Description

BP Esculap 20mg – Tadalafil Tablets

Manufacturer: Balkan Pharmaceuticals
Active Substance: Tadalafil Citrate
Active Half-Life: 17.5 hours
Dosage: 3 pills per week
Strength: 4 tablets (20 mg per tablet)

Product Description

BP Esculap 20mg is an oral pharmaceutical product containing tadalafil as its active substance. Tadalafil is a well-established medication belonging to the class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. This class also includes sildenafil (Viagra) and vardenafil (Levitra). Esculap is indicated for the treatment of erectile dysfunction in adult males—the inability to attain or maintain a penile erection sufficient for satisfactory sexual activity.

The mechanism of action of tadalafil is well understood at the pharmacological level. Penile erection is achieved through the engorgement of the penis with blood. This occurs when the blood vessels supplying the penis dilate to deliver more blood while the vessels draining the penis constrict to reduce outflow. Sexual stimulation triggers the production and release of nitric oxide in the penile tissue. Nitric oxide activates the enzyme guanylate cyclase, which in turn produces cyclic guanosine monophosphate (cGMP). It is cGMP that is primarily responsible for the vascular changes that produce an erection.

The enzyme phosphodiesterase type 5 (PDE5) is responsible for the degradation of cGMP. When PDE5 destroys cGMP, the blood vessels return to their normal state, blood leaves the penis, and the erection subsides. Tadalafil functions as a selective inhibitor of PDE5. By preventing PDE5 from breaking down cGMP, tadalafil allows cGMP to persist for a longer period. This prolonged presence of cGMP leads to sustained vasodilation and a more durable erectile response. It is important to note that tadalafil requires sexual stimulation to be effective; without the activation of the nitric oxide-cGMP pathway, the medication will not produce an erection.

For most individuals, the recommended starting dose of tadalafil for use as needed is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg based upon individual efficacy and tolerability. BP Esculap 20mg provides the maximum single-dose strength approved for on-demand use. The 20 mg strength is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

A distinguishing feature of tadalafil is its exceptionally long half-life of approximately 17.5 hours. Clinical studies have demonstrated significant activity for up to 24 to 36 hours following administration. This prolonged duration of action offers greater flexibility compared to shorter-acting PDE5 inhibitors. The medication may be taken from 30 minutes to 36 hours prior to sexual activity. Tadalafil can be taken with or without food, and the tablet should be swallowed whole without being divided or crushed.

Individuals taking medications that increase tadalafil blood levels should not exceed a total dose of 10 mg within a 72-hour period. Patients should also be aware that tadalafil 10 mg and 20 mg formulations are intended for on-demand use and are not recommended for daily continuous administration.

Important Safety Information

Contraindications

BP Esculap 20mg is contraindicated in the following circumstances:

• Known hypersensitivity or allergy to tadalafil or any of the excipients in the formulation

• Concurrent use of any form of organic nitrate, either regularly or intermittently

• Use of guanylate cyclase stimulators such as riociguat (Adempas)

• Severe cardiovascular disease or history of myocardial infarction within the preceding 90 days

• History of stroke within the preceding 6 months

• Uncontrolled hypotension or uncontrolled hypertension

• History of non-arteritic anterior ischemic optic neuropathy (NAION), a condition involving sudden vision loss

• Use of recreational inhaled nitrates such as amyl nitrate, butyl nitrate, or nitrite (“poppers”)

Warnings

Combining tadalafil with any nitrate medication can cause a sudden and dangerous drop in blood pressure, potentially leading to dizziness, fainting, heart attack, or stroke. Patients should not use nitrates within 48 hours of the last dose of tadalafil. Tadalafil potentiates the hypotensive effects of nitrates.

Common Side Effects

The most frequently reported side effects associated with tadalafil include headache, flushing (warmth or redness in the face and neck), nasal congestion, indigestion (dyspepsia), and back pain or muscle aches.

Top 10 Frequently Asked Questions

1. What is BP Esculap 20mg?

BP Esculap 20mg is a pharmaceutical product manufactured by Balkan Pharmaceuticals containing tadalafil as the active ingredient. Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor used for the treatment of erectile dysfunction in adult males. It is the generic equivalent of the brand-name medication Cialis.

2. How does BP Esculap 20mg work?

Tadalafil works by selectively inhibiting the enzyme phosphodiesterase type 5 (PDE5), which is responsible for breaking down cyclic guanosine monophosphate (cGMP) in the penile tissue. By preventing the degradation of cGMP, tadalafil allows the blood vessels in the penis to remain dilated, facilitating increased blood flow and enabling an erection in response to sexual stimulation.

3. How should I take BP Esculap 20mg?

The 20 mg strength is intended for on-demand use prior to anticipated sexual activity. The tablet should be swallowed whole with or without food and should not be divided or crushed. The medication can be taken anywhere from 30 minutes to 36 hours before sexual activity. The maximum dosing frequency is once per day.

4. How long does the effect of BP Esculap 20mg last?

Tadalafil has a half-life of approximately 17.5 hours. Clinical studies indicate that the medication remains effective for up to 24 to 36 hours following administration. This extended duration of action provides greater flexibility compared to other PDE5 inhibitors.

5. Can I take BP Esculap 20mg daily?

The 20 mg strength is not recommended for continuous daily use. For daily use, lower doses such as 2.5 mg or 5 mg are typically prescribed. The 10 mg and 20 mg strengths are intended for on-demand use prior to anticipated sexual activity.

6. What are the contraindications for BP Esculap 20mg?

BP Esculap 20mg is contraindicated in patients taking any form of organic nitrate, either regularly or intermittently. It is also contraindicated with guanylate cyclase stimulators such as riociguat, in patients with severe cardiovascular disease, recent heart attack or stroke, uncontrolled blood pressure, or a history of NAION (sudden vision loss).

7. Can I take BP Esculap 20mg with other medications?

Tadalafil can interact with several medications. Nitrates and guanylate cyclase stimulators are strictly contraindicated. Caution is advised with alpha-blockers, certain antifungals, antibiotics, and medications that affect liver metabolism. Patients taking ritonavir or other CYP3A4 inhibitors may require dose adjustments. Always consult a healthcare provider regarding potential drug interactions.

8. What are the common side effects of BP Esculap 20mg?

The most commonly reported side effects include headache, flushing, nasal congestion, indigestion, and back pain or muscle aches. These effects are generally mild to moderate in intensity and typically resolve on their own. Patients experiencing persistent or severe side effects should seek medical attention.

9. Is sexual stimulation required for BP Esculap 20mg to work?

Yes. Tadalafil requires sexual stimulation to be effective. The medication facilitates the erectile response by maintaining elevated cGMP levels, but the initial release of nitric oxide triggered by sexual arousal is still necessary to initiate the erection process.

10. Who manufactures BP Esculap 20mg?

BP Esculap 20mg is manufactured by Balkan Pharmaceuticals, a pharmaceutical company based in Moldova. Balkan Pharmaceuticals is the sole producer in Moldova of the Esculap tadalafil product.

References and Reputable Sources

• U.S. Food and Drug Administration (FDA) – Tadalafil Prescribing Information: DailyMed – Tadalafil Tablets

• DailyMed – CIALIS (tadalafil) Label: https://dailymed.awsprod.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bcd8f8ab-81a2-4891-83db-24a0b0e25895

• National Center for Biotechnology Information – Tadalafil Mechanism of Action: https://www.ncbi.nlm.nih.gov/

• MedlinePlus – Tadalafil Drug Information: https://medlineplus.gov/

• FDA Approval History – Cialis (tadalafil): Approved November 21, 2003

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