Ebastine Substipharm
Ebastine Substipharm Uses, Dosage, Side Effects, Food Interaction and all others data.
Ebastine Substipharm, 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 | Ebastine Substipharm |
| 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 | Netherlands |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Ebastine Substipharm is used for the symptomatic treatment of: Seasonal and perennial allergic rhinitis, Idiopathic chronic urticaria.
Ebastine Substipharm is also used to associated treatment for these conditions: Allergic Rhinitis (AR)
Dosage
Ebastine Substipharm 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.
Ebastine Substipharm 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. Ebastine Substipharm 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. Ebastine Substipharm 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 Ebastine Substipharm during pregnancy and lactation has not been established.
Contraindication
Patients with a known hypersensitivity to Ebastine Substipharm 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 Ebastine Substipharm. 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 Ebastine Substipharm
Ebastine Substipharm contains Ebastine see full prescribing information from innovator Ebastine Substipharm Monograph, Ebastine Substipharm MSDS, Ebastine Substipharm FDA label
FAQ
What is Ebastine Substipharm used for?
Ebastine Substipharm is a second-generation antihistamine which has been shown to be an effective treatment for both seasonal and perennial allergic rhinitis.
How safe is Ebastine Substipharm?
Ebastine Substipharm appears to be a safe, effective and well-tolerated second-generation antihistamine in the treatment of allergic rhinitis and chronic idiopathic urticaria.
How does Ebastine Substipharm work?
Ebastine Substipharm 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 Ebastine Substipharm?
Common side effects of Ebastine Substipharm are include:
- Nausea
- Drowsiness
- Dry mouth
- Nose bleed
- Weakness
- Indigestion
- Sleepiness
- Headache
- Drowsiness
- Abdominal pain
- Pharyngitis
- Dyspepsia
- Asthenia
- Sinusitis
Is Ebastine Substipharm safe during pregnancy?
It is preferable to avoid the use of Ebastine Substipharm during pregnancy.
Is Ebastine Substipharm safe during breastfeeding?
Preliminary evidence indicates that the amounts in milk are unlikely to affect a breastfed infant.
Can I drink alcohol with Ebastine Substipharm?
Do not drink alcohol while taking this medication as it may cause increased sleepiness. Stop taking Ebastine Substipharm at least three days before taking an allergy test as it can affect the test results.
Can I drive after taking Ebastine Substipharm?
Do not drive if you experience drowsiness after taking this medicine.
How many time can I take Ebastine Substipharm daily?
One 10mg tablet is usually taken once a day.
Can I take Ebastine Substipharm on an epmty?
It should be taken regardless of food or meal.
How long does Ebastine Substipharm 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 Ebastine Substipharm stay in my system?
The pharmacokinetics of Ebastine Substipharm is linear in the therapeutic dose range; maximum plasma concentrations of Ebastine Substipharm are achieved 4–6 h after dosing; and steady-state is reached after 4 days.
Is Ebastine Substipharm safe for heart patients?
The overall cardiac tolerability of Ebastine Substipharm is excellent. In Ebastine Substipharm dose-ranging studies in adults and children, there were no meaningful dose-related changes in the QTc interval.
Is it safe to stop taking Ebastine Substipharm ?
Do not stop taking Ebastine Substipharm without talking to your doctor. Your doctor may start you on a low dose of Ebastine Substipharm 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 Ebastine Substipharm?
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 Ebastine Substipharm?
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 Ebastine Substipharm safe for heart patients?
The overall cardiac tolerability of Ebastine Substipharm is excellent. In Ebastine Substipharm dose-ranging studies in adults and children, there were no meaningful dose-related changes in the QTc interval.
Can I take Ebastine Substipharm every day?
The recommended dose of Ebastine Substipharm tablets is one 5 mg tablet once daily.
Does Ebastine Substipharm cause drowsiness?
Some of the common and major side effects of Ebastine Substipharm are: Nausea, Drowsiness.
