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Yashica Pharmaceuticals
Yashica Pharmaceuticals
Yashica Pharmaceuticals

Yashica Pharmaceuticals

Yashica

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Home » Finished Formulation » Naloxone Hydrochloride Injections

Naloxone Hydrochloride Injections

Being pioneers in the medical industry, we bring forth hygienically formulated array of Yashinalox (Naloxone HCl) that is an opioid antagonist that functions competitively at opioid receptors. It is an effective antagonist of opioids that possess agonist or mixed agonist-antagonist activity although larger doses may be needed for compounds with the latter activity. It is a special vnarcotic drug used to reverse the effects of other narcotic drugs that are used in the surgical operations or to treat acute pain. Yashinalox inj constitutes naloxone hydrochloride USP 0.4mg in definite quantity and may also be used treat narcotic drug overdose or to diagnose narcotic drug addiction.


Composition:
  • Each ml contains: naloxone hydrochloride USP 0.4mg, water for injection USP q. s.
Catogery:
  • Opioid receptor antagonist
Molecular formula:
  • C19H21NO4 .HCL
Molecular weight:
  • 363.84
Pharmacokinetics:
  • Naloxone is absorbed from the gastrointestinal tract but it is subject to considerable first-pass metabolism. It is metabolized in the liver, mainly by glucuronide, and excreted in the urine. It has a plasma half-life of about 1 hour after parenteral administration. Naloxone crosses the placenta.
Indications:
  • It is used to reverse opioid central depression, including respiratory depression, induced by natural or synthetic opioids in the treatment of known or suspected opioid overdosage, postoperatively after the use of opioids during surgery, and in neonates after the administration of opioid analgesics to the mother during labour.
Dosage and administration:
  • Naloxone hydrochloride is usually given intravenously for a rapid onset of action, which occurs within 2 minutes. The onset of action is only slightly less rapid when it is given intramuscularly or subcutaneously.
  • In the treatment of known or suspected opioid overdosage, the initial dose of naloxone hydrochloride is 0.4 to 2mg given intravenously and repeated if necessary at intervals of 2 to 3 minutes. If no response has been observed after a total dose of 10mg then the diagnosis of overdosage with drugs other than opioids should be considered. If the patient is suspected of being physically dependent on opioids the dose may be reduced to 100 to 200 micrograms to avoid precipitating withdrawal symptoms. In children, the usual initial dose is 10 micrograms/kg intravenously followed, if necessary, by a larger dose of 100 micrograms/kg (for an alternative children’s dose suggested in the USA to treat opioid intoxication. In both adults and children, if the intravenous route is not feasible the intramuscular or subcutaneous route can be used.
  • Naloxone hydrochloride may also be used postoperatively to reverse central depression resulting from the use of opioids during surgery. For adults, a dose of 100 to 200 micrograms (1.5 to 3 micrograms/kg) may be given intravenously at intervals of at least 2 minutes, titrated for each patient in order to obtain an optimum respiratory response while maintaining adequate analgesia. All patients receiving naloxone should be closely observed as the duration of action of many opioids exceeds that of naloxons and repeated doses by intravenous, intramuscular, or subcutaneous injection may be required. Alternatively, to sustain opioid antagonism, an intravenous infusion may be used. The manufacturer recommends naloxone hydrochloride 4 micrograms/mL in sodium chloride 0.9% or glucose 5% infused at a rate titrated in accordance with the patient’s response, both to the infusion and previous bolus injections; more concentrated solutions have also been used, and an infusion rate of 400 to 800 micrograms/hour has been suggested.
  • Opioid-induced depression in neonates resulting from the administration of opioid analgesics to the mother during labour may be reversed by giving naloxone hydrochloride 10 micrograms/kg to the infant by intravenous, intramuscular, or subcutaneous injection, repeated at intervals of 2 to 3 minutes if necessary. Alternatively, a single intramuscular does of about 60 micrograms/kg may be given at birth for a more prolonged action. Naloxone should be given with caution to the infants of opioid dependent mothers since withdrawal symptoms can result.
Contraindications:
  • Naloxone Hydrochloride Injections is contraindicated in patients known to be hypersensitive to it
Warning:
  • Naloxone hydrochloride should be administered cautiously to persons including newborns of mothers who are known or suspected to be physically dependent on opioids. In such cases an abrupt and complete reversal of narcotic effects may precipitate an acute abstinence syndrome.
  • The patient who has satisfactorily responded to naloxone should be kept under continued surveillance and repeated doses of naloxone should be administered, as necessary, since the duration of action of some narcotics may exceed that of naloxone.
  • Naloxone is not effective against respiratory depression due to non-opioid drugs. Reversal of buprenorphine induced respiratory depression may be incomplete. If an incomplete response occurs, respirations should be mechanically assisted.
Precautions:
  • In addition to naloxone, other resuscitative measures such as maintenance of a free airway, artificial ventilation, cardiac massage, and vasopressor agents should be available and employed when necessary to counteract acute narcotic poisoning.
  • Several instances of hypotension, hypertension, ventricular tachycardia and fibrillation, and pulmonary edema have been reported. These have occurred in postoperative patients, most of whom had pre-existing cardiovascular disorders or received other drugs which may have similar adverse cardiovascular effects. Although a direct cause-and-effect relationship has not been established, naloxone should be used with caution in patients with pre-existing cardiac disease or patients who have received potentially cardio-toxic drugs.
Pregnancy:
  • Naloxone hydrochloride should be used during pregnancy only if clearly needed
Nursing mothers:
  • It is not known whether naloxone is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naloxone is administered to a nursing woman.
Adverse reactions:
  • Abrupt reversal of narcotic depression may result in nausea, vomiting, sweating, tachycardia, increased blood pressure, tremulousness, seizures and cardiac arrest. In post-operative patients, larger than necessary dosage of naloxone hydrochloride may result in significant reversal of analgesia and in excitement. Hypotension, hypertension, ventricular teachycardia and fibrillation, and pulmonary and pulmonary edema have been associated with the use of naloxone postoperatively.
Presentation:
  • 10 ampoules of 1ml in a plastic tray and each tray packed in a printed carton
Storage:
  • Store between temperature 8° to 25°C. Protect from light
  • Keep out of the reach of children

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