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PROPERTIES

Nitriate Is A Short-acting Hypotensive Agent With A Duration Of Action Of 1 to 10 Minutes. It Produces Peripheral Vasodilatation And Reduces Peripheral Resistance By A Direct Action On Both Veins And Arterioles. Its Effect Appear Within A few Seconds Of IV Infusion And The Blood Pressure Should Be Monitored Closely During Administration.
Sodium Nitroprusside Is Converted In The Erythrocytes To Cyanide Which Is Metabolised In The Liver To Thiocyanate by the Enzyme Rhodanase In The Presence Of Thiosulphate And Slowly Excreted In The Urine.
The Plasma Half - Life Of Thiocyanate Is To Be About 3 to 7 Days And thiocyanate Can Accumulate To Toxic Concentrations If High Doses Of Sodium Nitroprusside Are Given For More Than 3 Days

COMPOSITION

Lyophilized

Sodium Nitroprusside (Expressed As The Dihydrate Salt)

Solvent Water For Injection

Pervial

50mg

4mL

PerBox

250mg

20mL

INDICATIONS

During Acute Hypertensive Crises Requiring Urgent Correction Of Arterial Blood pressure

In Anaesthesiology To Induce Controlled Hypotension During Surgical Operations

In Cardiology For Several Acute Cardiac Disorders , Especially Left Ventricular Failure

CONTRA INDICATIONS

The Usual Contraindications To Controlled Hypotension

Accentuated Declivitous Position Of The Patient

Hypovolemia

Thyroid Insufficiency

Sulphuryl Transferase Deficiency(Lang's Rhodanase)

PRECAUTIONS

Related To Clinical Context

In Patients With Impaired Renal Or Hepatic Function Increase Monitoring Of The Thiocyanate Level (It Must Not Exceed 5mg/100ml)

Some Aged Persons reacting More Markedly To Nitriate , A Cautious Initial Dosage Is required

Nitriate Should Be Administered Cautiously To Patients With Hypothyroidism , as Thiocyanate Inhibits Binding And Uptake Of Iodine

The Safety Of nitriate Has Not been Proved In Childern And Pregnant Women.

Surveillance Of Treatment During Treatment With Nitriate Monitoring Of Arterial Blood Gases And Daily Assay Of Plasma Thiocyanate Rate Are Required

ADVERSE EFFECT

Related To Induced Hypotension Nausea Vomiting , Headache, Sweating , Palpitations May Occur Following A Sudden Fall Of Blood Pressure But Someitems Also At the Beginning Of The Infucion. The following Effects May Be Exceptionally Observer

Inhibition Of The Normal way Of Degradation Of Sodium Nitroprusside With Accumulation Of Cyanide In Case Of Unexplained Metabolic Acidosis During Or Following Infusion , Anticyanide Treatment Should Be Started And The Blood Thiocyanate Level Should Be Monitored.

Occurrence Of Methaemoglobin With Cyanosis

Very Rare Cases Of Hypothyroidism Related To High Thiocyanate levels

DOSAGE AND ADMINSTRATION

ADMINSTRATION

Direct IV Injections Are Formally Contraindicated Inject Nitriate Solution By An Automatic syringeOr Or Infusion Pump While Monitiring Blood Pressure And Protected From Light

PREPRATION

Dissolve The Contents Of One Vial Of Nitriate With One Ampoule Of Solvent Immediately Before Use To Get The Desired Concentration Dilute The Obtained Solution Exclusively In 5% Glucoses Solution This Solution Should Not Be Used More Than 4 Hours After Prepration It Normally Has A Pale Brown Colour Replace The Solution If It Turns Blue Green Or Dark Red Do Not Add Any Other Drug To The Nitriate Solution

DOSAGE

In A Patient Not Receiving Any Other Hypotensive Drug. The Dossage Can Be Established As Follow:

Initial Does 0.5 Ug/Kg/Min, Gradually, Increase And Adjust The Flow Rate Untill The Expected Haemodynamic Effect Is Obtained;

Mean Does 3 Ug/Kg/Min, But There Could Be High Individual Variations.
It Is Recommended Not Be Exceed:

An Instantaneous Flow Rate Of 8 Ug/Kg/Min, For Treatments Exceding Several Hours.

A Total Does Of 1.2 Mg/Kg For ControlledHypotension In A Anaesthesiology, i.e 10 Ug/Kg/Min, For A Period Of 2 Hours.

If The Blood Pressure Is Not Markedly Reduced Within 10 Min At A Flow Rate Of 8 Ug/Kg/Min, Stop The NITRIATE Infusion. Ganglion Blocking Agents May Increase The Hypotension Effect Of NITRIATE .

OVERDOSSAGE

In Case Of Massive Overdossage With Sign Of Cyanide Poisoning Stop The Nitriate Infussion Immediately Treatment Of Cyanide Poisoning Is Administration Of Hydroxocobalamin Base (30 To 60 mg/kg By IV Injection) Or Sodium Nitrite And Thiosulphate

STORAGE

Nitriate Should Be Stored In A Cool Place Protected From Light

FROM AND PRESENTATIONS

Powder For Injection - Vial of 50 mg Of Sterile Lyophilized And 4-ml Ampoule Of Solvent Box Of 5 Vials Allow The Prepration Of A Basic Solution Which Can Only Be Injected After Dilution In 5% Glucose Solution


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