Tadali Superb (Tadalafil and Dapoxetine Tablets) - Product Information
Tadali Superb (Tadalafil and Dapoxetine Tablets) is a combination medicine containing 20 mg of Tadalafil and 60 mg of Dapoxetine Hydrochloride in a single tablet. Tadalafil is a phosphodiesterase-5 (PDE5) inhibitor which is used for the treatment of erectile dysfunction (ED) and Dapoxetine Hydrochloride is a selective serotonin reuptake inhibitor (SSRI) used to treat premature ejaculation. Tadali Superb is used when treatment of male erectile dysfunction as well as treatment of premature ejaculation in men are necessary at the same time.
Tadali Superb tablets are manufactured by Alpha-Pharma Healthcare, India in the strengths of 80 mg. You can buy Tadali Superb online at only $0.90 a pill from Clearsky Pharmacy. We also have in stock Alphagra Superb (Sildenafil and Dapoxetine Tablets) which is also used to treat the same indications.
Name of the Drug
We supply original Tadali Superb tablets manufactured by Alpha-Pharma Healthcare Ltd., India. Tadali Superb is available as tablets of 80 mg containing 20 mg of Tadalafil and 60 mg of Dapoxetine Hydrochloride.
Manufacturer of Tadali Superb Tablets
Alpha-Pharma Healthcare
Website:www.alpha-pharma.com
Generic forms and brand names of Tadalafil and Dapoxetine Tablets
Tadalafil and Dapoxetine tablets are available under various Drug brand names that include Tadali Superb, Super Tadalis and Super Tadarise.
Active Ingredients present in Tadali Superb Tablets
The active ingredients present in Tadali Superb tablets are Tadalafil and Dapoxetine Hydrochloride. Each Tadali Superb tablet contains 20 mg of Tadalafil and 60 mg of Dapoxetine Hydrochloride.
Uses of Tadali Superb (Tadalafil 20mg and Dapoxetine 60mg Tablets)
Tadali Superb tablets, a combination medicine containing 20 mg of Tadalafil and 60 mg of Dapoxetine Hydrochloride, manufactured by Alpha-Pharma Healthcare Ltd., India are used to treat male erectile dysfunction when at the same time treatment of premature ejaculation is also desirable.
Tadalafil tablets, are used for the treatment of erectile dysfunction (ED) in adult men.
Dapoxetine, a selective serotonin reuptake inhibitor, is indicated for the treatment of premature ejaculation in men aged 18 to 64 years. In well designed clinical trials in men with premature ejaculation, treatment with Dapoxetine significantly increased intravaginal ejaculation latency times relative to placebo and was generally well tolerated.
Tadali Superb tablets should be administered only as on-demand treatment before anticipated sexual activity.
Tadali Superb (Tadalafil and Dapoxetine Tablets) - Dosage
The recommended Tadali Superb dosage is orally one tablets once a day, with or without meals.
The tablet has to be administered one to three hours before sexual activity. Do not take more than 1 tablet in any 24 hour period. i.e. At least 24 hours should pass before you take the next dose.
Tadali Superb Storage
Store Tadali Superb tablets are to be stored at room temperature (15°C to 30°C) away from moisture and sunlight. Do not store above 30°C. Keep them in the original package. Protect from light.
Tadali Superb Contraindications
Tadali Superb tablets are contraindicated in patients with a hypersensitivity to Tadalafil, Dapoxetine Hydrochloride or any inactive ingredient present in tablets. Tadali Superb tablets are contraindicated in the following cases:
- Administration of Tadali Superb to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. During clinical pharmacology studies, Tadalafil was shown to potentiate the hypotensive effect of nitrates.
- Tadali Superb is contraindicated in patients with significant pathological cardiac conditions.
- Tadali Superb must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
- Tadali Superb is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
- The co-administration of PDE5 inhibitors, including Tadalafil, a component of Tadali Superb, with guanylate cyclase stimulators, such as Riociguat, is contraindicated as it may potentially lead to symptomatic hypotension.
- Tadali Superb is contraindicated for concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI. Similarly, an MAOI should not be administered within 7 days after Tadali Superb has been discontinued.
- Tadali Superb is contraindicated for concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine.
- Tadali Superb is contraindicated for 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.
- Tadali Superb is contraindicated for concomitant treatment with potent CYP3A4 inhibitors such as Ketoconazole, Itraconazole, Ritonavir, Saquinavir, Telithromycin, Nefazodone, Nelfinavir, Atazanavir, etc.
- Tadali Superb is contraindicated in patients with moderate and severe hepatic impairment.
Tadali Superb (Tadalafil and Dapoxetine Tablets) - Warnings and Precautions
The precautions to be taken when undergoing treatment with Tadali Superb (Tadalafil and Dapoxetine Tablets) are given below:
- A medical history and physical examination of the patient should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
- Patients should not use Tadalafil and Dapoxetine tablets if sex is inadvisable due to cardiovascular status. Before starting any treatment for erectile dysfunction, doctors must consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure and as such potentiates the hypotensive effect of nitrates.
- Use of Tadali Superb with alpha-blockers, antihypertensives or substantial amounts of alcohol (5 units or more) may lead to hypotension
- Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials of Tadalafil.
In patients receiving concomitant antihypertensive medicinal products, Tadalafil may induce a blood pressure decrease. When starting treatment with Tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy.
- Tadali Superb is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when Tadali Superb is used as a treatment for ED and premature ejaculation in men taking alpha-blockers.
- Patients should seek emergency treatment if an erection lasts more than 4 hours. Use this medicine with caution in patients predisposed to priapism.
- Patients should stop using Tadali Superb (Tadalafil and Dapoxetine Tablets) and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
- This medicine must be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.Patients with a “crowded” optic disc may also be at an increased risk of NAION.
- Patients should stop using Tadali Superb and seek prompt medical attention in the event of sudden decrease or loss of hearing.
- Patients must be advised not to use Tadali Superb in combination with recreational drugs. Recreational drugs with serotonergic activity such as ketamine, methylenedioxy-methamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Tadali Superb.
- Due to increased Tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of this medicine is not recommended in patients with severe renal impairment.
- Caution should be exercised when prescribing Tadali Superb to patients using potent CYP3A4 inhibitors (Ritonavir, Saquinavir, Ketoconazole, Itraconazole, And Erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined.
- Possibly prodromal symptoms such as nausea, dizziness/lightheadedness, and diaphoresis were reported more frequently among patients treated with Dapoxetine compared to placebo.
- Tadali Superb should not be administered to patients with a history of mania/hypomania or bipolar disorder and must be discontinued in any patient who develops symptoms of these disorders. Treatment with Tadali Superb must be discontinued in any patient who develops seizures and avoided in patients with unstable epilepsy.
- Combining alcohol with Tadali Superb may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury.
- An orthostatic test should be performed before starting treatment with this medicine. In case of a history of documented or suspected orthostatic reaction, treatment with Tadali Superb must be avoided.
- Grapefruit and grapefruit juice may interact with Tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking Tadali Superb.
Effects On Ability To Drive And Use Machines
Dapoxetine Hydrochloride, a constituent of Tadali Superb tablets has minor or moderate influence on the ability to drive and use machines. Dizziness, disturbance in attention, syncope, blurred vision and somnolence have been reported in subjects receiving dapoxetine in clinical trials. Therefore, patients should be warned to avoid situations where injury could result, including driving or operating hazardous machinery.
Tadali Superb (Tadalafil and Dapoxetine Hydrochloride Tablets) and Alcohol
Drinking alcohol decreases the blood which stays within your penis, which makes it harder for you to get an erection. In addition, alcohol and Tadalafil can interact. Tadalafil lowers your blood pressure, as does alcohol and hence combining it with alcohol may further increase this effect. You may be more likely to experience symptoms such as dizziness, lightheadedness, fainting, flushing, headache, and heart palpitations.
Combining alcohol with Dapoxetine may increase alcohol-related neurocognitive 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 Tadali Superb tablets.
Tadali Superb Interactions
- Tadalafil can potentiate the hypotensive effects of nitrates, alpha blockers, antihypertensives or alcohol
- CYP3A4 inhibitors (e.g. Ketoconazole, Ritonavir) increase Tadalafil exposure. For concomitant use with potent CYP3A4 inhibitors, dose adjustment may be needed
- CYP3A4 inducers (e.g. rifampin) decrease Tadalafil exposure
- In patients receiving an SSRI like Dapoxetine, 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.
- Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias
- 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.
- The use of Priligy 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 Priligy and such medicinal products is required.
Tadali Superb Side Effects
The most common side effects caused by Dapoxetine 60 mg during clinical trials are nausea (22.2%), dizziness (10.9%), headache (8.8%), diarrhoea (6.9%), insomnia (3.9%) and fatigue (4.1%). The most common side effects leading to discontinuation were nausea (2.2% of Dapoxetine-treated subjects) and dizziness (1.2% of Dapoxetine-treated subjects).
The most common side effects with an incidence rate of 2% or more caused by Tadalafil include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb.
If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea.
Rarely, sudden decreased vision, including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking Tadalafil and get medical help right away.
Tadali Superb (Tadalafil and Dapoxetine Tablets) - Overdosage
Tadali Superb overdose symptoms are a combination of the overdose symptoms of Tadalafil and Dapoxetine Hydrochloride.
During clinical trials single doses up to 500 mg of Tadalafil have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to Tadalafil elimination.
The overdose effects due to Tadalafil can cause prolonged erections, known as priapism, nausea, chest pains and irregular heartbeat. In case priapism is not treated within 24 hours the penis may become permanently damaged, leading to difficulties achieving an erection in future.
In general, symptoms of overdose with Dapoxetine Hydrochloride are somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness.
In the event of Tadali Superb overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as Tadalafil is highly bound to plasma proteins and it is not eliminated in the urine. Due to high protein binding and large volume of distribution of Dapoxetine Hydrochloride, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.
Tadalafil and Dapoxetine Tablets During Pregnancy
Tadali Superb is a combination medication containing Tadalafil and Dapoxetine. Tadalafil has been classified by the US FDA as Pregnancy Category B. Dapoxetine Hydrochloride has been classified by the US FDA as Pregnancy Category C. Tadali Superb (Tadalafil and Dapoxetine Tablets) is not indicated for use by women.
There are limited data from the use of Tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Tadalafil during pregnancy.
Animal studies with Dapoxetine Hydrochloride do not indicate direct or indirect harmful effects with respect to fertility, pregnancy or embryonal/foetal development.
Do not use this medicine without your doctor's consent in case you are pregnant. Stop using this medication and inform your doctor immediately if you become pregnant during treatment.
Tadali Superb (Tadalafil and Dapoxetine Tablets) - Nursing Considerations
Tadali Superb (Tadalafil and Dapoxetine Tablets) is not indicated for use by women.
It is not known whether Dapoxetine or its metabolites are excreted in human milk.
Available pharmacodynamic/toxicological data in animals have shown excretion of Tadalafil in milk. While Tadalafil or some metabolite of Tadalafil was excreted into rat milk, drug levels in animal breast milk may not accurately predict levels of drug in human breast milk. A risk to the suckling child cannot be excluded. Tadalafil should not be used during breast feeding.
Do not use this medication without telling your doctor if you are breast-feeding a baby.
Buy Tadali Superb (Tadalafil and Dapoxetine Tablets) Pills Online at Only $0.90 per Pill
You can buy Tadalafil and Dapoxetine tablets online from Clear Sky Pharmacy at a cheap price. Tadali Superb 80 mg pills, manufactured by Alpha-Pharma Healthcare Ltd., India are supplied in a blister strip of 10 tablets. The 80 mg tablets cost only $0.90 per unit when you place an order for 500 tablets.
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The above information is provided to the best of our knowledge and in good faith, it is without a warrant of any kind, expressed or implied.
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