| Product Name: | Lidocaine Hydrochloride Injection USP |
| Brand Name: | Generic |
| Strength: | 10mg/1ml (1%), 20mg/1ml (2%), 50mg/1ml(5%) |
| Dosage Form: | Liquid Injection (Sterile and Nonpyrogenic) |
| Packing: | 1%(2ml, 5ml, 10ml 20ml,30ml, 50ml Vial/Ampoule), 2%(2ml, 5ml, 10ml, 20ml, 50ml Vial/Ampoule), 5%(50ml Vial) |
| Route of Administration: | For Infiltration and Nerve Block |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Local Anesthetic, Antiarrhythmic (Class IB) |
| Indication: | Lignocaine Injection belongs to two groups of medicines known as local anesthetics and antiarrhythmic drugs. Local anesthetics stop pain and feeling in the area around where it is injected; and antiarrhythmic drugs work by restoring irregular and/or rapid heartbeats to normal. |
| Storage: | Store at 20°C to 25°C (68°F to 77°F) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Lidocaine Hydrochloride Injection USP 10mg/1ml (1%)
- Lidocaine Hydrochloride Injection USP 20mg/1ml (2%)
- Lidocaine Hydrochloride Injection USP 50mg/1ml (5%)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lidocaine Hydrochloride Injection USP 10mg/1ml (1%)
Each ml contains:
Lidocaine Hydrochloride Anhydrous USP
Eq to Lidocaine Hydrochloride…………..10mg
Sodium chloride USP………………………….7mg
Methylparaben USP (preservative)…….1mg
Water for Injection USP……………………..q.s - Lidocaine Hydrochloride Injection USP 20mg/1ml (2%)
Each ml contains:
Lidocaine Hydrochloride Anhydrous USP
Eq to Lidocaine Hydrochloride…………..20mg
Sodium chloride USP………………………….7mg
Methylparaben USP (preservative)…….1mg
Water for Injection USP……………………..q.s - Lidocaine Hydrochloride Injection USP 50mg/1ml (5%)
Each ml contains:
Lidocaine Hydrochloride Anhydrous USP
Eq to Lidocaine Hydrochloride…………..50mg
Sodium chloride USP………………………….7mg
Methylparaben USP (preservative)…….1mg
Water for Injection USP……………………..q.s
THERAPEUTIC INDICATIONS:
Lignocaine Injection belongs to two groups of medicines known as local anaesthetics and antiarrhythmic drugs. Local anaesthetics stop pain and feeling in the area around where it is injected; and antiarrhythmic drugs work by restoring irregular and/or rapid heartbeats to normal.
DIRECTION OF USE:
For Infiltration and Nerve Block.
Use Aseptic Technique. Remove cover from plastic vial and cleanse stopper with antiseptic.
See package insert for full prescribing information.
CAUTION & Warning:
CAUTION: The injection should not be used if it contains visible particulate matter.
Not for Epidural or Caudal use.
Use only if seal is intact and undamaged.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68°F to 77°F).
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.