Vazculep

Name: Vazculep

Dosing & Uses

Dosage Forms & Strengths

injectable solution

  • 10mg/mL

Mild to Moderate Hypotension

Initial: 2-5 mg IM or SC; not to exceed 5 mg

Maintenance: 1-10 mg

Severe Hypotension/Shock

100-180 mcg increments IV bolus, THEN

40-60 mcg/min continuous IV infusion

Dosage Forms & Strengths

injectable solution

  • 10mg/mL

Hypotension

5-20 mcg/kg IV bolus q10-15min PRN, OR  

0.1-0.5 mcg/kg/min IV continuous infusion

Warnings

Black Box Warnings

Physicians should completely familiarize themselves with complete contents of package insert prior to prescribing phenylephrine hydrochloride injection

Contraindications

Hypersensitivity to phenylephrine or sulfites

Severe hypertension

Ventricular tachycardia

Closed-angle glaucoma

Cautions

Cerebrovascular insufficiency

Cardiovascular disease

Hypertension

Diabetes mellitus

Thyroid disease

Prostatic hypertrophy

Geriatric patients

Uses For Vazculep

Phenylephrine injection is used to treat hypotension (low blood pressure) that may occur during surgery.

This medicine is to be given only by or under the direct supervision of your doctor.

Proper Use of Vazculep

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Drug Interactions

Interactions that Augment Pressor Effect

The increasing blood pressure effect of Vazculep is increased in patients receiving:

  • Monoamine oxidase inhibitors (MAOI)
  • Oxytocin and oxytocic drugs
  • Tricyclic antidepressants
  • Angiotensin, aldosterone
  • Atropine
  • Steroids, such as hydrocortisone
  • Norepinephrine transporter inhibitors, such as atomoxetine
  • Ergot alkaloids, such as methylergonovine maleate

Interactions that Antagonize the Pressor Effect

The increasing blood pressure effect of Vazculep is decreased in patients receiving:

  • α-adrenergic antagonists
  • Phosphodiesterase Type 5 inhibitors
  • Mixed α- and β-receptor antagonists
  • Calcium channel blockers, such as nifedipine
  • Benzodiazepines
  • ACE inhibitors
  • Centrally acting sympatholytic agents, such as reserpine, guanfacine

How Supplied/Storage and Handling

Vazculep (phenylephrine hydrochloride) Injection, 10 mg/mL, is supplied as follows:

NDC No. Strength How Supplied
76014-004-25 10 mg/mL 1 mL vial; for single use (supplied in packages of 25)
76014-004-10 10 mg/mL 5 mL vial; Pharmacy Bulk Package (supplied in packages of 10)
76014-004-33 10 mg/mL 10 mL vial; Pharmacy Bulk Package (supplied as a single unit)

Vial stoppers are not manufactured with natural rubber latex. Store Vazculep (phenylephrine hydrochloride) Injection, 10 mg/mL at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in carton until time of use. The 1 mL vials are for single use only; the 5 and 10 mL vials are pharmacy bulk packages.

The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

Patient Counseling Information

If applicable, inform patient, family member, or caregiver that certain medical conditions and medications might influence how Vazculep (phenylephrine hydrochloride) Injection works.


Manufactured for:

Avadel Legacy Pharmaceuticals, LLC

Chesterfield, MO 63005


Rev. 02/17


Package Label - Principal Display Panel - 5 mL Vial - Extended Content Label

Package Label - Principal Display Panel - 10 mL Vial - Container Label

Package Label - Principal Display Panel - 5 mL Vial - Alternate Extended Content Label

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