Delepe 60 mg 6 tablets

Delepe 60 mg 6 tablets

Composition:
Each film-coated tablet contains:
Dapoxetine hydrochloride equivalent to 60 mg dapoxetine.
Excipients:
Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, and OPADRY brown coating.
Description:
Brown, flat, D-shaped film-coated tablets engraved with “D” on one side.
DELEPE contains dapoxetine, a selective serotonin reuptake inhibitor (SSRI) designed specifically for the treatment of premature ejaculation in adult men.
Indications for Use:
DELEPE is indicated for the treatment of premature ejaculation (PE) in adult men aged 18-64 years who meet all of the following criteria:
- Intravaginal ejaculatory latency time (IELT) of less than two minutes;
- Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes;
- Marked personal distress or interpersonal difficulty due to PE;
- Poor control over ejaculation;
- A history of PE in most intercourse attempts over the prior six months;
- DELEPE should only be used as on-demand treatment before anticipated sexual activity.
Dosage and Method of Administration:
For oral use only.
The recommended starting dose is 30 mg, taken as needed 1-3 hours before sexual activity.
If response to 30 mg is insufficient and the patient tolerates it well, the dose may be increased to 60 mg, taken as needed approximately 1-3 hours before sexual activity.
DELEPE must not be taken more than once every 24 hours and is not intended for continuous daily use.
Tablets should be swallowed whole with at least one full glass of water and may be taken with or without food.
Contraindications:
- Hypersensitivity to dapoxetine or any excipient.
- Significant cardiac disorders, including heart failure (NYHA class II-IV), conduction abnormalities, ischemic or valvular disease, or history of syncope.
- Moderate or severe hepatic impairment (Child-Pugh Class B or C).
- Concomitant use with monoamine oxidase inhibitors (MAOIs), thioridazine, SSRIs, SNRIs, tricyclic antidepressants, or other serotonergic agents (e.g., tramadol, linezolid, lithium, St. John’s Wort).
- Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, ritonavir).
- History of mania or severe depression.
Precautions:
- DELEPE should only be prescribed to men with a confirmed diagnosis of premature ejaculation.
- Use with caution in patients with mild to moderate renal impairment; not recommended in severe renal impairment.
- Caution is advised when increasing the dose in CYP2D6 poor metabolizers or patients taking CYP2D6 inhibitors.
- Syncope and orthostatic hypotension have been reported; patients should avoid sudden position changes and remain well hydrated.
- Alcohol consumption should be avoided due to increased risk of dizziness, somnolence, and syncope.
- Use with caution in patients with glaucoma or raised intraocular pressure.
- Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine (contains lactose).
Side Effects:
The most commonly reported adverse reactions are nausea, dizziness, headache, diarrhea, insomnia, and fatigue.
Other adverse effects may include:
- Psychiatric: anxiety, agitation, restlessness, abnormal dreams, decreased libido, irritability, mood changes.
- Nervous system: somnolence, tremor, paresthesia, syncope, dizziness, disturbed attention.
- Cardiac and vascular: bradycardia, tachycardia, hypotension, flushing, sinus arrest.
- Gastrointestinal: vomiting, constipation, abdominal pain, flatulence, dry mouth.
- Skin: hyperhidrosis, pruritus, cold sweat.
- Reproductive system: erectile dysfunction, ejaculation failure, genital paresthesia.
- General:
Asthenia, irritability, feeling jittery, abnormal sensations.
- Most adverse effects are mild to moderate and transient. 
- Syncope, if occurs, usually appears within 3 hours after dosing.
Pregnancy and Breastfeeding:
DELEPE is not indicated for use in women.
It is not known whether dapoxetine or its metabolites are excreted in human milk.
Storage Conditions:
Store at a temperature not exceeding 30°C in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing 2 strips of 3 film-coated tablets and a package insert.