Indications

Rupatrol is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.

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Pharmacology

Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.

Dosage & Administration

Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.

Children aged 2 to 11 years:

• Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food.
• Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.

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Interaction

With medicine: The concomitant administration of Rupatrol 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatrol should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatrol should be used with caution when it is co-administered with statins, CNS depressants or alcohol.

With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine

Contraindications

Hypersensitivity to Rupatadine or to any of the excipients.

Side Effects

Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.

Pregnancy & Lactation

There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine unless the potential benefit outweighs the potential risk for the infant. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.

Precautions & Warnings

Rupatrol should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatrol should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatrol 10 mg tablets is at present not recommended in these patients.

Use in Special Populations

Elderly: Rupatrol should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.

Children: Neither the safety nor the efficacy of Rupatrol has been established in patients less than 12 years of age.

Patients with renal or hepatic insufficiency: Use of Rupatrol is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.

Overdose Effects

The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.

Therapeutic Class

Non-sedating antihistamines

Storage Conditions

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Chemical Structure

Common Questions about Rupatrol 10 mg Tablet

What is Rupatrol 10 mg Tablet?

Rupatrol 10 mg Tablet is H1-receptors antagonist. It also antagonizes the platelet activating factor (PAF).

What is Rupatrol 10 mg Tablet used for?

Rupatrol 10 mg Tablet is commonly used to treat seasonal & perennial allergic rhinitis and urticaria.

Are there any pregnancy warnings?

Rupatrol 10 mg Tablet is maybe unsafe to use during pregnancy.

Are there any breast-feeding warnings?

Unknown. Human and animal studies are not available. Please consult your doctor.

Is it safe to drive while on Rupatrol 10 mg Tablet?

There is no data available. Please consult doctor before consuming the drug.

Does this affect kidney function?

Caution should be advised in patients with renal impairment.

Does Rupatrol 10 mg Tablet affect liver function?

There is no data available. Please consult doctor before consuming Rupatrol 10 mg Tablet.

What is the onset of action of Rupatrol 10 mg Tablet?

The action is initiated in the first 75 minutes after administration.

How long is the duration of effect?

The duration of action of Rupatrol 10 mg Tablet is in between 8 to 10 hrs.

Quick Tips

• Your doctor has prescribed Rupatrol 10 mg Tablet to help relieve allergy symptoms such as itching, swelling, and rashes.
• As compared to other similar medications, it is much less likely to make you feel sleepy.
• Be cautious while driving or doing anything that requires concentration as it can cause dizziness and sleepiness.
• Do not drink alcohol while taking this medication as it may cause increased sleepiness.
• Stop taking Rupa at least three days before taking an allergy test as it can affect the test results.

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