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ALREE-10 Tablets | Levocetirizine 10 mg

ALREE-10

Product Composition

Manufacturer of Each uncoated tablet contains: Levocetirizine 10 mg Tablets

Packaging Details

20 x 10 Blister

Product Description

ALREE-10 Tablets

Levocetirizine Hydrochloride 10 mg

ALREE-10 is an oral antihistamine formulation containing Levocetirizine Hydrochloride IP 10 mg per film-coated tablet, as shown on the supplied artwork. It is intended for symptomatic management of histamine-mediated allergic conditions.


1. Product Information

Parameter Details
Brand Name ALREE-10
Generic Name Levocetirizine Hydrochloride
Strength 10 mg
Dosage Form Film-Coated Tablet
Route Oral
Therapeutic Category Antihistamine / Anti-Allergic
Pack Size 20 × 10 Tablets
Prescription Status Rx, as shown on artwork
Colour Quinoline Yellow

Composition

Each film-coated tablet contains:

  • Levocetirizine Hydrochloride IP — 10 mg
  • Excipients — q.s.
  • Colour: Quinoline Yellow

2. What is ALREE-10 Used For?

Levocetirizine is a selective H1-antihistamine used for symptomatic relief of allergic conditions.

Depending on the patient’s condition and physician assessment, levocetirizine may be used for symptoms such as:

  • Sneezing
  • Runny nose
  • Nasal itching
  • Itchy or watery eyes
  • Throat/nasal itching
  • Allergic rhinitis
  • Seasonal allergic symptoms
  • Perennial allergic symptoms
  • Allergic skin itching
  • Urticaria (hives)

Current professional labeling describes levocetirizine for allergic-rhinitis symptoms and uncomplicated skin manifestations of chronic idiopathic urticaria.


3. Mechanism of Action

Levocetirizine Hydrochloride

Levocetirizine is an H1-histamine receptor antagonist.

During an allergic reaction, allergens can trigger the release of histamine.

Allergen exposure
↓
Histamine release
↓
H1 receptor activation
↓
Sneezing + itching + runny nose + watery eyes

Levocetirizine blocks peripheral H1 receptors and reduces the effects of histamine.

Result

H1 receptor blockade
↓
Reduced histamine-mediated allergic symptoms
↓
Relief from sneezing, itching and rhinorrhea.


4. Therapeutic Benefits

✔ Relief from sneezing

Helps reduce histamine-mediated nasal symptoms.

✔ Helps control runny nose

Reduces histamine-related nasal secretions.

✔ Helps relieve nasal itching

Reduces histamine-mediated itching and irritation.

✔ Helps relieve itchy/watery eyes

Can help control ocular symptoms associated with allergic rhinitis.

✔ Helps control allergic itching

H1-antihistamine activity can reduce histamine-mediated itching.

✔ Support in urticaria

Levocetirizine is used for the uncomplicated skin manifestations of chronic idiopathic urticaria.


5. Common Clinical Applications

Condition / Symptom Role
Allergic rhinitis Symptomatic relief
Seasonal allergies Symptomatic relief
Perennial allergic rhinitis Symptomatic relief
Sneezing H1-antihistamine action
Runny nose H1-antihistamine action
Nasal itching H1-antihistamine action
Itchy/watery eyes Symptomatic relief
Urticaria / hives Relief of allergic skin symptoms
Allergic itching Symptomatic relief

6. Allergic Rhinitis

Allergic rhinitis commonly produces:

  • Repeated sneezing
  • Runny nose
  • Nasal itching
  • Nasal irritation
  • Itchy eyes
  • Watery eyes

Levocetirizine acts primarily on the histamine-mediated component of these symptoms.

It provides symptomatic relief but does not eliminate the underlying allergic tendency or remove the allergen.


7. Urticaria / Hives

Urticaria may present with:

  • Raised wheals
  • Redness
  • Skin itching
  • Recurrent allergic skin symptoms

Histamine is an important mediator in many urticarial reactions.

Levocetirizine blocks H1 receptors and can therefore reduce histamine-mediated itching and other uncomplicated skin manifestations of chronic idiopathic urticaria.


8. Suggested Use & Dosage

Important for ALREE-10

The artwork establishes a 10 mg tablet strength, but does not provide a dosing schedule.

Current professional labeling for levocetirizine describes 5 mg once daily in the evening for adults and children 12 years and older, with lower doses and adjustments for specific populations.

Therefore, for ALREE-10, do not state that patients should routinely take one 10 mg tablet daily unless that specific strength and regimen are supported by the product’s current approved Indian prescribing information.

Recommended website wording

Take ALREE-10 Tablets only as directed by the physician.

Administration

  • Take orally with water.
  • Follow the prescribed dose and duration.
  • May be taken with or without food.
  • Do not exceed the prescribed dose.
  • Do not independently increase the dose if symptoms persist.

9. Side Effects

Possible adverse effects include:

Common

  • Drowsiness
  • Fatigue
  • Headache
  • Dry mouth
  • Dizziness

Drowsiness and fatigue are recognized adverse effects of levocetirizine.

Other possible effects

  • Nausea
  • Abdominal discomfort
  • Gastrointestinal symptoms
  • Skin reactions

Rare but serious

Seek immediate medical attention for:

  • Facial swelling
  • Lip or tongue swelling
  • Difficulty breathing
  • Severe allergic reaction
  • Severe skin reaction

10. Drowsiness & Driving

Although levocetirizine is a newer-generation antihistamine, drowsiness can occur.

Patients should determine their individual response before:

  • Driving
  • Operating machinery
  • Working at heights
  • Performing activities requiring full mental alertness

Current professional labeling specifically advises caution with driving and hazardous activities.


11. Alcohol & CNS Depressants

Alcohol, sedatives and tranquilizers may increase impairment or drowsiness.

Patients should avoid or limit alcohol while taking levocetirizine, particularly if they experience sedation.


12. Precautions & Warnings

Inform the physician before using ALREE-10 if the patient has:

  • Kidney disease
  • Difficulty urinating
  • Enlarged prostate
  • Previous allergy to levocetirizine
  • Previous allergy to cetirizine
  • Significant drowsiness with antihistamines

Because levocetirizine is substantially eliminated through the kidneys, renal function is an important consideration.


13. Contraindications

Levocetirizine should not be used in patients with known hypersensitivity to:

  • Levocetirizine
  • Cetirizine
  • Any component of the formulation

Current professional labeling also contraindicates levocetirizine in patients with end-stage renal disease or those undergoing hemodialysis.

For your final Indian product literature, these details should be checked against the current approved Indian package insert.


14. Drug Interactions

Tell the doctor or pharmacist about all medicines being taken.

Particular attention should be given to:

Alcohol

May increase drowsiness.

Sedatives

May increase CNS depression.

Tranquilizers

May increase impairment.

Other antihistamines

May increase antihistamine-related effects.

Other medicines causing drowsiness

May further impair alertness.


15. Pregnancy & Breastfeeding

Use during pregnancy or breastfeeding should be based on medical advice and an individual risk-benefit assessment.

Patients who are:

  • Pregnant
  • Planning pregnancy
  • Breastfeeding

should inform their healthcare professional before using ALREE-10.


16. Use in Elderly Patients

Elderly patients may have reduced renal function and may therefore require individualized treatment.

They may also be more susceptible to:

  • Drowsiness
  • Dizziness
  • Urinary retention
  • Other medication-related effects

Renal function should be considered when determining the appropriate levocetirizine dose.


17. Renal Impairment

This is an important consideration for levocetirizine.

Because the medicine is substantially excreted through the kidneys, patients with reduced renal function may require dose adjustment.

Current professional labeling provides progressively lower dosing recommendations with increasing renal impairment and states that patients with end-stage renal disease or undergoing hemodialysis should not receive levocetirizine.


18. Hepatic Impairment

Hepatic impairment alone generally has less impact on levocetirizine elimination than renal impairment.

However, patients with combined hepatic and renal impairment may require dose adjustment because renal function substantially influences drug clearance.


19. When to Seek Medical Attention

Seek urgent medical attention if the patient develops:

  • Difficulty breathing
  • Facial, lip or tongue swelling
  • Severe allergic reaction
  • Severe dizziness
  • Severe skin reaction
  • Significant difficulty passing urine
  • Excessive or unusual sedation

20. Storage

Store ALREE-10 Tablets:

  • In a cool, dry place.
  • Away from direct sunlight.
  • Away from excessive heat and moisture.
  • In the original packaging.
  • Out of reach of children.

Do not use after the expiry date.


21. Key Product Features

ALREE-10 Tablets

Levocetirizine Hydrochloride 10 mg formulation

  • Levocetirizine Hydrochloride IP — 10 mg
  • Film-coated tablet
  • Oral administration
  • Antihistamine / anti-allergic
  • Intended for symptomatic management of allergic conditions
  • 20 × 10 Tablets
  • Rx product as shown on artwork
  • Colour: Quinoline Yellow

22. Why Choose ALREE-10?

Levocetirizine-based antihistamine

Levocetirizine is a selective H1-antihistamine used for histamine-mediated allergic symptoms.

Broad allergy symptom coverage

It can provide symptomatic relief across:

Sneezing + Runny Nose + Nasal Itching + Ocular Symptoms + Allergic Itching

Single active ingredient

The formulation contains levocetirizine as its active pharmaceutical ingredient, allowing targeted antihistamine therapy.

ALREE-5 Tablets | Levocetirizine 5 mg ALREE-10 Tablets | Levocetirizine 10 mg ALREE-M Tablets | Levocetirizine + Montelukast ALREE Syrup 2.5 mg/5 mL | Levocetirizine Hydrochloride

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Besides Changodar Bridge, Changodar, Ahmedabad-382213.

+91 99139 17125

info.amcerebiosciences@gmail.com

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