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Dextroamphetamine Sulfate - Extended-Release (Dextroamphetamine Sulfateextended-Release)

Trade Name : Dextroamphetamine SulfateExtended-Release

Impax Generics

CAPSULE, EXTENDED RELEASE

Strength 5 mg/1

DEXTROAMPHETAMINE SULFATE Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]

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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 Dextroamphetamine Sulfate - Extended-Release (Dextroamphetamine Sulfateextended-Release) which is also known as Dextroamphetamine SulfateExtended-Release and Manufactured by Impax Generics. It is available in strength of 5 mg/1 per ml. Read more

Dextroamphetamine Sulfate - Extended-Release (Dextroamphetamine Sulfateextended-Release) 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

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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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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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  • Dextroamphetamine sulfate is the dextro isomer of the compoundn -amphetamine sulfate, an sympathomimetic amine of the amphetamine group. Chemically,n dextroamphetamine is -alpha-methylphenethylamine, and is present in all forms ofn dextroamphetamine sulfate as the neutral sulfate.
  • Structural formula:
  • Eachu00a0extended-release capsule is so prepared that ann initial dose is released promptly and the remaining medication isn released gradually over a prolonged period. Each small sphericaln capsule, contains dextroamphetamine sulfate. The 5 mg capsule isn imprinted u201c327u201d on the YELLOW cap, andn u201cCPu201d and u201c5 mgu201d on the body. Then 10 mg capsule is imprinted u201c328u201d on the ORANGE cap,n and u201cCPu201d and u201c10 mgu201d on then body. The 15 mg capsule is imprinted u201c329u201d on then RED cap, and u201cCPu201d and u201c15 mgu201d onn the body. Product reformulation in 1996 has caused a minor change in then color of the time-released pellets within each capsule. Inactiven ingredients now consist of cetyl alcohol, D&C Yellow No. 10,n dibutyl sebacate, ethylcellulose, FD&C Red No. 40, FD&Cn Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts ofn other inactive ingredients.
  • Amphetamines are noncatecholamine, sympathomimetic amines withn CNS stimulant activity. Peripheral actions include elevations ofn systolic and diastolic blood pressures and weak bronchodilator andn respiratory stimulant action.
  • There is neither specific evidence that clearly establishes then mechanism whereby amphetamines produce mental and behavioral effects inn children, nor conclusive evidence regarding how these effects relate ton the condition of the central nervous system.
  • Dextroamphetamine sulfate extended releaseu00a0capsules aren formulated to release the active drug substance in a more gradual fashion thann the standard formulation, as demonstrated by blood levels. Then formulation has not been shown superior in effectiveness over the samen dosage of the standard, noncontrolled-release formulations given inn divided doses.
  • The pharmacokinetics of the tablet and extended-releasen capsule were compared in 12 healthy subjects. The extent ofn bioavailability of the extended-release capsule was similarn compared to the immediate-release tablet. Followingn administration of three 5-mg tablets, average maximaln dextroamphetamine plasma concentrations (C) ofn 36.6u00a0ng/mL were achieved at approximatelyn 3u00a0hours.u00a0 Following administration of onen 15-mg extended-release capsule, maximal dextroamphetamine plasman concentrations were obtained approximately 8u00a0hoursn after dosing. The average C wasn 23.5u00a0ng/mL. The average plasma Tn was similar for both the tablet and extended-release capsule andn was approximately 12u00a0hours.
  • In 12 healthy subjects, the rate and extent ofn dextroamphetamine absorption were similar followingn administration of the extended-release capsule formulation inn the fed (58 to 75u00a0gm fat) and fasted state.
  • Dextroamphetamine sulfateu00a0is indicated in:
  • Advanced arteriosclerosis, symptomatic cardiovascular disease,n moderate to severe hypertension, hyperthyroidism, known hypersensitivityn or idiosyncrasy to the sympathomimetic amines,n glaucoma.Agitatedn states.Patients with an history of drugn abuse.Known hypersensitivity or idiosyncrasy to amphetamine.In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine sulfate. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions]
  • Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Drug Interactions].
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  • Dextroamphetamine sulfate is a Schedule II controlledn substance.Amphetamines have been extensively abused. Tolerance,n extreme psychological dependence and severe social disability haven occurred. There are reports of patients who have increased the dosage ton many times that recommended. Abrupt cessation following prolonged highn dosage administration results in extreme fatigue and mental depression;n changes are also noted on the sleep EEG.n Manifestations of chronicn intoxication with amphetamines include severe dermatoses, markedn insomnia, irritability, hyperactivity, and personality changes. The mostn severe manifestation of chronic intoxication is psychosis, oftenn clinically indistinguishable from schizophrenia. This is rare with oraln amphetamines.
  • Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has also been reported. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
  • Treatment
  • Consult with a Certified Poison Control Center for up to date guidance and advice.
  • u00a0
  • Consult with a Certified Poison Control Center for up to daten guidance and advice. Management of acute amphetamine intoxication isn largely symptomatic and includes gastric lavage, administration ofn activated charcoal, administration of a cathartic, and sedation.n Experience with hemodialysis or peritoneal dialysis is inadequate ton permit recommendation in this regard. Acidification of the urinen increases amphetamine excretion, but is believed to increase risk ofn acute renal failure if myoglobinuria is present. If acute, severen hypertension complicates amphetamine overdosage, administration ofn intravenous phentolamine (Bedford Laboratories) has been suggested.n However, a gradual drop in blood pressure will usually result whenn sufficient sedation has been achieved.n Chlorpromazine antagonizesn the central stimulant effects of amphetamines and can be used to treatn amphetamine intoxication.n Since much ofn theu00a0extended-release capsule medication is coated for gradualn release, therapy directed at reversing the effects of the ingested drugn and at supporting the patient should be continued for as long asn overdosage symptoms remain. Saline cathartics are useful for hasteningn the evacuation of pellets that have not already releasedn medication.
  • Amphetamines should be administered at the lowest effectiven dosage and dosage should be individually adjusted. Late evening dosesn should be avoided because of the resulting insomnia.
  • Dextroamphetamine Sulfate Extended-Release Capsules are suppliedn as follows:
  • Dextroamphetamine Sulfaten Extended-Release Capsules, 5 mg: n- u201c327u201dn- u201cCPu201dn- u201c5 mgu201d
  • Dextroamphetamine Sulfaten Extended-Release Capsules, 10 mg: n- u201c328u201dn- u201cCPu201dn- u201c10 mgu201d
  • Dextroamphetamine Sulfaten Extended-Release Capsules, 15 mg: n- u201c329u201dn- u201cCPu201dn- u201c15 mgu201d
  • Store at controlled room temperature betweenn 20u00b0u00a0to 25u00b0C (68u00b0u00a0ton 77u00b0F) [See USP].
  • Dispense in a tight, light-resistant container.
  • Manf. by:Catalent Pharma SolutionsWinchester, KYn 40391n n
  • Dist. by:Impax GenericsHayward, CA 94544
  • Rev. May, 2017
  • For additional copies of the printed patient information/medication guide, please visit www.impaxlabs.com or contact us at 1-800-934-6729.
  • Read the Medication Guide that comesn withu00a0Dextroamphetamine Sulfate Extended-Releasen Capsulesu00a0before you or your child starts taking it and eachn time you get a refill. There may be new information. This Medicationn Guide does not take the place of talking to your doctor about your orn your childu2019s treatment with Dextroamphetamine Sulfaten Extended-Release Capsules.
  • NDC 0115-1702-10DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULESn
  • NDC 0115-1703-10DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULESn
  • NDC 0115-1704-10DEXTROAMPHETAMINE SULFATEEXTENDED-RELEASE CAPSULESn

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