Neoclobenate GM Overdose

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Consists of Clobetasol Topical, Miconazole Topical, Neomycin Topical

What happens if I overdose Clobetasol Topical (Neoclobenate GM)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include muscle weakness; severe or persistent headache; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; drowsiness; flushing; rapid breathing; fruit-like breath odor); unusual weight gain, especially in the face; vision changes.

Proper storage of Clobetasol Topical (Neoclobenate GM):

Store Clobetasol Topical (Neoclobenate GM) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not store above 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not refrigerate or freeze. Do not store in the bathroom. Keep Clobetasol Topical (Neoclobenate GM) out of the reach of children and away from pets.

Overdose of Clobetasol Topical (Neoclobenate GM) in details

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Symptoms:

Topically applied Clobetasol Topical (Neoclobenate GM) may be absorbed in sufficient amounts to produce systemic effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercortisolism may occur.

Treatment: In the event of overdose, Clobetasol Topical (Neoclobenate GM) should be withdrawn gradually by reducing the frequency of application or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.

Further management should be as clinically indicated or as recommended by the national poisons center, where available.

What should I avoid while taking Clobetasol Topical (Neoclobenate GM)?

Clobetasol topical should not be used to treat any skin condition your doctor has not prescribed it for.

Avoid using clobetasol topical to treat skin on your face, underarms, or groin area without your doctor's advice.

Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use clobetasol topical on broken or infected skin. Also avoid using this medication in open wounds.

Clobetasol Topical (Neoclobenate GM) warnings

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Effects on the Endocrine System

Clobetasol Topical (Neoclobenate GM) Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential for systemic absorption, use of topical corticosteroids, including Clobetasol Topical (Neoclobenate GM) Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of Clobetasol Topical (Neoclobenate GM) Cream on the HPA axis, subjects with plaque psoriasis applied Clobetasol Topical (Neoclobenate GM) Cream twice daily to at least 20% of involved Body Surface Area (BSA) for 15 days. Abnormal ACTH stimulation tests suggestive of HPA axis suppression were seen in 3 of 24 (12.5%) subjects on Clobetasol Topical (Neoclobenate GM) Cream. In another trial to evaluate the effects of Clobetasol Topical (Neoclobenate GM) Cream on the HPA axis, subjects with moderate to severe plaque psoriasis applied Clobetasol Topical (Neoclobenate GM) Cream twice daily to at least 25% of involved BSA for 28 consecutive days. Abnormal ACTH stimulation test suggestive of HPA axis suppression was seen in 8 of 26 (30.8%) of subjects on Clobetasol Topical (Neoclobenate GM) Cream.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.

Minimize the unwanted risks from endocrine effects by mitigating risk factors favoring increased systemic bioavailability and by using the product as recommended.

Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios.

Local Adverse Reactions with

Topical Corticosteroids

Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including Clobetasol Topical (Neoclobenate GM) Cream. Some local adverse reactions may be irreversible.

Concomitant Skin Infections

Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of Clobetasol Topical (Neoclobenate GM) Cream until the infection has been adequately treated.

Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.

What should I discuss with my healthcare provider before taking Clobetasol Topical (Neoclobenate GM)?

Some medical conditions may interact with Clobetasol Topical (Neoclobenate GM). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Clobetasol Topical (Neoclobenate GM). Because little, if any, of Clobetasol Topical (Neoclobenate GM) is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Clobetasol Topical (Neoclobenate GM) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Clobetasol Topical (Neoclobenate GM) precautions

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Effects on the Endocrine System

Clobetasol Topical (Neoclobenate GM) Cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Because of the potential for systemic absorption, use of topical corticosteroids, including Clobetasol Topical (Neoclobenate GM) Cream, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a trial evaluating the effects of Clobetasol Topical (Neoclobenate GM) Cream on the HPA axis, subjects with plaque psoriasis applied Clobetasol Topical (Neoclobenate GM) Cream twice daily to at least 20% of involved Body Surface Area (BSA) for 15 days. Abnormal ACTH stimulation tests suggestive of HPA axis suppression were seen in 3 of 24 (12.5%) subjects on Clobetasol Topical (Neoclobenate GM) Cream. In another trial to evaluate the effects of Clobetasol Topical (Neoclobenate GM) Cream on the HPA axis, subjects with moderate to severe plaque psoriasis applied Clobetasol Topical (Neoclobenate GM) Cream twice daily to at least 25% of involved BSA for 28 consecutive days. Abnormal ACTH stimulation test suggestive of HPA axis suppression was seen in 8 of 26 (30.8%) of subjects on Clobetasol Topical (Neoclobenate GM) Cream.

If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and glucosuria. These complications are rare and generally occur after prolonged exposure to larger than recommended doses, particularly with high-potency topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.

Minimize the unwanted risks from endocrine effects by mitigating risk factors favoring increased systemic bioavailability and by using the product as recommended.

Pediatric patients may be more susceptible to systemic toxicity because of their larger skin surface to body mass ratios.

Local Adverse Reactions with

Topical Corticosteroids

Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including Clobetasol Topical (Neoclobenate GM) Cream. Some local adverse reactions may be irreversible.

Concomitant Skin Infections

Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of Clobetasol Topical (Neoclobenate GM) Cream until the infection has been adequately treated.

Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, discontinue the topical corticosteroid and institute appropriate therapy.

What happens if I miss a dose of Clobetasol Topical (Neoclobenate GM)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose Miconazole Topical (Neoclobenate GM)?

An overdose of miconazole vaginal is unlikely. If you do suspect that a much larger than normal dose has been used or that miconazole vaginal has been ingested, contact an emergency room or a poison control center.

Overdose of Miconazole Topical (Neoclobenate GM) in details

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This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

To help prevent vaginal yeast infections, dry the genital area thoroughly after showering, bathing, or swimming. Avoid wearing tight jeans, nylon underwear, pantyhose, a wet bathing suit, or damp/sweaty exercise clothes for long periods. Wear cotton underwear, and change your underwear daily.

If your sexual partner experiences symptoms, they should contact their doctor right away.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

What should I avoid while taking Miconazole Topical (Neoclobenate GM)?

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Miconazole may damage a condom or diaphragm. Use another form of birth control while using miconazole vaginal.

Miconazole Topical (Neoclobenate GM) warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

What should I discuss with my healthcare provider before taking Miconazole Topical (Neoclobenate GM)?

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Miconazole Topical (Neoclobenate GM) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Miconazole Topical (Neoclobenate GM) precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as terconazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this medication: diabetes, immune system problems (such as HIV-AIDS), frequent vaginal yeast infections (more than 3 in 6 months or 4 in 1 year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask your doctor whether you can have sexual intercourse while using this product. This product may weaken rubber products (such as latex condoms, diaphragms, cervical caps) and lead to failure. This can result in pregnancy. Therefore, do not use these products during treatment with this medication and for 3 days after treatment is over. Consult your doctor about other forms of barrier protection/birth control (such as polyurethane condoms) during this time.

Do not use this medication for self-treatment if you are pregnant. During pregnancy, this medication should be used only when clearly needed. If you are pregnant, follow your doctor's instructions on how to use the applicator to insert this medication. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

What happens if I miss a dose of Miconazole Topical (Neoclobenate GM)?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and apply only the next regularly scheduled dose. Do not use a double dose of this medication.

What happens if I overdose Neomycin Topical (Neoclobenate GM)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include change in urination frequency or amount of urine.

Proper storage of Neomycin Topical (Neoclobenate GM):

Store Neomycin Topical (Neoclobenate GM) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Neomycin Topical (Neoclobenate GM) out of the reach of children and away from pets.

Overdose of Neomycin Topical (Neoclobenate GM) in details

Because of low absorption, it is unlikely that acute overdosage would occur with oral Neomycin Topical (Neoclobenate GM). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Neomycin Topical (Neoclobenate GM) from the blood.

What should I avoid while taking Neomycin Topical (Neoclobenate GM)?

If you are being treated for hepatic coma, avoid eating foods that are high in protein. Follow your doctor's instructions about any other restrictions on food, beverages, or activity.

Neomycin Topical (Neoclobenate GM) warnings

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.

What should I discuss with my healthcare provider before taking Neomycin Topical (Neoclobenate GM)?

Some medical conditions may interact with Neomycin Topical (Neoclobenate GM). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Neomycin Topical (Neoclobenate GM). Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Neomycin Topical (Neoclobenate GM) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Neomycin Topical (Neoclobenate GM) precautions

General

Prescribing Neomycin Topical (Neoclobenate GM) 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 Topical (Neoclobenate GM) may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

Neomycin Topical (Neoclobenate GM) 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 Topical (Neoclobenate GM).

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 Topical (Neoclobenate GM) are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of Neomycin Topical (Neoclobenate GM). If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral Neomycin Topical (Neoclobenate GM) 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 Topical (Neoclobenate GM) increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for The Patient

Patients should be counseled that antibacterial drugs including Neomycin Topical (Neoclobenate GM) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Neomycin Topical (Neoclobenate GM) 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 Neomycin Topical (Neoclobenate GM) 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.

Laboratory Tests

Patients with renal insufficiency may develop toxic Neomycin Topical (Neoclobenate GM) 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 (eighth cranial 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.

Drug Interactions

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 Topical (Neoclobenate GM).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance Neomycin Topical (Neoclobenate GM)’s nephrotoxicity and/or ototoxicity and potentiate Neomycin Topical (Neoclobenate GM)’s neuromuscular blocking effects.

Oral Neomycin Topical (Neoclobenate GM) 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 Neomycin Topical (Neoclobenate GM) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Neomycin Topical (Neoclobenate GM) to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

Nursing Mothers

It is not known whether Neomycin Topical (Neoclobenate GM) 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.

Pediatric Use

The safety and efficacy of oral Neomycin Topical (Neoclobenate GM) 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 Topical (Neoclobenate GM) should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

What happens if I miss a dose of Neomycin Topical (Neoclobenate GM)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.



References

  1. DailyMed. "MICONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. DrugBank. "Clobetasol". http://www.drugbank.ca/drugs/DB11750 (accessed September 17, 2018).

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