ROBINUL Solution for injection (2017)

Βιβλιογραφική αναφορά

Συγγραφείς

West-Ward Pharmaceuticals Corp.

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1. Description

ROBINUL (glycopyrrolate) Injection is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, USP 0.2 mg Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative) pH adjusted, ...

2. 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 respond ...

3. Indications and Usage

In Anesthesia ROBINUL Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; ...

4. 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, ROBINUL Injection may be ...

5. Warnings

This drug should be used with great caution, if at all, in patients with glaucoma. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly ...

6.1. General

Investigate any tachycardia before giving ROBINUL Injection since an increase in the heart rate may occur. Use with caution in patients with: coronary artery disease; congestive heart failure; cardiac ...

6.2. Information for Patients

Because ROBINUL Injection may produce drowsiness or blurred vision, the patient should be cautioned not to engage in activities requiring mental alertness and/or visual acuity such as operating a motor ...

6.4. Drug Interactions

The concurrent use of ROBINUL Injection with other anticholinergics or medications with anticholinergic activity, such as phenothiazines, antiparkinson drugs, or tricyclic antidepressants, may intensify ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted. In reproduction studies in ...

6.7. Pregnancy

Teratogenic effects Pregnancy category B Reproduction studies with glycopyrrolate were performed in rats at a dietary dose of approximately 65 mg/kg/day (exposure was approximately 320 times the maximum ...

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ROBINUL Injection is administered to a nursing woman. As with ...

6.10. Pediatric Use

Due to its benzyl alcohol content, ROBINUL Injection should not be used in neonates, i.e., patients less than 1 month of age. Safety and effectiveness in pediatric patients have not been established for ...

6.11. Geriatric Use

Clinical Studies of ROBINUL Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience ...

7. Adverse Reactions

Anticholinergics, including ROBINUL Injection, can produce certain effects, most of which are extensions of their pharmacologic actions. Adverse reactions may include xerostomia (dry mouth); urinary hesitancy ...

9. 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 in increments ...

10. Dosage and Administration

<b>NOTE: CONTAINS BENZYL ALCOHOL</b> (see <em>PRECAUTIONS</em>) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution ...

11. How Supplied

ROBINUL (glycopyrrolate) Injection, 0.2 mg/mL, is available in: 1 mL single dose vials packaged in 25s (NDC 0641-6104-25) 2 mL single dose vials packaged in 25s (NDC 0641-6105-25) 5 mL multiple dose vials ...

12. Storage and Handling

Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).