Erec Tablets
(Sildenafil 100 mg)
Composition:
Each tablet contains:
Sildenafil 100mg
Properties:
– Sildenafil is a phosphodiesterase inhibitor.
– Sildenafil competitively inhibits phosphodiesterase enzyme type 5
Inhibition of that isoenzyme increases stores of cGMP, the second
messenger of nitric oxide and a mediator of vasodilatation in the penis, which relaxes corpus cavemosal smooth muscle cells and increases blood flow into cavernosal spaces, this leads to increased intra cavernosal pressure which is a major factor in producing erection. Relaxation of the corpus cavemosal smooth muscles is mediated by nitric oxide and cGMP. Sildenafil at recommended doses has no effect in the absence of sexual stimulation.
Indications:
Erectile dysfunction.
Doses:
1.Adult dosage: half tablet (50 mg sildenafil) should be administered
orally before sexual activity for treatment of erectile dysfunction. Erec may be taken at anytime between half to four hours before sexual activity.
2.Doses range from 25 mg to 100 mg daily with a maximum frequency of one time daily.
3.A dose of 25 mg should be used in patients with hepatic impairment, severe renal failure and age over 65 years old. As that may lead to increase in Sildenafil serum level and so increase in both the efficacy and incidence of adverse effects .
Contraindications :
1- Consistent with its known effects on the nitric oxide I cGMP
pathway, Erec was shown to potentiate the hypotensive effects of
nitrates, and its administration to patients who are using organic
nitrates, either regulariy and J or intermittently in any form is
contraindicated.
2- There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular diseases. Therefore, treatment for erectile dysfunction, induding Erec should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
3- Erec is contraindicated in patients with retinal nerve atrophy & any disturbance of vision.
4- Hypersensitivity to sildenafil or any component of the tablet.
5- Prolonged erection greater than 4 hours and priapism (painful
erection greater than 6 hours in duration), the patient should seek
immediate medical assistance, if priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
Side effects:
1- Body as a whole: Face oedema, headache, photosensitivity
reactions, shock, asthenia, chills, allergic reactions, chest pain, visual changes, blue and transient increased brightness when taking
sildenafil at doses over 200mg.
2- Cardiovascular: angina pectoris, AV block, syncope, tachycardia,
hypotension, myocardial ischemia, cerebral thrombosis, cardiac
arrest, heart failure, flushing is reported in dose ranging up 10 100 mg daily, cardiomyopathy, abnormal ECG.
3- Hemic & lymphatic: Anemia & leucopenia.
4- Musculoskeletal: Arthritis, arthrosis, myalgia, tendon rupture,
synovitis, sildenafil was associated with mild & transient pelvic
musculoskeletal pain.
5- Nervous system: Tremors, vertigo, depression, insomnia, abnormal dreams, ataxia, neuralgia, neuropathy, paralhesia and hypertonia.
6- Skin appendages: Urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis or exfoliative dermatitis.
7- Special senses: Mydriasis, conjunctivitis, eye pain, deafness, eye hemorrhage, cataract, dry eye, photophobia or ear pain.
8 – Digestive: vomiting, glossitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, liver function tests abnormalities, rectal hemorrhage or gingivitis.
9.Urogenital: cystitis, nocturia, urinary frequency, breast enlargement, urinary incontinence, abnonnal ejaculation. genital edema or anorgasmia.
Drug- Drug interactions:
– Sildenafil interacts with Cimetidine, erythromycin, ketoconazole,
itraconazole, soquinavir, ritonavir as they increase sildenafil serum
level.
– Rifampicin decreases sildenafil serum level.
Precautions:
The drug is used with caution in:
1- Patients who have suffered from myocardial infarction, stroke or life threatening arrhythmia within the last 6 months.
2- Patients with resting hypotension (RP. <90/50) or hypertension
(B.P.>170/110)
3- Patients with cardiac failure or coronary artery disease causing
unstable angina.
4- Patients with anatomical deformation of the penis (cavernal fibrosis, Peyronie’s disease).
5- Patients with sickle cell anemia, multiple myeloma or leukemia.
6- Patients with retinitis pigmentosa.
7- Patients with bleeding disorders or active peptic ulceration.
Storage:
Store below 30°C away from direct sunlight & out of reach of children.
Package:
A box containing 1,3,25, 50 or 100 strips, each of 1, 2 or 4 tablets & an insert.
Manufactured by:
ADWIA Company
10 of Ramadan City Egypt
