Label: GLYCOPYRROLATE injection, solution

  • NDC Code(s): 70121-1698-1, 70121-1698-7, 70121-1699-1, 70121-1699-7
  • Packager: Amneal Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 30, 2025

If you are a consumer or patient please visit this version.

  • DESCRIPTION
    Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains glycopyrrolate, USP 0.2 mg, water for injection, USP q.s., pH adjusted, when necessary, with hydrochloric ...
  • CLINICAL PHARMACOLOGY
    Glycopyrrolate, like other anticholinergic (antimuscarinic) agents, inhibits the action of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that ...
  • INDICATIONS AND USAGE
    In Anesthesia - Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free ...
  • CONTRAINDICATIONS
    Known hypersensitivity to glycopyrrolate or any of its inactive ingredients. In addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate ...
  • WARNINGS
    This drug should be used with great caution, if at all, in patients with glaucoma. Glycopyrrolate injection may produce drowsiness or blurred vision. The patient should be cautioned regarding ...
  • PRECAUTIONS
    General - Investigate any tachycardia before giving glycopyrrolate injection since an increase in the heart rate may occur. Use with caution in patients with: coronary artery disease; congestive ...
  • ADVERSE REACTIONS
    Anticholinergics, including glycopyrrolate injection, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry ...
  • OVERDOSAGE
    To combat peripheral anticholinergic effects, a quaternary ammonium anticholinesterase such as neostigmine methylsulfate (which does not cross the blood-brain barrier) may be given intravenously ...
  • DOSAGE AND ADMINISTRATION
    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Glycopyrrolate injection may be ...
  • HOW SUPPLIED
    Glycopyrrolate Injection USP, 0.2 mg/mL is available as a preservative-free, sterile, clear, colorless solution supplied in prefilled single-dose glass syringes as ...
  • INSTRUCTIONS FOR USE
    Glycopyrrolate (glye” koe pir’ oh late) Injection, USP - Figure 1: Outer Packaging and Prefilled Syringe - NOTES: - Do not introduce any other fluid into the syringe at any time.  - Do not ...
  • PRINCIPAL DISPLAY PANEL
    NDC 70121-1698-1 - Glycopyrrolate Injection USP, 0.2 mg/mL - Rx only - 1 mL Prefilled Single-Dose Syringe Label - Amneal Pharmaceuticals LLC - NDC 70121-1698-7 - Glycopyrrolate Injection USP ...
  • INGREDIENTS AND APPEARANCE
    Product Information