pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism of Actions Carbinoxamine maleate, an ethanolamine derivative, is an antihistamine with anticholinergic (drying) and sedative properties. Carbinoxamine appears to compete with histamine (type H1) for receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract.

Histamine H1 ReceptorMonoamine Oxidase

Indications

Sourced from openFDA
  • Carbinoxamine maleate is effective for the symptomatic treatment of: Seasonal and perennial allergic rhinitis. Vasomotor rhinitis.ICD-10: J30.9

Contraindications

Sourced from openFDA
  • Carbinoxamine maleate is contraindicated in children younger than 2 years of age. Carbinoxamine maleate is contraindicated in nursing mothers.contraindicated

Dosage & administration

Sourced from openFDA

Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS ). Carbinoxamine maleate should be taken on an empty stomach with water. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in adults in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily. Clinical experience suggests the following dosage schedule: Usual Adult Dosage: 1 tablet (6 mg) 3 to 4 times daily

Warnings & precautions

Sourced from openFDA

Deaths have been reported in children less than 2 years of age who were taking antihistamines, including carbinoxamine-containing drug products, therefore, carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS ). Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction.

Adverse reactions

Sourced from openFDA

The most frequent adverse reactions are underlined: 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 Hematologic : Hemolytic anemia, thrombocytopenia, agranulocytosis Central nervous system: Sedation , sleepiness , dizziness , disturbed coordination , fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions Gastrointestinal: Epigastric distress , anorexia, nausea, vomiting, diarrhea, constipation Urogenital: Urinary frequency, difficult urination, urinary retention, early menses Respiratory: Thickening of bronchial secretions , tightness of chest and wheezing, nasal stuffiness To report SUSPECTED ADVERSE REACTIONS, contact Leading Pharma, LLC at 1-844-740-7500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Animal reproductive studies have not been conducted with carbinoxamine maleate. It is also not known whether carbinoxamine maleate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Carbinoxamine maleate should be given to a pregnant woman only if clearly needed.

Pharmacokinetics

Sourced from openFDA
Metabolism
and Metabolism Carbinoxamine is well absorbed from the GI tract and appears to be extensively metabolized by the liver, and excreted in the urine as inactive metabolites within 24 hours. Virtually no intact drug is extended in the urine.

Overdosage

Sourced from openFDA

Manifestations Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms- dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur. Especially in infants and children, antihistamine overdosage may cause hallucinations, convulsions, or death. The oral LD 50 of carbinoxamine maleate in guinea pigs is 411 mg/kg. Treatment The treatment of overdosage with carbinoxamine maleate is essentially symptomatic and supportive. Vital signs (including respiration, pulse, blood pressure, and temperature) and EKG should be monitored. Induction of vomiting is not recommended. Activated charcoal should be given and gastric lavage should be considered after ingestion of a potentially life-threatening amount of drug. In the presence of severe anticholinergic effects, physostigmine may be useful. Vasopressors may be used to treat hypotension.

Approval history

Sourced from openFDA
  • Mar 19, 2003ANDAANDA040442Genus
  • Apr 25, 2003ANDAANDA040458Genus
  • May 27, 2011ANDAANDA090756Mission Pharmacal
  • Mar 28, 2013NDANDA022556Aytu
  • May 31, 2016ANDAANDA207484Mikart
  • Dec 19, 2024ANDAANDA215476Leading

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
184 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective168.7%
  2. 2Drug Toxicity147.6%
  3. 3Headache137.1%
  4. 4Sinusitis105.4%
  5. 5Pyrexia94.9%
  6. 6Pain84.3%
  7. 7Pruritus84.3%
  8. 8Urticaria84.3%
  9. 9Fatigue73.8%
  10. 10Product Dose Omission Issue73.8%
  11. 11Rash73.8%
  12. 12Somnolence73.8%
  13. 13Unresponsive To Stimuli73.8%
  14. 14Vomiting73.8%
  15. 15Anxiety63.3%

Frequently asked questions

How does Carbinoxamine work?
Mechanism of Actions Carbinoxamine maleate, an ethanolamine derivative, is an antihistamine with anticholinergic (drying) and sedative properties. Carbinoxamine appears to compete with histamine (type H1) for receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract.
What is Carbinoxamine used for?
According to FDA labeling, Carbinoxamine carries indications including: Carbinoxamine maleate is effective for the symptomatic treatment of: Seasonal and perennial allergic rhinitis. Vasomotor rhinitis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Carbinoxamine?
Carbinoxamine is classified as Aminoalkyl ethers, Histamine-1 Receptor Antagonist, Histamine H1 Receptor Antagonists, Monoamine Oxidase Inhibitors, Decreased Histamine Activity.
What are the brand names for Carbinoxamine?
Carbinoxamine is marketed under brand names including Carbzah, Karbinal, Ryvent.
What are the contraindications for Carbinoxamine?
Carbinoxamine labeling lists contraindications including: Carbinoxamine maleate is contraindicated in children younger than 2 years of age. Carbinoxamine maleate is contraindicated in nursing mothers.. Always consult the full prescribing information and a clinician.
Note. Data for carbinoxamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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