Apcalis SX

Apcalis SX is a popular oral jelly used to treat erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) in adult men.

Apcalis SX contains 20 mg of tadalafil, the same active ingredient as Cialis — the second most prescribed drug in ED after Viagra. This fast-acting drug improves erectile function up to thirty-six hours post-dose, earning it the nickname ‘the weekend drug.’

This article covers the mechanism of action, dose, usage, safety profile, and drug interaction of Apcalis SX. Read on to know more about the drug.

What is Apcalis SX?

Apcalis SX is manufactured by the Indian pharmaceutical company Ajanta Pharma. It is an easy-to-swallow jelly containing the active ingredient tadalafil, an inhibitor of the enzyme phosphodiesterase 5 (PDE-5).

This group of drugs is commonly used in adult males with ED. It is a safe and efficient alternative to the conventional tablet forms of tadalafil. Because it’s fast-acting, it’s one of the most preferred tadalafil-containing medications on the market.

Apcalis oral jelly is easy to swallow and is quickly absorbed into the body. It is available in a pack of seven assorted fruity flavors.

Apcalis SX oral jelly is not an aphrodisiac. It works only in the presence of a sexual stimulus. It relaxes the penile blood vessels, increasing the blood flow to the penis. This ultimately leads to hardening and erection. The use of tadalafil offers no protection against sexually transmitted diseases [1].

What is the Dose of Apcalis SX?

Apcalis SX is offered in four different strengths. The doses available are:

• 2.5mg
• 5 mg
• 10 mg
• 20 mg 

It should be used on an as-needed basis to induce and maintain an erection. If sexual activity is not anticipated, there is no reason to take the drug.

The starting dose is 10 mg and is decreased to 5 mg or increased to 20 mg, depending on tolerability and efficacy. Take it before sexual activity. Regardless of the dose, do not use it more than once daily.

Apcalis-SX for Once Daily Use for Erectile Dysfunction

Apcalis SX can also be used every day in patients with ED. The required dose is 2.5 mg. This may be increased to 5 mg. It should be taken once a day at approximately the same time every day. The timing of the dose is not related to sexual activity.

Apcalis-SX for Once Daily Use for Benign Prostatic Hyperplasia

In patients who have BPH, a daily dose of 5 mg is required. It should be taken once a day at approximately the same time every day. 

Dose adjustments are needed for patients undergoing renal dialysis and for individuals with mild or moderate hepatic impairment [1].

How Should I take Apcalis SX?

Apcalis SX oral jelly comes in a sachet that can be squeezed out onto a spoon or taken with water and swallowed. It is also available in tablet form.

A high-fat meal delays the onset of action for sildenafil and vardenafil, but tadalafil has no relationship to food. Take this medication as it is instructed. Do not stop the drug without consulting your healthcare provider.

How Long Does It Take for Apcalis SX To Kick In?

Apcalis SX has a short onset of action. The maximum plasma concentration is achieved within 30 minutes after a single oral dose.

How Long Does Apcalis SX Last?

Apcalis SX is one of the longest-lasting ED medications available and can last up to thirty-six hours post-dose [1].

The longer half-life of tadalafil (compared with sildenafil and vardenafil) is due to its slow half-life. It takes about 17.5 hours for half of the drug to be metabolized in the body.

Because of this, planned sexual activity is not a necessity. This longer half-life also forms the basis of its use in pulmonary arterial hypertension [2].

How Much Does Apcalis SX Cost?

Apcalis SX 20 mg oral jelly costs $28.93 for a pack of 7 sachets of different flavors. The price varies according to the dose of the drug.

The History of Apcalis SX

Tadalafil was discovered by GlaxoSmithKline under a partnership between Glaxo and the biotechnology company ICOS Corporation. Phase one clinical trial for Tadalafil began in 1995, which then progressed to Phase 3. In 1998, ICOS Corporation and Eli Lilly and Company formed Lilly ICOS to develop and commercialize tadalafil for ED.

In 2000 Lilly ICOS filed a new drug application for tadalafil [3]. The Food and Drug Administration (FDA) approved it in 2003 for use in ED [1]. In 2011, the FDA approved tadalafil for treating BPH with or without coexisting ED [4].

Who Should Take Apcalis SX?

Apcalis SX is recommended for use in adult men with ED or for patients with BPH. These patients may or may not have co-existing ED. Tadalafil is also used in pulmonary arterial hypertension [1, 2].

Safety Concerns & Side Effects Related to Apcalis SX

Apcalis SX may cause some unwanted effects depending upon the nature of use:

Apcalis SX for Use as Needed for ED

• Back pain
• Headache
• Heartburn
• Muscle pain
• Nasal congestion
• Pain in the limbs

Apcalis SX for Once Daily Use For ED

Additional side effects include:

• Abdominal Pain
• Cough
• Diarrhea
• Dizziness
• Hypertension
• Nasopharyngitis
• Reflux
• Upper respiratory tract infection
• Urinary tract infection

Apcalis SX for Once Daily Use for BPH or ED & BPH

• Joint Pain
• Muscle spasm
• Nausea
• Reflux
• Vomiting

Apcalis SX is not recommended for use in pregnancy (Pregnancy Category B), nursing mothers, and pediatric patients. It should be used with caution in men older than sixty-five years. Dose adjustments are required in patients with liver and kidney impairments [1].

Potential Drug Interactions With Apcalis SX

Certain medications that should not be mixed with Apcalis SX are:

Nitrates

Co-administration of Apcalis SX and Nitrates is contraindicated. Tadalafil potentiates the blood-pressure-lowering effects of Nitrates.

Antihypertensives 

Apcalis SX causes potentiation of the blood-pressure-lowering effects of selected antihypertensives (angiotensin II receptor blockers, amlodipine, metoprolol, enalapril, and more).

Alcohol

Both alcohol and tadalafil are mild vasodilators. When taken together, it causes additive blood pressure-lowering effects. It can also cause headaches, dizziness, and increased heart rate.

Antacids

Simultaneous use leads to reduced absorption of tadalafil. Hence, decreased effects can occur.

CYP3A4 Inhibitors

These drugs increase the effects of tadalafil by altering the metabolism of the CYP3A4 enzyme. This action can cause the medications to stay in the body longer than they should, increasing the risk of adverse side effects.

HIV Protease Inhibitor (Ritonavir)

Ritonavir increases the blood level of tadalafil.

CYP450 Inducers

They reduce the efficacy of tadalafil by decreasing its blood levels.

Who Should Avoid Using Apcalis SX?

Apcalis SX should not be used by:

• Patients with known hypersensitivity to tadalafil
• Men with cardiac disease who have been advised to refrain from sexual activity
• Pediatric population
• Pregnant and breastfeeding mothers
•  Individuals with severe hepatic impairment
•  Individuals with renal impairments
•  Patients with a history of non-arteritic anterior ischaemic optic neuropathy (NAION)
•  Patients using Nitrates
•  Patients on drugs that can potentially interact with tadalafil [1]

What Is the Mechanism of Action of Apcalis SX?

Penile erection results from increased blood flow to the penis, which is achieved by the relaxation of penile arteries and the smooth muscle corpus cavernosum. This reaction is mediated by nitric oxide (NO) released from the nerve ending and endothelial cells.

NO stimulates the synthesis of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum leading to smooth muscle relaxation and increased blood flow. Tadalafil is a selective inhibitor of the PDE-5 enzyme, which increases the amount of cGMP and enhances erectile function.

Local release of NO requires sexual stimulation. The inhibitory action of tadalafil on PDE5 has no effect in the absence of sexual stimulation [1].

Clinical Studies involving Apcalis SX

Apcalis SX for Use as Needed for ED

Tadalafil has been evaluated in twenty-two different clinical trials involving more than 4,000 patients. It is effective in improving erectile function in men with ED.

Comparable results were also obtained in ED patients with diabetes and ED patients following radical prostatectomy.

Apcalis SX for Once Daily Use for ED

Similar results were obtained in other clinical trials involving a total of 853 patients [1].

Apcalis SX for Once Daily Use for BPH or ED and BPH

The efficacy and safety of tadalafil were evaluated in many randomized, placebo-controlled, multinational, double-blind, parallel-design studies. Statistically significant improvement in symptoms was obtained in these trials [1].

Apcalis SX in Pulmonary Arterial Hypertension

Studies have shown that tadalafil is well-tolerated in patients with pulmonary arterial hypertension [2, 5].

Can Apcalis SX be Used in Women?

There have been emerging reports of the benefits of tadalafil in women. It has been used to reverse drug-induced sexual dysfunction often caused by serotonin-enhancing antidepressants [6]. It can also be used in pulmonary arterial hypertension.

Apcalis SX is not recommended for use in pregnant and lactating mothers[1].    

Other Drugs That Work Like Apcalis SX?

Tadalafil, the active ingredient of Cialis and Apcalis SX, is not patented. The generic version of the drug is available at a cheaper cost.

Other PDE-5 inhibitor drugs include:

• Avanafil (Avana Stendra ,Avaforce)
• Mirodenafil (Mvix)
• Sildenafil (Viagra, Edegra, Suhagra, Kamagra, Penegra, etc.)
• Udenafil (Zydena)
• Vardenafil (Levitra, Zhewitra,Savitra, etc)

Natural Alternatives to Apcalis SX

Herbal and natural formulations can act as an alternative to Apcalis SX. Keep in mind that the following options lack clinical testing and FDA approval for use in ED.

• DHEA
• Horny goat weed
• Melatonin
• Red Ginseng (Korean)
• Vitamin E

Where to Buy Apcalis SX?

Apcalis SX is a prescription-only medicine available online or at local pharmacies. Many individuals prefer purchasing the drug online as it maintains privacy while saving money and time.

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References Cited

1. Administration, U. S. F. and D. (n.d.). CIALIS (tadalafil) tablets Label.
2. Henrie, A. M., Nawarskas, J. J., & Anderson, J. R. (2015). Clinical utility of tadalafil in the treatment of pulmonary arterial hypertension: an evidence-based review. Core evidence, 10, 99.
3. Daugan, A., Grondin, P., Ruault, C., Le Monnier de Gouville, A. C., Coste, H., Kirilovsky, J., … & Labaudinière, R. (2003). The discovery of tadalafil: a novel and highly selective PDE5 inhibitor. 1: 5, 6, 11, 11a-tetrahydro-1 H-imidazo [1 ‘, 5 ‘: 1, 6] pyrido [3, 4-b] indole-1, 3 (2 H)-dione analogues. Journal of medicinal chemistry, 46(21), 4525-4532.
4.  Hatzimouratidis, K. (2014). A review of the use of tadalafil in the treatment of benign prostatic hyperplasia in men with and without erectile dysfunction. Therapeutic advances in urology, 6(4), 135-147.
5.  Galiè, N., Brundage, B. H., Ghofrani, H. A., Oudiz, R. J., Simonneau, G., Safdar, Z., … & Barst, R. J. (2009). Tadalafil therapy for pulmonary arterial hypertension. Circulation, 119(22), 2894-2903.
6. Ashton, A. K., & Weinstein, W. (2006). Tadalafil reversal of sexual dysfunction caused by serotonin enhancing medications in women. Journal of sex & marital therapy, 32(1), 1-3.