ANTIDIARRHEAL LOPERAMIDE - loperamide hydrochloride solution 
Holliday-Scott S.A.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Antidiarrheal LOPERAMIDE Solution

Antidiarrheal LOPERAMIDE Solution

Oral Way For dogs and cats  Loperamide is meperidine derivative.  The antidiarrheic action is achieved by its modulating effect on intestinal motility, which, in turn is achieved through the stimulation of the rhythmic segmentation (acting on circular smooth muscle) and by decreasing the peristalsis (with either no effect on the longitudinal smooth muscle, or relaxing it), as well as due to the antisecretory effect, increasing the absorption of nutrients, water and electrolytes, achieved by blocking the channel of calcium or by inhibiting the calcium binding protein, calmodulin

Formula:

Each ml of oral solution contains:
Loperamide hydrochloride...........2 mg Vehicle q.s.

Indications:

Symptomatic treatment of acute and chronic diarrhea.

KEEP OUT OF REACH OF CHILDREN.

National poison centre: 1-800-222-1222 (Puerto Rico and USA)
National poison centre: 0-800-333-0160 / (54 11) 4654-6648 (Argentina)

Side effects:

Constipation, after prolonged treatment.

Contraindications:

Toxigenic Infections with e. Coli, Salmonella, Shigella and Pseudomembranous Colitis caused by antibiotics. In these cases, diarrhea plays a protective role, since it accelerates the elimination of micro-organisms, thus avoiding the proliferation of the same, the invasion of mucosa and the absorption of toxic products (enterotoxemia).

Dose:

Dogs and cats: 0.1 mg/2.204 Lb. equivalent to 1 drop per 2.204 Lb. every 8 hours.

During the administration of the product, you will observe:
(1) Lower frequency in bowel movements.
(2) Lower volume of stool.
(3) Changes in consistency: from fluid to solid.
(4) Control of diarrhea.

Presentation:

10 ml dropper

Keep between 40 degree and 95 degree F

Elaborado por: / Elaborated by:

HOLLIDAY-SCOTT S.A.
Int. Neyer 924 - (B1643GAT) Beccar
Buenos Aires - Argentina

Tel./Fax: (54-11) 4732-0222
E-mail: info@holliday.com.ar
Distributed in Puerto Rico by
International Med Distributors
PO BOX 627 Dorado PR 00646 - E-mail:
info@internationalmeddistributors.com

7 798042 365296

Antidiarrheal LOPERAMIDE Solution 10ml (58670-000-10)

Loperamide BottleLoperamide InsertLoperamide Outer

ANTIDIARRHEAL LOPERAMIDE 
loperamide hydrochloride solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58670-000
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58670-000-101 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/31/2013
Labeler - Holliday-Scott S.A. (970253217)
Establishment
NameAddressID/FEIBusiness Operations
Holliday-Scott S.A.970253217manufacture
Establishment
NameAddressID/FEIBusiness Operations
Vasudha Pharma Chem Limited725431626api manufacture

Revised: 7/2013
Document Id: 8b730cf1-a89e-49ee-b6e8-27762bed4bb3
Set id: 273e6635-c3e6-4739-9fd0-d227c789c367
Version: 1
Effective Time: 20130731
 
Holliday-Scott S.A.