Starfil 50mg

Tablet
Sildenafil Citrate
BENHAM pharmaceuticals

Other Strength:
- Starfil 100mg

Alternative:
- Enegra 50mg
- Silagra 50mg
- Vigorex 50mg
- Enigma 50mg
- Adegra 50mg
- Viamax 50mg
- X-Cite 50mg
- Veagra 50mg



Starfil
Presentation:
Starfil 50 tablet: Each tablet contains Sildenafil Citrate INN 70.24 mg equivalent to Sildenafil 50 mg.
Starfil 100 tablet: Each tablet contains Sildenafil Citrate INN 140.48 mg equivalent to Sildenafil 100 mg.
Descriptions:
Sildenafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). when sexual stimulation causes the local release of nitric oxide; inhibition of PDE5 by Sildenafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Sildenafil has no effect in the absence of sexual stimulation.

Indication:
Sildenafil is indecated for the treatment of erectile dysfunction and pulmonary arterial hypertension.

Dosage & Administration:
Erectile dysfunction: For most patients, the recommended dose is 50 mg taken, an needed, approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectivensess and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.

The following factors are associated with increased plasma levels of Sildenafil: age>65, hepatic impairment, sever renal impairment, and concomitant use of potent cytochrome P450 3A4 inhibitors (Ketoconazole, itraconazole, erythromycin, saquinavir). Since higher Plasma levels may increase both the efficacy and incidence of adverse events. a starting dose of 25 mg should be considered in these patients. Sildenafil was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated. When Sildenafil is co-administered with an alpha-blocker, patients should be stable on alphablocker therapy prior to initiating Sildenafil treatment and Sildenafil should be initated at the lowest dose. Pulmonary arterial hypertension: The recommended dose of Sildenafil Citrate is 20 mg three times a day and should be taken approximately 4-6 hours apart, with or without food.

Side Effects:
Body as a whole: face edema, photosensitivity reaction, shock, asthenia, pain chills, accidental fall, abdominal pain allergic reaction, chest pain, accidental injury.
Cardiovascuar: Angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electro-cardiogram, cardiomyopathy.
Digestive: Vomitign, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, liver function tests abnormal, rectal hemorrhage, gingivitis.

Hemic and Lymphatic: Anemia and leukopenia.
Metabolic and Nutritional: Thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia.
Musculoskeletal: Arthritis, arthrosis, myaligia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.
Nervous: Ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, somnolence, abnormal dreams, reflexes decreased, hyperesthesia,
Respiratory: Asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.
Skin and Appendages: Urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.
Special Senses: Sudden decrease or loss of hearing, mydriasis, conjunctivitis,photophobia tinnitus, eye pain, ear pain, eye hemorrhage, cataract, dry eyes.
Urogeital: Cystitis, nocturia, urinary frequency, breast enlargement, urinary incontinence, abnormal ejaculation, genital edema and anorgasmia.

Cardiovascular and cerebrovascular: Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of Sildenafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of Sildenafil without sexual activity. Others were reported to have occurred hours to days after the use of Sildenafil and sexual activity. It is not possible to determine whether these events are related directly to Sildenafil, to sexual activity, to the patient\’s underlying 23 cardiovascular disease, to a combination of these factors, or to other factors. Nervous: Seizure, seizure recurrence, anxiety, and transient global amnesia,

Urogenital: Prolonged erection, priapism and hematuria.
Special Senses: Diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning,ocular swelling/pressure, increased intraocular pressure, retinal vascular disease or bleeding, vitreous detachment/traction, paramacular edema and epistaxis

Precautions:
General : The evaluation of erectile dysfunction should include a delermination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
Before prescriing Sildenafil, it is important to note the following:
Starfil Sildenafil caution is advised when Phosphodiesterase Type 5 (PDE5) inhibitors are co-adinistered with alpha-blockers. PDE5 inhibitors, including Sildenafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated.In some patients. concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (e.g. dizziness, lightheadedness, fainting). Consideration should be given to the following:
● Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patents who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
● In those patients who are stable on alpha-blocker therapy, PDE5 inhibirors should be initiated at the lowest dose.
● In those patients already taking and optimized dose of a PDE5 inhibiror. alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.
● Safety of combined use of PDE5 inhibirtors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive drugs. Sildenafil has systemic vasodilatory properties and may augment the Sildenafil has systemic vasodilatory properties and may augment the blood pressure lowering effect of other anti-hypertensive mediactions. patients on multiple antihypertensive medications were included in the pivotal clinical trials for Sildenafil. In a separate drug interaction study, when amlodinpine, 5 mg or 10 mg. and Sildenafil, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted. The safety of Sildenafil is unknown in patients with bleeding disorders and patients with active peptic ulceration. Sildenafil should be used 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). The safety and efficacy of combinations of Sildenafil with othertreatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Contraindications:
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. Sildenafil is contraindicated in patients with a known hypersensitivity to any component of the tablet.

Use in Pregnancy & Lactation:
pregnancy category B. Sildenafil is not indicated for use in newborns, children, or women.
Geriatric Use: Healthy elderly volunteers (65 years or over) had a reduced clearance of Sildenafil. Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered.

Overdose:
In studies with healthy volunteers of single doses up to 8000 mg, adverse events were similar to those seen at lower doses but incidence rates and sererities were increased. 24 In cases of overdose, standard supportinve measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as Sildenafil is highly bound to plasma proteins and it is not eliminated in the urine. Drug Interction: Sildenafil metabolism is principally mediated by the cytpchrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor router). Therefore, inhibitors of these isoenzymes 15 may reduce Sildenafil clearance and inducers of these isoenzymes may increase Sildenafil clearance. Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma Sildenafil concentrations when coadministered with Sildenafil (50 mg) to healthy volunteers. When a single 100 mg dose of Sildenafil was administered with erythromycin, a specific CYP3A4 inhibiror, at steady state (500 mg bid for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC). In addition, in a study performed in healthy male volunteers, co-administration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibiror, at steady state (1200 mg tid) with Sildenafil (100 mg single dose) resulted in a 140% increase in Sildenafil Cmax and a 210% increase in Sildenafil AUC. Sildenafil had no effect on saquinavir pharmacokinetics. Stronger CYP3A4 inhibirors such as ketoconazole or itraconazole would be expected to have still greater effects, and population date from patients in clinical trials did indicate a reduction in Sildenafil clearance when it was coadministerd with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine). Inanother study in healthy male volunteers, coadministration with the HIV protease inhibiror ritonavir, which is a highly potent P450 inhibitor, at steady stage (500 mg bid0 with Sildenafil (100 mg single sose) reaulted in a 300% (4- fold) increase in Sildenafil Cmax and a 1000% (11-fold) increase in Sildenafil plasma AUC. At 24 hours the plasma levels of Sildenafil ware still approximately 200 mg/ml. compared to approximately 5 mg /ml when Sildenafil was dosed alone. This is consistent with ritonavir\’s marked effects on a broad range of P450 substrates. Sildenafil had no effect on ritonavir pharmacokinetics. Although the interaction between other protease inhibitors and Sildenfil has not been studied, their concomitant use is expected to increase Sildenafil levels. In a study of healthy male volunteers, co-administration of Sildenfil at steady state (80 mg t.id.0 with endothelin receptor antagnist bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of cytpchrome P450 2C19) at steady state (125 mg b.i.d.) resulted in a 63% decrease of Sildenafil AUC and a 55 % decrease in Sildenafil Cmax. Concomitant administration of stogn CYP3A4 inducers. such as rifampin, is expected to cause greater decreases in plasma levels of Sildenafil. Single soses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Sildenafil. Pharmacokingetic data from parients in clinical trials showed no effect on Sildenafil pharmacokinetics of CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, ACE inhibitors, and calcium channel blockers. The AUC of the cacive metabolite, N-desmethyl Sildenafil, was increased 62% by loop and potassium-sparing diuretics and 102% by 16 nonspeclific beta-blockers. These effects on the metabolite are not expected to be of clinical consequence. Warnings:
In patients with preexisting cardiovarcular disease, there is a potential risk in sexual activity. Sildenafil should not be generally used in men for whom sexual activity is inadisable because of their underlying cardiovascular status. Sildenafil has systemic vasodilatory properties (mean maximum decrease of 8.5/5.55 mmHg). patients with left ventricular outflow obstruction (e.g aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood can be particularly sensitive to the actions of vasodilators including Sildenfil. There is no controlled clinical data on the safety or efficacy of Sildnafil in patients who have suffered amyocardal infraction. stroke, or like-threatening arrhythmia within the last 6 months.

এই পাতাটি ১৭৯ বার দেখা হয়েছে