Restoration Therapy. Thyroid. Thyroid Compounding and Custom Compounding Formulas: Restoration Therapy cont. Its all about balance!!!!!

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Gerald Hoover
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1 Thyroid Compounding and Custom Compounding Formulas: Restoration Therapy! Replace hormone exogenously as needed! Goal: lowest amount of hormone required to achieve the physiological level and control symptoms! Be conservative: dose low and go slow on changes! Consider delivery system, timing, route, symptoms, side effects! Efficacy can be significantly increased by altering the route of administration, timing and application. 1 2 Restoration Therapy cont. Thyroid! Correct hormones problems through functional medicines! Lifestyle, diet, exercise! Not every individual with symptoms of hormone imbalance needs hormone replacement therapy...! Test for the 32 vitamins, anti-oxidants and use pharmaceutical and hypoallergenic grades vitamins Its all about balance!!!!!! Optimal Thyroid function requires adequate nutritional intake, it is related to toxin exposure, other hormonal functions and possible medication interactions! Consider replacement of both T3 and T4 to optimize thyroid function! Accurate measuring technique determines optimal thyroid replacement! Treatment of thyroid dysfunction should be individualized and customized to each patient 3 4 1

2 Thyroid Thyroid drug Interactions Deficiency (Hypothyrodism):! Weight gain/water retention! Low Energy! Dry skin! Constipation! Hair loss! Low body temperature (differential diagnosis with WDS)! Amiodarone (Cordarone )! Carbamazepine (Tegretol ) Levo/Carbidopa (Sinemet )! Androgens (Testosterone, DHEA) Danocrine (Danazol )! Phenytoin (Dilantin ) Metoclopramide (Reglan )! Lithium! Estrogens (patch, tablets, topical, oral contraceptives)! Glucorticoids (hydrocortisone, prednisone, prednisolone, etc.)! Cholestyramine (Questran ) 5 6 Thyroid Testing Rx! TSH, free T3, T4, TSH, R T3! TSH o 1.5 UIU/ml! Free T3 o pg/ml Thyroid 15mg Form: Tablet / Capsule / Vegi capsule Qty: Refills: 30mg 45mg Filler: Avicel / Probiotic / Methocel (SR caps) 60mg Other: mg Directions (sig) : 7 2

Thyroid SR Capsules Thyroid Capsules In Avicel and

3 Thyroid SR Capsules Thyroid Capsules In Avicel and Methocel SR - slow Release Thyroid.Commercially Available Thyroid.Commercially! Commercially available 30mg 60mg Commercially does not allow! Commercially available tablets contain fillers and excipients that may not be tolerated by all patients. When we compound customized dosages, we have the ability to omit any problemcausing inactive ingredients and substitute non-reactive fillers.! Lactose 3

4 Conversion chart Thyroid Medication for Consideration! Limited dosage strengths! Limited dosage forms! Thyroid drug shortages! Brand and generic non-equivalence! Batch variability with desiccated thyroid! Pharmacodynamic variability! Inert ingredients sensitivity Thyroid Dosing *Refer to conversion chart*! Dessicated thyroid (T3 : T4) (1:3.3) o 1 Grain Dessicated Th = 60 mg o E.g.2 mg T4 equivalent 2 grain of dessicated thyroid! Armor Thyroid o 1 grain of armor: 38 mcg T4 /9 mcg T3 Adrenals and Testosterone! Test in one cycle (30 days)! Thyroid support (zinc, Se, protein ) 15 4

5 Cortisol Deficiency Symptoms Cortisol Testing and Dosing! Irritability, depression, anger! Confusion, brain fog! Low tolerance for stress! Paranoia! 4 pt cortisol testing o Am testing is not enough! Hydrocortisone 5-25 mg /day BID-TID! Compounded Bio-identical cortisol SR once daily! Adrenal support formula (pharmaceutical grade)! Life style modification, stress relief, sleep and nutritional balancing DHEA dosing in Men and Women Testosterone in Women Men! Dose: mg Women! Dose: 5-20 mg Saliva Total serum! pg/ml ng/dl! Bio-available 4-25 ng/dl 7-keto DHEA! Dose: mg

6 Testosterone Testosterone in Men! Peri-Menopause and Menopause! Topical: mg OD! Safety: o D/C if pt has thinning hair or hirsutism Saliva pg/ml! Optimal pg/ml! BHRT pg/ml Serum ng/ml! Free (No Albumin) ng /dl Testosterone Dosing in Men and Women Testosterone /Andropause! Cream / Gel! Buccal / SL o Not a palatable taste though avoids GIT destruction and liver first pass effect!! HCG! HCG + T! T cypionate! Patch (consider alcohol content and skin irritation )! Topical: mg daily! Cypionate; mg IM weekly! Cyclic method o 10 weeks: weekly testosterone IM o 2 weeks off! HCG qod! Clomid 5 days

7 Compounded Testosterone: Disage Forms & Ranges Safety of Testosterone in Men Testosterone is most commonly prescribed as indicated below, though it is usually combined with other hormones. Safety:! Risk of prostate cancer! (Pt and family history )! PSA testing Side Effects:! Lower serum count (controversy)! Decrease in testicle size! Increase libido! Assertive behavior Endometriosis: Dosing Guidelines Custom Compounding! Turska s formula herbal tincture (Bryonia, Aconite, Gelsemium, Phytolacca)! Herbal tincture with chasetree, dandelion, prickly ash, motherwort! Progesterone cream o (1-3%) off for the first 7 days, then day 8-28: ¼ to ½ tsp twice daily! Progesterone oil filled capsules o (25-100mg) cotton seed oil, safflower oil, castor oil! Progesterone injection o (50mg/ml) in ethyl oleate! Dietary recommendations: o High fiber, protein, turmeric, ginger, milk thistle, flax seed o Decrease dairy, red meat, sugar and caffeine! Daily Supplementation: o Vitamin C (6-10g), Vitamin E ( IU), GLA (300mg), Selenium ( mcg), lipotropics (2-4 capsules) 28 7

8 Bacterial Vaginosis Vaginal Dryness! Boric acid 600 mg suppositories! Y stat capsules (vaginal)! Chlorhexidine gluconate 0.5% vaginal gel! Metronidazole 125 mg /ml +Nystatin 25,000/ml vaginal cream *(MD Rx required)! e.g Breast cancer lady, no estrogen, painful sexual intercourse! Estriol 0.05% vaginal cream! Sodium Hyaluronate 5mg/gm vaginal gel! Vitamin E 200 IU /gm vaginal gel! Vitamin E 200 IU /gm vaginal suppository! Glycerin 15 % + Vitamin E acetate 0.2 % vaginal gel Vaginal Atrophy Female sexual dysfunction/libido! Hyaluronic acid 5mg/gm vaginal cream! Estriol 5mg/ml vaginal cream! Estriol 1 mg + Progesterone 30 mg suppository All of the following require a Rx:! Testosterone 1 % + Aminophylline 3% + Arginine 6 % + Pentoxyphyline 5 % topical gel ( scream cream )! Oxytocin 40 IU /gm - 120mIU vaginal cream! Sildenafil 1 % topical cream

Genital Vaginal warts! TCA (trichloroacetic acid) 80 % topical solution (RX)! Deoxy-D _ glucose 0.2% + cimetidine 10 % + Acyclovir 5 % +EGCG 1% +Imiquimod + tea tree oil 2.5 % vaginal gel!

9 Genital Vaginal warts! TCA (trichloroacetic acid) 80 % topical solution (RX)! Deoxy-D _ glucose 0.2% + cimetidine 10 % + Acyclovir 5 % +EGCG 1% +Imiquimod + tea tree oil 2.5 % vaginal gel! Podophyllum 25 % in tincture of benzoin (RX) Genital Herpes Lesions Hair Loss! Acyclovir 5% Amitryptiline 2% + ketoprofen % + bupivacaine 1% + gabapentin 6% topical gel! EGCG1 % + Tea Tree oil 1% + Deoxy-D_Glucose 0.2% topical anhydrous base! Use a base that is water soluble though has much adhesive properties to increase mucosal surfaces contact time, hypoallergenic! Minoxidil 2 % + tretinoin % _ progesterone 0.05 % topical gel! Minoxidil 8.5 % -10 % + finasteride 0.1 % scal solution! Minoxidil 5% + azelic acid 1.5 % _ tretinoin % + progesterone 0.25% + finasteride 0.1% topical foam

10 Acne & Rosacea Vulvodynia! Benzoyl peroxide 5 % + Niacinamide 4 % + Biotin 0.1 % facial gel! Benzoyl peroxide 10 % + clindamycin 1 % clear topical Gel! Niacinamide 4 % + zinc Pyrithione 0.5 % topical gel! Rosacea! Niacinamide 5 % + Biotin 0.2 % + DMSO 2 % topical cream! Amitriptyline % + % Vaginal gel *(Rx required)! Gabapentin 6 % Vaginal gel! Ketamine 0.5 % + Diazepam 1 % +Baclofen 2% vaginal gel! Ketamine 5 % + Lidocaine 5 % + Diazepam 1 % Vaginal gel Cervical Dysplasia Vaginitis! Vitamin A suppository o 10,000-18,oooIU! Vag Pack suppositories o Golden seal, Tea tree oil, Cedar leaf oil, Bitter orange oil)! Herbal C vaginal suppository o Myrrh, Purple coneflower, Old man s Beard, Marshmallow, Cranesbills, Yarrow! Treatment protocol: o Week 1 Vitamin A from day 1 to 6 o Week 2 Herbal C from day 1 to 6 o Week 3 Vitamin A from day 1 to 6 o Week 4 Herbal C from day 1 to 6 Acute Vaginitis:! Boric acid powder capsules! Take 3 Lactobacillus capsules daily Chronic Vaginitis:! Garlic capsules! Boric Acid powder capsules

Candida Vaginal Dryness! Boric acid suppository! Caprylic acid & vitamin A suppository! Caprylic acid suppository (with Geranium, Witch hazel, Red raspberry)! Tea tree oil suppository!

11 Candida Vaginal Dryness! Boric acid suppository! Caprylic acid & vitamin A suppository! Caprylic acid suppository (with Geranium, Witch hazel, Red raspberry)! Tea tree oil suppository! Tea tree oil, Calendula & Hydrastis suppository! Y-Stat vaginal suppository Vaginal Lubrication:! Feminine lubricating suppository (Caprylic TG, acid,vitamin E oil and Calendula)! Isoflavonieds gel! Estriol 0.5mg-1mg Vaginal Moisturizing! Vitamin E succinate suppository! Vitamin E succinate & Black cohosh suppository Feminine Lubricating Cream:! Aloe vera gel, cinnamon leaf, vitamin E, Emollient base References References! Part II (Controlled Acts) (Reg. 107/96) of the General Regulation requires that a prescription contain: General Knowledge Base of DSM-IV Reference to! Millon, Theodore; Davis, Roger O.! Oxford, England: John Wiley & Sons. (1996). xiii 818 pp. 2nd Edition! Ontario.ca/laws/regulation/110058! Drug and Pharmacies Regulation Act, R.S.O.1990, c. H.4 (hereinafter DPRA! Regulated Health Professions Act, 1991, S.O. 1991, c. 18! Prescribe and dispense the drug. For more information on dispensing, please see the CPSO s Dispensing Drugs Policy! CPSO s Consent to Medical Treatment Policy! Section 4(3) of the Drug Interchangeability and Dispensing Fee Act, R.S.O. 1990, c. P.23 requires that this notation be handwritten on the prescription! Ontario College of Pharmacists, Prescription (OCP, 2014).! Ontario College of Pharmacists, Policy on Faxed Prescriptions (OCP, 2007).! Ect! Prescribing Drugs: Is a controlled act as set out in the Regulated Health Professions Act, Concern with Electronic Prescribing (eprescribing), Verbal prescribing! Pharmacy Compounding! NAPRA's Guidelines to Pharmacy Compounding (2006)! Health Canada's Policy on Manufacturing and Compounding Drug Products in Canada (POL-0051) (2009) 43 11

References (cont.) References! Alberta College of Pharmacists, Standards of Practice, The Pharmacist, January 1, 1996. http://www.altapharm.org/document_library/standards_of_practice.pdf! Pcca, Texas!

fpp.pdf! Compliance Policy Guide, Compliance Policy Guidance for FDA Staff and Industry, Chapter 4, Sub Chapter 460, Sec. 460.200 Pharmacy Compounding. http:// www.fda.

12 References (cont.) References! Alberta College of Pharmacists, Standards of Practice, The Pharmacist, January 1, Pcca, Texas! College of Pharmacists of British Columbia, Framework of Professional Practice, April 1, Compliance Policy Guide, Compliance Policy Guidance for FDA Staff and Industry, Chapter 4, Sub Chapter 460, Sec Pharmacy Compounding. Good Compounding Practices Applicable to State Licensed Pharmacies. Guidelines for Bulk Compounding of Products in Hospitals, Canadian Society of Hospital Pharmacists, Drug Products in Canada. pol_fram_man_comp_drug_prod_can_e.pdf! International Academy of Compounding Pharmacists Code of Ethics Kastango, E. S, The Cost of Quality in Pharmacy, International Journal of Pharmacy Compounding, Vol 6, No 6 November/December 2002, pp Prince Edward Island Pharmacy Board Sterile Compounding Guidelines, September SterileCompoundingGuidelines2004.pdf 46 References References! LowDose Estriol Pessaries for the Treatment of Vaginal Atrophy: A DoubleBlind Placebo! Controlled Trial Investigating the Efficacy of Pessaries Containing 0,2 mg and 0.03 mg Estriol.! S. Palacios, et al; LowDose, Vaginally Administered Estrogens May Enhance Local Benefits of Systemic Therapy! in the Treatment of! Urogenital Atrophy in Postmenopausal Women on Hormone Therapy.! N. Biglia, et al; LowDose Vaginal Estrogens or Vaginal Moisturizer in Breast Cancer Survivors with Urogenital! Atrophy: A Preliminary Study.A. Cano, et al; The Therapeutic Effect of a New U! ltra Low Concentration Estriol Gel Formulation (0.005% Estriol! Vaginal Gel) on Symptoms and Signs of Postmenopausal Vaginal Atrophy: Results from a Pivotal Phase III Study.! ESTROGENS CARDIOVASCULAR! M.E. Mendelsohn, et al;! The Protective Effects of Estogen on the! Cardiovascular System! M.C. Snabes, et al;! Physiologic Estradiol Replacement Therapy and! Cardiac Structure and Function in Normal zer, et al;! Estrogen Effects in the Heart! L. Mosca; The Role of Hormone Replacement Therapy in the Prevention of! Postmenopausal Heart Disease

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Compounding Opportunities Women s Health& Men s Health

Compounding Opportunities Women s Health& Men s Health Andrea Branvold, MS, RPh BHRT Vegas February 19,2015 Bacterial Vaginosis Formula #9076 Metronidazole 125mg/mL/ Nystatin 25,000U/mL Vaginal Cream Formula