PHENOBARBITAL WITH BELLADONNA ALKALOIDS elixir

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

PHENOBARBITAL (UNII: YQE403BP4D) (PHENOBARBITAL - UNII:YQE403BP4D), HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X), ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I), SCOPOLAMINE HYDROBROMIDE (UNII: 451IFR0GXB) (SCOPOLAMINE - UNII:DL48G20X8X)

Disponible des:

Lazarus Pharmaceuticals, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Possibly effective for use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS. Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis. Phenobarbital with Belladonna Alkaloids Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients.

Resumen del producto:

Phenobarbital with Belladonna Alkaloids Elixir is supplied as a purple colored, grape flavored liquid. NDC: 71914-162-01: 5 mL unit-dose cup NDC: 71914-162-10: Case contains 10 unit-dose cups of 5 mL (NDC: 71914-162-01), packed in 1 tray of 10 unit-dose cups 4 oz. bottles NDC: 71914-162-04 16 oz. (Pint) bottles NDC: 71914-162-16 AVOID FREEZING Store at 20° – 25° C (68°- 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, using a child-resistant closure. All prescriptions using this product shall be pursuant to State statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Manufactured for: Lazarus Pharmaceuticals, Inc.

Estat d'Autorització:

unapproved drug other

Fitxa tècnica

PHENOBARBITAL WITH BELLADONNA ALKALOIDS- PHENOBARBITAL WITH
BELLADONNA ALKALOIDS ELIXIR
LAZARUS PHARMACEUTICALS, INC.
_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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PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR
PHENOBARBITAL WITH BELLADONNA ALKALOIDS ELIXIR
​Rx Only
Rev. 1/18​
DESCRIPTION:
Each 5 mL (teaspoonful) of elixir contains:
Phenobarbital, USP ...................................................
16.2 mg
Hyoscyamine Sulfate, USP ................................... 0.1037 mg
Atropine Sulfate, USP ...........................................
0.0194 mg
Scopolamine Hydrobromide, USP ......................... 0.0065 mg
INACTIVE INGREDIENTS:
Ethyl Alcohol, Purified Water, Glycerin, Methylparaben Sodium,
Propylparaben Sodium,
Saccharin Sodium, Xylitol, Citric Acid, Stevia Reb-A, Natural and
Artificial Grape Flavor
CLINICAL PHARMACOLOGY:
This drug combination provides natural belladonna alkaloids in a
specific, fixed ratio
combined with phenobarbital to provide peripheral
anticholinergic/antispasmodic action
and mild sedation.
INDICATIONS AND USAGE:
Possibly effective for use as adjunctive therapy in the treatment of
irritable bowel
syndrome (irritable colon, spastic colon, mucous colitis) and acute
enterocolitis. May also
be useful as adjunctive therapy in the treatment of duodenal ulcer.
IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER
ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL
ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
CONTRAINDICATIONS:
Glaucoma, obstructive uropathy (for example, bladder neck obstruction
due to prostatic
hypertrophy); obstructive disease of the gastrointestinal tract (as in
achalasia,
pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of
the elderly or debilitated
patient; unstable cardiovascular status in acute hemorrhage; severe
ulcerative colitis
especially if complicated by toxic