Nitrofurantoin Macrocrystals (Nitrofurantoin Macrocrystals)

Trade Name : Nitrofurantoin Macrocrystals

Amneal Pharmaceuticals of New York LLC

CAPSULE

Strength 50 mg/1

NITROFURANTOIN Nitrofurans [CS],Nitrofuran Antibacterial [EPC]

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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 Nitrofurantoin Macrocrystals (Nitrofurantoin Macrocrystals) which is also known as Nitrofurantoin Macrocrystals and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 50 mg/1 per ml. Read more

Nitrofurantoin Macrocrystals (Nitrofurantoin Macrocrystals) 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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  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin macrocrystals and other antibacterial drugs, nitrofurantoin macrocrystals should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Nitrofurantoin Capsules USP (Macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Nitrofurantoin Capsules USP (Macrocrystals) are an antibacterial agent for specific urinary tract infections.
  • Nitrofurantoin, USP (macrocrystals) is chemically designated as 2,4-Imidazolidinedione, 1-[[(5-nitro-2-furanyl)methylene]amino]- and has the following structural formula:
  • CHNO(anhydrous)u00a0u00a0u00a0u00a0u00a0u00a0u00a0 M.W. 238.16
  • Each capsule, for oral administration, contains 50 mg or 100 mg of nitrofurantoin, USP (macrocrystals). In addition, each capsule contains the following inactive ingredients: corn starch, edible black ink (black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol, shellac glaze), gelatin, lactose monohydrate, talc, titanium dioxide and colorant D&C Red No. 33.
  • Nitrofurantoin macrocrystals are a larger crystal form of nitrofurantoin. The absorption of nitrofurantoin macrocrystals is slower and its excretion somewhat less when compared to nitrofurantoin. Blood concentrations at therapeutic dosage are usually low. It is highly soluble in urine, to which it may impart a brown color.
  • Following a dose regimen of 100 mg q.i.d. for 7 days, average urinary drug recoveries (0 to 24 hours) on day 1 and day 7 were 37.9% and 35%.
  • Unlike many drugs, the presence of food or agents delaying gastric emptying can increase the bioavailability of nitrofurantoin macrocrystals, presumably by allowing better dissolution in gastric juices.
  • Nitrofurantoin is a nitrofuran antimicrobial agent with activity against certain Gram-positive and Gram-negative bacteria.
  • Nitrofurantoin Capsules USP (Macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of , enterococci, , and certain susceptible strains of and species.
  • Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules USP (Macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules USP (Macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Capsules USP (Macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Nitrofurantoin Capsules USP (Macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of Nitrofurantoin Capsules USP (Macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.
  • Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug.
  • Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38 to 42 weeksu2019 gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age.
  • Nitrofurantoin macrocrystals are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin.
  • Nitrofurantoin macrocrystals are also contraindicated in those patients with known hypersensitivity to nitrofurantoin.
  • No data
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  • Occasional incidents of acute overdosage of nitrofurantoin macrocrystals have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. It is dialyzable.
  • Nitrofurantoin capsules (macrocrystals) should be given with food to improve drug absorption and, in some patients, tolerance.
  • Nitrofurantoin Capsules USP (Macrocrystals) are available as pink opaque/white opaque capsules, imprinted with z, u201cZenith 50 mgu201d on the cap and u201c2130u201d, underlined with a double bar, on the body, in black ink, containing 50 mg nitrofurantoin macrocrystals, packaged in bottles of 100 (NDC 0115-1643-01) and 1000 capsules (NDC 0115-1643-03).
  • Nitrofurantoin Capsules USP (Macrocrystals) are available as pink opaque capsules, imprinted with z, u201cZenith 100 mgu201d on the cap and u201c2131u201d, underlined with a triple bar, on the body, in black ink, containing 100 mg nitrofurantoin macrocrystals, packaged in bottles of 100 (NDC 0115-1645-01) and 1000 capsules (NDC 0115-1645-03).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Manufactured In Israel By:n Jerusalem, 9777402, Israeln Distributed by:n Bridgewater, NJ 08807n Rev. 03-2019-00
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