Lejam 60mg indications
Lejam 60mg is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years.
Lejam 60mg should only be prescribed to patients who meet all the following criteria: An intravaginal ejaculatory latency time (IELT) of less than two minutes; persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; marked personal distress or interpersonal difficulty as a consequence of PE; poor control over ejaculation; a history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Lejam 60mg should be administered only as on-demand treatment before anticipated sexual activity. Lejam 60mg should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.
Uses of Lejam 60mg in details
It is used to treat premature ejaculation in adult men aged 18 to 64 years. This may reduce the frustration or worry related to early ejaculation.
Lejam 60mg description
Each film-coated tablet contains Dapoxetine (as hydrochloride) 30 mg and 60 mg.
Excipients/Inactive Ingredients: Each 30 mg tablet contains 45.88 mg of lactose. Each 60 mg tablet contains 91.75 mg of lactose.
Tablet Core: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate 17. Tablet Coating: Lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin, iron oxide black (E172), iron oxide yellow (E172).
Lejam 60mg dosage
Adult Men (Aged 18-64 Years): The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment with Lejam 60mg should not be initiated with the 60 mg dose.
Lejam 60mg is not intended for continuous daily use. Lejam 60mg should be taken only when sexual activity is anticipated. Lejam 60mg must not be taken more frequently than once every 24 hours.
If the individual response to 30 mg is insufficient and the patient has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose may be increased to a maximum recommended dose of 60 mg taken as needed approximately 1 to 3 hours prior to sexual activity. The incidence and severity of adverse events is higher with the 60 mg dose.
If the patient experienced orthostatic reactions on the starting dose, no dose escalation to 60 mg should be performed.
A careful appraisal of individual benefit risk of Lejam 60mg should be performed by the physician after the first four weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment with Lejam 60mg is appropriate.
Data regarding the efficacy and safety of Lejam 60mg beyond 24 weeks are limited. The clinical need of continuing and the benefit risk balance of treatment with Lejam 60mg should be re-evaluated at least every six months.
Elderly (Age 65 Years and Over): The efficacy and safety of Lejam 60mg have not been established in patients age 65 years and over.
Paediatric Population: There is no relevant use of Lejam 60mg in this population in the indication of premature ejaculation.
Patients with Renal Impairment: Caution is advised in patients with mild or moderate renal impairment. Lejam 60mg is not recommended for use in patients with severe renal impairment.
Patients with Hepatic Impairment: Lejam 60mg is contraindicated in patients with moderate and severe hepatic impairment (Child-Pugh Class B and C).
Known CYP2D6 Poor Metabolizers or Patients Treated with Potent CYP2D6 Inhibitors Caution is advised if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer genotype or in patients concomitantly treated with potent CYP2D6 inhibitors.
Patients Treated with Moderate or Potent Inhibitors of CYP3A4: Concomitant use of potent CYP3A4 inhibitors is contraindicated. The dose should be restricted to 30 mg in patients concomitantly treated with moderate CYP3A4 inhibitors and caution is advised.
Administration: For oral use. Tablets should be swallowed whole to avoid the bitter taste. It is recommended that tablets be taken with at least one full glass of water. Lejam 60mg may be taken with or without food.
Precautions to be Taken Before Handling or Administering the Medicinal Product: Before treatment is initiated, see Precautions regarding orthostatic hypotension.
Lejam 60mg interactions
Pharmacodynamic Interactions: Potential for Interaction with Monoamine Oxidase Inhibitors: In patients receiving an SSRI in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued an SSRI and have been started on a MAOI. Some cases 7 presented with features resembling neuroleptic malignant syndrome. Animal data on the effects of combined use of an SSRI and MAOIs suggest that these medicinal products may act synergistically to elevate blood pressure and evoke behavioural excitation. Therefore, Lejam 60mg should not be used in combination with a MAOI, or within 14 days of discontinuing treatment with a MAOI. Similarly, a MAOI should not be administered within 7 days after Lejam 60mg has been discontinued.
Potential for Interaction with Thioridazine: Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias. Medicinal products such as Lejam 60mg that inhibit the CYP2D6 isoenzyme appear to inhibit the metabolism of thioridazine and the resulting elevated levels of thioridazine are expected to augment the prolongation of the QTc interval. Lejam 60mg should not be used in combination with thioridazine or within 14 days of discontinuing treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after Lejam 60mg has been discontinued.
Medicinal/Herbal Products with Serotonergic Effects: As with other SSRIs, co-administration with serotonergic medicinal/herbal products [including MAOIs, L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium and St. John's Wort (Hypericum perforatum) preparations] may lead to an incidence of serotonin associated effects. Lejam 60mg should not be used in combination with other SSRIs, MAOIs or other serotonergic medicinal/herbal products or within 14 days of discontinuing treatment with these medicinal/herbal products. Similarly, these medicinal/herbal products should not be administered within 7 days after Lejam 60mg has been discontinued.
CNS Active Medicinal Products: The use of Lejam 60mg in combination with CNS active medicinal products (e.g., antiepileptics, antidepressants, antipsychotics, anxiolytics, sedative hypnotics) has not been systematically evaluated in patients with premature ejaculation. Consequently, caution is advised if the concomitant administration of Lejam 60mg and such medicinal products is required.
Pharmacokinetic Interactions: Effects of Co-Administered Medicinal Products on the Pharmacokinetics of Lejam 60mg: In vitro studies in human liver, kidney, and intestinal microsomes indicate Lejam 60mg is metabolized primarily by CYP2D6, CYP3A4 and flavin monooxygenase 1 (FMO1). Therefore, inhibitors of these enzymes may reduce Lejam 60mg clearance.
CYP3A4 Inhibitors: Potent CYP3A4 inhibitors. Administration of ketoconazole (200 mg twice daily for 7 days) increased the Cmax and AUCinf of Lejam 60mg (60 mg single dose) by 35% and 99%, respectively. Considering the contribution of both unbound Lejam 60mg and desmethyldapoxetine, the Cmax of the active fraction may be increased by approximately 25% and the AUC of the active fraction may be doubled if taken with potent CYP3A4 inhibitors.
The increases in the Cmax and AUC of the active fraction may be markedly increased in a part of the population which lack a functional CYP2D6 enzyme, i.e., CYP2D6 poor metabolizers, or in combination with potent inhibitors of CYP2D6.
Therefore, concomitant use of Lejam 60mg and potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir and atazanavir, is contraindicated.
Moderate CYP3A4 inhibitors. Concomitant treatment with moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem) may also give rise to significantly increased exposure of Lejam 60mg and desmethyldapoxetine, especially in CYP2D6 poor metabolizers. The maximum dose of Lejam 60mg should be 30 mg if Lejam 60mg is combined with any of these drugs.
These two measures apply to all patients unless the patient has been verified to be a CYP2D6 extensive metabolizer by geno- or phenotyping. In patients verified to be CYP2D6 extensive metabolizers, a maximum dose of 30 mg is advised if Lejam 60mg is combined with a potent CYP3A4 inhibitor and caution is advised if Lejam 60mg in 60 mg doses is taken concomitantly with a moderate CYP3A4 inhibitor.
Potent CYP2D6 Inhibitors: The Cmax and AUCinf of Lejam 60mg (60 mg single dose) increased by 50% and 88%, respectively, in the presence of fluoxetine (60 mg/day for 7 days). Considering the contribution of both unbound Lejam 60mg and desmethyldapoxetine, the Cmax of the active fraction may be increased by approximately 50% and the AUC of the active fraction may be doubled if taken with potent CYP2D6 inhibitors. These increases in the Cmax and AUC of the active fraction are similar to those expected for CYP2D6 poor metabolizers and may result in a higher incidence and severity of dose dependent adverse events.
PDE5 Inhibitors: Lejam 60mg should not be used in patients using PDE5 inhibitors due to possible reduced orthostatic tolerance. The pharmacokinetics of Lejam 60mg (60 mg) in combination with tadalafil (20 mg) and sildenafil (100 mg) were evaluated in a single dose crossover study. Tadalafil did not affect the pharmacokinetics of Lejam 60mg. Sildenafil caused slight changes in Lejam 60mg pharmacokinetics (22% increase in AUCinf and 4% increase in Cmax), which are not expected to be clinically significant.
Concomitant use of Lejam 60mg with PDE5 inhibitors may result in orthostatic hypotension. The efficacy and safety of Lejam 60mg in patients with both premature ejaculation and erectile dysfunction concomitantly treated with Lejam 60mg and PDE5 inhibitors has not been established.
Effects of Lejam 60mg on the Pharmacokinetics of Co-Administered Medicinal Products: Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Lejam 60mg to patients receiving daily doses of tamsulosin did not result in changes in the pharmacokinetics of tamsulosin. The addition of Lejam 60mg to tamsulosin did not result in a change in the orthostatic profile and there were no differences in orthostatic effects between tamsulosin combined with either 30 or 60 mg Lejam 60mg and tamsulosin alone; however, Lejam 60mg should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance.
Medicinal products metabolized by CYP2D6: Multiple doses of Lejam 60mg (60 mg/day for 6 days) followed by a single 50 mg dose of desipramine increased the mean Cmax and AUCinf of desipramine by approximately 11% and 19%, respectively, compared to desipramine administered alone. Lejam 60mg may give rise to a similar increase in the plasma concentrations of other drugs metabolized by CYP2D6. The clinical relevance is likely to be small.
Medicinal Products Metabolized by CYP3A4: Multiple dosing of Lejam 60mg (60 mg/day for 6 days) decreased the AUCinf of midazolam (8 mg single dose) by approximately 20% (range -60 to +18%). The clinical relevance of the effect on midazolam is likely to be small in most patients. The increase in CYP3A activity may be of clinical relevance in some individuals concomitantly treated with a medicinal product mainly metabolized by CYP3A and with a narrow therapeutic window.
Medicinal Products Metabolized by CYP2C19: Multiple dosing of Lejam 60mg (60 mg/day for 6 days) did not inhibit the metabolism of a single 40 mg dose of omeprazole. Lejam 60mg is unlikely to affect the pharmacokinetics of other CYP2C19 substrates.
Medicinal Products Metabolized by CYP2C9: Multiple dosing of Lejam 60mg (60 mg/day for 6 days) did not affect the pharmacokinetics or pharmacodynamics of a single 5 mg dose of glyburide. Lejam 60mg is unlikely to affect the pharmacokinetics of other CYP2C9 substrates.
Warfarin and Medicinal Products that Are Known to Affect Coagulation and/or Platelet Function: There are no data evaluating the effect of chronic use of warfarin with Lejam 60mg; therefore, caution is advised when Lejam 60mg is used in patients taking warfarin chronically. In a pharmacokinetic study, Lejam 60mg (60 mg/day for 6 days) did not affect the pharmacokinetics or pharmacodynamics (PT or INR) of warfarin following a single 25 mg dose. There have been reports of bleeding abnormalities with SSRIs.
Ethanol: Coadministration of a single dose of ethanol, 0.5 g/kg (approximately 2 drinks), did not affect the pharmacokinetics of Lejam 60mg (60 mg single dose); however, Lejam 60mg in combination with ethanol increased somnolence and significantly decreased self-rated alertness. Pharmacodynamic measures of cognitive impairment (Digit Vigilance Speed, Digit Symbol Substitution Test) also showed an additive effect when Lejam 60mg was coadministered with ethanol. Concomitant use of alcohol and Lejam 60mg increases the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Lejam 60mg may increase these alcohol-related effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Lejam 60mg.
Lejam 60mg side effects
Summary of the Safety Profile: Syncope and orthostatic hypotension have been reported in clinical trials.
The following adverse drug reactions were reported during Phase 3 clinical trials most commonly and were dose related: Nausea (11.0% and 22.2% in 30 mg and 60 mg prn Lejam 60mg groups, respectively), dizziness (5.8% and 10.9%), headache (5.6% and 8.8%), diarrhoea (3.5% and 6.9%), insomnia (2.1% and 3.9%) and fatigue (2.0% and 4.1%). The most common adverse events leading to discontinuation were nausea (2.2% of Lejam 60mg-treated subjects) and dizziness (1.2% of Lejam 60mg-treated subjects).
Tabulated List of Adverse Reactions: The safety of Lejam 60mg was evaluated in 4224 subjects with premature ejaculation who participated in five double-blind, placebo-controlled clinical trials. Of the 4224 subjects, 1616 received Lejam 60mg 30 mg as needed and 2608 received 60 mg, either as needed or once daily.
Table 3 presents the adverse reactions that have been reported.
Adverse drug reactions reported in the 9-month long-term open-label extension trial were consistent with those reported in the double-blind studies and no additional adverse drug reactions were reported.
Description of Selected Adverse Reactions: Syncope characterized as loss of consciousness, with bradycardia or sinus arrest observed in patients wearing Holter monitors, has been reported in clinical trials and is considered medicinal product-related. The majority of cases occurred during the first 3 hours after dosing, after the first dose or associated with study-related procedures in the clinical setting (such as blood draw and orthostatic maneuvers and blood pressure measurements). Prodromal symptoms often preceded the syncope.
The occurrence of syncope and possibly prodromal symptoms appears dose dependent as demonstrated by higher incidence among patients treated with higher than recommended doses in Phase 3 clinical trials.
Orthostatic hypotension has been reported in clinical trials. The frequency of syncope characterized as loss of consciousness in the Lejam 60mg clinical development program varied depending on the population studied and ranged from 0.06% (30 mg) to 0.23% (60 mg) for subjects enrolled in the Phase 3 placebo-controlled clinical trials to 0.64% (all doses combined) for Phase 1 non-PE healthy volunteer studies.
Other Special Populations: Caution is advised if increasing the dose to 60 mg in patients taking potent CYP2D6 inhibitors or if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer genotype.
Withdrawal Effects: Abrupt discontinuation of chronically administered SSRIs used to treat chronic depressive disorders has been reported to result in the following symptoms: Dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.
Results of a safety study showed a slightly higher incidence of withdrawal symptoms of mild or moderate insomnia and dizziness in subjects switched to placebo after 62 days of daily dosing.
Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
Lejam 60mg contraindications
Hypersensitivity to Lejam 60mg or to any of the excipients of Lejam 60mg.
Significant pathological cardiac conditions such as: Heart failure (NYHA class II-IV); conduction abnormalities such as AV block or sick sinus syndrome; significant ischemic heart disease; significant valvular disease; a history of syncope; a history of mania or severe depression. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with a MAOI. Similarly, a MAOI should not be administered within 7 days after Lejam 60mg has been discontinued.
Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after Lejam 60mg has been discontinued.
Concomitant treatment with serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects [e.g., L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)] or within 14 days of discontinuing treatment with these medicinal/herbal products. Similarly, these medicinal/herbal products should not be administered within 7 days after Lejam 60mg has been discontinued.
Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc..
Moderate and severe hepatic impairment.
Active ingredient matches for Lejam 60mg:
Dapoxetine in Oman.
List of Lejam 60mg substitutes (brand and generic names)
|Sort by popularity|
|Unit description / dosage (Manufacturer)||Price, USD|
|Lejam 30mg (Oman)|
|Priligy (Austria, Finland, Germany, Italy, Mexico, New Zealand, Portugal)|
|Tablet, Film-Coated; Oral; Dapoxetin 30 mg (A.Menarini)|
|Tablet, Film-Coated; Oral; Dapoxetin 60 mg (A.Menarini)|
|Priligy 30 mg x 3's (A.Menarini)|
|Priligy 60 mg x 3's (A.Menarini)|
|Priligy FC tab 30 mg 3's (A.Menarini)||$ 24.00|
|Priligy film-coated tab 30 mg 3's (A.Menarini)|
|Priligy film-coated tab 30 mg 6's (A.Menarini)|
|Priligy film-coated tab 60 mg 3's (A.Menarini)|
|Priligy film-coated tab 60 mg 6's (A.Menarini)|
|Priligy FC tab 30 mg 1's (A.Menarini)||$ 24.00|
|Priligy FC tab 30 mg 6's (A.Menarini)||$ 24.00|
|Priligy 30 (Serbia)|
|Priligy 30mg (Austria, Hungary, Luxembourg, Switzerland)|
|Priligy 60mg (Austria, Hungary, Luxembourg)|
|RISTOR 200 MG INJECTION 1 vial / 300 ML injection each (Indoco Remedies Ltd)||$ 4.68|
|RISTOR 30 MG TABLET 1 strip / 4 tablets each (Indoco Remedies Ltd)||$ 1.56|
|RISTOR 60 MG TABLET 1 strip / 4 tablets each (Indoco Remedies Ltd)||$ 2.27|
|RISTOR TABLET 1 strip / 10 tablets each (Indoco Remedies Ltd)||$ 4.75|
|Ristor 200mg Injection (Indoco Remedies Ltd)||$ 0.02|
|Ristor NA Tablet (Indoco Remedies Ltd)||$ 0.47|
|SENSAPE TABLET 1 strip / 4 tablets each (Vilco Laboratories Pvt Ltd)||$ 1.35|
|Sensape 30mg Tablet (Vilco Laboratories Pvt Ltd)||$ 0.34|
|30 mg x 6's (Emcure Pharmaceuticals Ltd.)||$ 2.29|
|Sustinex 60 mg Tablet (Emcure Pharmaceuticals Ltd.)||$ 0.54|
|Sustinex 30 mg Tablet (Emcure Pharmaceuticals Ltd.)||$ 0.38|
|Sustinex 30mg TAB / 6 (Emcure Pharmaceuticals Ltd.)||$ 2.55|
|SUSTINEX 30MG TABLET 1 strip / 6 tablets each (Emcure Pharmaceuticals Ltd.)||$ 2.80|
|SUSTINEX 60MG TABLET 1 strip / 6 tablets each (Emcure Pharmaceuticals Ltd.)||$ 3.26|
|SUSTINEX -30 TABLET 1 strip / 6 tablets each (Emcure Pharmaceuticals Ltd.)||$ 2.80|
|SUSTINEX tab 30 mg x 6's (Emcure Pharmaceuticals Ltd.)||$ 2.55|
|Sustinex 30mg TAB / 6 (Emcure Pharmaceuticals Ltd.)||$ 2.55|
|VIGLAST 30MG TABLET 1 strip / 4 tablets each (Alkem Laboratories Ltd)||$ 1.57|
|30 mg x 4's (Cipla Limited)||$ 1.65|
|Xydap 30 mg Tablet (Cipla Limited)||$ 0.41|
|Xydap 30mg TAB / 4 (Cipla Limited)||$ 1.65|
|XYDAP 30 MG TABLET 1 strip / 4 tablets each (Cipla Limited)||$ 1.50|
|XYDAP film-coated tab 30 mg x 4's (Cipla Limited)||$ 1.65|
|Xydap 30mg TAB / 4 (Cipla Limited)||$ 1.65|
- PubChem. "Dapoxetine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Dapoxetine". http://www.drugbank.ca/drugs/DB04884 (accessed September 17, 2018).
- MeSH. "MeSH Tree: MeSH (Medical Subject Headings) is the NLM controlled vocabulary thesaurus used for indexing articles for PubMed.". http://www.nlm.nih.gov/mesh/meshhome... (accessed September 17, 2018).
ReviewsThe results of a survey conducted on ndrugs.com for Lejam 60mg 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 Lejam 60mg. 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.
Consumer reported usefulNo survey data has been collected yet
1 consumer reported price estimatesWas 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 Lejam 60mg 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.
10 consumers reported time for resultsTo what extent do I have to use Lejam 60mg before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 day and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Lejam 60mg. To get the time effectiveness of using Lejam 60mg drug by other patients, please click here.
|> 3 month||2||20.0%|
23 consumers reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology