Spedra is an oral drug used mainly to treat men’s erectile dysfunction (ED). Spedra comes with Avanafil as the active component, which is a phosphodiesterase type 5 (PDE5) inhibitor. Avanafil increases blood flow to penis upon sexual stimulation and assists men in attaining and maintaining an erection.
Spedra 100 mg
| Product Details | |
|---|---|
| Composition | Active ingredient: Avanafil Inactive ingredients: • Mannitol • Fumaric Acid • Hydroxypropylcellulose • Low-Substituted Hydroxypropylcellulose • Calcium Carbonate • Magnesium Stearate • Ferric Oxide Yellow |
| Packaging Type | Box |
| Pack Size | 4 × 1 |
| Dosage | 100 mg |
| Therapeutic Class | Sex Stimulants & Rejuvenators |
| Action Class | Phosphodiesterase Type-5 (PDE5) Inhibitors |
| Chemical Class | Pyrimidine Carboxamides |
| Manufacturer | Sanofi Winthrope Industrie in Ambares |
| Shelf Life | More than 24 months |
| Usages | Erectile Dysfunction |
| Country of Origin | Made in Ambares, France |
| Storage | Store at 20°–25°C |
Spedra 200 mg
| Product Details | |
|---|---|
| Composition | Active ingredient: Avanafil Inactive ingredients: • Mannitol • Fumaric Acid • Hydroxypropylcellulose • Low-Substituted Hydroxypropylcellulose • Calcium Carbonate • Magnesium Stearate • Ferric Oxide Yellow |
| Packaging Type | Box |
| Pack Size | 4 × 1 |
| Dosage | 200 mg |
| Therapeutic Class | Sex Stimulants & Rejuvenators |
| Action Class | Phosphodiesterase Type-5 (PDE5) Inhibitors |
| Chemical Class | Pyrimidine Carboxamides |
| Manufacturer | Sanofi Winthrope Industrie in Ambares |
| Shelf Life | More than 24 months |
| Usages | Erectile Dysfunction |
| Country of Origin | Made in Ambares, France |
| Storage | Store at 20°–25°C |
How does it work?
Avanafil inhibits the phosphodiesterase enzyme, releasing nitric oxide, which relaxes smooth muscles and vessels, improving blood flow to the penis.
- Sexual arousal triggers the release of nitric oxide in the penis.
- Nitric oxide increases the levels of cyclic guanosine monophosphate (cGMP).
- cGMP relaxes the smooth muscles in the penis, allowing blood vessels to dilate and increasing blood flow.
Duration of Action: 6 hours
Uses of Spedra:
- Erectile Dysfunction: Spedra is indicated for the treatment of ED in adult males, enhancing blood flow to the male genitalia.
- Enhances Sexual Function: Aids men in attaining and sustaining an erection upon sexual stimulation.
Dosage:
- Spedra 100/200 mg can be taken 30 minutes prior to sexual relations.
- The dose can be adjusted to 50 mg or 200 mg depending on your response and tolerability by your doctor.
- Make sure not to exceed the dosage of Spedra 100 mg per day.
Side effects:
- Nausea
- Flushing
- Headaches
- Back pain
- Sore Throat
Spedra is well-tolerated, with most users experiencing minimal side effects that can vary in severity and impact from person to person.
Efficacy:
Both the Spedra dosages i.e., 100 mg and 200 mg demonstrated statistically significant improvements in erectile function, as measured by the International Index of Erectile Function (IIEF) and Sexual Encounter Profile (SEP).
Pharmacokinetics
Pharmacokinetic Interaction takes place when a drug influences the Absorption, Distribution, Metabolism, or excretion (ADME) of another drug. This may result in an alteration in the concentration of one or both drugs in the body and thus may alter their effects or enhance the risk of side effects.
- Absorption: Spedra is absorbed rapidly, with a median time to maximum plasma concentration (Tmax) of approximately 30-45 minutes.
- Distribution: Avanafil is approximately 99% consist of plasma protein.
- Metabolism: Spedra is metabolized primarily by the CYP3A4 enzyme.
Interaction:
Spedra interactions are classified into several categories:
Drug Interactions:
- CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir): Increase avanafil levels, CYP3A4 inhibitors can retard the metabolism of avanafil, with consequent higher levels and a greater risk of adverse effects.
- CYP3A4 Inducers (e.g., rifampicin, bosentan): Reduce avanafil concentration, CYP3A4 inducers may speed up avanafil metabolism, weakening is efficacy.
- Nitrates (e.g., nitroglycerin, isosorbide dinitrate): Severe hypotension, Tadalafil may enhance the blood pressure-lowering effects of nitrates and cause potentially hazardous reductions in blood pressure.
- Alpha-blockers (e.g., doxazosin, tamsulosin): Increase risk of hypotension, avanafil has the potential to increase alpha-blockers hypotensive effects.
- Antihypertensives: (e.g., ACE inhibitors, beta-blockers): Additive hypotensive effects, avanafil has the potential to enhance the blood pressure-reducing effects of these medications, so the risk of hypotension is increased.
- Alcohol: Increased the risk of hypotension and side effects: Alcohol can potentiate the blood pressure-lowering action of avanafil and enhance the risk of side effects such as dizziness and headache.
- Other PDE5 Inhibitors: Increased risk of side effects, Concomitant use of avanafil with other PDE5 (e.g., Sildenafil, Vardenafil) may raise the risk of side effects because of additive effects.
Food Interactions
- Grapefruit: Grapefruit and grapefruit juice may raise levels of avanafil in the blood, which could result in higher side effects.
- Alcohol: Drinking a lot of alcohol with avanafil might cause side effects to be greater, such as dizziness, headache, and low blood pressure. Taking moderate alcohol is recommended.
Disease Interactions
- People with heart disease or high blood pressure might have increased risks when using avanafil.
- Abnormal liver or kidney function may change the metabolism and elimination of avanafil, requiring dose modification.
- Diseases such as retinitis pigmentosa might be worsened by avanafil.
- Priapism, a lasting erection of the penis, may occur with avanafil in some patients.
Therapeutic Suggestions
- Adjustments in dose can be made when avanafil is administered with CYP3A4 inhibitors or inducers.
- Concomitant use should be avoided of avanafil with nitrates or other PDE5 inhibitors.
- Blood pressure should be monitored when avanafil is administered with antihypertensives or alpha-blockers.
- Alcohol should be consumed in limited amounts to prevent side effects.
Precautions:
- Avoid alcohol while taking the Spedra medications.
- Let your physician know if you have any heart, Kidney conditions, like Kidney or liver disease, heart failure, coronary artery disease, or recent myocardial infarction.
- If you have a prolonged erection (over 4 hours), seek immediate medical care.
Conclusion
Avanafil has been identified to be a promising treatment for ED. Avanafil was approved for the treatment of ED in the US and Europe in 2012 and 2013. This drug also has the advantages of rapid onset of action (Tmax 35 min) and short half-life (< 1.5 h) compared to other PDE5 inhibitors. It works by mediating the breakdown of cyclic guanosine monophosphate (cGMP), inducing smooth muscle relaxation in the corpus cavernosum of the penis, increasing local blood flow, and leading to erection. However, little information is available on its efficacy and safety.
FAQ’S
What does Spedra used for?
Spedra is an oral drug used mainly to treat men’s erectile dysfunction (ED).
How does Spedra work?
Spedra inhibits the phosphodiesterase enzyme, releasing nitric oxide, which relaxes smooth muscles and vessels, improving blood flow to the penis.
Can Spedra be taken with Food?
Yes, it can be taken with or without food.
How long does Spedra take to work?
Spedra typically starts working within 15-30 minutes after oral administration.
Is it safe for everyone?
Spedra is generally safe, but men with certain medical conditions like kidney, liver, and heart should avoid this medication.
English
Arabic