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vardenafil hydrochloride

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Overview

What is Staxyn?

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 Pharmaburst™ B2 (crospovidone, mannitol, silica colloidal hydrated, and sorbitol).



What does Staxyn look like?



What are the available doses of Staxyn?

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

What should I talk to my health care provider before I take Staxyn?

How should I use Staxyn?

STAXYN is indicated for the treatment of erectile dysfunction.

STAXYN is available in 10 mg orally disintegrating tablets. STAXYN is not interchangeable with vardenafil 10 mg film-coated tablets (LEVITRA). STAXYN provides higher systemic exposure compared to vardenafil 10 mg film-coated tablets (LEVITRA).

STAXYN should be taken orally, as needed, approximately 60 minutes before sexual activity. The maximum dosing frequency is one STAXYN tablet per day. Sexual stimulation is required for a response to treatment.

STAXYN 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 vardenafil need to be prescribed vardenafil film-coated tablets .


What interacts with Staxyn?

Sorry No Records found


What are the warnings of Staxyn?

Sorry No Records found


What are the precautions of Staxyn?

Sorry No Records found


What are the side effects of Staxyn?

Sorry No records found


What should I look out for while using Staxyn?

•

2.4

4.1


What might happen if I take too much Staxyn?

The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the film–coated tablets administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.” 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.


How should I store and handle Staxyn?

Storage and Handling Avoid heat. VIOKACE tablets should be stored in a dry place in the original container. Store at room temperature (20-25°C, 68-77°F), brief excursion permitted up to 40°C (104°F) for up to 24 hrs. between uses to . VIOKACE is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten. The desiccant packet will protect the product from moisture. Storage and Handling Avoid heat. VIOKACE tablets should be stored in a dry place in the original container. Store at room temperature (20-25°C, 68-77°F), brief excursion permitted up to 40°C (104°F) for up to 24 hrs. between uses to . VIOKACE is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten. The desiccant packet will protect the product from moisture. Storage and Handling Avoid heat. VIOKACE tablets should be stored in a dry place in the original container. Store at room temperature (20-25°C, 68-77°F), brief excursion permitted up to 40°C (104°F) for up to 24 hrs. between uses to . VIOKACE is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten. The desiccant packet will protect the product from moisture. Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017Acetaminophen and codeine phosphate tablets USP (white, round, unscored):List No. 0050, acetaminophen 300 mg and codeine phosphate 15 mg, debossed “2” on one side and “TV”-“50” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0050-01List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0150-01 Bottles of 1000…………………………………..NDC 0093-0150-10 List No. 0350, acetaminophen 300 mg and codeine phosphate 60 mg, debossed “4” on one side and “93”-“350” on the other side of tablet. Bottles of 100……………………………………NDC 0093-0350-01 Bottles of 500……………………………………NDC 0093-0350-05 Bottles of 1000…………………………………..NDC 0093-0350-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Distributed By:Teva Pharmaceuticals USA, Inc.North Wales, PA 19454Rev. AN 7/2017


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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 cGMP-specific PDE5; therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.

In vitro

Non-Clinical Toxicology
•

2.4

4.1

Neprilysin Inhibitors:

Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema (see ).

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:

The following serious adverse reactions with the use of STAXYN (vardenafil) are discussed elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).