Carbinoxamine extended-release
Other products: Carbinoxamine
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
General Administration Instructions The dosage of Karbinal ER should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated. Administer Karbinal ER by the oral route only. 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 correct dose. Shake Karbinal ER well before use.
General Administration Instructions The dosage of Karbinal ER should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated. Administer Karbinal ER by the oral route only. 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 correct dose. Shake Karbinal ER well before use.
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Carbinoxamine extended-release
Label text (1 paragraph)
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 anticholinergic (drying) effects. ( 4 and 7 ) Alcohol and CNS depressants (hypnotics, sedatives, tranquilizers, etc.): Avoid concomitant use due to additive adverse effects. ( 7 )
Contraindications
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)]. Children younger than 2 years of age ( 4 ) Patients with known hypersensitivity to the drug or any of the inactive ingredients ( 4 ) Monoamine oxidase inhibitors (MAOI) ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely to be a cause of clinically apparent liver injury.
Carbinoxamine is a first generation antihistamine that is used for symptoms of allergic rhinitis and the common cold. Carbinoxamine has not been linked to instances of clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Published data over decades of use of antihistamines, including carbinoxamine, have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal out comes. However, published dat a specifically evaluating the risk of carbinoxamine were not found. Animal reproductive studies have not been conducted with carbinoxamine maleate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Breastfeeding (LactMed)
Small occasional doses of carbinoxamine are probably acceptable during breastfeeding. Larger doses or more prolonged use may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. The manufacturer recommends avoiding breastfeeding during carbinoxamine use because severe toxicity has occurred in children under 2 years. The nonsedating antihistamines are preferred alternatives.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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