KARBINAL ER

Karbinal ER after single-dose administration of 16 mg was bioequivalent to the reference carbinoxamine immediate-release oral solution after the administration of two doses of 8 mg six hours apart under fasting conditions. The carbinoxamine mean (SD) peak plasma concentration (C max ) was 28.7 (5.3) ng/mL at 6.7 hours after Karbinal ER administration. The plasma half-life of carbinoxamine was 17.0 hours. There was no effect of food on the pharmacokinetic parameters. Karbinal ER after multiple-do...

The effectiveness and safety of Karbinal ER is based on demonstration of bioequivalence to the immediate-release reference product [see Pharmacokinetics (12.3) ].

The following clinically significant adverse reactions are descrived elsewhere in the labeling: Somnolense and Impaired Mental Alertness [see Warnings and Precautions (5.2) ]. Allergic Reactions due to Sulfites, including Anaphylaxis [see Warnings and Precautions (5.2)]. The most frequent adverse reactions include: sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions. In clinical use, younger children and older adults may be particu...

Karbinal ER is contraindicated in: children younger than 2 years of age because deaths have been reported in this age group (see Warnings and Precautions (5.1)] patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Karbinal ER [see Warnings and Precautions (5.1)] patients who are taking monoamine oxidase inhibitors (MAOI) [see Drug Interactions(7)]. Childre...

Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. ( 5.2 ) Anticholinergic actions: 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, pyloroduodenal obstruction. ( 5.3 ) Contains sodium metabisulfite, a sulfite that may cau...

7 DRUG INTERACTIONS Do not use of Karbinal ER in patients who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Avoid use of Karbinal ER with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.) due to additive effects. Monoamine oxidase inhibitors (MAOIs): Prolong and intensify the antichol...