Stiba5 mg/5 ml

Stiba is a second-generation (non-sedating) H1-antihistamine indicated for the following, in order of evidence strength:

• Established/approved uses:
  • Symptomatic relief of seasonal allergic rhinitis (hay fever) — sneezing, rhinorrhea, nasal itching/congestion, and itchy/watery eyes.
  • Symptomatic relief of perennial allergic rhinitis.
  • Chronic idiopathic urticaria (hives) — reduction of pruritus and number/size of wheals.
• Guideline-supported use: As part of a stepwise allergic rhinitis/urticaria treatment plan per allergy society guidelines, generally as monotherapy; combination with intranasal corticosteroids may be used for inadequate response to Stiba alone in allergic rhinitis.

Stiba only relieves symptoms; it does not cure the underlying allergic condition.

Each tablet/orodispersible tablet of Ebastine is formulated with Ebastine as the active pharmaceutical ingredient, commonly available as 10 mg and 20 mg tablets and as a 5 mg/5 mL oral syrup, along with standard pharmaceutically acceptable excipients (binders, fillers, disintegrants, sweeteners/flavoring for the syrup and orodispersible forms).

Stiba is a long-acting, selective peripheral histamine H1-receptor antagonist belonging to the second-generation (non-sedating) antihistamine class. After oral administration it undergoes extensive first-pass hepatic metabolism, primarily via CYP3A4, to its pharmacologically active metabolite, carStiba, which is responsible for most of its clinical antihistaminic effect. Stiba has a low propensity to cross the blood-brain barrier at recommended doses, giving it a low-sedation profile compared with first-generation antihistamines.

Second-generation (non-sedating) selective H1-receptor antagonist (antihistamine).

Ebastine selectively and competitively blocks peripheral histamine H1-receptors, preventing histamine-mediated vasodilation, increased capillary permeability, and stimulation of sensory nerve endings that produce the classic allergic symptoms of sneezing, itching, rhinorrhea, and wheal-and-flare reactions.

Following oral intake, Ebastine is rapidly absorbed and almost completely converted by first-pass hepatic metabolism (mainly CYP3A4) into its active carboxylic acid metabolite, carebastine, which has a plasma elimination half-life of approximately 10–19 hours, supporting once-daily dosing. Onset of antihistaminic effect is generally within 1–3 hours, with a duration of action of 24 hours or longer. At recommended doses, Ebastine has minimal central nervous system penetration and negligible anticholinergic activity, accounting for its low sedation and dry-mouth profile relative to first-generation antihistamines.

Take Stiba by mouth once daily, at about the same time each day, with or without food. Orodispersible tablets dissolve on the tongue; conventional tablets should be swallowed whole with water; syrup should be measured accurately with the supplied measuring device. Do not exceed the dose recommended by your physician.

The following interactions with Stiba are clinically significant:

• Strong CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, and similar agents): Co-administration increases plasma concentrations of Stiba and its active metabolite carStiba and can further prolong the QT interval. Concurrent use should be avoided or undertaken with caution and ECG monitoring, particularly at higher doses of Stiba.
• CYP3A4 inducers (e.g., rifampicin): May reduce plasma levels of Stiba/carStiba and its antihistaminic efficacy.
• Other QT-prolonging drugs: Concomitant use with other agents known to prolong the QT interval, or in patients with hypokalemia/hypomagnesemia, should be approached with caution due to additive risk of QT prolongation.
• CNS depressants/alcohol: Although Stiba itself has a low sedative profile, caution is advised with alcohol or sedating drugs as mild additive sedation is possible in some individuals.

No clinically significant interactions have been demonstrated between Stiba and theophylline, warfarin, cimetidine, or diazepam.

Most patients tolerate Stiba well. Reported adverse effects include:

• Very common/common: Dry mouth, headache, somnolence (drowsiness).
• Uncommon: Dizziness, altered taste (dysgeusia), abdominal pain, dyspepsia, nausea, insomnia.
• Rare: Hypersensitivity reactions (including angioedema, rash), palpitations, and, rarely, abnormalities in liver enzymes/hepatitis.

Patients should seek prompt medical attention for signs of a severe allergic reaction (facial/throat swelling, difficulty breathing) or palpitations/irregular heartbeat while taking Stiba.

Pregnancy: Data on the use of Stiba in pregnant women are limited. Animal reproduction studies have not shown clear evidence of harm, but human safety has not been firmly established. As a precaution, Stiba should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; consult a physician before use.

Lactation: It is not well established whether Stiba or its active metabolite passes into human breast milk in clinically significant amounts. As a precaution, use during breastfeeding is generally discouraged unless considered necessary by a physician, who should weigh the benefits of treatment against any possible risk to the nursing infant.

• QT prolongation: Stiba should be used with caution in patients with known QT-interval prolongation, uncorrected electrolyte disturbances (particularly hypokalemia or hypomagnesemia), significant cardiac disease, or when co-administered with other QT-prolonging drugs or strong CYP3A4 inhibitors (see Interactions). Higher doses of Stiba carry a greater theoretical risk.
• Hepatic impairment: Use with caution in patients with severe hepatic impairment; dose should not exceed 10 mg once daily in this group (see Use in Special Populations).
• Excipients: Some formulations of Stiba (e.g., orodispersible tablets) may contain aspartame or lactose — caution in patients with phenylketonuria, galactose intolerance, or lactase deficiency.
• Driving/operating machinery: Although Stiba has a low-sedation profile, individual sensitivity varies; patients should assess their own response before driving or operating machinery.

Clinical experience with Stiba overdose is limited; doses up to 100 mg have not produced clinically significant symptoms beyond a modest, generally asymptomatic prolongation of the QT interval. Possible features of overdose include drowsiness, headache, and antimuscarinic-type symptoms (dry mouth, tachycardia).

There is no specific antidote. In case of suspected overdose of Stiba, seek immediate medical attention or contact a poison control center/emergency services. Management is supportive and may include gastric lavage if presenting soon after ingestion, cardiac (ECG) monitoring, and symptomatic treatment under medical supervision.

Store at room temperature (below 30°C), in the original package, protected from light and moisture. Keep out of reach of children.

• Pediatric: Use of Stiba is established for children 2 years and older using age-appropriate syrup or tablet doses; safety and efficacy of the 20 mg dose have not been established in children. See Dosage & Administration and Pediatric Uses.
• Elderly: No dose adjustment is generally required based on age alone, but elderly patients may have higher likelihood of concomitant QT-prolonging medications or cardiac conditions, warranting caution with Stiba.
• Renal impairment: No dose adjustment is generally required.
• Hepatic impairment: No adjustment needed for mild-to-moderate impairment; in severe hepatic impairment, limit Stiba to a maximum of 10 mg once daily.
• Pregnancy/lactation: See Pregnancy and Lactation section.

Duration of treatment with Stiba depends on the condition and symptom pattern: seasonal allergic rhinitis may be treated for the duration of the pollen/allergen season, perennial allergic rhinitis and chronic idiopathic urticaria may require longer-term, continuous daily use as directed by a physician. Response should be reassessed periodically, and use should not continue indefinitely without medical review.

Antihistamines (H1-receptor antagonists) — second-generation, non-sedating.

Ebastine and its active metabolite carebastine act as selective, competitive antagonists at peripheral histamine H1-receptors. By blocking histamine binding, Ebastine inhibits histamine-induced increases in vascular permeability, vasodilation, smooth muscle contraction, and sensory nerve stimulation, thereby reducing the sneezing, itching, rhinorrhea, nasal congestion, and wheal-and-flare responses characteristic of allergic disease. Its limited penetration of the blood-brain barrier at therapeutic doses accounts for its low sedative potential compared with first-generation antihistamines.

Use of Stiba in the pediatric population is generally established from age 2 years onward for allergic rhinitis, using age- and weight-appropriate syrup or tablet strengths (see Dosage & Administration). Safety and efficacy of Stiba for chronic idiopathic urticaria and for the 20 mg dose have not been established in children under 12 years, and such use should follow physician guidance. Children should be dosed according to the lowest effective strength for their age group.