⚡ Quick Answer — What is Ondem Injection?
Ondem Injection zawiera ondansetron 2 mg/ml in 2 ml ampoules (4 mg total) — a selective serotonin antagonista receptorów 5-HT3 used in hospitals to prevent and treat wywołanym chemioterapią, wywołanym radioterapią, oraz post-operative nausea and vomiting (PONV). Administered by a healthcare professional intravenously (slow push or short infusion) or intramuscularly. Onset within 5–10 minutes IV. Manufactured by Alkem Laboratories — the generic equivalent of Zofran injection. FDA single-dose cap 16 mg IV due to QT signal at higher doses.
📦 Każde zamówienie jest objęte naszą Reshipment Assurance Policy — jeśli Twoja przesyłka nie dotrze w ciągu 20 dni roboczych, wysyłamy ją ponownie.
Dlaczego warto zamawiać z MedsBase
Nasze leki generyczne pochodzą od producentów posiadających certyfikat WHO-GMP i są wysyłane na cały świat w dyskretnym, zwykłym opakowaniu — bez nazwy leku na zewnątrz przesyłki. Płatności kartami są kierowane przez regulowanego procesora (opis wyciągu zawiera nazwę regulowanego procesora płatności — nigdy “MedsBase” ani żadnej nazwy leku). Akceptujemy również kryptowaluty i przelewy bankowe SEPA. Każde zamówienie jest objęte naszą Reshipment Assurance Policy.
Dlaczego warto zamawiać z MedsBase
Ondem Injection is supplied from a producenta certyfikowanego przez WHO-GMP. Każde zamówienie jest wysyłane dyskretnie na całym świecie i objęte naszą Reshipment Assurance Policy — if it does not arrive within 20 business days, we reship at no cost. Ondem Injection is the global standard parenteral 5-HT3 antagonist for inpatient antiemesis. Alkem is one of India’s largest WHO-GMP injectable manufacturers and the formulation is bioequivalent to the reference brand.
Mechanizm działania
Chemotherapy, radiation, and surgical stress damage gut enterochromaffin cells, releasing massive amounts of serotoniny (5-HT). The serotonin binds 5-HT3 receptors on vagal afferents and on the chemoreceptor trigger zone (area postrema), generating the strongest known oral/intestinal emetic stimulus. Ondansetron is a highly selective antagonist at the 5-HT3 receptor — it interrupts this signal at both peripheral and central sites without affecting D2, H1, muscarinic, or alpha-adrenergic receptors. The clean receptor profile explains the absence of sedation, extrapyramidal reactions, and anticholinergic side effects that limit older antiemetics like prochlorperazine and metoclopramide.
Wskazania
- CINV: moderately or highly emetogenic chemotherapy — usually with dexamethasone ± aprepitant for highly emetogenic regimens.
- Nudności wywołane radioterapią: total body irradiation, high-dose abdominal/pelvic radiation.
- Nudności i wymioty pooperacyjne (PONV): single 4 mg dose at induction or end of surgery; prophylaxis for high-risk patients (Apfel score ≥ 2).
- Severe gastroenteritis in patients unable to retain oral fluids.
- Refractory hyperemesis gravidarum — second/third-line after doxylamine+B6 and metoclopramide.
Dawka
| Wskazanie | Dawka |
|---|---|
| CINV (highly emetogenic) | 8 mg slow IV (over > 15 min) 30 min before chemo, then 8 mg every 4 h × 2 doses, then transition to oral 8 mg every 12 h |
| CINV (moderately emetogenic) | 8 mg slow IV 30 min before chemo, then transition to oral |
| Nudności i wymioty pooperacyjne (dorośli) | 4 mg slow IV at induction or end of surgery (single dose); some protocols 8 mg for high-risk |
| Pediatryczne (CINV) | 5 mg/m² IV before chemo (max 8 mg per dose); weight-based for gastroenteritis |
| Maksymalna dawka jednorazowa | 16 mg IV (FDA cap due to QT signal); slow IV push over 30 sec or short infusion 15 min |
| Ciężka niewydolność wątroby | Maksymalnie 8 mg/dobę (Child-Pugh C) |
Compatible with 0.9% sodium chloride and 5% dextrose; do not mix in the same syringe with other drugs. Administer slow IV (over 30 seconds for push or 15 min for infusion) — rapid bolus increases the QT signal.
Efekty uboczne
- Częste: headache (often within minutes of injection), constipation, mild flushing, transient AST/ALT rise, fatigue
- Rzadsze: dizziness, hot flushes, hiccups, mild bradycardia, hypotension after rapid IV
- Rzadkie, ale poważne: QT prolongation/torsades (especially with single doses > 16 mg), serotonin syndrome (with SSRIs/SNRIs/triptans), severe hypersensitivity, transient blindness (very rare), arrhythmia
- Niezbyt częste: reakcje pozapiramidowe (rzadko w przypadku ondansetronu w przeciwieństwie do starszych leków przeciwwymiotnych)
Interakcje lekowe
- Apomorfina: ABSOLUTNE przeciwwskazanie — zgłaszano ciężkie niedociśnienie i utratę przytomności.
- Inne leki wydłużające odstęp QT (azytromycyna, klarytromycyna, citalopram, escitalopram, metadon, amiodaron, sotalol, fluorochinolony, hydroksychlorochina, leki przeciwpsychotyczne): unikać kombinacji lub monitorować EKG.
- Leki serotoninergiczne (SSRIs, SNRIs, MAOIs, triptans, tramadol, fentanyl, linezolid, methylene blue): rare serotonin syndrome reported.
- Silne induktory CYP3A4 (rifampicin, phenytoin, carbamazepine): may lower ondansetron levels and reduce efficacy.
- Tramadol: ondansetron może zmniejszać efekt przeciwbólowy tramadolu (blokada 5-HT3 zakłóca hamowanie bólu w drodze zstępującej).
Najczęściej zadawane pytania
How quickly does Ondem Injection work?
Onset is within 5–10 minutes after slow IV push and 15–30 minutes after IM injection. Antiemetic effect lasts 8–12 hours. The IV form is preferred for active vomiting where oral routes are unreliable.
Why is the IV ondansetron dose capped at 16 mg?
FDA review of cardiac safety data found that single IV doses > 16 mg significantly increase the risk of QT prolongation and torsades-de-pointes. The 16 mg cap applies to single doses; total daily dose can still be 24 mg given as 8 mg every 8 hours.
Can Ondem Injection be given IM?
Yes — IM is a reasonable route when IV access is difficult, with onset 15–30 minutes (slower than IV but faster than oral). The standard IM dose is 4 mg; do not exceed 16 mg per single dose.
Can Ondem Injection be used in pregnancy?
Reserved for refractory hyperemesis gravidarum after doxylamine+B6 and metoclopramide have failed. Some observational studies suggest a small first-trimester cardiac and cleft-palate signal — weigh against the maternal risk of severe untreated hyperemesis. Specialist supervision recommended.
Is Ondem Injection safe in children?
Yes — weight or BSA-based dosing is well established for paediatric chemotherapy and severe gastroenteritis. The dose is typically 5 mg/m² IV before chemo (max 8 mg) or weight-based (0.15 mg/kg) for gastroenteritis.
Why does Ondem Injection cause constipation?
5-HT3 receptors in the gut wall regulate gut motility — blocking them reduces peristalsis and slows colonic transit. Constipation is the most clinically meaningful side effect; pre-empt with hydration, fibre, and prophylactic laxatives during multi-day chemo courses.
Does Ondem Injection cause sedation?
No. Unlike promethazine, prochlorperazine, and metoclopramide, ondansetron does not cause sedation, extrapyramidal reactions, or anticholinergic side effects.
Can Ondem Injection be mixed with chemotherapy in the same line?
Ondansetron is incompatible with several chemotherapy agents in the same syringe; flush the line with normal saline between drugs. Compatibility is product-specific and should be checked against pharmacy guidelines for each chemotherapy combination.
What if a single dose > 16 mg is needed?
For highly emetogenic chemotherapy, give 8 mg slow IV every 4 hours rather than a single high dose. Switching to a different 5-HT3 (granisetron, palonosetron) or adding an NK1 antagonist (aprepitant) is usually a better strategy than exceeding the 16 mg single-dose cap.
How is Ondem Injection stored?
Store ampoules at room temperature (15–25°C), protect from light. Do not freeze. Inspect the solution before use — it should be clear and colourless.
Inne metody leczenia nudności
- Ondem (ondansetron oral tablet — oral switch after IV)
- Emeset 4 ODT (oral disintegrating — transition from IV)
- Granicip (granisetron — once-daily 5-HT3)
- Dompewal (domperidone — alternative class)
- Stemetil MD (prochlorperazine ODT — rescue antiemetic)
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