PAREGORIC liquid

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

MORPHINE (UNII: 76I7G6D29C) (MORPHINE - UNII:76I7G6D29C)

Beschikbaar vanaf:

Hi-Tech Pharmacal Co., Inc.

INN (Algemene Internationale Benaming):

MORPHINE

Samenstelling:

MORPHINE 2 mg in 5 mL

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Paregoric is useful for the treatment of diarrhea. Hypersensitivity to morphine. Because of its stimulating effect on the spinal cord, morphine should not be used in convulsive states, such as those occurring in status epilepticus, tetanus, and strychnine poisoning. This preparation should not be used in diarrhea caused by poisoning until the toxic material is eliminated from the gastrointestinal tract. Paregoric is a Schedule lll narcotic. Morphine can produce drug dependence and, therefore, has the potential for being abused. Patients receiving therapeutic dosage regimens of 10 mg every 4 hours for 1 to 2 weeks have exhibited mild withdrawal symptoms. Development of the dependent state is recognizable by an increased tolerance to the analgesic effect and the appearance of purposive phenomena (complaints, pleas, demands, or manipulative actions) shortly before the time of the next scheduled dose. A patient in withdrawal should be treated in a hospital environment. Usually, it is necessary only to provide sup

Product samenvatting:

Paregoric, USP 2 mg*/5 mL, *each 5 mL contains 2 mg of anhydrous morphine (from opium tincture); alcohol 45% and is available in 16 fl. oz (473 mL) bottles. Store at controlled room temperature, 15°-30°C (59°-86°F) [see USP]. PROTECT FROM LIGHT AVOID EXCESSIVE HEAT SHAKE WELL BEFORE USING NOTE: This product may deposit a sediment if exposed to low temperatures. Filter if necessary. Dispense in a tight, light-resistant container as defined in the USP. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by the purchaser. Rx Only Manufactured By: HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev. 855:05 03/16

Autorisatie-status:

unapproved drug other

Productkenmerken

PAREGORIC- PAREGORIC LIQUID
HI-TECH PHARMACAL CO., 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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PAREGORIC, USP
*EACH 5 ML CONTAINS 2 MG OF ANHYDROUS MORPHINE
RX ONLY
DESCRIPTION
EACH 5 ML CONTAINS:
Anhydrous Morphine
..........................................................................................................
2 mg
(from opium tincture)
Alcohol
................................................................................................................................
45%
INACTIVE INGREDIENTS: anise oil, benzoic acid, camphor, alcohol,
glycerin, and purified water.
CLINICAL PHARMACOLOGY
Morphine produces its major effects on the central nervous system
(CNS) and on the bowel.
INDICATIONS AND USAGE
Paregoric is useful for the treatment of diarrhea.
CONTRAINDICATIONS
Hypersensitivity to morphine. Because of its stimulating effect on the
spinal cord, morphine should not
be used in convulsive states, such as those occurring in status
epilepticus, tetanus, and strychnine
poisoning.
This preparation should not be used in diarrhea caused by poisoning
until the toxic material is
eliminated from the gastrointestinal tract.
PRECAUTIONS
GENERAL
_Head Injury and Increased Intracranial Pressure_ - The respiratory
depressant effects of narcotics and
their capacity to elevate cerebrospinal-fluid pressure may be markedly
exaggerated in the presence of
head injury, other intracranial lesions, or a preexisting increase in
intracranial pressure. Furthermore,
narcotics produce additional effects that may obscure the clinical
course in patients with head injuries.
_Acute Abdominal Conditions_ - The administration of morphine or other
narcotics may obscure the
diagnosis or clinical course in patients with acute abdominal
conditions.
_Special-Risk Patients_ - Morphine should be given with caution to
certain patients, such as the elderly or
debilitated and those with s