Fortrustep Tablet

Brand Name:  Fortrustep 60 mg Tablet
                        Fortrustep 30 mg Tablet
Active Ingredient: Dapoxetine Hydrochloride    

When is Fortrustep Tablet prescribed for?

Fortrustep is indicated for the treatment of premature ejaculation (PE) in men aged 18 to 64 years.  

How should you take Fortrustep Tablet?

  • The recommended starting dose for patients (Adult men 18 -64 years) is 30 mg taken as needed about 1 to 3 hours before sexual activity. The maximum recommended treatment frequency is once every 24 hours.
    If the effect of 30 mg is insufficient, and adverse event were acceptable, the dose an increase to the maximum recommended dose is one 60 mg. If the patient has orthostatic reactions with the starting dose should dose one should not be increased to 60 mg.
  • Fortrustep can be taken without food and the tablets should be swallowed whole to avoid the bitter taste.
    It is recommended that the tablets be taken at least a full glass of water. 

When you should not take Fortrustep Tablet?

  • Hypersensitivity to the active substance or any excipients
  • Significant pathological heart conditions such as:
  1. ​​Heart failure (NYHA class II-IV)
  2. ​Conduction abnormalities (AV block II-III or sick sinus node) that are not treated with permanent pacemakers.
  3. Significant ischemic heart disease
  4. Significant valvular disease
  • MAOIs should not be administered within 7 days of treatment with Fortrustep has been discontinued.
  • Thioridazine should not be administered within 7 days of treatment with Fortrustep has been discontinued.
  • Concomitant treatment with SSRIs ,(SNRI), tricyclic antidepressants (TCA)] or other drugs / herbal products with serotonergic effects [eg L-tryptophan, triptans, tramadol, linezolid, lithium, St.John's wort ( Hypericum perforatum )] or within 14 days after treatment with these medications / herbal products has ceased.
  • These drugs / herbal products should not be administered within 7 days of treatment with Fortrustep has been discontinued.
  • Concomitant treatment with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir
  • Moderately and severely impaired liver function.

Possible Drug interaction with Fortrustep Tablet:
Pharmacodynamics interactions

  • Potential interaction with monoamine oxidase inhibitors
  • Potential Interaction with Thioridazine
  • Drug / herbal products with serotonergic effects
  • CNS -active drugs

Pharmacokinetic interactions

  • Potent CYP3A4 inhibitors
  • Moderate CYP3A4 inhibitors
  • Potent inhibitors of CYP2D6
  • Dapoxetine should be prescribed with caution in patients using PDE5 inhibitors because of possible decreased orthostatic tolerance.
  • Concomitant administration of single doses or multiple doses of 30 mg or 60 mg of dapoxetine in patients receiving daily doses of tamsulosin did not show any changes in tamsulosin pharmacokinetics.
  • Drugs metabolised by CYP2D6: Dapoxetine can give rise to a similar increase in plasma concentrations of other drugs metabolized by CYP2D6. The clinical relevance is probably minor.
  • Drugs that are metabolized by CYP3A4: The increase in CYP3A activity may have clinical relevance in some patients being treated with drugs primarily metabolized by CYP3A and have a narrow therapeutic window.
  • Drugs metabolized by CYP2C19: Dapoxetine is unlikely to affect the pharmacokinetics of one of other CYP2C19 substrates.
  • Warfarin: There are no data evaluating the effect of chronic use of warfarin with dapoxetine. Therefore, caution should be exercised in the use of dapoxetine in patients taking warfarin for a long time.
  • Ethanol: Concurrent use of alcohol and dapoxetine increase the risk or severity of side effects such as dizziness, drowsiness, slow reflexes or impaired judgment.

Special warning and precaution when using Fortrustep Tablet:

Use with "recreational drugs"
"Recreational drugs" with serotonergic activity such as ketamine,
Methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may cause potentially serious side effects if they are combined with Fortrustep.

Ethanol
The combination of alcohol and dapoxetine may increase alcohol-related neurocognitive effects and also increase neurocardiogenic side effects, such as syncope, and thus increase the risk of accidental injury.

Syncope
Possible prodromal symptoms such as nausea, dizziness / lightheadedness, and sweating were reported more frequently in patients treated with dapoxetine compared with placebo.
The cases of syncope were considered to have vasovagal etiology and most occurred during the first 3 hours after dosing.

Orthostatic hypotension
An orthostatic test should be performed before starting treatment. In previous documented or suspected orthostatic reaction, treatment with Fortrustep avoided.
In addition, Fortrustep prescribed with caution in patients taking drugs with vasodilating properties (such as alpha-adrenergic receptor antagonists, nitrates, PDE5 inhibitors) because of potentially reduced orthostatic tolerance.

Moderate CYP3A4 inhibitors

Potent inhibitors of CYP2D6
Suicide / suicidal thoughts

In clinical trials with dapoxetine for the treatment of premature ejaculation, there was no clear indication for treatment induced suicidality.

Mania
Fortrustep should not be used by patients with mania / hypomania, or bipolar disorder.

Seizures
Fortrustep should be discontinued in patients who experience a seizure and avoided in patients with unstable epilepsy.

Use in children and adolescents under age 18
Fortrustep should not be used by people under 18 years of age.

Co-morbid depression and mental disorders
Concomitant Fortrustep and antidepressants, including SSRIs and SNRIs, is contraindicated
Dapoxetine is not indicated for mental disorders and should not be used in men with such disorders as schizophrenia, or those who suffer from co-morbid depression.

Bleeding
Caution is advised in patients taking dapoxetine, particularly with concomitant use of medications known to affect platelet function.

Renal impairment
Fortrustep is not recommended for patients with severe renal impairment and caution.

Withdrawal Effects
Abrupt discontinuation of chronically administered SSRIs, used to treat chronic depression, has been reported to cause the following symptoms: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (eg paraesthesia, such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional instability, insomnia and hypomania.

A double-blind, clinical trial in patients with PE, which was designed to evaluate withdrawal effects after 62 days of dosing daily or as needed by 60 mg dapoxetine, however, showed no signs of withdrawal syndrome

Lactose intolerance
Patients with rare hereditary problems should not take this drug intolerance, the Lapp lactase deficiency or glucose –galactose malabsorption.

Special information if you are pregnant or breastfeeding
Fortrustep is not indicated for use by women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryo.It is not known if either dapoxetine or its metabolite is excreted in human milk.

Possible Side Effects with Fortrustep Tablet:

  • Syncope, defined as loss of consciousness, have been reported in clinical trials and considered to be drug related.
  • Orthostatic hypotension has been reported in clinical trials
  • The most common adverse drug reactions reported in clinical trials were headache, dizziness, nausea, diarrhea, insomnia and fatigue.
  • The most common adverse event which led to discontinuation were nausea (2.2% of the patients treated with dapoxetine) and dizziness