Dermikem OC Overdose

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Consists of Clobetasol, Ofloxacin, Ornidazole, Terbinafine

What happens if I overdose Clobetasol (Dermikem OC)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, 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 (Dermikem OC):

Store Clobetasol (Dermikem OC) 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 (Dermikem OC) out of the reach of children and away from pets.

Overdose of Clobetasol (Dermikem OC) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Symptoms: nausea, vomiting, drowsiness, dizziness, confusion, leg cramps, skin rash, diarrhea, dehydration may, disruption of water and electrolyte balance.

Treatment: discontinuation of the drug, induction of vomiting, gastric lavage, symptomatic treatment of dehydration and disorders of water and electrolyte balance, arterial hypotension, maintenance of vital functions; in the case of hyperkalemia - fast IV injection of 20-50% solution of glucose and insulin - 0.25-0.5 units / g of glucose. Used diuretics, and potassium carve ion exchange resins. Perhaps hemodialysis. There is no specific antidote for Clobetasol (Dermikem OC).

What should I avoid while taking Clobetasol (Dermikem OC)?

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

Avoid using Clobetasol (Dermikem OC) 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 (Dermikem OC) topical on broken or infected skin. Also avoid using this medication in open wounds.

Clobetasol (Dermikem OC) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Effects on Endocrine System

Clobetasol (Dermikem OC)-E Foam has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Systemic absorption of Clobetasol (Dermikem OC)-E has caused reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. Use of Clobetasol (Dermikem OC)-E Foam for longer than 2 weeks may suppress the immune system..

In a trial including 37 subjects aged 12 years and older with at least 30% body surface area (BSA), adrenal suppression was identified in 6 out of 37 subjects (16.2%) after 2 weeks of treatment with Clobetasol (Dermikem OC)-E..

Because of the potential for systemic absorption, use of Clobetasol (Dermikem OC)-E 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 adrenocorticotrophic 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 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 1 corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

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

Local Adverse Reactions with

Topical Corticosteroids

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, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

If irritation develops, treatment with Clobetasol (Dermikem OC)-E Foam should be discontinued and appropriate therapy instituted.

Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Clobetasol (Dermikem OC)-E Foam should be discontinued until the infection has been adequately treated.

Flammable Contents

The propellant in Clobetasol (Dermikem OC)-E Foam is flammable. Avoid fire, flame, or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

What should I discuss with my healthcare provider before taking Clobetasol (Dermikem OC)?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Clobetasol (Dermikem OC), the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Clobetasol (Dermikem OC) or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Clobetasol (Dermikem OC) topical cream, foam, gel, ointment, or scalp solution in children 12 years of age and older. However, because of Clobetasol (Dermikem OC)'s toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using Clobetasol (Dermikem OC), follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of Clobetasol (Dermikem OC) topical cream, foam, gel, ointment, or scalp solution is not recommended. The safety and efficacy of Clobetasol (Dermikem OC) topical lotion, shampoo, or spray have not been established in children and use is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Clobetasol (Dermikem OC) topical in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution in patients receiving Clobetasol (Dermikem OC) topical cream.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Clobetasol (Dermikem OC), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Clobetasol (Dermikem OC) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of Clobetasol (Dermikem OC). Make sure you tell your doctor if you have any other medical problems, especially:

Clobetasol (Dermikem OC) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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General: Clobetasol (Dermikem OC) propionate is a super-potent topical corticosteroid that has been shown to suppress the adrenals at 7.0 g of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam per day. Lesser amounts of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam were not studied. Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Conditions which augment systemic absorption include the application of more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression. If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. See PRECAUTIONS-Pediatric Use.

If irritation develops, Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than by noting a clinical exacerbation, as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam should be discontinued until the infection has been adequately controlled.

Laboratory Tests: The following tests may be helpful in evaluating patients for adrenal suppression:

ACTH stimulation test

A.M. plasma cortisol test

Urinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of Clobetasol (Dermikem OC) propionate.

Clobetasol (Dermikem OC) propionate was non-mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

Studies in the rat following subcutaneous administration of Clobetasol (Dermikem OC) propionate at dosage levels up to 0.05 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose.

Pregnancy: Teratogenic Effects: Pregnancy Category C: 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 to laboratory animals.

Clobetasol (Dermikem OC) propionate has not been tested for teratogenicity by the topical route; however, it is absorbed percutaneously, and when administered subcutaneously, it was a significant teratogen in both the rabbit and the mouse. Clobetasol (Dermikem OC) propionate has greater teratogenic potential than steroids that are less potent.

Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) based on body surface area comparisons. Abnormalities seen included cleft palate and skeletal abnormalities.

In rabbits, Clobetasol (Dermikem OC) propionate was teratogenic at doses of 0.003 and 0.01 mg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) based on body surface area comparisons. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities.

There are no adequate and well-controlled studies of the teratogenic potential of Clobetasol (Dermikem OC) propionate in pregnant women. Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers: 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. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam in pediatric patients have not been established; therefore, use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of adrenal suppression and Cushing's syndrome when they are treated with topical corticosteroids. Pediatric patients are therefore at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

Adrenal 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 an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use: Clinical studies of Clobetasol (Dermikem OC) (Clobetasol (Dermikem OC) propionate) Foam did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

What happens if I miss a dose of Clobetasol (Dermikem OC)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

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 Ofloxacin (Dermikem OC)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Ofloxacin (Dermikem OC) may be harmful if swallowed.

Proper storage of Ofloxacin (Dermikem OC):

Store Ofloxacin (Dermikem OC) at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ofloxacin (Dermikem OC) out of the reach of children and away from pets.

Overdose of Ofloxacin (Dermikem OC) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Information on overdosage with ofloxacin is limited. One incident of accidental overdosage has been reported. In this case, an adult female received 3 grams of ofloxacin intravenously over 45 minutes. A blood sample obtained 15 minutes after the completion of the infusion revealed an ofloxacin level of 39.3 μg/mL. In 7 h, the level had fallen to 16.2 μg/mL, and by 24 h to 2.7 μg/mL. During the infusion, the patient developed drowsiness, nausea, dizziness, hot and cold flushes, subjective facial swelling and numbness, slurring of speech, and mild to moderate disorientation. All complaints except the dizziness subsided within 1 h after discontinuation of the infusion. The dizziness, most bothersome while standing, resolved in approximately 9 h. Laboratory testing reportedly revealed no clinically significant changes in routine parameters in this patient.

In the event of an acute overdose, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Ofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

What should I avoid while taking Ofloxacin (Dermikem OC)?

You may be taking certain other medicines that should not be taken at the same time as ofloxacin. Avoid taking the following medicines within 2 hours before or after you take ofloxacin. These other medicines can make ofloxacin much less effective when taken at the same time:

Avoid exposure to sunlight or tanning beds. Ofloxacin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ofloxacin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Ofloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ofloxacin (Dermikem OC) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

Tendinopathy and Tendon Rupture

Fluoroquinolones, including Ofloxacin (Dermikem OC)® (ofloxacin), are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ofloxacin (Dermikem OC)® (ofloxacin) should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

THE SAFETY AND EFFICACY OF OFLOXACIN IN PEDIATRIC PATIENTS AND ADOLESCENTS (UNDER THE AGE OF 18 YEARS), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.

In the immature rat, the oral administration of ofloxacin at 5 to 16 times the recommended maximum human dose based on mg/kg or 1-3 times based on mg/m² increased the incidence and severity of osteochondrosis. The lesions did not regress after 13 weeks of drug withdrawal. Other quinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species.

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including Ofloxacin (Dermikem OC)® (ofloxacin), have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid Ofloxacin (Dermikem OC)® (ofloxacin) in patients with a known history of myasthenia gravis.

Central Nervous System Effects

Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including ofloxacin. Quinolones, including ofloxacin, may also cause central nervous system stimulation which may lead to: tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia and depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ofloxacin, the drug should be discontinued and appropriate measures instituted. Insomnia may be more common with ofloxacin than some other products in the quinolone class. As with all quinolones, ofloxacin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including ofloxacin. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. This drug should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.

Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.

Peripheral Neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ofloxacin. Ofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ofloxacin (Dermikem OC)® (ofloxacin), and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Ofloxacin has not been shown to be effective in the treatment of syphilis.

Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with ofloxacin for gonorrhea should have a follow-up serologic test for syphilis after three months and, if positive, treatment with an appropriate antimicrobial should be instituted.

What should I discuss with my healthcare provider before taking Ofloxacin (Dermikem OC)?

Some medical conditions may interact with Ofloxacin (Dermikem OC). 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 Ofloxacin (Dermikem OC). 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 Ofloxacin (Dermikem OC) 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.

Ofloxacin (Dermikem OC) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.

General: As with other anti-infective preparations, prolonged use may result in over-growth of nonsusceptible organisms, including fungi. If the infection is not improved after one week, cultures should be obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

The systemic administration of quinolones, including ofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.

Young growing guinea pigs dosed in the middle ear with 0.3% ofloxacin otic solution showed no systemic effects, lesions or erosions of the cartilage in weightbearing joints, or other signs of arthropathy. No drug-related structural or functional changes of the cochlea and no lesions in the ossicles were noted in the guinea pig following otic administration of 0.3% ofloxacin for one month.

No signs of local irritation were found when 0.3% ofloxacin was applied topically in the rabbit eye. Ofloxacin was also shown to lack dermal sensitizing potential in the guinea pig maximization study.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to determine the carcinogenic potential of ofloxacin have not been conducted. Ofloxacin was not mutagenic in the Ames test, the sister chromatid exchange assay (Chinese hamster and human cell lines), the unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or the mouse micro-nucleus assay. Ofloxacin was positive in the rat hepatocyte UDS assay, and in the mouse lymphoma assay. In rats, ofloxacin did not affect male or female reproductive performance at oral doses up to 360 mg/kg/day. This would be over 1000 times the maximum recommended clinical dose, based upon body surface area, assuming total absorption of ofloxacin from the ear of a patient treated with Ofloxacin (Dermikem OC)® Otic (ofloxacin otic solution) twice per day.

Pregnancy

Teratogenic effects: Pregnancy Category C.

Ofloxacin has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day.

These dosages resulted in decreased fetal body weights and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively.

Ofloxacin has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount of ofloxacin that will be delivered ototopically at the recommended clinical doses.

Nonteratogenic Effects: Additional studies in the rat demonstrated that doses up to 360 mg/kg/day during late gestation had no adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin (Dermikem OC)® Otic (ofloxacin otic solution) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: In nursing women, a single 200 mg oral dose resulted in concentrations of ofloxacin in milk which were similar to those found in plasma. It is not

known whether ofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions from ofloxacin 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: Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed

Indications:

Safety and efficacy in pediatric patients below these ages have not been established. Although no data are available on patients less than age 6 months, there are no known safety concerns or differences in the disease process in this population that will preclude use of this product.

No changes in hearing function occurred in 30 pediatric subjects treated with ofloxacin otic and tested for audiometric parameters. Although quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after systemic administration, young growing guinea pigs dosed in the middle ear with 0.3% ofloxacin otic solution for one month showed no systemic effects, quinoloneinduced lesions, erosions of the cartilage in weight-bearing joints, or other signs of arthropathy.

What happens if I miss a dose of Ofloxacin (Dermikem OC)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of ofloxacin otic unless otherwise directed by your doctor.

Ornidazole (Dermikem OC) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

Ornidazole (Dermikem OC) is used to treat stomach and duodenal (upper small intestine) ulcers; hypersecretory (increased acid secretion) conditions; heartburn and gastroesophageal reflux disease (stomach contents bubbling into the esophagus causing pain). Notify your physician if you are pregnant or nursing. Ornidazole (Dermikem OC) may be taken with or without food. Shake the oral suspension vigorously for 5-10 seconds before taking. Unused oral suspension should be discarded after 30 days. Notify your physician if you develop black, tarry stools or coffee-ground vomit.

Ornidazole (Dermikem OC) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.

In patients with ataxia, vertigo and mental confusion, ornidazole should be prescribed with caution because it has been occasionally reported to aggravate neurological complications in patients with central and peripheral nervous system disorders. During prolonged treatment with ornidazole, blood dyscrasias, namely mild leucopenia, have been rarely reported. In case leucopenia occurs, the decision to discontinue the therapy should depend upon the gravity of infection.

Use in pregnancy & lactation: Adequate clinical trials have not been conducted. Ornidazole should be prescribed only if the potential benefits justify the potential risk to fetus/neonate.

What happens if I overdose Terbinafine (Dermikem OC)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include dizziness; frequent urination; rash; severe headache or nausea; stomach pain; vomiting.

Proper storage of Terbinafine (Dermikem OC):

Store Terbinafine (Dermikem OC) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Terbinafine (Dermikem OC) out of the reach of children and away from pets.

Overdose of Terbinafine (Dermikem OC) in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.

The low systemic absorption of topical terbinafine renders overdosage extremely unlikely. Accidental ingestion of the contents of one 30 g tube of Terbinafine (Dermikem OC), which contains terbinafine hydrochloride 300 mg, is comparable to one Terbinafine (Dermikem OC) 250 mg tablet (adult oral unit dose).

Should a larger amount of Terbinafine (Dermikem OC) be inadvertently ingested, adverse effects similar to those observed with an overdosage of Terbinafine (Dermikem OC) tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.

The recommended treatment of overdosage consists of eliminating Terbinafine (Dermikem OC), primarily by the administration of activated charcoal and giving symptomatic supportive therapy, if needed.

What should I avoid while taking Terbinafine (Dermikem OC)?

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication.

Avoid exposure to sunlight or tanning beds. Terbinafine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Terbinafine (Dermikem OC) warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

Hepatotoxicity

Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Terbinafine (Dermikem OC) Tablets in individuals with and without preexisting liver disease.

In the majority of liver cases reported in association with use of Terbinafine (Dermikem OC) Tablets, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with Terbinafine (Dermikem OC) Tablets should be discontinued if biochemical or clinical evidence of liver injury develops.

Terbinafine (Dermikem OC) Tablets are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine (Dermikem OC) Tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Periodic monitoring of liver function tests is recommended. Terbinafine (Dermikem OC) should be immediately discontinued in case of elevation of liver function tests. Patients prescribed Terbinafine (Dermikem OC) Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patient’s liver function should be immediately evaluated.

Taste Disturbance Including Loss of Taste

Taste disturbance, including taste loss, has been reported with the use of Terbinafine (Dermikem OC) Tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a taste disturbance occur, Terbinafine (Dermikem OC) Tablets should be discontinued.

Smell Disturbance Including Loss of Smell

Smell disturbance, including loss of smell, has been reported with the use of Terbinafine (Dermikem OC) Tablets. Smell disturbance may resolve after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a smell disturbance occur, Terbinafine (Dermikem OC) Tablets should be discontinued.

Depressive Symptoms

Depressive symptoms have occurred during postmarketing use of Terbinafine (Dermikem OC) Tablets. Prescribers should be alert to the development of depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.

Hematologic Effects

Transient decreases in absolute lymphocyte counts (ALCs) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 subjects receiving Terbinafine (Dermikem OC) Tablets (1.7%) and 3/137 subjects receiving placebo (2.2%) had decreases in ALC to below 1000/mm3 on 2 or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment continues for more than 6 weeks. Cases of severe neutropenia have been reported. These were reversible upon discontinuation of Terbinafine (Dermikem OC) Tablets, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete blood count should be obtained. If the neutrophil count is ≤1000 cells/mm3, Terbinafine (Dermikem OC) Tablets should be discontinued and supportive management started.

Serious Skin/Hypersensitivity Reactions

There have been postmarketing reports of serious skin/hypersensitivity reactions [e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome]. Manifestations of DRESS syndrome may include cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more organ complications such as hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive skin rash or signs/symptoms of the above drug reactions occur, treatment with Terbinafine (Dermikem OC) Tablets should be discontinued.

Lupus Erythematosus

During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking Terbinafine (Dermikem OC) Tablets. Terbinafine (Dermikem OC) Tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.

Laboratory Monitoring

Measurement of serum transaminases (ALT and AST) is advised for all patients before taking Terbinafine (Dermikem OC) Tablets.

What should I discuss with my healthcare provider before taking Terbinafine (Dermikem OC)?

Some medical conditions may interact with Terbinafine (Dermikem OC). 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 Terbinafine (Dermikem OC). 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 Terbinafine (Dermikem OC) 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.

Terbinafine (Dermikem OC) precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.

Hepatotoxicity

Cases of liver failure, some leading to liver transplant or death, have occurred with the use of Terbinafine (Dermikem OC) Tablets in individuals with and without preexisting liver disease.

In the majority of liver cases reported in association with use of Terbinafine (Dermikem OC) Tablets, the patients had serious underlying systemic conditions. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease. Treatment with Terbinafine (Dermikem OC) Tablets should be discontinued if biochemical or clinical evidence of liver injury develops.

Terbinafine (Dermikem OC) Tablets are not recommended for patients with chronic or active liver disease. Before prescribing Terbinafine (Dermikem OC) Tablets, liver function tests should be performed since hepatotoxicity may occur in patients with and without pre-existing liver disease. Periodic monitoring of liver function tests is recommended. Terbinafine (Dermikem OC) should be immediately discontinued in case of elevation of liver function tests. Patients prescribed Terbinafine (Dermikem OC) Tablets should be warned to report immediately to their physician any symptoms of persistent nausea, anorexia, fatigue, vomiting, right upper abdominal pain or jaundice, dark urine, or pale stools. Patients with these symptoms should discontinue taking oral terbinafine, and the patient’s liver function should be immediately evaluated.

Taste Disturbance Including Loss of Taste

Taste disturbance, including taste loss, has been reported with the use of Terbinafine (Dermikem OC) Tablets. It can be severe enough to result in decreased food intake, weight loss, anxiety, and depressive symptoms. Taste disturbance may resolve within several weeks after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a taste disturbance occur, Terbinafine (Dermikem OC) Tablets should be discontinued.

Smell Disturbance Including Loss of Smell

Smell disturbance, including loss of smell, has been reported with the use of Terbinafine (Dermikem OC) Tablets. Smell disturbance may resolve after discontinuation of treatment, but may be prolonged (greater than 1 year), or may be permanent. If symptoms of a smell disturbance occur, Terbinafine (Dermikem OC) Tablets should be discontinued.

Depressive Symptoms

Depressive symptoms have occurred during postmarketing use of Terbinafine (Dermikem OC) Tablets. Prescribers should be alert to the development of depressive symptoms, and patients should be instructed to report depressive symptoms to their physician.

Hematologic Effects

Transient decreases in absolute lymphocyte counts (ALCs) have been observed in controlled clinical trials. In placebo-controlled trials, 8/465 subjects receiving Terbinafine (Dermikem OC) Tablets (1.7%) and 3/137 subjects receiving placebo (2.2%) had decreases in ALC to below 1000/mm3 on 2 or more occasions. In patients with known or suspected immunodeficiency, physicians should consider monitoring complete blood counts if treatment continues for more than 6 weeks. Cases of severe neutropenia have been reported. These were reversible upon discontinuation of Terbinafine (Dermikem OC) Tablets, with or without supportive therapy. If clinical signs and symptoms suggestive of secondary infection occur, a complete blood count should be obtained. If the neutrophil count is ≤1000 cells/mm3, Terbinafine (Dermikem OC) Tablets should be discontinued and supportive management started.

Serious Skin/Hypersensitivity Reactions

There have been postmarketing reports of serious skin/hypersensitivity reactions [e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, bullous dermatitis, and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome]. Manifestations of DRESS syndrome may include cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more organ complications such as hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. If progressive skin rash or signs/symptoms of the above drug reactions occur, treatment with Terbinafine (Dermikem OC) Tablets should be discontinued.

Lupus Erythematosus

During postmarketing experience, precipitation and exacerbation of cutaneous and systemic lupus erythematosus have been reported in patients taking Terbinafine (Dermikem OC) Tablets. Terbinafine (Dermikem OC) Tablets should be discontinued in patients with clinical signs and symptoms suggestive of lupus erythematosus.

Laboratory Monitoring

Measurement of serum transaminases (ALT and AST) is advised for all patients before taking Terbinafine (Dermikem OC) Tablets.

What happens if I miss a dose of Terbinafine (Dermikem OC)?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

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. "TERBINAFINE: 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. "OFLOXACIN: 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. "Ornidazole". http://www.drugbank.ca/drugs/DB13026 (accessed September 17, 2018).

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