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Skivalorine syrup

Desloratadine

  Skivalorine Syrup is a clear orange colored liquid containing 2.5mg/5mL desloratadine.

The syrup contains the following inactive ingredients: propylene glycol USP, sorbitol solution USP, citric acid (anhydrous) USP, Na citrate dihydrate USP, sodium benzoate N F, disodium edetate USP, purified water USP.

It also contains granulated sugar, natural and artificial flavor for bubble gum and FDC Yellow #6 dye.

Action:

  Desloratadine is the active metabolite of loratadine, an antihistamine that reduces the natural chemical histamine in the body.

Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Uses:

  Used in the symptomatic relief of allergic conditions including rhinitis and chronic urticaria , sneezing, watery eyes, and runny nose.

 It is also used to treat skin hives and itching in people with chronic skin reactions.

precautions

  Before taking desloratadine, tell your doctor or pharmacist if you are allergic to it; or to loratadine; or if you have any other allergies.

This product may contain inactive ingredients, which can cause allergic reactions or other problems.

  Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

Limit alcohol intake, as it may intensify drug side effects.

  Desloratadine should be used only when clearly needed during pregnancy.

Discuss the risks and benefits with your doctor.

This drug passes into breast milk.

SIDE EFFECTS:

  Throat discomfort, muscle pain, nausea, indigestion, loss of appetite, diarrhea, dizziness, fatigue, trouble sleeping, nosebleeds, or dry mouth may occur.

  If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Desloratadine does not usually cause drowsiness when used at recommended doses and under normal circumstances. However, be sure of the drug's effects before engaging in activities that require alertness such as driving or using machinery.

  Tell your doctor immediately if this unlikely but serious side effect occurs:

Rapid or pounding heartbeat, dark urine, yellowing eyes or skin.

A very serious allergic reaction to this drug is unlikely, but seeks immediate medical attention if it occurs.

   Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

Fast, pounding, or uneven heartbeat;

Fever, flu symptoms;

Seizure (convulsions); or

Jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

Dry mouth, sore throat, cough.

Adverse effects

Observed During Clinical Practice

  The following spontaneous adverse events have been reported during the marketing of desloratadine: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, Dyspnea, and anaphylaxis), psychomotor hyperactivity, seizures, and elevated liver enzymes including bilirubin, and very rarely hepatitis.

Dose

  The age-appropriate dose should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (1/2 teaspoon).

Children 6 to 11 months of age:

The recommended dose is 2 mL (1.0 mg) once daily.

 Children 12 months to 5 years of age:

The recommended dose (is 1/2 teaspoonful (1.25 mg in 2.5 mL) once daily.

Children 6 to 11 years of age:

 The recommended dose of (desloratadine) Syrup is 1 teaspoonful (2.5 mg in 5 mL) once daily.

Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data.
 Storage

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

Protect from light.