What is Powerecta?
Powerecta is used to treat men who have erectile dysfunction (also called sexual impotence). Powerecta belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.
Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, Powerecta helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, Powerecta will not work to cause an erection.
Powerecta is available only with your doctor's prescription.
Powerecta indications
Powerecta hydrochloride orally disintegrating tablets are indicated for the treatment of erectile dysfunction.
How should I use Powerecta?
Use Powerecta orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Powerecta orally disintegrating tablets. Talk to your pharmacist if you have questions about this information.
- Take Powerecta orally disintegrating tablets by mouth with or without food.
- Take Powerecta orally disintegrating tablets about 1 hour before sexual activity.
- Do not take Powerecta orally disintegrating tablets more often than once daily or as directed by your doctor.
- Be sure your hands are completely dry before you remove Powerecta orally disintegrating tablets from the blister.
- Take Powerecta orally disintegrating tablets immediately after you remove it from the blister. Do not store the removed tablet for future use.
- Do not crush or split Powerecta orally disintegrating tablets. Place Powerecta orally disintegrating tablets on the tongue. Allow it to completely dissolve.
- Take Powerecta orally disintegrating tablets without liquid.
- Do not eat grapefruit or drink grapefruit juice while you use Powerecta orally disintegrating tablets.
- If you miss a dose of Powerecta orally disintegrating tablets and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor.
Ask your health care provider any questions you may have about how to use Powerecta orally disintegrating tablets.
Uses of Powerecta in details
Use: Labeled Indications
Erectile dysfunction: Treatment of erectile dysfunction (ED)
Off Label Uses
Pulmonary arterial hypertension
Data from a small, randomized, double-blinded, placebo-controlled trial suggest that Powerecta may be beneficial for the treatment of pulmonary arterial hypertension (WHO Group I; efficacy established in patients with WHO/NYHA functional class II and III) in adults by improving exercise ability and hemodynamics and delaying clinical worsening. Access Full-Off Label Monograph.
Powerecta description
Powerecta is an oral therapy for the treatment of erectile dysfunction. It is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMPspecific phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP.
Powerecta dosage
General
Powerecta hydrochloride orally disintegrating tablets are available in 10 mg orally disintegrating tablets. Powerecta hydrochloride orally disintegrating tablets are not interchangeable with Powerecta 10 mg film-coated tablets (Powerecta). Powerecta hydrochloride orally disintegrating tablets provide higher systemic exposure compared to Powerecta 10 mg film-coated tablets (Powerecta)
Powerecta hydrochloride orally disintegrating tablets should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one Powerecta hydrochloride orally disintegrating tablet per day. Sexual stimulation is required for a response to treatment.
Powerecta hydrochloride orally disintegrating tablets should be placed on the tongue where it will disintegrate. The tablet should be taken without liquid. It should be taken immediately upon removal from the blister.
Those patients who require a lower or higher dose of Powerecta need to be prescribed Powerecta film-coated tablets.
Use with Food
Powerecta hydrochloride orally disintegrating tablets can be taken with or without food.
Use in Special Populations
Hepatic Impairment: Do not use Powerecta hydrochloride orally disintegrating tablets in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.
Renal Impairment: Do not use Powerecta hydrochloride orally disintegrating tablets in patients on renal dialysis.
Concomitant Medications
Nitrates: Concomitant use with nitrates in any form is contraindicated.
Guanylate Cyclase (GC) Stimulators, such as riociguat: Concomitant use is contraindicated.
CYP3A4 Inhibitors: Do not use Powerecta hydrochloride orally disintegrating tablets with potent or moderate CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin and erythromycin.
Alpha-Blockers: In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended starting dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including Powerecta. In patients taking alpha-blockers, do not initiate Powerecta therapy with Powerecta hydrochloride orally disintegrating tablets. Lower doses of Powerecta film-coated tablets should be used as initial therapy in these patients. Patients taking alpha-blockers who have previously used Powerecta film-coated tablets may change to Powerecta hydrochloride orally disintegrating tablets at the advice of their healthcare provider
A time interval between dosing should be considered when Powerecta hydrochloride orally disintegrating tablets are prescribed concomitantly with alpha-blocker therapy.
Powerecta interactions
See also:
What other drugs will affect Powerecta?
Potential For Pharmacodynamic Interactions With Powerecta
Nitrates
Concomitant use of Powerecta and nitrates and nitric oxide donors is contraindicated. The blood pressure lowering effects of sublingual nitrates (0.4 mg) taken 1 and 4 hours after Powerecta and increases in heart rate when taken at 1, 4 and 8 hours after Powerecta were potentiated by a 20 mg dose of Powerecta in healthy middle-aged subjects. These effects were not observed when Powerecta 20 mg was taken 24 hours before the nitroglycerin (NTG). Potentiation of the hypotensive effects of nitrates for patients with ischemic heart disease has not been evaluated, and concomitant use of Powerecta and nitrates is contraindicated
Antihypertensives
Powerecta may add to the blood pressure lowering effects of antihypertensive agents. In a clinical pharmacology study of patients with erectile dysfunction, single doses of Powerecta 20 mg caused a mean maximum decrease in supine blood pressure of 7 mmHg systolic and 8 mmHg diastolic (compared to placebo), accompanied by a mean maximum increase of heart rate of 4 beats per minute. The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1.
Alcohol
Powerecta (20 mg) did not potentiate the hypotensive effects of alcohol during the 4-hour observation period in healthy volunteers when administered with alcohol (0.5 g/kg body weight, approximately 40 mL of absolute alcohol in a 70 kg person). Alcohol and Powerecta plasma levels were not altered when dosed simultaneously.
Effect Of Other Drugs On Powerecta
In Vitro Studies
Studies in human liver microsomes showed that Powerecta is metabolized primarily by cytochrome P450 (CYP) isoforms 3A4/5, and to a lesser degree by CYP2C9. Therefore, inhibitors of these enzymes are expected to reduce Powerecta clearance.
In VivoStudies
Potent CYP3A4 Inhibitors
Ketoconazole (200 mg once daily) produced a 10-fold increase in Powerecta AUC and a 4-fold increase in maximum concentration (Cmax) when co-administered with Powerecta (5 mg) in healthy volunteers. A 5-mg Powerecta dose should not be exceeded in a 24-hour period when used in combination with 200 mg once daily ketoconazole. Since higher doses of ketoconazole (400 mg daily) may result in higher increases in Cmax and AUC, a single 2.5 mg dose of Powerecta should not be exceeded in a 24-hour period when used in combination with ketoconazole 400 mg daily.
Indinavir (800 mg t.i.d.) co-administered with Powerecta 10 mg resulted in a 16-fold increase in Powerecta AUC, a 7-fold increase in Powerecta Cmax and a 2-fold increase in Powerecta half-life. It is recommended not to exceed a single 2.5 mg Powerecta dose in a 24-hour period when used in combination with indinavir.
Ritonavir (600 mg b.i.d.) co-administered with Powerecta 5 mg resulted in a 49-fold increase in Powerecta AUC and a 13-fold increase in Powerecta Cmax. The interaction is a consequence of blocking hepatic metabolism of Powerecta by ritonavir, a HIV protease inhibitor and a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9. Ritonavir significantly prolonged the half-life of Powerecta to 26 hours. Consequently, it is recommended not to exceed a single 2.5 mg Powerecta dose in a 72-hour period when used in combination with ritonavir..
Moderate CYP3A4 Inhibitors
Erythromycin (500 mg t.i.d.) produced a 4-fold increase in Powerecta AUC and a 3-fold increase in Cmax when co-administered with Powerecta 5 mg in healthy volunteers. It is recommended not to exceed a single 5 mg dose of Powerecta in a 24-hour period when used in combination with erythromycin.
Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase Powerecta exposure.
Other Drug Interactions
No pharmacokinetic interactions were observed between Powerecta and the following drugs: glyburide, warfarin, digoxin, an antacid based on magnesium-aluminum hydroxide, and ranitidine. In the warfarin study, Powerecta had no effect on the prothrombin time or other pharmacodynamic parameters.
Cimetidine (400 mg b.i.d.) had no effect on Powerecta bioavailability (AUC) and maximum concentration (Cmax) of Powerecta when co-administered with 20 mg Powerecta in healthy volunteers.
Effects Of Powerecta On Other Drugs
In vitro studies
Powerecta and its metabolites had no effect on CYP1A2, 2A6, and 2E1 (Ki > 100 micromolar). Weak inhibitory effects toward other isoforms (CYP2C8, 2C9, 2C19, 2D6, 3A4) were found, but Ki values were in excess of plasma concentrations achieved following dosing. The most potent inhibitory activity was observed for Powerecta metabolite M1, which had a Ki of 1.4 micromolar toward CYP3A4, which is about 20 times higher than the M1 Cmax values after an 80 mg Powerecta dose.
In Vivo Studies
Nifedipine: Powerecta 20 mg, when co-administered with slow-release nifedipine 30 mg or 60 mg once daily, did not affect the AUC or Cmax of nifedipine, a drug that is metabolized via CYP3A4. Nifedipine did not alter the plasma levels of Powerecta when taken in combination. In these patients whose hypertension was controlled with nifedipine, Powerecta 20 mg produced mean additional supine systolic/diastolic blood pressure reductions of 6/5 mmHg compared to placebo.
Ritonavir and Indinavir: Upon concomitant administration of 5 mg of Powerecta with 600 mg BID ritonavir, the Cmax and AUC of ritonavir were reduced by approximately 20%. Upon administration of 10 mg of Powerecta with 800 mg TID indinavir, the Cmax and AUC of indinavir were reduced by 40% and 30%, respectively.
Aspirin: Powerecta (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by aspirin (two 81 mg tablets).
Other interactions: Powerecta had no effect on the pharmacodynamics of glyburide (glucose and insulin concentrations) and warfarin (prothrombin time or other pharmacodynamic parameters).
Powerecta side effects
See also:
What are the possible side effects of Powerecta?
The following serious adverse reactions with the use of Powerecta (Powerecta) are discussed elsewhere in the labeling:
- Cardiovascular Effects
- Priapism
- Effects on Eye
- Sudden Hearing Loss
- QT Prolongation
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Powerecta was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year.
In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for Powerecta compared to 1.1% for placebo.
When Powerecta was taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported.
Table 1: Adverse Reactions Reported By ≥ 2% of Patients Treated with Powerecta and More Frequent on Drug than Placebo in Fixed and Flexible All the events listed in the above table were deemed to be adverse drug reactions with the exception of accidental injury.
Back pain was reported in 2.0% of patients treated with Powerecta and 1.7% of patients on placebo.
Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of Powerecta.
All Powerecta Studies
Powerecta film-coated tablets and Powerecta orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.
In the placebo-controlled clinical trials for Powerecta film-coated tablets and Powerecta orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for Powerecta compared to 0.8% for placebo.
The following section identifies additional, less frequent adverse reactions ( < 2%) reported during the clinical development of Powerecta film-coated tablets and Powerecta orally disintegrating tablets. Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:
Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest pain
Auditory: tinnitus, vertigo
Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension
Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases
Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia
Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure
Respiratory: dyspnea, sinus congestion
Skin and appendages: erythema, rash
Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis
Urogenital: increase in erection, priapism
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Powerecta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Ophthalmologic
Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including Powerecta. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors.
Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience. It is not possible to determine whether these events are related directly to the use of Powerecta.
Neurologic
Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with Powerecta.
Otologic
Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including Powerecta. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of Powerecta, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.
Powerecta contraindications
See also:
What is the most important information I should know about Powerecta?
Nitrates
Administration of Powerecta hydrochloride orally disintegrating tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including Powerecta hydrochloride orally disintegrating tablets, may potentiate the hypotensive effects of nitrates. A suitable time interval following Powerecta hydrochloride orally disintegrating tablets dosing for the safe administration of nitrates or nitric oxide donors has not been determined.
Guanylate Cyclase (GC) Stimulators
Do not use Powerecta hydrochloride orally disintegrating tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including Powerecta hydrochloride orally disintegrating tablets may potentiate the hypotensive effects of GC stimulators.
Active ingredient matches for Powerecta:
Vardenafil in Egypt.
List of Powerecta substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Levitra ODT 10mg (Vietnam) | |
| Rectivard (Egypt) | |
| Solvetra (Egypt) | |
| Starexon (Romania) | |
| Staxyn Orally Disintegrating Tablets | |
| VALIF | |
| Valif 10mg Tablet (Ajanta Pharma Ltd) | $ 0.02 |
| Varafil (Vietnam) | |
| Varafil 10 mg x 1 Blister x 1 Tablet | |
| Varafil 10 mg x 1 Blister x 2 Tablet | |
| Varafil 10 mg x 2 Blister x 2 Tablet | |
| Vardegin (Sweden) | |
| Vardenafil (Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Barbados, Belgium, Belize, Bermuda, Bosnia & Herzegowina, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia (Hrvatska), Czech Republic, Denmark, Ecuador, El Salvador, Finland, France, Georgia, Germany, Greece, Guatemala, Haiti, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Luxembourg, Malaysia, Mexico, Netherlands, Netherlands Antilles, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Kingdom, United States, Vietnam) | |
| Levitra 10 mg tablet | $ 19.04 |
| Levitra 20 mg tablet | $ 19.04 |
| Levitra 5 mg tablet | $ 19.04 |
| Levitra 2.5 mg tablet | $ 18.66 |
| Generic Vardenafil 20 mg - 10 Tablets | $ 44.95 |
| Generic Vardenafil 20 mg - 30 Tablets | $ 89.95 |
| Generic Vardenafil 20 mg - 60 Tablets | $ 134.95 |
| Generic Vardenafil 20 mg - 90 Tablets | $ 159.95 |
| Generic Vardenafil 20 mg - 180 Tablets | $ 264.95 |
| Vardenafil brand 20 mg - 8 Tablets | $ 89.99 |
| Vardenafil brand 20 mg - 12 Tablets | $ 124.95 |
| Vardenafil brand 20 mg - 16 Tablets | $ 164.95 |
| Vardenafil professional 20 mg - 10 Tablets | $ 49.95 |
| Vardenafil professional 20 mg - 30 Tablets | $ 89.95 |
| Vardenafil professional 20 mg - 60 Tablets | $ 149.99 |
| Vardenafil professional 20 mg - 90 Tablets | $ 199.99 |
| Vardenafil Accord (Malta, Netherlands, Sweden) | |
| Vardenafil Actavis (Estonia) | |
| Vardenafil Alembic (Estonia) | |
| Vardenafil Chanelle orodispersible (United Kingdom) | |
| Vardenafil Crescent (United Kingdom) | |
| Vardenafil GMP (Georgia) | |
| Vardenafil Goibela (Sweden) | |
| Vardenafil Hydrochloride Teva (United States) | |
| Vardenafil Krka (Sweden) | |
| Vardenafil Mylan (United Kingdom) | |
| Vardenafil Orally Disintegrating Tablets | |
| Vardenafil Sandoz (Estonia, Netherlands, Romania) | |
| Vardenafil Sandoz 10mg (Switzerland) | |
| Vardenafil Sandoz 20mg (Switzerland) | |
| Vardenafil Sandoz 5mg (Switzerland) | |
| Vardenafil Stada (Netherlands, Sweden) | |
See 109 substitutes for Powerecta | |
References
- DailyMed. "VARDENAFIL HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "Vardenafil". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Vardenafil". http://www.drugbank.ca/drugs/DB00862 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Powerecta are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Powerecta. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
1 consumer reported useful
Was the Powerecta drug useful in terms of decreasing the symptom or the disease?According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
| Users | % | ||
|---|---|---|---|
| Useful | 1 | 100.0% | |
Consumer reported price estimates
No survey data has been collected yet3 consumers reported time for results
To what extent do I have to use Powerecta before I begin to see changes in my health conditions?As part of the reports released by ndrugs.com website users, it takes 3 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Powerecta. To get the time effectiveness of using Powerecta drug by other patients, please click here.
| Users | % | ||
|---|---|---|---|
| 3 month | 1 | 33.3% | |
| 5 days | 1 | 33.3% | |
| 1 day | 1 | 33.3% | |
16 consumers reported age
| Users | % | ||
|---|---|---|---|
| > 60 | 6 | 37.5% | |
| 16-29 | 4 | 25.0% | |
| 30-45 | 3 | 18.8% | |
| 46-60 | 3 | 18.8% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
