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

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DOW COLLEGE OF PHARMACY

DOW UNIVERSITY OF HEALTH SCIENCES

Welcome at e-Doctor Training Session

Presenter:
Dr Ale Zehra
• B.Pharm, MPhil, PhD
• Assistant Professor, Pharmacy Practice,
Dow College of Pharmacy.
• EX-Clinical Pharmacist, Agha Khan
University Hospital, Karachi, Pakistan.
DOW COLLEGE OF PHARMACY
DOW UNIVERSITY OF HEALTH SCIENCES

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”
Q. The Three Types of Claims?
„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. The Three Types of Claims?
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 in Market?
Q. What is omega-3 polyunsaturated fatty acids?
Ans.
Part 1
Thank You
Feed back at : ale.zehra@duhs.edu.pk
Part 2
Q. Biotin?
✓Biotin also called vitamin H, vitamin B₇ or vitamin B₈.

✓ It is found in many foods such as eggs, milk, or bananas.

✓ Used for hair loss, brittle nails, nerve damage, and many other conditions.

✓There is no recommended dietary allowance (RDA) established for biotin.

✓ Dose: The adequate intakes for biotin are 30- 35mcg for adults over 18 years,
pregnant women and breast-feeding women.

✓Children:7 mcg for infants, 8 mcg for children 1-3 years, 12 mcg- 25mcg for
children 4-18 years.

✓NO laboratory test for detecting low biotin levels, so this condition is usually
identified by its symptoms.
Q. Biotin
✓Laboratory tests: Biotin supplements might interfere with the results of many
different blood lab tests. Biotin can cause falsely high or falsely low test results.

✓Some early research shows that taking biotin along with chromium might lower
blood sugar in people with diabetes.

Dosage Form in Pakistan?


Q. Biotin Dosage Form in Pakistan?
Q. Vitamin B Complex ?
✓ Vitamin B • Vitamin B comes in many forms B1, B2, B3,
B5, B6, B7, B9, B12 – – – – –

✓ B1 – Thiamine – supports metabolism


✓ B2 – Riboflavin – supports metabolism
✓ B3 – Niacin – supports metabolism
✓ B5 – Pantothenic Acid – Oxidation of fatty acids and carbohydrates
✓ B6 – Pyridoxine – metabolism of amino acids and lipids. Important
role in gluconeogenesis
✓ B7 – Biotin – metabolism of proteins and lipids
✓ B9 – Folic Acid – metabolism of nucleic acids and amino acids
✓ B12 – Cobalamin – cellular metabolism of carbohydrates, proteins,
and lipids
Q. Who Should Take a B-Complex Vitamin?
• Since B vitamins are found in many foods, However, certain
circumstances increase the need for B vitamins, making
supplements necessary.

• High Demand in Pregnant or Breastfeeding Women, Older Age,


Vegetarians and Vegans,

• It may Reduce Symptoms of Anxiety or Depression


Q. RDAs for each of the B vitamins (The National Institutes of Health Office of
Dietary Supplements). Older adults may require higher dosages of some B vitamins.

During During
Females
Males pregnancy breastfeeding
Vitamin B-1 1.2 mg 1.1 mg 1.4 mg 1.4 mg
Vitamin B-2 1.3 mg 1.1 mg 1.4 mg 1.6 mg

Vitamin B-3 16 mg 14 mg 18 mg 17 mg

Vitamin B-5 5 mg 5 mg 6 mg 7 mg
Vitamin B-6 1.3 mg 1.5 mg 1.9 mg 2.0 mg
Vitamin B-7 30 mcg 30 mcg 30 mcg 35 mcg

Vitamin B-9 400 mcg 400 mcg 600 mcg 500 mcg

Vitamin B-12 2.4 mcg 2.4 mcg 2.6 mcg 2.8 mcg
Q. Vitamins and Mineral Combination Brands
Q. Vitamin B12
✓ Used in Vitamin B12 deficiency, Pernicious anemia, Also effective for Cyanide
poisoning.
✓ Doses (ADULTS PO):
▪ General supplemental dose is 1-25 mcg per day.
▪ For vitamin B12 deficiency: 300-10,000 mcg daily.
▪ For high blood levels of homocysteine: 400-500 mcg in combination with 0.54-5
mg of folic acid and 16.5 mg of pyridoxine has been used.
▪ For preventing age-related macular degeneration (AMD): 1 mg of vitamin B12, 2.5
mg of folic acid, and 50 mg of pyridoxine daily has been used for 7.3 years.
✓ APPLIED TO THE SKIN: For atopic dermatitis (eczema): A specific vitamin B12
0.07% cream applied twice daily has been used.
Q. Vitamin B12
✓ For canker sores: vitamin B12 500 mcg daily in four doses for 2 days has been
used.

✓ APPLIED UNDER THE SKIN:


✓ For nerve damage from shingles: As an injection under the skin, 1000 mcg of
vitamin B12, with or without 100 mg of thiamine or 20 mg of lidocaine, 6 times
weekly for up to 4 weeks.

✓ For vitamin B12 deficiency: Injecting 0.2 mcg/kg of vitamin B12 into the muscle or
under the skin once daily for 2 days, followed by a 1000 mcg injection daily for 2-7
days.

✓ Additional injections on monthly may be needed depending on level of symptom


improvement and cause of vitamin B12 deficiency.

✓ Side Effects & Safety: Vitamin B12 is LIKELY SAFE for most people when taken by
mouth, applied to the skin, taken through the nose, administered as a shot, or
injected into the vein (by IV). Vitamin B12 is considered safe, even in large doses.
Q. Vitamin B12
Q. 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.

✓ Commonly taken by mouth for the treatment and prevention of low calcium
levels, latent tetany, osteoporosis, rickets and osteomalacia

✓ Calcium is sometimes taken by mouth to reduce high levels of the


parathyroid hormone (hyperparathyroidism) and treat symptoms of
premenstrual syndrome (PMS) along with many other conditions.

✓ Calcium is given intravenously (by IV) for very low calcium levels of the blood
and related symptoms. It is also used for high potassium levels in the blood.

✓ Calcium-rich foods include milk and dairy products, kale and broccoli, as well
as the calcium-enriched citrus juices, mineral water.
Q. Calcium
✓ Calcium-rich foods include milk and dairy products, kale and broccoli, as well as
the calcium-enriched citrus juices, mineral water.

✓ Side Effects & Safety: Calcium can cause some minor side effects such as belching
or gas.

✓But calcium is POSSIBLY UNSAFE when taken by mouth in high doses.


✓ The Institute of Medicine sets the daily tolerable upper intake level (UL) for
calcium at 2000 mg for adults ages 19-50 years and 2000 mg for adults 51 years
and older.

✓ Taking more than this amount of calcium daily can increase the chance of having
serious side effects, HYPERCALCEMIA and milk-alkali syndrome, kidney failure
and death.
Q. Calcium and Drug Interaction?
✓ Major Interaction----Do not take this combination
▪ Ceftriaxone (Rocephin) interacts with CALCIUM
▪ Calcium should not be administered intravenously within 48 hours of
intravenous ceftriaxone.

✓ Moderate Interaction---- Be cautious with this combination

▪ Antibiotics (Quinolone antibiotics) interacts with CALCIUM-----Decrease


the effectiveness of some antibiotics-----take calcium supplements at least
1 hour after.

▪ Antibiotics (Tetracycline antibiotics) interacts with CALCIUM ---- Decreases


the amount of tetracyclines that can be absorbed.

▪ Bisphosphonates interacts with CALCIUM


Q. Calcium Doses By Mouth

•For preventing low calcium levels: 1-2 grams elemental calcium


daily is typically used. Sometimes it is taken with 800 IU of vitamin D.

•For heartburn: 0.5-1.5 grams of calcium carbonate is used as needed.

•To reduce phosphates in adults with chronic renal


failure: 1-6.5 grams per day of calcium carbonate or calcium acetate has
been used.

•For preventing weak bones (osteoporosis) caused by


corticosteroid use: Divided daily doses of 0.5-1 gram of elemental calcium
daily.
Q. Calcium Doses By Mouth
•For reducing parathyroid hormone levels (hyperparathyroidism): 1.2-
4 grams of calcium, usually as a carbonate salt. Often it is used in combination
with a low-phosphate diet or 800 IU of vitamin D.

•Osteoporosis: Most experts recommend taking 1000-1200 mg of calcium daily


to prevent osteoporosis and broken bones.

•For increasing fetal bone density in pregnant women:300-2000


mg/day, taken during the second and third trimesters.

•For high cholesterol: 800 mg daily for up to 2 years. Calcium 1200 mg taken
in 2-3 divided doses daily, alone or in combination with vitamin D 400 IU daily,

•For weight loss: Calcium 800-1200 mg/day with or without a calorie-


restricted diet has been used.
Q. Calcium Doses By INTRAVENOUS:

•For low calcium levels in the blood: 100-200 mg of calcium is given as a


bolus dose.

•For high potassium levels in the blood: 20 mL of 10% calcium gluconate is


administered over 5-10 minutes in most adults.
Q. Calcium Doses By INTRAVENOUS:

•For low calcium levels in the blood: 100-200 mg of calcium is given as a


bolus dose.

•For high potassium levels in the blood: 20 mL of 10% calcium gluconate is


administered over 5-10 minutes in most adults.
Q. Calcium Brands
Q. Vitamin D
✓ Vitamin D is required for the regulation of the minerals calcium and phosphorus found in
the body.

✓ It also plays an important role in maintaining proper bone structure.

✓ Sun exposure is an easy, reliable way for most people to get vitamin D.

✓ Vitamin D deficiency is more common than once might expect.

✓ Dose By Mouth:
❖ Vitamin D deficiency: 50,000 IU per week for 6-12 weeks has been used.

❖ For preventing osteoporosis: Cholecalciferol 400-1000 IU/day

❖ For preventing bone loss due to use of corticosteroids: Calcitriol Or Alfacalcidol


0.25-1.0 mcg/day for 6-36 months along with Calcium.

❖ For heart failure: 800 IU/day Cholecalciferol has been taken alone or along with 1000
mg/day of calcium for 3 years.
Q. Vitamin D- Dose By Mouth
• For bone loss caused by having too much parathyroid hormone
(hyperparathyroidism): Cholecalciferol800 IU/day for 3 months.

• Multiple sclerosis (MS): 400 IU/day used to prevent MS.

• For preventing respiratory tract infections: Cholecalciferol 300-4000 IU for 7


weeks to 13 months.

• For preventing tooth loss in the elderly: 700 IU/day cholecalciferol has been
taken in combination with calcium 500 mg/day for 3 years.

Moderate Interaction (Be cautious with this combination!)


• Aluminum interacts with VITAMIN D

• Aluminum is found in most antacids. Vitamin D can increase how much aluminum the
body absorbs. This interaction might be a problem for people with kidney disease.
Take vitamin D two hours before, or four hours after antacids .
Q. Vitamin D- Side Effects & Safety
• When taken by mouth: Vitamin D is LIKELY SAFE when taken by mouth in recommended
amounts.

• Most people do not commonly experience side effects with vitamin D, unless too much is
taken.

• Some side effects of taking too much vitamin D include weakness, fatigue, sleepiness,
headache, loss of appetite, dry mouth, metallic taste, nausea, vomiting, and others.

Special Precautions & Warnings!


✓ Pregnancy and breast-feeding: Vitamin D is LIKELY SAFE during pregnancy and breast-
feeding when used in daily amounts below 4000 units.

✓ Vitamin D is POSSIBLY UNSAFE when used in higher amounts during pregnancy or while
breast-feeding.

✓ Using higher doses might cause serious harm to the infant.


Q. Vitamin D- Brands
Thank You
Feed back at : ale.zehra@duhs.edu.pk

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