Duraject-60 Allegens medicine for premature ejaculation, self-control ejaculation (1 blister x 4 tablets)

Dosage form Box of 1 blister x 4 tablets
Specifications Dapoxetine
Ingredient Akums Drugs & Pharmaceutical Ltd.

Ingredient

Composition information	Content
Dapoxetine	60mg

Uses

Indications

Premature ejaculation in men aged 18 - 64 with symptoms:

Persistent ejaculation and relapse when there is a minimum sexual stimulation before, during or immediately after penetration and before the patient is intended. Serotonin is selected at the nerve synap, helping to maintain the balance of serotonin in the central nervous system. The impact of dapoxetin is due to the inhibition of the reabsorption of serotonin shipping.

dapoxetin is also related to and inhibited the reabsorption of dopamine and norepinephrin transport substances.

Pharmacokinetics

absorption

dapoxetin is quickly absorbed into the bloodstream. The maximum plasma concentration (CMAX) reaches about 1-2 hours after taking the drug. Absolute bioavailability is 42% (about 15 - 76% fluctuations).

Distribution

In vitro experiments show that more than 99% dapoxetin binds to plasma proteins. 98.5% of metabolites have desmethyldapoxetin activity (Ded) linked to plasma proteins. Dapoxetin has an average stable distribution of 162 liters.

Metabolism

In vitro studies show that dapoxetin is metabolized by enzyme combinations in the liver and kidneys, mainly CYP2D6, CYP3A4 and Flavin Monooxygenase (FMO1). After drinking, most dapoxetin is metabolized through the following main biological metabolic paths: n-oxidation, n-demethylation, naphthyl hydroxylation, glucuronicization and sulfate.

Elimination

Dapoxetin metabolites are excreted mainly in the urine in the form of compounds. No unchanged form of dapoxetin in urine.

Before taking Duraject-60 Allegens medicine for premature ejaculation, self-control ejaculation (1 blister x 4 tablets)

How to use

can drink when hungry or full. Swallow the tablet with a glass of water.

Patients with renal failure: No dose adjustment but need to be cautious in patients with mild or medium renal impairment. Do not use drugs for patients with severe renal failure.

Patients with liver failure: No dose adjustment in patients with mild liver failure. Do not use dapoxetin for patients with medium and severe liver failure.

Patients aged 65 and older: The effect and safety of the drug is not known in patients aged 65 and over.

Patients with poor metabolism by CYP2D6 enzyme or people treated with CYP2D6 inhibitors: Be cautious when used with dapoxetin doses 60 mg.

Patients treated with CYP3A4 inhibitors from average to severe: Do not use the same drug as severe CYP3A4 inhibitors. Must be cautious and use Duraject-60 when used in combination with medium CYPA4 inhibitors.

Dosage

Starting dose is 30 mg of dapoxetin, orally before sex 1-3 hours. If the dose of 30 mg dapoxetin is ineffective and the side effect is acceptable, it may increase to a maximum dose of 60 mg. The maximum frequency of use of 60 mg is 1 time in 24 hours.

What to do when using overdose?

Due to the large ratio of plasma proteins and distribution of dapoxetin HCl, measures such as forced diuretic, dialysis, hemodialysis, blood change do not bring benefits. There is no specific antidote for dapoxetin.

What to do when forgetting a dose?

Side Effects

The unwanted effects occur when taking the drug presented in the following table:

Agency system
is very common (1/10) 1/1000) Be vigilant, abnormal disorders of sleep, difficulty sleeping, insomnia in the middle of the night, nightmares, grinding teeth. (Akathisia), taste disorders, sleep a lot, sleep, sedation, reduced level of alertness dizzy during exertion, suddenly sleepy

Ear and ear disorders

Sinusitis dizziness

digestive disorders vomiting diarrhea, vomiting, constipation, abdominal pain, upper abdominal pain,
digestive disorders, flatulence, stomach discomfort, abdominal distention, dry mouth abdominal uncomfortable, uncomfortable epigastric region Soft Sweating increases itching, cold sweat

general disorders Dimeter, vertical hypertension

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

too hypersensitivity to any ingredients of the drug.

Chronic cardiovascular disease such as grade IV - IV atrial atrial block, heart failure II - IV NYHA, patients are using a pacemaker, chronic valve disease, pronounced myocardial anemia; Sinus syndrome has not been treated.

Use with Maoi (monoamin oxydase inhibitor) or within 14 days of stopping using Maoi. Do not use maoi for at least 7 days after stopping drinking duraject-60.

Used with Thioridazin or within 14 days after stopping using Thioridazin; Do not use thioridazin within 7 days after stopping drinking duraject-60.

Used with Serotonin reabsorption inhibitors, 3 -round antidepressants, herbal drugs that have sympathetic effects or within 14 days after stopping the treatment of these drugs; Do not take these drugs within 7 days after stopping using Duraject-60.

Not used with strong CYP3A4 inhibitors (ketoconazole, iTraconazole, ...).

Do not use drugs for children and people under 18 years old.

Do not use for patients with medium to severe liver failure, patients with severe renal impairment.

Be cautious when using

Do not drink alcohol when using the drug.

People with a history of hypotension should avoid using dapoxetin.

Be careful when using dapoxetin with CYP3A4 inhibitors and CYP2D6 inhibitors.

Patients with a history of mild mania or bipolar disorder should not use dapoxetin.

In case these symptoms appear after using dapoxetin, the drug should be stopped.

Stop using dapoxetin if the patient appears seizure symptoms; Dapoxetin should be avoided in patients with unstable epilepsy. Patients with control epilepsy should be carefully monitored when using dapoxetin.

In patients with both depression and mental disorders, if the signs and symptoms of depression are found in the use of dapapoxetin, they need to stop taking the drug.

Be cautious when using dapoxetin along with drugs that affect the function of platelets as well as in patients with a history of bleeding or coagulation disorders.

Patients with genetically tolerant, lactase or glucose-galulose-Galactose deficiency

There is no data on safety and effectiveness of dapoxetin in the elderly (2.65 years).

using dapoxetin can cause eye disorders such as pupils or pain. Precautions when taking drugs in patients with glaucoma or the risk of glazing angle.

The effect of the drug on driving and operating machinery

dapoxetin has a slight or medium impact on the ability to drive and operate machinery. Symptoms such as dizziness, disorder of attention, fainting, blurred vision and drowsiness have been recorded in clinical trials. Therefore, patients should be warned to avoid the risk of injury while driving or operating machinery.

Use drugs for women during pregnancy and lactation

dapoxetin is not indicated for women. Therefore, do not use this medication for pregnant and lactating women.

Drug interaction

dapoxetin can cause interaction with thioridazin and maoi, so do not use dapoxetin within 14 days after stopping thioridazin and maoi. Similarly, do not use thioridazin and maoi within 7 days after stopping dapoxetin.

Do not use herbal drugs or herbal products with sympathetic effects within 7 days after stopping dapoxetin.

Do not use dapoxetin along with strong CYP3A4 inhibitors, such as ketoconazole, iTraconazole, ritonavir, saquinavir, telithromycin, nefazodon, nelfinavir and atazanavir.

Be careful when using dapoxetin along with moderate CYP3A4 inhibitors, CYP2D6 inhibitors, central nervous system stimulants and warfarin.

Be cautious when prescribing dapoxetin for patients using receptor antagonists A-adrenergic due to posture hypotension.

dapoxetin is said to have no effect on pharmacokinetics of drugs metabolized by CYP2C19 & CYP2C9 and PDE5 inhibitors.

Concomitance use of alcohol and dapoxetin increases the possibility of occurring or increasing the severity of side effects such as dizziness, drowsiness, slow or confusing reflexes. Due to red, patients should avoid drinking while using dapoxetin.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

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