Vardenafil Hydrochloride (Staxyn)

Trade Name : Staxyn

GlaxoSmithKline LLC

TABLET, ORALLY DISINTEGRATING

Strength 11.85 mg/1

VARDENAFIL HYDROCHLORIDE Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Vardenafil Hydrochloride (Staxyn) which is also known as Staxyn and Manufactured by GlaxoSmithKline LLC. It is available in strength of 11.85 mg/1 per ml. Read more

Vardenafil Hydrochloride (Staxyn) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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5.4

STAXYN is indicated for the treatment of erectile dysfunction.

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STAXYN is available in 10 mg white, round, orally disintegrating tablets (not scored), no debossing.

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The evaluation of erectile dysfunction should include a medical assessment, a determination of potential underlying causes and the identification of appropriate treatment.
Before prescribing STAXYN, it is important to note the following:

5.2n- 7.2
5.5n- 6.2
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The following serious adverse reactions with the use of STAXYN (vardenafil) are discussed elsewhere in the labeling:
Adverse reactions reported by u2265 2% of patients treated with STAXYN: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain. ()
To report SUSPECTED ADVERSE REACTIONS, contact BayerHealthCare Pharmaceuticals at 1-888-84-BAYER (1-888-842-2937) or FDA at 1-800-FDA-1088 or n

The drug interaction studies described below were conducted using vardenafil film-coated tablets.

No data

The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the filmu2013coated tablets administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or u201cabnormal vision.u201d Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects.
When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed. No muscle or neurological toxicity was identified.
In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine.

STAXYN (vardenafil hydrochloride) is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific PDE5.
Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:
Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water.
STAXYN is formulated as white round orally disintegrating tablets with no debossing. Each tablet contains 11.85 mg vardenafil hydrochloride, which corresponds to 10 mg vardenafil, and the following inactive ingredients: aspartame, peppermint flavor, magnesium stearate, and Pharmaburstu2122 B2 (crospovidone, mannitol, silica colloidal hydrated, and sorbitol).

No data

Carcinogenesis
Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400- and 170-fold for male and female rats, respectively, and 21-and 37-fold for male and female mice, respectively, the exposures observed in human males given the maximum recommended human dose (MRHD) of 20 mg.
Mutagenesis
Vardenafil was not mutagenic as assessed in either the bacterial Ames assay or the forward mutation assay in Chinese hamster V cells. Vardenafil was not clastogenic as assessed in either the chromosomal aberration test or the mouse micronucleus test.
Impairment of Fertility
Vardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in males, and for 14 days prior to mating and through day 7 of gestation in females. In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg.

The efficacy and safety of STAXYN were evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials (studies 1 and 2). STAXYN was dosed without regard to meals on an as-needed basis in men with erectile dysfunction (ED), many of whom had multiple other medical conditions. In both pivotal studies, randomization was stratified so that approximately 50% of patients were u226565 years old. Primary efficacy assessment was by means of the Erectile Function (EF) Domain score of the validated International Index of Erectile Function (IIEF) Questionnaire and two questions from the Sexual Encounter Profile (SEP) dealing with the ability to achieve vaginal penetration (SEP2), and the ability to maintain an erection long enough for successful intercourse (SEP3). The primary endpoints were assessed at 3 months.
Study 1 evaluated 355 mainly European (Belgium, France, Germany, Spain, South Africa, and Netherlands) patients (mean age 61.9; 67% White, 4% Black, 3% Asian, 26% Unknown). The mean baseline EF domain scores were 13 for both placebo and STAXYN groups. Study 2 evaluated 331 mainly North American (USA, Canada, Mexico, and Australia) patients (mean age 61.7; 69% White, 5% Black, 4% Asian, 22% Hispanic). The mean baseline EF domain scores were 12 for STAXYN and 13 for placebo.
In both studies STAXYN demonstrated clinically meaningful and statistically significant improvements over placebo in all 3 primary efficacy variables (see Table 7).

No data

See FDA-approved patient labeling (Patient Information)
Use with Other Formulations of Vardenafil
Inform patients that STAXYN is not interchangeable with vardenafil film-coated tablets (LEVITRA) as it provides higher systemic exposure. They should also discuss that the maximum dosage is one STAXYN tablet per 24 hours.
Nitrates
Discuss with patients that STAXYN is contraindicated with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of vardenafil with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.
Guanylate Cyclase (GC) Stimulators
Inform patients that Staxyn is contraindicated in patients who use guanylate cyclase stimulators, such as riociguat.
Cardiovascular
Discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.
Concomitant Use with Drugs which Lower Blood Pressure
Inform patients that in some patients concomitant use of PDE5 inhibitors, including STAXYN, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). Patients who are taking alpha-blockers should only use STAXYN when previous treatment with vardenafil film-coated tablets has been well tolerated Patients should be advised of the possible occurrence of symptoms related to postural hypotension and appropriate countermeasures. Patients should be advised to contact the prescribing physician if other anti-hypertensive drugs or new medications that may interact with STAXYN are prescribed by another healthcare provider.
Recommended Administration
Discuss with patients the appropriate use of STAXYN and its anticipated benefits. It should be explained that sexual stimulation is required for an erection to occur after taking STAXYN. STAXYN should be taken approximately 60 minutes before sexual activity. Patients should be counseled regarding the dosing of STAXYN, especially regarding the maximum daily dose. Patients should be advised to contact their healthcare provider if they are not satisfied with the quality of their sexual performance with STAXYN or in the case of an unwanted effect.
Priapism
Inform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for vardenafil and this class of compounds. In the event that an erection persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Drug Interactions
Advise patients to contact the prescribing physician if new medications that may interact with STAXYN are prescribed by another healthcare provider.
Sudden Loss of Vision
Inform patients to stop use of all PDE5 inhibitors, including STAXYN, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a u201ccrowdedu201d optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including Staxyn, for this uncommon condition n n
Sudden Hearing Loss
Advise patients to stop taking PDE5 inhibitors, including STAXYN, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including STAXYN. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors n
Sexually Transmitted Disease
Inform patients that STAXYN offers no protection against sexually transmitted diseases. Counsel patients that protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.
Dose Adjustment
STAXYN is available only in a single strength. Patients who require a different dosage should be prescribed vardenafil film-coated tablets (LEVITRA).

FDA-approved patient labeling
STAXYN (stax-in)
(vardenafil HCl)n- orally disintegrating tablets
Read the Patient Information about STAXYN before you start taking it and again each time you get a refill. There may be new information. You may also find it helpful to share this information with your partner. This leaflet does not take the place of talking with your doctor. You and your doctor should talk about STAXYN when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your doctor or pharmacist.
WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT STAXYN?
STAXYN is not interchangeable with vardenafil film-coated tablets (LEVITRA).
STAXYN can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.
STAXYN contains phenylalanine which can be harmful to people who have phenylketonuria. Talk to your doctor if you have phenylketonuria.
Do not take STAXYN if you:
(See )
Tell all your healthcare providers that you take STAXYN.
WHAT IS STAXYN?
STAXYN is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men.
ED is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him. STAXYN may help a man with ED get and keep an erection when he is sexually excited.
STAXYN does not:
STAXYN is only for men with ED. STAXYN is not for women or children. STAXYN must be used only under a doctoru2019s care.
HOW DOES STAXYN WORK?
When a man is sexually stimulated, his bodyu2019s normal physical response is to increase blood flow to his penis. This results in an erection. STAXYN helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.
WHO CAN TAKE STAXYN?
Talk to your doctor to decide if STAXYN is right for you.
STAXYN has been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes.
WHO SHOULD NOT TAKE STAXYN?
Do not take STAXYN if you:
WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING STAXYN?
Before taking STAXYN, tell your doctor about all your medical problems, including if you:
CAN OTHER MEDICATIONS AFFECT STAXYN?
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. STAXYN and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take any of the following:
Patients taking these drugs should not use STAXYN.
Patients taking alpha-blockers should not initiate vardenafil therapy with STAXYN. Patients taking alpha-blockers who have previously used vardenafil film-coated tablets may switch to STAXYN at the advice of their healthcare provider.
HOW SHOULD YOU TAKE STAXYN?
Take STAXYN exactly as your doctor prescribes. STAXYN comes in 10 mg orally disintegrating tablets. The dose is one STAXYN tablet. Doses should be taken at least 24 hours apart.
Take 1 STAXYN tablet about 1 hour (60 min) before sexual activity. Some form of sexual stimulation is needed for an erection to happen with STAXYN. STAXYN may be taken with or without meals.
Place on the tongue where it will dissolve rapidly. The tablet should be taken whole and not crushed or split.
The tablet should not be taken with liquid.
It should be taken immediately upon removal from the blister.
Call your doctor or emergency room immediately if you accidentally took more STAXYN than prescribed.
If you receive STAXYN in a blisterpack, examine the blisterpack before use. Do not use if blisters are torn, broken, or missing.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF STAXYN?
The most common side effects with STAXYN are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, and back pain. These side effects usually go away after a few hours. Call your doctor if you get a side effect that bothers you or one that will not go away.
STAXYN may uncommonly cause:
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including vardenafil) reported a sudden decrease or loss of vision in one or both eyes. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STAXYN, and call a doctor right away.
Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including vardenafil. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience these symptoms, stop taking STAXYN and contact a doctor right away.
These are not all the side effects of STAXYN. For more information, ask your doctor or pharmacist.
HOW SHOULD STAXYN BE STORED?
GENERAL INFORMATION ABOUT STAXYN
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use STAXYN for a condition for which it was not prescribed. Do not give STAXYN to other people, even if they have the same symptoms that you have. It may harm them.
This leaflet summarizes the most important information about STAXYN. If you would like more information, talk with your healthcare provider. You can ask your doctor or pharmacist for information about STAXYN that is written for health professionals.
For more information you can also visit www.STAXYN.com or call 1-888-825-5249.
WHAT ARE THE INGREDIENTS OF STAXYN?
Active Ingredient:
Inactive Ingredients of STAXYN:
Phenylketonurics: STAXYN contains 1.01 mg phenylalanine per tablet.
Products cited in STAXYN USPI
LEVITRA is a registered trademark of Bayer AG and is used under license by GlaxoSmithKline.
Norvir (ritonavir) is a trademark of Abbott Laboratories
Crixivan (indinavir sulfate) is a trademark of Merck & Co., Inc.
Invirase or Fortavase (saquinavir mesylate) is a trademark of Roche Laboratories Inc.
Reyataz (atazanavir sulfate) is a trademark of Bristol-Myers Squibb Company
Nizoral (ketoconazole) is a trademark of Johnson & Johnson
Sporanox (itraconazole) is a trademark of Johnson & Johnson
Hytrin (terazosin HCl) is a trademark of Abbott Laboratories
Flomax (tamsulosin HCl) is a trademark of Yamanouchi Pharmaceutical Co., Ltd.
Cardura (doxazosin mesylate) is a trademark of Pfizer Inc.
Minipress (prazosin HCl) is a trademark of Pfizer Inc.
Rapaflo (silodosin) is a trademark of Watson Pharma Inc.
Uroxatral (alfuzosin HCl) is a trademark of Sanofi-Synthelabo
Pharmaburst B2 is a trademark of SPI Pharma Inc.
Revision Date 8/2017
Manufactured for:
Bayer HealthCare Pharmaceuticals Inc.Whippany, NJ 07981
Manufactured in Germany
Distributed by:
GlaxoSmithKlineResearch Triangle ParkNC 27709
Rx Only
STAXYN is a registered trademark of Bayer AG and is used under license by GlaxoSmithKline
u00a92010 Bayer HealthCare Pharmaceuticals Inc.

STAXYN 10 mg, 4 Tablet Carton
Rx only u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0173-0822-04
STAXYNu2122n- (vardenafil hydrochloride)n- orally disintegrating tablets
10 mg * PER TABLET
Place the orally disintegrating tablet in the mouth, on the tongue.
The orally disintegrating tablet should be taken without liquid.
Rx only
4 tablets

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Vardenafil Hydrochloride (Staxyn)

Trade Name : Staxyn

TABLET, ORALLY DISINTEGRATING

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Vardenafil Hydrochloride (Staxyn)

Trade Name : Staxyn

TABLET, ORALLY DISINTEGRATING

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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