Da Sutra 30 X
Sildenafil Citrate IP 50 mg and Dapoxetine Hydrochloride IP 30 mg Tablets
PHARMACOLOGY
Dapoxetine Hydrochloride is a selective serotonine reuptake inhibitor (SSRI) indicated for the treatment of premature ejaculation. Sildenafil Citrate is a selective inhibitor of phosphodiesterase-5 and indicated for the treatment of erectile dysfunction.
The rationale for this fixed dose combination arises from the following facts and evidences
Conditions of erectile dysfunction (ED) and premature ejaculation (PE) co-exist as co-morbidities in approximately 31.9% patients with pe (Ref.: European Urology; 2007, 51,816-824). Other studies (e.g. Int J Androl 2005;28 (Supp, 2) :40-5.) have also demonstrated a high prevalence of co-morbid PE and ED.
After successfull treatment for erectile dysfunction with Sildenafil, 28% patients develop premature ejaculation, which needs further treatment with a drug like Dapoxetine (Ref,: International Journal of Andrology, 2002, 25,5,301-305.) PDE5-inhibitor like Sildenafil can enhance the effectiveness of SSRI like Dapoxetine (Ref. Chin Med J 2007;120 (11): 1000-1006.
In addition, Dapoxetine has no clinically significant pharmacokinetic interactions with Sildenafil and the combination is well tolerated (Ref,: International Journal of Impotence Research, 2006, 18, 104-110).
MEDICINAL BENEFITS
Da Sutra 30 X Tablets, 4's is used in the treatment of premature ejaculation and erectile dysfunction. It helps to improve ejaculation and erection time. It can help to resolve your problems in sexual relationships and the stress, worry, or frustration associated with it. It helps to boost your confidence and inprove sexual performance. Take this medicine exactly as prescribed by your doctor for the best results.
DIRECTIONS FOR USE
Da Sutra 30 X Tablets, 4's is available in the form of tablets. Tablets should be swallowed as a whole with a glass of water. Do not crush, chew, or break the tablets. In general, this medicine is taken 1 to 3 hours before the sexual activity and one tablets is taken once a day. However, the exact dose and duration are given by the doctor based on your health condition.
SIDE EFFECTS OF DA SUTRA 30 X TABLETS, 4'S
- Dizziness
- Headache
- Nausea (feeling sick)
- Stuffy nose
- Facial flushing (reddening of the face)
- Indigestion
- Dry mouth
- Vision problems such as light sensitivity or blurred vision
Before taking Da Sutra 30 X Tablet, 4's, inform your doctor it you have sickle cell anaemia (abnornal production of red blood cells), leukaemia (blood cancer), multiple myeloma (cancer of bone marrow), peyronie's disease (deformity in the penis), ulcer, or bleeding in the stomach, heart problems, been taking recreational drugs such as ecstasv and narcotics. mood disorders, mental illness, fits, are alcoholic, bleeding or blood clotting problems, kidney problems, and glaucoma (increased pressure in the eye). Da Sutra 30 X Tablets,4's should not be taken along with medicines such as nitrates (to treat blood pressure or chest pain), antidepressants, antibiotics, or pain killers. Inform your doctor if you are taking any of the above medicines. If you experience a sudden decrease in vision or loss of vision while using Da Sutra 30 x Tablets, 4's stop taking this medicine and consult your doctor immediately.
DRUG INTERACTIONS
DRUG-DRUG INTERACTION: Da Sutra 30 X Tablets, 4's should not be used along with medicines used to treat chest pain (amyl nitrite and nitroglycerin), monoamine oxidase inhibitors (MAOI) used to treat depression, and other antidepressants (lithium and hypericum performance), a medicine used to treat psychosis (thioridazine), antibiotic (linezolid), pain killer (tramadol), a medicine that regulates sleep (tryptophan). Medicines used to after stopping the above medicines before you start taking Da Sutra 30 X Tablets, 4's or wait at least 7 days after stopping Da Sutra 30 X Tablets, 4's before you start taking the above medicines. Da Sutra 30 X Tablets, 4's may interact with antifungal agents (ketoconazole and itraconazole), medicines used to treat HIV (ritonavir, saquinavir, and atazanavir, etc.), antibiotic 9telithromycin), medicines used to treat high blood pressure, and alpha-blockers that are used to treat high blood pressure or prostate problems in men (alfuzosin, doxazosin, and tamsulosin, etc.)
DRUG-FOOD INTERACTIONS: Do not drink grapefruit juice at least 24 hours before taking Da Sutra 30 X Tablets, 4's and avoid alcohol while taking this medicine as it may increase the risk of side-effects. In addition, avoid heavy meals before taking this medicines as it may cause Da Sutra 30 X Tablet, 4's to delay its effect.
DRUG-DISEASE INTERACTIONS: Da Sutra 30 X Tablets, 4's should not be used in patients with severe heart or liver problem, a recent history of heart attack or stroke, hypotension (low blood pressure ), retinits pigmentosa (a rare inherited eye disease), or loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION) (an eye disease), history of fainting, and mania or depression.
According to the understanding to the pathway of NO-cGMP, which plays a vital role in the relaxation of smooth muscle, the possible mechanisms involved in PDE5-Is enhancing the effectiveness of SSRIs in the combination therapy to PE, can be explained as follows: relaxing the smooth muscles of vas deferens, seminal vesicle, prostate and urethra; prolonging the duration of erection; decreasing the central sympathetic output; and increasing confidence, the perception of ejaculatory control, overall sexual satisfaction, and decreasing the postorgasmic refractory time to achieve a second eraction after ejaculation.
MECHANISM OF ACTION OF DAPOXETINE HYDROCHLORIDE
The mechanism of action of Dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre-and post-synaptic receptors. Human ejaculation is primarily medicated by the sympathetic nervous system. The ejaculatory pathway originates from a spinal reflex centre, mediated by the brain stem, which is influenced initially by a number of nuclei in the brain (medical preoptic and paraventricular nuclei).
MECHANISM OF ACTION OF SILDENAFIL CITRATE
The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. No then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil has no direct relaxant effects on isolated human corpus cavernousum, but enhances the effects of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by Sildenafil causes incresed levels of cGMP in the corpus cavernosum, resulting in smooth muscles relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effects in the absence of sexual stimulation.
PHARMACOKINETIC-DAPOXETINE HYDROCHLORIDE
ABSORPTION: Dapoxetine is rapidly absorbed, with maximum plasma concentrations (Cmax) occuring approximatyely 1-2 hours after tablets intake. The absolute bioavailability is 42% (range: 15 to 76%). Following single oral doses of 30 mg and 60 mg in the fasted state, peak plasma concentrations of dapoxetine were 297 ng/ml after 1.01 hours and 498 ng/ml after 1.27 hours, respectively. Ingestion of a high fat meal modestly reduced the Cmax (by 10%) and modestly increased the area under the curve (AUC: by 12%) of dapoxetine and slightly delayed the time for Dapoxetine to reach peak concentrations; however, the extent of absorption was not affected by consumption of a high fat meal. These changes are not clinically significant.
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