Azatadine maleate MCQs With Answer

Azatadine maleate MCQs With Answer

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Azatadine maleate MCQs With Answer

Azatadine maleate is a first‑generation H1 antihistamine used historically for allergic rhinitis and urticaria; a clear grasp of its pharmacology, formulations, and safety profile is vital for B. Pharm students. This introduction and question set cover mechanism of H1 receptor antagonism, physicochemical features of the maleate salt, pharmacokinetics (absorption, hepatic metabolism, CNS penetration), clinical uses, common adverse effects (sedation, anticholinergic effects), important drug interactions, formulation and stability considerations, and assay methods used in quality control. Questions include case‑based and mechanism‑driven items to strengthen exam readiness and patient counselling skills. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary pharmacological action of azatadine maleate?

  • Beta‑adrenergic receptor agonist
  • H1 histamine receptor antagonist
  • COX‑2 inhibitor
  • Muscarinic receptor agonist

Correct Answer: H1 histamine receptor antagonist

Q2. Why is azatadine formulated as the maleate salt in many preparations?

  • To increase melting point and make it insoluble
  • To decrease water solubility for sustained release
  • To improve water solubility and stability
  • To make it photoreactive

Correct Answer: To improve water solubility and stability

Q3. A common central nervous system adverse effect of azatadine is:

  • Hypertension
  • Seizures in all patients
  • Significant sedation and drowsiness
  • Insomnia and agitation

Correct Answer: Significant sedation and drowsiness

Q4. Which patient condition requires caution when prescribing azatadine due to its anticholinergic effects?

  • Type I diabetes
  • Narrow‑angle glaucoma
  • Hypothyroidism
  • Hyperlipidemia

Correct Answer: Narrow‑angle glaucoma

Q5. The most appropriate analytical technique for precise assay of azatadine in pharmaceutical formulations is:

  • Thin‑layer chromatography (TLC) only
  • High‑performance liquid chromatography (HPLC)
  • Gravimetric analysis
  • Simple pH titration

Correct Answer: High‑performance liquid chromatography (HPLC)

Q6. Azatadine’s ability to cause sedation is primarily due to:

  • Its inhibition of renal transporters
  • Peripheral H2 receptor blockade
  • Crossing the blood–brain barrier and central H1 blockade
  • Direct stimulation of opioid receptors

Correct Answer: Crossing the blood–brain barrier and central H1 blockade

Q7. Which of the following interactions is clinically important with azatadine?

  • Reduced effect with levothyroxine
  • Increased CNS depression with alcohol or benzodiazepines
  • Complete antagonism by proton pump inhibitors
  • Marked increase in renal clearance with aspirin

Correct Answer: Increased CNS depression with alcohol or benzodiazepines

Q8. In a formulation stability study, azatadine maleate is most likely to degrade under which condition?

  • Neutral pH at low temperature
  • Exposure to strong light and heat
  • Storage in amber glass at 4°C
  • Desiccated, cool environment

Correct Answer: Exposure to strong light and heat

Q9. Which dosage forms are commonly available for azatadine for outpatient use?

  • Intravenous only
  • Oral tablets and syrup
  • Subcutaneous depot injection
  • Topical ophthalmic gel only

Correct Answer: Oral tablets and syrup

Q10. A pharmacist counseling a patient taking azatadine should advise:

  • Avoid driving or operating machinery if feeling drowsy
  • To take it with grapefruit juice to increase effect
  • It is safe to combine with alcohol for better sleep
  • No need to report urinary retention

Correct Answer: Avoid driving or operating machinery if feeling drowsy

Q11. The primary route of elimination for many first‑generation antihistamines like azatadine is:

  • Exhalation unchanged in breath
  • Hepatic metabolism and renal excretion of metabolites
  • Fecal excretion of unchanged drug only
  • Skin desquamation

Correct Answer: Hepatic metabolism and renal excretion of metabolites

Q12. Which monitoring is most relevant during chronic use of sedating antihistamines in elderly patients?

  • Regular ECG for QT prolongation only
  • Assessing for cognitive impairment, falls, and anticholinergic burden
  • Monitoring blood glucose weekly
  • Daily liver biopsy

Correct Answer: Assessing for cognitive impairment, falls, and anticholinergic burden

Q13. A distinguishing clinical advantage of second‑generation antihistamines over azatadine is:

  • Greater anticholinergic effects
  • Less sedation and reduced CNS penetration
  • Higher propensity for drug–drug interactions
  • Exclusive parenteral availability

Correct Answer: Less sedation and reduced CNS penetration

Q14. Which statement about the maleate salt form is correct?

  • Maleate salts always decrease drug absorption
  • Maleate salt formation can improve taste masking and solubility
  • Maleate salts are only used for injectable drugs
  • Maleate salts make a compound non‑ionizable

Correct Answer: Maleate salt formation can improve taste masking and solubility

Q15. In an overdose of azatadine presenting with severe anticholinergic delirium, an appropriate antidotal agent is:

  • Flumazenil
  • Physostigmine (administered cautiously)
  • Naloxone
  • Sodium bicarbonate only

Correct Answer: Physostigmine (administered cautiously)

Q16. Which quality control parameter is especially important for an oral azatadine syrup?

  • Particle size distribution of a dry powder
  • Microbial limits, pH, and preservative efficacy
  • Assay of parenteral sterility
  • Hardness of tablet coating

Correct Answer: Microbial limits, pH, and preservative efficacy

Q17. Which pharmacodynamic property explains the use of azatadine in allergic rhinitis?

  • Blockade of histamine‑mediated vasodilation and increased vascular permeability
  • Inhibition of angiotensin converting enzyme
  • Activation of β2 adrenergic receptors in the nose
  • Direct bronchodilation through muscarinic stimulation

Correct Answer: Blockade of histamine‑mediated vasodilation and increased vascular permeability

Q18. When developing a tablet formulation of azatadine maleate, which excipient function is most critical?

  • Opacifier to change tablet color only
  • Diluents, disintegrants, and stabilizers to ensure content uniformity and release
  • Protease enzymes to increase absorption
  • Strong oxidizing agents to sterilize

Correct Answer: Diluents, disintegrants, and stabilizers to ensure content uniformity and release

Q19. A pharmacokinetic property typical of first‑generation antihistamines like azatadine is:

  • Poor oral absorption with zero bioavailability
  • High lipophilicity and significant volume of distribution
  • Exclusively renal clearance without metabolism
  • Very short onset of action within seconds via IV only

Correct Answer: High lipophilicity and significant volume of distribution

Q20. Which laboratory test change would most likely be associated with azatadine toxicity?

  • Marked hypoglycemia on fasting
  • Anticholinergic signs with possible hyperthermia and urinary retention; no specific routine lab abnormality
  • Rapid fall in hemoglobin within hours
  • Immediate severe hyponatremia in all cases

Correct Answer: Anticholinergic signs with possible hyperthermia and urinary retention; no specific routine lab abnormality

Q21. In pregnancy, first‑generation antihistamines such as azatadine are generally:

  • Strictly contraindicated at all stages
  • Used with caution; follow current guidelines and risk–benefit assessment
  • Guaranteed to cause teratogenicity
  • The recommended first choice for induction of labor

Correct Answer: Used with caution; follow current guidelines and risk–benefit assessment

Q22. Which of the following is an important counseling point for parents when giving azatadine syrup to children?

  • Double the dose if symptoms persist after one hour
  • Measure dose accurately with a calibrated device and watch for drowsiness
  • Mix with carbonated drinks to enhance potency
  • It is safe to give with multiple CNS depressants

Correct Answer: Measure dose accurately with a calibrated device and watch for drowsiness

Q23. For stability testing of azatadine tablets, which ICH condition is commonly evaluated?

  • Exposure to pure nitrogen only
  • Long‑term and accelerated conditions (e.g., 25°C/60% RH and 40°C/75% RH)
  • Only freezing temperatures
  • Immediate exposure to 100% relative humidity only

Correct Answer: Long‑term and accelerated conditions (e.g., 25°C/60% RH and 40°C/75% RH)

Q24. Which physicochemical test helps determine the ionization state of azatadine in solution?

  • Melting point determination
  • pKa and pH‑solubility profile
  • Karl Fischer titration
  • Differential scanning calorimetry for polymorphs only

Correct Answer: pKa and pH‑solubility profile

Q25. Compared to non‑sedating antihistamines, azatadine’s clinical limitation is mainly:

  • Higher cost of therapy
  • Greater central side effects such as sedation and impaired psychomotor performance
  • Inability to block peripheral H1 receptors
  • Exclusively topical use

Correct Answer: Greater central side effects such as sedation and impaired psychomotor performance

Q26. Which excipient consideration is important when preparing an azatadine oral suspension to ensure chemical stability?

  • Use of reactive oxidizers to maintain potency
  • Control of pH, preservatives, and avoidance of high temperatures
  • High sugar content only to improve solubility
  • Inclusion of proteolytic enzymes

Correct Answer: Control of pH, preservatives, and avoidance of high temperatures

Q27. A B. Pharm student asked how azatadine exerts anti‑allergic effects at the cellular level. Best explanation:

  • Stimulates mast cell degranulation to release histamine
  • Competes with histamine at H1 receptors and reduces histamine‑mediated responses
  • Directly destroys histamine molecules in plasma
  • Blocks synthesis of histamine from histidine permanently

Correct Answer: Competes with histamine at H1 receptors and reduces histamine‑mediated responses

Q28. When performing dissolution testing for azatadine tablets, which factor is least likely to influence the dissolution rate?

  • Agitation speed of dissolution apparatus
  • Particle size and crystal form of the drug
  • Color of the tablet coating only
  • Composition and amount of disintegrant

Correct Answer: Color of the tablet coating only

Q29. Which statement about drug interactions and azatadine is correct?

  • Azatadine universally decreases the effect of all antibiotics
  • Coadministration with other CNS depressants potentiates sedative effects
  • Azatadine induces cytochrome P450 enzymes to lower levels of all drugs
  • It has no interactions and is safe with all other medicines

Correct Answer: Coadministration with other CNS depressants potentiates sedative effects

Q30. In designing an MCQ for exam preparation on azatadine, which focus is most valuable for B. Pharm students?

  • Only the historical marketing data of the product
  • Mechanism, dosing, adverse effects, formulation, stability, and counselling points
  • Exclusive memorization of brand logos
  • Irrelevant trivia about non‑pharmaceutical topics

Correct Answer: Mechanism, dosing, adverse effects, formulation, stability, and counselling points

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