Orciprenaline

Evidence Level: L5 Predicted Indications: 6

Table of Contents

  1. Orciprenaline
    1. Pharmacist Assessment Report
    2. Orciprenaline: Respiratory malformation
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. India Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Orciprenaline: Respiratory malformation

One-Sentence Summary

Orciprenaline (metaproterenol) is a non-selective beta-adrenergic agonist bronchodilator, originally used for asthma, bronchitis and pulmonary emphysema. This prediction is essentially an umbrella term for the drug’s existing indications rather than a true repurposing.


Quick Overview

Item Content
Original Indication Not recorded in the local data
Predicted New Indication Respiratory malformation
TxGNN Prediction Score 0.9998
Evidence Level L5
India Market Status Listed in a compiled Indian medicine price dataset (1 of 1) – CDSCO approval status is not included in this data
Number of Listed Products 1 (valid: 1)
Recommended Decision Proceed with Guardrails

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Based on known information, orciprenaline is a non-selective beta-adrenergic agonist that relaxes bronchial smooth muscle. Its efficacy in asthma, bronchitis and emphysema is established.

The mechanism, bronchodilation through beta-receptor stimulation, applies directly to airway obstruction.

The main caveats are cardiac effects from beta-1 stimulation (a faster heart rate and higher blood pressure than salbutamol in a paediatric comparison) and the availability of more selective beta-2 agonists. Current guidelines generally favour those agents.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

PMID Year Type Journal Key Findings
6248395 1980 Double-blind crossover trial J Int Med Res Oral orciprenaline 10 mg vs fenoterol 5 mg in 44 asthma patients; FEV1 rose over 4 hours with both drugs, peaking at 3 hours
7047707 1982 Randomised double-blind crossover J Pediatr Oral metaproterenol vs theophylline in 34 children with chronic asthma; no serious adverse effects, tremor more frequent with metaproterenol
45195 1979 Double-blind crossover Br J Clin Pharmacol Four beta-2 aerosols (fenoterol, orciprenaline, salbutamol, terbutaline) compared in 9 patients with reversible airway obstruction
4888877 1969 Double-blind trial Br Med J In 24 chronic asthma patients, salbutamol acted longer than isoprenaline and slightly more intensely and longer than orciprenaline
5565461 1971 Comparative study Arch Dis Child In 12 asthmatic children, all three aerosols relieved bronchoconstriction similarly; orciprenaline raised heart rate 26% vs 13% for salbutamol
13895 1976 Comparative study Bull Eur Physiopathol Respir Five oral beta-agonists in reversible obstructive chronic bronchitis; carbuterol and fenoterol were more potent than orciprenaline
2975286 1987 Clinical pharmacology J Asthma Bronchodilators including orciprenaline work better at night or in the morning, when bronchial patency is low
3335167 1988 Cohort Chest In 59 patients with emphysema and chronic bronchitis, airway reversibility after inhaled orciprenaline was examined in relation to 4-year survival
29906501 2018 Review Adv Drug Deliv Rev Historical overview of repurposing drugs as inhaled asthma therapies
2991865 1985 Review Pharmacotherapy Review of fenoterol, a close chemical relative of orciprenaline, which has higher bronchodilating potency

India Market Information

Authorization Number Product Name Dosage Form Approved Indication
161670 Orcibest Tablet (Zydus Cadila) Strip of 15 tablets Not listed

Safety Considerations

  • Disease-related cautions (from the knowledge graph, not label text): The drug is linked to contraindication or caution signals in hypertension, epilepsy, diabetes mellitus, diabetic ketoacidosis, coronary artery disease, myocardial ischaemia, hyperthyroidism, Graves disease and thyrotoxicosis.
  • Drug Interactions: 374 interactions are recorded. Examples include:
    • Major: dolasetron.
    • Moderate: epinephrine, isometheptene, diethylpropion, clarithromycin, famotidine, and several antidiabetic agents (acarbose, metformin, chlorpropamide, alogliptin, canagliflozin, dapagliflozin, albiglutide, dulaglutide).
    • Minor: corticosteroids (hydrocortisone, dexamethasone, triamcinolone, betamethasone, budesonide, beclomethasone).
  • Cardiovascular caution: Tachycardia and arrhythmia are the main concerns, particularly in older patients with COPD.

Please also refer to the package insert for label warnings and contraindications.


Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Orciprenaline’s bronchodilator effect in obstructive airway disease is supported by consistent historical comparative studies, and the predicted indication overlaps with its approved uses. However, the evidence is old and has no registered trials. Newer selective beta-2 agonists are preferred in current practice.

To proceed, the following is needed:

  • The package insert for Orcibest Tablet (warnings, contraindications, approved indication), which is a blocking gap for safety screening
  • Detailed mechanism of action data
  • A cardiovascular safety plan for older patients and those with the comorbidities listed above
  • A comparison with current standard bronchodilators (selective beta-2 agonists, antimuscarinics)

Other predictions reviewed (all Hold, except COPD):

  • Chronic obstructive pulmonary disease: Proceed with Guardrails (L3). It overlaps with the existing bronchitis and emphysema indications and rests on 1964-1988 studies only.
  • Anaphylaxis (L4, Hold): only animal and tissue studies exist, and epinephrine is the standard of care.
  • Interstitial emphysema (L4, Hold): the single linked item is an indirect Cochrane review in preterm infants.
  • Respiratory malformation, Rienhoff syndrome, bronchial neoplasm, food-dependent exercise-induced anaphylaxis, compensatory emphysema, hyperlucent lung (L5, Hold): there is no credible mechanistic link or direct evidence, so these predictions appear to be TxGNN model (deep learning) artifacts.

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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