Ebastina Generis

Ebastina Generis Uses, Dosage, Side Effects, Food Interaction and all others data.

Ebastina Generis, a piperidine derivative, is a long-acting, nonsedating, second-generation histamine receptor antagonist that binds preferentially to peripheral H1 receptors. It is metabolised to active metabolite, carebastine. It has antihistaminic, antiallergic activity and prevents histamine-induced bronchoconstriction. It does not have significant sedative or antimuscarinic actions.

Trade Name Ebastina Generis
Generic Ebastine
Ebastine Other Names Ebastina, Ebastine
Type
Formula C32H39NO2
Weight Average: 469.6576
Monoisotopic: 469.298079497
Groups Approved, Investigational
Therapeutic Class Non-sedating antihistamines
Manufacturer
Available Country Portugal
Last Updated: September 19, 2023 at 7:00 am
Ebastina Generis
Ebastina Generis

Uses

Ebastina Generis is used for the symptomatic treatment of: Seasonal and perennial allergic rhinitis, Idiopathic chronic urticaria.

Ebastina Generis is also used to associated treatment for these conditions: Allergic Rhinitis (AR)

Dosage

Ebastina Generis dosage

Children between 2 and 5 years: 2.5 ml (half teaspoonful) once daily (up to 5 ml in severe cases such as perennial allergic rhinitis)

Children between 6 and 11 years: 5 ml (one teaspoonful) / 5 mg (half tablet) once daily (up to 10 ml in severe cases such as perennial allergic rhinitis)

Adults and older children more than 11 years: 10 mg (1 tablet) or 10 ml (two teaspoonfuls) once daily.

Ebastina Generis may be taken with or without food.

Side Effects

The most common side-effects are headache, dry mouth and drowsiness. Other less commonly reported side-effects include pharyngitis, abdominal pain, dyspepsia, asthenia, epistaxis, rhinitis, sinusitis, nausea and insomnia.

Precaution

It is advisable to exercise caution when using ebastine in patients known to have the following conditions: long QT syndrome, hypokalaemia, treatment with any medicine known to produce an increase in QT interval or inhibit CYP3A4 enzyme systems such as azole antifungals and macrolide antibiotics. Use in Pregnancy and Lactation The safety of ebastine during pregnancy and lactation has not been established. Ebastina Generis should not be used during pregnancy only if clearly needed. It is not known whether ebastine is excreted in milk, therefore, ebastine should not be used during lactation.

Interaction

The interaction of ebastine in combination with either ketoconazole or erythromycin (both known to prolong the QTc interval) has been evaluated. A significant pharmacokinetic and pharmacodynamic interaction has been observed with this combination; an 18-19 msec (4.7% - 5%) increase in QTc has been reported with either combination. Ebastina Generis does not interact with the kinetics of theophylline, warfarin, cimetidine, diazepam or alcohol. The sedation effect of alcohol and diazepam may be enhanced. When ebastine is administered with food, there is a 1.5 to 2.0 fold increase in the plasma levels and the AUC of the main active acid metabolite of ebastine. This increase does not alter the Tmax. The administration of ebastine with food does not cause a modification in its clinical effect.

Food Interaction

  • Take with or without food. Taking ebastine with food may increase its bioavailability.

Pregnancy & Breastfeeding use

The safety of Ebastina Generis during pregnancy and lactation has not been established.

Contraindication

Patients with a known hypersensitivity to Ebastina Generis or any of its ingredients.

Acute Overdose

No clinically meaningful signs or symptoms were observed up to 100 mg given once daily. There is no specific antidote for Ebastina Generis. In case of accidental over dosages, gastric lavage, monitoring of vital functions including ECG, and symptomatic treatment should be carried out.

Storage Condition

Store below 25° C.

Innovators Monograph

You find simplified version here Ebastina Generis

Ebastina Generis contains Ebastine see full prescribing information from innovator Ebastina Generis Monograph, Ebastina Generis MSDS, Ebastina Generis FDA label

FAQ

What is Ebastina Generis used for?

Ebastina Generis is a second-generation antihistamine which has been shown to be an effective treatment for both seasonal and perennial allergic rhinitis.

How safe is Ebastina Generis?

Ebastina Generis appears to be a safe, effective and well-tolerated second-generation antihistamine in the treatment of allergic rhinitis and chronic idiopathic urticaria.

How does Ebastina Generis work?

Ebastina Generis works by inhibiting the H1 receptor that is mainly responsible for allergic responses like hives (skin rash triggered by a reaction).

What are the common side effects of Ebastina Generis?

Common side effects of Ebastina Generis are include:

  • Nausea
  • Drowsiness
  • Dry mouth
  • Nose bleed
  • Weakness
  • Indigestion
  • Sleepiness
  • Headache
  • Drowsiness
  • Abdominal pain
  • Pharyngitis
  • Dyspepsia
  • Asthenia
  • Sinusitis

Is Ebastina Generis safe during pregnancy?

It is preferable to avoid the use of Ebastina Generis during pregnancy.

Is Ebastina Generis safe during breastfeeding?

Preliminary evidence indicates that the amounts in milk are unlikely to affect a breastfed infant.

Can I drink alcohol with Ebastina Generis?

Do not drink alcohol while taking this medication as it may cause increased sleepiness. Stop taking Ebastina Generis at least three days before taking an allergy test as it can affect the test results.

Can I drive after taking Ebastina Generis?

Do not drive if you experience drowsiness after taking this medicine.

How many time can I take Ebastina Generis daily?

One 10mg tablet is usually taken once a day. 

Can I take Ebastina Generis on an epmty?

It should be taken regardless of food or meal.

How long does Ebastina Generis take to work ?

The effect of this medicine can be observed within 1 to 3 hours of administration of the dose. The effect of this medicine lasts for an average duration of 24 hours.

How long does Ebastina Generis stay in my system?

The pharmacokinetics of Ebastina Generis is linear in the therapeutic dose range; maximum plasma concentrations of Ebastina Generis are achieved 4–6 h after dosing; and steady-state is reached after 4 days.

Is Ebastina Generis safe for heart patients?

The overall cardiac tolerability of Ebastina Generis is excellent. In Ebastina Generis dose-ranging studies in adults and children, there were no meaningful dose-related changes in the QTc interval.

Is it safe to stop taking Ebastina Generis ?

Do not stop taking Ebastina Generis without talking to your doctor. Your doctor may start you on a low dose of Ebastina Generis and increase your dose after 4 to 6 weeks. Your doctor may increase your dose again 3 or more months later.

What happen If I missed Ebastina Generis?

If you missed any dose, take it as early as you remember. If it is time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose of medicine to compensate for a missed one.

What happen if I overdose on Ebastina Generis?

The symptoms of barnd overdose include increased heart rate, abnormal behaviour, headache, dizziness, oliguria low urine output), and gastrointestinal disorders. Consult your doctor immediately if you happen to take an overdose of this medicine

Is Ebastina Generis safe for heart patients?

The overall cardiac tolerability of Ebastina Generis is excellent. In Ebastina Generis dose-ranging studies in adults and children, there were no meaningful dose-related changes in the QTc interval.

Can I take Ebastina Generis every day?

The recommended dose of Ebastina Generis tablets is one 5 mg tablet once daily.

Does Ebastina Generis cause drowsiness?

Some of the common and major side effects of Ebastina Generis are: Nausea, Drowsiness.

*** Taking medicines without doctor's advice can cause long-term problems.
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