Atropine And Pralidoxime Chloride (Duodote)

Trade Name : DuoDote

Meridian Medical Technologies, Inc.

KIT

Strength

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atropine And Pralidoxime Chloride (Duodote) which is also known as DuoDote and Manufactured by Meridian Medical Technologies, Inc.. It is available in strength of per ml. Read more

Atropine And Pralidoxime Chloride (Duodote) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • DuoDote, a combination of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). ()n
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  • DuoDote is intended as an initial treatment as soon as symptoms appear; definitive medical care should be sought immediately. ()n
  • Dosage for Mild Symptoms: If the patient experiences two or more mild symptoms, administer one injection intramuscularly into the mid-lateral thigh. If, at any time after the first dose, the patient develops any of the severe symptoms, administer two additional injections intramuscularly in rapid succession. ()n
  • Dosage for Severe Symptoms: If a patient has any of the severe symptoms, immediately administer three injections intramuscularly into the patient's mid-lateral thigh in rapid succession. ()n
  • Each single-dose DuoDote autoinjector contains the following in two separate chambers:n
  • When activated, DuoDote sequentially administers both drugs intramuscularly through a single needle in one injection.n
  • Each single-dose DuoDote autoinjector contains atropine (2.1 mg/0.7 mL) plus pralidoxime chloride (600 mg/2 mL). ()n
  • None.n
  • None. ()n
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  • Cardiovascular (CV) Risks:
  • Heat Injury:
  • Acute Glaucoma:
  • Urinary Retention
  • Pyloric Stenosis:
  • Exacerbation of Chronic Lung Disease:
  • The following serious adverse reactions are described elsewhere in the labeling:n
  • The following adverse reactions associated with the use of atropine and pralidoxime chloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.n
  • Common adverse reactions of atropine include dryness of mouth, blurred vision, dry eyes, photophobia, confusion, headache, and dizziness among others. () The common adverse reactions of pralidoxime chloride include changes in vision, dizziness, headache, drowsiness, nausea, tachycardia, increased blood pressure, muscular weakness, dry mouth, emesis, rash, dry skin, hyperventilation, decreased renal function, excitement, manic behavior, and transient elevation of liver enzymes and creatine phosphokinase. ()n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or www.meridianmeds.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Since pralidoxime in DuoDote reactivates cholinesterases and succinylcholine and mivacurium are metabolized by cholinesterases, patients with organophosphorus nerve agent or organophosphorus insecticide poisoning who have received DuoDote may exhibit accelerated reversal of the neuromuscular blocking effects of succinylcholine and mivacurium (relative to poisoned patients who have not received pralidoxime). Monitor for neuromuscular effects with concomitant administration.n
  • Succinylcholine and Mivacurium:
  • 7.1
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  • Geriatric patients may be more susceptible to the effects of atropine. ()n
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  • Each prefilled DuoDote autoinjector provides a single intramuscular dose of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, in a self-contained unit, specifically designed for administration by emergency medical services personnel.n
  • When activated, each DuoDote autoinjector delivers the following:n
  • Atropine occurs as white crystals, usually needle-like, or as a white, crystalline powder. It is slightly soluble in water with a molecular weight of 289.38. Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, with activity due almost entirely to the levo isomer of the drug.n
  • Chemically, atropine is designated as 1u03b1H,5u03b1H-Tropan-3u03b1-ol(u00b1)-tropate. Its empirical formula is CHNO and its structural formula is as follows:n
  • Pralidoxime chloride is an odorless, white to pale-yellow crystalline powder, freely soluble in water, with a molecular weight of 172.61. Chemically, pralidoxime chloride is designated as 2-formyl-l-methylpyridinium chloride oxime. Its empirical formula is CHClNO and its structural formula is indicated above.n
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  • Each single-dose DuoDote (atropine and pralidoxime chloride) autoinjector contains atropine (2.1 mg/0.7 mL; colorless to yellow solution, visible in front chamber) and pralidoxime chloride (600 mg/2 mL; colorless to yellow solution, not visible in rear chamber) and is available in a single unit carton, NDC-11704-620-01.n
  • Each DuoDote autoinjector is supplied in a pouch that provides protection from light.n
  • Store at 25u00baC (77u00baF); excursions permitted between 15u00baC and 30u00baC (between 59u00baF and 86u00baF) [See USP Controlled Room Temperature]. Not made with natural rubber latex. Keep from freezing. Protect from light.n
  • Use by Healthcare Providers
  • Instruction Sheet for Healthcare Providers
  • DuoDote should be administered by healthcare providers who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication.n
  • Individuals should not rely solely upon atropine and pralidoxime to provide complete protection from chemical nerve agents and insecticide poisoning.n
  • Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use.n
  • Evacuation and decontamination procedures should be undertaken as soon as possible. Medical personnel assisting evacuated victims of nerve agent poisoning should avoid contaminating themselves by exposure to the victim's clothing.n
  • DuoDote is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). DuoDote should only be administered to patients experiencing symptoms of organophosphorus poisoning in a situation where exposure is known or suspected. DuoDote should be administered as soon as symptoms of organophosphorus poisoning appear.n
  • The number of DuoDote autoinjectors to administer to an individual is based on severity of symptoms. Common symptoms of organophosphorus exposure are listed below. Individuals may not have all symptoms:n
  • Dosage for Mild Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds)n- First Dosen- mild
  • Trained healthcare providers with mild symptoms may self-administer a single dose of DuoDote.n
  • Wait 10 to 15 minutes for DuoDote to take effect. If, after 10 to 15 minutes, the patient does not develop any of the symptoms listed above, no additional DuoDote injections are recommended, but definitive medical care should ordinarily be sought immediately. For healthcare providers who have self-administered DuoDote, an individual decision will need to be made to determine their capacity to continue to provide emergency care.n
  • Additional Dosesn- at any time after the first dosen- severe
  • Dosage for Severe Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds)n- severe
  • Emergency care of the severely poisoned individual should include removal of oral and bronchial secretions, maintenance of a patent airway, supplemental oxygen, and, if necessary, artificial ventilation.n
  • An anticonvulsant such as a benzodiazepine may be administered to treat convulsions if suspected in the unconscious individual. The effects of nerve agents and some insecticides can mask the motor signs of a seizure.n
  • Close supervision of all severely poisoned patients is indicated for at least 48 to 72 hours.n
  • DuoDote is a registered trademark of:Meridian Medical Technologies, Inc.Columbia, MD 21046A Pfizer Company1-800-438-1985u00a9 2016 by Meridian Medical Technologies, Inc., a Pfizer companyRevised: 10/20170002022n
  • Principal Display Panel - DuoDote Carton Label
  • For use inn or n
  • For adults and pediatricpatients weighingn
  • 41 kg +n
  • or 90 lb +n
  • NDC 11704-620-01
  • DuoDoten
  • (atropine and pralidoxime chloride injection)n
  • Each auto-injector delivers an intramuscular injection ofn n
  • Store at 25u00b0C (77u00b0F). Excursions permitted to 15-30u00b0C (59-86u00b0F).n
  • Keep from freezing. Protect from light.n
  • Rx Only
  • 11704-62001n

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