- Enoxaparin: 20 mg/0.2 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL prefilled syringes
- Dalteparin: 2,500 IU/0.2 mL, 5,000 IU/0.2 mL, 7,500 IU/0.3 mL prefilled syringes
- Nadroparin: 2,850 IU/0.3 mL, 5,700 IU/0.6 mL prefilled syringes
- Tinzaparin: NOT AVAILABLE in India
- Certoparin: NOT AVAILABLE in India
- Reviparin: NOT AVAILABLE in India
Adult indications
Primary Indications (Approved / Standard in India)
Note: Enoxaparin is the most widely available and studied LMWH in India. Dosing below refers primarily to Enoxaparin unless otherwise specified.
1. Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
Clinical Notes:
- Duration: 5–10 days; overlap with oral anticoagulant (warfarin) until INR ≥2 for at least 24 hours
- Transition to DOAC (rivaroxaban, apixaban) may be considered after initial treatment
- Monitor platelet count for HIT surveillance
- Once-daily dosing (1.5 mg/kg) may be preferred for outpatient management
2. Prophylaxis of Venous Thromboembolism (VTE) in High-Risk Patients
(Post-operative, immobilised medical patients, critically ill)
Clinical Notes:
- Initiate 6–12 hours post-surgery once haemostasis is secured
- Duration: 7–14 days for general surgery; extend up to 35 days for major orthopaedic surgery (hip/knee replacement)
- Reduce to 20 mg SC once daily in patients with body weight <45 kg or high bleeding risk
- For medical patients, continue until patient is ambulatory
Alternative LMWH Dosing for VTE Prophylaxis:
3. Acute Coronary Syndromes (Unstable Angina / NSTEMI)
Clinical Notes:
- Duration: 2–8 days or until revascularisation
- Use in conjunction with dual antiplatelet therapy (aspirin + P2Y12 inhibitor)
- Reduce dose in elderly ≥75 years: 0.75 mg/kg SC every 12 hours (no initial IV bolus)
- In renal impairment (CrCl <30 mL/min): 1 mg/kg SC once daily
4. ST-Elevation Myocardial Infarction (STEMI) — With or Without Fibrinolysis
Clinical Notes:
- Duration: Until revascularisation or up to 8 days
- Adjust dose in renal impairment
- If PCI performed within 8 hours of last SC dose, no additional anticoagulation needed
- If PCI performed 8–12 hours after last SC dose, give additional 0.3 mg/kg IV bolus
5. Anticoagulation During Pregnancy
(Mechanical heart valves, VTE treatment/prophylaxis, thrombophilia)
Clinical Notes:
- Specialist initiation and monitoring mandatory
- Monitor anti-Xa levels 4 hours post-dose, especially with mechanical valves
- Discontinue 24 hours before planned delivery; switch to UFH if delivery imminent
- Resume 6–12 hours post-delivery if no bleeding
Secondary Indications — Adults (Off-label, if any)
Paediatric indications
Primary Indications (Approved / Standard in India)
Treatment of Venous Thromboembolism (DVT/PE), Arterial Thrombosis, Central Line-Associated Thrombosis
Note: Enoxaparin is the preferred LMWH for paediatric use in India per IAP and AIIMS protocols.
Titration:
- Check anti-Xa level 4 hours after 3rd or 4th dose
- Adjust dose by 10–25% increments to achieve target anti-Xa
- Recheck anti-Xa after each dose adjustment
Safety Monitoring:
- Baseline: CBC with platelet count, PT, aPTT, renal function, LFTs
- Platelet count every 2–3 days for first 2 weeks
- Anti-Xa levels mandatory for dose adjustment
- Monitor for bleeding (injection sites, mucous membranes, intracranial in neonates)
- Assess renal function periodically
Minimum Age: Use with caution in preterm neonates; specialist paediatric haematology supervision mandatory in neonates.
Secondary Indications — Paediatrics (Off-label, if any)
Age Restriction: Not recommended in preterm neonates except under specialist paediatric haematology or neonatology supervision with anti-Xa monitoring capability.
Renal Adjustments
Clinical Notes:
- Calculate creatinine clearance (Cockcroft-Gault) for accurate dosing decisions
- Anti-Xa monitoring recommended if LMWH must be used in severe renal impairment
- Dalteparin and Nadroparin also require dose reduction in renal impairment; specific guidance limited in Indian literature
- UFH is preferred in severe renal dysfunction due to reversibility and non-renal clearance
Contraindications
- Active major bleeding (gastrointestinal, intracranial, retroperitoneal)
- History of heparin-induced thrombocytopenia (HIT) type II
- Severe thrombocytopenia (platelet count <50,000/μL unless thrombotic emergency)
- Hypersensitivity to heparin, LMWH, or porcine-derived products
- Recent haemorrhagic stroke
- Severe uncontrolled hypertension
- Active bacterial endocarditis
- Recent or planned lumbar puncture, spinal, or epidural anaesthesia within inadequate time window
Cautions
- Recent major surgery, trauma, or invasive procedures
- History of peptic ulcer disease or gastrointestinal bleeding
- Spinal/epidural anaesthesia — strict timing protocols required (minimum 12 hours after prophylactic dose; 24 hours after therapeutic dose before procedure)
- Elderly patients (≥75 years) — increased bleeding risk
- Low body weight (<45 kg) — consider dose reduction
- Obesity (>100 kg) — may need higher doses; consider anti-Xa monitoring
- Uncontrolled hypertension
- Diabetic retinopathy with haemorrhagic risk
- Concurrent antiplatelet therapy
- Renal impairment (CrCl <30 mL/min) — drug accumulation risk
Pregnancy
Lactation
Elderly
- Starting dose: Use standard weight-based dosing for treatment; standard prophylactic doses acceptable
- Age ≥75 years with ACS/STEMI: Reduce dose to 0.75 mg/kg SC every 12 hours (no IV bolus)
- Titration: Not routinely required; reassess renal function before and during therapy
- Extra risks:
-
- Increased bleeding risk due to age-related vascular fragility
- Declining renal function — recalculate CrCl frequently
- Higher fall risk — assess and counsel
- Polypharmacy — review for drug interactions
- Increased sensitivity to anticoagulant effects
- Monitoring: More frequent CBC, renal function assessment, and clinical bleeding surveillance
Major drug interactions
Moderate drug interactions
Common Adverse effects
- Injection site pain, bruising, and haematoma (10–20%)
- Minor bleeding (gingival bleeding, epistaxis, haematuria)
- Mild thrombocytopenia (non-immune; within first 2 days)
- Transient elevation of hepatic transaminases
- Local skin irritation at injection site
Serious Adverse effects
- Heparin-induced thrombocytopenia (HIT) type II: Immune-mediated; typically day 5–14; paradoxical thrombosis; requires immediate discontinuation and alternative anticoagulation (fondaparinux, argatroban)
- Major haemorrhage: Intracranial, retroperitoneal, gastrointestinal — requires discontinuation; partial reversal with protamine sulfate (60–80% neutralisation)
- Spinal/Epidural haematoma: Associated with neuraxial anaesthesia; can cause permanent paralysis; strict timing protocols essential
- Skin necrosis at injection site: Rare
- Osteoporosis: With prolonged use (>3 months); less common than with UFH
- Hyperkalaemia: Due to aldosterone suppression; monitor potassium in prolonged use
- Anaphylaxis: Rare hypersensitivity reaction
Monitoring requirements
Anti-Xa Target Levels:
Brands in India
Enoxaparin:
- Clexane® (Sanofi)
- Lonopin® (Abbott)
- Enclex® (Cipla)
- Lupenox® (Lupin)
- Enoxaparin Injection IP (Alkem, Intas, Glenmark, multiple generics)
Dalteparin:
Nadroparin:
Note: Multiple generic enoxaparin formulations available; confirm dosage equivalence and bioequivalence before switching brands. LMWHs are not interchangeable with each other.
Price range (INR)
NLEM Status: Enoxaparin (6,000 IU injection) is included in NLEM 2022; NPPA price-controlled for ceiling prices.
Government Supply: Available through government hospitals and NHM procurement.
Clinical pearls
- Enoxaparin is the most widely available and best-studied LMWH in India; use it as the default choice unless specific indications favour alternatives
- LMWHs are not interchangeable — do not switch between enoxaparin, dalteparin, and nadroparin during a treatment course
- Anti-Xa monitoring is not routine but essential in: pregnancy (especially mechanical valves), extremes of body weight, renal impairment, paediatrics, and when therapeutic efficacy is uncertain
- Always calculate creatinine clearance before initiating LMWH, especially in elderly patients — even "normal" serum creatinine may mask significant renal impairment
- Strict timing protocols must be followed for neuraxial procedures: minimum 12 hours after prophylactic dose, 24 hours after therapeutic dose; reinitiate 4–6 hours after catheter removal
- Protamine sulfate provides only partial reversal (60–80%) of LMWH; in life-threatening bleeding, give protamine 1 mg per 1 mg enoxaparin (if given within 8 hours); consider anti-Xa levels and additional supportive measures
Version
RxIndia v1.0 — 29 May 2025
Reference
-
- CDSCO product information
- Indian Pharmacopoeia / National Formulary of India
- NLEM 2022
- AIIMS Drug Formulary and Anticoagulation Guidelines
- API Textbook of Medicine
- IAP Guidelines for Paediatric Thrombosis Management
- ICMR/National Guidelines for Management of VTE
- Cardiological Society of India (CSI) ACS Management Guidelines
- NCG Guidelines for Cancer-Associated Thrombosis
- Indian Society of Haematology and Blood Transfusion (ISHBT) protocols