NDC 44523-825 Carbinoxamine Maleate

NDC Product Code 44523-825

NDC 44523-825-01

Package Description: 1 BOTTLE in 1 CARTON > 100 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Carbinoxamine Maleate with NDC 44523-825 is a product labeled by Biocomp Pharma, Inc.. The generic name of Carbinoxamine Maleate is . The product's dosage form is and is administered via form.

Labeler Name: Biocomp Pharma, Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Biocomp Pharma, Inc.
Labeler Code: 44523
Start Marketing Date: 05-27-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Carbinoxamine Maleate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Carbinoxamine maleate is a histamine-H1 receptor blocking
agent.Each tablet contains 4 mg carbinoxamine
maleate and the following inactive ingredients: anhydrous lactose,
magnesium stearate, microcrystalline cellulose, and sodium starch
glycolate.Carbinoxamine maleate is freely soluble
in water. Its structure is:2-[(4-chlorophenyl)-2-pyridinylmethoxy]- N, N-dimethylethanamine (Z)-2-butenedioate
(1:1)C16H19CIN2O•C4H4O4MW=406.86

Mechanism Of Actions

Carbinoxamine maleate,
an ethanolamine derivative, is an antihistamine with anticholinergic
(drying) and sedative properties. Carbinoxamine appears to compete
with histamine (type H1) for receptor sites
on effector cells in the gastrointestinal tract, blood vessels and
respiratory tract.

Pharmacokinetics And Metabolism

Carbinoxamine
is well absorbed from the GI tract and appears to be extensively metabolized
by the liver, and excreted in the urine as inactive metabolites within
24 hours. Virtually no intact drug is extended in the urine.In a study comparing a controlled-release suspension and
a solution of carbinoxamine, healthy volunteers were administered
a single dose of 8 mg carbinoxamine. A time to maximum concentration
(Tmax) was between 1.5 hours to 5 hours, a peak plasma concentration
(Cmax) of about 24 ng/mL was observed, and extent of exposure (AUC)
was about 286 ng hr/mL. The serum half-life is reported to be 10 to
20 hours.

Drug/Food Interactions

Carbinoxamine
should not be used in patients with hypersensitivity to carbinoxamine.Carbinoxamine
may increase the effects of other drugs such as barbiturates, TCAs,
MAO inhibitors such as Phenelzine (Nardil), Tranylcypromine (Parnate),
or Selegiline (Eldepryl), alcohol, other antihistamines, and CNS depressants.
Carbinoxamine can be taken with or without food.

Cardiovascular Effects

Cardiac effects, including
prolongation of QT interval have not been adequately studied. Unlike
other newer antihistamines, severe adverse cardiovascular effects
are uncommon, and usually limited to over dosage situations.

Special Populations

Pediatric PatientsCarbinoxamine
should not be used in newborn or premature infants. Neonates have
an increased susceptibility to anticholinergic side effects, such
as CNS excitation, which may lead to convulsions.Pregnancy and LactationSafe use of carbinoxamine during pregnancy has not been
established. Therefore, carbinoxamine should not be used in women
who are, or may become pregnant. Carbinoxamine is in the FDA pregnancy
Category C.Women who are breastfeeding should
avoid use of carbinoxamine, since small amounts appear to be distributed
into breast milk.Geriatric PatientsCarbinoxamine is more likely to cause
dizziness, sedation, and hypotension in elderly patients. The incidence
of adverse reactions is higher in the elderly; therefore, a dosing
adjustment may be necessary in this sub-population.

Indications And Usage

Carbinoxamine maleate
is effective for the symptomatic treatment of:Seasonal and perennial allergic rhinitis.Vasomotor
rhinitis.Allergic conjunctivitis due to inhalant
allergens and foods.Mild, uncomplicated allergic
skin manifestations of urticaria and angio-edema.Dermatographism.As therapy for anaphylactic
reactions adjunctiveto epinephrine and other standard
measures after the acute manifestations have been controlled.Amelioration of the severity of allergic reactions to
blood or plasma.

Contraindications

Carbinoxamine maleate is contraindicated in children
younger than 2 years of age.Carbinoxamine maleate
is contraindicated in nursing mothers.Carbinoxamine
maleate is contraindicated in patients who are hypersensitive to the
drug or on monoamine oxidase inhibitor therapy. (See Drug Interactions
section).

Warnings

Deaths have been reported in children less than
2 years of age who were taking antihistamines, including carbinoxamine-containing
drug products, therefore, carbinoxamine maleate is contraindicated
in children younger than 2 years of age (see CONTRAINDICATIONS).Antihistamines should be used with considerable caution
in patients with: narrow angle glaucoma, stenosing peptic ulcer, symptomatic
prostatic hypertrophy, bladder neck obstruction, pyloroduodenald obstruction.

General

As many other antihistamines, carbinoxamine maleate
has an atropine-like action and, therefore, should be used with caution
in patients with: increased intraocular pressure, hyperthyroidism,
cardiovascular disease, hypertension.Antihistamines
such as carbinoxamine maleate should not be used to treat lower respiratory
tract symptoms, including asthma.

Information For Patients

Carbinoxamine
maleate may cause drowsiness; alcohol, sedatives, and tranquilizers
may increase the drowsiness effect. Avoid alcoholic beverages while
taking this product. Do not take this product if you are taking sedatives
or tranquilizers, without first consulting your doctor. Use caution
when driving a motor vehicle or operating machinery.

Drug Interactions

Monoamine oxidase inhibitors prolong and intensify
the anticholinergic (drying) effects of antihistamines.Carbinoxamine maleate has additive effects with alcohol
and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No long-term studies in animals have been performed to determine
the possible effects of carbinoxamine maleate on carcinogenesis, mutagenesis,
and fertility.

Pregnancy

Pregnancy Category C:Animal
reproductive studies have not been conducted with carbinoxamine maleate.
It is also not known whether carbinoxamine maleate can cause fetal
harm when administered to a pregnant woman or can affect reproductive
capacity. Carbinoxamine maleate should be given to a pregnant woman
only if clearly needed.

Nursing Mothers

Because of the higher
risk of antihistamines for infants generally and for newborns and
prematures in particular, use of carbinoxamine maleate is contraindicated
in nursing mothers. (see CONTRAINDICATIONS section).

Pediatric Use

Carbinoxamine maleate
is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).Neonates have an increased susceptibility to anticholinergic
side effects, such as CNS excitation, which may lead to convulsions.Carbinoxamine maleate may diminish mental alertness in
children. In the young child, particularly, they may produce excitation.

Geriatric Use

Carbinoxamine maleate
is more likely to cause dizziness, sedation, and hypotension in elderly
patients (approximately 60 years or older). Sedating drugs may also
cause confusion and over sedation in the elderly. Therefore, dose
selection for an elderly patient should be cautious, usually starting
at the low end of the dosing range, reflecting the greater frequency
of decreased hepatic renal, or cardiac function, and of concomitant
disease or other drug therapy.

Adverse Reactions

The most frequent
adverse reactions are underlined:Body
as a Whole: Urticaria, drug rash, anaphylactic shock, photosensitivity,
excessive perspiration, chills, dryness of mouth, nose and throat.Cardiovascular: Hypotension, headache,
palpitations, tachycardia, extrasystoles.Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis.Central Nervous System: Sedation,
sleepiness, dizziness, disturbed coordination, fatigue,
confusion, restlessness, excitation, nervousness, tremor, irritability,
insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo,
tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.Gastrointestinal: Epigastric
distress, anorexia, nausea, vomiting, diarrhea, constipation.Urogenital: Urinary frequency, difficult
urination, urinary retention, early menses.Respiratory: Thickening of bronchial
secretions, tightness of chest and wheezing, nasal stuffiness.To report SUSPECTED ADVERSE
REACTIONS, contact BioComp Pharma, Inc. at 1-866-762-2365 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch

Overdosage

Manifestations: Antihistamine overdosage
reactions may vary from central nervous system depression to stimulation.
Stimulation is particularly likely in children. Atropine-like signs
and symptoms - dry mouth; fixed, dilated pupils; flushing; and gastrointestinal
symptoms may also occur.Especially in infants
and children, antihistamine overdosage may cause hallucinations, convulsions,
or death.The oral LD50 of carbinoxamine maleate in guinea pigs is 411 mg/kg.Treatment: The treatment
of overdosage with carbinoxamine maleate is essentially symptomatic
and supportive. Vital signs (including respiration, pulse, blood pressure,
and temperature) and EKG should be monitored. Induction of vomiting
is not recommended. Activated charcoal should be given and gastric
lavage should be considered after ingestion of a potentially life-threatening
amount of drug. In the presence of severe anticholinergic effects,
physostigmine may be useful. Vasopressors may be used to treat hypotension.

Dosage And Administration

Carbinoxamine
maleate is contraindicated in children younger than 2 years of age
(see CONTRAINDICATIONS).Carbinoxamine maleate
should be taken on an empty stomach with water.DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE
OF THE PATIENT.Carbinoxamine maleate dosage
should bebased on the severity of the condition and the response of
the patient. The drug is well tolerated in adults in doses as high
as 24 mg daily, in divided doses, over prolonged periods. On the other
hand, some patients respond to as little as 4 mg daily.Clinical experience suggests the followingdosage schedules:TabletsUsual Adult Dosage: 1 or 2 tablets (4 to 8 mg) 3 to 4 times daily.Usual Child’s Dosage: Six to eleven years – ½ to 1 tablet (2 to 4 mg) 3 to 4 times daily.

How Supplied

Carbinoxamine Maleate Tablets, USP 4 mg are supplied
as white, round, scored tablets, debossed "CM" on one side and scored
on the other, and supplied in bottles of 100 tablets, NDC 44523-825-01.Store at 20°C to 25°C (68°F to
77°F) [See USP controlled room temperature.]Dispense in a tight, light-resistant container with a child-resistant
closure as defined in the official compendium.Manufactured for:BioComp Pharma®, Inc.San
Antonio, TX 78230 1355I8250 C01 Rev 004140

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