Alprostadil (MUSE)

US NDC LINE: 0037-8110

Trade Name: MUSE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Meda Pharmaceuticals

Presentation: SUPPOSITORY

Strength: 125 ug/1

Storage and handling

ALPROSTADIL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [CS],Venous Vasodilation [PE]

  • No data
  • MUSE (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (micro-suppository measuring 1.4 mm in diameter by 3 mm or 6 mm in length) that resides in the tip of a translucent hollow applicator. MUSE is administered by inserting the applicator stem into the urethra after urination. The pellet containing alprostadil is delivered by depressing the applicator button . The components of the delivery system are constructed of medical grade polypropylene. Each MUSE system is packaged in an individual foil pouch.
  • The active ingredient in MUSE is alprostadil, which is chemically identical to the naturally occurring eicosanoid, prostaglandin E (PGE). The chemical name for alprostadil is prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-(11u03b1,13E,15S)-(1R,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxo-cyclopentane heptanoic acid, and the molecular weight is 354.49. The empirical formula is CHO. The structural formula of alprostadil is represented below:
  • Alprostadil is a white to off-white crystalline powder with a melting point between 115u00b0 and 116u00b0C. Its solubility at 35u00b0C is 8000 mcg per 100 mL double-distilled water. The inactive ingredient in MUSE is polyethylene glycol 1450, USP. There are no other active agents or excipients in MUSE.
  • MUSE is available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg.
  • No data
  • The MUSE system was evaluated in 7 placebo-controlled trials of various design in over 2500 patients with a history of erectile dysfunction of various etiologies. These trials assessed erectile function in the clinic and sexual intercourse in outpatient settings. In studies of sexual performance, patients were screened in the clinic, generally using doses of 125 mcg to 1000 mcg, for a satisfactory erectile response, then sent home with the selected dose or placebo for evaluation of sexual performance. Not all patients beginning titration had a successful dose and some patients could not tolerate MUSE, principally because of penile pain, so that the success rates in the studies described below must be understood to represent response rates only in patients who were successfully titrated.
  • In 2 identical multicenter, double-blind, placebo-controlled, parallel-group studies, 1511 monogamous and heterosexual patients with a mean 4-year history of erectile dysfunction and at least a 3-month history of no erections adequate for sexual intercourse without medical assistance, were enrolled and began dose titration in the clinic with doses between 125 mcg and 1000 mcg. 996 patients (66%) completed dose titration, achieved an erection sufficient for intercourse, and were randomized equally to placebo or active treatment and followed during at-home treatment for up to 3 months. 874 patients and partners completed 3 months of follow-up. About 10%, 20%, 30%, and 40% of patients were titrated to 125 mcg, 250 mcg, 500 mcg, and 1000 mcg, respectively. Couples on active therapy were more likely to have at least 1 successful sexual intercourse (65% vs. 19%) than were couples on placebo. Among patients who reported successful intercourse at least once with active treatment, approximately 7 of 10 MUSE systems resulted in successful sexual intercourse. Results were similar in patients with erectile dysfunction stemming from surgery or trauma, diabetes, vascular disease, or other etiologies, and were similar in Caucasians and non-Caucasians. In administrations resulting in sexual intercourse, the duration of erections sufficient for penetration was 6 minutes on placebo and 16 minutes on active drug. Successful therapy with MUSE was associated with improvement in the quality of life measures of u201cemotional well-beingu201d for patients and u201crelationship with partneru201d for both patients and their female partners.
  • MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered placebo.
  • MUSE is contraindicated in men with any of the following:
  • Because of the potential for symptomatic hypotension and syncope, which occurred in 3% and 0.4%, respectively, of patients during in-clinic dosing, MUSE titration should be carried out under medical supervision. During post-marketing surveillance syncope occurring within one hour of administration has been reported. Patients should be cautioned to avoid activities, such as driving or hazardous tasks, where injury could result if hypotension or syncope were to occur after MUSE administration.
  • No data
  • No data
  • Overdosage has not been reported with MUSE. Overdosage with MUSE may result in hypotension, persistent penile pain and possibly priapism (rigid erection lasting u2265 6h). Priapism can result in permanent worsening of erectile function. Patients suspected of overdosage who develop these symptoms should be kept under medical supervision until systemic or local symptoms have resolved.
  • MUSE is a transurethral delivery system available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg. MUSE should be administered as needed to achieve an erection. The onset of effect is within 5-10 minutes after administration. The duration of effect is approximately 30-60 minutes. However, the actual duration will vary from patient to patient. Each patient should be instructed by a medical professional on proper technique for administering MUSE prior to self-administration. The maximum frequency of use is no more than 2 systems per 24-hour period.
  • MUSE is supplied in individual foil pouches containing one (1) system per pouch. MUSE is available in unit cartons containing six (6) systems. MUSE is available in the following 4 dosage strengths:
  • Rx Only.
  • Store unopened foil pouches in a refrigerator at 2u00b0-8u00b0C (36u00b0-46u00b0F). Do not expose MUSE to temperatures above 30u00b0C (86u00b0F). MUSE may be kept by the patient at room temperature (below 30u00b0C or 86u00b0F) for up to 14 days prior to use.
  • Medical information line at Meda Pharmaceuticals Inc. 1-888-345-MUSE (1-888-345-6873).
  • MUSE is a registered trademark of Meda AB, a Mylan company.
  • Distributed by:n Somerset, New Jersey 08873-4120
  • http://www.muserx.net Catalog Number: 05-10-00001FIN-1001-04Revised: 4/2018u00a92018 Mylan Specialty L.P.
  • Please read this pamphlet before using MUSE (alprostadil). This pamphlet is a quick reference source on important information about MUSE for you and your partner. n
  • WHAT IS MUSE?
  • MUSE represents a unique approach for the treatment of erectile dysfunction, commonly called impotence. It is based on the discovery that the urethra (the normal pathway for urine) can absorb certain medications into the surrounding erectile tissues thereby creating an erection. There are 4 dose strengths available: 125, 250, 500, and 1000 micrograms. The MUSE applicator (Fig.1) contained in each foil pouch is intended for 1 administration only. Your dose of MUSE will be determined by you and your physician. After administration, the erection process will begin within 5 u2013 10 minutes, and may last 30 u2013 60 minutes. However, the actual duration will vary from patient to patient.
  • WHAT IS MUSE USED FOR?
  • MUSE is indicated for the treatment of erectile dysfunction. Erectile dysfunction is the inability to attain or maintain an erection sufficient for sexual intercourse.
  • WHO SHOULD NOT USE MUSE?
  • You should not use MUSE if you have any of the following:
  • WHAT ARE THE POSSIBLE SIDE EFFECTS OF MUSE?
  • The most common side effects that have been observed using MUSE follow:
  • Side effects reported less frequently:n n
  • If you have a history of fainting be sure to discuss this with your doctor prior to using MUSE. If you do experience dizziness or feel faint, this may be due to the lowering of your blood pressure. Lie down immediately and raise your legs. If symptoms persist, call your doctor promptly. Because of the potential for these side effects, MUSE titration should be carried out under medical supervision.
  • Call your doctor for medical advice about side effects. n
  • Changing Your Dosage
  • It is assumed that you and your doctor have determined the proper dose of MUSE. If you suspect that your dose needs to be increased or decreased to achieve the response that works best for you, please call your doctor to determine if your dose needs to be reevaluated. Do not use MUSE more than twice in a 24-hour period.
  • WHAT ARE THE POSSIBLE SIDE EFFECTS OF MUSE FOR YOUR PARTNER?
  • The most common reported side effects observed in women whose partners use MUSE are mild vaginal itching or burning. Using a water-based lubricant can help to make vaginal penetration easier. Your partner may want to consult her health care provider if she has not had sexual intercourse for an extended period of time.
  • IMPORTANT INFORMATION FOR YOU AND YOUR PARTNER
  • Pregnancy
  • MUSE has no contraceptive properties.
  • Because MUSE has not been tested during human pregnancy, it is recommended that couples use adequate contraception if the female partner is of childbearing potential. MUSE should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.
  • Sexually Transmitted Diseases
  • MUSE will not protect you or your partner from sexually transmitted diseases like chlamydia, gonorrhea, herpes simplex virus, viral hepatitis, human immunodeficiency virus (HIV - the virus that causes AIDS), human papilloma virus (genital warts), and syphilis. Latex condoms can protect against these sexually transmitted diseases.
  • HOW SHOULD I STORE MUSE?
  • It is recommended that MUSE be stored in a refrigerator. MUSE may be kept at room temperature (less than 30u00b0C/86u00b0F) for up to 14 days prior to use. It is very important that MUSE not be exposed to temperatures above 30u00b0C/86u00b0F since this will make MUSE ineffective. MUSE should not be exposed to high temperatures or placed in direct sunlight.
  • Storage When Traveling
  • When traveling, store MUSE in a portable ice pack or cooler. Do not store in the trunk of a car or in baggage storage areas where MUSE may be exposed to extremes in temperature.
  • HOW TO ADMINISTER MUSE:
  • Arrayn- After you have administered MUSE, it is important to sit, or preferably stand or walk about for 10 minutes while the erection is developing. This increases blood flow to the penis and will enhance your erection.
  • ADDITIONAL INFORMATION AND PRACTICAL TIPS
  • Factors Which May Enhance Your Erection:
  • Factors Which May Reduce Your Erection:
  • COMMONLY ASKED QUESTIONS ABOUT MUSE
  • Will insertion of MUSE hurt?
  • At first, you may feel some minor discomfort from insertion. Urinating prior to administration will reduce the chance of discomfort or abrasions and is important for dissolving the medicated pellet. Be sure to straighten your penis to its full length when inserting the MUSE applicator. With repeated use, administration will become much easier.
  • What are the side effects associated with MUSE?
  • Most of the side effects reported in men are relatively minor and include burning and aching in the penis and groin. Rarely noted are prolonged erection, light-headedness, dizziness, fainting, rapid pulse, and swelling of the leg veins. If you feel dizzy, light-headed, faint, or experience rapid pulse, lie down immediately and raise your legs. If symptoms persist, call your doctor promptly. Because of the potential for these side effects, MUSE titration should be carried out under medical supervision.
  • (See also: on the other side.)
  • In women, mild vaginal itching and burning have been observed.
  • After I administer MUSE, can we immediately lie down and begin sexual activity?
  • You can begin sexual activity, but having the man lie down, especially on his back shortly after administration, is not recommended. This will reduce blood flow to the penis and may reduce the erection. It is important to sit, stand or walk about for 10 minutes after administration. Many couples have used this time to incorporate various types of foreplay. After this initial period, you can assume different positions leading to sexual intercourse. Some couples have noticed that the erection is better maintained in positions that favor blood flow into the penis during intercourse.
  • Please review the video and patient starter booklet available from your doctor which illustrates various positions that will enhance your erection.
  • How long will the effect of MUSE last?
  • An erection should begin within 5 u2013 10 minutes after administering MUSE. The duration of effect is approximately 30 u2013 60 minutes. However, the actual duration will vary from patient to patient.
  • What will the erection be like? How will it compare to the erections I had when I was younger?
  • An effective dose of MUSE should produce an erection sufficient for sexual intercourse. MUSE may not create an erection such as those you experienced when you were younger. Some patients may experience some mild pain and aching in the penis or groin area. Also, your erection may continue after orgasm.
  • How do I know if I have the correct dose of MUSE?
  • You and your physician will determine the appropriate dose of MUSE. If your erection cannot be maintained for the time needed to have foreplay and sexual intercourse, you may need to have your dose increased. Similarly, an erection that lasts longer than desired may require a dose decrease. Call your doctor if you suspect you may require a dosing adjustment.
  • After my erection is over, will my penis feel sensitive?
  • Your penis may feel full, warm, and somewhat sensitive to the touch. These effects are normal and may last a few hours.
  • Can I reuse MUSE?
  • No. MUSE is intended for single-dose application only.
  • How do I dispose of the MUSE applicator?
  • After you have administered MUSE, replace the cover on the applicator, place in the opened foil pouch, fold, and discard as normal household waste.
  • If my erection lasts longer than desired, what should I do?
  • Note: Call your doctor promptly if you have a rigid erection that lasts more than 4 hours.
  • An application of ice packs to the inner thigh may shorten the duration of the erection, since the cold will restrict blood flow to the penis. If used, ice packs should be applied alternately to each inner thigh for a period not exceeding 10 minutes.
  • How often can I safely use MUSE?
  • MUSE should not be used more than twice per day.
  • If you have any additional questions about MUSE, please call the toll free patient information line at Meda Pharmaceuticals Inc. 1-888-367-MUSE (1-888-367-6873), or visit the MUSE product web site, http://www.muserx.net
  • MUSE is a registered trademark of Meda AB, a Mylan company.
  • Distributed by:n n Somerset, New Jersey 08873-4120
  • http://www.muserx.net Catalog Number: 05-10-00000FIS-1001-04Revised: 4/2018u00a92018 Mylan Specialty L.P.
  • NDC
  • MUSEn (alprostadil)urethral suppository
  • Transurethral Systemu00a0u00a0u00a0u00a0u00a0125 mcg
  • Store in a refrigerator at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).Please read patient instruction leaflet regarding usage and storage.
  • Rx only
  • Contents: 6 single-use systems
  • MUSE and MEDA PHARMACEUTICALS are registered trademarks, and theMEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity.
  • U.S. Patent No. 5,886,039
  • http://www.muserx.net
  • Distributed by:n Somerset, New Jersey 08873-4120
  • CAT. NO. 06-10-01256D
  • UC-100100-04
  • Revised 06/2017
  • NDC
  • MUSEn (alprostadil)urethral suppository
  • Transurethral Systemu00a0u00a0u00a0u00a0u00a0250 mcg
  • Store in a refrigerator at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).Please read patient instruction leaflet regarding usage and storage.
  • Rx only
  • Contents: 6 single-use systems
  • MUSE and MEDA PHARMACEUTICALS are registered trademarks, and theMEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity.
  • U.S. Patent No. 5,886,039
  • http://www.muserx.net
  • Distributed by:n Somerset, New Jersey 08873-4120
  • CAT. NO. 06-10-02506D
  • UC-100200-04
  • Revised 06/2017
  • NDC
  • MUSEn (alprostadil)urethral suppository
  • Transurethral Systemu00a0u00a0u00a0u00a0u00a0500 mcg
  • Store in a refrigerator at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).Please read patient instruction leaflet regarding usage and storage.
  • Rx only
  • Contents: 6 single-use systems
  • MUSE and MEDA PHARMACEUTICALS are registered trademarks, and theMEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity.
  • U.S. Patent No. 5,886,039
  • http://www.muserx.net
  • Distributed by:n Somerset, New Jersey 08873-4120
  • CAT. NO. 06-10-05006D
  • UC-100300-04
  • Revised 06/2017
  • NDC
  • MUSEn (alprostadil)urethral suppository
  • Transurethral Systemu00a0u00a0u00a0u00a0u00a01000 mcg
  • Store in a refrigerator at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).Please read patient instruction leaflet regarding usage and storage.
  • Rx only
  • Contents: 6 single-use systems
  • MUSE and MEDA PHARMACEUTICALS are registered trademarks, and theMEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity.
  • U.S. Patent No. 5,886,039
  • http://www.muserx.net
  • Distributed by:n Somerset, New Jersey 08873-4120
  • CAT. NO. 06-10-10006D
  • UC-100400-05
  • Revised 2/2018

Disclaimer

  • Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alprostadil (MUSE) which is also known as MUSE and Manufactured by Meda Pharmaceuticals. It is available in strength of 125 ug/1 per ml.

Alprostadil (MUSE) 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.

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator Sourcing services from India and RoW markets. Our Service included...
Read More
Name Patient Supply

Name Patient Supply

With rapidly changing lifestyle and ever increasing stress levels, disease patterns have seen a shift towards rarer and more un...
Read More
Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic, proteins etc. temperature maintenance has become as important as the...
Read More
Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE. GNH India brings over 10 years of experience in clinical...
Read More
Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active involvement in Manufacturing and interaction with various laboratories and manufacturers...
Read More
Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following quality levels: US FDA / UK MHRA approved facilities WHO GMP...
Read More
Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise noted in quotation. The preferred method of payment is wire...
Read More
Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2021 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.