Carbinoxamine Maleate Extended-Release Oral Suspension 4 mg/5mL
Carbinoxamine Maleate · SUSPENSION, EXTENDED RELEASE · Neos Therapeutics, LP
Carbinoxamine Maleate Extended-Release Oral Suspension is a suspension, extended release containing carbinoxamine maleate at 4 mg/5mL, taken oral. Manufactured by Neos Therapeutics, LP.
Key Facts
- Brand Name
- Carbinoxamine Maleate Extended-Release Oral Suspension
- Generic Name
- Carbinoxamine Maleate
- NDC Code (Product)
62542-101- Manufacturer
- Neos Therapeutics, LP
- Strength
- 4 mg/5mL
- Dosage Form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA022556
- Marketing Start
- 06/01/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Carbinoxamine Maleate extended-release oral suspension is indicated for adults and pediatric patients 2 years of age and older 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 Carbinoxamine Maleate extended-release oral suspension is an H1 receptor antagonist indicated for adults and pediatric patients 2 years of age and older for the symptomatic treatment of: Seasonal and perennial allergic rhinitis ( 1 ) Vasomotor rhinitis ( 1 ) Allergic conjunctivitis due to inhalant allergens and foods ( 1 ) Mild, uncomplicated allergic skin manifestations of urticaria and angioedema ( 1 ) Dermatographism (1) As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled ( 1 ) Ameliorati…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults and Adolescents 12 years of age and older ( 2.2 ): 7.5 mL to 20 mL (6 mg to 16 mg) orally every 12 hours Pediatric patients 2 years to 11 years of age (approximately 0.2 mg/kg/day to 0.4 mg/kg/day) ( 2.3 ): 2 years to 3 years – 3.75 mL to 5 mL (3 mg to 4 mg) orally every 12 hours 4 years to 5 years – 3.75 mL to 10 mL (3 mg to 8 mg) orally every 12 hours 6 years to 11 years – 7.5 mL to 15 mL (6 mg to 12 mg) orally every 12 hours 2.1 General Administration Instructions The dosage of Carbinoxamine Maleate Extended-Release Oral Suspension 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 Carbinoxamine Maleate Extended-Release Oral Suspension by the oral route only. Measure Carbinoxamine Maleate Extended-Release Oral Suspension 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. Shake Carbinoxamine Maleate extended-release oral suspension w…
Contraindications
4 CONTRAINDICATIONS Carbinoxamine Maleate Extended-Release Oral Suspension 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 Carbinoxamine Maleate Extended-Release Oral Suspension [see Warnings and Precautions (5.4)]. 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)
Drug Interactions
7 DRUG INTERACTIONS Do not use Carbinoxamine Maleate extended-release oral suspension in patients who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Avoid use of Carbinoxamine Maleate extended-release oral suspension 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)
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Somnolence and Impaired Mental Alertness [see Warnings and Precautions (5.2)] Allergic Reactions due to Sulfites, including Anaphylaxis [see Warnings and Precautions (5.4)] The most frequent adverse reactions include: sedation, sleepiness, dizziness, disturbed coordination, epigastic distress, and thickening of bronchial secretions. In clinical use, younger children and older adults may be particularly sensitive to adverse reactions [see Pediatric Use (8.4) and Geriatric Use (8.5)]. The following adverse reactions, listed by body system, have been identified in case reports and during the use of carbinoxamine in observational studies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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. Central Nerv…
Frequently Asked Questions
What is Carbinoxamine Maleate Extended-Release Oral Suspension used for?
Carbinoxamine Maleate Extended-Release Oral Suspension contains Carbinoxamine Maleate. It is a suspension, extended release taken oral. Consult your doctor for specific uses.
Is Carbinoxamine Maleate Extended-Release Oral Suspension a controlled substance?
Carbinoxamine Maleate Extended-Release Oral Suspension is not classified as a controlled substance by the DEA.
What is the generic name for Carbinoxamine Maleate Extended-Release Oral Suspension?
The generic name for Carbinoxamine Maleate Extended-Release Oral Suspension is Carbinoxamine Maleate. There are 9 other brand versions of Carbinoxamine Maleate.
What is the NDC code for Carbinoxamine Maleate Extended-Release Oral Suspension 4 mg/5mL?
The NDC (National Drug Code) for Carbinoxamine Maleate Extended-Release Oral Suspension 4 mg/5mL is 62542-101, listed by Neos Therapeutics, LP.