Emposil Uses

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What is Emposil?

Emposil is used to treat men who have erectile dysfunction (also called sexual impotence). Emposil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, Emposil helps to maintain an erection after the penis is stroked. Without physical action to the penis, such as that occurring during sexual intercourse, Emposil will not work to cause an erection.

Emposil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is a type of high blood pressure that occurs between the heart and the lungs. When hypertension occurs in the lungs, the heart must work harder to pump enough blood through the lungs. Emposil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

Emposil is available only with your doctor's prescription.

Emposil indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Emposil is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Emposil was added to background epoprostenol therapy.

Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II–III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).

Limitation of Use: Adding Emposil to bosentan therapy does not result in any beneficial effect on exercise capacity.

How should I use Emposil?

Use Emposil suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Emposil suspension.

Uses of Emposil in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Erectile dysfunction: Emposil: Treatment of erectile dysfunction.

Pulmonary arterial hypertension: Emposil: Treatment of pulmonary arterial hypertension (WHO group I; efficacy established predominately in patients with WHO/NYHA functional class II and III) in adults to improve exercise ability and delay clinical worsening.

Off Label Uses

High-altitude pulmonary edema

Based on the 2019 Wilderness Medical Society consensus guidelines for the prevention and treatment of acute altitude illness, Emposil is a recommended option for the prevention and treatment of high-altitude pulmonary edema (as an adjunct to descent, oxygen, or portable hyperbaric therapy). Supplemental oxygen and descent are the mainstays of treatment. For prevention, Emposil should only be considered for patients with a history of high-altitude pulmonary edema, especially multiple episodes.

Raynaud phenomenon

Data from a meta-analysis and small controlled trials support the use of Emposil for Raynaud phenomenon related to systemic sclerosis, demonstrating a decrease in the frequency and severity of attacks.

Emposil description

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Each film-coated tablet contains Sildenafil equivalent to 50 mg Emposil.

Each film-coated tablet contains Sildenafil equivalent to 100 mg Emposil.

Each orodispersible tablet contains Sildenafil equivalent to 50 mg Emposil.

Excipients/Inactive Ingredients: Film-Coated Tablets: In addition to the active ingredient, Emposil, each tablet contains the following inactive ingredients: Microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose (hypromellose), titanium dioxide (E171), lactose, triacetin, and FD & C Blue #2 aluminum lake [indigo carmine aluminum lake (E132)].

Orodispersible Tablets: In addition to the active ingredient, Emposil, each orodispersible tablet contains the following inactive ingredients: Microcrystalline cellulose, silica hydrophobic colloidal, croscarmellose sodium, magnesium stearate, indigo carmine aluminium lake (E132), sucralose, mannitol, crospovidone, polyvinyl acetate, povidone, flavouring (contains: Maltodextrin and dextrin), natural flavouring (contains: Maltodextrin, E422 glycerol and E1520 propylene glycol), lemon flavouring (contains: Maltodextrin and E307 alpha tocopherol).

Emposil dosage

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Emposil Dosage

Generic name: Emposil 20mg

Dosage form: tablet, film coated; injection; oral powder

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Emposil Tablets and

Oral Suspension

The recommended dose of Emposil is 5 mg or 20 mg three times a day. Administer Emposil doses 4–6 hours apart.

In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg three times a day is not recommended.

Emposil Injection

Emposil injection is for the continued treatment of patients with PAH who are currently prescribed oral Emposil and who are temporarily unable to take oral medication.

The recommended dose is 2.5 mg or 10 mg administered as an intravenous bolus injection three times a day. The dose of Emposil injection does not need to be adjusted for body weight.

A 10 mg dose of Emposil injection is predicted to provide pharmacological effect of Emposil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose.

Reconstitution of the Powder for

Oral Suspension

  1. Tap the bottle to release the powder.
  2. Remove the cap.
  3. Accurately measure out 60 mL of water and pour the water into the bottle. (Figure 1)

    Figure 1

  4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 2)

    Figure 2

  5. Remove the cap.
  6. Accurately measure out another 30 mL of water and add this to the bottle. You should always add a total of 90 mL of water irrespective of the dose prescribed. (Figure 3)

    Figure 3

  7. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 4)

    Figure 4

  8. Remove the cap.
  9. Press the bottle adaptor into the neck of the bottle (as shown on Figure 5, below). The adaptor is provided so that you can fill the oral syringe with medicine from the bottle. Replace the cap on the bottle.

    Figure 5

  10. Write the expiration date of the constituted oral suspension on the bottle label (the expiration date of the constituted oral suspension is 60 days from the date of constitution).

Incompatibilities

Do not mix with any other medication or additional flavoring agent.

More about Emposil (Emposil)

Consumer resources

Professional resources

Related treatment guides

Emposil interactions

See also:
What other drugs will affect Emposil?

Effects of Other Drugs on Emposil Emposil Citrate

In Vitro Studies: Emposil Emposil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce Emposil clearance.

In Vivo Studies: Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma Emposil concentrations when coadministered with Emposil (50 mg) to healthy volunteers.

When a single 100 mg dose of Emposil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 182% increase in Emposil systemic exposure (AUC). In addition, coadministration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor, at steady state (1200 mg tid) with Emposil (100 mg single dose) resulted in a 140% increase in Emposil Cmax and a 210% increase in Emposil AUC. Emposil Emposil citrate had no effect on saquinavir pharmacokinetics. Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole would be expected to have still greater effects, and population data from patients in clinical trials did indicate a reduction in Emposil clearance when it was coadministered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine).

Coadministration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (400 mg bid) with Emposil (100 mg single dose) resulted in a 300% (4-fold) increase in Emposil Cmax and a 1000% (11-fold) increase in Emposil plasma AUC. At 24 hours the plasma levels of Emposil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when Emposil was dosed alone. This is consistent with ritonavirs marked effects on a broad range of P450 substrates. Emposil Emposil citrate had no effect on ritonavir pharmacokinetics.

It can be expected that concomitant administration of CYP3A4 inducers, such as rifampin, will decrease plasma levels of Emposil.

Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Emposil.

Pharmacokinetic data from patients in clinical trials showed no effect on Emposil pharmacokinetics of CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, ACE inhibitors, and calcium channel blockers. The AUC of the active metabolite, N-desmethyl Emposil, was increased 62% by loop and potassium-sparing diuretics and 102% by nonspecific beta-blockers. These effects on the metabolite are not expected to be of clinical consequence.

Effects of Emposil Emposil Citrate on Other Drugs

In Vitro Studies: Emposil Emposil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 >150 mM). Given Emposil peak plasma concentrations of approximately 1 mcM after recommended doses, it is unlikely that Emposil will alter the clearance of substrates of these isoenzymes.

In Vivo Studies: When Emposil 100 mg oral was coadministered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.

No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.

Emposil Emposil citrate (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg).

Emposil Emposil citrate (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.08%.

Emposil Emposil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.

Emposil side effects

See also:
What are the possible side effects of Emposil?

The following serious adverse events are discussed elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Safety data of Emposil in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Emposil-treated patients with PAH, WHO Group I.

The overall frequency of discontinuation in Emposil-treated patients on 20 mg three times a day was 3% and was the same for the placebo group.

In Study 1, the adverse reactions that were reported by at least 3% of Emposil-treated patients (20 mg three times a day) and were more frequent in Emposil-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature.

Table 1: Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Emposil-Treated Patients than Placebo-Treated Patients and Incidence ≥ 3% in Emposil-Treated Patients)

Placebo, %

(n = 70)

Emposil 20 mg three times a day, %

(n = 69)

Placebo-Subtracted, %
Epistaxis 1 9 8
Headache 39 46 7
Dyspepsia 7 13 6
Flushing 4 10 6
Insomnia 1 7 6
Erythema 1 6 5
Dyspnea exacerbated 3 7 4
Rhinitis 0 4 4
Diarrhea 6 9 3
Myalgia 4 7 3
Pyrexia 3 6 3
Gastritis 0 3 3
Sinusitis 0 3 3
Paresthesia 0 3 3

At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.

The incidence of retinal hemorrhage with Emposil 20 mg three times a day was 1.4% versus 0% placebo and for all Emposil doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg three times a day and at all doses studied was 1.4% for Emposil versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.

In a placebo-controlled fixed dose titration study (Study 2) of Emposil (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the Emposil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2.

Table 2: Adverse Reactions (%) in patients with PAH in Study 2 (incidence in Emposil + Epoprostenol group at least 6% greater than Epoprostenol group)

Emposil + Epoprostenol

(n = 134)

Epoprostenol

(n = 131)

(Emposil + Epoprostenol) minus Epoprostenol
Headache 57 34 23
Edema^ 25 13 14
Dyspepsia 16 2 14
Pain in extremity 17 6 11
Diarrhea 25 18 7
Nausea 25 18 7
Nasal congestion 9 2 7
^includes peripheral edema

Emposil Injection

Emposil injection was studied in a 66-patient, placebo-controlled study in patients with PAH at doses targeting plasma concentrations between 10 and 500 ng/mL (up to 8 times the exposure of the recommended dose). Adverse events with Emposil injection were similar to those seen with oral tablets.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Emposil (marketed for both PAH and erectile dysfunction). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular Events

In postmarketing experience with Emposil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of Emposil without sexual activity. Others were reported to have occurred hours to days after use concurrent with sexual activity. It is not possible to determine whether these events are related directly to Emposil, to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these or other factors.

Nervous system

Seizure, seizure recurrence

Emposil contraindications

See also:
What is the most important information I should know about Emposil?

Do not take Emposil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Emposil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of Emposil.

Do not take Emposil more than once a day. Allow 24 hours to pass between doses. Do not take Emposil while also taking Emposil, unless your doctor tells you to.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Emposil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking Emposil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether Emposil is the actual cause of vision loss.

Stop using Emposil and get emergency medical help if you have sudden vision loss.



Active ingredient matches for Emposil:

Sildenafil in Indonesia.

Sildenafil citrate in Indonesia.


Unit description / dosage (Manufacturer)Price, USD
Emposil 50 mg x 4's$ 28.52
Emposil 100 mg x 4's$ 35.96

List of Emposil substitutes (brand and generic names):

Elonza FC tab 100 mg 2 x 2's (Unison)
50 mg x 4's (Aden Healthcare)$ 1.11
100 mg x 10's (Aden Healthcare)$ 1.75
Enigma 50mg TAB / 4 (Aden Healthcare)$ 1.11
Enigma 100mg TAB / 10 (Aden Healthcare)$ 1.75
ENIGMA tab 50 mg x 4's (Aden Healthcare)$ 1.11
ENIGMA tab 100 mg x 10's (Aden Healthcare)$ 1.75
Enigma 50mg TAB / 4 (Aden Healthcare)$ 1.11
Enigma 100mg TAB / 10 (Aden Healthcare)$ 1.75
Enigma 100mg Tablet (Aden Healthcare)$ 0.44
Enigma 50mg Tablet (Aden Healthcare)$ 0.28
ENIGMA-100 TABLET 1 strip / 4 tablets each (Aden Healthcare)$ 1.75
ENIGMA-50 TABLET 1 strip / 4 tablets each (Aden Healthcare)$ 1.11
ENTHUSIA Capsule/ Tablet / 50mg / 4 units (Lupin)$ 1.14
ENTHUSIA Capsule/ Tablet / 100mg / 4 units (Lupin)$ 1.71
Enthusia 50mg TAB / 4 (Lupin)$ 1.14
Enthusia 100mg TAB / 4 (Lupin)$ 1.71
50 mg x 4's (Lupin)$ 1.14
100 mg x 4's (Lupin)$ 1.71
ENTHUSIA 100 MG TABLET 1 strip / 4 tablets each (Lupin)$ 0.23
ENTHUSIA 50 MG TABLET 1 strip / 4 tablets each (Lupin)$ 0.20
ENTHUSIA tab 50 mg x 4's (Lupin)$ 1.14
ENTHUSIA tab 100 mg x 4's (Lupin)$ 1.71
Enthusia 50mg TAB / 4 (Lupin)$ 1.14
Enthusia 100mg TAB / 4 (Lupin)$ 1.71
Enthusia 100mg Tablet (Lupin)$ 0.06
Enthusia 50mg Tablet (Lupin)$ 0.05
50 mg x 10's (Panjon)
Erec 50mg TAB / 10 (Panjon)
EREC 50MG TABLET 1 strip / 4 tablets each (Panjon)$ 0.60
EREC tab 50 mg x 4's (Panjon)$ 0.60
Erec 50mg TAB / 10 (Panjon)
Erec 50mg Tablet (Panjon)$ 0.15

References

  1. PubChem. "sildenafil". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "sildenafil". http://www.drugbank.ca/drugs/DB00203 (accessed September 17, 2018).
  3. MeSH. "Urological Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Emposil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Emposil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported useful

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1 consumer reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Emposil drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Expensive1
100.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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