Incepta Pharmaceuticals Ltd.
Maturex 30 is indicated for
Precautions and warnings
General: Dapoxetine is only indicated in men with PE, Safety has not been habitual and there are no data on the ejaculation-delaying effects in men without PE.
Use with Recreational Drugs: Patients should be wise not to use Dapoxetine in combination with activity drugs, Recreational drugs with serotonergic activity e. g. , ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethyl amide (LSD) may head to potentially serious reactions if combined with Dapoxetine, These reactions include, but are not limited to, arrhythmia, hyperthermia and serotonin syndrome.
Use Of Dapoxetine with activity drugs with ataractic properties e. g. , narcotics and benzodiazepines may far increase somnolence and dizziness.
Ethanol: Combining alcohol with Dapoxetine may increase alcohol-related neurocognitive effects and may also raise neurocardiogenic inauspicious events e. g. , syncope, thereby increasing the risk of chance injury; therefore, patients should be wise to invalidate alcohol while attractive Dapoxetine.
Possibly Symptom symptoms e. g. , nausea, dizziness/lightheadedness and diaphoresis were according more frequently among patients tempered with Dapoxetine compared to placebo.
Orthostatic Hypotension: An erect test should be performed before initiating therapy, In case of a history of Hecht or suspected erect reaction, treatment with Dapoxetine should be avoided.
Dapoxetine Is not indicated for medicine disorders and should not be used in men with these disorders e. g. , schizophrenia, or in those wretched with co-unhealthy depression, as worsening of symptoms associated with depression cannot be excluded.
Withdrawal Effects: Abrupt discontinuation of chronically administered SSRIs used to treat chronic depressive disorders has been according to lead in the following symptoms: Dysphoric mood, irritability, agitation, dizziness, receptive disturbances e. g. , paresthesias, tense shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.
Syncope characterized as loss of consciousness has been reported.The majority of cases occurred during the first 3 hrs after dosing
- after the 1st dose or associated with study-related procedures in the clinic setting (eg
- blood draw
- orthostatic maneuvers
- blood pressure measurements). Prodromal symptoms often preceded the syncope.
Orthostatic hypotension has been reported in clinical trials.
The most common adverse drug reactions (5%) reported during clinical trials were headache
- fatigue. The most common events leading to discontinuation were nausea
Potential serious reactions along with MAOIs, Inhibits metabolism of thioridazine, Risk of serotonergic-associated effects along with serotonergic medicative/flavorer products (including L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium and amp; St, John's wort prep),CNS-active medicative products.
Possible reduction of clearance along with CYP2D6, CYP3A4 and amp; flavin monooxygenase 1 inhibitors, Increased exposure along with strong example ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir and amp; atazanavir) and amp; moderate example erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem) CYP3A4 inhibitors; potent CYP2D6 inhibitors.
Possible Reduced erect tolerance along with PDE-5 inhibitors and amp; ?-sympathomimetic Receptor antagonists, Increases plasma con of desipramine and amp; other drugs metabolized by CYP2D6, Decreases Acing of midazolam, Warfarin (chronic therapy),Alcohol.
Known hypersensitivity to dapoxetine Hlc or to any of the excipients.
Patients with key unhealthy cardiac conditions e. g. , heart failure (NYHA sort II-IV), conduction abnormalities (2nd- or 3rd-degree AV block or disturbed sinus syndrome) not proofed with a abiding pacemaker, significant ischemic heart disease or significant control disease].
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 Dapoxetine 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 Dapoxetine has been discontinued.
Concomitant Treatment with serotonin re-uptake inhibitors [discriminating serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicative/flavoring products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products,Similarly these healthful/flavorer products should not be administered within 7 days after Dapoxetine has been discontinued.
Mode of actions
Dapoxetine selectively inhibits the repute of serotonin, It has limited honorable process at other neurotransmitter sites including muscarinic receptors.
Dosage & Administration
Recommended Starting Dose: 30 mg, taken as needed approximately 1-3 hrs prior to sexual activity.
Maximum Recommended Dosing Frequency: Once every 24 hrs. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg.
Elderly (>65 years): Safety and efficacy of Dapoxetine have not been established in patients >65 years as limited data are available in this population.
Children and Adolescents: Dapoxetine should not be used in individuals
Pregnancy & Lactation
FDA has not yet classified this medicine into a specified pregnancy category. Although there is no enough evidence that taking this medicine during you are pregnant is harmful.
Discuss with your doctor if you are trying to get pregnant while taking this medicine too.
If you do become pregnant while you are taking this medicine, you should continue to take it and contact with your doctors as quickly as possible. They can assist you to decide whether or not to keep taking this medicine. If you abandon taking this medicine and become sick, this would be more pernicious to your child than staying on the medication.
There is no specific information about whether this medicine is passed on to the baby through breast milk. During this medication, if your baby becomes very sleepy, restless, fatigued, exhibit feeding problems, stop breastfeeding and talk to your doctors very quickly.
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