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pms-DOCUSATE SODIUM. (Docusate Sodium Capsules USP). 100 mg & 200 mg. THERAPEUTIC CLASSIFICATION. Stool softener.
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(Docusate Sodium Capsules USP) 100 mg & 200 mg STOOL SOFTENER PHARMASCIENCE INC. DATE OF REVISION: 6111 Royalmount Avenue Suite #100 February 14, 2012 Montréal, Québec H4P 2T Control #: 153488
pms-DOCUSATE SODIUM (Docusate Sodium Capsules USP) 100 mg & 200 mg THERAPEUTIC CLASSIFICATION Stool softener ACTION AND CLINICAL PHARMACOLOGY Docusate sodium is a surface active agent that gently acts to maintain soft stools for easy natural passage. Docusate sodium reduces surface film tension of the interfacing liquid contents of the bowel promoting permeation of additional liquid into the stool to form a softer mass. INDICATIONS AND CLINICAL USE In the management and prophylaxis of constipation due to hard, dry stools, when peristaltic stimulants are contraindicated and maximum ease of passage is desirable to avoid difficult or painful defecation. In patients who should not strain during defecation such as those with an episiotomy wound, painful thrombosed hemorrhoids, fissures or perianal abscesses, body wall and diaphragmatic hernias, anorectal stenosis, or postmyocardial infarction. CONTRAINDICATIONS Do not use when abdominal pain, nausea or vomiting is present.
SODIUM may enhance the systematic absorption of these agents. Although such combinations are intentionally used in some Afixed-dose@ laxative preparations, the propensity for toxic effects is greatly increased. Liver injury has been reported with the Danthron combination following repeated dosage. ADVERSE REACTIONS Adverse reactions indicating need for medical attention: undetermined allergies (skin rash). Adverse reactions indication need for medical attention only if continuing or are bothersome: stomach and/or intestinal cramping; throat irritation with liquid forms. REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: Report online at www.healthcanada.gc.ca/medeffect Call toll-free at 1- 866 - 234 - 2345 Complete a Canada Vigilance Reporting Form and:
**- Fax toll-free to 1- 866 - 678 - 6789, or
There are no known cases of overdosage. Diarrhea and abdominal cramps may be controlled by a reduction of the dosage. For management of a suspected drug overdose, contact your regional Poison Control Center immediately. DOSAGE AND ADMINISTRATION NOTE: Intake of at least 6 to 8 full glasses (240 mL) of fluid per day is necessary to aid in producing a soft stool and protect the patient against dehydration when large volumes of water are lost with passage of the stool. The effect on the stools can be observed within the 1st^ to the 3rd^ day after the first oral dose. Usual Oral Dose Adult and children (12 years and over): 100 to 200 mg per day, with one full glass (240 mL) of water or other liquids, the dose being adjusted for patient size and need. Children (6 to 12 years): 100 mg per day, with one full glass (240 mL) of water or other liquids, the dose being adjusted for patient size and need.
Capsules: 100 mg: Each reddish orange, oblong, softgel capsule, printed in white ink “PMS” on one side and “ 100 ” on the other, contains: Docusate Sodium 100 mg and the following non-medicinal ingredients: FD&C Yellow No. 6, FD&C Red No. 40, gelatine, glycerine, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium methylparaben, sodium propylparaben, sorbitol, and titanium dioxide. Available in bottles of 100 and 1000. Blisters of 30. 200 mg: Each orange, oblong, softgel capsule, printed in white ink with “PMS” on one side and “200” on the other side contains: Docusate Sodium 2 00 mg, and the following non- medicinal ingredients: FD&C Yellow No. 6, FD&C Red No. 40, gelatine, glycerine, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium methylparaben, sodium propylparaben, sorbitol, and titanium dioxide. Available in bottles of 100 and 1000. Blisters of 30. Store between 15 and 30C in a tight, light resistant container in a dry area. Keep out of reach of children.
