DEXCHLORPHENIRAMINE MALEATE solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Dexchlorpheniramine Maleate (UNII: B10YD955QW) (Dexchlorpheniramine - UNII:3Q9Q0B929N)

可用日期:

Foxland Pharmaceuticals, Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. This drug should not be used in newborn or premature infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Antihistamines should NOT be used to treat lower respiratory tract symptoms including asthma. Antihistamines are also contraindicated in the following conditions:

產品總結:

Dexchlorpheniramine Maleate Oral Solution, USP is supplied as a red colored, cherry flavored liquid in the following sizes: 4 fl oz (118 mL), NDC 69067-102-04 16 fl oz (473 mL), NDC 69067-102-16 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.

授权状态:

Abbreviated New Drug Application

产品特点

DEXCHLORPHENIRAMINE MALEATE- DEXCHLORPHENIRAMINE MALEATE SOLUTION
FOXLAND PHARMACEUTICALS, INC.
----------
DEXCHLORPHENIRAMINE MALEATE ORAL SOLUTION, USP
RX ONLY
DESCRIPTION
EACH 5 ML (TEASPOONFUL) CONTAINS:
Dexchlorpheniramine Maleate, USP 2 mg
Dexchlorpheniramine Maleate, USP, an antihistamine agent, is a white,
odorless crystalline powder that
is freely soluble in water. The molecular formula is C
H ClN · C H O , designated chemically as
(+)-2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl] pyridine maleate
(1:1).
M.W. = 390.86
INACTIVE INGREDIENTS: Citric acid, cherry flavoring, FD&C Red No. 40,
glycerin, menthol,
methylparaben, propylene glycol, propylparaben, purified water, sodium
citrate dihydrate, and sugar.
CLINICAL PHARMACOLOGY
Dexchlorpheniramine maleate is an antihistamine with anticholinergic
(drying) and sedative side effects.
Antihistamines appear to compete with histamine for cell receptor
sites on effector cells.
INDICATIONS AND USAGE
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
As therapy for anaphylactic reactions adjunctive to epinephrine and
other standard measures after the
acute manifestations have been controlled.
CONTRAINDICATIONS
USE IN NEWBORN OR PREMATURE INFANTS
This drug should not be used in newborn or premature infants.
16
19
2
4
4
4
USE IN NURSING MOTHERS
Because of the higher risk of antihistamines for infants generally and
for newborns and prematures in
particular, antihistamine therapy is contraindicated in nursing
mothers.
USE IN LOWER RESPIRATORY DISEASE
Antihistamines SHOULD NOT be used to treat lower respiratory tract
symptoms including asthma.
Antihistamines are also contraindicated in the following conditions:
WARNINGS
Antihistamines should be used with considerable caution in patients
with:
USE IN CHILDREN
In infants and children, especially, antihistamine