Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Ryvent TM (carbinoxamine maleate tablets USP, 6 mg) is supplied as a white, round tablet, debossed “404” on one side and “ADG” on the other side, in bottles of 100 tablets, NDC 15370-130-10 and bottles of 2 tablets as physician samples, NDC 15370-130-02. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the official compendium. Rx only Manufactured for: Carwin Pharmaceutical Associates, LLC Hazlet, NJ 07730 www.carwinpharma.com Code 1159B00 Rev. 09/16; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL container label
- HOW SUPPLIED Ryvent TM (carbinoxamine maleate tablets USP, 6 mg) is supplied as a white, round tablet, debossed “404” on one side and “ADG” on the other side, in bottles of 100 tablets, NDC 15370-130-10 and bottles of 2 tablets as physician samples, NDC 15370-130-02. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the official compendium. Rx only Manufactured for: Carwin Pharmaceutical Associates, LLC Hazlet, NJ 07730 www.carwinpharma.com Code 1159B00 Rev. 09/16
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL container label
Overview
Carbinoxamine maleate is a histamine-H 1 receptor blocking agent. Each tablet contains 6 mg carbinoxamine maleate and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Carbinoxamine maleate is freely soluble in water. Its structure is: 2-[(4-chlorophenyl)-2-pyridinylmethoxy]-N, N-dimethylethanamine (Z)-2-butenedioate (1:1) C 16 H 19 CIN 2 O·C 4 H 4 O 4 MW= 406.86 carbinoxamine maleate chemical structure
Indications & Usage
Carbinoxamine maleate is effective 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.
Dosage & Administration
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
WARNINGS 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.
Contraindications
Carbinoxamine maleate is contraindicated in children younger than 2 years of age. Carbinoxamine maleate is contraindicated in nursing mothers. Carbinoxamine maleate is contraindicated in patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy (see Drug Interactions ).
Adverse Reactions
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 Call your doctor for medical advice about side effects. Report side effects to 1-844-700-5011.
Drug Interactions
Monoamine oxidase inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. Carbinoxamine maleate has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).
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