Liple

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Liple uses


DESCRIPTION

Liple® (alprostadil) is a single-use, medicated transurethral system for the delivery of Liple to the male urethra. Liple 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. Liple is administered by inserting the applicator stem into the urethra after urination. The pellet containing Liple is delivered by depressing the applicator button . The components of the delivery system are constructed of medical grade polypropylene. Each Liple system is packaged in an individual foil pouch.

The active ingredient in Liple is Liple, which is chemically identical to the naturally occurring eicosanoid, prostaglandin E1 (PGE1). The chemical name for Liple is prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-(11α,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 C20H34O5. The structural formula of Liple is represented below:

Liple is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 mcg per 100 mL double-distilled water. The inactive ingredient in Liple is polyethylene glycol 1450, USP. There are no other active agents or excipients in Liple.

Liple is available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg.

Figure 1 Structural Formula

CLINICAL PHARMACOLOGY

Mechanism of Action: Prostaglandin E1 is a naturally occurring acidic lipid that is synthesized from fatty acid precursors by most mammalian tissues and has a variety of pharmacologic effects. Human seminal fluid is a rich source of prostaglandins, including PGE1 and PGE2, and the total concentration of prostaglandins in ejaculate has been estimated to be approximately 100–200 mcg/mL. In vitro, Liple has been shown to cause dose-dependent smooth muscle relaxation in isolated corpus cavernosum and corpus spongiosum preparations. Additionally, vasodilation has been demonstrated in isolated cavernosal artery segments that were pre-contracted with either norepinephrine or prostaglandin F2 α. When Liple was injected into the corpus cavernosum of pigtail monkeys in vivo, dose-dependent increases in cavernosal artery blood flow were observed.

In human studies using Doppler duplex ultrasonography, intraurethral administration of 500 mcg of Liple resulted in an increase in cavernosal artery diameter and a 5- to 10-fold increase in peak systolic flow velocities. These results suggest that intraurethral Liple is absorbed from the urethra, transported throughout the erectile bodies by communicating vessels between the corpus spongiosum and corpora cavernosa, and able to induce vasodilation of the targeted vascular beds.

The vasodilatory effects of Liple on the cavernosal arteries and the trabecular smooth muscle of the corpora cavernosa result in rapid arterial inflow and expansion of the lacunar spaces within the corpora. As the expanded corporal sinusoids are compressed against the tunica albuginea, venous outflow through subtunical vessels is impeded and penile rigidity develops. This process is referred to as the corporal veno-occlusive mechanism.

The most notable systemic effects of Liple are vasodilation, inhibition of platelet aggregation, and stimulation of intestinal and uterine smooth muscle. Intravenous doses of 1 to 10 micrograms per kilogram of body weight lower blood pressure in mammals by decreasing peripheral resistance. Reflex increases in cardiac output and heart rate may accompany these effects.

Pharmacokinetics:

About 80% of Liple administered by Liple is absorbed within 10 minutes and is rapidly cleared from the systemic circulation by the lungs, leaving barely detectable systemic blood levels.

Absorption: Liple is designed to deliver Liple directly to the urethral lining for transfer via the corpus spongiosum to the corpora cavernosa. Intraurethral administration of Liple is preceded by urination, and the residual urine disperses the medicated pellet, permitting Liple to be absorbed by the urethral mucosa. The transurethral absorption of Liple after Liple administration is biphasic. Initial absorption is rapid, with approximately 80% of an administered dose absorbed within 10 minutes. The mean time to the maximum plasma PGE1 concentration after a 1000 mcg intraurethral dose of Liple is approximately 16 minutes.

In 10 normal human volunteers, endogenous PGE1 levels in the ejaculate averaged 31 mcg (range 0–161 mcg). In these same volunteers, an average of 123 mcg of additional PGE1 (range 30–369 mcg) was present in the ejaculate obtained 10 minutes after the highest dose (1000 mcg) of Liple. The mean total endogenous PGE content (PGE1, PGE2, 19-OH-PGE1, and 19-OH-PGE2) of the ejaculate in these subjects was 444 mcg (range 0–1423 mcg).

Distribution: Following Liple administration, Liple is absorbed from the urethral mucosa into the corpus spongiosum. A portion of the administered dose is transported to the corpora cavernosa through collateral vessels, while the remainder passes into the pelvic venous circulation through veins draining the corpus spongiosum. The half-life of Liple in humans is short, varying between 30 seconds and 10 minutes, depending on the body compartment in which it is measured and the physiological status of the subject. Nearly all of the Liple entering the central venous circulation is removed in a single pass through the lungs; thus peripheral venous plasma levels of PGE1 are low or undetectable (<2 picograms/mL) after Liple administration. The mean maximum plasma PGE1 concentration following intraurethral administration of the highest dose of Liple (1000 mcg) was barely detectable (11.4 picograms/mL). In a study of 14 subjects, the plasma PGE1 level was shown to be undetectable within 60 minutes of Liple administration in most subjects.

Metabolism: Liple is rapidly metabolized locally by enzymatic oxidation of the 15-hydroxyl group to 15-keto-PGE1. The enzyme catalyzing this process has been isolated from many tissues in the lower genitourinary tract including the urethra, prostate, and corpus cavernosum. 15-keto-PGE1 retains little (1–2%) of the biological activity of PGE1. 15-keto-PGE1 is rapidly reduced at the C13-C14 position to form the most abundant metabolite in plasma, 13,14-dihydro,15-keto PGE1 (DHK-PGE1), which is biologically inactive. The majority of DHK-PGE1 is further metabolized to smaller prostaglandin remnants that are cleared primarily by the kidney and liver. Between 60% and 90% of PGE1 has been shown to be metabolized after 1 pass through the pulmonary capillary beds.

Excretion: After intravenous administration of tritium-labeled Liple in man, labeled drug disappears rapidly from the blood in the first 10 minutes, and by 1 hour radioactivity in the blood reaches a low level. The metabolites of Liple are excreted primarily by the kidney, with approximately 90% of an administered intravenous dose excreted in the urine within 24 hours of dosing. The remainder is excreted in the feces. There is no evidence of tissue retention of Liple or its metabolites following intravenous administration.

Pharmacokinetics in Special Populations:

Pulmonary Disease: The near-complete pulmonary first-pass metabolism of PGE1 is the primary factor influencing the systemic pharmacokinetics of Liple and is a reason that peripheral venous plasma levels of PGE1 are low or undetectable (<2 picograms/mL) following Liple administration. Patients with pulmonary disease therefore may have a reduced capacity to clear the drug. In patients with the adult respiratory distress syndrome (ARDS), pulmonary extraction of intravascularly administered Liple was reduced by approximately 15% compared to a control group of patients with normal respiratory function (66±3.2% vs. 78±2.4%).

Geriatrics: The effects of age on the pharmacokinetics of Liple have not been evaluated.

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CLINICAL TRIALS

The Liple 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 Liple, 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 Liple 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 Liple was associated with improvement in the quality of life measures of “emotional well-being” for patients and “relationship with partner” for both patients and their female partners.

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INDICATIONS AND USAGE

Liple 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.

CONTRAINDICATIONS

Liple is contraindicated in men with any of the following:

  • Known hypersensitivity to Liple.
  • Abnormal penile anatomy: Liple is contraindicated in patients with urethral stricture, balanitis (inflammation/infection of the glans of the penis), severe hypospadias and curvature, and in patients with acute or chronic urethritis.
  • Sickle cell anemia or trait, thrombocythemia, polycythemia, multiple myeloma: Liple is contraindicated in patients who are prone to venous thrombosis or who have a hyperviscosity syndrome and are therefore at increased risk of priapism (rigid erection lasting 6 or more hours).
  • Liple should not be used in men for whom sexual activity is inadvisable.
  • Liple should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.

WARNINGS

Because of the potential for symptomatic hypotension and syncope, which occurred in 3% and 0.4%, respectively, of patients during in-clinic dosing, Liple 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 Liple administration.

PRECAUTIONS

General Precautions:

  • A complete medical history and physical examination should be undertaken to exclude reversible causes of erectile dysfunction prior to the initiation of Liple therapy. In addition, underlying disorders that might preclude the use of Liple should be sought.
  • Cardiovascular effects: During in-clinic dosing, patients should be monitored for symptoms of hypotension, and the lowest effective dose of Liple should be prescribed.
  • Hematologic effects: Patients administering Liple improperly may be at risk of urethral abrasion resulting in minor bleeding or spotting. Patients on anticoagulant therapy or with bleeding disorders may be at higher risk of bleeding. Patients on anticoagulant therapy have been safely treated with Liple; however, the risk/benefit ratio in these patients should be considered prior to prescribing Liple.
  • Resumption of sexual activity: Sexual intercourse is considered a vigorous physical activity, and it increases heart rate as well as cardiac work. Physicians may want to examine the cardiac fitness of patients prior to treating erectile dysfunction.
  • Priapism and prolonged erection: In clinical trials of Liple, priapism (rigid erection lasting ≥6 hours) and prolonged erection (rigid erection lasting 4 hours and <6 hours) were reported infrequently (<0.1% and 0.3% of patients, respectively). Nevertheless, these events are a potential risk of pharmacologic therapy and can cause penile injury. Physicians should lower the dose or consider discontinuing Liple treatment in any patient who develops priapism or prolonged erection.
  • Drug-Drug Interactions: Because there are low or undetectable (<2 picograms/mL) amounts of Liple found in the peripheral venous circulation following Liple administration, systemic drug-drug interactions with Liple are unlikely. Although formal studies have not been conducted, the concomitant use of Liple and anti-hypertensive medications may increase the risk of hypotension. It is therefore advised that caution be used in the administration of Liple to individuals on anti-hypertensive medications. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to Liple.
  • Drug-Device Interactions: Use of Liple in patients with penile implants has not been studied.
  • Sexual Preference: There is no experience in homosexual men and no experience with other than vaginal intercourse.

Information for Patients:

Patients should be informed that Liple offers no protection from the transmission of sexually transmitted diseases. Patients and partners who use Liple need to be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted agents, including the human immunodeficiency virus (HIV).

Although unreported in clinical trials, there is the possibility that an overdosage of Liple can cause priapism, a painful erection of the penis sustained for hours and unrelieved by sexual intercourse or masturbation. This condition is serious and, if untreated, it can lead to permanent inability to have an erection. Patients who experience a prolonged erection should seek prompt medical attention.

Patients should be instructed how to administer Liple. A patient package insert must be given to each patient at the initiation of Liple therapy.

Information for Partners:

Partners of patients using Liple should be informed that Liple offers no protection from the transmission of sexually transmitted diseases. Patients and partners who use Liple should be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted agents, including the human immunodeficiency virus. Human semen contains PGE1, but additional amounts may be present from Liple administration. Partners who have experienced an extended period of sexual abstinence should be encouraged to seek advice from a health care professional prior to resuming sexual intercourse. The use of a water-based lubricant may facilitate vaginal penetration.

It is recommended that couples using Liple employ adequate contraception if the female partner is of childbearing potential. There is no information on the effects on early pregnancy of PGE1 at the levels received by female partners. Liple has no contraceptive properties. Liple should not be used if the female partner is pregnant, unless the couple uses a condom barrier.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term carcinogenicity studies of Liple have not been conducted. Liple showed no evidence of mutagenicity in vitro in the Ames bacterial reverse mutation test, the unscheduled DNA synthesis assay in rat hepatocytes, or the Chinese hamster ovary forward gene mutation assay; nor was there evidence of mutagenicity in vivo in the mouse micronucleus assay. Liple concentrations increased chromosomal aberrations above control incidence in the in vitro Chinese hamster ovary chromosomal aberration assay.

In dogs, sperm concentration, morphology, and motility were unaffected by daily intraurethral administration of up to 3000 mcg Liple (alprostadil) for 13 weeks (200 mcg/kg/day or about 3.5 times the maximum recommended daily dose adjusted for body surface area). Liple concentrations of 400 mcg/mL had no effect on human sperm motility or viability in vitro.

Pregnancy: Pregnancy Category C: Liple has been shown to be embryotoxic (decreased fetal weight) when administered as a subcutaneous bolus to pregnant rats at doses as low as 500 mcg/kg/day. Doses of 2000 mcg/kg/day resulted in increased resorptions, reduced numbers of live fetuses, increased incidences of visceral and skeletal variations (primarily left umbilical artery and generalized reduction in ossification of the entire skeleton) and gross visceral and skeletal malformations (primarily edema, hydrocephaly, anophthalmia/microphthalmia, and skeletal anomalies). The latter dose produced maternal toxicity (ataxia, lethargy, diarrhea, and retarded body weight gain). When administered by continuous intravenous infusion, evidence of embryotoxicity (decreased fetal weight gain and increased incidence of hydroureter) was observed at 2000 mcg/ kg/day, a dose that was also associated with a decrease in maternal weight gain. Intravaginal administration of up to 4000 mcg/day of Liple (alprostadil) to pregnant rabbits (1100 mcg/kg/day or about 12.5 times the maximum recommended daily dose adjusted for body surface area) resulted in no evidence of harm to the fetus. Liple should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.

Nursing Mothers and Pediatric Use:

Liple is not indicated for use in newborns, children, or women.

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ADVERSE REACTIONS

In-Clinic Titration:

In the 2 largest double-blind, parallel, placebo-controlled trials, 1511 patients received Liple at least 1 time in the clinic setting. The most frequently reported drug-related side effects during in-clinic titration included pain in the penis, urethra (13%), or testes (5%). These discomforts were most commonly reported as mild and transient, but about 7% of patients withdrew at this stage because of adverse events. Urethral bleeding/spotting and other minor abrasions to the urethra were reported in approximately 3% of patients. Symptomatic lowering of blood pressure (hypotension) occurred in 3% of patients; in addition, some lowering of blood pressure may occur without symptoms. Dizziness was reported in 4% of patients. Syncope (fainting) was reported by 0.4% of patients. (See WARNINGS ).

Home Treatment:

996 patients (66% of those who began titration) were studied during the home treatment portion of 2 Phase III placebo-controlled studies. Fewer than 2% of patients discontinued from these studies primarily because of adverse events. The following table summarizes the frequency of adverse events reported by patients using Liple or placebo.

Liple Placebo Liple Placebo
Event n = 486 n = 511 Event n = 486 n = 511
UROGENITAL SYSTEM BODY AS A WHOLE
Penile Pain 32% 3% Flu Symptoms 4% 2%
Urethral Burning 12% 4% Headache 3% 2%
Minor Urethral Bleeding/ 5% 1% Pain 3% 1%
Spotting Accidental Injury 3% 2%
Testicular Pain 5% 1% Back Pain 2% 1%
NERVOUS SYSTEM Pelvic Pain 2% <1%
Dizziness 2% <1% RESPIRATORY
Rhinitis 2% <1%
Infection 3% 2%

Other drug-related side effects observed during in-clinic titration and home treatment include swelling of leg veins, leg pain, perineal pain, and rapid pulse, each occurring in <2% of patients.

Female Partner Adverse Events: The most common drug-related adverse event reported by female partners during placebo-controlled clinical studies was vaginal burning/itching, reported by 5.8% of partners of patients on active vs. 0.8% of partners of patients on placebo. It is unknown whether this adverse event experienced by female partners was a result of the medication or a result of resuming sexual intercourse, which occurred much more frequently in partners of patients on active medication.

To report suspected adverse reactions, contact Meda Pharmaceuticals Inc. at 1-888-345-6873 or contact FDA at 1-800-FDA-1088, fax 1-800-FDA-0178 or online at www.fda.gov/medwatch/report.htm.

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OVERDOSAGE

Overdosage has not been reported with Liple. Overdosage with Liple may result in hypotension, persistent penile pain, and possibly priapism (rigid erection lasting ≥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.

DOSAGE AND ADMINISTRATION

Liple is a transurethral delivery system available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg. Liple 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 Liple prior to self-administration. The maximum frequency of use is no more than 2 systems per 24-hour period.

Initiation of Therapy:

Dose titration should be administered under the supervision of a physician to test a patient's responsiveness to Liple, to demonstrate proper administration technique, and to monitor for evidence of hypotension (see WARNINGS ). Patients should be individually titrated to the lowest dose that is sufficient for sexual intercourse. The lower doses of Liple (125 mcg or 250 mcg) are recommended for initial dosing. If necessary, the dose should be increased (or decreased) on separate occasions in a stepwise manner until the patient achieves an erection that is sufficient for sexual intercourse.

Home Treatment Regimen:

Liple should be used as needed to achieve an erection. The maximum frequency of use is 2 administrations per 24-hour period. Each Liple is for single use only and should be properly discarded after use.

HOW SUPPLIED

Liple is supplied in individual foil pouches containing one (1) system per pouch. Liple is available in unit cartons containing six (6) systems. Liple is available in the following 4 dosage strengths:

Dosage NDC Numbers Identifying
Strength Carton Pouch Package Color
125 mcg 0037-8110-06 0037-8110-01 Tan
250 mcg 0037-8120-06 0037-8120-01 Green
500 mcg 0037-8130-06 0037-8130-01 Blue
1000 mcg 0037-8140-06 0037-8140-01 Burgundy

Rx Only.

STORAGE AND HANDLING

Store unopened foil pouches in a refrigerator at 2°– 8°C (36°– 46°F). Do not expose Liple to temperatures above 30°C (86°F). Liple may be kept by the patient at room temperature (below 30°C or 86°F) for up to 14 days prior to use.

Medical information line at Meda Pharmaceuticals Inc. 1-888-345-MUSE (1-888-345-6873).

Liple and MEDA PHARMACEUTICALS are registered trademarks, and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity.

Distributed by:

MEDA

PHARMACEUTICALS®

Somerset, New Jersey 08873-4120

http://www.muserx.net

Catalog Number: 05-10-00001E

IN-1001-03

Revised August 2014

U.S. Patent No. 5,886,039

©2014 Meda Pharmaceuticals Inc.

Liple®

(alprostadil ) urethral suppository

PATIENT INFORMATION

Please read this pamphlet before using Liple® (alprostadil). This pamphlet is a quick reference source on important information about Liple for you and your partner. Before administering Liple, please review the patient video and education booklet. These materials provide visual instruction and more detailed information as well as practical tips on how to use Liple.

WHAT IS Liple?

Liple 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 Liple applicator (Fig.1) contained in each foil pouch is intended for 1 administration only. Your dose of Liple will be determined by you and your physician. After administration, the erection process will begin within 5 – 10 minutes, and may last 30 – 60 minutes. However, the actual duration will vary from patient to patient.

WHAT IS Liple USED FOR?

Liple 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 Liple?

You should not use Liple if you have any of the following:

  • Known hypersensitivity to Liple (the active medication in Liple)
  • An abnormally formed penis
  • Have been advised not to undertake sexual activity
  • Conditions that might result in long-lasting erections, such as sickle cell anemia or trait, leukemia, or tumor of the bone marrow (multiple myeloma)
  • Liple should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF Liple?

The most common side effects that have been observed using Liple follow:

  • Aching in the penis, testicles, legs, and in the perineum (area between the penis and rectum)
  • Warmth or burning sensation in the urethra
  • Redness of the penis due to increased blood flow
  • Minor urethral bleeding or spotting due to improper administration.

Side effects reported less frequently:

  • Prolonged erection - PLEASE NOTE: IF YOUR ERECTION IS RIGID FOR MORE THAN 4 HOURS, CALL YOUR DOCTOR PROMPTLY.
  • Swelling of leg veins
  • Light-headedness/Dizziness
  • Fainting - PLEASE NOTE: AFTER USING Liple, YOU SHOULD AVOID ACTIVITIES, SUCH AS DRIVING OR HAZARDOUS TASKS WHERE INJURY COULD RESULT IF DIZZINESS OR FAINTING WERE TO OCCUR. IN PATIENTS EXPERIENCING THESE SYMPTOMS, THE SYMPTOMS HAVE USUALLY OCCURRED DURING INITIATION OF THERAPY AND WITHIN ONE HOUR OF Liple ADMINISTRATION.
  • Rapid pulse.

If you have a history of fainting be sure to discuss this with your doctor prior to using Liple. 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, Liple titration should be carried out under medical supervision.

Call your doctor for medical advice about side effects. To report side effects, contact Meda Pharmaceuticals Inc. at 1-888-367-6873 or contact FDA at 1-800-FDA-1088, fax 1-800-FDA-0178 or online at www.fda.gov/medwatch/report.htm.

Changing Your Dosage

It is assumed that you and your doctor have determined the proper dose of Liple. 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 Liple more than twice in a 24-hour period.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF Liple FOR YOUR PARTNER?

The most common reported side effects observed in women whose partners use Liple 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

Liple has no contraceptive properties.

Because Liple has not been tested during human pregnancy, it is recommended that couples use adequate contraception if the female partner is of childbearing potential. Liple should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.

Sexually Transmitted Diseases

Liple 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 Liple?

It is recommended that Liple be stored in a refrigerator. Liple may be kept at room temperature (less than 30°C/86°F) for up to 14 days prior to use. It is very important that Liple not be exposed to temperatures above 30°C/86°F since this will make Liple ineffective. Liple should not be exposed to high temperatures or placed in direct sunlight.

Storage When Traveling

When traveling, store Liple in a portable ice pack or cooler. Do not store in the trunk of a car or in baggage storage areas where Liple may be exposed to extremes in temperature.

HOW TO ADMINISTER Liple:

  • Immediately prior to administration, urinate and gently shake the penis several times to remove excess urine. A moist urethra makes administration of Liple easier. The medicated pellet has been specially developed to dissolve in the small quantity of urine that remains in the urethra after urination.
  • Open the foil pouch by tearing fully across from the notched edge (Fig. 2). Let the Liple slide out of the pouch. Save the pouch for discarding the Liple applicator later.
  • To remove the protective cover from the applicator stem (Fig. 3), hold the body of the applicator with your thumb and forefinger. Twist the body and pull out the applicator from the cover, being careful not to push in or pull out the applicator button. Avoid touching the applicator stem and tip. Save the cover for discarding the Liple applicator later.
  • Visually inspect the Liple. The Liple system is see-through, and you will be able to see the medicated pellet at the end of the stem. Make sure that the pellet is present before insertion (Fig. 4).
  • Hold the applicator in a way which is the most comfortable for you. (Fig. 5a and 5b)
  • Please review Figure 6a, the anatomy of the penis. While sitting or standing, whichever is more comfortable for you, take several seconds to gently and slowly stretch the penis upward to its full length, with gentle compression from top to bottom of the glans (Fig. 6b). This straightens and opens the urethra. Slowly insert the Liple stem into the urethra up to the collar (Fig. 6c). If you feel any discomfort or a pulling sensation, withdraw the applicator slightly and then gently reinsert.
  • Gently and completely push down (Fig. 7) the button at the top of the applicator until it stops. It is important to do this to ensure that the medicated pellet is completely released. Hold the applicator in this position for 5 seconds.
  • Gently rock the applicator from side to side. This will separate the medicated pellet from the applicator tip (Fig. 8). If you apply too much pressure you may scratch the lining of the urethra causing it to bleed.
  • Remove the applicator while keeping the penis upright.
  • Visually inspect the applicator tip to see that the medication is no longer in the applicator. Do not touch the stem. If you notice some residual medication in the end of the applicator, gently reinsert into the urethra and repeat steps 7, 8, and 9.
  • Holding the penis upright and stretched to its full length, roll the penis firmly between your hands for at least 10 seconds. This will ensure that the medication is adequately distributed along the walls of the urethra (Fig. 9). If you feel a burning sensation, it may help to continue to roll the penis for an additional 30 – 60 seconds or until the burning subsides.
  • Remember, each Liple is good for a single administration only. Replace the cover on the Liple applicator, place in the opened foil pouch, fold, and discard as normal household waste.

After you have administered Liple, 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:

  • Being well rested and relaxed
  • Sexual foreplay with your partner or self-stimulation while sitting or standing
  • Pelvic exercises (for example, Kegel exercises) these consist of tightening and releasing your pelvic and buttock muscles. These are the muscles you use to stop urination
  • Various positions that may favor blood flow into the penis. Please refer to the patient starter booklet and video for illustrative examples.

Factors Which May Reduce Your Erection:

  • Anxiety, fatigue, tension, and too much alcohol
  • Lying on your back too soon after administration of Liple may decrease blood flow to the penis and result in loss of erection
  • Urination or dribbling immediately following administration may result in loss of medication from the urethra
  • Using medications that contain decongestants, such as over-the-counter cold remedies, allergy, sinus medications, and appetite suppressants, may block the effect of Liple.

COMMONLY ASKED QUESTIONS ABOUT Liple

Will insertion of Liple 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 Liple applicator. With repeated use, administration will become much easier.

What are the side effects associated with Liple?

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, Liple titration should be carried out under medical supervision.

(See also: “WHAT ARE THE POSSIBLE SIDE EFFECTS OF Liple?” on the other side.)

In women, mild vaginal itching and burning have been observed.

After I administer Liple, 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 Liple last?

An erection should begin within 5 – 10 minutes after administering Liple. The duration of effect is approximately 30 – 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 Liple should produce an erection sufficient for sexual intercourse. Liple 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 Liple?

You and your physician will determine the appropriate dose of Liple. 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 Liple?

No. Liple is intended for single-dose application only.

How do I dispose of the Liple applicator?

After you have administered Liple, 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 Liple?

Liple should not be used more than twice per day.

If you have any additional questions about Liple, please call the toll free patient information line at Meda Pharmaceuticals Inc. 1-888-367-MUSE (1-888-367-6873), or visit the Liple product web site, http://www.muserx.net

Liple and MEDA PHARMACEUTICALS are registered trademarks, and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity.

Distributed by:

MEDA

PHARMACEUTICALS®

Somerset, New Jersey 08873-4120

http://www.muserx.net

Catalog Number: 05-10-00000E

IS-1001-03

Revised August 2014

U.S. Patent No. 5,886,039

©2014 Meda Pharmaceuticals Inc.

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5a and 5b Fig. 6a Fig. 6b and 6c Fig. 7 Fig. 8 Fig. 9

MUSE Principal Display Panel - 125 mcg pouch

NDC 0037-8110-01

Liple®

(alprostadil) urethral suppository

Transurethral System

125 mcg

Contents: One single-use applicator.

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Please read patient instruction leaflet regarding usage and storage.

Disposal: Replace cover on applicator, place in opened pouch, fold, and discard as normal household waste.

Rx only

MUSE and MEDA PHARMACEUTICALS are registered trademarks and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity

Distributed by:

MEDA

PHARMACEUTICALS®

Somerset, New Jersey 08873-4120

LP-100100-03

Revised August 2014

Cat. No. 03-10-G01250D U.S. Patent No. 5,886,039

125 mcg pouch

MUSE Principal Display Panel - 250 mcg pouch

NDC 0037-8120-01

Liple®

(alprostadil) urethral suppository

Transurethral System

250 mcg

Contents: One single-use applicator.

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Please read patient instruction leaflet regarding usage and storage.

Disposal: Replace cover on applicator, place in opened pouch, fold, and discard as normal household waste.

Rx only

MUSE and MEDA PHARMACEUTICALS are registered trademarks and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity

Distributed by:

MEDA

PHARMACEUTICALS®

Somerset, New Jersey 08873-4120

LP-100200-03

Revised August 2014

Cat. No. 03-10-G02500D U.S. Patent No. 5,886,039

250 mcg pouch

MUSE Principal Display Panel - 500 mcg pouch

NDC 0037-8130-01

Liple®

(alprostadil) urethral suppository

Transurethral System

500 mcg

Contents: One single-use applicator.

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Please read patient instruction leaflet regarding usage and storage.

Disposal: Replace cover on applicator, place in opened pouch, fold, and discard as normal household waste.

Rx only

MUSE and MEDA PHARMACEUTICALS are registered trademarks and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity

Distributed by:

MEDA

PHARMACEUTICALS®

Somerset, New Jersey 08873-4120

LP-100300-03

Revised August 2014

Cat. No. 03-10-G05000D U.S. Patent No. 5,886,039

500 mcg pouch

MUSE Principal Display Panel - 1000 mcg pouch

NDC 0037-8140-01

Liple®

(alprostadil) urethral suppository

Transurethral System

1000 mcg

Contents: One single-use applicator.

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Please read patient instruction leaflet regarding usage and storage.

Disposal: Replace cover on applicator, place in opened pouch, fold, and discard as normal household waste.

Rx only

MUSE and MEDA PHARMACEUTICALS are registered trademarks and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity

Distributed by:

MEDA

PHARMACEUTICALS®

Somerset, New Jersey 08873-4120

LP-100400-03

Revised August 2014

Cat. No. 03-10-G10000D U.S. Patent No. 5,886,039

1000 mcg pouch

Liple pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Liple available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Liple destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Liple Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Liple pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."MUSE (ALPROSTADIL) SUPPOSITORY [MEDA PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Liple?

Depending on the reaction of the Liple after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Liple not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Liple addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Liple, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Liple consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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Visitor reported useful

No survey data has been collected yet

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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