DICYCLOMINE HYDROCHLORIDE capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DICYCLOMINE HYDROCHLORIDE (UNII: CQ903KQA31) (DICYCLOMINE - UNII:4KV4X8IF6V)

Tersedia dari:

Bryant Ranch Prepack

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride 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: - unstable cardiovascular status in acute hemorrhage - myasthenia gravis [see Warnings and Precautions (5.4)] - glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1)] - obstructive uropathy [see Warnings and Precautions (5.8)] - obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5)] - severe ulcerative colitis [see Warnings and Precautions (5.7)] - reflux esophagitis Pregnancy Category B Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to w

Ringkasan produk:

NDC: 63629-8049-1: 30 Capsules in a BOTTLE

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICYCLOMINE
HYDROCHLOLRIDE CAPSULES AND DICYCLOMINE HYDROCHLORIDE TABLETS SAFELY
AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DICYCLOMINE
HYDROCHLOLRIDE CAPSULES
AND DICYCLOMINE HYDROCHLORIDE TABLETS.
DICYCLOMINE HYDROCHLOLRIDE CAPSULES, FOR ORAL USE
DICYCLOMINE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1950
RECENT MAJOR CHANGES
Warnings and Precautions, Peripheral and Central Nervous System (5.3)
07/2012
INDICATIONS AND USAGE
Dicyclomine hydrochloride is an antispasmodic and anticholinergic
(antimuscarinic) agent indicated for the
treatment of functional bowel/irritable bowel syndrome (1)
DOSAGE AND ADMINISTRATION
Dosage for dicyclomine hydrochloride must be adjusted to individual
patient needs (2).
If a dose is missed, patients should continue the normal dosing
schedule (2).
ORAL IN ADULTS (2.1):
Starting dose: 20 mg four times a day. After a week treatment with the
starting dose, the dose may be
escalated to 40 mg four times a day, unless side effects limit dosage
escalation
Discontinue dicyclomine hydrochloride if efficacy not achieved or side
effects require doses less than 80
mg per day after two weeks of treatment
DOSAGE FORMS AND STRENGTHS
Dicyclomine Hydrochloride Capsules USP, 10 mg (3)
Dicyclomine Hydrochloride Tablets USP, 20 mg (3)
CONTRAINDICATIONS
Infants less than 6 months of age (4)
Nursing mothers (4)
Unstable cardiovascular status in acute hemorrhage (4)
Myasthenia gravis (4)
Glaucoma (4)
Obstructive uropathy (4)
Obstructive disease of the gastrointestinal tract (4)
Severe ulcerative colitis (4)
Reflux esophagitis (4)
WARNINGS AND PRECAUTIONS
Cardiovascular conditions: worsening of conditions (5.2)
Peripheral and central nervous system: heat prostration can occur with
drug use (fever and heat stroke
due to decreased sweating); drug should be discontinued and supportive
measur