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Product

Therapeutic Category

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Loratadine 10mg USP Tablets


Generic Name

Loratidine


Packing

100 Tablets


Therapeutic Category

Antiallergy


Storage


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Product Description

Product Overview


DRUG DESCRIPTION

Loratadine CAS number 79794-75-5

Loratadine is a white to off-white powder not soluble in water, but very soluble in acetone, alcohol, and chloroform. It has a molecular weight of 382.89, and empirical formula of C22H23CIN2O2; its chemical name is ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene) -1-piperidinecarboxylate

Loratadine Tablets contain 10 mg micronized loratadine, an antihistamine, to be administered orally. It also contains the following inactive ingredients: corn starch, lactose, and magnesium stearate.

Loratadine Syrup contains 1 mg/mL micronized loratadine, an antihistamine, to be administered orally. It also contains the following inactive ingredients:citric acid, edetate disodium, artificial flavor, glycerin, propylene glycol, sodium ben-zoate, sugar, and water. The pH is between 2.5 and 3.1.

Loratadine REDITABS (loratadine rapidly-disintegrating tablets) contain 10 mg micronized loratadine, an antihistamine, to be administered orally. It disintegrates in the mouth within seconds after placement on the tongue, allowing its contents to be subsequently swallowed with or without water. Loratadine REDITABS (loratadine rapidly-disintegrating tablets) also contain the following inactive ingredients: citric acid, gelatin, mannitol, and mint flavor.

DOSAGE

* Take Loratadine by mouth with or without food.
* If you miss a dose of Loratadine , 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.

The usual dose of loratadine is 10 mg daily for adults and children older than six years of age.

Take this medication by mouth once a day or as directed. Do not increase your dose or take this more often than directed. Do not take this medication for several days before allergy testing since test results can be affected.

SIDE EFFECTS

Loratadine CAS number 79794-75-5

Headache, fatigue, dry mouth, thirst, dry nose or hoarseness may occur. These effects should lessen as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: nervousness, rapid or pounding heartbeat, unusual weakness, stomach pain, dizziness, diarrhea, wheezing, increased physical activity. Loratadine 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. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Non-sedating antihistamine

As a non-sedating antihistamine, loratadine causes less sedation and psychomotor impairment than the older antihistamines because it penetrates the blood brain barrier only to a slight extent.

Although drowsiness is rare, patients should nevertheless be advised that it can occur and may affect performance of skilled tasks (e.g. driving); excess alcohol should be avoided.

Most common side-effects

Drowsiness, headache, psychomotor impairment, and antimuscarinic effects such as urinary retention, dry mouth, blurred vision, and gastrointestinal disturbances are the most common side effects.

Other rarer side-effects

Hypotension, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, lower back pain, tremor, convulsions, palpitation, arrhythmias, hypersensitivity reactions (including bronchospasm, angioedema, and anaphylaxis, rashes, and photosensitivity reactions), blood disorders, liver dysfunction, and angle-closure glaucoma are less common side effects.

PRECAUTIONS

Loratadine CAS number 79794-75-5

Before taking loratadine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. 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. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk. Breast-feeding is not recommended while using this drug.

Loratadine should be used with caution in hepatic disease and dose reduction may be necessary in renal impairment. Caution may be required in epilepsy. Children and the elderly are more susceptible to side-effects

INTERACTION

Loratadine CAS number 79794-75-5

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain additional antihistamines that could increase your risk for side effects. Ask your pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

If you are taking this medication under your doctor’s direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain additional antihistamines that could increase your risk for side effects. Ask your pharmacist about using these products safely.

If you are scheduled for allergy testing, ask your doctor if you should stop taking this medication for several days before testing. This drug may affect your allergy test results.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

USES:

This medication is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from “hay fever” and other allergies. It is also used to relieve itching from hives.

Loratadine does not prevent hives or prevent/treat a serious allergic reaction (e.g., anaphylaxis). Therefore, if your doctor has prescribed epinephrine to treat allergic reactions, always carry your epinephrine injector with you. Do not use loratadine in place of your epinephrine.

HOW TO USE:

If you are using the over-the-counter product to self-treat, read all the directions on the product package before taking this medication. If your doctor has prescribed this medication, follow your doctor’s directions and the instructions on your prescription label. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually once a day or as directed by your doctor or the product package. If you are using the chewable tablets, chew each tablet well and swallow. Dosage is based on your age, condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age.

MISSED DOSE:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:

Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Protect from light. Do not store in the bathroom. Keep all medicines away from children and pets.

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