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Adrelid

Shrezar Healthcare Nig. Ltd
Onike, Yaba, Lagos, Nigeria.
Email: info@shrezarhealth.com
Tel: 234 1 7929821, 234 1 4548179

Brand Name

Adrelid

Manufacturer

SHREECHEM PHARMACEUTICALS PVT. LTD. R-914/915, T.T.C. Indl. Area, Navi Mumbai - 400701, INDIA.

Therapeutic Class

Anesthetics, Local

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Injection(NRN: A4-8387): Each mL contains Lidocaine HCI BP 2% w/v Adrenaline Acid Tartrate BP Equivalent to Adrenaline 1: 100000 (0.0 1 mg) Water for Injection BP q.s.

Pack size: Pack of 25 vials, 1 vial of 50 mL.

Adrelid Injection

Pharmacology

Lidocaine (lignocaine) is a local anesthetic. At high doses lidocaine has a quinidine like action on the myocardium i.e. cardiac depressant. All local anaesthetics stimulate the CNS and may produce anxiety, restlessness and tremors.

Combination with adrenaline restricts systemic spread of lidocaine (lignocaine) and its systemic adverse effects. Adrenaline also prolongs the duration of local anesthetic effect of lidocaine.

Indications

ADRELID (LIDOCAINE & ADRENALINE) Injection is indicated for the production of local anaesthesia by Local infiltration and Minor and major nerve blocks.

Contra-indications

ADRELID (LIDOCAINE & ADRENALINE) Injection is contraindicated in Hypersensitivity to local anaesthetics of the amide type, or to any of the excipients. Hypersensitivity to methyl and/or propyl paraben.

Formulations of lidocaine containing parabens should be avoided in patients allergic to ester local anaesthetics.

Precautions/Warnings

WARNING: Do not use the solution if any particle, leakage or breakage is found.

Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available. When performing major blocks, or using large doses, an IV cannula should be inserted before the local anaesthetic is injected.

PRECAUTIONS:
Some patients require special attention in order to reduce the risk of dangerous side effects.
- Patients with epilepsy.
- Patients with impaired respiratory function.
- The elderly and patients in poor general condition.
- Patients with partial or complete heart conduction block· due to the fact that local anaesthetics may depress myocardial conduction.
- Patients with advanced liver disease or severe renal dysfunction.
- Patients treated with anti-arrhythmic drugs class lll (e.g. amiodarone) should be under close surveillance and ECG monitoring considered,   since cardiac effects may be additive.
- Patients with acute porphyria.

LIDOCAINE & ADRENALINE Injection is probably porphyrinogenic and should only be prescribed to patients with acute porphyria on strong or urgent indications. Appropriate precautions should be taken for all porphyric patients,
Solutions containing adrenaline should be used with caution in patients with hypertension, cardiac disease, cerebrovascular insufficiency hyperthyroidism, advanced diabetes and any other pathological condition that may be aggravated by the effects of adrenaline.

Use in Pregnancy & Lactation:
Although there is no evidence from animal studies of harm to the foetus, as with all drugs, LIDOCAINE & ADRENALINE Injection should not be given during early pregnancy unless the benefits are considered to outweigh the risks.
The addition of adrenaline may potentially decrease uterine blood flow and contractility, especially after inadvertent injection into maternal blood vessels.

Foetal adverse effects due to local anaesthetics, such as foetal bradycardia, seem to be most apparent in paracervical block anaesthesia. Such effects may be due to high concentrations of anaesthetic reaching the foetus.

Lidocaine may enter the mother's milk, but in such small amounts that there is generally no risk of this affecting the neonate. It is not known whether adrenaline enters breast milk or not, but it is unlikely to affect the breast-fed child.

Interactions

Adverse Effects

Adverse reactions to Lidocaine & Adrenaline are rare and are usually the result of excessively high blood concentrations due to inadvertent intravascular injection, excessive dosage, rapid absorption or occasionally to hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. In such circumstances systemic effects occur involving the central nervous system and/or the cardiovascular system.

Common:

Vascular disorders: Hypo tension, hypertension

Gastrointestinal disorders: Nausea, vomiting

Nervous system disorders: paraesthesia, dizziness

Cardiac disorders: bradycardia

Uncommon:

Nervous system disorders: Convulsions, Numbness of tongue and Paraesthesia circumoral, Tinnitus, Tremor, Dysarthria, Hyperacusis, Visual disturbances, CNS depression.

Rare:

Cardiac disorders: Cardiac arrest, Cardiac arrhythmias

Immune system disorders: Allergic reactions, Anaphylactic reaction

Respiratory disorders: Respiratory depression

Nervous system disorders: Neuropathy, peripheral nerve injury, Arachnoiditis

Eye disorders: Diplopia

OVERDOSE: Accidental intravascular injections of local anaesthetics may cause immediate systemic toxic reactions. In the event of overdose, systemic toxicity appears later (1560 minutes after injection) due to the slower increase in local anaesthetic blood concentration.

Dosage & Administration

The dosage should be adjusted according to the response of the patient and the site of administration. The lowest concentration and smallest dose producing the required effect should be given. The dosage varies depending on the area to be anaesthetised, vascularity of the tissues, number of neuronal segments to be blocked, individual tolerance and the anaesthetic technique.

The lowest dosage needed to provide anaesthesia should be administered. Unnecessarily high doses of local anaesthetics are to be avoided. In general, surgical anaesthesia (e.g. epidural administration) requires the use of higher concentrations and doses. When blocking smaller nerves, or when a less intense block is required, the use of a lower concentration is indicated.

The volume of drug used will affect the extent and spread of anaesthesia. The maximum dose for healthy adults should not exceed 200 mg. Care should be taken to prevent acute toxic reactions by avoiding intra vascular injection. Careful aspiration before and during the injection is recommended. When a large dose is to be injected, e.g. in epidural block, a test dose of 3-5 mL of lidocaine containing adrenaline (epinephrine) is recommended.

An accidental intravascular injection may be recognised by a temporary increase in heart rate. The main dose should be injected slowly while keeping in constant verbal contact with the patient. If toxic symptoms occur, the injection should be stopped immediately.

Children: The dosage should be calculated on a weight basis and should not exceed 5 mg/kg.

Storage/Handling Recommendations

Store below 25°C in a dry place. Protect from light.

Keep all medicines out of reach of children.

WARNING: Do not use the solution if any particle, leakage or breakage is found.

Review Date

2015-10-12 04:34:04