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metronidazole

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Overview

What is MetroLotion?

MetroLotion (metronidazole lotion) Topical Lotion 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:



What does MetroLotion look like?



What are the available doses of MetroLotion?

Sorry No records found.

What should I talk to my health care provider before I take MetroLotion?

Sorry No records found

How should I use MetroLotion?

MetroLotion Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

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 MetroLotion Topical Lotion to dry (not less than 5 minutes).


What interacts with MetroLotion?

MetroLotion Topical Lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.



What are the warnings of MetroLotion?

Sorry No Records found


What are the precautions of MetroLotion?

General:

Information for Patients:

Drug Interactions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Ultraviolet radiation-induced carcinogenesis was enhanced in albino mice by intraperitoneal injection of metronidazole at a dosage of 45 mg/m/day, 5 days per week for 10 weeks, as indicated by a decreased latency period to the development of skin neoplasms. It is unclear how this level of exposure compares to the clinical situation with respect to the concentration of the drug or metabolics in the skin. This study did not determine if metronidazole must be present during exposure to ultraviolet radiation in order to enhance tumor formation; metronidazole may promote tumor formation in cells that have previously been initiated by ultraviolet radiation.

Metronidazole exhibited mutagenic activity in several bacterial and mammalian assay systems. Intraperitoneal administration of metronidazole to mice resulted in a dosage-dependent increase in the incidence of chromosomal aberrations in peripheral lymphocytes was reported in patients with Crohn`s disease who were treated with metronidazole for 1 to 24 months at a dosage of 200 to 1200 mg/day. However, similar results were not observed in another study, in which humans were treated for 8 months.

In rats, oral metronidazole at a dosage of approximately 1800 mg/m/day (approximately 200 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of body surface area)) induced inhibition of spermatogenesis and severe testicular degeneration.

Teratogenic Effects:

Pregnancy Category B:

Nursing Mothers:

Pediatric Use:

  • This medication is to be used only as directed by the physician.
  • It is for external use only.
  • Avoid contact with the eyes.
  • Cleanse affected area(s) before applying this medication.
  • Patients should report any adverse reaction to their physician.



What are the side effects of MetroLotion?

In a controlled clinical trial, safety data from 141 patients who used MetroLotion 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, MetroLotion Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, MetroLotion Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, MetroLotion Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), MetroLotion Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, MetroLotion Topical Lotion 4 (6%), lotion vehicle 0; dry skin, MetroLotion Topical Lotion 0, lotion vehicle 1 (l%); and worsening of rosacea, MetroLotion Topical Lotion 1 (1%), 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.


What should I look out for while using MetroLotion?

MetroLotion Topical Lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.


What might happen if I take too much MetroLotion?

Sorry No Records found


How should I store and handle MetroLotion?

MetroLotion (metronidazole lotion) Topical Lotion, 0.75% is supplied in the following size:2 fl. oz. (59 mL) plastic bottle - 0299-3838-02Storage:Protect from freezing.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA GALDERMA is a registered trademark. Revised: June 2014MetroLotion (metronidazole lotion) Topical Lotion, 0.75% is supplied in the following size:2 fl. oz. (59 mL) plastic bottle - 0299-3838-02Storage:Protect from freezing.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA GALDERMA is a registered trademark. Revised: June 2014MetroLotion (metronidazole lotion) Topical Lotion, 0.75% is supplied in the following size:2 fl. oz. (59 mL) plastic bottle - 0299-3838-02Storage:Protect from freezing.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA GALDERMA is a registered trademark. Revised: June 2014MetroLotion (metronidazole lotion) Topical Lotion, 0.75% is supplied in the following size:2 fl. oz. (59 mL) plastic bottle - 0299-3838-02Storage:Protect from freezing.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA GALDERMA is a registered trademark. Revised: June 2014MetroLotion (metronidazole lotion) Topical Lotion, 0.75% is supplied in the following size:2 fl. oz. (59 mL) plastic bottle - 0299-3838-02Storage:Protect from freezing.Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, Texas 76177 USA GALDERMA is a registered trademark. Revised: June 2014


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

Pharmacokinetics:

Non-Clinical Toxicology
MetroLotion Topical Lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.

Concomitant administration of a loop diuretic had no effect on the calcium-lowering action of pamidronate disodium.

Caution is indicated when pamidronate disodium is used with other potentially nephrotoxic drugs.

In multiple myeloma patients, the risk of renal dysfunction may be increased when pamidronate disodium is used in combination with thalidomide.

General:

Information for Patients:

Drug Interactions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Ultraviolet radiation-induced carcinogenesis was enhanced in albino mice by intraperitoneal injection of metronidazole at a dosage of 45 mg/m/day, 5 days per week for 10 weeks, as indicated by a decreased latency period to the development of skin neoplasms. It is unclear how this level of exposure compares to the clinical situation with respect to the concentration of the drug or metabolics in the skin. This study did not determine if metronidazole must be present during exposure to ultraviolet radiation in order to enhance tumor formation; metronidazole may promote tumor formation in cells that have previously been initiated by ultraviolet radiation.

Metronidazole exhibited mutagenic activity in several bacterial and mammalian assay systems. Intraperitoneal administration of metronidazole to mice resulted in a dosage-dependent increase in the incidence of chromosomal aberrations in peripheral lymphocytes was reported in patients with Crohn`s disease who were treated with metronidazole for 1 to 24 months at a dosage of 200 to 1200 mg/day. However, similar results were not observed in another study, in which humans were treated for 8 months.

In rats, oral metronidazole at a dosage of approximately 1800 mg/m/day (approximately 200 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of body surface area)) induced inhibition of spermatogenesis and severe testicular degeneration.

Teratogenic Effects:

Pregnancy Category B:

Nursing Mothers:

Pediatric Use:

In a controlled clinical trial, safety data from 141 patients who used MetroLotion 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, MetroLotion Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, MetroLotion Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, MetroLotion Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), MetroLotion Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, MetroLotion Topical Lotion 4 (6%), lotion vehicle 0; dry skin, MetroLotion Topical Lotion 0, lotion vehicle 1 (l%); and worsening of rosacea, MetroLotion Topical Lotion 1 (1%), 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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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