Sterile Compounding
- 17P (17 alpha hydroxyprogesterone)*
- Intracavernosal injections of papaverine and phentolamine, sometimes with prostaglandin E1 (“tri-mix”) in customized doses*
- Riboflavin
- Vitamin B-12
- Diagnostic preparations (i.e., methylene blue)
- Glutathione
*see more info below
Ask us about combinations to meet specific needs or medications that are currently unavailable or have been discontinued for non-safety reasons (such as when a newer therapy reduces the need and therefore decreased use results in the medication no longer being profitable to manufacturer).
17-Alpha Hydroxyprogesterone Caproate (17P) decreases the risk of pre-term delivery (PTD) in pregnant women with a history of spontaneously giving birth before 37 weeks gestation, and who are therefore at risk of experiencing another pre-term birth. Typically, women receive weekly intramuscular injections of 250 mg of 17P, ideally starting at 16 weeks gestation and continuing to 36 weeks and 6 days.
N Engl J Med. 2003 Jun 12;348(24):2379-85.
Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.
Meis PJ, Klebanoff M et al.
Click here to access the PubMed abstract of this article.
Obstet Gynecol. 2005 May;105(5 Pt 1):1128-35.
17 hydroxyprogesterone for the prevention of preterm delivery.
Meis PJ; Society for Maternal-Fetal Medicine.
Click here to access the PubMed abstract of this article.
Manag Care. 2005 Oct;14(10):58-63.
17 alpha-hydroxyprogesterone caproate (17P) usage in a Medicaid managed care plan and reduction in neonatal intensive care unit days.
Mason MV et al.
Click here to access the PubMed abstract of this article.
Am J Obstet Gynecol 2007;196:224.e1-224.e4.
Increased recurrence of preterm delivery with early cessation of 17-alpha-hydroxyprogesterone caproate.
Andrei Rebarber et al.
Am J Obstet Gynecol 2007;196:453.e1-453.e4.
Cervical length changes during preterm cervical ripening: effects of 17-α-hydroxyprogesterone caproate.
Fabio Facchinetti et al.
Obstet Gynecol. 2007 Oct;110(4):865-72.
Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo.
Northen AT et al.
Click here to access the PubMed abstract of this article.
Intracavernosal injections
Intracavernosal injection of drugs such as papaverine, phentolamine, and prostaglandin E1 is an effective treatment for patients with erectile dysfunction (ED).
Clin Cornerstone. 2005;7(1):37-45.
Available and future treatments for erectile dysfunction.
Click here to access the PubMed abstract of this article.
Treatment with self-injections of vasoactive drugs in diabetic men with severe ED is a safe and effective long term treatment. A key for successful maintenance therapy is the adjustment of the dosage to optimal levels for satisfactory erections.
Asian J Androl. 2006 Mar;8(2):219-24
Long-term treatment with intracavernosal injections in diabetic men with erectile dysfunction.
Click here to access the PubMed abstract of this article.
Early combination therapy: intracavernosal injections and sildenafil following radical prostatectomy increases sexual activity and the return of natural erections.
Int J Impot Res. 2006 Feb 16
Early combination therapy: intracavernosal injections and sildenafil following radical prostatectomy increases sexual activity and the return of natural erections.
Click here to access the PubMed abstract of this article.
More patients with ED and using ICI preferred it as their main treatment than was expected, even though they had a good response to oral sildenafil. A better quality of erection with ICI was the reason why experienced patients chose this method, differing from the choice of patients starting treatment for ED.
BJU Int. 2003 Aug;92(3):277-80
Preference for oral sildenafil or intracavernosal injection in patients with erectile dysfunction already using intracavernosal injection for > 1 year.
Click here to access the PubMed abstract of this article.
We can compound sterile ophthalmic drops, ointments, sprays, injections and pre-op solutions, including anesthetics, antibiotics, antioxidants, antivirals, cataract therapies, corticosteroids, ophthalmic decongestants, miotics, mydriatics, and lubricants.
Preparations can contain a single drug or a combination in the most appropriate strength and concentration for a specific use, such as fortified antibiotic or pre-op drops.
Examples of preservative-free preparations include drops or sprays containing the following medications, alone or in combination:
- Cyclopentolate
- Homatropine
- Phenylephrine
- Proparacaine
- Scopolamine
- Tetracaine
- Tropicamide
We use only the highest quality ingredients from an FDA registered supplier. Ask us about medications that are commercially unavailable or have been discontinued (for reasons other than safety concerns). We welcome the opportunity to answer your questions, and to work with you to compound medications that meet the specific needs of your practice. Please contact our compounding pharmacist with questions or to discuss any unique needs.
Autologous Serum Eye Drops
Conventional treatment of dry eye mainly consists of the use of preservative-free artificial eye drops and punctal occlusion. None of the commercially available artificial tear preparations include essential tear components such as epidermal growth factor, hepatocyte growth factor, fibronectin, neurotrophic growth factor, and vitamin A – all of which have been shown to play important roles in the maintenance of a healthy ocular surface epithelial milieu. Autologous serum (AS) eye drops contain these essential factors and are beneficial in the treatment of ocular surface diseases such as persistent epithelial defects (PED), superior limbic keratoconjunctivitis, keratoconjunctivitis sicca, and neurotrophic keratopathy. AS treatment has been demonstrated to be more effective than artificial tears in a randomized control study. In in vivo and in vitro experiments, AS eye drops showed marked suppression of apoptosis in the conjunctival and corneal epithelium. Albumin, the major protein in serum, improved ocular surface damage in vivo and rescued apoptosis after serum deprivation in vitro.
Autologous serum eye drops are non-allergenic and their biomechanical and biochemical properties are similar to normal tears. The protocol by Tsubota and associates entails obtaining a total of 40 ml of blood by venopuncture and centrifuging for 5 minutes at 1,500 rpm. The serum is then carefully separated in a sterile manner and diluted with sterile saline (preservative free) to prepare 20-50% autologous serum drops. Typically, aliquots of the final preparation are prepared in 5 ml vials with ultraviolet light protection, because vitamin A is easily degraded by light. Patients are instructed to keep the vials they are using in a refrigerator at 4 C and to store the other vials in a freezer until needed.
In the study by Kojima et al., none of the patients had punctal occlusion, which allowed evaluation of the solitary effect of autologous serum drops. They found significant improvements in tear stability, ocular surface vital staining scores, and pain symptom scores in patients treated with autologous serum eyedrops compared with those assigned to nonpreserved artificial tears; and concluded that autologous serum is superior to conventional treatment with artificial tears for improving ocular surface health and subjective comfort.
Am J Ophthalmol. 2005 Feb;139(2):242-6
The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study.
Click here to access the PubMed abstract of this article.
Locally applied acetylcysteine, a mucolytic, regulates mucus secretion and reduces mucus accumulation, and has an antiproliferative effect on keratinocytes. Therapy with acetylcysteine ophthalmic has proved more efficient than artificial tears in reducing subjective symptoms of dry eye syndrome. The advantages of acetylcysteine include more convenient instillation timing (4 times daily) and reduced nocturnal discomfort.
Acta Med Croatica. 2005;59(4):337-40.
[Comparison of local acetylcysteine and artificial tears in the management of dry eye syndrome].
[Article in Croatian]
Pokupec et al.
Click here to access the PubMed abstract of this article.
The efficacy of topical N-acetyl-cysteine (NAC) therapy was evaluated in patients with meibomian gland dysfunction (MGD). One month of topical NAC 5% (four times daily) provided statistically significant improvements in fluorescein break-up time (FBUT) values and Schirmer scores as compared with preservative-free artificial tears. Significant improvements for the symptoms of ocular burning, foreign body sensation, and intermittent filmy or blurred vision were noted in both groups; and only the NAC-treated group showed improvement for the symptom of itching. Conclusions: Topical administration of NAC is thought to be effective and well tolerated in patients with MGD.
J Ocul Pharmacol Ther. 2010 Jul 24. [Epub ahead of print]
Intravitreal Bevacizumab for Neovascular AMD
Bevacizumab (Avastin™) is derived from the same monoclonal antibody precursor as ranibizumab (Lucentis™), yet bevacizumab costs considerably less than ranibizumab when administered as an intravitreal injection. Results of triple therapy using bevacizumab and intravitreal injections of dexamethasone or triamcinolone in combination with photodynamic therapy are encouraging.
N Engl J Med. October 5, 2006; 355(14):1409-1412
Acta Ophthalmol. 2010 Aug;88(5):594-600. Epub 2009 May 22.
Effect of intravitreal bevacizumab (Avastin) in neovascular age-related macular degeneration using a treatment regimen based on optical coherence tomography: 6- and 12-month results.
Leydolt C et al.
Click here to access the PubMed abstract of this article.
Retina. 2008 Oct;28(9):1325-37.
Long-term safety and efficacy of intravitreal bevacizumab (Avastin) for the management of central retinal vein occlusion.
Gregori et al.
Click here to access the PubMed abstract of this article.
Ophthalmic Surg Lasers Imaging. 2009 May-Jun;40(3):293-5.
Sustained elevation in intraocular pressure associated with intravitreal bevacizumab injections.
Kahook et al.
Click here to access the PubMed abstract of this article.
Retina. 2009 May;29(5):573-8.
Same-day triple therapy with photodynamic therapy, intravitreal dexamethasone, and bevacizumab in wet age-related macular degeneration.
Bakri SJ, Couch SM, McCannel CA, Edwards AO.
Click here to access the PubMed abstract of this article.
Acta Ophthalmol. 2010 Aug;88(5):558-63. Epub 2009 Apr 27.
Macular function after intravitreal triamcinolone acetonide injection for diabetic macular oedema.
Karacorlu M, Ozdemir H, Senturk F, Karacorlu SA, Uysal O.
Click here to access the PubMed abstract of this article.
Cycloplegic (Mydriatic) Eye Spray
Children often resist instillation of mydriatic drops for dilated fundus evaluation. As cycloplegic sprays have proven useful, two studies in children aged 3-13 years, compared administration of one drop each of 1% tropicamide and 2.5% phenylephrine in each eye or one application of mydriatic spray (containing concentrations of 0.5% tropicamide and 2.5% phenylephrine) to each closed eyelid. These studies indicate that use of mydriatic sprays on closed eyelids is as efficacious as use of mydriatic drops in open eyes, and is a preferred method of administration for children.
Because mydriatic sprays are compounded, the physician has flexibility in prescribing the concentration and combinations of medications, and may also include homatropine, scopolamine or proparacaine.
Optom Vis Sci. 1997 Mar;74(3):160-3.
Efficacy of a mydriatic spray in the pediatric population.
Click here to access the PubMed abstract.
Binocul Vis Strabismus Q. 1999;14(2):107-10
A randomized comparison study of drop versus spray topical cycloplegic application.
Click here to access the PubMed abstract.
Another study compared the tolerance and efficacy of cyclopentolate spray versus drops in 62 eyes of 32 children. The nonparametric Wilcoxon test for paired data showed no significant difference between cycloplegic measurements with drops or spray. The report concluded that cyclopentolate spray is a good alternative to traditional drops, leading to equal cycloplegic efficacy but greater tolerance in children. The spray was also easier to administer.
J Fr Ophtalmol. 2006 Oct;29(8):896-9.
Comparative study of cyclopentolate drops versus spray in cycloplegia in children.
[Article in French]
Chafai A, Ajdnik S, Lejeune L, Cordonnier M.
Click here to access the PubMed abstract.
Combination Therapy / Pre-op Drops
Many procedures call for multiple eye drops administered in a short period of time. The problem is that consecutive drops wash out and dilute the preceding medication, causing decreased effectiveness and repeated administration. While some clinics will mix all of the drops together (slurry) before administration, this results in a significant dilution of active ingredients from their therapeutic concentration. We can prepare combination eye drops that maintain the original therapeutic concentration in each drop. In addition, the viscosity can be increased to maintain tissue contact time. Other benefits include simplified administration, reduced staff time (fewer drops), improved accuracy and less waste.
Men with erectile dysfunction (ED) who used triple therapy (papaverine/phentolamine/prostaglandin-E1) by intracavernosal injection (ICI) and then changed to oral sildenafil found they had a greater preference than expected for triple therapy. Overall, the erection quality with ICI was better than that with sildenafil.1 Fear of pain with intracavernosal injection (ICI) therapy may discourage its use. Yet, findings from a Cleveland Clinic study show that in the majority of ED patients, discomfort is minimal.2
Treatment with self-injections of vasoactive drugs in men with diabetes (both type 1 and type 2) and severe ED is a safe and effective alternative in the long term. The key is adjustment of the therapeutic method and dosage to optimal levels for satisfactory erections.3
Early intracavernosal injections following radical prostatectomy facilitated early sexual intercourse, patient satisfaction and potentially earlier return of natural erections, according to a study from the Glickman Urological Institute, Cleveland Clinic Foundation. Early combination therapy with sildenafil allowed a lower dose of intracavernous injections, minimizing the penile discomfort.4
A higher percentage of positive response in patients with erectile dysfunction was achieved with the trimix modality. Choice of more potent ICI regimens can improve efficacy.5
1 BJU Int. 2003 Aug;92(3):277-80.
Preference for oral sildenafil or intracavernosal injection in patients with erectile dysfunction already using intracavernosal injection for > 1 year.
Click here to access the PubMed abstract of this article.
2 J Sex Med. 2005 May;2(3):428-31.
Use of a visual analog scale to assess pain of injection with intracavernous injection therapy.
Click here to access the PubMed abstract of this article.
3 Asian J Androl. 2006 Mar;8(2):219-24.
Long-term treatment with intracavernosal injections in diabetic men with erectile dysfunction.
Click here to access the PubMed abstract of this article.
4 Int J Impot Res. 2006 Sep-Oct;18(5):446-51. Epub 2006 Feb 16.
Early combination therapy: intracavernosal injections and sildenafil following radical prostatectomy increases sexual activity and the return of natural erections.
Click here to access the PubMed abstract of this article.
5 Arch Esp Urol. 2001 May;54(4):355-9.
[Response to intracavernous administration of 3 different drugs in the same group of patients with erectile dysfunction]
Click here to access the PubMed abstract of this article.
- Methocarbomol
- Mitomycin C
- Guaifenesin
- Methylene Blue*
- Ophthalmic Preparations*
*see more info below
Ask us about combinations to meet specific needs or medications that are currently unavailable or have been discontinued for non-safety reasons (such as when a newer therapy reduces the need and therefore decreased use results in the medication no longer being profitable to manufacturer).
Pluronic Gels Enhance Platinum Drug Sensitivity
Platinum based chemotherapy drugs (cisplatin, carboplatin, oxiliplatin) are frequently used in the treatment of neoplasia and other solid tumors in both humans and animals. In spite of positive results achieved in these cases, therapy is often limited by serious systemic adverse effects (nephrotoxicity, myelosuppression) and also by emergence of tumor resistance. By delivering these drugs locally through intratumoral or regional administration, systemic toxicities have been reduced, but the problem of drug resistance remains a major issue.
Thermoreversible pluronic gels (liquid at cold temperatures and solid gels at body temperature) have desirable properties that would facilitate local infusion of antineoplastic drugs to limit systemic toxicity, and are also amphiphilic allowing incorporation of many drug moieties. An investigation in 2001 discovered that pluronic polymers interact with resistant cancer cells sensitizing them to various antineoplastic agents and alter drug efflux transporter and detoxification systems. Because tumor cell resistance to the platinum drugs is thought to be mediated by elevated glutathione, a pathway also affected by pluronic polymers, the combination of platinum drugs and pluronic is a potentially useful construct. A group of investigators recently demonstrated that pluronics enhanced the cytotoxicity of carboplatin two-fold in an in vitro experimental cell culture of colorectal carcinoma cells.
One potential area of application for this concept is in equine sarcoidosis. Traditionally, equine sarcoid cells have been injected with a 1:1 mixture of either carboplatin or cisplatin in sesame oil and injected directly into the sarcoid masses. As injection of oily vehicles can result in local irritation and restrict the bioavailability of anti-neoplastic agents, veterinary clinicians are beginning to consider replacement of the sesame oil vehicle with pluronic gel polymers which can be prepared by compounding pharmacists
Br J Cancer. Dec 2001;85(12):1987-1997.
Mechanism of sensitization of MDR cancer cells by Pluronic block copolymers: Selective energy depletion.
Batrakova EV, Li S, Elmquist WF, Miller DW, Alakhov VY, Kabanov AV.
Click here to access the PubMed abstract of this article.
J Control Release. 2005 Aug 18;106(1-2):188-97.
Enhancement of carboplatin toxicity by Pluronic block copolymers.
Exner AA, Krupka TM, Scherrer K, Teets JM.
Click here to access the PubMed abstract of this article.
Methylene Blue for Drought-Affected Animals
The exceptional drought that is currently plaguing many areas in the United States has caused many problems for livestock producers and their stock. The drought is also exceptional in that it is forcing many veterinarians and pharmacists to consider use of the chemical agents listed in Appendix A in the FDA’s Compliance Policy Guide for Compounding of Drugs For Use in Animals. The appendix – which lists ammonium molybdate, ammonium tetrathiomolybdate, ferric ferrocyanide, methylene blue, picrotoxin, pilocarpine, sodium nitrite, sodium thiosulfate, and tannic acid – represents the most effective antidotes used to treat livestock poisoning.
In conditions of drought, plants are no longer able to convert nitrogen to proteins. When livestock graze on nitrogen-saturated plants, they not only suffer from inadequate protein intake, but also become nitrate poisoned. Sheep, goats and cattle intoxicated with nitrate exhibit signs of labored breathing, staggering gait, and sudden death, all of which are due to oxidative injury to hemoglobin, leading to methemoglobinemia and hypoxia. If not treated, these animals will functionally suffocate, even while breathing air.
While it is generally a good idea to steer clear of compounding for food animal patients, compounding pharmacists can literally save hundreds of animal lives by compounding methylene blue 1% injection for nitrate poisoned livestock. Solutions of methylene blue powder and sterile water are easily autoclaved in 500ml plastic, autoclavable serum bottles, which is the average volume required to treat an adult cow suffering from nitrate poisoning. For more information on methylene blue treatment of nitrate toxicity in livestock, see Nitrate and Nitrite Poisoning: Introduction, in the Merck Veterinary Manual, Merck & Co., Inc., Whitehouse Station, NJ, 2006.
Veterinary Ophthalmic Preparations
Many agents used in veterinary ophthalmology are no longer or never were commercially available. Examples of agents that are commonly used by veterinarians but are no longer commercially available currently include oxytetracycline ophthalmic ointment, idoxuridine ophthalmic solution and ointment, vidarabine ophthalmic solution, miconazole solution, trifluridine ophthalmic solution, tetracycline ophthalmic solution, rose bengal solution, and chloramphenicol ophthalmic ointment. Even if commercially available, products may be of inappropriate concentration to achieve a therapeutic effect in a given patient (e.g. cyclosporin A) or may have agents and excipients that have adverse effects in animal patients (e.g. neomycin sulfate in cats). In other cases, no product is commercially available and the needed preparation must be compounded from other non-ophthalmic drugs or from bulk chemicals (e.g. acetylcysteine ophthalmic solution and disodium edetate ophthalmic solution). For these reasons, pharmacists are frequently called upon to compound sterile preparations for use in the animal eye. To ensure adequate stability, uniformity, and sterility, both the American Society of Health-Systems Pharmacists and the United States Pharmacopoeial Convention have published guidelines for pharmacy-prepared ophthalmic preparations. These guidelines address the following areas of concern:
Validation of Formulation
Documentation
Sterility and use of Preservatives
Clarity
Tonicity
Buffering and pH
Viscosity Enhancers
Quality Control
Packaging
Expiration Dating
Considerations for use of ophthalmics in veterinary patients
General Principles of ocular penetration
Corneal penetration
Key points for corneal penetration of drugs:
- lipophilic
- equilibrium between ionized and non-ionized forms
- small molecular weight (<350)
- high local concentrations
Intravitreal penetration
Topical Mitomycin C Adjunct Therapy for Equine Ocular Squamous Cell Carcinoma
During surgery for SCC, many equine ophthalmologists also treat the eye with a topical solution of mitomycin C at a concentration of 0.4mg – 4mg/ml applied to the eye for 1-5 minutes. Following surgery, some clinicians will apply mitomycin C 0.4mg/ml topical solution to the affected eye three times daily for 7 days in repeating cycles until tumor resolution. Mitomycin C is a potent anti-neoplastic, cytotoxic agent and should be handled and disposed of accordingly.
Aust Vet J. 2006 Jan-Feb;84(1-2):43-6.
The use of mitomycin C as an adjunctive treatment for equine ocular squamous cell carcinoma.
Click here to access the PubMed abstract of this article.
Stanozolol
In a study conducted at the Animal Health Unit and Gastrointestinal Sciences, University of Calgary, Alberta, ten healthy, intact, adult male sled dogs received either stanozolol tablets, 2 mg/dog PO, q12h, for 25 days or an intramuscular injection of stanozolol 25 mg on Days 7, 14, 21, and 28. A 15N amino acid (5.27 mmol) was infused intravenously into each dog on Day 0 (before stanozolol treatment) and on Day 31 (after stanozolol treatment). Both oral and injectable stanozolol resulted in significant increases in amino acid nitrogen retention compared to pretreatment values. Oral stanozolol increased nitrogen retention from 29.2 +/-8.2% to 50.3 +/- 9.2%, while stanozolol injection increased nitrogen retention from 26.6 +/- 9.9% to 67.0 +/- 7.5%. The nitrogen retention action of stanozolol may be beneficial in dogs under stress of surgical trauma and chronic disease.
In a separate blinded crossover trial at the College of Veterinary Medicine, Kansas State University, 22 castrated Beagles with experimentally induced chronic renal failure were treated with stanozolol. Cowan et al. concluded that for dogs with mild-to-moderate, nonuremic, experimentally induced, chronic renal failure, stanozolol had positive effects on nitrogen balance and lean body mass. Stanozolol did not have a significant effect on body fat, bone mineral content, or food consumption per kilogram of body weight.
Anabolic steroids such as stanozolol have been used to treat geriatric dogs. These drugs can increase nitrogen and mineral retention so that the body can better utilize dietary protein. As a result, the dog’s appetite may improve, resulting in more strength, energy, and weight gain. There is one reported case of the use of stanozolol (0.5 mg/kg, SQ, BID, PRN) to stimulate appetite in a rabbit. However, this class of drugs is not without potentially serious side-effects which must be considered before using them. Anabolic steroids should be used with caution in animals with heart, liver, or kidney problems, or in animals with breast or prostate cancer. Stanozolol should not be used in pregnant animals, during lactation, in young animals, or in male breeding animals. Anabolic steroids may increase the effects of warfarin and other anticoagulants.
In dogs, reported side effects are mainly androgenic, including increased aggression, increased activity, weight gain and mood alterations. However, in cats with and without chronic renal failure, there are reported cases of hepatotoxicity that appear to be related to the use of stanozolol.
J Am Vet Med Assoc. 1997 Sep 15;211(6):719-22
Effect of stanozolol on body composition, nitrogen balance, and food consumption in castrated dogs with chronic renal failure.
Click here to access the PubMed abstract of this article.
Can J Vet Res. 2000 Oct;64(4):246-8
The effect of stanozolol on 15nitrogen retention in the dog.
Click here to access the PubMed abstract of this article.
Veterinary Forum. April 1999
Effect of stanozolol on body composition, nitrogen balance, and food consumption in castrated dogs with chronic renal failure.
Click here to access the PubMed abstract of this article.
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