CIALIS 20mg. Tablets.
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Description
Tadalafil 20mg.
DESCRIPTION
Oral selective phosphodiesterase-5 (PDE5) inhibitor
Approved for treating pulmonary arterial hypertension, male erectile dysfunction (ED), and benign prostatic hyperplasia (BPH)
Duration of action (up to 36 hours) for the treatment of ED is longer than sildenafil, allowing for spontaneity in sexual activity
COMMON BRAND NAMES
Adcirca, Cialis
HOW SUPPLIED
Adcirca/Cialis/Tadalafil Oral Tab: 2.5mg, 5mg, 10mg, 20mg
DOSAGE & INDICATIONS
The recommended starting dose in most patients is 10 mg PO, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. The usual onset of action is within 30 to 45 minutes and the usual duration is up to 36 hours. Tadalafil improved ED compared to placebo up to 36 hours following dosing; therefore, when advising patients on optimal use, this should be taken into consideration. Phase III data report that doses of 20 mg PO improved sexual function in 64% of diabetics with ED. In one clinical study, positive responses were noted at doses of 2, 5, 10, and 25 mg. Doses 5 mg or more were superior to placebo in inducing and maintaining erections adequate for penetration.
-PDE5 inhibitors are first line agents for ED according to guidelines. Although associated with high rates of success, approximately 35% of ED patients fail to respond to PDE5 inhibitor therapy. A course of an alternate PDE5 inhibitor may be considered if a patient does not respond to a PDE5 inhibitor trial; a treatment failure may be deemed after at least 4 unsuccessful trials. Patients refractory to PDE5 inhibitors should be counseled on appropriate use, potentially modifiable factors (e.g. hormonal abnormalities, food or drug interactions, lack of adequate sexual stimulation, heavy alcohol use, and the patient’s relationship with his partner), and the risks and benefits of other therapies. Second-line treatment options include intracavernous injection and intra-urethral therapy. Follow-up visits for ED patients, regardless of therapy, are necessary to determine whether therapy continues to be effective and whether cardiovascular health has significantly changed.
2.5 mg PO once daily at about the same time each day. May increase to 5 mg PO once daily depending on efficacy and tolerability. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.
5 mg PO once daily, taken at approximately the same time every day, without regard to timing of sexual activity. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.
40 mg PO (two 20 mg tablets) once daily with or without food. Dividing the dose over the course of the day is not recommended by the manufacturer. Studies establishing effectiveness were comprised predominately of patients with NYHA Functional Class II to III symptoms and etiologies of idiopathic or heritable pulmonary arterial hypertension (PAH) (61%) or PAH associated with connective tissue diseases (23%). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.
5 mg PO once daily, taken at approximately the same time every day, without regard to timing of sexual activity. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.
5 mg PO once daily, taken at approximately the same time every day. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.
A retrospective, pooled-analysis of 19 double-blind, placebo-controlled studies evaluated the efficacy of tadalafil (10 or 20 mg PO prior to anticipated sexual activity) in improving sexual dysfunction in men on antidepressant therapy (i.e., SSRIs, TCAs, MAOIs, serotonin and norepinephrine reuptake inhibitors, and others). Tadalafil at both doses significantly improved erectile function in these patients compared to patients receiving placebo. Although tadalafil was effective, it was not known it the etiology of sexual dysfunction in these patients was specifically due to antidepressant therapy or secondary to other factors (e.g., cardiovascular or neurological disorder, depressive disorder).
10 mg PO twice daily is recommended in clinical practice guidelines. Slow ascent is the primary recommended method for prevention of high altitude pulmonary edema (HAPE). Pharmacologic prophylaxis should only be considered for individuals with a prior history of HAPE, and nifedipine is preferred. Start prophylaxis the day prior to ascent. Continue prophylaxis for 5 days after reaching target altitude or until descent is initiated.
†Indicates off-label use
MAXIMUM DOSAGE
40 mg/day PO for pulmonary hypertension; 5 mg/day PO for erectile dysfunction for once daily use; 20 mg/dose PO for erectile dysfunction for as needed use, not to exceed 1 dose/24 hours in most patients; 5 mg/day PO for benign prostatic hyperplasia (BPH) or combined treatment of erectile dysfunction/BPH for once daily use.
40 mg/day PO for pulmonary hypertension; 5 mg/day PO for erectile dysfunction for once daily use; 20 mg/dose PO for erectile dysfunction for as needed use, not to exceed 1 dose/24 hours in most patients; 5 mg/day PO for benign prostatic hyperplasia (BPH) or combined treatment of erectile dysfunction/BPH for once daily use.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
Mild to moderate impairment (Child-Pugh class A or B): Do not exceed 10 mg PO once daily when used as needed for erectile dysfunction (ED). The use of tadalafil once daily has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised in this patient population. Consider a starting dose of 20 mg/day PO when used for pulmonary hypertension.
Severe impairment (Child-Pugh class C): Tadalafil is not recommended.
CrCl greater than 80 mL/minute: No dosage adjustment needed.
CrCl 51 to 80 mL/minute: For as needed or daily use for erectile dysfunction, for once daily use for benign prostatic hyperplasia (BPH), or daily use for a combination of erectile dysfunction and BPH, no dosage adjustment needed. For pulmonary arterial hypertension (PAH), starting dose of 20 mg PO once daily is recommended; increase to 40 mg PO once daily as tolerated.
CrCl 30 to 50 mL/minute: For as needed use for erectile dysfunction, starting dose of 5 mg PO not more than once daily is recommended; maximum dose should be limited to 10 mg not more than once every 48 hours. For once daily use for erectile dysfunction, no dosage adjustment is needed. For once daily use in benign prostatic hyperplasia (BPH) or erectile dysfunction and BPH, a starting dose of 2.5 mg is recommended; an increase to 5 mg may be considered based upon individual response and tolerability. For pulmonary arterial hypertension (PAH), a starting dose of 20 mg PO once daily is recommended; increase to 40 mg PO once daily as tolerated.
CrCl less than 30 mL/minute: For as needed use (e.g., PRN) for erectile dysfunction, the maximum recommended dose is 5 mg PO given not more than once every 72 hours. Once daily use for erectile dysfunction, for pulmonary arterial hypertension (PAH), benign prostatic hyperplasia (BPH), or a combination of erectile dysfunction and BPH is not recommended.
Intermittent hemodialysis
The maximum recommended dose in patients with erectile dysfunction receiving tadalafil for use as needed (e.g., PRN) is 5 mg PO given not more than once every 72 hours. Not recommended for once daily use for erectile dysfunction, benign prostatic hyperplasia (BPH), a combination of erectile dysfunction and BPH, or pulmonary arterial hypertension.
ADMINISTRATION
May be administered without regard to meals.
For pulmonary hypertension: Administer the entire dose once daily; do not give in divided doses over the course of the day.
For as needed use for erectile dysfunction: May be taken between 30 minutes and 36 hours of anticipated sexual activity.
For once daily use for erectile dysfunction: Take at approximately the same time each day, without regard to timing of sexual activity.
For once daily use for benign prostatic hyperplasia: Take at approximately the same time each day.
For once daily use for those with combined benign prostatic hyperplasia and erectile dysfunction: Take at approximately the same time each day, without regard to timing of sexual activity.
STORAGE
Adcirca:
– Store at controlled room temperature (between 68 and 77 degrees F)
Cialis:
– Store at 77 degrees F; excursions permitted to 59-86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
Tadalafil is contraindicated in patients with a known hypersensitivity to the drug or any component of the tablet.
The safety and efficacy of combinations of tadalafil with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
Because the efficacy of concurrent use of tadalafil and alpha-blockers in the treatment of benign prostatic hyperplasia (BPH) has not been adequately studied, and due to the potential vasodilatory effects of such combination treatment, tadalafil is not recommended for use with alpha-blockers when treating BPH (see Drug Interactions).
Tadalafil is contraindicated in patients who are currently on nitrate/nitrite therapy. Consistent with its known effects on the nitric oxide/cGMP pathway, tadalafil may potentiate the hypotensive effects of organic nitrates and nitrites. Patients receiving nitrates in any form are not to receive tadalafil. This includes any patient who receives intermittent nitrate therapies. It is unknown if it is safe for patients to receive nitrates once tadalafil has been administered.
Use tadalafil cautiously in patients with renal impairment. Dosing recommendations vary depending upon the severity of renal impairment, indication, and the dosing regimen being used (see Dosage in renal impairment). Tadalafil is not recommended in patients receiving the drug on a once daily basis for erectile dysfunction, benign prostatic hyperplasia, or pulmonary arterial hypertension when the creatinine clearance is less than 30 ml/min or the patient has renal failure or is receiving dialysis.
Use tadalafil with caution in patients with altered hepatic function secondary to hepatic disease and/or drug-induced inhibition. Dosage modifications are needed in patients with mild to moderate hepatic impairment (see Dosage). In patients with severe hepatic impairment, use of tadalafil is not recommended because of insufficient data. Additionally, tadalafil is metabolized by CYP3A4 in the liver. Dosage adjustments are necessary in patients taking potent CYP3A4 inhibitors such as ritonavir, ketoconazole, and itraconazole (see Dosage and Drug Interactions).
There is a degree of cardiac risk associated with sexual activity; therefore, prescribers should evaluate the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction. Tadalafil and other PDE5 inhibitors have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Health care professionals should consider whether the individual would be adversely affected by vasodilatory events. The following groups of patients with cardiac disease were excluded from clinical safety and efficacy trials for tadalafil, and, therefore, the manufacturer does not recommend the use of tadalafil in these groups until more data are available: myocardial infarction within the last 90 days; coronary artery disease resulting in unstable angina or angina occurring during sexual intercourse; NYHA Class II or greater heart failure in the last 6 months; uncontrolled cardiac arrhythmias; hypotension (< 90/50 mmHg); uncontrolled hypertension (> 170/100 mmHg); or a stroke within the last 6 months. Based on recommendations for sildenafil by the American College of Cardiology, it is recommended that tadalafil be used with caution in the following: patients with active coronary ischemia (angina) who are not taking nitrates (e.g., positive exercise test for ischemia); patients with congestive heart failure and borderline low blood pressure and borderline low volume status (hypovolemia); patients on a complicated, multidrug, antihypertensive program; and patients taking drugs that can prolong the half-life of tadalafil. Tadalafil is contraindicated in patients who are currently on nitrate/nitrite therapy. Also, patients with left ventricular outflow obstruction (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) or severely impaired autonomic control of blood pressure can be sensitive to the action of vasodilators, including PDE5 inhibitors. Due to the pulmonary vasodilation caused by tadalafil, patients with pulmonary veno-occlusive disease (PVOD) may experience significant worsening in cardiovascular status. Due to a lack of clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended. The possibility of associated PVOD should be considered should signs of pulmonary edema occur when tadalafil is administered.
Prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been associated with PDE5 inhibitor administration. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Use tadalafil, and other agents for the treatment of erectile dysfunction, with caution in patients with penile structural abnormality (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 disease, leukemia, multiple myeloma, polycythemia, or history of priapism).
Educate patients that tadalafil, when used for erectile dysfunction, offers no protection against sexually transmitted disease. Counsel patients about protective measures, including the prevention of transmission of human immunodeficiency virus (HIV) infection, as appropriate to the individual circumstances.
Use tadalafil cautiously in patients with pre-existing visual disturbance. Postmarketing reports of sudden vision loss have occurred with phosphodiesterase inhibitors. Vision loss is attributed to a condition known as non-arteritic anterior ischemic optic neuropathy (NAION), where blood flow is blocked to the optic nerve. Most of the patients who developed NAION had underlying anatomic or vascular risk factors for the development of NAION, including, but not limited to, low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. Advise patients of the increased risk of NAION if they have already experienced NAION in 1 eye. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in clinical trials; tadalafil use is not recommended in these patients.
Geriatric patients (>= 65 years) made up approximately 25% of patients in the primary efficacy and safety studies of tadalafil for the treatment of erectile dysfunction and 28% of patients in the clinical study of tadalafil for pulmonary arterial hypertension. In clinical trials for benign prostatic hyperplasia, geriatric patients greater than 65 years of age accounted for 40% of study participants and those 75 years of age and older accounted for 10% of study participants. No overall differences in efficacy and safety were observed between older and younger patients for these indications. No dose adjustment is warranted based on age alone. However, greater sensitivity to medications in some older individuals should be considered.
Prior to initiating treatment with tadalafil for benign prostatic hyperplasia (BPH), consideration should be given to other urological conditions that may cause similar symptoms. Prostate cancer and benign prostatic hyperplasia (BPH) cause many of the same symptoms and frequently they coexist. Prior to starting tadalafil therapy for BPH, patients should be evaluated to rule out the presence of prostate cancer.
Use tadalafil cautiously in patients with gastroesophageal reflux disease (GERD) or hiatal hernia associated with reflux esophagitis. Like sildenafil, tadalafil can possibly decrease the tone of the lower esophageal sphincter and inhibit esophageal motility. Additionally, tadalafil is an inhibitor of phosphodiesterase type 5 (PDE5), which is found in platelets. Some data indicate that tadalafil does not potentiate the increase in bleeding time caused by aspirin. However, the manufacturer recommends caution when administering tadalafil to patients with significant active peptic ulcer disease (PUD) since the effects of the drug in this patient population have not been formally studied.
There are no adequate and well-controlled studies of tadalafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies in rats and mice revealed no evidence of fetal harm. Because animal reproduction studies are not always predictive of human response, tadalafil (Adcirca) should be used during pregnancy only if clearly needed. Cialis is not indicated for use in women.
It is not known if tadalafil is excreted in breast milk. Adcirca should be used with caution in breast-feeding women ; Cialis is not indicated for use in women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Tadalafil is an inhibitor of phosphodiesterase type 5 (PDE5), which is found in platelets. Some data indicate that tadalafil does not potentiate the increase in bleeding time caused by aspirin. However, the manufacturer recommends caution when administering tadalafil to patients with significant hematological disease (e.g., bleeding disorders) since the effects of the drug in this patient population have not been formally studied.
The safety and efficacy of tadalafil in infants, children, and adolescents have not been established for the treatment of pulmonary hypertension or other uses. A randomized, double-blind, placebo-controlled trial in pediatric patients (7 to 14 years of age) with Duchenne muscular dystrophy, who received tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate any benefit of treatment with tadalafil on a range of assessments of muscle strength and performance.
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