- Approval Id
- d8b578db699e0987
- Drug Name
- LEVOPHED INJECTION 1 mg/ml
- Product Name
- LEVOPHED INJECTION 1 mg/ml
- Approval Number
- SIN05754P
- Approval Date
- 1991-04-08
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Important Dosage and Administration Instructions</strong></p>
<p><u>Correct Hypovolemia</u></p>
<p>Address hypovolemia before initiation of LEVOPHED therapy. If the patient does not respond to therapy, suspect occult hypovolemia <em>[see Warnings and Precautions (5.1) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</em></p>
<p><u>Administration</u></p>
<p>Dilute LEVOPHED prior to use <em>[see Dosage and Administration (2.3)]</em>.</p>
<p>Infuse LEVOPHED into a large vein. Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs <em>[see Warnings and Precautions (5.1) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]</em>. Avoid using a catheter-tie-in technique.</p>
<p><u>Discontinuation</u></p>
<p>When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal.</p>
<p><strong>2.2 Dosage</strong></p>
<p>After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion.</p>
<p>Typical maintenance intravenous dosage is 2 to 4 mcg per minute.</p>
<p><strong>2.3 Preparation of Diluted Solution</strong></p>
<p>Visually inspect LEVOPHED for particulate matter and discoloration prior to administration (the solution is colorless). Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.</p>
<p>Add the content of one LEVOPHED vial or ampule (4 mg in 4 mL) to 1,000 mL of 5% Dextrose Injection, USP or Sodium Chloride Injection solutions that contain 5% dextrose to produce a 4 mcg per mL dilution. Dextrose reduces loss of potency due to oxidation. Administration in saline solution alone is not recommended.</p>
<p>Use higher concentration solutions in patients requiring fluid restriction.</p>
<p><strong>2.4 Drug Incompatibilities</strong></p>
<p>Avoid contact with iron salts, alkalis, or oxidizing agents.</p>
<p>Whole blood or plasma, if indicated to increase blood volume, should be administered separately.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>LEVOPHED is indicated to raise blood pressure in adult patients with severe, acute hypotension.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>None.</p>
- Atc Code
- C01CA03
- Atc Item Name
- norepinephrine
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
