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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Sensape is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years.
Sensape 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.
Sensape should be administered only as on-demand treatment before anticipated sexual activity. Sensape should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.
Uses of Sensape 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.
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.
Sensape 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.
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 Sensape should not be initiated with the 60 mg dose.
Sensape is not intended for continuous daily use. Sensape should be taken only when sexual activity is anticipated. Sensape 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 Sensape 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 Sensape is appropriate.
Data regarding the efficacy and safety of Sensape beyond 24 weeks are limited. The clinical need of continuing and the benefit risk balance of treatment with Sensape should be re-evaluated at least every six months.
Elderly (Age 65 Years and Over): The efficacy and safety of Sensape have not been established in patients age 65 years and over.
Paediatric Population: There is no relevant use of Sensape in this population in the indication of premature ejaculation.
Patients with Renal Impairment: Caution is advised in patients with mild or moderate renal impairment. Sensape is not recommended for use in patients with severe renal impairment.
Patients with Hepatic Impairment: Sensape 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. Sensape 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.
Sensape interactions
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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, Sensape 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 Sensape 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 Sensape 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. Sensape 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 Sensape 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. Sensape 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 Sensape has been discontinued.
CNS Active Medicinal Products: The use of Sensape 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 Sensape and such medicinal products is required.
Pharmacokinetic Interactions:Effects of Co-Administered Medicinal Products on the Pharmacokinetics of Sensape: In vitro studies in human liver, kidney, and intestinal microsomes indicate Sensape is metabolized primarily by CYP2D6, CYP3A4 and flavin monooxygenase 1 (FMO1). Therefore, inhibitors of these enzymes may reduce Sensape clearance.
CYP3A4 Inhibitors: Potent CYP3A4 inhibitors. Administration of ketoconazole (200 mg twice daily for 7 days) increased the Cmax and AUCinf of Sensape (60 mg single dose) by 35% and 99%, respectively. Considering the contribution of both unbound Sensape 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 Sensape 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 Sensape and desmethyldapoxetine, especially in CYP2D6 poor metabolizers. The maximum dose of Sensape should be 30 mg if Sensape 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 Sensape is combined with a potent CYP3A4 inhibitor and caution is advised if Sensape in 60 mg doses is taken concomitantly with a moderate CYP3A4 inhibitor.
Potent CYP2D6 Inhibitors: The Cmax and AUCinf of Sensape (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 Sensape 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: Sensape should not be used in patients using PDE5 inhibitors due to possible reduced orthostatic tolerance. The pharmacokinetics of Sensape (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 Sensape. Sildenafil caused slight changes in Sensape pharmacokinetics (22% increase in AUCinf and 4% increase in Cmax), which are not expected to be clinically significant.
Concomitant use of Sensape with PDE5 inhibitors may result in orthostatic hypotension. The efficacy and safety of Sensape in patients with both premature ejaculation and erectile dysfunction concomitantly treated with Sensape and PDE5 inhibitors has not been established.
Effects of Sensape on the Pharmacokinetics of Co-Administered Medicinal Products:Tamsulosin: Concomitant administration of single or multiple doses of 30 mg or 60 mg Sensape to patients receiving daily doses of tamsulosin did not result in changes in the pharmacokinetics of tamsulosin. The addition of Sensape 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 Sensape and tamsulosin alone; however, Sensape 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 Sensape (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. Sensape 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 Sensape (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 Sensape (60 mg/day for 6 days) did not inhibit the metabolism of a single 40 mg dose of omeprazole. Sensape is unlikely to affect the pharmacokinetics of other CYP2C19 substrates.
Medicinal Products Metabolized by CYP2C9: Multiple dosing of Sensape (60 mg/day for 6 days) did not affect the pharmacokinetics or pharmacodynamics of a single 5 mg dose of glyburide. Sensape 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 Sensape; therefore, caution is advised when Sensape is used in patients taking warfarin chronically. In a pharmacokinetic study, Sensape (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 Sensape (60 mg single dose); however, Sensape 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 Sensape was coadministered with ethanol. Concomitant use of alcohol and Sensape increases the chance or severity of adverse reactions such as dizziness, drowsiness, slow reflexes, or altered judgment. Combining alcohol with Sensape 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 Sensape.
Sensape side effects
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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 Sensape 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 Sensape-treated subjects) and dizziness (1.2% of Sensape-treated subjects).
Tabulated List of Adverse Reactions: The safety of Sensape was evaluated in 4224 subjects with premature ejaculation who participated in five double-blind, placebo-controlled clinical trials. Of the 4224 subjects, 1616 received Sensape 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 Sensape 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.
Sensape contraindications
Hypersensitivity to Sensape or to any of the excipients of Sensape.
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 Sensape 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 Sensape 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 Sensape has been discontinued.
Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc..
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).
Reviews
The results of a survey conducted on ndrugs.com for Sensape 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 Sensape. 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.
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