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Spedra is a brand name for Avanafil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.
Verbatim from this product's EMA label. Tap a section to expand.
1). Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.
Special populations Elderly(≥ 65 years old) Dose adjustments are not required in elder patients. Limited data are available in elder patients aged 70 years or above. Renal impairment Dose adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min).
2). Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function. 2). Patients with mild to moderate hepatic impairment (Child-Pugh class A or B) should initiate treatment with the minimum efficacious dose and adjust posology based on tolerance.
Use in men with diabetes Dose adjustments are not required in diabetic patients. 3 Paediatric population There is no relevant use of Spedra in the paediatric population in the indication of erectile dysfunction. 5). 5). Method of administration For oral use.
2).
Summary of the safety profile The safety profile of Spedra is based on 2,566 subjects exposed to avanafil during the clinical development program. The most common adverse reactions reported in clinical studies were headache, flushing, nasal and sinus congestion and back pain.
Overall adverse events and adverse reactions for avanafil-treated subjects were more frequent in subjects with a Body Mass Index (BMI) <25 (normal BMI subjects). In the long term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure.
Tabulated list of adverse reactions The table below lists the adverse reactions observed in placebo-controlled clinical trials according to the MedDRA frequency convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Adverse reaction (MedDRA Preferred Term) System Organ Class Common Uncommon Rare Infections and infestations Influenza Nasopharyngitis Immune system disorders Seasonal allergy Metabolism and nutrition disorders Gout Psychiatric disorders Insomnia Premature ejaculation Inappropriate affect Nervous system disorders Headache Dizziness Somnolence Sinus headache Psychomotor hyperactivity Eye disorders Vision blurred Cardiac disorders Palpitations Angina pectoris Tachycardia Vascular disorders Flushing Hot flush Hypertension Hypotension Respiratory, thoracic and mediastinal disorders Nasal congestion Sinus congestion Dyspnoea exertional Rhinorrhoea Upper respiratory tract congestion Epistaxis 9 Adverse reaction (MedDRA Preferred Term) System Organ Class Common Uncommon Rare Gastrointestinal disorders Dyspepsia Nausea Vomiting Stomach discomfort Dry mouth Gastritis Abdominal pain lower Diarrhoea Skin and subcutaneous tissue disorders Rash Musculoskeletal and connective tissue disorders Back pain Muscle tightness Flank pain Myalgia Muscle spasms Renal and urinary disorders Pollakiuria Reproductive system and breast disorders Penis disorder Spontaneous penile erection Pruritus genital General disorders and administration site conditions Fatigue Asthenia Chest pain Influenza like illness Oedema peripheral Investigations Hepatic enzyme increased Electrocardiogram abnormal Heart rate increased Blood pressure increased Blood urine present Cardiac murmur Prostate specific antigen increased Weight increased Blood bilirubin increased Blood creatinine increased Body temperature increased Description of selected adverse reactions observed with other PDE5 inhibitors Non-arteritic anterior ischaemic optic neuropathy (NAION) and sudden loss of hearing have been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors.
4 A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. 3). 3). g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Priapism Patients who experience erections lasting 4 hours or more (priapism) should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Avanafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Visual problems Visual defects, including Central Serous Chorioretinopathy (CSCR), and cases of non-arteritic anterior ischaemic optic neuropathy (NAION) have been reported in connection with the intake of PDE5 inhibitors. 3). Effect on bleeding In vitro studies with human platelets indicate that PDE5 inhibitors do not have an effect on platelet aggregation on their own, but at supratherapeutic doses they potentiate the anti-aggregatory effect of the nitric oxide donor sodium nitroprusside.
In humans, PDE5 inhibitors do not appear to affect bleeding time alone or in combination with acetylsalicylic acid. There is no safety information on the administration of avanafil to patients with bleeding disorders or active peptic ulceration.
Therefore, avanafil should be administered to such patients only after careful benefit-risk assessment. Decreased or sudden loss of hearing Patients should be advised to stop taking PDE5 inhibitors, including avanafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
1. 5). 5). Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra. The use of avanafil is contraindicated in: - Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; - Patients with resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg); - Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater.
Patients with severe hepatic impairment (Child-Pugh C). Patients with severe renal impairment (creatinine clearance < 30 mL/min). 4). Patients with known hereditary degenerative retinal disorders. 5).
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4). Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors. No cases were reported during clinical trials of avanafil. Haematuria, haematospermia and penile haemorrhage has been reported in a small number of post- marketing and clinical trial cases with other PDE5 inhibitors.
5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.
5). Consideration should be given to the following: Patients should be stable on alpha-blocker therapy prior to initiating Spedra. Patients who demonstrate haemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of avanafil.
In those patients who are stable on alpha-blocker therapy, avanafil should be initiated at the lowest dose of 50 mg. In those patients already taking an optimised dose of Spedra, alpha-blocker therapy should be initiated at the lowest dose.
Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking avanafil. 5 The safety of combined use of avanafil and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive medicinal products.
5). Concomitant use of other treatments for erectile dysfunction The safety and efficacy of combinations of Spedra and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. Patients should be informed not to take Spedra in such combinations.
5). Patients should be advised that concurrent use of avanafil and alcohol may increase the likelihood of hypotension, dizziness, or syncope. Physicians should also advise patients on what to do in the event of postural hypotensive symptoms.
Populations not studied Avanafil has not been evaluated in patients with erectile dysfunction due to spinal cord injury or other neurological disorders and in subjects with severe renal or hepatic impairment.