BENTYL Solution for injection (2023)

Βιβλιογραφική αναφορά

Συγγραφείς

A-S Medication Solutions

Λέξεις κλειδιά

50090-4553

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1. Indications and Usage

BENTYL (dicyclomine hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

2. Dosage and Administration

Dosage must be adjusted to individual patient needs. 2. 1 Intramuscular Dosage and Administration in Adults BENTYL Intramuscular Injection must be administered via intramuscular route only. Do not administer ...

3. Dosage Forms and Strengths

BENTYL injection 20 mg/2 mL (10 mg/mL).

4. Contraindications

BENTYL is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4)], nursing mothers [see Use in Specific Populations (8.3)], and in patients with: ...

5. Warnings and Precautions

5.1 Inadvertent Intravenous Administration BENTYL solution is for intramuscular administration only. Do not administer by any other route. Inadvertent intravenous administration may result in thrombosis, ...

6. Adverse Reactions

The pattern of adverse effects seen with dicylomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12)]. They are a consequence of the inhibitory ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of BENTYL. Because these reactions are reported voluntarily from a ...

7. Drug Interactions

7.1 Antiglaucoma Agents Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently ...

8.1. Pregnancy

Adequate and well-controlled studies have not been conducted with BENTYL in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of ...

8.2. Lactation

BENTYL is contraindicated in women who are breastfeeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants from BENTYL, ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. BENTYL is contraindicated in infants less than 6 months of age [see Contraindications (4)]. There are published cases ...

8.5. Geriatric Use

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

8.6. Renal Impairment

Effects of renal impairment on PK, safety and efficacy of BENTYL have not been studied. BENTYL drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may ...

8.7. Hepatic Impairment

Effects of renal impairment on PK, safety and efficacy of BENTYL have not been studied. BENTYL should be administered with caution in patients with hepatic impairment.

10. Overdosage

In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room. The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred ...

11. Description

BENTYL is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form: BENTYL injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT ...

12.1. Mechanism of Action

Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: a specific anticholinergic effect (antimuscarinic) at ...

12.2. Pharmacodynamics

BENTYL can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.

12.3. Pharmacokinetics

Absorption and Distribution In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine produced no deleterious effects on ...

14. Clinical Studies

In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 ...

16.1. How Supplied

Product: 50090-4553 NDC: 50090-4553-0 2 mL in a AMPULE Distributed by: Allergan USA, Inc., Madison, NJ 07940

16.2. Storage and Handling

Store at room temperature, preferably below 86°F (30°C). Protect from freezing.

17. Patient Counseling Information

17.1 Inadvertent Intravenous Administration BENTYL Injection is for intramuscular administration only. Do not administer by any other route. Inadvertent administration may result in thrombosis or thrombophlebitis, ...