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All rights reserved Smith's Pharmacy, 3463 Yonge St., Toronto, Ontario, M4N 2N3

Thyroid Compounding and Custom Compounding Formulas:

1 All rights reserved Smith's Pharmacy, 3463 Yonge St., Toronto,

Ontario, M4N 2N3

! 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.

Restoration Therapy

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! 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 !!!!!

Restoration Therapy cont.

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! 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

Thyroid

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Deficiency (Hypothyrodism):

! Weight gain/water retention

! Low Energy ! Dry skin

! Constipation

! Hair loss ! Low body temperature (differential diagnosis with WDS)

Thyroid

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! 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®)

Thyroid drug Interactions

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! TSH, free T3, T4, TSH, R T3

! TSH o  ≤1.5 UIU/ml

! Free T3 o  3.5 -4.2 pg/ml

Thyroid Testing

7 All rights reserved Smith's Pharmacy 2015

Thyroid

15mg Form: Tablet / Capsule / Vegi capsule Qty:______ Refills:______

30mg

45mg Filler: Avicel / Probiotic / Methocel (SR caps)

60mg

Other:______mg Directions (sig) :______________________________________

Rx

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All rights reserved Smith's Pharmacy 2015

Thyroid SR Capsules

• InAvicelandMethocel• SR-slowRelease


Thyroid Capsules


Thyroid….Commercially Available

• 60mg• Commerciallydoesnotallow


! Commerciallyavailable30mg

! 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 problem-causing inactive ingredients and substitute non-reactive fillers.

! Lactose

Thyroid ….Commercially

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Conversion chart


! 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 Medication for Consideration


*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

! Test in one cycle (30 days)

! Thyroid support (zinc, Se, protein )

Thyroid Dosing

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Adrenals and Testosterone

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! Irritability, depression, anger

! Confusion, brain fog

! Low tolerance for stress

! Paranoia

Cortisol Deficiency Symptoms


Ontario, M4N 2N3

! 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

Cortisol Testing and Dosing

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Men

!  Dose: 25-100 mg

Women !  Dose: 5-20 mg

7-keto DHEA !  Dose: 20- 200 mg

DHEA dosing in Men and Women


Ontario, M4N 2N3

Testosterone in Women

Totalserum

!  30-55pg/ml 40-65ng/dl

!  Bio-available4-25ng/dl

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Saliva

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! Peri-Menopause and Menopause

! Topical: 0.25 – 4 mg OD

! Safety: o  D/C if pt has thinning hair or hirsutism

Testosterone


Ontario, M4N 2N3

Testosterone in Men

Serum

70-150pg/ml

!  Optimal 100-150pg/ml

!  BHRT 115-800pg/ml

240-830ng/ml

!  Free(NoAlbumin) 15-27ng/dl

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Saliva


! 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 )

Testosterone Dosing in Men and Women


Ontario, M4N 2N3

! Topical: 50-200 mg daily

! Cypionate; 50- 150 mg IM weekly ! Cyclic method o  10 weeks: weekly testosterone IM

o  2 weeks off

! HCG qod

! Clomid 5 days

Testosterone /Andropause

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All rights reserved Smith's Pharmacy, 3463 Yonge St., Toronto, Ontario, M4N 2N3 25

Testosterone is most commonly prescribed as indicated below, though it is usually combined with other hormones.

Compounded Testosterone: Disage Forms & Ranges


Safety of Testosterone in Men

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

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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 (400-800IU), GLA (300mg), Selenium

(200-400mcg), lipotropics (2-4 capsules)

Endometriosis: Dosing Guidelines

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! 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)

Bacterial Vaginosis

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! 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 Dryness

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! Hyaluronic acid 5mg/gm vaginal cream

! Estriol 5mg/ml vaginal cream

! Estriol 1 mg + Progesterone 30 mg suppository

Vaginal Atrophy

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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

Female sexual dysfunction/Libido

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! 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 Vaginal warts

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! 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

Genital Herpes Lesions

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! Minoxidil 2 % + tretinoin 0.025 % _ progesterone 0.05 % topical gel

! Minoxidil 8.5 % -10 % + finasteride 0.1 % scal solution

! Minoxidil 5% + azelic acid 1.5 % _ tretinoin 0.025 % + progesterone 0.25% + finasteride 0.1% topical foam

Hair Loss

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! 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

Acne & Rosacea

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! Amitriptyline Hcl @ % + Baclofen @ % 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

Vulvodynia

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! 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

Cervical Dysplasia

39 All rights reserved Smith's Pharmacy, 3463 Yonge St., Toronto, Ontario, M4N 2N3

Acute Vaginitis:

! Boric acid powder capsules ! Take 3 Lactobacillus capsules daily

Chronic Vaginitis:

! Garlic capsules

! Boric Acid powder capsules

Vaginitis

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!  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

Candida

41 All rights reserved Smith's Pharmacy, 3463 Yonge St., Toronto, Ontario, M4N 2N3

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

Vaginal Dryness

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References

43 All rights reserved Smith's Pharmacy 2015

!  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, 1991.

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)

References

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!  Alberta College of Pharmacists, Standards of Practice, The Pharmacist, January 1, 1996. http://www.altapharm.org/document_library/standards_of_practice.pdf

!  Pcca, Texas !  College of Pharmacists of British Columbia, Framework of Professional Practice,

April 1, 2003. http://www.bcpharmacists.org/standards/pdf/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.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html

!  Good Compounding Practices Applicable to State Licensed Pharmacies. http://www.nabp.net/law/modelact/download/appendixc.pdf

!  Guidelines for Bulk Compounding of Products in Hospitals, Canadian Society of Hospital Pharmacists, 1992. http://www.cshp.ca/default.asp

!  Drug Products in Canada. http://www.hcsc.gc.ca/hpfb-dgpsa/inspectorate/pol_fram_man_comp_drug_prod_can_e.pdf

!  International Academy of Compounding Pharmacists Code of Ethics http://www.iacprx.org/code_of_ethics/index.html

!  Kastango, E. S, “The Cost of Quality in Pharmacy”, International Journal of Pharmacy Compounding, Vol 6, No 6 November/December 2002, pp. 404-408. http://www.ijpc.com/_pdf/quality.pdf

!  Prince Edward Island Pharmacy Board Sterile Compounding Guidelines, September 2004. http://www.napra.org/pdfs/provinces/pe/SterileCompoundingGuidelines2004.pdf

References (cont.)


References

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All rights reserved Smith's Pharmacy, 3463 Yonge St., Toronto, Ontario, M4N 2N3 47

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

References

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