neomycin and polymyxin b sulfates and hydrocortisone
Pharmaranks rates Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Neomycin and Polymyxin B Sulfates and Hydrocortisone is a combination medicine containing Hydrocortisone, Neomycin Sulfate, and Polymyxin B Sulfate.
Hydrocortisone and Neomycin Sulfate and Polymyxin B Sulfate · by Sandoz
Generic of Casporyn Hc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Hydrocortisone and Neomycin Sulfate and Polymyxin B Sulfate
- Form
- Drops
- Strength
- Hydrocortisone 1%; Neomycin Sulfate EQ 3.5MG BASE/ML; Polymyxin B Sulfate 10,000 UNITS/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Sandoz
- Half-life
- about 1.5 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.15 per gm — not your price
- FDA application
- ANDA062488
What is Neomycin and Polymyxin B Sulfates and Hydrocortisone?
From the FDA label:Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.01% (added as a preservative) and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80, glacial acetic acid and Water for Injection. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formula are: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formula are: Hydrocortisone, 11β,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is: neomycin-chemical polymyxin-chemical polymyxin-text hydrocortisone-chemical
How to use
Therapy with this product should be limited to 10 consecutive days. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 drops of the suspension should be instilled into the affected ear 3 or 4 times daily. For infants and children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear. If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further suspension every 4 hours. The wick should be replaced at least once every 24 hours. SHAKE WELL BEFORE USING.
Side effects
Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS ). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population. 2 In another study, the incidence was found to be approximately 1%. 3 The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Stinging and burning have been reported rarely when this product has gained access to the middle ear.
Warnings
Important safety information
Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk is greater with prolonged use. Therapy should be limited to 10 consecutive days (see PRECAUTIONS—General ). Patients being treated with eardrops containing neomycin should be under close clinical observation. Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension should not be used in any patient with a perforated tympanic membrane. Discontinue promptly if sensitization or irritation occurs. Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin. The manifestation of sensitization to neomycin is usually a low-grade reddening with swelling, dry scaling, and itching; it may be manifest simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms regress quickly on withdrawing the medication. Neomycin-containing applications should be avoided for the patient thereafter.
Who should not take Neomycin and Polymyxin B Sulfates and Hydrocortisone
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.
How long does Hydrocortisone and Neomycin Sulfate and Polymyxin B Sulfate stay in your body?
The elimination half-life of hydrocortisone and neomycin sulfate and polymyxin b sulfate is about 1.5 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma (terminal) elimination half-life; the FDA label states "The terminal half-life of hydrocortisone is about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets" in healthy adults, so roughly 90% of a dose clears within about 8 hours and nearly all within ~12 hours. Hydrocortisone is not a prodrug, but its half-life measures how fast the drug leaves the blood, not how long its effects last: as a short-acting glucocorticoid its biological (tissue) effect on the body persists well beyond blood clearance, and this short plasma half-life is why oral replacement is usually dosed 2-3 times a day. Because hydrocortisone is metabolized in the liver, significant liver impairment can slow clearance; the label does not give a specific half-life adjustment for age, kidney, or liver function. Half-life is not the same as a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: ALKINDI SPRINKLE (hydrocortisone) oral granules — FDA prescribing information, DailyMed.
Dosage forms
Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- How is Neomycin and Polymyxin B Sulfates and Hydrocortisone rated?
- pharmaranks gives Neomycin and Polymyxin B Sulfates and Hydrocortisone a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Neomycin and Polymyxin B Sulfates and Hydrocortisone cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.15 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Neomycin and Polymyxin B Sulfates and Hydrocortisone?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Neomycin and Polymyxin B Sulfates and Hydrocortisone. To pay less, Neomycin and Polymyxin B Sulfates and Hydrocortisone is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Neomycin and Polymyxin B Sulfates and Hydrocortisone?
- Neomycin and Polymyxin B Sulfates and Hydrocortisone is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
- Is Neomycin and Polymyxin B Sulfates and Hydrocortisone a brand-name or generic drug?
- Neomycin and Polymyxin B Sulfates and Hydrocortisone is a generic medication; its active ingredient is Hydrocortisone and Neomycin Sulfate and Polymyxin B Sulfate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Neomycin and Polymyxin B Sulfates and Hydrocortisone available over the counter?
- No. Neomycin and Polymyxin B Sulfates and Hydrocortisone is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Neomycin and Polymyxin B Sulfates and Hydrocortisone come in?
- Neomycin and Polymyxin B Sulfates and Hydrocortisone is currently marketed as drops, per the FDA's National Drug Code Directory.
- Is Neomycin and Polymyxin B Sulfates and Hydrocortisone FDA-registered?
- Neomycin and Polymyxin B Sulfates and Hydrocortisone is on record with the U.S. FDA under application number ANDA062488. You can verify this on its official FDA label.
- Has Neomycin and Polymyxin B Sulfates and Hydrocortisone been recalled by the FDA?
- Neomycin and Polymyxin B Sulfates and Hydrocortisone has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Neomycin and Polymyxin B Sulfates and Hydrocortisone safe?
- There's no single safe-or-not verdict. pharmaranks gives Neomycin and Polymyxin B Sulfates and Hydrocortisone a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Neomycin and Polymyxin B Sulfates and Hydrocortisone?
- Neomycin and Polymyxin B Sulfates and Hydrocortisone's side effects are taken directly from its FDA label. From the label: Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS ). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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neomycin and polymyxin b sulfates and hydrocortisone
68/100