DARTISLA ODT

DARTISLA ODT — glycopyrrolate tablet, orally disintegrating
Edenbridge Pharmaceuticals LLC.

1 INDICATIONS & USAGE

DARTISLA ODT is indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
Limitations of Use DARTISLA ODT is not indicated as monotherapy for treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

2 DOSAGE & ADMINISTRATION

2.1 Important Dosing Information

  • Patients receiving the 1 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 0.85 mg dosage strength of DARTISLA ODT [see Dosage Forms and Strengths (3) and Clinical Pharmacology (12.3)].
  • Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT [see Dosage Forms and Strengths (3) and Clinical Pharmacology (12.3)].

2.2 Recommended Dosage

Initial dosage:

• The recommended initial dosage is 0.85 mg orally three times daily (in the morning, early afternoon, and at bedtime).
• Some patients may require 1.7 mg at bedtime to assure overnight control of symptoms.
• For maintenance, a dosage of 0.85 mg orally twice is frequently adequate.

Dosage for patients switching from 2 mg glycopyrrolate products:

• The recommended dosage is 1.7 mg two or three times daily at equally spaced intervals.

• The maximum recommended daily dosage is 6.8 mg.
• Use the lowest effective dosage to control symptoms.

2.3 Administration Instructions

  • Administer DARTISLA ODT at least one hour before or two hours after food [see Clinical Pharmacology (12.3)].
  • Use dry hands when opening the blister card and do not open the blister until ready to administer.
  • Open the package and peel back the foil on the blister to expose the tablet and gently remove from the blister. Do not push the tablet through the foil.
  • Do not break or cut the tablet.
  • Immediately place the tablet on the tongue, allow it to disintegrate, and swallow without water.

3 DOSAGE FORMS & STRENGTHS

Dartisla ODT is available as:

· 0.85 mg of glycopyrrolate Orally Disintegrating Tablets (white to off-white, round, and debossed with the symbol 0.85-debossing)

· 1.7 mg of glycopyrrolate Orally Disintegrating Tablets (white to off-white, round, and debossed with the symbol 1.7-debossing)

4 CONTRAINDICATIONS

DARTISLA ODT is contraindicated in:

  • Patients at risk for anticholinergic toxicity due to an underlying medical condition, including:
    • Glaucoma [see Warnings and Precautions ( 5.1)]
    • Obstructive uropathies including prostatic hypertrophy
    • Mechanical obstructive diseases of gastrointestinal tract (e.g., pyloroduodenal stenosis, strictures) [see Warnings and Precautions ( 5.2)]
    • Gastrointestinal motility disorders (e.g., achalasia, paralytic ileus, intestinal atony) [see Warnings and Precautions ( 5.3)]
    • Bleeding gastrointestinal ulcer
    • Active inflammatory or infectious colitis which can lead to toxic megacolon
    • History of or current toxic megacolon
    • Myasthenia gravis
  • Patients with a hypersensitivity to glycopyrrolate or any of the inactive ingredients in DARTISLA ODT [see Adverse Reactions ( 6) and Description ( 11)].

5 WARNINGS AND PRECAUTIONS

5.1 Precipitation of Acute Glaucoma

Glycopyrrolate may cause increased intraocular pressure in patients with glaucoma and reduce the effects of antiglaucoma agents. Instruct patients to discontinue DARTISLA ODT and promptly seek medical care if they experience symptoms of acute angle closure glaucoma (pain and reddening of the eyes accompanied by dilated pupils) [see Contraindications ( 4)]

5.2 Partial or Complete Mechanical Intestinal Obstruction

DARTISLA ODT may worsen intestinal mechanical obstruction, and diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. If partial or complete intestinal obstruction is suspected, discontinue use of DARTISLA ODT and evaluate for potential intestinal obstruction [see Contraindications ( 4)].

5.3 Gastrointestinal Adverse Reactions Due to Decreased Gastrointestinal Motility

Glycopyrrolate reduces gastrointestinal motility and may result in delayed gastric emptying, constipation, and intestinal pseudo-obstruction and may precipitate or aggravate paralytic ileus and toxic megacolon [see Contraindications ( 4)]. The risk of gastrointestinal adverse reactions is further increased with use of other anticholinergics and other medications that decrease gastrointestinal peristalsis. Monitor patients for symptoms of decreased gastrointestinal motility. Concomitant use of DARTISLA ODT and other anticholinergics or other medications that decrease GI peristalsis is not recommended [see Drug Interactions ( 7.2)].

5.4 Cognitive and Visual Adverse Reactions

Glycopyrrolate may produce drowsiness and blurred vision and impair the mental and/or physical abilities required for the performance of hazardous tasks such as driving a motor vehicle, operating machinery or performing other hazardous work [see Adverse Reactions ( 6)]. Concomitant use of other drugs that have anticholinergic properties may increase these effects [see Drug Interactions ( 7.1)] . Inform patients not to operate motor vehicles or other dangerous machinery or perform other hazardous tasks until they are reasonably certain that DARTISLA ODT does not affect them adversely. Discontinue DARTISLA ODT if signs or symptoms of cognitive or visual impairment develop.

5.5 Heat Prostration at High Environmental Temperatures

In the presence of a high environmental temperature, heat prostration resulting in fever and heat stroke can occur with use of DARTISLA ODT due to decreased sweating, particularly in geriatric patients [see Adverse Reactions ( 6)]. Advise patients to avoid exposure to hot or very warm environmental temperatures when taking DARTISLA ODT. DARTISLA ODT is not recommended in geriatric patients [see Warnings and Precautions (5.7)].

5.6 Other Conditions Exacerbated by Anticholinergic Adverse Reactions

DARTISLA ODT is not recommended in patients with other conditions exacerbated by anticholinergic adverse reactions (e.g., autonomic neuropathy, hyperthyroidism, cardiac disease, and hiatal hernia associated with reflux esophagitis) and in patients taking other anticholinergic medications [see Drug Interactions ( 7.1)] .

5.7 Increased Risk of Anticholinergic Adverse Reactions in Geriatric Patients

Geriatric patients 65 years of age and older are at increased risk of anticholinergic adverse reactions that may lead to complications of urinary retention, bowel obstruction, heat prostration, arrhythmias, delirium, and falls or fractures. DARTISLA ODT is not recommended in geriatric patients and may be contraindicated in some geriatric patients with underlying medical conditions [see Contraindications ( 4), Warnings and Precautions ( 5.2, 5.5 ), Adverse Reactions ( 6) and Use in Specific Populations ( 8.5)].

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