Description
Labetalol 100mg/20mL Injection (1’s) is a sterile, nonpyrogenic, clear to light yellow aqueous solution supplied in a 20 mL multiple-dose vial. It is indicated for the intravenous treatment of severe hypertension and hypertensive emergencies, including hypertensive crises with end-organ damage.
Composition:
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Active Ingredient: Labetalol Hydrochloride 100 mg
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Concentration: 5 mg/mL
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Formulation: For intravenous injection only
Dosage and Administration:
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Initial Dose: Administer 20 mg (4 mL) over at least one minute.
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Subsequent Doses: If hypertension remains uncontrolled after 5 and 10 minutes, administer another 20 mg (4 mL). Additional doses of 40 mg (8 mL) and then 80 mg (16 mL) may be given at 10-minute intervals as needed.
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Maximum Dose: Do not exceed a total dose of 300 mg.
Precautions:
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Contraindications: Do not administer to patients with asthma, chronic obstructive pulmonary disease (COPD), heart failure, severe hypotension, bradycardia (<50/min), atrioventricular heart blocks, Raynaud’s syndrome, or hepatic impairment.
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Caution: Use with caution in patients with diabetes (risk of hypoglycemia), renal impairment, or peripheral vascular disease. Monitor maternal blood pressure, heart rate, and fetal heart rate during administration.
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Drug Interactions: Avoid or monitor combination with mefloquine, digoxin, amiodarone, diltiazem, verapamil (risk of bradycardia); tricyclic antidepressants, neuroleptics, other antihypertensive drugs (risk of hypotension).
Side Effects:
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Common: Bradycardia, orthostatic hypotension, heart failure, bronchospasm, hypoglycemia, gastrointestinal disturbances, dizziness, headache, weakness, urinary retention.
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Serious: Abrupt fall in maternal blood pressure with placental hypoperfusion and fetal death when administered too rapidly by IV injection or in case of overdose.
Storage:
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Store below 25°C (77°F). Protect from freezing and light. Retain in carton until time of use.
Note: This medication should only be used by well-trained personnel in well-equipped hospitals. Always follow the dosage and administration instructions provided by your healthcare provider.
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