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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:
Karbinalâ„¢ 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 1-866-764-7822 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
FSC Pediatrics
6100 Fairview Road, Suite 300
Charlotte, NC 28210
704-941-2500
www.fscpediatrics.com
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