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Normodyne (LABETALOL)
Normodyne (generic name: LABETALOL) is a beta-Adrenergic Blocker Small molecule drug developed by Merck & Co.. It is currently FDA-approved (first approved 1984) for Hypertensive disorder.
Normodyne (Labetalol) is a beta-adrenergic blocker, a small molecule drug that targets the beta-1 adrenergic receptor. It was originally developed by CNTY LINE PHARMS and is now owned by Schering. Normodyne is used to treat hypertensive disorders and was FDA approved in 1984. The drug is off-patent, with 23 generic manufacturers available. Key safety considerations include its potential to cause hypotension and bradycardia.
At a glance
| Generic name | LABETALOL |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | beta-Adrenergic Blocker |
| Target | Beta-1 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1984 |
Approved indications
- Hypertensive disorder
Common side effects
- Dizziness
- Fatigue
- Nausea
- Headache
- Asthenia
- Gastrointestinal
- Vomiting
- Dyspepsia
- Abdominal pain
- Diarrhea
- Paresthesia
- Drowsiness
Drug interactions
- methoxyflurane
- piroxicam
- sevoflurane
- sulindac
- tolazamide
- tolbutamide
- verapamil
Key clinical trials
- Safety and Efficacy of Dexmedetomidine in Controlling Hemodynamics During Resection of Active Thyroid Secreting Tumors (PHASE2,PHASE3)
- Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2) (PHASE3)
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
- Safest Choice of Antihypertensive Regimen for Postpartum Hypertension (PHASE3)
- Hypotensive Anesthesia for Orthognathic Surgery (PHASE4)
- Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study (NA)
- A Comparison of Nicardipine and Labetalol for Blood Pressure Control in Intensive Care Patients After Hemorrhagic Stroke Brain Surgery (NA)
- Comparison of Post-Craniotomy Blood Pressure Targets (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Normodyne CI brief — competitive landscape report
- Normodyne updates RSS · CI watch RSS
- Merck & Co. portfolio CI
Frequently asked questions about Normodyne
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Related
- Drug class: All beta-Adrenergic Blocker drugs
- Target: All drugs targeting Beta-1 adrenergic receptor
- Manufacturer: Merck & Co. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertensive disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing