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National Drug Formulary

TRANDATE INJECTION 100 MG/20 ML [SIN02281P]

Active ingredients: TRANDATE INJECTION 100 MG/20 ML

View product's general information
Last updated 24 April 2026

Product Info

TRANDATE INJECTION 100 MG/20 ML

[SIN02281P]

Product information

Active Ingredient and Strength

LABETALOL HCL - 100 MG/20 ML

Dosage Form

INJECTION

Manufacturer and Country

UBI PHARMA INC - TAIWAN

Registration Number

SIN02281P

Licence Holder

DCH AURIGA SINGAPORE

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

C07AG01

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

Indications

TRANDATE injection is indicated for:

▪ severe hypertension, including severe hypertension of pregnancy, when rapid control of blood pressure is essential
▪ May be used to achieve control hypotension during anaesthesia

Dosing

Dosage and Administration

TRANDATE injection is intended for i.v. use in hospitalised patients. Patients should always receive the drug whilst in the supine or left lateral position. Raising the patient into the upright position within 3 h of i.v. TRANDATE administration should be avoided since excessive postural hypotension may occur. It is desirable to monitor the blood pressure and heart rate after injection and during infusion. In most patients, there is a small decrease in the heart rate; severe bradycardia is unusual but may be controlled by injecting atropine 1 to 2 mg intravenously. Respiratory function should be observed particularly in patients with any known impairment.

TRANDATE injection has been administered to patients with uncontrolled hypertension already receiving other hypotensive agents, including beta-blocking drugs, without adverse effects.

Populations

• Adults

Trandate Injection Dosage Table 1



• Paediatric population

Safety and efficacy in paediatric patients aged 0 to 18 years has not been established. No data are available.

Contraindications

Contraindications

TRANDATE injection is contraindicated in second or third degree heart block (unless pacemaker is in situ), cardiogenic shock and other conditions associated with severe and prolonged hypotension or severe bradycardia.

Non-selective beta-blockers should not be used in patients with asthma or a history of obstructive airway disease.

Uncompensated heart failure

Unstable/uncontrolled heart insufficiency

Sick sinus syndrome (including sinus atrial block) unless pacemaker in situ

Sinus node dysfunction

Prinzmetal angina

TRANDATE injection is contraindicated for patients known to have hypersensitivity to the active substance or to any of the excipients listed.