Pampara

Pampara

pralidoxime

Manufacturer:

Siu Guan

Distributor:

Averroes Pharma
Full Prescribing Info
Contents
Pralidoxime chloride.
Description
Each ampoule contains 500 mg of Pralidoxime (as chloride).
Action
Pharmacology: Mode of Action: Pralidoxime is cholinesterase reactivator and its principal mode of action is by reactivating the enzyme cholinesterase which has been inhibited by phosphorylation.
Summary of Pharmacodynamics and Pharmacokinetics: Blood concentrations are rapidly attained after intramuscular or intravenous injection. Pralidoxime is not bound to plasma protein and does not readily pass into the central nervous system. Pralidoxime is rapidly excreted in the urine partly unchanged and partly as a metabolite. The elimination half-life is approximately 1 to 2 hours.
Indications/Uses
Pampara Injection is indicated in the treatment of poisoning due to organophosphates pesticides or related compounds. Pralidoxime is an adjunct to atropine in the treatment of poisoning due to those pesticides and chemicals of the organophosphate class which have anticholinesterase activity.
Pampara Injection is indicated in the treatment of overdosage by anticholinesterase drugs in the treatment of myasthenia gravis.
Dosage/Direction for Use
Recommended Dose: Pralidoxime may be administered subcutaneously, intramuscularly or intravenously by slow intravenous injection of a 5% to 10% solution in water for injection over 5 to 10 minutes or alternatively by infusion in 100 ml of sodium chloride injection (0.9%) over a period of 15 to 30 minutes.
In the treatment of organophosphorous poisoning, atropine sulfate 2 mg should be given by subcutaneous or intramuscular injection and repeated at intervals of 5 to 60 minutes until the patient shows signs of atropine toxicity: Atropinisation should then be maintained throughout the course of pralidoxime treatment which may continue 48 hours or more large amounts of atropine may be required concomitantly. 1 to 2 g of Pralidoxime should be administered intramuscularly or intravenously and repeated, if necessary according to the patient's condition: a maximum dose of 12 g of 24 hours has been suggested.
In children, Pralidoxime 20 to 60 mg per kg body weight may be given depending on the severity of poisoning and response to treatment. The dose of Pralidoxime may need to be reduced in patients with impaired renal function.
Anticholinesterase overdosage: As an antagonist to such anticholinesterase as neostigmine, pyridostigmine, and ambenonium, which are used in the treatment of myasthenia gravis, Pampara may be given in a dosage of 1 to 2 g intravenously followed by increments of 250 mg every five minutes.
Overdosage
Symptoms and Treatment of Overdose: The symptoms observed in normal subjects include dizziness, blurred vision, diplopia, headache, impaired accommodation, nausea, slight tachycardia. In therapy it has been difficult to differentiate side effects due to the drug from those due to the effects of the poison. Treatment of over dosage includes artificial respiration and other supportive therapy.
Contraindications
Pampara injection is contraindicated in patients of known hypersensitivity to the active ingredient and other situations in which the potential risk clearly outweighs potential benefit.
Special Precautions
Pampara injection has been very well tolerated in most cases, but it must be remembered that the desperate condition of the organophosphate-poisoned patients will generally mask such minor signs and symptoms have been noted in normal subjects.
Intravenous administration of Pampara Injection should be carried out slowly and preferably, by infusion, since certain side effect, such as tachycardia, laryngospasm, and muscle rigidity, have been attributed in a few cases to a too rapid rate of injection.
Pampara Injection is excreted in the urine, a decrease in renal function will result in increased blood levels of the drug thus the dosage of Pampara injection should be reduced in the presence of renal insufficiency.
Pampara Injection should be used with great caution in treating organophosphate overdosage in cases of myasthenia gravis since it may precipitate a myasthenia crisis.
Use In Pregnancy & Lactation
Pregnancy category C: Well-controlled studies in humans have not been done. Animal reproduction studies have not been conducted with Pralidoxime. It is also not known whether Pralidoxime can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pralidoxime should only be given to pregnant woman only if the potential benefit outweighs the potential risk.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Pralidoxime is administered to a nursing woman.
Side Effects
The side effects include drowsiness, dizziness, and disturbances of vision, nausea, tachycardia, headaches, hyperventilation, and muscular weakness have been reported after the use of Pampara injection. However, it is very difficult to differentiate the toxic effects produced by atropine or the organophosphate compounds from those of the drug. When atropine and Pampara injection are used together, the signs of atropinization may occur earlier than might be expected when atropine is use alone. This is especially true if the total dose of atropine has been large and the administraion of Pampara injection has been delayed. Excitement and manic behavior immediately following recovery of consciousness have been reported in several cases. However, similar behaviour has occured in case of organophosphate poisoning that were not treated with Pampara injection.
Drug Interactions
The following precautions should be kept in mind in the treatment of anticholinesterase poisoning. Although these drugs do not interact directly with the action of Pampara injection, the action of barbiturates are potentiated by the anticholinesterases. Hence the use of such drugs i.e. morphine, theophylline, aminophylline, succinylcholine, reserpine and phenothiazine-type tranquilizers should be avoided in the treatment of convulsion in patients of organophosphate poisoning.
Pampara should be used with great caution in treating organophosphate overdosage in cases of myasthenia gravis since it may precipitate a myasthenia crisis.
Because pralidoxime is excreted in the urine, a decrease in renal function will result in increased blood levels of the drugs. Thus the dosage of pralidoxime should be reduced in the presence of renal insufficiency.
Caution For Usage
Incompatibilities: Pralidoxime may be diluted with 5% to 10% solution for injection or alternatively by infusion in 100 ml of sodium chloride injection (0.9%).
Storage
Protect from light and store below 30°Celsius.
Shelf-Life: The injections can be used within 48 months from the date of manufacture if kept as recommended.
ATC Classification
V03AB04 - pralidoxime ; Belongs to the class of antidotes. Used in the management of organo-phosphate poisoning.
Presentation/Packing
Inj 500 mg/20mL (a clear and colorless to slightly yellow liquid in glass ampoules) x 5's.
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