DICYCLOMINE HYDROCHLORIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

NuCare Pharmaceuticals, Inc.

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 C

Ringkasan produk:

Dicyclomine Hydrochloride Tablets USP, 20 mg 20 mg blue, round, flat-faced, beveled edge tablets, debossed LAN over 1282, supplied in bottles of 20, 30, 60 and 90 tablets. To prevent fading, avoid exposure to direct sunlight. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP. Bottles of 20 tablets: NDC 66267-074-20 Bottles of 30 tablets: NDC 66267-074-30 Bottles of 60 tablets: NDC 66267-074-60 Bottles of 90 tablets: NDC 66267-074-90

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICYCLOMINE HYDROCHLORIDE CAPSULES, USP
AND DICYCLOMINE HYDROCHLORIDE TABLETS, USP SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR
DICYCLOMINE HYDROCHLORIDE CAPSULES, USP AND DICYCLOMINE HYDROCHLORIDE
TABLETS, USP.
DICYCLOMINE HYDROCHLORIDE CAPSULES USP, FOR ORAL USE
DICYCLOMINE HYDROCHLORIDE TABLETS USP, 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); d