Labetalol Hydrochloride Injection 100mg/20ml Injection
Labetalol Hydrochloride
5mg/ml
AKORN, INC
| Pack size | 1 Multidose Vial (20ml) |
|---|---|
| Dispensing mode | POM |
| Source | USA |
| Agent | UNIQUE LIFE MEDICINES TRADING |
| Retail Price | 32.50 AED |
Available as:
Indications
Labetalol Hydrochloride Injection 100mg/20ml Injection is used for:
Hypertension, Hypotensive anaesthesia
Adult Dose
Oral
Hypertension
Adult: Initially, 100 mg bid, may increase gradually according to patients response to 200-400 mg bid. Max: 2.4 g/day in 2-4 divided doses.
Elderly: Initially, 50-100 mg bid. Maintenance: 100-200 mg bid.
Intravenous
Emergency treatment of hypertension
Adult: 20 mg injected slowly for at least 2 min, followed by 40-80 mg dose every 10 min, if necessary up to 300 mg. Patient should remain supine during and 3 hr after the procedure.
Hypertension in pregnancy
Adult: Start infusion at a rate of 20 mg/hr, doubled every 30 min until a satisfactory response is achieved or a dose of 160 mg/hr is reached.
Hypertension after myocardial infarction
Adult: Initiate infusion at a rate of 15 mg/hr, then increase gradually until a favourable response is obtained or a dose of 120 mg/hr is reached.
Hypotensive anaesthesia
Adult: Initially, 10-20 mg, increase at 5-10 mg increments if satisfactory hypotension is not achieved after 5 min. Administer higher initial doses if halothane anaesth is not used.
Incompatibility: Na bicarbonate 5% and alkaline solutions.
Child Dose
Hypertensive Emergency
0.4-1 mg/kg/hr by continuous IV infusion; not to exceed 3 mg/kg/hr
Renal Dose
Administration
Should be taken with food. Take immediately after meals.
IV Preparation
Standard diluent: 500 mg/250 mL D5W
Minimum volume: 250 mL D5W
IV Administration
Requires infusion pump
Slow direct IV push administered over 2 minutes
Loading infusions (2 mg/min) require close monitoring of HR and BP and are terminated after response occurs or a cumulative dose of 300 mg is reached
Continuous infusions of 2-6 mg/hr have been used in some settings and should not be confused with loading infusions
Contra Indications
2nd and 3rd degree heart block, cardiogenic shock, obstructive airway disease e.g. bronchial asthma, uncompensated heart failure, severe bradycardia, sick sinus syndrome, Prinzmetal's angina, severe peripheral arterial disease.
Precautions
Phaeochromocytoma, compensated heart failure, nonallergic bronchospasm. Avoid abrupt withdrawal. DM. Hepatic impairment. Perform LFTs. Elderly. Pregnancy and lactation.
Lactation: Small amounts excreted; use with caution
Pregnancy-Lactation
Pregnancy category: C
Lactation: Small amounts excreted; use with caution
Interactions
Synergistic hypotensive effect w/ halothane. Increased absolute bioavailability w/ cimetidine. Decreased absolute bioavailability w/ glutethimide. Additive hypotensive effect w/ nitroglycerin. Increased incidence of tremor w/ TCAs. Increased risk of bradycardia and heart block w/ Ca channel blocker (e.g. verapamil, diltiazem).
Adverse Effects
Side effects of Labetalol Hydrochloride :
>10%
Dizziness (1-20%), Lightheadedness (1-20%), Nausea (<19%), Tingling sensation of scalp (4-12%), Fatigue (1-11%)
1-10%
Elevated serum blood urea nitrogen (BUN) (<8%), Elevated serum creatinine (8%), Congestion of nasal sinus (1-6%), Orthostatic hypotension (1-5%), Absence of ejaculation (<5%), Paresthesia (<5%), Elevated liver enzymes (4%), Diaphoresis (<4%), Edema (<2%), Bronchospasm (1-2%), Dyspnea (1-2%), Pruritus (1%), Rash (1%), Altered taste sense (1%), Ventricular arrhythmia (1%; IV)
Frequency Not Defined
Angioedema, Bradycardia, Alopecia, Cholestatic jaundice, Depression, Diabetes insipidus, Hepatitis, Raynaud syndrome, Toxic myopathy, Urinary retention, Urticaria, Raynaud phenomenon
Potentially Fatal: Hepatic injury.
Mechanism of Action
Labetalol competitively inhibits the adrenergic stimulation of beta-receptors w/in the myocardium, bronchial and vascular smooth muscle, and alpha1-receptors w/in vascular smooth muscle. It also has some intrinsic beta2-agonist and membrane-stabilising activity.
Note
Labetalol Hydrochloride Injection 100mg/20ml 5mg/ml Injection manufactured by AKORN, INC. Its generic name is Labetalol Hydrochloride. Labetalol Hydrochloride Injection 100mg/20ml is availble in United Arab Emirates.
Farmaco UAE drug index information on Labetalol Hydrochloride Injection 100mg/20ml Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.