Leta-GM

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Leta-GM uses

Leta-GM consists of Clobetasol Propionate, Gentamicin, Miconazole.

Clobetasol Propionate:


Leta-GM information

Leta-GM (Clobetasol Propionate) (also known as Clobevate, Cormax, Cormax Scalp Application, Embeline, Olux, and Temovate) is a strong corticosteroid, used to treat a variety of skin conditions such as dermatitis, allergies, rashes and eczema.

Leta-GM indications

Leta-GM (Clobetasol Propionate) is a popular medicine that is generally prescribed in the treatment of the patients with skin diseases in order to reduce the itching, redness and swelling of the affected parts of the body. Leta-GM (Clobetasol Propionate) is meant only for external use. Patients should not allow the medication to get into their eyes, nose and mouth. Patients should also avoid putting dressings, other skin medications or bandages on the area which is treated with Leta-GM (Clobetasol Propionate) Pharmaniaga.

Leta-GM warnings

Before beginning the treatment with Leta-GM (Clobetasol Propionate) the patients should inform their doctor or personal healthcare provider if they are allergic to any of this drug's components or to any other corticosteroids such as Prednisone or hydrocortisone. Patients should also tell the doctor if they have other allergies. Before using Leta-GM (Clobetasol Propionate) patients must tell their PD about their medical history, especially if they have immune system problems, poor blood circulation or other skin conditions such as dermatitis. In very rare cases this medicine might be absorbed into the bloodstream and this condition will require treatment also based on corticosteroids. This may happen in children who are using it or in the case of individuals who have been using it for long periods of time. Pregnant women should not use Leta-GM (Clobetasol Propionate) Pharmaniaga, unless it is clearly needed; however, they should discuss with their personal healthcare provider the benefits and risks of such a treatment.

Leta-GM intake guidelines

Patients should use Leta-GM (Clobetasol Propionate) only on the skin and not on the groin, underarms, face, unless their doctor or personal healthcare provider advises them to do so. You should wash and dry your hands very well and thoroughly clean the affected area before applying Leta-GM (Clobetasol Propionate) Pharmaniaga. This medicine should be applied in a thin film to the affected area and then rubbed. This process should be done by patients two times a day, except the cases when the doctor has prescribed them other instructions. When the patients must apply this medicine near the eyes, they should be extra careful not to put it in their eyes because this can lead to a medical condition known as glaucoma.

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Leta-GM dosage

Leta-GM (Clobetasol Propionate) should be applied directly on the affected skin areas at least twice a day. The treatment should not last longer than four weeks, as this medicine contains a very strong topical corticosteroid. Usually the dose should not be more than 50g a week.

You should not use a medicine which looks discolored or that contains any sort of particle. Do not stop your treatment with Leta-GM (Clobetasol Propionate) without your physician's approval, even if you feel that your condition has not improved at all. If you feel that your treatment with this medicine is not working properly, you should alert your personal health care provider.

Leta-GM overdose

In most of the cases that involve an overdose of Leta-GM (Clobetasol Propionate) Pharmaniaga, the medicine is absorbed in an abnormally high amount in the patient's blood stream; this can lead to systemic effects. The systemic absorption usually cases reversible adrenal suppression which may eventually lead to an insufficiency of corticosteroids in the organism. In other cases the patients may experience symptoms of Cushing's syndrome, glucosuria and even hyperglycemia which are also due to the systemic absorption.

Leta-GM missed dose

It is important to try to take each of your scheduled doses of Leta-GM (Clobetasol Propionate) at their due time. However, if you happen to miss taking one of your prescribed doses of this product you should use it as soon as you recall. If it is already time for another dose, we advise you to forget about the one that you have missed and to proceed with your regular dosing schedule. Do not apply double doses of Leta-GM (Clobetasol Propionate) without your personal physician's approval.

Leta-GM side effects

The most common side effects that patients who are under treatment with Leta-GM (Clobetasol Propionate) may experience are the following: burning, stinging, dryness, redness, itching, and so on. These side effects usually appear when the product is applied to the skin for the first time, but they should pass in a few days; in case these side effects do not go away the patients should contact their pharmacist or personal healthcare provider.

Individuals should alert their doctor or health care specialist if they develop any of the following side effects: stretch marks, acne, hair bumps (also known as follicullitis), skin thinning, skin discoloration, extreme hair growth and unwanted hair growth. Patients should also inform their doctor if the redness, irritation and swelling do not improve. Serious allergic reactions are very rare in patients who are using Leta-GM (Clobetasol Propionate) Pharmaniaga, but in case the patients experience rash, swelling, itching, breathing problems, severe dizziness, they should inform their physician as quickly as they can. This is not a complete list with the side effects that the intake of this medicine can lead to; this is why it is very important to discuss with your doctor in the case in which you develop other symptoms than those listed above.

Leta-GM drug reactions

Generally it is improbable for Leta-GM (Clobetasol Propionate) to interact with other drugs. However, it is well known that many drugs harmfully interact among each other and this is why it is very important to inform your doctor about all the other medicines that you are taking during your therapy with this drug (including vitamins, minerals, over-the-counter medications or herbal products). It is also important to not start taking a new drug without consulting with your personal healthcare provider.

Gentamicin:



F-27078915

NADA #141-177, Approved by FDA.

PRODUCT

INFORMATION

VETERINARY

For Otic Use in Dogs Only

CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Keep this and all drugs out of the reach of children.

DESCRIPTION Each gram of Leta-GM (Gentamicin) Otic Suspension contains Leta-GM (Gentamicin) sulfate, USP equivalent to 3 mg Leta-GM (Gentamicin) base; mometasone furoate monohydrate equivalent to 1 mg mometasone; and 10 mg clotrimazole, USP in a mineral oilbased system containing a plasticized hydrocarbon gel.

PHARMACOLOGY

Leta-GM (Gentamicin): Leta-GM (Gentamicin) sulfate is an aminoglycoside antibiotic active against a wide variety of gram-negative and grampositive bacteria. In vitro tests have determined that Leta-GM (Gentamicin) is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. In clinical trials, Leta-GM (Gentamicin) was shown to have a range of activity against the following organisms commonly isolated from infected canine ears:

Pseudomonas spp. (including P. aeruginosa), coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci.

Mometasone: Mometasone furoate monohydrate is a synthetic adrenocorticoid characterized by a novel (2') furoate 17-ester having chlorine at the 9 and 21 positions, which have shown to possess high topical potency.

Systemic absorption of mometasone furoate ointment was found to be minimal (2%) over 1 week when applied topically to dogs with intact skin. In a 6-month dermal toxicity study using 0.1% mometasone ointment on healthy intact skin in dogs, systemic effects typical of corticosteroid therapy were noted.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids.

Clotrimazole: Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of dermatophytes and yeast. The primary action of clotrimazole is against dividing and growing organisms.

In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis. Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In an induced otitis externa study using dogs infected with Malassezia pachydermatis, 1% clotrimazole in the vehicle formulation was effective both microbiologically and clinically in terms of reduction of exudate, odor, and swelling.

In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application.

Gentamicin-Mometasone-Clotrimazole: By virtue of its three active ingredients, Leta-GM (Gentamicin) Otic Suspension has antibacterial, anti-inflammatory, and antifungal activity. In clinical field trials, Leta-GM (Gentamicin) Otic Suspension was effective in the treatment of otitis externa associated with bacteria and Malassezia pachydermatis. Leta-GM (Gentamicin) Otic Suspension reduced discomfort, redness, swelling, exudate, and odor.

INDICATIONS Leta-GM (Gentamicin) Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

CONTRAINDICATIONS If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

WARNINGS The use of these components has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg, geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of Leta-GM (Gentamicin) Otic Suspension immediately and flush the ear canal thoroughly with a nonototoxic solution.

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs that received corticosteroids during pregnancy.

Field and experimental data have demonstrated that corticostroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

PRECAUTIONS Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.

Administration of recommended doses of Leta-GM (Gentamicin) Otic Suspension beyond 7 days may result in delayed wound healing. If overgrowth of nonsusceptible bacteria or fungi occurs, treatment should be discontinued and appropriate therapy instituted.

Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects.

Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly acting corticosteroid should be considered in especially stressful situations.

TOXICOLOGY Field and safety studies with Leta-GM (Gentamicin) Otic Suspension have shown a wide safety margin at the recommended dose level in dogs (see PRECAUTIONS/ADVERSE REACTIONS ).

ADVERSE REACTIONS

Leta-GM (Gentamicin): While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns, or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear, and renal toxicity.

Mometasone: ALP (SAP) and ALT (SGPT) enzyme elevations, weight loss, anorexia, polydipsia, polyuria, neutrophilia, and lymphopenia have occurred following the use of parenteral, high-dose, and/or prolonged or systemic synthetic corticosteroids in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin not present before therapy.

Leta-GM (Gentamicin) Otic Suspension: In field studies following once daily teatment with Leta-GM (Gentamicin) Otic Suspension, ataxia, proprioceptive deficits, and increased water consumption were observed in less than 1% of 164 dogs. In a field study following twice-daily treatment with Leta-GM (Gentamicin) Otic Suspension, inflammation of the pinna and diarrhea were observed in less than 1% of 141 dogs.

DOSAGE AND ADMINISTRATION

The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g, 15 g, and 30 g bottles (2 drops from the 215 g bottle) of Leta-GM (Gentamicin) Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g, 15 g, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.

HOW SUPPLIED Leta-GM (Gentamicin) Otic Suspension is available in 7.5 g (NDC 14043-120-75), 15 g (NDC 14043-120-15), 30 g (NDC 14043-120-30), and 215 g (NDC 14043-120-21) plastic bottles.

Store between 2° and 25°C (36° and 77°F). Shake well before use.

U.S. Patent No. 6,127,353.

Distributed by

PATTERSON VETERINARY

137 Barnum Road, Devens, MA 01434

www.pattersonvet.com

Made in Canada.

9/15

85239791

Miconazole:


1 INDICATIONS AND USAGE

  • Leta-GM Ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and /or budding yeast) in immunocompetent pediatric patients 4 weeks and older. (1)
  • Leta-GM (Miconazole) Ointment should not be used as a substitute for frequent diaper changes. (1)
  • Leta-GM (Miconazole) Ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. (1)

1.1 Indication

Leta-GM (Miconazole) Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicansis not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.

Leta-GM (Miconazole) should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.

Leta-GM (Miconazole) should not be used as a substitute for frequent diaper changes. Leta-GM (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.

1.2 Limitations of Use

The safety and efficacy of Leta-GM (Miconazole) have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).

The safety and efficacy of Leta-GM (Miconazole) have not been evaluated in incontinent adult patients. Leta-GM (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

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2 DOSAGE AND ADMINISTRATION

Leta-GM (Miconazole) is not for oral, ophthalmic, or intravaginal use.

Before applying Leta-GM (Miconazole), gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area.

Apply Leta-GM (Miconazole) to the affected area at each diaper change for 7 days. Continue treatment for the full 7 days, even if there is improvement. The safety of Leta-GM (Miconazole) when used for longer than 7 days is not known. Do not use Leta-GM (Miconazole) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.

Gently apply a thin layer of Leta-GM (Miconazole) to the diaper area with the fingertips. Do not rub Leta-GM (Miconazole) into the skin as this may cause additional irritation. Thoroughly wash hands after applying Leta-GM (Miconazole).

  • Leta-GM (Miconazole) Ointment is for topical use only. Leta-GM (Miconazole) Ointment is not for oral, ophthalmic, or intravaginal use. (2)
  • Leta-GM (Miconazole) Ointment should be applied as a thin layer to the affected area at each diaper change for 7 days. (2)
  • Leta-GM (Miconazole) Ointment should be used as part of a treatment regimen that includes gentle cleansing of the diaper area and frequent diaper changes. (2)

3 DOSAGE FORMS AND STRENGTHS

White ointment containing 0.25% Leta-GM (Miconazole) nitrate, 15% zinc oxide, and 81.35% white petrolatum.

  • Ointment with 0.25% Leta-GM (Miconazole) nitrate, 15% zinc oxide, and 81.35% white petrolatum. (3)

4 CONTRAINDICATIONS

None

  • None
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5 WARNINGS AND PRECAUTIONS

If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.

The safety and efficacy of Leta-GM (Miconazole) have not been evaluated in incontinent adult patients. Leta-GM (Miconazole) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

  • If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. (5)

6 ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Prestium Pharma, Inc. at 1-866-897-5002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the Leta-GM group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with Leta-GM (Miconazole) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.

6.2 Post-marketing Experience

The following adverse reactions have been identified during post approval use of Leta-GM (Miconazole).

GASTROINTESTINAL DISORDERS: vomiting

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: burning sensation, condition aggravated, inflammation, pain

INJURY, POISONING AND PROCEDURAL COMPLICATIONS: accidental exposure

SKIN AND SUBCUTANEOUS TISSUE DISORDERS: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation

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.

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7 DRUG INTERACTIONS

Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a Leta-GM (Miconazole) intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and Leta-GM (Miconazole) is unknown.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Leta-GM in pregnant women. Therefore, Leta-GM (Miconazole) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Leta-GM (Miconazole) nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day, which are 28 and 45 times the maximum possible topical exposure of caregivers, respectively, assuming 100% absorption.

8.3 Nursing Mothers

Safety and efficacy of Leta-GM (Miconazole) have not been established in nursing mothers. It is not known if the active components of Leta-GM (Miconazole) may be present in milk.

8.4 Pediatric Use

Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants.

Leta-GM should not be used to prevent diaper dermatitis.

The safety of Leta-GM (Miconazole) when used for longer than 7 days is not known. Do not use more than 7 days.

8.5 Geriatric Use

Safety and efficacy in a geriatric population have not been evaluated.

11 DESCRIPTION

Leta-GM (Miconazole) contains the synthetic antifungal agent, Leta-GM (Miconazole) nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.

The chemical name of Leta-GM (Miconazole) nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C18H14Cl4N2O-HNO3 and molecular weight of 479.15. The structural formula of Leta-GM (Miconazole) nitrate is as follows:

The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.

The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula CnH2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.

Each gram of Leta-GM (Miconazole) contains 2.5 mg of Leta-GM (Miconazole) nitrate USP, 150 mg of zinc oxide USP, and 813.5 mg of white petrolatum USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm® 1001/B fragrance.1

Leta-GM (Miconazole) is a smooth, uniform, white ointment.

Structural formula of Leta-GM (Miconazole) nitrate

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The Leta-GM component of Leta-GM (Miconazole) is an antifungal agent. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.

12.2 Pharmacodynamics

The human pharmacodynamics of Leta-GM (Miconazole) is unknown.

12.3 Pharmacokinetics

The topical absorption of Leta-GM from Leta-GM (Miconazole) was studied in immunocompetent male and female infants and children (n=17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of Leta-GM (Miconazole) were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of Leta-GM (Miconazole) were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.

12.4 Microbiology

The Leta-GM (Miconazole) nitrate component in this product has been shown to have in vitro activity against Candida albicans, an organism that is associated with diaper dermatitis. The activity of Leta-GM (Miconazole) nitrate against C. albicans is based on the inhibition of the ergosterol biosynthesis in the cell membrane. The accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell. In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Clinical Study 1 (see Clinical Studies (14)) does not appear to indicate that resistance to Leta-GM (Miconazole) nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of Leta-GM (Miconazole) nitrate against C. albicans in the setting of diaper dermatitis is unclear.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Leta-GM (Miconazole) in animals has not been evaluated.

Leta-GM (Miconazole) nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.

Leta-GM (Miconazole) nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day, which is 89 times the maximum possible topical exposure of caregivers, assuming 100% absorption.

14 CLINICAL STUDIES

Study 1 was a double-blind, multicenter study in which Leta-GM (Miconazole) was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated psuedohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.

The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.

Study results are shown in the following table.

Overall Cure at Day 14
Leta-GM (Miconazole)

n=112

Zinc Oxide/White Petrolatum

n=124

26 (23%) 12 (10%)

Two additional studies provided supportive evidence of the clinical efficacy of Leta-GM (Miconazole) in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Leta-GM is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:

50g (NDC 40076-002-50)

16.2 Storage Conditions

Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling

Patients using Leta-GM (Miconazole) should be informed about the following information:

  • Leta-GM (Miconazole) is to be used only for diaper dermatitis that is complicated by documented candidiasis (i.e. documented by microscopic testing).
  • Leta-GM (Miconazole) should not be used as a substitute for frequent diaper changes.
  • Leta-GM (Miconazole) should not be used to prevent diaper dermatitis.
  • Leta-GM (Miconazole) should not be used long term.
  • Leta-GM (Miconazole) should be used only as directed by the health care provider.
  • Leta-GM (Miconazole) is for external use only. It is not for oral, ophthalmic, or intravaginal use.
  • Gently cleanse the diaper area with lukewarm water or a very mild soap and pat the area dry with a soft towel before applying Leta-GM (Miconazole).
  • Gently apply Leta-GM (Miconazole) to the diaper area with the fingertips after each diaper change. Do not rub Leta-GM (Miconazole) into the skin as this may cause additional irritation.
  • Thoroughly wash hands after applying Leta-GM (Miconazole).
  • Treatment should be continued for 7 days, even if there is improvement. Do not use Leta-GM (Miconazole) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
  • Leta-GM (Miconazole) should not be used on children for whom it is not prescribed.

Manufactured for:

Prestium Pharma, Inc.

Newtown, PA 18940

Manufactured by:

GlaxoSmithKline

Mississauga, ON, Canada

Made in Canada

© 2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.

Revised Oct 2013 VSN:3PI

FDA-Approved Patient Labeling

Leta-GM (Miconazole)® (Vu-sion) Ointment

(0.25% Leta-GM (Miconazole) nitrate, 15% zinc oxide and 81.35% white petrolatum)

IMPORTANT: For Skin Use Only. Do not use in the mouth, eyes, or vagina.

Read the Patient Information that comes with Leta-GM (Miconazole) before you use it on your child. This leaflet does not take the place of talking to your health care provider about your child’s medical condition or treatment. If you have any questions or if you are not sure about any of the information on Leta-GM (Miconazole), ask your health care provider, or pharmacist.

What is Leta-GM (Miconazole)?

Leta-GM (Miconazole) is a prescription skin medicine used to treat diaper rash that also has a yeast infection in children who are at least 4 weeks old and who have a normal immune system. Leta-GM (Miconazole) contains medicines that will help treat the yeast infection and the diaper rash, but you must also change your child’s diapers very often so that your child is not wearing a wet or soiled diaper. Even if you use Leta-GM (Miconazole), diaper rash will not go away if you do not keep your child’s diaper area clean and dry. You should use water or a very mild cleanser to clean your child’s diaper area. Leta-GM (Miconazole) is not to be used to prevent diaper rash or to be used for more than 7 days.

Your health care provider will need to do a special test to tell if your child’s diaper rash also has a yeast infection. Do not use Leta-GM (Miconazole) on your child’s diaper rash unless your health care provider tells you that there is also a yeast infection.

Who should not use Leta-GM (Miconazole)?

Leta-GM (Miconazole) is not for treatment of all cases of diaper rash. Leta-GM (Miconazole) is only for diaper rash that also has a yeast infection. Most cases of diaper rash do not need the yeast medicine that is in Leta-GM (Miconazole) because most cases of diaper rash do not also have a yeast infection.

Do not use Leta-GM (Miconazole) on any other children or other family member.

Do not use Leta-GM (Miconazole) on your child’s diaper rash if they are allergic to anything in it. See the end of this leaflet for a list of ingredients in Leta-GM (Miconazole).

Do not use on infants less than 4 weeks of age.

Do not use in infants or children who do not have a normal immune system.

How should I use Leta-GM (Miconazole) on my child?

Leta-GM (Miconazole) is applied to the skin on your child’s diaper area at each diaper change for 7 days.

Apply Leta-GM (Miconazole) for the full 7 days even if the diaper rash starts to go away. Call your child’s health care provider if the diaper rash gets worse or does not go away with 7 days of treatment with Leta-GM (Miconazole). Leta-GM (Miconazole) should not be used for more than 7 days.

To apply Leta-GM (Miconazole):

  • Gently, clean the skin on your child’s diaper area with warm ( not hot ) water. You may also use a very mild soap. Pat the area dry with a soft towel.
  • Use your fingertips and gently apply a thin layer of Leta-GM (Miconazole) to your child’s diaper area at each diaper change. Do not rub Leta-GM (Miconazole) into your child’s skin. Rubbing the skin can cause more irritation.
  • Wash your hands after applying Leta-GM (Miconazole) on your child.

Leta-GM (Miconazole) is for skin use only.

Call your child’s health care provider or poison control center right away if any Leta-GM (Miconazole) is swallowed. Call your child’s health care provider if Leta-GM (Miconazole) gets in the eye.

Keep out of reach of children.

What other steps will help diaper rash go away?

  • Check your child’s diaper often. Change the diaper at the first sign of wetness.
  • Clean your child’s diaper area after each diaper change. Gently wipe the diaper area from the front to back using warm ( not hot )water. You may also use a mild soap. Rinse the diaper area well. Pat dry with a soft towel.
  • Keep the diaper area open to air when possible.
  • Even if you use Leta-GM (Miconazole), diaper rash will not go away if you do not keep your child’s diaper area clean and dry.

What are the possible side effects of Leta-GM (Miconazole)?

Leta-GM (Miconazole) may cause irritation. You should call your child’s health care provider if irritation appears or if the diaper rash gets worse.

How should I store Leta-GM (Miconazole)?

  • Keep Leta-GM (Miconazole) out of the reach of children to avoid the risk of accidental ingestion.
  • Store Leta-GM (Miconazole) at room temperature between 68°F to 77°F (20°C to 25°C).

General information about Leta-GM (Miconazole)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

Do not use Leta-GM (Miconazole) for a condition for which it was not prescribed. Do not give Leta-GM (Miconazole) to other children or family members, even if they have the same symptoms your child has. It may harm them.

This leaflet summarizes the most important information about Leta-GM (Miconazole). If you would like more information, talk to your child’s health care provider. You can ask your child’s health care provider or pharmacist for information about Leta-GM (Miconazole) that is written for healthcare professionals.

Side effects may be reported to Prestium Pharma, Inc. at 1-866-897-5002 or the FDA at 1-800-FDA-1088.

What are the ingredients in Leta-GM (Miconazole)?

Active Ingredients: Leta-GM (Miconazole) nitrate, zinc oxide, and white petrolatum

Inactive Ingredients: trihydroxystearin, butylated hydroxyltoluene (BHT), and Chemoderm® 1001/B fragrance

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

The Patient Information leaflet was last revised: October 2013

Manufactured for:

Prestium Pharma, Inc.

Newtown, PA 18940

Manufactured by:

GlaxoSmithKline

Mississauga, ON, Canada

Made in Canada

© 2013 Delcor Asset Corporation, an affiliate of

Prestium Pharma, Inc.

Revised Oct 2013

VSN:3PIL

Principal Display Panel

NDC 40076-002-50

Leta-GM (Miconazole)®

(miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP)

Ointment

50 grams

Rx only

Principal Display Panel NDC 40076-002-50 Vusion® (miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP) Ointment 50 grams Rx only

Leta-GM pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Leta-GM available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Leta-GM destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Leta-GM Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Leta-GM pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CLOBEX (CLOBETASOL PROPIONATE) SPRAY [GALDERMA LABORATORIES, L.P.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."LEGACY (GENTAMICIN) SOLUTION [AGRI LABORATORIES, LTD.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."RASH RELIEF ANTIFUNGAL (MICONAZOLE) LIQUID [TOUCHLESS CARE CONCEPTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Leta-GM?

Depending on the reaction of the Leta-GM after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Leta-GM not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Leta-GM addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Leta-GM, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Leta-GM consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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