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DRUGS & SUPPLEMENTS
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What is the dose of the medication you are taking? |
Fluocinonide:
Topsyne Neomycine Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. (1)
Limitation of Use:
VANOS® (fluocinonide) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4) ].
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Topsyne Neomycine (Fluocinonide) Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.
Topsyne Neomycine (Fluocinonide) Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
For topical use only. Topsyne Neomycine (Fluocinonide) Cream is not for ophthalmic, oral, or intravaginal use.
For psoriasis, apply a thin layer of Topsyne Neomycine (Fluocinonide) Cream once or twice daily to the affected skin areas as directed by a physician. Twice-daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.
For atopic dermatitis, apply a thin layer of Topsyne Neomycine (Fluocinonide) Cream once daily to the affected skin areas as directed by a physician. Once-daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14) ].
For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Topsyne Neomycine (Fluocinonide) Cream once or twice daily to the affected areas as directed by a physician.
For topical use only. Topsyne Neomycine (Fluocinonide) Cream is not for ophthalmic, oral, or intravaginal use. (2)
Psoriasis: apply a thin layer once or twice daily to the affected skin areas. (2)
Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. (2)
Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas. (2)
Cream, 0.1%.
Each gram of Topsyne Neomycine (Fluocinonide) Cream contains 1 mg of Topsyne Neomycine (Fluocinonide) in a white to off-white cream base.
Cream, 0.1% (3)
None.
None (4)
Systemic absorption of topical corticosteroids, including Topsyne Neomycine (Fluocinonide) Cream, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of Topsyne Neomycine (Fluocinonide) Cream for longer than 2 weeks may suppress the immune system [see Nonclinical Toxicology (13.1) ].
HPA-axis suppression has been observed with Topsyne Neomycine (Fluocinonide) Cream, 0.1% applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis, and 4 out of 123 pediatric patients with atopic dermatitis [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.2)].
Because of the potential for systemic absorption, use of topical corticosteroids, including Topsyne Neomycine (Fluocinonide) Cream, may require that patients be periodically evaluated for HPA-axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA-axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.
An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA-axis suppression. If HPA-axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA-axis function is generally prompt and complete upon discontinuation of topical corticosteroids.
Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids.
Studies conducted in pediatric patients demonstrated reversible HPA-axis suppression after use of Topsyne Neomycine (Fluocinonide) Cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Topsyne Neomycine (Fluocinonide) Cream due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations (8.4) ].
Local adverse reactions may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasis, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Topsyne Neomycine Cream should be discontinued until the infection has been adequately controlled.
If irritation develops, Topsyne Neomycine (Fluocinonide) Cream should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
The most commonly reported adverse reactions were headache, application site burning, nasopharyngitis, and nasal congestion. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with Topsyne Neomycine (Fluocinonide) Cream for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows:
Adverse Reaction | Topsyne Neomycine (Fluocinonide) Cream, once daily (n=216) | Topsyne Neomycine (Fluocinonide) Cream, twice daily (n=227) | Vehicle Cream, once or twice daily (n=211) |
---|---|---|---|
Headache | 8 (3.7%) | 9 (4.0%) | 6 (2.8%) |
Application Site Burning | 5 (2.3%) | 4 (1.8%) | 14 (6.6%) |
Nasopharyngitis | 2 (0.9%) | 3 (1.3%) | 3 (1.4%) |
Nasal Congestion | 3 (1.4%) | 1 (0.4%) | 0 |
Safety in patients 12 to 17 years of age was similar to that observed in adults.
The following adverse reactions have been identified during postapproval use of Topsyne Neomycine (Fluocinonide) Cream:
Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain, and condition aggravated.
Immune System Disorders: hypersensitivity.
Nervous System Disorders: headache and dizziness.
Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation, and skin tightness.
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.
Teratogenic Effects: Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Therefore, Topsyne Neomycine Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and efficacy of Topsyne Neomycine Cream in pediatric patients younger than 12 years of age have not been established; therefore, use in pediatric patients younger than 12 years of age is not recommended.
HPA-axis suppression was studied in four sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area (BSA), treated once daily or twice daily with Topsyne Neomycine (Fluocinonide) Cream. The first cohort of 31 patients (mean 36.3% BSA) 12 to <18 years old; the second cohort included 31 patients (mean 39.0% BSA) 6 to <12 years old; the third cohort included 30 patients (mean 34.6% BSA) 2 to <6 years old; the fourth cohort included 31 patients (mean 40.0% BSA) 3 months to <2 years old. Topsyne Neomycine (Fluocinonide) Cream caused HPA-axis suppression in 1 patient in the twice-daily group in Cohort 1, 2 patients in the twice-daily group in Cohort 2, and 1 patient in the twice-daily group in Cohort 3. Follow-up testing 14 days after treatment discontinuation, available for all 4 suppressed patients, demonstrated a normally responsive HPA axis. Signs of skin atrophy were present at baseline and severity was not determined, making it difficult to assess local skin safety. Therefore, the safety of Topsyne Neomycine (Fluocinonide) Cream in patients younger than 12 years of age has not been demonstrated [see Warnings and Precautions (5.2) ].
HPA-axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age.
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
HPA-axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to cosyntropin (ACTH1–24) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Clinical studies of Topsyne Neomycine (Fluocinonide) Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Topically applied Topsyne Neomycine (Fluocinonide) Cream can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) ].
Topsyne Neomycine (Fluocinonide) (fluocinonide) Cream, 0.1% contains Topsyne Neomycine (Fluocinonide), a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Topsyne Neomycine (Fluocinonide) has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C26H32F2O7 and it has a molecular weight of 494.58.
It has the following chemical structure:
Topsyne Neomycine (Fluocinonide) is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol.
Each gram of Topsyne Neomycine (Fluocinonide) Cream contains 1 mg micronized Topsyne Neomycine (Fluocinonide) in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Topsyne Neomycine Cream in corticosteroid responsive dermatoses is unknown.
Vasoconstrictor studies performed with Topsyne Neomycine (Fluocinonide) Cream in healthy subjects indicate that it is in the super-high range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.
Application of Topsyne Neomycine (Fluocinonide) Cream twice daily for 14 days in 18 adult subjects with plaque-type psoriasis (10–50% BSA, mean 19.6% BSA) and 31 adult subjects (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2–10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 subjects with psoriasis (with 12% and 25% BSA) and 1 subject with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH1–24) [see Warnings and Precautions (5.1) ].
HPA-axis suppression following application of Topsyne Neomycine (Fluocinonide) Cream, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to <18 years of age with atopic dermatitis (mean BSA range 34.6%-40.0%). HPA-axis suppression was observed in 4 patients in the twice-daily groups. Follow-up testing 14 days after treatment discontinuation demonstrated a normally responsive HPA axis in all 4 suppressed patients [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ].
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Topsyne Neomycine (Fluocinonide) Cream because of severe immunosuppression induced in a 13-week dermal rat study. The effects of Topsyne Neomycine (Fluocinonide) on fertility have not been evaluated.
Topsyne Neomycine (Fluocinonide) revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames test and chromosomal aberration assay using human lymphocytes). However, Topsyne Neomycine (Fluocinonide) was positive for clastogenic potential when tested in the in vivo mouse micronucleus assay.
Topical (dermal) application of 0.0003%–0.03% Topsyne Neomycine (Fluocinonide) cream to rats once daily for 13 weeks resulted in a toxicity profile generally associated with long-term exposure to corticosteroids including decreased skin thickness, adrenal atrophy, and severe immunosuppression. A NOAEL could not be determined in this study. In addition, topical (dermal) application of 0.1% Topsyne Neomycine (Fluocinonide) cream plus ultraviolet radiation (UVR) exposure to hairless mice for 13 weeks and 150–900 mg/kg/day of 0.1% Topsyne Neomycine (Fluocinonide) cream to minipigs (a model which more closely approximates human skin) for 13 weeks produced glucocorticoid-related suppression of the HPA axis, with some signs of immunosuppression noted in the dermal minipig study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.
Topical doses of 0% (fluocinonide cream vehicle), 0.0001%, 0.005%, and 0.001% Topsyne Neomycine (Fluocinonide) cream were evaluated in a 52-week dermal photocarcinogenicity study (40 weeks of treatment followed by 12 weeks of observation) conducted in hairless albino mice with concurrent exposure to low level ultraviolet radiation. Topical treatment with increasing concentrations of Topsyne Neomycine (Fluocinonide) cream did not have an adverse effect in this study. The results of this study suggest that topical treatment with Topsyne Neomycine (Fluocinonide) Cream would not enhance photocarcinogenesis.
Two adequate and well-controlled efficacy and safety studies of Topsyne Neomycine (Fluocinonide) Cream have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with Topsyne Neomycine (Fluocinonide) Cream for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2.
Topsyne Neomycine (Fluocinonide) Cream, once daily (n=107) | Vehicle, once daily (n=54) | Topsyne Neomycine (Fluocinonide) Cream, twice daily (n=107) | Vehicle, twice daily (n=55) | |
---|---|---|---|---|
Subjects cleared | 0 (0) | 0 (0) | 6 (6%) | 0 (0) |
Subjects achieving treatment success | 19 (18%) | 4 (7%) | 33 (31%) | 3 (5%) |
Topsyne Neomycine (Fluocinonide) Cream, once daily (n=109) | Vehicle, once daily (n=50) | Topsyne Neomycine (Fluocinonide) Cream, twice daily (n=102) | Vehicle, twice daily (n=52) | |
---|---|---|---|---|
Subjects cleared | 11 (10%) | 0 (0) | 17 (17%) | 0 (0) |
Subjects achieving treatment success | 64 (59%) | 6 (12%) | 58 (57%) | 10 (19%) |
No efficacy studies have been conducted to compare Topsyne Neomycine (Fluocinonide) (fluocinonide) Cream, 0.1% with any other topical corticosteroid product, including Topsyne Neomycine (Fluocinonide) cream 0.05%.
VANOS® (fluocinonide) Cream, 0.1% is white to off-white in color and is supplied in tubes as follows:
Store at controlled room temperature 15° to 30°C (59° to 86°F).
Keep the tube tightly closed.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patients using Topsyne Neomycine (Fluocinonide) Cream should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects:
Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada
U.S. Patent Numbers 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and 8,232,264
Topsyne Neomycine (Fluocinonide) is a trademark of Valeant Pharmaceuticals
International, Inc. or its affiliates.
©Valeant Pharmaceuticals North America LLC
9481801
Patient Information
VANOS® (VAN-ōs) (fluocinonide)
Cream, 0.1%
IMPORTANT: For skin use only. Do not get Topsyne Neomycine (Fluocinonide) Cream in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.
Read the Patient Information that comes with Topsyne Neomycine (Fluocinonide) Cream before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your condition or treatment.
What is Topsyne Neomycine (Fluocinonide) Cream?
Topsyne Neomycine (Fluocinonide) Cream is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.
It is not known if Topsyne Neomycine (Fluocinonide) Cream is safe and effective in children under 12 years of age.
What should I tell my doctor before using Topsyne Neomycine (Fluocinonide) Cream?
Before using Topsyne Neomycine (Fluocinonide) Cream, tell your doctor if you:
Tell your doctor about all the medicine you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a corticosteroid medicine by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.
How should I use Topsyne Neomycine (Fluocinonide) Cream?
What are the possible side effects with Topsyne Neomycine (Fluocinonide) Cream?
Topsyne Neomycine (Fluocinonide) Cream may cause side effects, including:
The most common side effect of Topsyne Neomycine (Fluocinonide) Cream is burning of your skin treated with Topsyne Neomycine (Fluocinonide) Cream.
Talk to your doctor about any side effect that bothers you or that does not go away.
These are not all the side effects with Topsyne Neomycine (Fluocinonide) Cream. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Valeant Pharmaceuticals North America LLC at 1-800-321-4576.
How should I store Topsyne Neomycine (Fluocinonide) Cream?
Keep Topsyne Neomycine (Fluocinonide) Cream and all medicines out of reach of children.
General information about Topsyne Neomycine (Fluocinonide) Cream
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Topsyne Neomycine (Fluocinonide) Cream for a condition for which it was not prescribed. Do not give Topsyne Neomycine (Fluocinonide) Cream to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Topsyne Neomycine (Fluocinonide) Cream. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about Topsyne Neomycine (Fluocinonide) Cream that is written for healthcare professionals.
What are the ingredients in Topsyne Neomycine (Fluocinonide) Cream?
Active ingredient: Topsyne Neomycine (Fluocinonide) 0.1%
Inactive ingredients: anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada
U.S. Patent Numbers 6,765,001; 7,217,422; 7,220,424; 7,771,733; 7,794,738 and 8,232,264
Topsyne Neomycine (Fluocinonide) is a trademark of Valeant Pharmaceuticals
International, Inc. or its affiliates.
©Valeant Pharmaceuticals North America LLC
Rev. 05/2017
9481801
Neomycin Sulfate:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Topsyne Neomycine (Neomycin Sulfate) tablets and other antibacterial drugs, Topsyne Neomycine (Neomycin Sulfate) tablets 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.
Suppression of Intestinal Bacteria
Topsyne Neomycine (Neomycin Sulfate) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).
Hepatic Coma (Portal-Systemic Encephalopathy)
Topsyne Neomycine (Neomycin Sulfate) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
Topsyne Neomycine (Neomycin Sulfate) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.
Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Topsyne Neomycine (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.
Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Prescribing Topsyne Neomycine tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.
Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.
Cross-allergenicity among aminoglycosides has been demonstrated.
Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.
Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.
There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.
An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.
Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.
Patients should be counseled that antibacterial drugs including Topsyne Neomycine (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Topsyne Neomycine (Neomycin Sulfate) tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Topsyne Neomycine (Neomycin Sulfate) tablets or other antibacterial drugs in the future.
Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.
Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve function.
Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.
Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ).
Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.
Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.
Oral Topsyne Neomycine (Neomycin Sulfate) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.
No long-term animal studies have been performed with Topsyne Neomycine to evaluate carcinogenic or mutagenic potential or impairment of fertility.
See WARNINGS section.
It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The safety and efficacy of oral Topsyne Neomycine (Neomycin Sulfate) in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.
The most common adverse reactions to oral Topsyne Neomycine (Neomycin Sulfate) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).
Because of low absorption, it is unlikely that acute overdosage would occur with oral Topsyne Neomycine (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.
Hemodialysis will remove Topsyne Neomycine (Neomycin Sulfate) from the blood.
To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.
Hepatic Coma
For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:
Preoperative Prophylaxis for Elective Colorectal Surgery
Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.
Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.
Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.
Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Topsyne Neomycine (Neomycin Sulfate) (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.
Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.
Topsyne Neomycine (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:
Bottles of 100 (NDC 0527-1210-01)
Store at 20° to 25°C (68° to 77°F).
Dispense in tight containers as defined in the USP/NF.
Distributed By:
Lannett Company, Inc.
Philadelphia, PA 19154
Made in the USA
Rev. 01/17
CIB71710A
Depending on the reaction of the Topsyne Neomycine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Topsyne Neomycine 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 Topsyne Neomycine 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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The information was verified by Dr. Rachana Salvi, MD Pharmacology