Lecture 24 Part 1 - Nutritional Suppliment Part-1-2 PDF

DOW COLLEGE OF PHARMACY
DOW UNIVERSITY OF HEALTH SCIENCES
Welcome at e-Doctor Training Session
Presenter:
Dr Ale Zehra
• B.Pharm, M.Phil, Ph.D
• Assistant Professor, Pharmacy Practice,
Dow College of Pharmacy.
• EX-Clinical Pharmacist, Agha Khan
University Hospital, Karachi, Pakistan.
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Nutritional Supplement & Hematinic
Dr Ale Zehra
B.Pharm, M.Phil, Ph.D
Assistant Professor, Pharmacy Practice,
Dow College of Pharmacy.
Q. What thought come to mind when you hear
Nutritional Supplement?
• It is a not a substitute of healthy
diet which can eat on regular
basis.
Q. What is Nutritional Supplement?
• “A nutritional supplement” is a product intended for
ingestion that contains a “dietary ingredient” intended to
add further nutritional value to the diet.
• The ingredient may be minerals, vitamins, herb, a

concentrate (metabolite, constituent, or extract), an
amino acid.
• Supplements can help you get adequate dietary intake of

essential nutrients and help reduce your risk of disease
Q. Dosage form in market?
• These products are not represented

• Supplements are for use as conventional foods
found in forms such
OR
as:
✓ Tablet • as the sole item in a meal or diet
✓ Capsule OR
✓ Powder • not contain an article that is an
✓ Soft gel approved drug
✓ Gel cap
BUT
✓ Liquid form
• labeled as "dietary supplements."
Q. Fact Sheet?
• Until 1994, dietary supplements were under the regulatory
authority of the FDA (Federal Food, Drug, and Cosmetic Act of 1958—FD&C Act)
• „In 1994, the Dietary Supplements Health and Education Act

(DSHEA) removed FDA’s authority by excluding dietary supplements
from the FD&C Act
Q. What is FDA Responsibility over here?
• Manufacturer is responsible for ensuring the safety of dietary supplement before
it is marketed.
• Manufacturers must sure product label information is truthful and not misleading.
• Manufacturers do not need to register their products with the FDA
but!
✓ Manufacturers must notify FDA at least 75 days before marketing products
✓ After the product is marketed, FDA must show that a dietary

supplement is "unsafe," before it can take action to restrict, use, or
remove the product from the marketplace.
Q. The Three Types of Claims?
Health claims FDA Approval or “Authoritative
• Prevents acne statement” from a U.S. government
body or the National Academy of
• High-folic acid diet (0.4mg/d) prevents neural
Sciences
tube defects
• „Calcium-rich diets reduce risk of osteoporosis
„Nutrient content claims

− “Reduced fat” Regulated by FDA
„Must provide product composition
− “Low cholesterol” data.
− “Rich in fiber”
„Structure/function claims
− “Helps keep a healthy, silky skin”
„Nutrient content claims
− “Reduced fat”
− “Low cholesterol”
− “Rich in fiber”
„Structure/function claims Regulated by FDA

− “Helps keep a healthy, silky skin” „Must provide product
composition data.
Q. Indications for Nutritional Supplements?
• Pregnancy
• Lactation
• Breast-fed infants
• Impaired absorption
• GI disorders
• Geriatric
Q. What are the common Dietary supplement?
• Calcium • Garlic
• Cassia Cinnamon
• Ginger
• Ginkgo
• Chromium
• Ginseng • Omega-3 Fatty Acid
• Coenzyme Q-10
• Glucosamine • Selenium
• Cranberry
• Green Tea • St. John's Wort
• Hoodia • Vitamin C
• Magnesium • Zinc
• Melatonin
• Vitamin B3
• Multivitamin
Q. WHAT IS CALCIUM?
✓ Calcium is a mineral that is an essential part of bones and teeth.
✓ The heart, nerves, and blood-clotting systems also need calcium to work.
Effective For...Indigestion, Hperkalemia, hypocalcemia, Kidney failure.
✓ Recommended amounts: 1000-1200 mg daily.
✓ Minor side effects: belching or gas.
✓ Pregnancy and breast-feeding amount: upto 3000mg/day
✓ Special Precautions & Warnings: Higher doses might cause high levels of
phosphorous and low levels of parathyroid hormone in the infant during
pregnancy and at birth which might increase the risk of seizures in the infant.
✓
Q. WHAT IS Coenzyme Q-10
✓ Coenzyme Q10 is a vitamin-like substance eaten in small amounts in
meats and seafood.
✓ Commonly used for conditions that affect the heart such as heart failure
and congestive heart failure, angina, and high blood pressure.
✓ It is also used for preventing migraine headache, Parkinson disease.
✓ Suggested Dosing: 50-200 mg BID-TID PO daily
✓ Warnings /Cautions: Biliary obstruction, concurrent antihypertensives,

concurrent cancer chemotherapy, concurrent radiation therapy, hepatic
insufficiency, hypertension
Q. Available Brands Coenzyme Q-10 in Pakistan
• Syrup:50mg/5ml
• Caps:10mg 30mg 50mg
Q. Folic Acid?
✓ It is a water-soluble B vitamin.
✓ Since 1998, folic acid has been added to cold cereals, flour, breads, pasta,
bakery items, cookies, and crackers, as required by federal law.
✓ Women who are pregnant or might become pregnant take folic acid to prevent
miscarriage and "neural tube defects."
✓ Effective for: Folate deficiency.
✓ Recommended Dose: 250 mcg (micrograms) to 1 mg (milligrams) per

day.
✓ Prevention Neural tube birth defects: 400 mcg -600 mcg.
✓ Pregnancy and breast-feeding: 300-400 mcg to prevent birth defects.

Q. Folic Acid?
• If Previous pregnancy complicated by neural tube defects usually take 4 mg per
day beginning one month before and continuing for up to 3 months after
conception.
• Methotrexate Toxicity: 1mg per day is probably enough, but up to 5 mg per day
may be used.
• Side effect: Doses > 1.2 mg daily might cause abdominal cramps, diarrhea, rash,
sleep disorders, irritability, confusion, nausea, stomach upset.
• Special Precautions & Warnings: Angioplasty---- Using folic acid, vitamin B6, and
vitamin B12 intravenously (by IV) or by mouth might worsen narrowed arteries.
• Drug Interactions: Methotrexate

Q. Folic Acid in Market?
Q. What is omega-3 polyunsaturated fatty acids?
Ans.
• Used together with diet and exercise to help lower triglyceride levels in the
blood.
• Assess triglyceride levels carefully before starting therapy and identify other
possible causes (e.g. diabetes, hypothyroidism, medications) and manage
appropriately.
• Patients should be on a lipid lowering diet prior to using this medication,

and continue the diet during use of this medication.
• Side effect: Fever, chills, body aches, flu symptoms,chest pain, uneven
heartbeats.
• Capsules should be swallowed whole; do not break, crush, chew or dissolve

capsules.
Q. What is omega-3 polyunsaturated fatty acids?
Ans.
Part 1
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DOW COLLEGE OF PHARMACY

DOW UNIVERSITY OF HEALTH SCIENCES

Welcome at e-Doctor Training Session

Thank you so much for a such wonderful

Thank you so much for a such wonderful feedback!

Thank you so much for a such wonderful feedback!

Nutritional Supplement & Hematinic

• The ingredient may be minerals, vitamins, herb, a

• Supplements can help you get adequate dietary intake of

• These products are not represented

• „In 1994, the Dietary Supplements Health and Education Act

• Manufacturers do not need to register their products with the FDA

✓ After the product is marketed, FDA must show that a dietary

„Nutrient content claims

„Structure/function claims Regulated by FDA

Effective For...Indigestion, Hperkalemia, hypocalcemia, Kidney failure.

✓ Recommended amounts: 1000-1200 mg daily.

✓ Minor side effects: belching or gas.

✓ Pregnancy and breast-feeding amount: upto 3000mg/day

✓ It is also used for preventing migraine headache, Parkinson disease.

✓ Suggested Dosing: 50-200 mg BID-TID PO daily

✓ Warnings /Cautions: Biliary obstruction, concurrent antihypertensives,

✓ Effective for: Folate deficiency.

✓ Recommended Dose: 250 mcg (micrograms) to 1 mg (milligrams) per

✓ Prevention Neural tube birth defects: 400 mcg -600 mcg.

✓ Pregnancy and breast-feeding: 300-400 mcg to prevent birth defects.

• Drug Interactions: Methotrexate

• Patients should be on a lipid lowering diet prior to using this medication,

• Capsules should be swallowed whole; do not break, crush, chew or dissolve

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