Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
UNIVERSITI TEKNOLOGI MARA (UiTM)
PUNCAK ALAM CAMPUS
FACULTY OF HEALTH SCIENCES
BACHELOR OF PHYSIOTHERAPY (Hons.)
HS244
KNOW YOUR MEDICINE
UPH 654
CASE STUDY (20%)
PREPARED BY:
HANNANI HUSNA BINTI MOHDTAJAHARULL
(2020810158)
HS2444E
PREPARED FOR:
PN NUR SABIHA MD HUSSIN
SUBMISSION DATE:
21st May 2021
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
INFORMATION ON AMLODIPINE 10mg
Description of Subject
Name of the Mrs. T
subject
Age 50 years old
Weight 140kg (BMI 62.
Height 150cm
Past Amlodipine besylate 10mg tablets (last 5 years)
medication
Daflon 500mg (in April 2021, 3 pills only)
list
Current
medication Amlodipine besylate 10mg tablets
list
Support at home: Husband and children
Marital status: Married and blessed with 3 children.
Occupation: Lawyer
Nature of work: Consist of sitting (>1 hour) alternately walking (<5mins) per day.
Smoking: Non-smoker
Alcohol intake: None
Social history
Recreational drug: None
Supplement intake: Olive oil 1 Tbsp every night before bed
Allergies: None
Hobby: Gardening
Activity level: Sedentary lifestyle; low physical activity
Pets: Bantam chicken
▪ Prolapsed intervertebral disk (PID) (late 2010-2011) – Not fully healed
(numb sensation over left 4th and 5th foot), currently not on any
Past medical medication intake for this condition; able to do functional activity
condition independently (sweeping floor, drying cloth etc)
▪ Hypertension since 2013 until now
▪ Obese Grade III
Current
medical ▪ Hypertension
condition ▪ Obese Grade III
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
Information on medicine
Generic name of
Amlodipine
medicine
Brand name of
Hovasc
medicine
Specific FDA- Approved
indication of ▪ Hypertension (HPT)
medicine - Sole agent to control blood pressure.
▪ Coronary Artery disease (CAD)
- Chronic stable angina
- Prinzmental angina (variant or vasospastic angina)
- CAD determined by angiography in patients without heart failure or
ejection fraction less than 40%
Non-FDA Approved
- Diabetic neuropathy
- Left ventricular hypertrophy
- Raynaud phenomenon
- Silent myocardial ischemia
(Bulsara, 2020)
Strength of the ▪ 2.5 milligrams (mg) per tablet
medicine ▪ 5 mg per tablet
▪ 10 mg per tablet
(Amlodipine: Indication, Dosage, Side Effect, Precaution | MIMS
Malaysia, 2019)
Dose of the Hypertension
medicine - Adults: Initial dose 5mg per day
*Max dose 10mg per day (may be increase after at least 1-2 weeks)
- Geriatric: Initial dose to 2.5mg per day
*Max dose 10mg per day
- Adolescent & Children (>6 years old): 2.5 - 5mg per day
*Max dose 5mg per day (may be increased after 4 weeks intervals
depends on clinical response)
- Children (<6 years old): 0.05-0.2 mg/kg per day
*Max dose 0.3 - 0.6 mg/kg per day
CAD, Chronic Stable Angina, Prinzmental Angina, CAD Documented by
Angiography and Without Heart Failure or Ejection Fraction less than 40%
- Adults: Initial dose 5 - 10mg per day
- Geriatric: Initial, 2.5mg per day
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
Patient with hepatic impairment
- Adults: Initial dose 2.5mg per day (HPT); 5mg per day (angina)
* adjust dosage based on clinical response.
* should be cautious as dosage recommendation have not been
established in patient with mild to moderate hepatic impairment thus
dosage should start at the lowest dosing range.
*titrated slowly and starts with 2.5mg per day in patients with severe
hepatic impairment.
Patient with renal impairment
- Normal dosage is recommended.
*amlodipine plasma concentration is not correlated with the degree of
renal impairment.
(Amlodipine 10mg Tablets - Summary of Product Characteristics
(SmPC) - (Emc), 2020; Bulsara, 2020; Amlodipine: Indication, Dosage,
Side Effect, Precaution | MIMS Malaysia, 2019)
Instruction on Basic instruction on Amlodipine intake:
how to take the 1. Follow all directions.
medicine 2. The recommended initial dose is 5mg per day and can be increased
maximally to 10mg per day.
3. This medicine can be used before or after food and drinks and should
always be taken at the same time each day with a drink of water. Intake
of amlodipine with grapefruit juice and natural liquorice should be
avoid as it can cause an unpredictable increase in blood pressure
lowering effect of Amlodipine.
4. If you do not understand the instruction written in the leaflet, ask
doctor or pharmacist.
Use in children and adolescent.
- Usual starting dose is 2.5mg per day and should not be taken by
breaking Amlodipine into two equal halves to obtain Amlodipine
2.5mg.
- It is important to continue taking the medicine and see doctor before
the tablets are finished.
In term of taking amlodipine more than prescribed.
- Seek immediate medical attention.
- Adverse effect includes hypotension, dizzy, lightheaded, faint, lose
consciousness and if blood pressure drop severe enough shock may
occur.
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
In term of forget to take Amlodipine
- Take next dose as usual at the right time.
- Do not take a double dose to make up the forgotten dose.
In term of stop taking Amlodipine
- The condition may return if Amlodipine is not taken as prescribed by
doctor.
(Amlodipine 10mg Tablets - Patient Information Leaflet (PIL) - (Emc),
2018; Amlodipine: Uses, Interactions, Mechanism of Action |
DrugBank Online, 2021)
Formulation of IUPAC Name
the medicine 3-O-ethyl 5-O-methyl 2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-6-methyl-
1,4-dihydropyridine-3,5-dicarboxylate
Molecular formular
C26H31ClN2O8S
Molecular weight
567.1 g/mol
Ingredients
- Active: Amlodipine besylate 10mg
- Inactive: Cellulose, Microcrystalline, Anhydrous Dibasic Calcium
Phosphate, Sodium Starch Glycolate (Type A), Magnesium Stearate
(DailyMed - Amlodipine Besylate - Amlodipine Besylate Tablet, 2021; National
Center for Biotechnology Information, 2021)
Route of Orally
administration - Amlodipine absorbed slowly and almost completely from the
gastrointestinal tract.
- Takes about 6-12 hours to reach peak plasma concentration.
- After 7-8 days of consecutive daily dosing, steady state plasma
amlodipine is achieved.
- Suspension: Shake well before using
(Amlodipine: Uses, Interactions, Mechanism of Action | DrugBank
Online, 2021)
Registration MAL07090927A (Amlodipine 10mg tablet)
number MAL07090925A (Amlodipine 5mg tablet)
(Hovasc Tablet, 2021)
Medication Shelf life
storage - 3 years
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
Storage
- Store at 15-30°C room temperature and avoid from storing above 30°C
to avoid blister.
- Protect from light by storing the medicine in the original package.
- Dispense in tight.
- Keep out of the sight and reach of children.
- Do not use this medicine after expiry date.
- Do not throw away the medicine via wastewater instead ask
pharmacist on how to dispose.
(Amlodipine 10mg Tablets - Summary of Product Characteristics (SmPC) -
(Emc), 2020; Amlodipine 10mg Tablets - Patient Information Leaflet (PIL) -
(Emc), 2018; Norvasc (Amlodipine) Dosing, Indications, Interactions, Adverse
Effects, and More, 2020)
Contraindications Contraindications
- Patient with hypersensitivity to dihydropyridine derivatives,
amlodipine, or any of the ingredients.
- Severe hypotension
- Shock
- Obstruction of the outflow tract of the left ventricle
- Unstable heart failure after acute myocardial infarction
Warning and precautions:
- Cardiac failure:
May increase the risk of future cardiovascular events and mortality.
Risk of pulmonary oedema
- Hepatic impairment:
Prolonged half-life (56 hours) of amlodipine
Should initiated amlodipine at lowest end dosing range.
Patient with severe hepatic impairment should be monitored closely
and slows the dose titration.
(Amlodipine 10mg Tablets - Summary of Product Characteristics (SmPC) -
(Emc), 2020)
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
Adverse reaction
Significant adverse ▪ Palpitation
effect ▪ Flushing ▪ Fatigue
▪ Abdominal ▪ Somnolence
pain ▪ Dizziness/ headache
▪ Nausea ▪ Oedema
General disorder Very common ▪ Oedema
▪ Fatigue
Common
▪ Asthenia
▪ Chest pain
Uncommon
▪ Malaise
Nervous system Dx ▪ Somnolence
Common
▪ Dizziness, headache
▪ Tremor
▪ Dysgeusia
Uncommon ▪ Syncope
▪ Hypoesthesia
▪ Paraesthesia
▪ Hypertonia
Very Rare
▪ Peripheral neuropathy
Eye Dx Common ▪ Visual disturbance
Cardiac Dx Common ▪ Palpitations
Uncommon ▪ Arrhythmia
Very rare ▪ Myocardial infarction
Musculoskeletal, ▪ Ankle swelling
Common
connective tissue ▪ Muscle cramps
and bone Dx ▪ Arthralgia
Uncommon ▪ Myalgia
▪ Back pain
Vascular dx Common ▪ Flushing
Uncommon ▪ Hypotension
Very rare ▪ Vasculitis
Respiratory, Common ▪ Dyspnoea
Thoracic, and ▪ Cough
Uncommon
mediastinal dx ▪ Rhinitis
Blood & Lymphatic ▪ Leukocytopenia
Very rare
system Dx ▪ Thrombocytopenia
Gastrointestinal dx ▪ Abdominal pain
Common ▪ Nausea
▪ Dyspepsia
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
▪ Altered bowel habits (including diarrhoea and
constipation)
▪ Vomiting
Uncommon
▪ Dry mouth
▪ Pancreatitis
Very rare ▪ Gastritis
▪ Gingival hyperplasia
Metabolism and ▪ Hyperglycaemia
Very rare
Nutrition Dx
Psychiatric Dx ▪ Insomnia
Uncommon
▪ Mood changes (including anxiety), depression
Rare ▪ Confusion
Immune system Dx Very rare ▪ Allergic reactions
Renal and urinary Dx ▪ Micturition disorder
Uncommon ▪ Nocturia
▪ Increased urinary frequency
Reproductive system ▪ Impotence, gynaecomastia
Uncommon
and breast Dx
Ear and Labyrinth Dx Uncommon ▪ Tinnitus
(Amlodipine 10mg Tablets - Summary of Product Characteristics (SmPC) - (Emc), 2020)
Use in pregnancy Pregnancy
and lactation - US FDA category: C
There is an adverse effect on the foetus in Animal reproduction
studies.
- Use of Amlodipine is contraindicated in United Kingdom (UK)
- The safety of amlodipine in pregnant women has not been established.
- Recommended only when there is no other safer alternative and when
it is the best to fight the disease for sake of mother and foetus.
- There is a reversible biochemical change in the head of spermatozoa
in some patients.
- Study by Mito et al (2019) No significant different in term of birth
defect in the first trimester from those with or without Amlodipine.
Lactation
- Not recommended in Australia and United states and a decision should
be made to discontinue breastfeeding or discontinue the medicine
usage as there is unknown effect infant.
- Contraindicated in UK.
- No adverse impact of amlodipine on breastfeed infants reported.
- No effect of amlodipine on milk production.
(Amlodipine 10mg Tablets - Summary of Product Characteristics (SmPC) -
(Emc), 2020; Amlodipine Pregnancy and Breastfeeding Warnings, 2019; Mito
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
et al., 2019; Amlodipine: Indication, Dosage, Side Effect, Precaution | MIMS
Malaysia, 2019; Norvasc (Amlodipine) Dosing, Indications, Interactions,
Adverse Effects, and More, 2020)
Shape of Oblong tablet with bevelled edges; uncoated; shallow convex with break bar
medicine on face and “HOVID” embossed on one face) x10x10’s.
(Hovasc Full Prescribing Information, Dosage & Side Effects | MIMS Hong
Kong, n.d.)
Colour of White or almost white
medicine
(Amlodipine 10mg Tablets - Summary of Product Characteristics (SmPC) -
(Emc), 2020)
Photo of
medicine
(Amlodipine 10mg (Norvasc®), 2018
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
REFERENCES
Amlodipine 10mg (Norvasc®). (2018, March 16). [Photograph]. I-Med.
https://imed2.github.io/HTML/Ubat/Amlodipine10.html
Amlodipine 10mg Tablets - Patient Information Leaflet (PIL) - (emc). (2018, August 11).
EMC. https://www.medicines.org.uk/emc/product/3473/pil
Amlodipine 10mg Tablets - Summary of Product Characteristics (SmPC) - (emc). (2020,
August 25). EMC. https://www.medicines.org.uk/emc/product/4582/smpc#gref
Amlodipine: Indication, Dosage, Side Effect, Precaution | MIMS Malaysia. (2019). MIMS.
https://www.mims.com/malaysia/drug/info/amlodipine?mtype=generic
Amlodipine Pregnancy and Breastfeeding Warnings. (2019, August 28). Drugs.Com.
https://www.drugs.com/pregnancy/amlodipine.html#ref_pregnancy
Amlodipine: Uses, Interactions, Mechanism of Action | DrugBank Online. (2021, May 14).
DrugBank. https://go.drugbank.com/drugs/DB00381
Bulsara, K. G. (2020, November 4). Amlodipine - StatPearls - NCBI Bookshelf. StatPearls
(Internet). https://www.ncbi.nlm.nih.gov/books/NBK519508/
DailyMed - Amlodipine Besylate - amlodipine besylate tablet. (2021). NIH.
https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3518853a-4c5b-4161-a178-
8da7f656f009##
Hovasc Full Prescribing Information, Dosage & Side Effects | MIMS Hong Kong. (n.d.).
MIMS. Retrieved May 15, 2021, from
https://www.mims.com/hongkong/drug/info/hovasc?type=full.
Bachelor in Physiotherapy (Hons)
UPH 654
Know your Medicine
Hovasc tablet. (2021, May 14). National Pharmaceutical Regulatory Agency (NPRA).
https://www.npra.gov.my/index.php/en/consumer-medication-information-leaflets-
rimup/item/hovasc-tablet.html
Mito, A., Murashima, A., Wada, Y., Miyasato‐Isoda, M., Kamiya, C. A., Waguri, M.,
Yoshimatsu, J., Yakuwa, N., Watanabe, O., Suzuki, T., Arata, N., Mikami, M., & Ito,
S. (2019). Safety of Amlodipine in Early Pregnancy. Journal of the American Heart
Association, 8(15). https://doi.org/10.1161/jaha.119.012093
National Center for Biotechnology Information. (2021). PubChem Compound Summary for
CID 60496, Amlodipine Besylate.
https://pubchem.ncbi.nlm.nih.gov/compound/Amlodipine-besylate
Norvasc (amlodipine) dosing, indications, interactions, adverse effects, and more. (2020,
February 11). Medscape. https://reference.medscape.com/drug/katerzia-norvasc-
amlodipine-342372#11
