antihistamine for children

Karbinal ER (carbinoxamine maleate) is an H1 receptor antagonist indicated 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 angioedema.
Dermatographism.
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
Amelioration of the severity of allergic reactions to blood or plasma.

Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension provides symptomatic relief of seasonal and perennial allergic rhinitis in children as young as 2 years old.


antihistamine medicine
* Data on File, FSC Laboratories, Inc. Plasma concentrations tested under fasting conditions after 9 days of treatment. The efficacy and safety of Karbinal ER is based on demonstration of bioequivalence to the immediate-release reference product.

Convenient Dosage

Pleasant strawberry-banana flavor
Provides long-lasting symptom relief for up to 12 hours for children as young as 2 years1
Can be taken with or without food1

prescription antihistamines
1. Karbinal ER Prescribing Information, November 2013

Total daily dose for 2-11 yrs is 0.2-0.4 mg/kg/day administered in 2 divided doses given every 12 hours1

  • Start with lower doses and increase as needed and tolerated.
  • Measure Karbinal ER with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose.
  • Maximum recommended dosage per age group is as follows: 2 to 3 years -- 5 mL (4mg) Q 12 hours; 4 to 5 years -- 10 mL (8 mg) Q 12 hours; 6 to 11 years -- 15 mL (12 mg) Q 12 hours. Maximum total daily dose of Karbinal ER is 32mg given in 2 divided doses Q 12 hours regardless of body weight.

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CONTRAINDICATIONS:
Children younger than 2 years of age.
Nursing mothers.
Patients with known hypersensitivity to the drug or any of its inactive ingredients.
Patients taking monoamine oxidase inhibitors (MAOI).

WARNINGS AND PRECAUTIONS:
Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products. Do not give Karbinal ER to children younger than 2 years of age.
Caution patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination, such as driving or operating machinery.
Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction.
Karbinal ER contains sodium metabisulfite, a sulfite which may cause anaphylaxis and life-threatening or less severe asthmatic episodes in susceptible individuals.

ADVERSE REACTIONS:
The most common adverse reactions include sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions.

DRUG INTERACTIONS:
Avoid use of Karbinal ER with monoamine oxidase inhibitors (MAOIs) which prolong and intensify the anticholinergic (drying) effects of antihistamines.
Avoid use of Karbinal ER with alcohol and CNS depressants (hypnotics, sedatives, tranquilizers, etc.) due to additive adverse effects.

USE IN SPECIAL POPULATIONS:
Because of the higher risk of mortality in infants, Karbinal ER is contraindicated in children younger than 2 years of age, and in nursing mothers.
May cause sedation or excitation in young children.
May cause dizziness, sedation, and hypotension in elderly patients. Start elderly patients on lower doses and observe closely for confusion and over-sedation.

INDICATIONS FOR USE:
Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension is an H1 receptor antagonist indicated 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 angioedema Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Amelioration of the severity of allergic reactions to blood or plasma.

Before prescribing Karbinal ER, please read the Full Prescribing Information.

To report suspected adverse reactions, please contact FSC at 1-877-622-2320 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
IMPORTANT SAFETY INFORMATION:

CONTRAINDICATIONS:
Children younger than 2 years of age.
Nursing mothers.
Patients with known hypersensitivity to the drug or any of its inactive ingredients.
Patients taking monoamine oxidase inhibitors (MAOI).

WARNINGS AND PRECAUTIONS:
Deaths have been reported in children less than 2 years of age who were taking carbinoxamine-containing drug products. Do not give Karbinal ER to children younger than 2 years of age.
Caution patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination, such as driving or operating machinery.
Use with caution in patients with increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction.
Karbinal ER contains sodium metabisulfite, a sulfite which may cause anaphylaxis and life-threatening or less severe asthmatic episodes in susceptible individuals.

ADVERSE REACTIONS:
The most common adverse reactions include sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions.

DRUG INTERACTIONS:
Avoid use of Karbinal ER with monoamine oxidase inhibitors (MAOIs) which prolong and intensify the anticholinergic (drying) effects of antihistamines.
Avoid use of Karbinal ER with alcohol and CNS depressants (hypnotics, sedatives, tranquilizers, etc.) due to additive adverse effects.

USE IN SPECIAL POPULATIONS:
Because of the higher risk of mortality in infants, Karbinal ER is contraindicated in children younger than 2 years of age, and in nursing mothers.
May cause sedation or excitation in young children.
May cause dizziness, sedation, and hypotension in elderly patients. Start elderly patients on lower doses and observe closely for confusion and over-sedation.

INDICATIONS FOR USE:
Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension is an H1 receptor antagonist indicated 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 angioedema Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Amelioration of the severity of allergic reactions to blood or plasma.

Before prescribing Karbinal ER, please read the Full Prescribing Information.

To report suspected adverse reactions, please contact FSC at 1-877-622-2320 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch