Document
DailyMed Label: PROMETHAZINE DM
Title
DailyMed Label: Promethazine DM
Date
2009
Document type
DailyMed Prescription
Name
Promethazine DM
Generic name
Promethazine DM
Manufacturer
Stat Rx USA
Product information
NDC: 16590-292
Product information
NDC: 16590-292
Description
DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains:
Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol
7%.
Inactive Ingredients: Ascorbic acid, citric acid, D and C yellow #10,
FD and C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene
glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium
citrate and sucrose.
Dextromethorphan hydrobromide is a salt of the methyl ether of the
dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically
designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide
monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly
soluble in water and freely soluble in alcohol. It has a molecular weight of
370.32, a molecular formula of C 18 H 25 NO•HBr•H 2 O, and the following
structural formula:
Promethazine is a racemic compound. Promethazine hydrochloride, a
phenothiazine derivative, is chemically designated as 10 H -Phenothiazine-10-ethanamine, N , N ,
α-trimethyl-monohydrochloride.
Promethazine hydrochloride occurs as a white to faint yellow, practically
odorless, crystalline powder which slowly oxidizes and turns blue on prolonged
exposure to air. It is soluble in water and freely soluble in alcohol. It has a
molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and
the following structural formula:
Structure Image 1
Structure Image 2
Indications
INDICATIONS AND USAGE Promethazine hydrochloride and dextromethorphan hydrobromide
syrup is indicated for the temporary relief of coughs and upper respiratory
symptoms associated with allergy or the common cold.
Dosage
DOSAGE AND ADMINISTRATION
Promethazine hydrochloride
and dextromethorphan hydrobromide syrup is contraindicated for children under 2
years of age
(see
WARNINGS –
Black Box Warning
and
Use In Pediatric
Patients
).
The average effective dose is given in the following table:
Adults
1 teaspoonful (5 mL) every 4 to 6 hours, not to
exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years
½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years
¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.
Contraindications
CONTRAINDICATIONS Dextromethorphan should not be used in patients receiving a
monoamine oxidase inhibitor (MAOI) (see
PRECAUTIONS,
Drug
Interactions
).
Promethazine is contraindicated in comatose states, and in individuals known
to be hypersensitive or to have had an idiosyncratic reaction to promethazine or
to other phenothiazines.
Antihistamines are contraindicated for use in the treatment of lower
respiratory tract symptoms, including asthma.
Precautions
PRECAUTIONS Animal reproduction studies have not been conducted with the drug
combination–promethazine and dextromethorphan. It is not known whether this drug
combination can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. Promethazine and dextromethorphan should be given
to a pregnant woman only if clearly needed.
General: Dextromethorphan should be used with caution in sedated patients,
in the debilitated, and in patients confined to the supine position.
Drugs having anticholinergic properties should be used with caution in
patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic
ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.
Promethazine should be used cautiously in persons with cardiovascular disease
or with impairment of liver function.
Adverse reactions
How supplied
HOW SUPPLIED This preparation is a clear syrup with yellow color and pineapple
menthol odor, containing promethazine hydrochloride 6.25 mg/5 mL,
dextromethorphan hydrobromide 15 mg/5 mL and alcohol 7 percent, and is available
in 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).
Keep tightly closed. Protect from light.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container with a child-resistant closure
as defined in the USP.
Manufactured for:
QUALITEST
PHARMACEUTICALS
Huntsville, AL 35811
8181650 R12/07-R1
Clinical pharmacology
CLINICAL PHARMACOLOGY
Dextromethorphan: Dextromethorphan is an antitussive agent and, unlike the isomeric
levorphanol, it has no analgesic or addictive properties.
The drug acts centrally and elevates the threshold for coughing. It is about
equal to codeine in depressing the cough reflex. In therapeutic dosage
dextromethorphan does not inhibit ciliary activity.
Dextromethorphan is rapidly absorbed from the gastrointestinal tract and
exerts its effect in 15 to 30 minutes. The duration of action after oral
administration is approximately three to six hours. Dextromethorphan is
metabolized primarily by liver enzymes undergoing O-demethylation,
N-demethylation, and partial conjugation with glucuronic acid and sulfate. In
humans, (+)-3-hydroxy-N-methyl-morphinan, (+)-3-hydroxymorphinan, and traces of
unmetabolized drug were found in urine after oral administration.
Promethazine: Promethazine is a phenothiazine derivative which differs
structurally from the antipsychotic phenothiazines by the presence of a branched
side chain and no ring substitution. It is thought that this configuration is
responsible for its relative lack (1/10 that of chlorpromazine) of dopamine
antagonist properties.
Promethazine is an H 1 receptor blocking agent. In
addition to its antihistaminic action, it provides clinically useful sedative
and antiemetic effects.
Promethazine is well absorbed from the gastrointestinal tract. Clinical
effects are apparent within 20 minutes after oral administration and generally
last four to six hours, although they may persist as long as 12 hours.
Promethazine is metabolized by the liver to a variety of compounds; the
sulfoxides of promethazine and N-demethylpromethazine are the predominant
metabolites appearing in the urine.
Package label
Promethazine DM Label
Label Image
3 organizations
1 product
Product
PROMETHAZINE DMOrganization
Physicians Total Care, Inc.Organization
NuCare Pharmaceuticals,Inc.Organization
STAT RX USA LLC