Dosage Strength & Form

10g/100ml (10%w/v) Fat Emulsion for Infusion (I.V.)

Descripton

Nirpid is stable fat emulsion prepared from Soybean Oil,Egg Lecithin,Glycerol and Water for Injection.Fat emulsion has the advantage of having high caloric yield. Nirpid is also Isotonic with blood and hence can be infused peripherally. The soybean oil of Nirpid provides essential fatty acid which helps to avoid essential fatty acid deficiency and its associated biochemical changes and clinical manifestation like scaly skin, growth retardation, sparse hair growth & delayed wound healing. A Parenteral feeding regimen, w/c contains carbohydrates, amino acid and fats provides a balanced metabolic load.Thus fat emulsions are indispensable unless fats are contraindicated.

Pharmacology

Nirpid is eliminated from the circulation via the same metabolic pathway as chylomicrons.Following IV injection, a transient hyperlipidemia occurs as the fat emulsion particles breakdown and release triglycerides. These exogenous triglycerides are hydrolyzed by lipoprotein lipase, a capillary endothelial enzyme that also metabolized endogenous serum triglycerides. Hence free Glycerol,free fatty acid and other glycerides are formed with adequate tissue perfusion. Intravenous fat emulsion are maximally cleared at the rate of 2-4g/kg/day. The free fatty acids either enter the tissue or circulate in the plasma & bind with albumin. Circulating free fatty acids are oxidized or converted to low-density lipo proteins that reenter the blood stream hence NIRPID is used as a source of energy. Choline helps to prevent deposition of the fats in the liver. Glycerol is oxidized to give energy and carbon dioxide or is used for synthesis of body fats.

Indications

Provides energy in Pre & Post-operative nutritional disturbances, Cancer & associated Cachexia,IV nutrition in Burns, G.I. tract diseases, Malabsorption, Impaired renal function, Prolonged unconsciousness-Head injury,Poisoning

Contraindications

Disturbances of fat metabolism,Advance liver disease, Acute shock,Egg allergies, Traumatic brain injury Coagulation disorders, Pulmonary hypertension

Warning

Nirpid should be given with caution to neonates and premature with hyperbillirubinemia and in cases with suspected pulmonary hypertension.In neonates particularly premature or long-term parenteral nutrition platelets counts,liver test and serum triglycerides concentration should be monitored.

Precautions

Before infusion,the patient’s liver function, haemogram, blood coagulation, platelets count and plasma lipid profile must be monitored. The lipid must be cleared from plasma after daily infusion

Caution

After the infusion is initiated the patient is closely observed for sings of acute hypersensitivity characterized by chills,palpitation,dyspnea. These reactions may be associated with faster flow rate and this occurrence necessitates a reduction in flow rate.

Do not store partially used bottle.Do not use the fluid if any separation of phases of the emulsion is visible.Emulsion should. Not be mixed with electrolytes or other additives.

Poor maternal weight gain increases the risk of delivery of a low birth weight infants,thus increasing the risk of neonatal death.Fat emulsion may be useful for preventing such nutritional deficits.Successful and safe administration of lipid emulsion in pregnant women has been reported.

Adverse Reactions

Rare adverse reactions occurred during infusion are two types. Immediate type reactions include febrile response, chills, shivering, pain in chest and back, palpitation, dizziness, tachypnea, hyper/hypotension,transient increase in liver enzymes.Delayed type reaction include hepatomegally, jaundice due to central lobularcholestasis, splenomegaly, thrombocytopenia, leucopenia. Too rapid infusions can lead to dilution of serum electrolytes, fat overload occurs during the infusion it must be postponed. Fat overload can be detected by milky appearance of plasma

Dosage

Adults: up to 2.5g/kg body weight/day, Infants: 0.5-4g/kg body weight/day

Infusion Rate

The infusion rate of NIRPID 10% for initial 15-30 min for adults should. Not exceed 1ml/min.If no adverse reaction are observed then subsequent infusion can be given over a period of 4 to 6 hrs. Infants: the infusion should be initiated at a rate of 0.1ml/min for 15 min.If no adverse reactions are observed,subsequent infusion can be given at not more than 50ml of NIRPID 10% per hour.

Administration

NIRPID is available as a sterile,non-pyrogenic,single dose container that can be administered through peripheral veins by central venous route using non-pyrogenic I.V. administration with aseptic technique.

Overdosage

If fat overload occurs during therapy, the fat infusion must be stopped immediately. Further therapy should be initiated with appropriate corrective measures

Storage

Store below 25 C.Do not freeze

Presentation

NIRPID 10% – in 100ml,250m, 500m glass bottle