Oraxin

For treatment of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and foods, mild uncomplicated allergic skin manifestations of urticaria and angioedema, amelioration of allergic reactions to blood or plasma, cold urticaria, dermatographism, and as therapy for anaphylactic reactions adjunctive to epinephrine. (Allergic conjunctivitis; Allergic reaction; Anaphylaxis; Anorexia nervosa; Cold urticaria; Cushing's disease; Decreased appetite caused by Chronic disease; Dermatographic urticaria; Migraine; Sexual dysfunction caused by antipsychotic agents; Sexual dysfunction caused by fluoxetine; Sexual dysfunction caused by monoamine oxidase inhibitors; Sexual dysfunction caused by tricyclic antidepressants; Vasomotor rhinitis; seasonal Allergic rhinitis;)

Oraxin an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose

Oraxin is used to treat sneezing, itching, watery eyes, runny nose, and other symptoms of allergies.

Oraxin may also be used for purposes not listed in this medication guide.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Each tablet contains 4 mg of Oraxin hydrochloride.

Pediatric Patients

Age 2 To 6 Years

The total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m2).

The usual dose is 2 mg (1/2 tablet) two or three times a day, adjusted as necessary to the size and response of the patient. The doe is not to exceed 12 mg a day.

Age 7 To 14 Years

The usual dose is 4 mg (1 tablet) two or three times a day adjusted as necessary to the size and response of the patient. The dose is not to exceed 16 mg a day.

Adults

The total daily dose for adults should bot exceed 0.5 mg/kg/day. The therapeutic range is 4 to 20 mg a day, with the majority of patients requiring 12 to 16 mg a day. An occasional patient may require as much as 32 mg a day for adequate relief. It is suggested that dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the size and response of the patient.

How supplied

Oraxin Hydrochloride Tablets USP are available as white to off white, flat-faced, beveledged, round shaped tablets, one side debossed with "CYP", the other side bisected, containing 4 mg of Oraxin HCl packaged in bottles of 100 tablets, NDC 62033-0346-0, and 1000 tablets, NDC 62033-0346-2.

PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required).

Store at 20 - 25 C (68 - 77 F) excursions permitted to 15 - 30 C (59 - 86 F)

Manufactured by: Stason Pharmaceuticals, Inc., Irvine, CA 92618. Revised: Nov 2010

See also:
What is the most important information I should know about Oraxin?

Always ask a doctor before giving a cold or allergy medicine to a child. Death can occur from the misuse of cold and allergy medicines in very young children.

You should not use this medication if you are allergic to Oraxin, or if you have narrow-angle glaucoma, a stomach ulcer or obstruction, an enlarged prostate or urination problems, if you are having an asthma attack, or if you are elderly or have a debilitating disease.

Before taking Oraxin, tell your doctor if you have glaucoma, a history of asthma, high blood pressure, heart disease, or an overactive thyroid.

Oraxin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of Oraxin.

Use Oraxin syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Oraxin syrup by mouth with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Oraxin syrup, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Oraxin syrup.

Use: Labeled Indications

Allergic conditions: Perennial and seasonal allergic rhinitis; vasomotor rhinitis; allergic conjunctivitis caused by inhalant allergens and foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; cold urticaria; dermatographism; adjunctive anaphylactic therapy.

Off Label Uses

Decreased appetite secondary to chronic disease

Data from a small randomized, double-blind, placebo-controlled trial with a long-term extension phase supports the use of Oraxin in the treatment of decreased appetite secondary to chronic disease. Additional trials may be necessary to further define the role of Oraxin in this condition.

Serotonin syndrome

Data from a limited number of patients studied (case series) suggests that Oraxin may be beneficial for the treatment of serotonin syndrome. Additional trials may be necessary to define the role of Oraxin in this condition.

See also:
What other drugs will affect Oraxin?

Monoamine oxidase inhibitors (MAOIs) prolong and intensify the anticholinergic effects of antihistamines.

Oraxin may have additive effects with alcohol and other CNS depressants like hypnotics, sedatives, tranquilizers and antianxiety agents.

See also:
What are the possible side effects of Oraxin?

Applies to Oraxin: oral solution, oral tablets

Side effects include:

Sedation, sleepiness (often transient), dizziness, disturbed coordination, restlessness, excitation.

Each capsule contains: Oraxin hydrochloride 2 mg, dried yeast IP'85 100 mg and approved colours used in the capsule shell.

Each 5 mL syrup contains: Oraxin hydrochloride 2 mg, tricholine citrate 275 mg, non-crystallising 70% sorbitol solution 2 g and flavoured syrupy base. Colour: Caramel.

Each 5 mL plain oral solution contains: Oraxin hydrochloride equivalent to anhydrous Oraxin hydrochloride 2 mg and flavoured syrupy base. Colour: Caramel.

Each mL drops contains: Oraxin hydrochloride 1.5 mg, tricholine citrate 55 mg and flavoured syrupy sorbitol base. Colour: Caramel.