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Lipril (Lisinopril Dihydrate Tablets) is used alone or along with other medications to treat high blood pressure (hypertension), heart failure and to improve survival in patients who have just had a heart attack.
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Levocetirizine dihydrochloride 5 mg film coated tablets smpc- taj pharmaceuti...Taj Pharma
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Metolar-XR (Metoprolol Capsules) is used for the treatment of hypertension (blood pressure), long-term treatment of angina pectoris, treatment of stable, symptomatic heart failure of ischemic, hypertensive or cardiomyopathic origin as well as for migraine prophylaxis.
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Lipril (Lisinopril Dihydrate Tablets) is used alone or along with other medications to treat high blood pressure (hypertension), heart failure and to improve survival in patients who have just had a heart attack.
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Metolar-XR (Metoprolol Capsules) is used for the treatment of hypertension (blood pressure), long-term treatment of angina pectoris, treatment of stable, symptomatic heart failure of ischemic, hypertensive or cardiomyopathic origin as well as for migraine prophylaxis.
ARBs (Angiotensin receptor blockers) are the most widely used anti hypertensive throughout the world. A solid knowledge related to ARB will make our practice more patients friendly & benefit will be maximum.
CONGESTIVE HEART FAILURE
Congestive heart failure is a syndrome that can be caused by a variety of abnormalities
Coronary artery disease
Heart attack
Cardiac myopathy
Conditions that overwork the heart
Hypertension
Valve disease
Thyroid disease
Kidney disease
Congenital birth defects
Diabetes
In the usual form of heart failure, the heart muscle has reduced contractility. This produces a reduction in cardiac output, which then becomes inadequate to meet the peripheral demands of the body.
Introduction.
Classification .
Drugs used in Coagulant and Anticoagulant Agents
Mechanism of action .
Structure
Synthesis
Adverse Drug Reactions .
Uses.
Reference
Lab Results Interpretation for Pharmacist A.NouriAhmed Nouri
PHARMACISTS dealing with LAB RESULTS reading, each pharmacist needs to have the basic knowledge regarding lab results and how to deal with it . Ahmed Nouri, PharmD
SEMINAR PRESENTATION ON CONTRAST INDUCED NEPHROPATHY BY PHARM D STUDENT
IT INCLUDES COMPLETE OVERVIEW OF THE TOPIC CIN.
POST CONTRAST ACUTE KIDNEY INJURY( PC-AKI) WITH TREATMENT AND MANAGEMENT.
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Ondansetron is used to treat nausea and vomiting caused by chemotherapy. It is also used to prevent or treat nausea and vomiting after surgery.
Ondansetron should be considered for infants and children age six months and older who present to the ED with vomiting related to suspected acute gastroenteritis, and who have mild to moderate dehydration or who have failed oral rehydration therapy.
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Adverse drug reaction- Drug Interaction .pptxMangeshBansod2
Classifications - Excessive pharmacological effects, secondary pharmacological effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions, and pharmacokinetic drug interactions, Methods for detecting drug interactions,
spontaneous case reports and record linkage studies, and Adverse drug reaction reporting and management.
Q-1The disease process I chose for this article is the treatment.docxwoodruffeloisa
Q-1
The disease process I chose for this article is the treatment of chronic hypertension and the medication I chose was Amlodipine (Norvasc).
Hypertension is on the rise in the world and becoming one of the highest occurring disease processes according to the World Health Organization (Lee et al., 2019). The age group with the largest rate of occurrence is patients ages 65 and older at a prevalence rate of 67% (Lee et al., 2019). Amlodipine (Norvasc) is a calcium channel blocker and has a longer half life with a slower onset when compared to other generations of calcium channel blockers (Lee et al., 2019).
The mechanism of action for Norvasc is that it inhibits the movement of calcium ions into the vascular smooth muscle cells and cardiac muscle cells to prevent the constriction of the cardiac muscle and vascular smooth muscle (Lee et al., 2019). This prevention of contraction keeps the vessels “wide” in order to allow easy flow of blood and to decrease blood pressure by decreasing peripheral vascular resistance (Lee et al., 2019). Oral administration
Some common adverse effects of Norvasc are due to the vasodilatation of the blood vessels (Hong et al., 2019). They include peripheral edema, dizziness, palpiations, fatigue, nausea, abdominal pain, somnolence, and flushing (Hong et al., 2019). Rare side effects include blood disorders, impotence, depression, peripheral neuropathy, insomnia, tachycardia, gingival enlargement, hepatitis, and jaundice (Hong et al., 2019).
There are several drugs that have an interaction with Norvasc (Hong et al., 2019). Mainly any drug that influences the level or efficiency of CYP3A inhibitors will also cause an increase of bioavailability of Norvasc in the body (Hong et al., 2019). Some other interactions occur when the patient is also taking cardizem, clarithromycin, and some antifungal (Hong et al., 2019). These interactions with drugs also increase the bioavailability of Norvasc in the body (Hong et al., 2019).
There was a time where a patient came into the ER with a hypertensive emergency and this patient was taking beta-blockers and an ARB. When this patient came to the ICU we started him on cardine for a B/P of 195/103. As we started to bring his pressure out of stroke range, they physician then started Norvasc at 5mg p.o. daily. We did give him his first dose, and noticed a further drop in blood pressure down to a normal range. We then titrated the patient off cardine and were able to keep him off with the new combination of anti-hypertensives and the fact that we were addressing three of the four ways to control hypertension.
References:
Hong, S. J., Jeong, H. S., Cho, J.-M., Chang, K., Pyun, W. B., Ahn, Y., … Kim, H.-S. (2019). Efficacy and Safety of Triple Therapy With Telmisartan, Amlodipine, and Rosuvastatin in Patients With Dyslipidemia and Hypertension: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial. Clinical Therapeutics, 41(2), 233–248. https://doi-org.lopes.idm.ocl ...
role of newer antiplatelet and anticoagulant in stroke and tia
Similar to (A) TO PREPARE AN APPLICATION FOR IND SUBMISSION FOR AZILSARTAN TABLET IN USA. (B) TO PREPARE CHECKLIST FOR AZILSARTAN TABLET AS PER USA. (20)
To compare filing process of NDA of different countries of India, US and Euro...Aakashdeep Raval
To compare filing process of NDA of different countries of India, US and Europe.
B) Preparation of global list documents of registration of IND and NDA as per USFDA and Europe.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
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Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
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Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
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2 Case Reports of Gastric Ultrasound
The Gram stain is a fundamental technique in microbiology used to classify bacteria based on their cell wall structure. It provides a quick and simple method to distinguish between Gram-positive and Gram-negative bacteria, which have different susceptibilities to antibiotics
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
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ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
(A) TO PREPARE AN APPLICATION FOR IND SUBMISSION FOR AZILSARTAN TABLET IN USA. (B) TO PREPARE CHECKLIST FOR AZILSARTAN TABLET AS PER USA.
1. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
EXPERIMENT NO: DATE:
AIM: (A) TO PREPARE AN APPLICATION FOR IND SUBMISSION FOR
AZILSARTAN TABLET IN USA.
(B) TO PREPARE CHECKLIST FOR AZILSARTAN TABLET AS PER USA.
REFERENCES:
1. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/
sbd_smd_2012_edarbi_145305-eng.php
2. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200796Orig1s000chemR.pdf
3. http://www.biomedcentral.com/1471-2261/13/46
4. http://en.wikipedia.org/wiki/azilsartan
5. www.edarbi.com/docx./Edarbi_pi.html
6. www.medicines.org.uk/cmc/medicine/26412/spc
Investigational New Drug Application
1. FDA Forms.
2. Table of contents
3. Introductory statements & General investigational plan
3.1 Product Information
3.1.1 Product Name
3.1.2 Brand Name
3.1.3 Active & Inactive Ingredient
3.1.4 Pharmacological Information
3.1.4.1 Mechanism Of Action
3.1.5 Structural Formula
3.1.6 Route of Administration
3.1.7 Indication
3.2 Brief summary of previous human experiments
3.3 General investigational plan
3.3.1 Rationale for Azilsartan
3.3.2 Indication
3.3.3 Clinical study & no. of patient to be given Azilsartan drug for study
3.3.4 Toxicological Data
4. Investigator’s Brochure
4.1 Brief description of Azilsartan
4.2 A summary of Pharmacological and toxicological effects of Azilsartan
4.3 A summary of pharmacokinetics and biological disposition of Azilsartan in animal
4.4 Description of possible risk and side effects to be anticipated on the basis of prior
experiment with Azilsartan under investigation.
5. Protocol
5.1 Study protocol
5.2 Clinical trial investigator information
5.3 Overall clinical trial official and content
6. Chemistry Manufacturing and Control data
6.1 Product data
7. Pharmacological and Toxicological data
8. Previous human experience
9. Additional information
2. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
Content
3. Introductory statement and general investigational plan
3.1Product Information:
3.1.1. Generic Name: Azilsartan (AY-zil-SAR-tan)
3.1.2. Brand Name: Edarbi
3.1.3. Active ingredients: tablet contains 42.68 or 85.36 mg of Azilsartan
kamedoxomil, which is equivalent to containing 40 mg or 80 mg respectively, of azilsartan
medoxomil.
Inactive ingredients:
Mannitol (E 421)
Fumaric acid (E 297)
Sodium hydroxide
Hydroxypropylcellulose (E 463)
Croscarmellose sodium
Cellulose, microcrystalline (E 460)
Magnesium stearate (E 572)
3.1.4. Pharmacological information:
3.1.4.1 Mechanism of Action :
Refer CMC section 6.
3.1.5. Structural Formula:
Refer CMC section 6.
3.1.6. Route of administration: Oral route.
Dose :- Tablets, oral 40 mg
- Tablets, oral 80 mg
3.1.7. Broad objectives: Indications:
Indications and Usage: Treatment of hypertension alone or in combination with other
antihypertensives.
Contraindications: Do not co-administer aliskiren with Edarbi in patients with diabetes
Precautions :
Fetal/Neonatal Morbidity and Mortality (Black Box Warning): Drugs that interfere
with therein‐angiotensin system can cause morbidity and death of the fetus when
given to a pregnant woman during the second or third trimester.
Drug Trade
Name
Biological
half-life
[h]
Protein
binding
[%]
Bioavailability
[%]
Renal/hepatic
clearance
[%]
Food
effect
Daily
dosage
[mg]
Azilsartan Edarbi 11 h >99% 60% 55%/42% No 40–80 mg
3. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
Azilsartan is a category C drug during the first trimester and category D in the
second and third trimesters.
Azilsartan should be discontinued as soon as possible when pregnancy is detected.
Using azilsartan during breastfeeding is not recommended as it is unknown if
azilsartan is excreted in breast milk.
Hypotension in Volume – or Salt‐Depleted Patients: After starting azilsartan,
symptomatic hypotension may occur in these patients. Before initiating azilsartan,
correct volume or salt depletion or start azilsartan at 40mg. If hypotension does
occur, place the patient in supine position and given an infusion of normal saline, if
necessary. Once the blood pressure has stabilized, treatment with azilsartan can be
continued.
Impaired Renal Function: In patients whose renal function may depend on the
activity of the renin angiotensin system, treatment with angiotensin receptor
blockers and angiotensinconverting enzyme inhibitors has been associated with
oliguria or progressive azotemia and rarely with acute renal failure and death.
Anaphylactic Reactions and Angioedema: Use caution when prescribing azilsartan
for patients with a history of angioedema related to ACE inhibitor therapy.
Although angiotensin II receptor blockers do cause an accumulation of kinins,
angioedema has been reported rarely in patients taking an angiotensin II receptor
blocker.
Pediatric Use: Safe use has not been evaluated in children under the age of 18.
Geriatric Use: No dosage adjustment is needed. Significant increases in serum creatinine
were seen more often in adults greater than 75 years of age.
Adverse Effects :
Occurring in > 1% and < 10% of patients
Gastrointestinal: Diarrhea (2%)
Other Fatigue (1.1‐2.5%) Occurring in < 1%
Cardiovascular: Hypotension/Orthostatic hypotension (0.4%)
Gastrointestinal: Nausea (0.3%)
Hematologic: Low hemoglobin (0.2%)
Low hematocrit (0.4%)
Low red blood cell count (0.3%)
Neurologic: Asthenia (0.3%)
Dizziness (0.3%)
Postural dizziness (0.3%)
Renal : Oliguria
Progressive azotemia
Respiratory: Cough (0.3%)
Drug Interactions:
Non‐steroidal anti‐inflammatory agents including selective cyclooxygenase‐2
inhibitors
Co‐administration of NSAIDs with azilsartan in patients who are elderly, volume-
depleted, or who have compromised renal function may result in deterioration of
renal function.
The antihypertensive effects of azilsartan may be lessened by NSAIDs.
4. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
Co‐administration with drugs that cause hyperkalemia, Eplerenone, potassium
salts, postassium‐sparing diuretics, tolvaptan, trimethoprim
Co‐administration with drugs that cause hypotension
Other antihypertensives, amifostine, diazoxide, ethanol, MAO inhibitors,
pentoxyifylline, Phosphor diesterase 5 inhibitors, prostacyclin analogues
Co‐administration with drugs that diminish the antihypertensive effect of
antihypertensives , Methylphenidate, yohimbine ,Lithium
Azilsartan may increase the serum concentration of lithium.
Rifamycin derivatives: Rifamycin derivatives may increase the metabolism of
azilsartan.
Pharmacokinetics:
Absorption:
Tmax : 1.5‐3 hours
Vd : 16 L
t1/2 : 11 hours
Clearance : 2.3 mL/min
Protein binding: >99%
Bioavailability: 60%
Metabolism: Azilsartan is metabolized via O‐dealkylation and decarboxylation into two
primary metabolites. CYP2C9 is the major enzyme responsible for azilsartan metabolism.
Elimination: Azilsartan is eliminated through the feces (55%) and the urine (42%). Only
15% is eliminated as the unchanged drug.
3.2. Brief summary of previous human experience:
NOT APPLICABLE
3.3 GENERAL INVESTIGATIONAL PLAN
3.3.1 The Rational for Azilsartan
Objectives: EARLY have two co-primary objectives:
1) Description of the safety profile of AZM (Azilsartan Medoxomil)
2) Achievement of Blood Pressure targets based on recent national and
international guidelines for patients treated with AZM in comparison to those
treated with ACE-inhibitors..
Secondary objectives are as follows:
1) Absolute and relative BP reduction with antihypertensive treatment over the
duration of one year.
2) Documentation of the adherence to guidelines for the diagnosis and treatment of
hypertension in ambulatory care.
3) Persistence understood as the mean duration of monotherapy and / or AZM
based combination therapy during follow-up.
4) Documentation of adverse events.
5) Prospective documentation of cardiovascular and renal events.
5. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
6) A pharmaco-economic evaluation of AZM use.
Additional objectives in a subgroup of patients with ABPM (Ambulatory Blood
Pressure Monitoring) are to document BP lowering and pulse pressure reduction over the 1
year follow-up considering prior and concomitant antihypertensive pharmacotherapy as
well as BP at baseline, and BP control with AZM in comparison to ACE-inhibitors
(specific ACE inhibitors will be considered given their sample size is sufficient). Second,
BP values obtained from ABPM will be compared to corresponding office Blood Pressure
values. Finally, central systolic and diastolic blood pressure, cardiac output (per minute),
peripheral resistance, augmentation index, and pulse wave velocity will be determined and
compared between patients receiving AZM or ACE-inhibitor treatment.
Adult patients (≥ 18 years) with essential arterial hypertension are included on a
consecutive basis, given they have provide written informed consent and fulfill the
following two criteria: 1) Participants have either no anti-hypertensive treatment prior to
inclusion or a prior non-RAS (Rennin Angiotensin System) based antihypertensive
monotherapy. 2) A monotherapy using AZM or any ACE-inhibitor is initiated at baseline.
Patients are excluded from participation if they 1) receive antihypertensive drugs
for an indication other than hypertension (e.g. beta blockers or diuretics for heart failure),
2) have a history of alcohol, drug abuse or illegal drug addiction, 3) have a life expectancy
of less than one year, 4) are pregnant or breast feeding, or 5) are participating in other
trials or registries. Further to this, patients with contraindications as to the summary of
product characteristics of AZM or the ACE inhibitors will not be permitted. Patient
recruitment started in January 2012 and will end on February 28th
2013 at the latest or as
soon as the recruitment target of 5000 patients is met.
3.3.2 Indications
As per section 3.1.7
3.3.3 Clinical Studies & No. of patients to be given AZILSARTAN drug for studies:
The antihypertensive effects of Edarbi have been demonstrated in a total of seven
double-blind, randomized studies, which included five placebo-controlled and four active
comparator-controlled studies (not mutually exclusive). The studies ranged from six weeks
to six months in duration, at doses ranging from 20 mg to 80 mg once daily. A total of
5941 patients (3672 given Edarbi, 801 given placebo, and 1468 given active comparator)
with mild, moderate or severe hypertension were studied. Overall, 51% of patients were
male and 26% were 65 years or older; 67% were white and 19% were black.
Two 6-week, randomized, double-blind studies compared the effect on blood
pressure of Edarbi at doses of 40 mg and 80 mg, with placebo and with active
comparators. Blood pressure reductions compared to placebo based on clinic blood
pressure measurements at trough and 24-hour mean blood pressure by ambulatory blood
pressure monitoring (ABPM) are shown in Table 1 for both studies. Edarbi, 80 mg, was
statistically superior to placebo and active comparators for both clinic and 24-hour mean
blood pressure measurements.
6. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
Table 1. Placebo Corrected Mean Change from Baseline in Systolic/Diastolic Blood
Pressure at 6 Weeks (mm Hg)
Study 1
N=1285
Study 2
N=989
Clinic Blood
Pressure
(Mean Baseline
157.4/92.5)
24 Hour Mean by
ABPM
(Mean Baseline
144.9/88.7)
Clinic Blood
Pressure
(Mean Baseline
159.0/91.8)
24 Hour Mean by
ABPM
(Mean Baseline
146.2/87.6)
Edarbi 40 mg -14.6/-6.2 -13.2/-8.6 -12.4/-7.1 -12.1/-7.7
Edarbi 80 mg -14.9/-7.5 -14.3/-9.4 -15.5/-8.6 -13.2/-7.9
Olmesartan 40
mg
-11.4/-5.3 -11.7/-7.7 -12.8/-7.1 -11.2/-7.0
Valsartan 320
mg
-9.5/-4.4 -10.0/-7.0
3.3.4 Toxicological Data
General nonclinical pharmacology/toxicology considerations
Azilsartan medoxomil is a competitive reversible ARB (IC50 = 0.62-2.6 nmol/L). The
drug produces a dose-dependent decrease in arterial blood pressure in a variety of
hypertensive animal models such as spontaneously hypertensive rats and renal
hypertensive dogs; it blocks the pressor effect of angiotensin II in rats.
3.3.4.1 Toxicology:
The toxicology program included assessment of the pro-drug (TAK-491) and
active moiety (TAK-536) in single and repeat-dose toxicity studies in rats (up to 26
weeks, ≤ 2000 mg/kg) and dogs (up to 26 weeks with TAK-491 (≤ 60 mg/kg) and up to
52 weeks with TAK-536 (≤300 mg/kg), rodent carcinogenicity studies, genotoxicity
studies, and reproduction and developmental toxicity studies. The major human
metabolite, TAK-536 M-II, was examined in rat and dog repeat-dose toxicity studies
(up to 13 weeks in duration), in 6-month transgenic mouse and 2-year rat
carcinogenicity assays, and in genotoxicity and reproduction/developmental studies.
The following toxicologic findings were observed with azilsartan medoxomil:
1. Dark red foci and stomach erosion (rats, 20-fold higher AUC than humans) and
GI ulceration (dogs, 5-fold higher AUC than humans); olmesartan medoxomil
produced similar findings.
2. Juxtaglomerular cell hypertrophy, consistent with chronic pharmacologic
effects of angiotensin-receptor blockers and ACE inhibitors;
3. Minimal or mild atrophy of the adrenal zona glomerulosa. These effects
appear in toxicology studies of other ARB and ACE inhibitors.
7. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
Toxicologic studies of the major metabolite TAK-536 M-II showed that this
compound is relatively devoid of pharmacologic activity; in 13-week repeat-dose rat
toxicity studies, renal/adrenal/stomach toxicities were not observed with reported
NOAELs in the 300 mg/kg/day (male) and 3000 mg/kg/day range.
3.3.4.2 Genetic toxicology:
Structural chromosomal aberrations were observed in the Chinese Hamster Lung
Cytogenetic Assay with the prodrug, azilsartan medoxomil (TAK-491) and the metabolite,
TAK-536 MII without metabolic activation. The active moiety, azilsartan (TAK-536) was
also positive in this assay both with and without metabolic activation. Other genetic
toxicity assays were negative. The reviewers recommended that these findings be added
to labeling.
4. Investigator’s brochure:
4.1. Brief description of azilsartan:
As per 3.1
4.2. A summary of pharmacological and toxicological effects of azilsartan :
As per 3.1.4 and 3.3.4
4.3. A summary of pharmacokinetics and biological disposition of azilsartan in
animals:
Absorption: Azilsartan medoxomil is rapidly hydrolyzed to azilsartan, the active
metabolite, in the gastrointestinal tract during absorption. Azilsartan medoxomil is
not detected in plasma after oral administration. Dose proportionality in exposure
was established for azilsartan in the azilsartan medoxomil dose range of 20 mg to
320 mg after single or multiple dosing.
The estimated absolute bioavailability of azilsartan following administration of
azilsartan medoxomil is approximately 60%. After oral administration of azilsartan
medoxomil, peak plasma concentrations (Cmax) of azilsartan are reached within 1.5 to
3 hours. Food does not affect the bioavailability of azilsartan.
Distribution Azilsartan medoxomil: The volume of distribution of azilsartan is
approximately 16L. Azilsartan is highly bound to human plasma proteins (>99%), mainly
serum albumin. Protein binding is constant at azilsartan plasma concentrations well above
the range achieved with recommended doses.
In rats, minimal azilsartan-associated radioactivity crossed the blood-brain barrier.
Azilsartan passed across the placental barrier in pregnant rats and was distributed to the
fetus. Chlorthalidone: In whole blood, chlorthalidone is predominantly bound to
erythrocyte carbonic anhydrase. In the plasma, approximately 75% of chlorthalidone is
bound to plasma proteins, 58% of the drug being bound to albumin.
Metabolism and Elimination Azilsartan medoxomil: Azilsartan is metabolized to two
primary metabolites. The major metabolite in plasma is formed by O-dealkylation,
referred to as metabolite M-II, and the minor metabolite is formed by decarboxylation,
referred to as metabolite M-I. Systemic exposures to the major and minor metabolites in
8. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
humans were approximately 50% and less than 1% of azilsartan, respectively. M-I and
MII do not contribute to the pharmacologic activity of azilsartan medoxomil. The major
enzyme responsible for azilsartan metabolism is CYP2C9.
Following an oral dose of
14
C-labeled azilsartan medoxomil, approximately 55% of
radioactivity was recovered in feces and approximately 42% in urine, with 15% of the
dose excreted in urine as azilsartan. The elimination half-life of azilsartan is
approximately 11 hours and renal clearance is approximately 2.3 mL/min. Steady-state
levels of azilsartan are achieved within 5 days and no accumulation in plasma occurs with
repeated once-daily dosing.
Vd = 16 liters
Half life = 11 hours
4.4. A description of possible risk and side effects and to be anticipated in the basis of
prior experiment with azilsartan under investigation:
General Disorders and Administration Site Conditions: asthenia, fatigue
Musculoskeletal and Connective Tissue Disorders: muscle spasm
Nervous System Disorders: dizziness, dizziness postural
Respiratory, Thoracic and Mediastinal Disorders: cough
Possible risk:
Fetal/Neonatal Morbidity and Mortality
Hypotension in Volume- or Salt-Depleted Patients
Impaired Renal Function
5. Protocols:
5.1. Study protocol:
Study Type Interventional
Study Phase Phase 3
Condition Hypertension
Intervention Drug: Azilsartan Medoxomil
Study Design Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Asses
sor)
Primary Purpose Treatment
Eligibility:
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Primary Endpoint:
9. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
Change in 24 hour mean systolic blood pressure (SBP) per ambulatory blood
pressure monitoring (ABPM) at 6 weeks 8.9 and 24 weeks 10.
Secondary and Other Endpoints:
Change in trough sitting SBP at 6 weeks8,9 and 24 weeks10
Change from baseline in 24 hour mean diastolic blood pressure (DBP) per
ABPM8-10
Change in trough sitting DBP8-10
Change in daytime mean, nighttime mean, mean at 0 to 12 hours, mean at trough
SBP and DBP per ABPM8
% responders (SBP < 140 mm Hg and/or decreased by > 20 mm Hg)8-10
This study has been completed.
5.2. Clinical trial investigator information:
Confidential
5.3. Overall clinical trial officials and contacts:
Confidential
6. Chemistry manufacturing and control data:
6.1. Product information:
The drug is medoxomil ester and potassium salt of azilsartan.
Chemical Name: (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-
dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate
monopotassium salt
Molecular Formula: C30H23KN4O8
Molecular Weight: 606.62
The drug substance is a hygroscopic white powder.
It is poorly soluble in aqueous solution but becomes slightly soluble at ph 9 and above.
It is fully characterized by a combination of quantitative elimental analysis uv
spectroscopy ir spectroscopy and mass spectroscopy .
Drug product name / code / type:
10. Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
a) Proprietary name NA
b) Non proprietary name (USAN)
c) Code name
d) Chem. Type
Pharmacological category : Anti-hypertensive
Dosage form: tablet
Strength or potency: 40mg , 80 mg
Route of administration : oral
. Mechanism of Action:
Azilsartan (INN, codenamed TAK-536) is an angiotensin-II receptor antagonist
used in the treatment of hypertension that was developed by Takeda.
Azilsartan medoxomil lowers blood pressure by blocking the action of angiotensin
II, a vasopressor hormone.
Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-
converting enzymes (ACE, kinase II). Angiotensin II is the principal pressor agent
of the renin-angiotensin system, with effects that include vasoconstriction,
stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal
reabsorption of sodium. Azilsartan blocks the vasoconstrictor and aldosterone-
secreting effects of angiotensin II by selectively blocking the binding of
angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle
and the adrenal gland. Its action is, therefore, independent of the pathway for
angiotensin II synthesis.
Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of
angiotensin II on renin secretion, but the resulting increased plasma renin activity
and angiotensin II circulating levels do not overcome the effect of azilsartan on
blood pressure.
7. Pharmacology and toxicology data:
As per 3.1.4 and 3.3.4
8. Previous human experience : NA
9. Additional information : NA