug, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, for example patients with resting hypotension (BP <90/50), or with fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction. Since there is no clinical data on administration to patients with veno-occlusive disease, administration to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil is administered, the possibility of associated PVOD should be considered. Caution is advised when phosphodiesterase type 5 (PDE5) inhibitors are co-administered with alpha-blockers. Use with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma or leukemia). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medicdbal assistance. Physicians should discuss with patients the contraindication with regular and/or intermittent use of organic nitrates. Patients should be advised to seek immediate medicdbal attention in the event of a sudden loss of vision in one or both eyes while taking all PDE5 inhibitors, including Slider. Dose selection for elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Pregnancy and lactation: There are no adequate and well-controlled studies of sildenafil in pregnant women. Caution should be used when administered to nursing women.
Pediatric use: Safety and effectiveness in pediatric pulmonary hypertension patients has not been established. See prescribing information for full details.
Epistaxis, headache, flushing, insomnia. Dyspnea exacerbated, diarrhea, myalgia.
C/I with nitrates, amyl nitrate, nicorandil, ketoconazole, itraconazole, ritonavir. Bosentan epoprostenol, iloprost, otehr PDE5 inhibitors. Erythromycin, saquinavir, clarithromycin, telithromycin, nefazodone, cimetidine, grapefruit juice, beta-blockers, alfa-blockers, vitamin K antagonists. Carbamazepine, phenytoin, phenobarbital, rifampicin, St. John’s wort.