Spedra Tablets
Avanafil
200mg
Sanofi Aventis Groupe
| Pack size | 4's Blister |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 162.00 AED |
Available as:
Indications
Spedra Tablets is used for:
Erectile Dysfunction
Adult Dose
Erectile Dysfunction
100 mg PO initially as early as 15 min before sexual activity; not to exceed 1 dose/day
Based on individual efficacy and tolerability, the dose may be increased to 200 mg taken as early as ~15 minutes before sexual activity, or decreased to 50 mg taken ~30 minutes before sexual activity
Use lowest effective dose
Hepatic impairment
Mild to moderate impairment: Dose adjustment not necessary
Severe impairment: Safety and efficacy not established; do not use
Child Dose
Renal Dose
Renal Impairment
Mild-to-moderate (CrCl ?30 mL/min): Dose adjustment not necessary
Severe impairment (CrCl 15-29 mL/min): Safety and efficacy not established; do not use
Administration
May take with or without food
Contra Indications
Hypersensitivity
Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension
Precautions
Potential for cardiovascular risk during sexual activity in patients with underlying cardiovascular conditions
Monitor patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis)
Dose should not exceed 50 mg/24hr when taking avanafil concomitantly with moderate CYP3A4 inhibitors
Initiate therapy at 50 mg/24hr if coadministered with antihypertensive medications like alpha-blockers
Priapism may occur especially in patients with predisposed conditions (eg, sickle cell anemia, multiple myeloma, or leukemia)
Discontinue therapy if sudden loss of vision in one or both eyes occur (could be a sign of non-arteritic anterior ischemic optic neuropathy)
Safety and efficacy not established in patients with hereditary retinal disorders, including retinitis pigmentosa (use not recommended)
Sudden hearing loss may occur; discontinue therapy if tinnitus symptoms occur
Alcohol may increase risk for orthostatic hypotension; may increase heart rate and cause dizziness and headache
Lactation: Safety and efficacy not established
Pregnancy-Lactation
Pregnancy Category: C
Lactation: Safety and efficacy not established
Interactions
Adverse Effects
Side effects of Avanafil :
>2%
Headache (5.6%)
Flushing (3.5%)
Nasal congestion (2.1%)
Nasopharyngitis (3.4%)
Back pain (2.5%)
Upper respiratory infection (<2%)
Bronchitis (<2%)
Influenza (<2%)
Sinusitis (<2%)
Sinus congestion (<2%)
Hypertension (<2%)
Dyspepsia (<2%)
Nausea (<2%)
Constipation (<2%)
Rash (<2%)
<1%
Peripheral edema
Fatigue
Angina
Deep vein thrombosis
Palpitations
Gastritis
Gastroesophageal reflux disease
Hypoglycemia
Hyperglycemia
Oropharyngeal pain
Stomach discomfort
Vomiting
Depression
Insomnia
Cough
Dyspnea exertional
Epistaxis
Wheezing
Pruritus
Urinary tract infection
Pollakiuria
Nephrolithiasis
Hematuria
Increased erection
Balanitis
Mechanism of Action
Sexual stimulation causes nitric oxide to be released in the corpus cavernosum; nitric oxide activates the enzyme guanylate cyclase, which in turn increases cGMP levels; increase in cGMP levels causes smooth muscle relaxation.
Phosphodiesterase type 5 inhibitors enhance the effects of nitric oxide in smooth muscle relaxation of the corpus cavernosum by inhibiting the degradation of cGMP.
Note
Spedra 200mg Tablets manufactured by Sanofi Aventis Groupe. Its generic name is Avanafil. Spedra is availble in United Arab Emirates.
Farmaco UAE drug index information on Spedra Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.