ROBINUL Tablet (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Casper Pharma LLC

Λέξεις κλειδιά

70199-007 70199-008

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

ROBINUL and ROBINUL FORTE are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use: ROBINUL and ROBINUL FORTE are not indicated ...

2. Dosage and Administration

2.1 Important Dosing Information ROBINUL FORTE is not recommended for patients in whom a lower dosage strength of oral glycopyrrolate (e.g., ROBINUL or another 1 mg tablet strength) is appropriate for ...

3. Dosage Forms and Strengths

Tablets: 1 mg, white, round, flat-faced, beveled-edge tablet, debossed CS and 007 on one side and functionally scored on the other side. 2 mg, white, round, flat-faced, beveled-edge tablet, debossed ...

4. Contraindications

ROBINUL and ROBINUL FORTE are contraindicated in: Patients at risk for anticholinergic toxicity due to an underlying medical condition, including:Glaucoma [see Warnings and Precautions (5.1)] ...

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 ROBINUL ...

6. Adverse Reactions

The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: Precipitation of Acute Glaucoma [see Warnings and Precautions (5.1)] Partial or Complete ...

7. Drug Interactions

7.1 Other Anticholinergic Drugs There is potential for an additive interaction between glycopyrrolate and concomitantly used anticholinergic drugs (e.g., tricyclic antidepressants, anti-epileptics, class ...

8.1. Pregnancy

Risk Summary Over decades of use, there is an absence of published data on orally administered glycopyrrolate in pregnant women, including an absence of any reports of a drug-associated risk of major birth ...

8.2. Lactation

Risk Summary There are no data on the presence of glycopyrrolate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. As with other anticholinergic drugs, ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Geriatric patients 65 years of age and older may be more sensitive to the anticholinergic adverse reactions of glycopyrrolate leading to complications of urinary retention, bowel obstruction, heat prostration, ...

8.6. Renal Impairment

Glycopyrrolate is substantially excreted by the kidney [see Clinical Pharmacology (12.3)]. Monitor patients with renal impairment for anticholinergic adverse reactions [see Adverse Reactions ...

10. Overdosage

Signs and symptoms of glycopyrrolate overdosage are related to excessive anti-muscarinic anticholinergic activity and are generally peripheral (e.g., flushing, hyperthermia, tachycardia, ileus, urinary ...

11. Description

ROBINUL and ROBINUL FORTE tablets contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium ...

12.1. Mechanism of Action

Glycopyrrolate, an anticholinergic (antimuscarinic) agent, inhibits the action of acetylcholine on parietal cells in the stomach and decreases the volume and acidity of gastric secretions.

12.2. Pharmacodynamics

No formal pharmacodynamic studies have been conducted with ROBINUL and ROBINUL FORTE.

12.3. Pharmacokinetics

Patients with Renal Impairment In the published literature, glycopyrrolate 4 mcg/kg was administered intravenously (ROBINUL and ROBINUL FORTE are not recommended for intravenous use) in uremic patients ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Reproduction studies in rats resulted in diminished rates of conception in a dose-related manner. Studies in dogs suggest that diminished rates of conception may be due to diminished seminal secretion, ...

16.1. How Supplied

ROBINUL (glycopyrrolate) tablets, 1 mg are white, round, flat-faced, beveled-edge tablet, debossed CS and 007 on one side and functionally scored on the other side. Available as Bottles of 30 NDC 70199-007-30 ...

16.2. Storage and Handling

Store at controlled room temperature, 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]. Keep out of reach of children. Dispense in ...

17. Patient Counseling Information

Precipitation of Acute Glaucoma Advise patients to discontinue ROBINUL and ROBINUL FORTE and promptly seek medical care if they experience symptoms of acute angle-closure glaucoma (pain and reddening of ...