Pharma at University Of Medicine And Pharmacy Of Cluj-Napoca | Flashcards & Summaries

Lernmaterialien für Pharma an der University of Medicine and Pharmacy of Cluj-Napoca

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Clinical evaluation of new drug

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Pharmacological: 

Pharmacodynamics: dose- effect, dose-efficiency, conditions for administration, mechanism of action

Pharmacokinetics: studies on healthy volunteers and patients regarding absorption, distribution, bio-transformation, elimination

drug-drug interactions

therapeutic:

open/controlled studies regarding efficacy and adverse effects

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Antivitamin K (warfarin): Clinical use

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Warfarin, Acenuramarol, Dicumarol

decrease functional amount of Vit K --> reduce factor VII, IX, X/ proteins C, S 

no immediate action (4-5d)

Clinical use: DVT, PE after heparin treatment, prophylaxis after high risk surgery, preventing stroke in AF patients, mechanical valves, ventricular assist devices

Dose: 5-10 mg initiation, 5-7mg maintenance

Monitoring: Daily testng in initiation aPTT, INR 2-3 times per week for 1-2 weeks; INR 2-3x, aPPT +25%, maintenance every 4 weeks

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Anticholinergic antispasmodic agents

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Block M3 receptors in smooth muscle, intestine, urinary tract, low effect on biliary tract

Atropine: oral, 0.3-1mg max 4mg

Butylscopolamine 10mg 3-4x

SE: Constipation, Dry mouth, blurred vision urinary retention

Clidinium/Otilonium bromide

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INF´s : side effects, CI, adm.

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SE: FLu like symptoms, thrombocytopenia, granulocytopenia, AST elevation, autoAB, neusea, fatique headache, anorexia, arthralgias, rash,alopecia, hypotension, edema

CI: psychosis, dpression, neutropenia, thrombocytopenia, symptomatic heart disease, decopmp. cirrhosis, uncontrolled seizures, history of organ transplant, pregnancy

Adm: SC or IM once/w

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Entecavir

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Guanosine analogue, inhibits HBV-DNA polymerase, adm. on empty stomachto increase absorption, not with GFR <30

Clinic: Chronic HBV first line, Chronic HBV with postive AGHBe -- naive or relapsed, adults, children <2, possible with liver cirrhosis, acute HBV with tenofovir

Dose: naive 0,5mg/d, relapsed or lamivudine resistance or decomp. cirrhosis 1mg/d for 5 years

SE: acute severe ecacerbation of disease, resistance(<1%), headache nauea, dizzyness, lactic acidosis, hepatomegaly with steatosis in decomp cirrhosis

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PPI´s : Mechanism of Action, Clinical Use

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MOA:

- irreversible PP inhibitor (T1/2: 18h)

- acid secretion inhibited (<90%)

- most efficient: max effect after 3-5 days and up to 3 days after treatment is stopped

- prodrug: activated by acid environment, diffusion into cells, bind to proton pump

Clinical use: 

Gastric/ duodenal ulcer: 20-40 mg/d for 4-8 weeks

Gerd: 4-8 weeks

HP inf.: triple therapy

First line in Zollinger-Ellison Sdr

Prophylaxis in NSAID

GERD maintenance

Heartburn

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Misoprostol

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PGE1 synthetic derivate, PG substitute; reduces food-stimulated gastric acid secretion, lower basal, protects cells, improve local circulation, promotes cure of gastric/ duodenal mucosa 

CLinical use: NSAID ulcer (+prophylaxis) 0.2mg qd, 0.4 mg bd 4-8 weeks 

SE: diarhea, abd. pain, stim. uterine contracions (not in pregnancy), may worsen IBD 

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H2 antihistamines: MOA, Clinical use

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MOA: oral/IV,IM; comp. blocks H2 receptor on parietal cells: supress basal/food-stimulated / nocturnal acid secretion (Ach, His, gastrin), also pepsin secr. 

Clinical Use: Gastric/Duod. Ulcer, prevention of stress ulcer, GERD, inferior to PPI´s

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Informed consent in clincal trials

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Written decision, datd and signed:

-aims

- methods

- finances

- conflict of interests ( Investigator)

- expected results/ potential risks

- potential constraint

If patient is not able to consent: legal representative


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Pancreatic enzymes

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Pancreatin: 20000 U of lipase, in non-alcoholic pancreatitis, before lipid rich meals

Clinic: chronic pancreatitis, cystic fibrosis, post pancreatectomy, gastrectomy, gastrectomy, pancreatic cancer

capsules, enteric coated microtablets

SE: diarrhea, nausea, hypersensitivity, hyperuricosuria in cystic fibrosis, malabsorption of folate and iron

dose adjusted for meal composition and severity

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Antacids: Representative drugs

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Aluminium Hydroxide: supension or gel 5-30mg

toxic reactions in renal failure

SE: constipation, nausea, vomitting, PO4 deficiency

DI: reduces bioavalability: Ferrum, Digoxin, Propranolol

Magnesium Compounds

- MG hydroxide: rapid, intense, short-time, laxative

-MG oxide: forms hydroxide, laxative/antacid

- MG trisilicate: slow, prolonged, absorp pepsin, laxative

-Mg carbonate: weak, prolonged, abd distension

Calcium carbonate: 1-2g/d  rapid, prolonged, rebound, anti- diarrhea, hypercalcemia!

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PPI´s: pharmacokinetics, side effects, Interactions

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Pharmacokinetics: well/rapidly absorbed, not affected by food intake, high protein bound, CYP 450 metabolism, renal excretion T1/2 increased with renal failure, rebound acid hypersecretion 

Side effects:

 Nausea, constipation, diarrhea; Skin erruptions

Long term: VitB12 def, hypomagnesia (renal failure) 

affacts calcium homeostasis

C.difficile infection

Cardiac conduction disturbances


Interactions: 

Atazanacir ( reduce absorption) 

Clopidogrel (inh. activation) 

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Beispielhafte Karteikarten für deinen Pharma Kurs an der University of Medicine and Pharmacy of Cluj-Napoca - von Kommilitonen auf StudySmarter erstellt!

Q:

Clinical evaluation of new drug

A:

Pharmacological: 

Pharmacodynamics: dose- effect, dose-efficiency, conditions for administration, mechanism of action

Pharmacokinetics: studies on healthy volunteers and patients regarding absorption, distribution, bio-transformation, elimination

drug-drug interactions

therapeutic:

open/controlled studies regarding efficacy and adverse effects

Q:

Antivitamin K (warfarin): Clinical use

A:

Warfarin, Acenuramarol, Dicumarol

decrease functional amount of Vit K --> reduce factor VII, IX, X/ proteins C, S 

no immediate action (4-5d)

Clinical use: DVT, PE after heparin treatment, prophylaxis after high risk surgery, preventing stroke in AF patients, mechanical valves, ventricular assist devices

Dose: 5-10 mg initiation, 5-7mg maintenance

Monitoring: Daily testng in initiation aPTT, INR 2-3 times per week for 1-2 weeks; INR 2-3x, aPPT +25%, maintenance every 4 weeks

Q:

Anticholinergic antispasmodic agents

A:

Block M3 receptors in smooth muscle, intestine, urinary tract, low effect on biliary tract

Atropine: oral, 0.3-1mg max 4mg

Butylscopolamine 10mg 3-4x

SE: Constipation, Dry mouth, blurred vision urinary retention

Clidinium/Otilonium bromide

Q:

INF´s : side effects, CI, adm.

A:

SE: FLu like symptoms, thrombocytopenia, granulocytopenia, AST elevation, autoAB, neusea, fatique headache, anorexia, arthralgias, rash,alopecia, hypotension, edema

CI: psychosis, dpression, neutropenia, thrombocytopenia, symptomatic heart disease, decopmp. cirrhosis, uncontrolled seizures, history of organ transplant, pregnancy

Adm: SC or IM once/w

Q:

Entecavir

A:

Guanosine analogue, inhibits HBV-DNA polymerase, adm. on empty stomachto increase absorption, not with GFR <30

Clinic: Chronic HBV first line, Chronic HBV with postive AGHBe -- naive or relapsed, adults, children <2, possible with liver cirrhosis, acute HBV with tenofovir

Dose: naive 0,5mg/d, relapsed or lamivudine resistance or decomp. cirrhosis 1mg/d for 5 years

SE: acute severe ecacerbation of disease, resistance(<1%), headache nauea, dizzyness, lactic acidosis, hepatomegaly with steatosis in decomp cirrhosis

Mehr Karteikarten anzeigen
Q:

PPI´s : Mechanism of Action, Clinical Use

A:

MOA:

- irreversible PP inhibitor (T1/2: 18h)

- acid secretion inhibited (<90%)

- most efficient: max effect after 3-5 days and up to 3 days after treatment is stopped

- prodrug: activated by acid environment, diffusion into cells, bind to proton pump

Clinical use: 

Gastric/ duodenal ulcer: 20-40 mg/d for 4-8 weeks

Gerd: 4-8 weeks

HP inf.: triple therapy

First line in Zollinger-Ellison Sdr

Prophylaxis in NSAID

GERD maintenance

Heartburn

Q:

Misoprostol

A:

PGE1 synthetic derivate, PG substitute; reduces food-stimulated gastric acid secretion, lower basal, protects cells, improve local circulation, promotes cure of gastric/ duodenal mucosa 

CLinical use: NSAID ulcer (+prophylaxis) 0.2mg qd, 0.4 mg bd 4-8 weeks 

SE: diarhea, abd. pain, stim. uterine contracions (not in pregnancy), may worsen IBD 

Q:

H2 antihistamines: MOA, Clinical use

A:

MOA: oral/IV,IM; comp. blocks H2 receptor on parietal cells: supress basal/food-stimulated / nocturnal acid secretion (Ach, His, gastrin), also pepsin secr. 

Clinical Use: Gastric/Duod. Ulcer, prevention of stress ulcer, GERD, inferior to PPI´s

Q:

Informed consent in clincal trials

A:

Written decision, datd and signed:

-aims

- methods

- finances

- conflict of interests ( Investigator)

- expected results/ potential risks

- potential constraint

If patient is not able to consent: legal representative


Q:

Pancreatic enzymes

A:

Pancreatin: 20000 U of lipase, in non-alcoholic pancreatitis, before lipid rich meals

Clinic: chronic pancreatitis, cystic fibrosis, post pancreatectomy, gastrectomy, gastrectomy, pancreatic cancer

capsules, enteric coated microtablets

SE: diarrhea, nausea, hypersensitivity, hyperuricosuria in cystic fibrosis, malabsorption of folate and iron

dose adjusted for meal composition and severity

Q:

Antacids: Representative drugs

A:

Aluminium Hydroxide: supension or gel 5-30mg

toxic reactions in renal failure

SE: constipation, nausea, vomitting, PO4 deficiency

DI: reduces bioavalability: Ferrum, Digoxin, Propranolol

Magnesium Compounds

- MG hydroxide: rapid, intense, short-time, laxative

-MG oxide: forms hydroxide, laxative/antacid

- MG trisilicate: slow, prolonged, absorp pepsin, laxative

-Mg carbonate: weak, prolonged, abd distension

Calcium carbonate: 1-2g/d  rapid, prolonged, rebound, anti- diarrhea, hypercalcemia!

Q:

PPI´s: pharmacokinetics, side effects, Interactions

A:

Pharmacokinetics: well/rapidly absorbed, not affected by food intake, high protein bound, CYP 450 metabolism, renal excretion T1/2 increased with renal failure, rebound acid hypersecretion 

Side effects:

 Nausea, constipation, diarrhea; Skin erruptions

Long term: VitB12 def, hypomagnesia (renal failure) 

affacts calcium homeostasis

C.difficile infection

Cardiac conduction disturbances


Interactions: 

Atazanacir ( reduce absorption) 

Clopidogrel (inh. activation) 

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