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Authoritative Clinical Reference
Schedule H
Intravenous (IV)
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Parameter Recommendation
Starting dose 0.25 mg/kg IV bolus administered over 1 minute, given 10–60 minutes before PCI
Titration Not applicable
Usual maintenance dose Continuous IV infusion at 0.125 mcg/kg/min immediately following bolus
Maximum dose 10 mcg/min infusion rate; infusion duration 12 hours (may extend to 24 hours in selected high-risk cases)
Clinical Notes:
Parameter Recommendation
Starting dose 0.25 mg/kg IV bolus over 1 minute
Titration Not applicable
Usual maintenance dose 0.125 mcg/kg/min continuous IV infusion for 12–24 hours
Maximum dose 10 mcg/min infusion rate
Clinical Notes:
Secondary Indications — Adults Only (Off-label)
Not applicable.
No established off-label indications in Indian clinical practice. Avoid use in:
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
NOT AVAILABLE in India
Secondary Indications — Paediatric (Off-label)
NOT AVAILABLE in India
Statement: Not recommended for use below 18 years except under specialist supervision in institutional research protocols.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|
Mild to moderate impairment No dose adjustment required
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| Haemodialysis | No specific data; use with extreme caution |
Note: Abciximab is not significantly cleared by kidneys, but bleeding risk increases with declining renal function.
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | No dose adjustment; use with caution |
| Severe impairment (Child-Pugh C) | Avoid use if coagulopathy present; increased bleeding risk; specialist decision only |
Aspect Recommendation
Overall safety statement Limited human data; animal studies suggest potential risk; use only if clearly needed
Preferred alternatives in Indian obstetric practice Low-dose aspirin; LMWH for anticoagulation needs
When it may be used Only in life-threatening maternal conditions where benefit outweighs risk; specialist decision mandatory
What to monitor Maternal platelet count, signs of bleeding, fetal wellbeing
Aspect Recommendation
Compatible with breastfeeding Not recommended
Preferred alternatives Defer breastfeeding for at least 24 hours post-infusion; consider aspirin if antiplatelet effect needed
Expected drug levels in milk Unknown; large molecular weight may limit transfer
What to monitor in infant Signs of bleeding, bruising if inadvertent exposure occurs
Aspect Recommendation
Recommended starting dose Standard dosing (0.25 mg/kg bolus followed by 0.125 mcg/kg/min infusion)
Need for slower titration Not applicable (single bolus + fixed-rate infusion)
Extra risks Significantly increased bleeding and thrombocytopenia risk in patients >75 years; higher incidence of major bleeding at vascular access sites; careful haemostasis essential; avoid unnecessary invasive procedures; closer platelet monitoring required
Interacting Drug Effect Recommendation
Oral anticoagulants (warfarin, acenocoumarol) Synergistic bleeding risk Contraindicated if INR >1.2
Thrombolytics (alteplase, streptokinase, tenecteplase) Markedly increased haemorrhagic risk Avoid concurrent use; use only in high-risk controlled settings
Unfractionated heparin Additive anticoagulation Required co-administration but monitor ACT closely; maintain ACT 200–300 seconds during PCI
Other GP IIb/IIIa inhibitors (eptifibatide, tirofiban) Overlapping mechanism; excessive platelet inhibition Avoid co-administration
Interacting Drug Effect Recommendation
Aspirin Synergistic antiplatelet effect Required co-therapy; increases bleeding risk—monitor closely
Clopidogrel / Prasugrel / Ticagrelor Enhanced platelet inhibition Often co-prescribed in PCI; increased bleeding—close monitoring essential
Low-molecular-weight heparins (enoxaparin) Additive bleeding risk Prefer single anticoagulant strategy; if used, adjust doses
NSAIDs Additive bleeding risk, GI toxicity Avoid concurrent use unless essential
Dextran Additive bleeding effect Avoid if possible
Adverse Effect Clinical Notes
Major haemorrhage GI bleeding, intracranial haemorrhage, retroperitoneal bleeding—may require transfusion or surgical intervention; discontinue immediately
Severe thrombocytopenia Platelet count <50,000/μL; may occur within 2–4 hours; discontinue and consider platelet transfusion
Anaphylaxis/severe hypersensitivity Rare; due to murine protein component; requires immediate discontinuation and emergency management
Pulmonary haemorrhage Rare; immediate discontinuation required
Cardiac tamponade Rare complication following coronary perforation
| Timing | Parameters |
|---|---|
| Baseline | Complete blood count (platelet count, haemoglobin, haematocrit), aPTT, PT/INR, serum creatinine, bleeding history |
During infusion Platelet count at 2–4 hours after bolus initiation, then at least once daily; ACT during PCI (target 200–300 seconds); continuous monitoring for bleeding at access sites, gums, urine
Post-infusion Platelet count monitoring for 24 hours post-completion; vascular access site observation for haematoma; haemoglobin if bleeding suspected
| Formulation | Approximate Price (per tablet) |
|---|---|
| 10 mg/5 mL vial ₹18,000–₹22,000 per vial |
Notes:
antiplatelet; GP IIb/IIIa inhibitor; PCI; interventional cardiology; ACS; NSTEMI; unstable angina; hospital-only; thrombocytopenia-risk; bleeding-risk; Schedule H; IV-only; India
RxIndia v1.0 — 04 Apr 2025
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