a variety of Arbinoxa Oral Solution Generic Name: carbinoxamine maleate Dosage Form: oral solution Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Drug Images Support Group Q & A Arbinoxa (Carbinoxamine Maleate) Oral Solution [Hawthorn Pharmaceuticals, Inc] Rx only Arbinoxa Oral Solution Description Carbinoxamine maleate is a histamine-H 1 receptor blocking agent. Each 5 mL (teaspoonful) of oral solution contains 4 mg carbinoxamine maleate and the following inactive ingredients: artificial bubble gum flavor, citric acid (anhydrous), glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate (hydrous) and sorbitol solution. 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 ClN 2 O C 4 H 4 O 4 MW = 406.86 Slideshow Understanding Anaphylaxis: Don't Let It Shock You Arbinoxa Oral Solution - Clinical Pharmacology Carbinoxamine maleate is an antihistamine with anticholinergic (drying) and sedative properties. Antihistamines appear to compete with histamine for receptor sites on effector cells. The pharmacological effects of carbinoxamine maleate after oral absorption have been shown to last approximately 4 hours. Interactions of carbinoxamine maleate with food or with other drugs and the possibility of cardiac conduction effects on the QT interval have not been studied. Indications and Usage for Arbinoxa Oral Solution 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. 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 section.) 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. Precautions General As with many other antihistamines, carbinoxamine maleate has an atropine-like action and, therefore, should be used with caution in patients with: increased intraocular pressure, hyperthyroidism, cardiovascular disease, hypertension. Antihistamines such as carbinoxamine maleate should not be used to treat lower respiratory tract symptoms, including asthma. Information for Patients Carbinoxamine maleate may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. 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.). Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies in animals have been performed to determine the possible effects of carbinoxamine maleate on carcinogenesis, mutagenesis, and fertility. Pregnancy Pregnancy Category C 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. Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, use of carbinoxamine maleate is contraindicated in nursing mothers (see CONTRAINDICATIONS section). Pediatric Use Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS ). Carbinoxamine maleate may diminish mental alertness in children. In the young child, particularly, they may produce excitation. Geriatric Use Carbinoxamine maleate is more likely to cause dizziness, sedation, and hypotension in elderly patients (approximately 60 years or older). Sedating drugs may also cause confusion and over sedation in the elderly. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic renal, or cardiac function, and of concomitant disease or other drug therapy. 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: Thickenings of bronchial secretions , tightness of chest and wheezing, nasal stuffiness. Overdosage Manifestations Antihistamine over dosage 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. Arbinoxa Oral Solution Dosage and 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 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 schedules: Oral Solution: Usual Adult Dosage: 1 or 2 teaspoonfuls (4 to 8 mg) 3 to 4 times daily Usual Child s Dosage (approximately 0.2 0.4 mg/kg/day divided into 3 to 4 doses): Six to eleven years to 1 teaspoonful (2 to 4 mg) 3 to 4 times daily. Dosing for children 2 to 5 years of age should be based on weight whenever possible. The usual dosage for children 2 to 5 years of age is approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 daily doses. In general, this corresponds to a dose of to teaspoonful (1 to 2 mg) 3 to 4 times daily. How is Arbinoxa Oral Solution Supplied Arbinoxa (Carbinoxamine Maleate) Oral Solution, 4 mg/5 mL is supplied as clear, colorless liquid with a bubble gum aroma, and is supplied in 16 oz bottles NDC 63717-871-16. 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. Manufactured for: Hawthorn Pharmaceuticals, Inc. Madison, MS 39110 Made in Canada 01/12 CW1876-1 PRINCIPAL DISPLAY PANEL - Bottle Label Bottle Label NDC 63717-871-16 Arbinoxa Oral Solution (Carbinoxamine Maleate) 4 mg/5 mL Rx only Hawthorn Pharmaceuticals, Inc. 16 fl oz (473 mL) Description: Each 5 mL (teaspoonful) Contains: Carbinoxamine Maleate USP, 4 mg. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure. Storage: Store at 20 to 25 C (68 to 77 F) [See USP controlled room temperature.] HL216 01/12 CW1875-2 Usual Dosage: See package insert for full prescribing information. Warning: Keep this and all medication out of the reach of children. Manufactured for: Hawthorn Pharmaceuticals, Inc. Madison, MS 39110 Made in Canada ARBINOXA carbinoxamine maleate solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:63717-871 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBINOXAMINE MALEATE (CARBINOXAMINE) CARBINOXAMINE MALEATE 0.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE SORBITOL Packaging # Item Code Package Description 1 NDC:63717-871-16 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090418 04/01/2011 Labeler - Hawthorn Pharmaceuticals, Inc. (118049704) Registrant - Hawthorn Pharmaceuticals, Inc. (118049704) Revised: 06/2012 Hawthorn Pharmaceuticals, Inc. Next Interactions Print this page Add to My Med List More about Arbinoxa (carbinoxamine) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: antihistamines Consumer resources Arbinoxa Arbinoxa (Advanced Reading) Professional resources Arbinoxa (FDA) Carbinoxamine Maleate (AHFS Monograph) Other brands: Karbinal ER , Palgic , Ryvent Related treatment guides Allergic Reactions Allergic Rhinitis Allergic Urticaria Conjunctivitis, Allergic Dermatographism Vasomotor Rhinitis} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Antihistamines Related Drugs antihistamines loratadine , cetirizine , Zyrtec , hydroxyzine , Claritin , promethazine Allergic Rhinitis prednisone , Zyrtec , promethazine , fluticasone nasal , loratadine , cetirizine , More... Allergic Reactions prednisone , promethazine , loratadine , triamcinolone , diphenhydramine , Benadryl , More... Allergic Urticaria hydroxyzine , Vistaril , Atarax , tetracaine topical , triprolidine , carbinoxamine , More... 3 more conditions... Arbinoxa Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Arbinoxa Images Arbinoxa 4 mg (CYP 870 ) View larger images} } to intensify
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