Metronidazole (Metronidazole)

Trade Name : Metronidazole

E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.

LOTION

Strength 7.5 mg/mL

METRONIDAZOLE Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]

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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 Metronidazole (Metronidazole) which is also known as Metronidazole and Manufactured by E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.. It is available in strength of 7.5 mg/mL per ml. Read more

Metronidazole (Metronidazole) 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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  • No data
  • No data
  • Metronidazole Topical Lotion, 0.75% contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. Metronidazole is an imidazole and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1-imidazole-1-ethanol. The molecular formula is CHNO and molecular weight is 171.16. Metronidazole is represented by the following structural formula:
  • The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
  • Absorption of metronidazole after topical application of metronidazole topical lotion is less complete and more prolonged than after oral administration. Detectable plasma levels were found in all subjects following the administration of a 1 gram dose of metronidazole topical lotion (containing 7.5 mg of metronidazole) applied every morning and evening for 4 days to the faces of 8 patients. The highest concentration (96 ng/mL) seen following the morning dose on Day 5 was approximately 80 times lower than the peak concentrations produced by a single 250 mg tablet of metronidazole. The mean (u00b1 SD) AUC after twice daily administration was 962 u00b1 373 ng.hr/mL.
  • Metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
  • A controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which metronidazole topical lotion was compared with its vehicle. Applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine. Patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. Metronidazole topical lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigator's global assessment of improvement. The results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigators' global assessment of improvement at week 12 are presented in the following table:
  • Metronidazole topical lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.
  • No data
  • In a controlled clinical trial, safety data from 141 patients who used metronidazole topical lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, metronidazole topical lotion 2 (3%), lotion vehicle 0; contact dermatitis, metronidazole topical lotion 2 (3%), lotion vehicle 1 (1%); pruritus, metronidazole topical lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), metronidazole topical lotion 1 (1%), lotion vehicle 2 (3%); erythema, metronidazole topical lotion 4 (6%), lotion vehicle 0; dry skin, metronidazole topical lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, metronidazole topical lotion 1 (1%), and lotion vehicle 7 (10%).
  • The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea.
  • Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. Patients may use cosmetics after waiting for the metronidazole topical lotion to dry (not less than 5 minutes).
  • Metronidazole Topical Lotion, 0.75% is supplied in the following size:
  • 2 Fl Oz (59 mL) plastic bottle u2013 NDC 0168-0383-60
  • Store at controlled room temperature, 20u00b0to 25u00b0C (68u00b0 to 77u00b0F). Protect from freezing.
  • E. FOUGERA & CO.A division of Fougera Pharmaceuticals Inc.Melville, New York 11747
  • I2383C/IF2383C R07/16 #124
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 59 ML LABEL
  • NDC 0168-0383-60
  • Fougera
  • METRONIDAZOLE
  • TOPICAL LOTION, 0.75%
  • Rx Only
  • For Topical Use Only.
  • Not for Ophthalmic Use.
  • WARNING: Keep away from children.
  • 2 Fl Oz (59 mL)
  • E. FOUGERA & CO.
  • A division of Fougera Pharmaceuticals Inc.
  • Melville, New York 11747
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 59 ML CARTON
  • NDC 0168-0383-60
  • Fougera
  • METRONIDAZOLE
  • TOPICAL LOTION,
  • 0.75%
  • Rx only
  • For Topical Use Only.
  • Not for Ophthalmic Use.
  • WARNING: Keep away
  • from children.
  • 2Fl Oz (59 mL)
  • E. FOUGERA & CO.
  • A division of Fougera Pharmaceuticals Inc.
  • Melville, New York 11747

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