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Tadalafil In Pharmacy Compounding

October 30, 2019 by freemexy  

Originally designed to treat cardiovascular diseases, phosphodiesterase-5 (PDE5) inhibitors made a major splash on the pharmaceutical market in 1998 with the approval of Viagra®. By far, it was the blockbuster drug of the decade. Other PDE5 inhibitors were soon to follow, and patent expiration dates have been an interesting phenomenon to watch, with multiple extensions involved. The good news is that tadalafil is now free of patents, and compounding pharmacies have some opportunities to use this drug in various customized medications.buyaas Tadalafil powder

Current Uses and Further Research
Tadalafil has labeled uses for benign prostatic hyperplasia, erectile dysfunction (ED) (including patients with diabetes mellitus or following radical prostatectomy), and improvement in exercise ability for patients with World Health Organization Group I pulmonary hypertension. There is a sub-group combination for benign prostatic hyperplasia and ED as well. Off-label uses include altitude-sickness prophylaxis (specifically prevention of high-altitude pulmonary edema), and treatment of sexual dysfunction in males receiving antidepressant therapy.1

Researchers have looked at or are currently looking at tadalafil in many other areas of interest as well. These include treatment for fetal growth restriction, Duchenne and Becker muscular dystrophies, male reproduction (increase in semen quality), improved endothelial function, passage of distal ureteral stones, treatment of myocardial ischemia/reperfusion injury and heart failure along with bladder ischemia, and aging bladder dysfunction.2,3,4,5

It is rare and also very exciting when compounders get such a new, widely researched and proven option for our tool boxes. With the current indications and potential uses, we will be able to use this ingredient in many ways with a variety of dosage forms to meet patient needs.

Potential Compounding Options with Tadalafil
The obvious compounding use for this ingredient is in various dosage forms for ED in men. For patients whose needs are not met with commercial products, we have created a variety of formulas (oral, sublingual/buccal, rapid dissolve, and nasal) of different strengths, following the FDA essential-copy guidance document, with dosages compliant in the potency differences from manufactured products where appropriate for individual patients.

Additional options include interesting combinations of ingredients. For example, activated vitamin B6 (pyridoxal 5 phosphate) can help decrease pituitary secretions, including prolactin, and excess prolactin is associated with decreased arousal in both men and women.6,7,8 Apomorphine has shown to be effective and well tolerated in the treatment of ED.9 There is an interesting link with vitamin B6 deficiency and increased risk of cardiovascular disease as well as high homocysteine levels linked to ED, suggesting that folate and vitamin B12 could also be beneficial.10,11

We have also received anecdotal reports of patients experiencing benefit with a combination of sildenafil and tadalafil.* It is important to understand that many of these formulas can be used for multiple reasons. Also, please note that this drug is not without adverse events, contraindications/precautions and drug-drug interactions, etc., when given percutaneously (transdermal or vaginal), because if it is absorbed, it can have an effect and must be excreted in some way.