Practical

Dr Akshay Dahiwele
Assistant Professor
JNMC Sawangi
FDC
 FDC
Ibuprofen : 400 mg
Paracetamol : 500 mg

1. Justification for this FDC

Ibuprofen have anti-inflammatory action and Paracetamol have
analgesic action, The combination is used to manage fever and pain.
2. Clinical Indication
RA, OA, Fever with Body ache
3. Frequency of Administration of this FDC
Three times a day
4. Contraindications
Gastritis, Peptic ulcer, GI bleeding
5. Precautions to be taken during therapy
Bleeding disorder, Bronchial Asthma
6. Adverse effects
Nausea, Vomiting, Epigastric pain
7. Mention the interaction of other drugs with this combination
Ibuprofen can decrease the antihypertensive effect of ACE inhibitors, ARB, and diuretics.
8. How food can affect GI absorption of this preparation
No effect of food on GI absorption
9. Safety in pregnancy. Justify your answer
In view of the known effects of NSAIDs on the fetal cardiovascular system (risk of closure of ductus
arteriosus), use in the last trimester is contraindicated
10. Mention Kinetics of elimination
Metabolized in liver, excreted in Urine
 FDC
Inj Xylocaine : 2 %
Adrenaline : 1 : 200,000

1. Justification for this FDC

Adrenaline prolongs duration of action of Xylocaine by decreasing their rate of removal from the
local site into the circulation. Enhances the intensity of nerve block. Reduces systemic toxicity of
Xylocaine
2. Clinical Indication
Xylocaine 2% with Adrenaline is indicated for regional anesthesia in closure of Cuts, incised and
lacerated wounds
3. Frequency of Administration of this FDC
Before applying sutures to the patient
4. Contraindications
Terminal end part of the body (tip of fingers), Ischemic heart disease, Uncontrolled hypertension,
cardiac arrhythmia
5. Precautions to be taken during therapy
Monitor Blood pressure, Heart rate
6. Adverse effects
Sudden rise in BP, Arrhythmia, Bradycardia
7. Mention the interaction of this FDC with other drugs
Phenothiazines and butyrophenones may oppose the vasoconstrictor effects of adrenaline giving rise
to hypotensive responses and tachycardia.
8. How food can affect GI absorption of this preparation
Food does not affect absorption
9. Safety in pregnancy. Justify your answer
Xylocaine should not be given during early pregnancy unless the benefits are considered to outweigh
the risks. Adrenaline may potentially decrease uterine blood flow and contractility
10. Mention Kinetics of elimination
Xylocaine undergoes first pass metabolism in the liver, Less than 10% of a dose is excreted unchanged
via the kidneys.
 FDC
Ferric Ammonium Citrate: 160 mg
Vit B 12: 7.5 mcg
Folic Acid : 0.5 mcg
1. Justification for this FDC
Ferric ammonium citrate, Vitamin B12 and Folic acid have a major role in production of RBCs.
Deficiency of any of this can cause anemia (either Iron deficiency anemia or megaloblastic anemia).
Given in combination for the treatment of anemia.
2. Clinical Indication
Iron deficiency anaemia or Megaloblastic anaemia
3. Frequency of Administration of this FDC
Twice a day
4. Contraindications
Peptic ulcer, Gastritis
5. Precautions to be taken during therapy
The formulation should be taken after meal to avoid symptoms of gastric irritation
6. Adverse effects
Epigastric pain. heartburn, nausea, vomiting, bloating. staining of teeth, metallic taste, colic
7. Mention the interaction of other drugs with this combination
Vitamin B12 absorption may be reduced by Para-aminosalicylic acid, colchinine, biguanides,
neomycin, cholestyramine, potassium chloride, methyldopa, and cimetidine.
8. How food can affect GI absorption of this preparation
Food increases absorption of this combination.
9. Safety in pregnancy. Justify your answer
Safe in pregnancy
10. Mention Kinetics of elimination
Metabolized in liver, excreted in Urine .
 FDC
Sulfamethoxazole: 400 mg
Trimethoprim: 40 mg

1. Justification for this FDC

Both sulfonamide and trimethoprim are bacteriostatic, but the combination becomes cidal against
many organisms.
2. Clinical Indication
Pneumocystis jiroveci pneumonitis, prophylaxis of toxoplasmosis, nocardiosis, uncomplicated
urinary tract infection, Acute otitis media, Acute exacerbation of chronic bronchitis
3. Frequency of Administration of this FDC
Orally, twice a day
4. Contraindications
Hypersensitivity to the sulfonamides,  in patients showing marked severe liver parenchymal
damage, in severe renal insufficiency
5. Precautions to be taken during therapy
Patients should be advised of the signs and symptoms and monitored closely for skin reactions.
6. Adverse effects
Nausea, vomiting, stomatitis, headache and rashes, Folate deficiency
7. Mention the drug interaction of this combination
Thrombocytopenia when used with Diuretics (Thiazide), concomitant treatment with zidovudine may
increase the risk of haematological adverse reactions to co-trimoxazole
8. How food can affect GI absorption of this preparation
Food does not affect absorption
9. Safety in pregnancy. Justify your answer
Trimethoprim and sulfamethoxazole cross the placenta and their safety in pregnant women has not
been established.
10. Mention Kinetics of elimination
The principal route of excretion of trimethoprim is renal and approximately 50% of the dose is
excreted in the urine within 24 hours as unchanged drug.
 FDC
Amoxycillin: 500 mg
Clavulanic acid: 125 mg

1. Justification for this FDC

Resistance to Amoxicillin has been developed because of Beta lactamases enzyme produced by the
bacteria. Clavulanic acid inhibits a wide variety (class II to class V) of Beta-lactamases produced by
both gram-positive and gram-negative bacteria.
2. Clinical Indication
Acute bacterial sinusitis (adequately diagnosed), Acute otitis media, Acute exacerbations of chronic
bronchitis (adequately diagnosed), Community acquired pneumonia, Cystitis, Pyelonephritis, Skin
and soft tissue infections in particular cellulitis 
3. Frequency of Administration of this FDC
Three times a day
4. Contraindications
Hypersensitivity to any of the penicillins
5. Precautions to be taken during therapy
Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the
occurrence of a morbilliform rash has been associated with this condition following the use of
amoxicillin.
6. Adverse effects
Diarrhea, Nausea, Vomiting, Candida stomatitis/vaginitis and rashes.
7. Mention the interactions of this combination with other drugs
Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity,
Probenecid decreases the renal tubular secretion of amoxicillin.
8. How food can affect GI absorption of this preparation
Food does not affect absorption
9. Safety in pregnancy. Justify your answer
Use should be avoided during pregnancy.
10. Mention Kinetics of elimination
The major route of elimination for amoxicillin is via the kidney, whereas for clavulanic acid it is by
both renal and non-renal mechanisms.
 FDC
Salbutamol: 400 mg
Bromohexeine: 500 mg
1. Justification for this FDC
Salbutamol is β2 receptor agonist, it produces bronchodilatation. Bromohexeine is mucolytic it
liquifies mucus secretions.
2. Clinical Indication
Chronic bronchial asthma, Bronchitis
3. Frequency of Administration of this FDC
5 ml TDS
4. Contraindications
Hypersensitivity, Hypertension, Cardiovascular diseases, Diabetes Mellitus,
Hyperthyroidism
5. Precautions to be taken during therapy
Patients with cardiac diseases and hypertension should be monitored for any adverse
effect
6. Adverse effects
Nausea, vomiting, Headache, Tremor, anxiety, palpitation, sweating, tachycardia
7. Mention the interaction of thiazide with this combination
Can cause Hypokalemia
8. How food can affect GI absorption of this preparation
Food does not affect absorption
9. Safety in pregnancy. Justify your answer
Safe in pregnancy
10. Mention Kinetics of elimination
Metabolized in liver, excreted in Urine
 FDC
Codeine Phosphate: 400 mg
Chlorpheniramine Maleate: 500 mg

1. Justification for this FDC

Codeine phosphate is a opioid derivative with antitussive action. Chlorpheniramine Maleate is an
antihistamine reduces mucus secretion.
2. Clinical Indication
Allergic rhinitis, Cough, Bronchitis
3. Frequency of Administration of this FDC
5 ml QID
4. Contraindications
Productive cough, children below 1 year of age
5. Precautions to be taken during therapy
Avoid driving, Avoid machine operations
6. Adverse effects
Addiction, constipation, sedation, drowsiness
7. Mention the interaction of sedative with this combination
Excessive sedation
8. How food can affect GI absorption of this preparation
Food does not affect absorption
9. Safety in pregnancy. Justify your answer
Not safe in pregnancy, can cross placental barrier.
10. Mention Kinetics of elimination
Metabolized in liver, excreted in Urine/faeces
 FDC
Ephedrine: 50 mg
Theophyline: 0.65 mg
Phenobarbitone: 30 mg

1. Justification for this FDC

Ephedrine is a sympathomimetic drug, theophylline is a bronchodilator and phenobarbitone
produces sedative effect.
2. Clinical Indication
Asthma, COPD
3. Frequency of Administration of this FDC
Twice a day
4. Contraindications
Hypertension, cardiac arrhythmia
5. Precautions to be taken during therapy
Cardiac diseases, Hypertension, Hepatic impairment
6. Adverse effects
Headache, nervousness and nausea,
7. Mention the interaction of other drugs with this combination
Carbamazepine, isoprenaline, phenytoin, rifampicin, ritonavir, sulphinpyrazone increase clearance
of theophylline
8. How food can affect GI absorption of this preparation
Food does not affect absorption
9. Safety in pregnancy. Justify your answer
Not safe in pregnancy, because theophylline has a narrow margin of safety.
10. Mention Kinetics of elimination
Metabolized in liver, excreted in Urine.
OSPE
Identification of instrument

1. Identify the given instrument

2. Mention the use of this instrument
3. Mention one advantage of using this
instrument
4. Mention one disadvantage associated with
the use of this instrument
5. Mention various parts of the Soxhlet
Apparatus.
1. Identify the given instrument

• Soxhlet Apparatus

2. Mention the use of this instrument

• To extract active principle of the drug

3. Mention one advantage of using this instrument

• Mechanically gentle process with efficient extraction

4. Mention one disadvantage associated with the use of this instrument

• The process of drug extraction is lengthy

5. Mention various components of the Soxhlet Apparatus

• Condenser, Extractor, Siphon, Distillation flask, Porous thimble, Heat source

Adverse Drug Reaction

1. Identify the adverse drug reaction

2. Name the drug responsible for this adverse drug
reaction
3. Mention other adverse effects associated with the
use of this drug
4. What precautions should be taken while
administering this drug
1. Identify the adverse drug reaction
Angioedema
2. Name the drug responsible for this adverse drug reaction
ACE inhibitors e.g. Enalepril, Captopril, Lisinopril, Ramipril

3. Mention other adverse effects associated with the use of this drug

Dry Cough, Hypotension, Rash, dysguesia, hyperkalaemia.

4. What precautions should be taken while administering this drug

An ACE inhibitor can cause an increase in potassium levels. This may lead to
kidney failure in people with damaged kidneys. ACEIs should not be administered
along with other drugs causing hyperkalaemia e.g. K+ sparing diuretics.
1. Identify the cause of passing dark coloured stool
2. How will you confirm blood in stools
3. Mention other adverse effects associated with the use of
Acetylsalicylic Acid (Aspirin)
4. What action should be taken with drug?
1. Identify the cause of passing dark coloured stool

Upper gastrointestinal bleed due to the use of Acetylsalicylic acid (Aspirin)

2. How will you confirm blood in stools

Faecal occult blood test (FOBT)

3. Mention other adverse effects associated with the use Acetylsalicylic Acid (Aspirin)

Gastritis, salicylism, Reye’s syndrome, hypersensitivity reaction, liver & kidney damage.

4. What action should be taken with the drug?

Patient should be advised to immediately stop taking Acetylsalicylic Acid (Aspirin)

Dosage form

1. Identify the given dosage form.

2. Enlist various other drugs administered by this dosage form
3. List various advantages of this dosage form.
4. What are the disadvantages of this dosage form
1. Identify the given dosage form.

• Given dosage form is Transdermal Patch

2. Enlist various other drugs administered by this dosage form

• Hyoscine, glyceryl trinitrate, fentanyl, nicotine, oestradiol.

3. List various advantages of this dosage form.

 Effect produced is sustained & prolonged.

 Convenient, good patient compliance.
 Hepatic first pass metabolism is avoided.
4. What are the disadvantages of this dosage form?

 Local irritation, erythema

 Loss of therapeutic effect if the patch drops from the body.
 If patch stick to other person it may cause adverse effect in that
person. e.g Clonidine may cause hypotension in child if patch is
applied to mother.
1. Name 2 drugs causing orange coloured urine

2. What are the causes of orange coloured urine

3. What action should be taken with drug

1. Name 2 drugs causing orange coloured urine

• Phenazopyridine, Sulfasalazine

2. What are the causes of orange coloured urine

• Dehydration, Vitamins and supplements, Chemotherapy, Liver dysfunction

3. What action should be taken with the drug

• Patient should be advised to inform the physician and improve hydration.

Case

1. What is the problem in given prescription for the patient?

2. If there is a problem in given prescription, then how to
manage the patient?
3. Which drug in prescription is the potent enzyme inducer?
4. Which are other examples of enzyme inducers?
1. What is the problem in given prescription for the patient?

Rifampicin can cause contraceptive failure.

2. If there is a problem in given prescription, then how to manage the patient?

Switch over to an oral contraceptive containing higher dose (50 μg) of estrogen or use alternative method of

contraception.

3. Which drug in prescription is the potent enzyme inducer?

Rifampicin

4 Which are other examples of enzyme inducers?

Phenytoin, Carbamazepine, Phenobarbitone, smoking tobacco.

ADR

1. Identify the adverse drug reaction in given image.

2. Enumerate cause of given adverse drug reaction.
3. Mention whether given adverse drug reaction is predictable
or unpredictable.
4. Is given adverse drug reaction reversible on stoppage of
concerned drug?
1. Identify the adverse drug reaction in given image.

• Cushing’s syndrome (Moon face) 

2. Enumerate cause of given adverse drug reaction.

• Long-term use of oral corticosteroid (Prednisolone).

3. Mention whether given adverse drug reaction is predictable or unpredictable.

• Predictable.

4 Whether given adverse drug reaction is reversible on stoppage of concerned drug?

• Reversible.
Instrument

1) Identify the instrument

2) Write its uses
3) Mention any two class of drugs which can be used
for screening by using this instrument
4) Mention any other instrument which work on the
same principle of Eddy’s hot plate analgesiometer
1. Identify the instrument.

Eddy,s hot plate analgesiometer

2. Write its uses.

Eddys hot plate analgesiometer is used mainly for testing efficacy of centrally acting analgesics

3. Mention any two class of drugs which can be used for screening by using this instrument.

Opioid analgesics and local anaesthetics.

4. Mention any other instrument which work on the same principle of eddy’s hot plate analgesiometer.

Tail Flick analgesiometer

Urine Discoloration

1) Mention any two drugs causing yellow coloured urine?

2) What are the interventions needs to be taken if a given drug

causes yellow colour of urine?

3) Mention any one cause other than drugs causing bright

yellow coloured urine?

4) Mention any two foods which can change the colour of

urine?
1. Mention any two drugs causing yellow coloured urine?

Nitrofurantoin and Metronidazole

2. What are the interventions needs to be taken if a given drug causes yellow colour of urine?

Inform it to the physician.

3. Mention any one cause other than drugs causing bright yellow coloured urine?

Dehydration

4 Mention any two foods which can change the colour of urine?

Blackberries and carrots

Dosage Form

1. Identify the given dosage form?

2. Give two advantages of given dosage form?
3. Give two examples of drugs which are given in this doses
form for treatment of chronic diseases like Hypertension &
diabetes?
4. Give two disadvantages of the given dosage form?
1. Identify the given dosage form?

Tablet

2. Give two advantages of given dosage form?

No skills required for administration Painless

3. Give two examples of drugs which are given in this doses form for treatment of chronic diseases like
Hypertension & diabetes?
Tablet Metformin used in diabetes, Tablet Telmisartan used in hypertension
4. Give two disadvantages of the given dosage form?

Cannot be given in emergency situation and Bioavailability is less due to first pass metabolism
Skill station: Routes of drug administration –
Subcutaneous Route (Insulin syringe)
1) Identify the instrument and route of drug administration for
which it is used
• Instrument – Insulin Syringe.
• Use – for subcutaneous drug administration

2) Give 2 advantages of this route

• Slow and sustain release of drug
• Drug will act for longer duration
3) Which drug is commonly administered by using this instrument?
• Insulin
4) What advice should be given to the patient after administering
drug through this route?
• Patient should not rub the site of injection
Adverse drug reaction - Lipodystrophy
1) Identify the given adverse drug reaction
 Lipodystrophy
2) Name of drugs causing this adverse drug reaction.
 Insulin injection
 Oral corticosteroid

3) Enumerate Clinical Indications of drugs causing this ADR (adverse

drug reaction).
 Oral corticosteroid – Inflammatory bowel diseases, autoimmune
conditions.
 Insulin injection – Diabetes mellitus

4) Identify the type of the given adverse drug reactions.

 Type B (Bizarre)