DICYCLOMINE HYDROCHLORIDE capsule DICYCLOMINE HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Mylan Institutional Inc.

INN (Internationale Bezeichnung):

DICYCLOMINE HYDROCHLORIDE

Zusammensetzung:

DICYCLOMINE HYDROCHLORIDE 10 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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)]

Produktbesonderheiten:

Dicyclomine Hydrochloride Capsules, USP are available containing 10 mg of dicyclomine hydrochloride, USP. The 10 mg capsules are a hard-shell gelatin capsule with a light turquoise blue opaque cap and light turquoise blue opaque body filled with a white to off-white powder. The capsule is axially printed with MYLAN over 1610 in black ink on both the cap and the body. They are available as follows: NDC 51079-118-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dicyclomine Hydrochloride Tablets, USP are available containing 20 mg of dicyclomine hydrochloride, USP. The 20 mg tablets are blue, round, unscored tablets debossed with M over D6 on one side of the tablet and blank on the other side. They are available as follows. NDC 51079-119-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] To prevent fading, avoid exposure to direct sunlight. .

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE CAPSULE
DICYCLOMINE HYDROCHLORIDE- DICYCLOMINE HYDROCHLORIDE TABLET
MYLAN INSTITUTIONAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICYCLOMINE HYDROCHLORIDE
CAPSULES AND DICYCLOMINE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR DICYCLOMINE HYDROCHLORIDE CAPSULES AND DICYCLOMINE
HYDROCHLORIDE
TABLETS.
DICYCLOMINE HYDROCHLORIDE 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 is an antispasmodic and anticholinergic (antimuscarinic)
agent indicated for the treatment of functional
bowel/irritable bowel syndrome ( 1)
DOSAGE AND ADMINISTRATION
Dosage for dicyclomine 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 4 times a day. After a week treatment with the
starting dose, the dose may be escalated to 40 mg
4 times a day, unless side effects limit dosage escalation
Discontinue dicyclomine if efficacy not achieved or side effects
require doses less than 80 mg per day after 2 weeks of
tre atme nt
DOSAGE FORMS AND STRENGTHS
Dicyclomine hydrochloride capsules 10 mg ( 3)
Dicyclomine hydrochloride tablets 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 a