PROMETHAZINE HYDROCHLORIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)

Available from:

Proficient Rx LP

INN (International Name):

PROMETHAZINE HYDROCHLORIDE

Composition:

PROMETHAZINE HYDROCHLORIDE 6.25 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Promethazine HCl Oral Solution is useful for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism. Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. Therapy adjunctive to meperidine or other analgesics for control of postoperative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness. Antiemetic therapy in postoperative patients. Promethazine HCl Oral Solution is contraindicated for use in pediatric pa

Product summary:

Promethazine Hydrochloride Oral Solution, USP, 6.25 mg/5 mL, is a clear, green oral solution supplied as follows: NDC 63187-858-04    Bottle of 4 fl. oz. (118 mL) Keep bottles tightly closed. Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Proficient Rx LP
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PATIENT INFORMATION LEAFLET
PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP 6.25 mg/5 mL
(Promethazine
Hydrochloride Syrup, 6.25 mg per 5 mL)
Rx Only
WHAT IS PROMETHAZINE HCL ORAL SOLUTION?
Promethazine is an antihistamine which can be taken by mouth as an
oral solution or tablet, rectally as a
suppository, or by injection. It can be used for:
•
“hay fever,” or, a stuffy runny nose from allergy
•
watery, itchy eyes due to inhaled allergies and foods
•
mild allergic skin reactions with itching and swelling
•
allergic reactions to blood or plasma
•
dermographism, a form of hives known as “skin writing”
•
serious allergic reactions along with epinephrine and other treatments
•
sedation before or after surgery, or during childbirth
•
prevention and control of nausea and vomiting after surgery
•
along with meperidine (demerol) or other pain medicines
•
sedation, relief of anxiety, and production of light sleep from which
the patient can be easily
aroused
•
treatment and prevention of motion sickness
WHO SHOULD NOT USE PROMETHAZINE HCL ORAL SOLUTION?
Promethazine should not be given to:
•
children under two years of age
•
patients who are unconscious
•
patients who are allergic to promethazine, any of the ingredients in
promethazine, or to other
phenothiazines
•
patients with lung symptoms including asthma
•
children who are vomiting unless the vomiting is prolonged and there
is a known cause
WHAT ARE THE RISKS?
The following are the major potential risks and side effects of
Promethazine HCl Oral Solution therapy.
However, this list is not complete.
•
Severe drowsiness and reduced mental alertness. Promethazine HCl Oral
Solution may cause
drowsiness which may impair your ability to ride a bike, drive a car,
or operate machinery. This
may be worsened if taken with alcohol or other drugs that also cause
central nervous system (CNS)
slowing such as sedatives, pain medicines, tranquilizers or certain
drugs for depression.
•
Serious breathing problems. Pr

Summary of Product characteristics

PROMETHAZINE HYDROCHLORIDE- PROMETHAZINE HYDROCHLORIDE SOLUTION
PROFICIENT RX LP
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PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION, USP
DESCRIPTION
Each teaspoonful (5 mL) of Promethazine HCl Oral Solution contains
6.25 mg promethazine HCl in a
flavored syrup base with a pH between 4.7 and 5.2. Alcohol 7%. The
inactive ingredients present are
ascorbic acid, citric acid, D&C Yellow No. 10, edetate disodium, ethyl
alcohol, FD&C Blue No. 1,
FD&C Red No. 40, glycerin, methylparaben, pineapple flavor, purified
water, sodium benzoate, sodium
citrate, sucralose, and sucrose.
Promethazine HCl is a racemic compound; the molecular formula is C
H N S•HCl and its molecular
weight is 320.89. Promethazine HCl, a phenothiazine derivative, is
chemically designated as 10-[2-
(Dimethylamino)propyl] phenothiazine monohydrochloride. Its structural
formula is:
Promethazine HCl occurs as a white to faint yellow, practically
odorless, crystalline powder which
slowly oxidizes and turns blue on prolonged exposure to air. It is
freely soluble in water and soluble in
alcohol.
CLINICAL PHARMACOLOGY
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 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-desmethylpromethazine are the predominant
metabolites appearing in the urine.
INDICATIONS AND USAGE
Promethazine HCl Oral Solution is useful for:
Perennial and sea