Palgic label

Palgic

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Side Effects & Adverse Reactions

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.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

Carbinoxamine maleate is a histamine-H1 receptor blocking agent.

Each tablet contains 4 mg carbinoxamine maleate and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

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:

carbinoxamine maleate chemical structure

2-[(4-chlorophenyl)-2-pyridinylmethoxy]-N, N-dimethyl-ethanamine (Z)-2-butenedioate (1:1)

C16H19CIN2O•C4H4O4

MW = 406.86

Palgic Manufacturers

  • Pamlab, L.l.c.
    Palgic | Pamlab, L.l.c.
    No Recall

    Palgic | Pamlab, L.l.c.

    Palgic | Pamlab, L.l.c.

    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:

    Tablets

    Usual Adult Dosage:

    1 or 2 tablets (4 to 8 mg) 3 to 4 times daily

    Usual Child’s Dosage:

    Six to eleven years – 1/2 to 1 tablet (2 to 4 mg) 3 to 4 times daily

    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 to 0.4 mg/kg/day, divided into 3 to 4 doses)

    Six to eleven years - ½ 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 1/4 to 1/2 teaspoonful (1 to 2 mg) 3 to 4 times daily.