ANTIDIARRHEAL LOPERAMIDE- loperamide hydrochloride solution

Antidiarrheal LOPERAMIDE by

Drug Labeling and Warnings

Antidiarrheal LOPERAMIDE by is a Animal medication manufactured, distributed, or labeled by Holliday-Scott S.A., Vasudha Pharma Chem Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ANTIDIARRHEAL LOPERAMIDE 
loperamide hydrochloride solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 58670-000
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58670-000-10	1 in 1 CARTON
1		10 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/31/2013

Labeler - Holliday-Scott S.A. (970253217)

Establishment
Name	Address	ID/FEI	Business Operations
Holliday-Scott S.A.		970253217	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Vasudha Pharma Chem Limited		725431626	api manufacture