Compounding Opportunities Women s Health& Men s Health

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1 Compounding Opportunities Women s Health& Men s Health Andrea Branvold, MS, RPh BHRT Vegas February 19,2015

2 Bacterial Vaginosis Formula #9076 Metronidazole 125mg/mL/ Nystatin 25,000U/mL Vaginal Cream Formula #7447 Chlorhexidine Gluconate 0.5% Vaginal Gel Formula #10207 Acetic Acid 0.9% (W/W)/Hydroxyquinoline Sultate 0.025% Vaginal Gel (VersaBase ) Formula #3876 Acidophilus Lactobacillus Vaginal Cream Formula #1329 Boric Acid 600mg Base MBK Vaginal Suppository (Pink Mold) Vaginal Dryness Formula Request she is looking for treatment options for a patient who is experiencing vaginal dryness and tearing during intercourse Formula Request for a lady who has breast cancer, needs something to apply vaginally since sex is painful, no estrogen We've had a practitioner inquire about "cuddle cream" to treat vaginal dryness and decreased sex drive. Does anyone have any experience with this compound that can advise me on drug/strength? Thanks! Vaginal Dryness Formula #5314 Estriol 0.05% Vaginal Cream Formula #11116 Estriol 0.1%/Testosterone 0.1% Vaginal Gel (Mucolox /VersaBase ) Formula #11117 Sodium Hyaluronate 5mg/gm Compound Vaginal Gel (Mucolox /VersaBase ) Formula #11119 Vitamin E 200iu/gm Vaginal Gel (Mucolox /VersaBase ) Formula #8990 Vitamin E 200iu Base MBK Vaginal Suppository Formula #10590 Glycerin 15%/Vitamin E Acetate 0.2% Vaginal Gel 2015 PCCA. All Rights Reserved 1

3 Vaginal Atrophy Document #98289 Treatment Options for Vaginal Atrophy: What Do the New Studies Show? Formula #9911 Hyaluronic Acid 5mg/gm Compound Vaginal Cream Formula #8980 Estriol5mg/ml Vaginal Cream Formula #9900 Dehydroepiandrosterone 13mg Base MBK Suppository (DHEA) Formula #9893 Estriol 1mg/Progesterone 30mg Base MBK Suppository Female Sexual Dysfunction/Libido Document #98539 Vaginal Atrophy and Female Sexual Dysfunction Treatment Chart Document #97920 Compounding Ideas/Formulations Marketing Sheet Female Sexual Dysfunction & Libido Female Sexual Dysfunction/Libido (cont d) Formula #6504 Testosterone 1% Topical Cream Formula #10988 Aminophylline 3%/Arginine HCl 6% Topical Gel (Spira Wash[TM]) Formula #10879 Papaverine HCl 0.1%/Arginine 6% Topical Lipoderm Arginine 6% in VersaBase Cream Formula #9915 Oxytocin 40 units/gm Vaginal Cream Formula #4932 Sildenafil 1% Topical Cream 2015 PCCA. All Rights Reserved 2

4 Vulvodynia Chronic vulvar pain without an identifiable cause Formula #11108 Amitriptyline HCl 2%/Baclofen 2% Vaginal Gel (Mucolox ) Formula #11110 Gabapentin 6% Vaginal Gel (Mucolox /VersaBase ) Formula #11109 Ketamine 0.5%/Diazepam 1%/Baclofen 2% Vaginal Gel (Mucolox /VersaBase ) Vulvodynia (cont d) Chronic vulvar pain without an identifiable cause Formula #9955 Ketamine 5%/Lidocaine 5%/Diazepam 1% Vaginal Cream (VersaBase ) Formula #10542 Baclofen 20mg/gm Diazepam 10mg/gm Vaginal Gel Genital/Vaginal Warts Formula #9996 Trichloroacetic Acid 80% (W/V) Topical Solution Formula #3278 Podophyllum 25% in Tincture of Benzoin 2015 PCCA. All Rights Reserved 3

5 New Formulas for Genital Warts Formula #11418 Deoxy D Glucose 0.2%/Imiquimod 5%/Tea Tree Oil 2.5%/Cimetidine 10% Topical Cream (VersaBase Formula #11015 Imiquimod 5%/Fluorouracil 1% Topical Cream (VersaBase ) Formula #11417 Cimetidine 10%/Fluorouracil 5%/Deoxy D Glucose 2%/Imiquimod 5% Topical Lipoderm Formula #11415 Deoxy D Glucose 0.2%/Cimetidine 10%/Acyclovir 5%/EGCg 1%/Imiquimod 5%/Tea Tree Oil 2.5% Vaginal Gel (MucoLox /VersaBase ) New Formulas for Genital Warts Formula #11001 Imiquimod 5%/Deoxy D Glucose 0.2% Topical Gel (PracaSil Plus) Formula #11414 Imiquimod 1%/Acylovir 2%/Deoxy D Glucose 0.2%/EGCg 1%/Aloe Vera 0.2%/Ibuprofen 2% Topical Gel (PracaSil Plus) Formula #11416 EGCg 1%/Cimetidine 10%/Deoxy D Glucose 2%/Tea Tree Oil 2.5% Vaginal Gel (MucoLox /VersaBase ) Genital Herpes Lesions Formula #11398 Acyclovir 5%/Amitriptyline HCl 2%/Ketoprofen 5%/Bupivacaine HCl 1%/Gabapentin 6% Topical Gel (PracaSil Plus) Formula # Acyclovir 5%/Lidocaine HCl 5%/Deoxy D Glucose 2% Vaginal Gel (MucoLox /VersaBase ) Formula #9625 Deoxy D Glucose 2%/EGCg 1% Topical Anhydrous Lipoderm Formula #9617 EGCg 1%/Tea Tree Oil 1%/ Deoxy D Glucose 0.2% Topical Anhydrous Lipoderm 2015 PCCA. All Rights Reserved 4

6 MucoLox MucoLox is a water soluble mucosal delivery system that can be used alone or with various APIs for potential use in formulations. It s unique muco adhesive properties, which increase contact time to mucosal surfaces, make MucoLox an ideal choice for use in oral, rectal (including enemas), and vaginal compounded preparations. MucoLox MucoLox contains a polymer network that provides a unique bond to the mucosa thus creating the coating effect long lasting moisturization and adhesion/coating properties. Helps to create the gradual and continued release of the API leading to improved contact time of the API to the mucosa Free of gluten, casein, dye, and parabens among other allergens Cervical Dysplasia and The Gowey Protocol 2015 PCCA. All Rights Reserved 5

Gowey Tincture Gowey Tincture contains Sarracenia flava. Topical use of Sarracenia flava and related species can be used for the following conditions: Viral diseases (i.e., HPV and HSV I/II) Squamous

7 Gowey Tincture Gowey Tincture contains Sarracenia flava. Topical use of Sarracenia flava and related species can be used for the following conditions: Viral diseases (i.e., HPV and HSV I/II) Squamous cell carcinoma Spider bites MRSA Wasp/bee stings Warts Dysplastic nevi Kaposi s sarcoma Gowey Tincture Note: Therapy works best when the lesion, spider bite, viral or bacterial infection is new or there is an active turnover of cells. There are different species of Sarracenia. Sarracenia purpurea is used orally. It is high in anthocyanins and low in alkaloids. Sarracenia flava, in contrast, is high in alkaloids and low in anthocyanins. Flava contains coniine, a known neurotoxin when taken orally at high doses. Therefore, Gowey Tincture (Sarracenia flava) is ONLY to be used topically. Gowey Protocol for Cervical Dysplasia Dr. Brandie Gowey used this treatment as an alternative care for cervical dysplasia in a case study done in under the supervision of the Naturopaths International IRB. The data from this study is compiled and published in her book Your Cervix (Just) Has A Cold PCCA. All Rights Reserved 6

8 Gowey Protocol for Cervical Dysplasia Cervical Dysplasia Dispense 2 4 ounces of Gowey Protocol Gel to the patient with a vaginal applicator. 4 8 grams is used nightly (Amount used depends on the position of the cervix; prolapsed, posteriorly rotated, etc., and diagnosis.) It is recommended that physicians be trained by Dr. Gowey in proper use of treatment prior to use in patients Gowey Protocol for Cervical Dysplasia Cervical Dysplasia Physicians are also to apply the Gowey Protocol Gel directly to the cervix in monthly visits with the patient. The Gowey Protocol Gel is very drying when applied to the skin. For some women stronger concentrations of the gel may burn and sting. The 20% concentration is well tolerated. Formulas Document #98717 Gowey Tincture Formula Spotlight by Melissa Merrell, PharmD Formula #10829 GoweyTincture 20% (W/W) Topical Gel (VersaBase) Formula #10830 GoweyTincture 30% (W/W) Topical Gel (VersaBase) 2015 PCCA. All Rights Reserved 7

VersaBase Gel (PCCA #30 3656) is the only recommended base to use with the Gowey Tincture PCOS and Related Formula Options Formula #10871 Metformin HCl 10% Topical Lipoderm Formula #11104 Minoxidil

9 VersaBase Gel (PCCA # ) is the only recommended base to use with the Gowey Tincture PCOS and Related Formula Options Formula #10871 Metformin HCl 10% Topical Lipoderm Formula #11104 Minoxidil 5%/Azelaic Acid 5% Topical Foam (VersaBase ) Formula #10360 Minoxidil 10%/Azelaic Acid 5% Topical Solution Formula #5568 Spironolactone 5% Topical Cream Progesterone MBK Suppositories (various strengths) Formula #8733 Benzoyl Peroxide 7%/Niacinamide 2%/Biotin 0.1% Facial Gel Hair Loss Formula #11352 Minoxidil 10%/finasteride 0.1% Topical solution Formula #11353 Minoxidil 10%/Finasteride 0.1% Topical Gel Formula #11354 Minoxidil 8.5%/Finasteride 0.1% Shampoo Formula #11355 Minoxidil 5%/Tretinoin 0.025%/Finasteride 0.05% Topical solution Formula #11356 Minoxidil 2%/Tretinoin 0.025%/Progesterone 0.05% Topical Gel (womens scalp gel) Formula #11359 Finasteride 0.25% Facial Cream 2015 PCCA. All Rights Reserved 8

10 Hair Loss Formula #11360 Finasteride 1.5 mg Capsule Formula #4196 Finasteride 0.1%/Minoxidil 3% Topical Gel Formula #10632 Minoxidil 8.5%/Finasteride 0.1% Scalp Solution Formula #11196 Minoxidil 5%/Azelaic Acid 1.5%/Tretinoin 0.025%/Progesterone 0.25%/Finasteride 0.1% Topical Foam Acne Formula #8733 Benzoyl Peroxide 7%/Niacinamide 2%/Biotin 0.1% Facial Gel Formula #10096 Salicylic Acid 1%/Mandelic Acid 1%/NataPres 5% Facial Foam Cleanser Formula #10609 Tretinoin 0.02%/Clindamycin 1%/Sulfacetamide Sodium 5% Topical Cream Acne Formula #6846 Benzoyl Peroxide 10%/Clindamycin 1% Clear Topical Gel Formula #10358 Salicylic Acid 2% Topical Occlusaderm ( Spot Treatment) Formula #9018 Salicylic Acid 2%/Mandelic Acid 5%/Niacinamide 5% Cleansing Pads 2015 PCCA. All Rights Reserved 9

11 Rosacea Formula # 6998 Nicotinamide Adenine Dinucleotide 1% Topical Ointment NADH Formula # 6992 Dapsone 5% Topical Cream (VersaBase ) Formula # Brimonidine Tartrate 0.5% Topical Gel Formula # Metronidazole 1%/Niacinamide 4% Topical Occlusaderm Rosacea Formula # Niacinamide 5%/Glyosaminoglycans 5%/Dimethyl Sulfone 2%/Biotin 0.2% Topical Cream (Occlusaderm ) Formula # Oxymetazoline HCl 0.06% Facial Lotion (VersaBase ) Formula # Metronidazole 1%/Niacinamide 4% Topical Gel (PracaSil Plus) Post surgical Scars Compounding Ideas/Formulations Marketing Sheet Scars, Document #98719 PCCA Formula # Aloe Vera 0.5% Topical Gel (PracaSil Plus) PCCA Formula # Betamethasone Valerate 0.1%/Tranilast 1%Topical Gel (PracaSil Plus) *Be aware of active ingredients in formula if pregnant or breastfeeding 2015 PCCA. All Rights Reserved 10

12 Stretch Marks Compounding Ideas/Formulations Marketing Sheet Scars, Document #98719 PCCA Formula # Aloe Vera 0.5% Topical Gel (PracaSil Plus) PCCA Formula # Tretinoin 0.1% Topical Gel (PracaSil Plus) (FormulaPlus BUD Study) (not for pregnant or breastfeeding patients) *Be aware of active ingredients in formula if pregnant or breastfeeding Erectile Dysfunction PCCA Formula # 5370 Sildenafil 20 mg T.T. (200 mg mold) Polyglycol Troche Base PCCA Formula #10924 Alprostadil 10 mcg/papaverine HCl 30 mg/phentolamine Mesylate 0.5 mg/ml Injection Solution (BUD Study) Tri Mix PCCA Formula # 4339 Papaverine HCl 18.9 mg/phentolamine Mesylate 0.9 mg/atropine Sulfate 0.18 mg/alprostadil 9 mcg/ml Injection Solution Quad Mix PCCA Formula # 7393 Papaverine HCl 30 mg/ml/phentolamine Mesylate 2 mg/ml/alprostadil 400 mcg/ml Urethral Gel Documents for Tri Mix & Quad Mix Trimix Algorithm Intercavernosal Injection Algorithm PCCA Document # Prostaglandin E1/Phentolamine/Papaverine Injection Patient Information Trimix Patient Directions PCCA Document # PCCA. All Rights Reserved 11

13 Videos for Education on Male Hypogonadism Document #98497 Video on Demand Webinar Overview: Men's Health: Restoring Testosterone by Bruce Biundo ( ) Document #98317 Video on Demand Webinar Overview: Testosterone Replacement Therapy by Mohit Khera, MD, MBA, MPH ( ) Hypogonadism Document #98474 Hormones, Male Male Hypogonadism Packet Document #94122 Hormones, Male Treatment Options for Male Hypogonadism Commonly Requested Formulas (Male Hypogonadism) Formula #7943 Testosterone 5% W/V VersaBase Gel Formula #9452 Testosterone 5% (W/W) Topical Lipoderm (BUD Study) Formula #10646 Clomiphene Citrate 5% (W/V) Topical Gel Formula #10637 Clomiphene Citrate 5%/Testosterone 5% (W/V) Topical Gel 2015 PCCA. All Rights Reserved 12

14 Commonly Requested Formulas (Male Hypogonadism) Formula #10638 Clomiphene Citrate 2.5%/Testosterone 2.5% (W/V) Topical Gel Formula #10753 Anastrozole 0.1% Topical Lipoderm[R] Formula #10969 Anastrozole 0.25 mg/0.2 ml Sublingual Drops Weight Loss HCG Diet PCCA Formula # HCG 125 U Base A Troche (Tablet Triturate 100 mg Mold) PCCA Formula # HCG 500 U/Gm Topical Lipoderm HMW HCG Helpful Documents Document #98130 Compounding Ideas/Formulations Marketing Sheet HCG Diet Document #98325 Is HCG the Missing Link? by Larry Thorne, BScPharm, RPh (Consultant's Corner, Apothagram) Document #98379 Video on Demand Webinar Overview: HCG for Weight Loss (# ) 2015 PCCA. All Rights Reserved 13

15 Videos for Education on Female Hormones Document #97865 Video on Demand Webinar Overview: Practical Approach to BHRT Parts 1 & 2 Document #98833 Video on Demand Overview: PCOS, Endometriosis, and Sleep Disorders in Menopause by Lena Edwards (# ) Videos for Education on Female Hormones Document #98826 Video on Demand Overview: What You Must Know About Women's Hormones by Pamela Smith (# ) Document #98827 Video on Demand Overview: Hormone Dosing and Compounded Dosage Forms by Pam Smith & Andrea Branvold (# ) Prescribers may contact your compounding pharmacist for questions or help! Thank you 2015 PCCA. All Rights Reserved 14

Compounding Options for Female and Male Patients

Compounding Options for Female and Male Patients Bruce Biundo, RPh and Andrea Branvold, RPh 2016 Las Vegas Hormone Replacement Therapy Symposium Las Vegas, NV February 11 13, 2016 Men s Health: Treating