Compounding Insight: Tadalafil as a compounded prescription

Tadalafil belongs to a class of drugs called phosphodesterase-5 (PDE-5) inhibitors which originally were designed to treat cardiovascular diseases. With the ground-breaking discovery of sildenafil (also in the same class of drugs as tadalafil) as a treatment for erectile disfunction in 1998, more and more options for treatment arose and tadalafil became commercially available in 2003.¹ 

It was not until 2018 however that tadalafil became free of patent and since then, many pharmaceutical companies have started to introduce tadalafil in their catalogs.²  As the molecule became more readily available allowing the prices to go down for consumers, and compounding pharmacies can now use this molecule in customized formulations. Today, tadalafil is used as a treatment for erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hyperplasia (BPH) in both the commercially available formulations and in non-standard delivery formulations custom made by compounding specialists.¹

Tadalafil in Pharmacy Compounding

Tadalafil can be compounded into non-standard delivery forms to treat different patient needs. Tadalafil can be compounded as a topical gel, oral sublingual formulation as troches or oral dissolving tablets, and in liquid suspensions. Xenex Labs has a database of formulas that partners can refer to. Please log-in to view the formulas you need.

Tadalafil may also be compounded with different ingredients to enhance its effects such as with Vitamin B12 to improve the production of blood in the body, therefore keeping a quality erection.³ Tadalafil can be compounded with vitamin B3 which may improve ED for people who suffer from dyslipidemia (the condition of having abnormal levels of blood lipids).⁴ Some compounding pharmacies have also blended tadalafil with oxytocin in sublingual troches which may assist with the patient’s mood and anxieties, increase libido, and may enhance tadalafil’s effects.  Many other combinations have been used – for more information, please contact Xenex Labs Customer Service.  

Tadalafil Maximum Dosage for Adults

• 40 mg/day for primary pulmonary hypertension
• 5 mg/day for once-daily administration in the treatment of erectile dysfunction
• 20 mg/dose PO for erectile dysfunction for as-needed use, not to exceed 1 dose/24 hours in most patients. 
• 5 mg/day PO for benign prostatic hyperplasia (BPH) or combined treatment of erectile dysfunction/BPH for once daily use.

Safety for consumers

• Tadalafil may interact with certain medications such as nitrates and alpha-blockers (and others) and some over-the-counter products.  Check with your health care provider before using.
• Avoid grapefruit juice ingestion while using this medication.  Grapefruit juice has been reported to decrease the metabolism of tadalafil, which may increase drug blood levels unexpectedly and potentially increase unwanted side effects.  Check with your health care provider for more information. 
• Avoid heavy drinking while using this medication

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Reviewed by: Paul Gibbons B.Sc. Pharm. RPh.
January 3rd, 2022

References:

1. ADCIRCA (tadalafil) dose, indications, adverse ... - pdr.net. (n.d.). Retrieved December 13, 2021, from https://www.pdr.net/drug-summary/Adcirca-tadalafil-2115.
2. Tadalafil: Summary report. The UMB Digital Archive. Retrieved December 13, 2021, from https://archive.hshsl.umaryland.edu/handle/10713/14953. 
3. Staff, H. H. P. (2020, August 31). Vitamin B12 deficiency can be sneaky, harmful. Harvard Health. Retrieved December 13, 2021, from https://www.health.harvard.edu/blog/vitamin-b12-deficiency-can-be-sneaky-harmful-201301105780.
4. Effect of niacin on erectile function in men suffering erectile dysfunction and dyslipidemia. The journal of sexual medicine. Retrieved December 13, 2021, from https://pubmed.ncbi.nlm.nih.gov/21810191/.