Herbal & cosmetics analysis seminar 2

1. 1)SPONTANIOUS REPORTING
SCHEMES FOR BIODRUG
ADVERSE REACTIONS
2) BIO DRUG –DRUG , FOOD
AND BIODRUG INTERACTIONS
DIPTI S
M PHARMACY (PHARMACEUTICAL ANALYSIS )
DEPARTMENT OF PHARMACEUTICAL
CHEMISTRY
SUBJECT :HERBAL AND COSMETICS ANALYSIS
REG NO: P1718001
1

2. CONTENT OF THE LECTURE
SAFETY MONITORINF OF HERBAL DRUGS
 SOURCES OF REPORTS
 HERBAL PRODUCTS TARGETED FOR
SAFETY REGULATIONS
 REPORTING OF SUSPECTED ADVERSE
DRUG REACTIONS
 ANALYSING CASE REPORTS
BIO DRUG-DRUG INTERACTIONS
BIO DRUG AND FOOD INTERACTIONS
2

3. SAFETY
MONITORING OF
HERBAL DRUGS
1) SOURCES OF ERROR
 The Council for International Organizations of Medical
Sciences (CIOMS) Working Group V has
recommended that, as a general guiding principle,
emphasis should be placed on the quality of a report
and not on its source. Thus, the value of a report lies
not in who made it, but in the care and thoroughness
with which it is prepared, documented, received,
recorded, followed-up, clarified and analysed .
 However, the source of a report can be an important
factor in evaluating the report as it may affect the
quality and value of the information. The nature,
degree and even feasibility of any follow-up will also be
highly dependent on the source
3

4. 4

5.  The most common sources of information on adverse
events and reactions to medicines are clinical trials and
spontaneous reports (voluntary, communications on
marketed medicinal products). The latter ordinarily far
exceed the former in numbers and type, especially
serious reports, over the lifetime of a product. In some
countries, adverse reaction reporting by physicians is
mandatory; such reports are regarded as spontaneous.
 In many countries, providers of herbal medicines other
than physicians, dentists, pharmacists and nurses are
excluded from reporting systems. If adequate coverage
of herbal medicines is to be achieved, national
reporting schemes should be developed to include all
providers of herbal medicines (both prescribers and
dispensers), and providers of traditional,
complementary and alternative medicine, according to
national circumstances.
5

6. REPORTS FROM HEALTH CARE PROFESSIONALS
 Internationally, adverse drug reaction reporting
systems in the post-marketing safety surveillance
setting depend primarily on voluntary reporting by
healthcare professionals, preferably those directly
associated with the care of the patient/consumer (i.e.
the patient’s primary health-care provider or
specialist).
 This is appropriate, since the understanding of
adverse drug reactions depends on medical
knowledge and such professionals should be aware of
the patient’s medical history and attuned to the
subtleties of clinical differential diagnosis.
6

7.  A substantial proportion of herbal medicines are
non-prescription medicines, and many come
directly into this category without prior post-
marketing safety monitoring as prescription
medicines. It is therefore most important to take
measures to strengthen pharmacovigilance
activity in the non-prescription medicines setting.
 Community pharmacists and nurses can play a
particularly useful role in monitoring the safety of
non-prescription medicines, although many such
products are sold outside pharmacies
7

8. REPORTS FROM CONSUMERS
 The involvement of consumers in the use of
herbal medicines and herbal products in health
care, and their concern regarding possible
adverse effects should be valued positively.
 Consumer reports on adverse reactions
should be accepted as a serious source of
information, which can contribute to the
identification of signals for unknown effects of
herbal medicines.
8

9.  For non-prescription medicines, often taken without
health professional involvement, reports received
directly from consumers may provide the only source
of signals. With herbal medicines in the non-
prescription medicines setting, there is clearly an
essential role for consumer reporting
 Consumer reporting, in one form or another, is
therefore an essential development if adequate
information on risk is to be obtained. However, only a
few national regulatory authorities currently explicitly
require collection of direct reports from consumers.
The CIOMS Working Group proposes several policy
approaches and practices aimed at ensuring that
consumer reports are treated with appropriate respect
and that there is a rational approach for handling them
9

10. REPORTS FROM MANUFACTURERS
 Manufacturers of herbal medicines could be a source of
information on adverse events associated with their products.
Some countries include reporting of adverse events by
manufacturers as part of their regulatory framework.
 Consumers may report directly to companies or their
representatives. However, there are reasons other than
concern about an adverse effect that might prompt a
consumer to contact a company.
 These include legal concerns and, most frequently, requests
for further information about the product. Another source of
consumer reports derives from a variety of industry
programmes in which adverse reaction information may be
solicited; such cases are not regarded as spontaneous
reports.
10

11.  REPORTS FROM OTHER SOURCES
♦ National poisons centres. Where resources are very limited
in the national situation and where no pharmacovigilance
centre has been established, a poisons centre could play a
core role in pharmacovigilance for and safety monitoring of
herbal medicines.
♦ Drug information centres may also be a first point of contact
and may provide a wealth of clinical information. National
pharmacovigilance centres should have a good level of
communication with such centres.
♦ Consumer organizations receive complaints about any type
of product in the marketplace and may obtain relevant
information about herbal medicines
♦ Clinical trials and studies can also be a source of
information (
11

12. 2) HERBAL PRODUCTS
TARGETED FOR SAFETY
MONITORING
In order to obtain comprehensive coverage, it is
useful to think of herbal products in the
following categories:
 according to their regulatory status
– herbal medicines in the prescription medicines
category
– herbal medicines in the non-prescription
medicines category
– other herbal products intended for use in
health care
12

13.  according to their registration/marketing status
– herbal medicines undergoing the new drug development
process: in clinical trials prior to national drug regulatory
approval
– herbal medicines undergoing the new drug development
process: under post-marketing safety surveillance
– herbal medicines undergoing re-evaluation under the current
protocol: in clinical trials
– herbal medicines undergoing re-evaluation under the current
protocol: under post-marketing safety surveillance – herbal
medicines on the market: under post-marketing safety
surveillance
– other herbal products marketed for health care, such as
dietary supplements.
13

14. REPORTING OF SUSPECTED ADVERSE
REACTIONS
 Only the following set of professionals can report the
observed adverse drug reactions
♦ Health professionals who are providers of herbal
medicines, including physicians, pharmacists and
nurses, should report to the national
pharmacovigilance centre.
♦ Patients/consumers should normally report to their
physicians or providers of herbal medicines. They
may also report directly to the national
pharmacovigilance centre, consumer organizations or
manufacturers.
♦ Manufacturers should report directly to the national
pharmacovigilance centre or national regulatory
authority.
14

15. REQUESTED INFORMATION
♦ where it is permitted by the country health information privacy code,
and with appropriate confidentiality, some form of identification of
the patient/consumer in order to avoid duplications and facilitate
follow-up
♦ age, sex and a brief medical history of the consumer/patient (when
relevant); in some countries, ethnicity may need to be specified
♦ details of suspected herbal product(s) if known: species name (Latin
binomial name and common vernacular name of medicinal plant)
and/or brand or ingredient name(s), including the part of medicinal
plant used, preparation methods; manufacturer, country of origin,
batch number, expiry date and provider
♦ administration details: dose and quantity supplied, dosage form,
route, start/stop dates
♦ indication or reason for use
15

16. ♦ adverse reaction data: date of onset (or duration from first
administration to onset of event), description with symptoms
and signs, severity and seriousness, results of clinical
investigations and tests, course and outcome, and
dechallenge/rechallenge with the same product, where
appropriate
♦ all other medicines used (including self-medication), with
administration details
♦ risk factors, e.g. age, impaired renal function, previous
exposure to the herbal medicine(s) concerned, previous
allergies, drug misuse or abuse, the social use of drugs
♦ name and address of reporter (to be considered confidential
and to be used only for data verification, completion and case
follow-up)
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17. HOW TO REPORT
 A single reporting form covering all medicines, including herbal
medicines, should be used. For health-care providers already
included in a national pharmacovigilance system, a familiar form will
facilitate reporting; the introduction of a second type of reporting
form may cause confusion. It is desirable to use a standard printed
or electronic reporting form and to ensure that forms are widely
available.
 It should also be acceptable to receive reports by telephone, letter
or e-mail. If possible, a sample of the herbal product and its
packaging should be submitted with the report.
 Consideration should be given to the distribution of reporting forms
to those involved in the provision of herbal medicines, such as
providers of traditional medicine and of complementary/alternative
medicine, who may not previously have been part of the national
pharmacovigilance system.
 It may be necessary to design a special reporting form for those not
familiar with the reporting of suspect reactions to medicines.
Educational materials, including a list of simple terminology that can
be understood by all parties, should be developed to inform and
assist those not familiar with reporting.
17

18. ASSESSMENT OF CASE REPORTS
 Assessment of reports on adverse reactions to herbal medicines
should be undertaken by national pharmacovigilance centres in the
same way as for other medicines. Each data element in the report
should be considered and a causality assessment made using a
standard approach. The assessment is usually based on:
♦ the association in time between administration of the herbal product
and the event
♦ the outcome of dechallenge and rechallenge
♦ known pharmacology (including current knowledge of the nature and
frequency of adverse reactions)
♦ medical or pharmacological plausibility (the sequence of symptoms,
signs and laboratory tests and also pathological findings and
knowledge of mechanisms)
♦ likelihood of other causes or their exclusion
♦ testing for adulterants or contaminants that could be the source of
adverse events.
♦ inappropriate use.
18

19. 19

20. BIO DRUG –DRUG
INTERACTIONS20

21. INTERACIONS OF ALOE AND
SOME ALLOPATHIC DRUGS
 Antidiabetic Medications - The combination
of aloe vera and glyburide, a medication used
to treat type 2 diabetes, may help control blood
sugar and triglyceride (fat) levels in the blood.
People with diabetes who use aloe latex either
alone or in combination with other medications
must be monitored closely by health care
providers to avoid potential complications from
low blood sugar levels.
21

22.  Hydrocortisone - Aloe gel may enhance the
ability of hydrocortisone to reduce swelling.
 Digoxin and Diuretics - Because oral aloe
can decrease levels of potassium, aloe latex
should not be used by individuals taking
diuretics or digoxin (a medication used to treat
irregular heart rhythms and congestive heart
failure). These medications lower potassium
levels in the body, so a combination of aloe
and digoxin or diuretics can result in
dangerously low levels of this important
mineral
22

23. INTERACTIONS OF GARLIC AND
OTHER MEDICATIONS
 Antiplatelet medications -- Garlic may
exaggerate the activity of medications that inhibit
the action of platelets in the body. Examples of
such medications include indomethacin,
dipyridamole, Plavix, and aspirin
 Blood-thinning medications -- There have been
reports of a possible interaction between garlic
and warfarin that could increase the risk of
bleeding in people taking this blood thinning
medication. Therefore, when taking medications
that may thin the blood, such as aspirin and
warfarin, you not use garlic supplements unless
you are under the supervision of a doctor.
23

24.  Protease inhibitors -- Garlic may reduce
blood levels of protease inhibitors, a
medication used to treat people with the
human immunodeficiency virus (HIV).
Protease inhibitors include indinavir, ritinavir,
and saquinavir.
24

25. INTERACTIONS OF HYPERCIUM
PERFORTUM WITH OTHER
DRUGS
Antidepressants -- St. John's wort may interact with
medications used to treat depression or other mood
disorders, including tricyclic antidepressants, SSRIs, and
monoamine oxidase inhibitors (MAOIs). Taking St. John's
wort with these medications tends to increase side effects,
and could potentially lead to a dangerous condition called
serotonin syndrome. Do not take St. John's wort with other
antidepressants, including: SSRIs: Citalopram (Celexa),
escitalopram (Lexapro), fluvoxamine (Luvox), paroxetine
(Paxil), fluoxetine (Prozac), sertraline (Zoloft)
 Tricyclics: Amitriptyline (Elavil), nortriptyline (Pamelor),
imipramine (Tofranil)
 MAOIs: Phenelzine, (Nardil), tranylcypromine (Parnate)
 Nefazodone (Serzone)
25

26.  Allergy drugs (antihistamines) -- St. John's
wort may reduce levels of these drugs in the
body, making them less effective:
 Loratadine (Claritin)
 Cetirizine (Zyrtec)
 Fexofenadine (Alleg
26

27.  Dextromethorphan (cough medicine) -- When taken at the
same time as dextromethorphan, a cough suppressant found
in many over-the-counter cough and cold medicines, St.
John's wort can increase the risk of side effects, including
serotonin syndrome.
 Digoxin -- St. John's wort may decrease levels of the
medication and reduce its effectiveness. Do not take St.
John's wort if you take digoxin.
 Drugs that suppress the immune system -- St. John's wort
can reduce the effectiveness of these medications, taken
after organ transplant or to control autoimmune diseases. In
fact, there have been many reports of cyclosporin blood
levels dropping in those with a heart or kidney transplant,
even leading to rejection of the transplanted organ.
27

28.  Drugs to fight HIV -- St. John's wort appears to interact with
at least two kinds of medications used to treat HIV and AIDS:
protease inhibitors and non-nucleoside reverse transcriptase
inhibitors. The Food and Drug Administration recommends
that St. John's wort not be used with any type of antiretroviral
medication used to treat HIV or AIDS.
 Contraseptives -- There have been reports of breakthrough
bleeding in women on birth control pills who were also taking
St. John's wort, and it is possible that the herb might interfere
with the effectiveness of birth control pills, leading to
unplanned pregnancies.
 Reserpine -- Based on animal studies, St. John's wort may
interfere with reserpine's ability to treat high blood pressure.
28

29.  Sedatives -- St. John's wort can increase the effect of
drugs that have a sedating effect, including:
 Anticonvulsants such as phenytoin (Dilantin) and
valproic acid (Depakote)
 Barbiturates
 Benzodiazepines such as alprazolam (Xanax) and
diazepam (Valium)
 Drugs to treat insomnia, such as zolpidem
(Ambien), zaleplon (Sonata), eszopiclone (Lunesta),
and ramelteon (Rozerem)
 Tricyclic antidepressants such as amitriptyline
(Elavil)
 Alcohol
29

30.  Theophylline -- St. John's wort can reduce levels
of this medication in the blood. Theophylline is
used to open the airways in those suffering from
asthma, emphysema, or chronic bronchitis.
 Triptans (used to treat migraines) -- St. John's
wort can increase the risk of side effects, including
serotonin syndrome, when taken with these
medications:
Naratriptan (Amerge)
Rizatriptan (Maxalt)
Sumatriptan (Imitrex)
Zolmitriptan (Zomig)
30

31.  Warfarin -- St. John's wort reduces the effectiveness
of warfarin, an anticoagulant (blood-thinner).
 Other drugs -- Because St. John's wort is broken
down by certain liver enzymes, it may interact with
other drugs that are broken down by the same
enzymes. Those drugs may include:
 Antifungal drugs, such as ketoconazole (Nizoral),
itraconazole (Sporanox), fluconazole (Diflucan)
 Statins (drugs taken to lower cholesterol)
 Some calcium channel blockers (taken to lower blood
pressure)
31

32. GARLIC AND OTHER
ALLOPATHIC MEDICATIONS
 Blood-thinning medications -- Although
ginger may interfere with blood clotting, there
have been no scientific or case reports of
interactions between ginger and blood-thinning
medications, such as aspirin and warfarin.
However, people taking medications that thin
the blood should use ginger only under the
supervision of a health care provider.
32

33. TURMERIC AND ALLOPATHIC
DRUGS
 Blood-thinning medications: Tumeric may make the effects
of these drugs stronger, raising the risk of bleeding. Blood-
thinners include warfarin (Coumadin), clopidogrel (Plavix), and
aspirin, among others.
 Drugs that reduce stomach acid: Turmeric may interfere
with the action of these drugs, increasing the production of
stomach acid:
Cimetidine (Tagamet)
Famotidine (Pepcid)
Ranitidine (Zantac)
Esomeprazole (Nexium)
Omeprazole
Lansoprazole (Prevacid)
33

34.  Drugs for diabetes (that lower blood
sugar): Turmeric may make the effects of
these drugs stronger, increasing the risk of
hypoglycemia (low blood sugar).
34

35. DRUG AND FOOD
INTERACTIONS
INTERACTION OF FRUIT JUICES AND DRUGS
 Among all fruit juices, grape fruit juice (GFJ)
possesses high interaction with almost all types of
drugs. The juice modifies the body’s way of
metabolizing the medication, affecting the liver’s ability
to work the drug through a person’s system. Taniguchi
in 2007 reported a case of purpura associated with
concomitant ingestion of cilostazol, aspirin and
grapefruit juice in 79 years old man. His purpura
disappeared upon cessation of grapefruit juice,
although his medication was not altered.
 The most probable cause of his purpura is an
increase in the blood level of cilostazol because of the
inhibition of cilostazol metabolism by components of
grapefruit juice;
35

36.  Numerous reports have documented drug interactions with GFJ that
occur via inhibition of CYP3A enzymes. Furanocoumarins present in
GFJ inhibit the intestinal CYP 3A4 and have been shown to
increase the oral bioavailability of medications that are CYP 3A4
substrates like Felodipine, midazolam, cyclosporine and raise their
concentrations above toxic levels.
 With new anticonvulsants, serum iron and sodium need to be
monitored. Additionally, users are advised to avoid drinking grape
fruit juice within 1-2 hr(s) of taking these
anticonvulsants.Furanocoumarines and active bioflavonoids present
in GFJ are also inhibitors of OATP and when ingested
concomitantly, can reduce the oral bioavailability of the OATP
substrate, fexofenadine. Overall, a series of flavonoids present in
GFJ are identified as esterase inhibitors, of which kaempferol and
naringenin are shown to mediate pharmacokinetic drug interaction
with most of the calcium channel antagonist and the statin groups of
drugs such as enalapril and lovastatin due to their capability of
esterase inhibition.
36

37.  Cholesterol-lowering agent lovastatin should be taken with
food to enhance gastrointestinal absorption and
bioavailability. The absorption of rosuvastatin, another anti-
hyper lipidemic agent, was significantly decreased in the fed
state compared with the fasting state, which suggests that
rosuvastatin should be administered on an empty stomach.
 Simvastatin, Ezetimibe, pravastatin and fluvastatin may be
taken without regards to food. However, high fiber diets may
lower the efficacy of these drugs. Concomitant administration
of statins with food may alter statin pharmacokinetics or
pharmacodynamics, increasing the risk of adverse reactions
such as myopathy or rhabdomyolysis or reducing their
pharmacological action. Consumption of pectin or oat bran
together with Lovastatin reduces absorption of the drug, while
alcohol intake does not appear to affect the efficacy and
safety of Fluvastatin treatment
37

38. INTERACTION OF WARFARION
WITH DIETRY SUPPLIMENTS
 Warfarin is commonly used to treat or prevent
thromboembolic events. Patients taking warfarin are at
particular risk of interactions with dietary supplements, yet
approximately 30% use herbal or natural product
supplements on a regular basis.There is a possible
interaction between warfarin and a high-protein diet. The
potential for increased dietary protein intake to raise serum
albumin levels and/or cytochrome P450 activity has been
postulated as mechanisms for the resulting decrease in
international normalized ratio (INRs)
 Some vegetables (broccoli, Brussels sprouts, kale, parsley,
spinach, and others) are high in vitamin K. Eating large
quantities or making sudden changes in the amounts eaten of
these vegetables, interferes with the effectiveness and safety
of warfarin therapy
38

39.  A number of studies have been documented on the
interaction of warfarin and cranberry juice. Cranberry
juice is a flavonoid, which has been shown to induce,
inhibit, or act as a substrate for the biosynthesis of
several cytochrome P-450 (CYP) isoenzymes.
Specifically, cranberry juice may inhibit the activity of
CYP2C9, the primary isoenzyme involved in the
metabolism of S-warfarin. It was suggested that
cranberry juice increased the International Normalized
Ratio (INR) of patients taking warfarin, but neither
clearly identified cranberry juice as the sole cause of
INR elevation. If warfarin sodium is ingested with leafy
green vegetables, the hypoprothrombinemic effect of
warfarin may be decreased and thromboembolic
complications may develop
39

40. ANTIHYPERTENSIVE DRUGS
AND FOOD INTERACTION
 Patients placed on anti hypertensive drugs will benefit
from concomitant moderate sodium restricted
diets. Propranolol serum levels may be increased if
taken with rich protein food. A change in diet from high
carbohydrates/low protein to low carbohydrate/high
protein may result in increased oral clearance.
Smoking may decrease its plasma levels of by
increasing its metabolism.
 The intestinal absorption of celiprolol (beta-blocker) is
inhibited when it is taken with orange juice.
Hesperidin, present in orange juice, is responsible for
the decreased absorption of celiprolol.The absorption
of ACEs inhibitors is increased when taken on an
empty stomach.While GFJ increases the
bioavailability of felodipine (Ca2 channel blocker)
40

41.  Licorice extract, a common ingredient of dietary supplement
contains glycyrrhizin and glycyrrhetinic acid. It is a potent
inhibitor of 11- bet- hydroxyl steroid dehydrogenase, it
increases excess of cortisol to mineralocorticoid receptors
causing sodium retention and potassium depletion, so it may
interfere with various medicines including antihypertensive
and antiarrhythmic agents. A high intake of liquorice can
cause hypermineralocorticoidism with sodium retention and
potassium loss, oedema, increased blood pressure and
depression of the renin-angiotensin-aldosterone
system. Studies showed that a daily consumption of
glycyrrhizic acid of 95 mg or more caused an increase in
blood pressure.
 A practical guideline for an acceptable daily intake of
glycyrrhizic acid seems to be 9.5 mg a day. This means no
more than 10-30g liquorice and no more than half a cup of
liquorice tea a day.
41

42. INTERACTIONS OF ANTIBIOTICS
AND FOOD
 Antibiotics are widely prescribed in medical practice.
Many of them induce or are subject to interactions that
may diminish their anti-infectious efficiency or elicit
toxic effects. Food intake can influence the
effectiveness of an antibiotic. Avoid co-administration
of antibiotics with milk products which are rich sources
of divalent ions, such as calcium and magnesium that
complex with some antibiotics and prevent their
absorption. The intake of dairy products, however,
needs to be monitored and encouraged with
appropriate consideration of specific antibiotics
involved.
 A number of studies give evidence that
fluoroquinolones forming slightly soluble complex with
metal ions of food show reduced
bioavailability. Casein and calcium present in milk
decrease the absorption of ciprofloxacin.
42

43.  The effect of interaction of five fruit juices on the dissolution
and absorption profiles of ciprofloxacin tablets were
determined. It was found that the absorption of ciprofloxacin
(500 mg) tablets can be reduced by concomitant ingestion of
the GFJ. Therefore, to avoid drug therapeutic failures and
subsequent bacterial resistance as a result of sub-therapeutic
level of the drug in the systemic circulation, ingestion of the
juice with ciprofloxacin should be discouraged.
 Azithromycin absorption is decreased when taken with food,
resulting in a 43% reduction in bioavailability.Tetracycline
should be taken one hour before or two hours after meals,
and not taken with milk because it binds calcium and iron,
forming insoluble chelates, and influencing its bioavailability.
43

44.  The effect of milk added to coffee or black tea
on the bioavailability of tetracycline was
evaluated in healthy individuals. Results
showed that even a little quantity of milk
containing extremely small amounts of calcium
severely impair the absorption of the drug, so
that the presence of this metal ion should be
carefully controlled in order to avoid
decreasing the available tetracycline.
44

45.  Food-drug interactions may reduce the
bioavailability of drugs taken after meals
(negative food effects). However, enteric-
coated tablets that start to disintegrate when
they reach the middle-to-lower region of the
small intestine could reduce negative food
effects. Results indicated that food-drug
interactions were avoided by separating the
main absorption site of drugs from that of food
components.
45

46. INTERACTION OF ANALGESICS
AND FOOD
 Analgesics and antipyretics are used to treat mild to moderate pain
and fever. For rapid relief, acetaminophen should be taken in an
empty stomach because food may slow the body absorption of
acetaminophen. Co-administration of acetaminophen with pectin
delays its absorption and onset. NSAIDs like ibuprofen, naproxen,
ketoprofen and others can cause stomach irritation and thus they
should be taken with food or milk. Avoid or limit the use of alcohol
because chronic alcohol use can increase the risk of liver damage
or stomach bleeding. The absorption of ibuprofen and oxycodone
when given in the combination tablet was affected by the
concomitant ingestion of food.
 The Cmax and AUC0-alpha of ibuprofen were significantly increased
after single and multiple doses of Coca-Cola, thereby indicating
increased extent of absorption of ibuprofen. The daily dosage and
frequency of ibuprofen must be reduced when administered with
Coca-Cola. Food intake did not appear to affect the extent of
absorption (ie, total exposure) of oral Diclofenac potassium soft
gelatin capsule at doses.
46

47. CASE STUDY : EFFECT OF
GINGER ON METRONIDAZOLE
A patient X reported that he had tremors in hands
and had metallic taste in his mouth along with
sharp pain in the upper abdomen . His case
report stated that he is suffering from amoebic
dysentery
Drug chart : Currently the patient is taking
metronidazole to cure his infestation
Diagnosis of the symptoms : The symptoms
could be due to increase in the Cmax Of the
drug taken
Cause : The patient consumes this medication
only at therapeutic level therefore food habbits
47

48.  ASSESSMENT OF FOOD HABBITS : The
patient said that he had consumed a large
quantity of ginger bread before taking the drug
metronidazole
 Corrective Action : The patient should be
advised not to consume ginger and
metronidazole together .Maintain a time gap
of 8 hours
48

49. CASE STUDY :2
HYDROCORTISONE AND
DIOSGENIN
A patient y was suffering from a skin allergy and was
reported to consume hydrocortisone tablets . She
reported symptoms like irrgeular mensturation
,increased sweating ,bloating of the stomach
CAUSE : The above are effects of consuming increased
steroids
DETERMING CAUSE OF SYMPTOMS : As per the
prescription the levels of cortisone are normal. There
fore the cause may be due to some change in food
habbits
49

50.  FOOD CHART DETERMINATION : In the food
chart it was determined that the patient
consumed a dietry suppliment having high
diosgenin content .Diosgenin is a steroid
congaing herb
 FINAL ASSESSMENT :from this it was
assured that the high levels of steroids caused
the changes
 CORRECTIVE ACTION :Do not consume
diosgenin and steroids
50

51. REFERENCES
 WHO GUIDELINES FOR THE RISK
ASSESSMENT OF HERBAL DRUGS page
number 17 to 28
 https://www.ncbi.nlm.nih.gov/pubmed/21838705
 http://://www.rehttpssearchgate.net/publication/31
7231718_Herbal_Drug_and_Food_Interaction
 https://www.mayoclinic.org/diseases-conditions
 http://www.onlinepbe.com/index.php/PBE/article/vi
ew/220/html
 PHARMACOLOGY AND TOXICOLOGY OF
HERBAL DRUGS –Millans John Cupps page
566to 590
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52.  THANK YOU
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