Betamethasone valerate/gentamicin/Miconazole Uses

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Consists of betamethasone valerate, gentamicin, Miconazole

What is Betamethasone valerate?

Reducing itching, redness, and swelling associated with skin conditions of the scalp. It may also be used for other conditions as determined by your doctor.

Betamethasone valerate is a topical corticosteroid. It works by depressing the formation, release, and activity of different cells and chemicals that cause swelling, redness, and itching.

Betamethasone valerate indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Betamethasone valerate, 0.12% is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

How should I use Betamethasone valerate?

Use Betamethasone valerate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Betamethasone valerate.

Uses of Betamethasone valerate in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Betamethasone valerate reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.

How to use Betamethasone valerate topical

Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor.

Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in, usually 1-3 times daily or as directed by your doctor. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in these areas, rinse with plenty of water.

Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.

Inform your doctor if your condition persists or worsens after 2 weeks.

Betamethasone valerate description

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Betamethasone valerate Cream: Betamethasone valerate contains Betamethasone valerate 0.1% as 17-valerate in a water-miscible base.

It also contains the following excipients: Chlorocresol, macrogol cetostearyl ether, cetostearyl alcohol, white soft paraffin, liquid paraffin, sodium acid phosphate, phosphoric acid, sodium hydroxide and purified water.

Betamethasone valerate RD Cream: Betamethasone valerate RD Cream contains Betamethasone valerate 0.025% as the valerate ester in a water-miscible base.

It also contains the following excipients: Cetostearyl alcohol, macrogol cetostearyl ether, white soft paraffin, liquid paraffin, chlorocresol, anhydrous disodium hydrogen phosphate, citric acid monohydrate and purified water.

Betamethasone valerate Scalp Application: Betamethasone valerate Scalp Application contains Betamethasone valerate 0.1% w/w as valerate. The vehicle contains 50% of isopropyl alcohol, which has antibacterial activity. This preparation complies with the specifications for Betamethasone valerate Valerate Scalp Application BP.

It also contains the following excipients: Carbomer, isopropyl alcohol, sodium hydroxide and purified water.

Betamethasone valerate dosage

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Betamethasone valerate Cream/Betamethasone valerate RD Cream: A small quantity should be applied to the affected area 2 or 3 times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day or even less often or by using the appropriate ready-diluted (1 in 4) preparation Betamethasone valerate RD Cream.

Betamethasone valerate Cream: Betamethasone valerate creams are especially appropriate for moist or weeping surfaces.

In the more resistant lesions eg, the thickened plaques of psoriasis on elbows and knees, the effect of Betamethasone valerate can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions thereafter, improvement can usually be maintained by regular application without occlusion.

Betamethasone valerate RD Cream: A small amount of Betamethasone valerate RD Cream may be applied up to 3 times daily. Betamethasone valerate RD Cream is especially appropriate for moist or weeping surfaces.

Betamethasone valerate Scalp Application: A small quantity of Betamethasone valerate Scalp Application should be applied to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day or less frequently.

Due to the flammable nature of Betamethasone valerate Scalp Application, patients should avoid smoking, heat including the use of hair dryer or being near an open flame during application and immediately after use.

Children: Betamethasone valerate valerate is contraindicated in children <1 year.

Children are more likely to develop local and systemic side effects of topical corticosteroids and in general, require shorter courses and less potent agents than adults.

Care should be taken when using Betamethasone valerate valerate to ensure the amount applied is the minimum that provides therapeutic benefit.

Elderly: The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic absorption occurs. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Renal/Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period), metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore, the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.

Betamethasone valerate interactions

See also:
What other drugs will affect Betamethasone valerate?

Concurrent use of barbiturates, carbamazepine, phenytoin, primidone or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroids. Conversely, oral contraceptives or ritonavir may increase plasma concentrations of corticosteroids.

Use of corticosteroids with potassium-depleting diuretics eg, thiazides or furosemide may cause excessive potassium loss. There is also an increased risk of hypokalemia with concurrent amphotericin B or bronchodilator therapy with xanthines or β2 agonist.

There may be an increased incidence of gastrointestinal bleeding and ulceration when corticosteroids are given with NSAIDs. Corticosteroids may alter response to anticoagulants increasing requirements of antidiabetic drugs and antihypertensives.

Corticosteroids may decrease serum concentrations of salicylates and may decrease the effect of antimuscarinics in myasthenia gravis.

Betamethasone valerate side effects

See also:
What are the possible side effects of Betamethasone valerate?

The most frequent adverse event was burning/itching/ stinging at the application site; the incidence and severity of this event were as follows:

Incidence and severity of burning/itching/stinging

Product

Total incidence

Maximum severity

Mild

Moderate

Severe

Betamethasone valerate, 0.12%

n=63

34 (54%)

28 (44%)

5 (8%)

1 (2%)

Betamethasone valerate

Valerate Lotion

n=63

33 (52%)

26 (41%)

6 (10%)

1 (2%)

Placebo Foam

n=32

24 (75%)

13 (41%)

7 (22%)

4 (12%)

Placebo Lotion

n=30

20 (67%)

12 (40%)

5 (17%)

3 (10%)

Other adverse events which were considered to be possibly, probably, or definitely related to Betamethasone valerate, 0.12% occurred in one patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Betamethasone valerate contraindications

See also:
What is the most important information I should know about Betamethasone valerate?

Hypersensitivity to Betamethasone valerate valerate or to any of the ingredients of Betamethasone valerate Cream/Betamethasone valerate RD Cream/Betamethasone valerate Scalp Application.

Betamethasone valerate valerate is contraindicated in dermatoses in infants <1 year, including dermatitis.

Betamethasone valerate Cream/Betamethasone valerate RD Cream: Rosacea; acne vulgaris; perioral dermatitis; perianal and genital pruritus; pruritus without inflammation; primary cutaneous viral infections (eg, herpes simplex, chickenpox).

The use of Betamethasone valerate Cream/Betamethasone valerate RD Cream is not indicated in the treatment of primarily infected skin lesions caused by infection with fungi or bacteria.

Betamethasone valerate Scalp Application: Infections of the scalp.

What is Gentamicin?

Gentamicin is an antibiotic. It fights bacteria in the body.

Gentamicin is used to treat severe or serious bacterial infections.

Gentamicin may also be used for purposes other than those listed in this medication guide.

Gentamicin indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of gentamicin and other antibacterial drugs, gentamicin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Gentamicin Sulfate Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative).

Clinical studies have shown Gentamicin Sulfate Injection, USP to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns).

Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity.

Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin.

Gentamicin Sulfate may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the box. If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted.

In serious infections when the causative organisms are unknown, Gentamicin Sulfate may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.

Gentamicin Sulfate has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci.

Gentamicin Sulfate Injection, USP has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms.

In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin.

How should I use Gentamicin?

Use Gentamicin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Gentamicin.

Uses of Gentamicin in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

This medication is used to treat minor skin infections (such as impetigo, folliculitis) or minor infections related to some skin conditions (such as eczema, psoriasis, minor burns/cuts/wounds). Gentamicin works by stopping the growth of certain bacteria. It belongs to a class of drugs known as aminoglycoside antibiotics.

This antibiotic only treats bacterial infections. It will not work for virus or fungus infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How to use Gentamicin topical

This medication is for use on the skin only.

Wash your hands before using. Clean and dry the affected area as directed. If you are treating impetigo, remove any dried, crusty skin to increase contact between the antibiotic and the infected area. Then gently apply a small amount of medication in a thin layer as directed by your doctor, usually 3 to 4 times a day. You may cover the area with a sterile gauze bandage if so directed. Keep the infected area clean. Wash your hands after use, unless you are using this product to treat the hands.

Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wipe off the medication and rinse thoroughly with water.

Dosage and length of treatment is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.

Continue to use this medication for the full length of treatment prescribed, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your skin infection persists or if it worsens.

Gentamicin description

Gentamicin also contains the following ingredients: Methyl paraben 1.8 mg, propyl paraben 0.2 mg, sodium bisulfite 3.2 mg, disodium ethylenediaminetetraacetate 0.1 mg and water for injection.

Gentamicin sulfate injection is a sterile solution of gentamicin sulfate water for injection. It contains the equivalent of not less than 90% and not more than 125% of the labeled amount of gentamicin. It may contain suitable buffers, preservatives, sequestering agents, unless it is intended for intrathecal use, in which case it contains only suitable tonicity agents.

Gentamicin dosage

Each ampoule is for use in a single patient on 1 occasion only.

Adults: Serious Infections (Systemic and Urinary Tract Infections): 3 mg/kg/day in 3 doses given every 8 hrs.

Life-Threatening Infections: Up to 5 mg/kg/day in 3 or 4 equal doses with reduction to 3 mg/kg/day as soon as clinically indicated. Doses should never exceed 5 mg/kg/day unless serum levels are monitored.

The following table should be used as a guide: See Table 1.

Children: The following table should be used as a guide: See Table 2.

Patients with Renal Impairment: Dosage should be adjusted to minimise the risk of toxicity. The 1st dose should be as normal eg, 80 mg (body weight >60 kg) and subsequent doses should be given less frequently, depending on the degree of renal impairment.

Table 3 should be used as a guide: See Table 3.

When only a serum urea concentration is available, this value may be utilized initially, however, it should be supplemented with a serum creatinine level or creatinine clearance rate whenever possible.

Note: The standard dose of 80 mg 3 times a day may be inappropriate and a more appropriate dose can be calculated using a nomogram which takes into account the patient's serum creatinine levels, body weight and age. This dose can be adjusted if necessary following determination of serum creatinine levels. Desirable serum levels of gentamicin are 5-8 mcg/mL as a peak and 1-2 mcg/mL as a trough.

Note: In children with impaired renal function, serum levels should be monitored and frequency of dosage reduced if indicated.

Adults with Renal Failure Undergoing

Haemodialysis: The amount of gentamicin removed from the blood may vary depending upon several factors including the dialysis method used. An 8-hr haemodialysis may reduce serum concentrations of gentamicin by approximately 50%. The recommended dosage at the end of each dialysis period is 1-1.7 mg/kg depending upon the severity of infection.

Administration: Gentamicin is normally given by IM injection.

Intravenous administration may be used for particular indications when the IM route is not appropriate. The dosage is the same for either route of administration. It is desirable to measure both peak and trough serum levels during treatment. Prior to administration, the patient's body weight should be measured for the correct calculation of dosage. In obese patients, the appropriate dose can be calculated by assuming the body weight is the patient's estimated lean body weight plus 40% of the excess. Blood specimens for the determination of peak gentamicin concentrations should be obtained approximately 1 hr following IM administration and 30-min after completion of a 30-min infusion. Blood specimens for the trough gentamicin concentration should be obtained immediately prior to the next IM or IV dose.

Intravenous Administration:

For IV administration, the prescribed dose of gentamicin may be diluted in 100-200 mL of sterile normal saline or 5% glucose in water. The concentration of gentamicin in the solution should not exceed 1 mg/mL. Infusion periods of 30 min to 2 hrs have been advocated. Administration of the dose by bolus injection produces serum levels which are initially in excess of what is regarded as being safe from toxic side effects. The high serum level does however rapidly fall and the potential danger or safety of this method is yet to be established. Gentamicin must not be mixed with other drugs, but should be administered by separate infusion.

Gentamicin interactions

See also:
What other drugs will affect Gentamicin?

Penicillins: Gentamicin is inactivated by solutions containing β-lactam antibiotics (penicillins and cephalosporins) so the 2 drugs should not be administered simultaneously nor should they be combined in the IV fluid. The inactivation of gentamicin by penicillins may occur in vivo, especially in patients with renal failure who maintain a higher level of the penicillin for a longer period of time. Therefore, when gentamicin and penicillins are used together in patients with renal failure, the time of administration of each drug should be staggered so that several hours separate each infusion.

Diuretics: Potent diuretics eg, ethacrynic acid or frusemide may potentiate the ototoxic effects of gentamicin.

Other Neurotoxic and/or Nephrotoxic Agents: Since the ototoxic or nephrotoxic effects of gentamicin may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic antibiotics, including other aminoglycosides, polymyxin B, colistin, cisplatin, vancomycin, amphotericin, clindamycin and cephalosporins.

Neuromuscular-Blocking Agents: Respiratory paralysis and prolongation of neuromuscular blockade may occur if a neuromuscular-blocking agent eg, suxamethonium (succinylcholine), tubocurarine, decamethonium, halogenated hydrocarbon inhalation anaesthetics, opioid analgesics or massive transfusions with citrated anticoagulated blood are administered to a patient receiving gentamicin.

Vitamin K: Gentamicin may inhibit the action of IV vitamin K upon the synthesis of clotting factors.

Potential Interactions: In vitro synergism and antagonism have been found between various antineoplastic agents and aminoglycosides.

Incompatibilities. When gentamicin is used in combination with any other drug, mixing the drugs before administration should be avoided at all costs.

Gentamicin side effects

See also:
What are the possible side effects of Gentamicin?

Nephrotoxicity: Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients with a history of renal impairment and in patients treated for longer periods or with larger dosages than recommended.

Neurotoxicity: Serious adverse effects on both vestibular and auditory branches of the eighth nerve have been reported, primarily in patients with renal impairment (especially if dialysis is required) and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and also hearing loss, which, as with the other aminoglycosides, may be irreversible. Hearing loss is usually manifested initially by diminution of high-tone acuity. Other factors which may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs.

Peripheral neuropathy or encephalopathy, including numbness, skin tingling, muscle twitching, convulsions, and a myasthenia gravis-like syndrome, have been reported.

NOTE: The risk of toxic reactions is low in patients with normal renal function who do not receive Gentamicin Sulfate at higher doses or for longer periods of time than recommended.

Other reported adverse reactions possibly related to gentamicin include: Respiratory depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weight loss and hypotension and hypertension; rash, itching, urticaria, generalized burning, laryngeal edema, anaphylactoid reactions, fever, and headache; nausea, vomiting, increased salivation, and stomatitis; purpura, pseudotumor cerebri, acute organic brain syndrome, pulmonary fibrosis, alopecia, joint pain, transient hepatomegaly and splenomegaly.

Laboratory abnormalities possibly related to gentamicin include: Increased levels of serum transaminase (SGOT, SGPT), serum LDH and bilirubin; decreased serum calcium, magnesium, sodium and potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesemia, hypocalcemia and hypokalemia.

While local tolerance of Gentamicin Sulfate is generally excellent, there has been an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.

Gentamicin contraindications

See also:
What is the most important information I should know about Gentamicin?

Known hypersensitivity to Gentamicin or aminoglycosides and/or preserving agents (para group allergy); patients with preexisting vestibular and/or cochlear disease should be given aminoglycosides for life-threatening conditions only.

Administration of other ototoxic and/or nephrotoxic antibiotics together with or immediately after Gentamicin should be avoided.

Caution should be exercised in patients with reduced renal function to avoid drug cumulation. Caution is also indicated in patients with milder degrees of renal insufficiency, neuromuscular disease (eg, myasthenia gravis or Parkinson's disease) and at an advanced age. As Gentamicin contains sulfite, it must not be used in asthmatics hypersensitive to sulfite.

Use in pregnancy & lactation: During pregnancy, Gentamicin should only be given for life-threatening conditions or if other antibiotics are ruled out. As Gentamicin is known to be present in breast milk, breastfeeding should be suspended if Gentamicin is administered during lactation.

What is Miconazole?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical (for the skin) is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections of the skin.

Miconazole topical may also be used for purposes not listed in this medication guide.

Miconazole indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Miconazole Cream:

Topical treatment of fungal infections, including tinea pedis (athlete's foot), jock itch (groin rash), tinea corporis (ringworm), pityriasis versicolor (white spots), candidiasis (thrush), thrush infected napkin rash, and fungal infections where bacterial infections may be present. Helps protect the skin from chafing, water, urine and other irritants.

Miconazole Powd: Treatment of fungal infections of the skin eg, athlete's foot, tinea, jock itch (groin rash) and napkin rash.

How should I use Miconazole?

Use Miconazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Miconazole.

Uses of Miconazole in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Miconazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Miconazole is an azole antifungal that works by preventing the growth of fungus.

How to use Miconazole topical

Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually twice a day or as directed by your doctor. If you are using the spray form, shake the bottle well before applying. Dosage and length of treatment depends on the type of infection being treated. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased.

Apply enough medication to cover the affected area and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor.

Do not apply this medication in the eyes, nose, mouth, or vagina.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting miconazole. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection.

Inform your doctor if your condition persists or worsens.

Miconazole description

Miconazole is an antifungal medication of the Imidazole class used to treat infections caused by a fungus or yeast. Miconazole topical (skin) preparations are also available for ringworm, jock itch, athlete's foot, and tinea versicolor or "sun fungus". Miconazole interacts with 14-± demethylase, a cytochrome P-450 enzyme that converts lanosterol to ergosterol, an essential component of the yeast membrane. In this way, tioconazole inhibits ergosterol synthesis, resulting in increased cellular permeability.

Miconazole dosage

Miconazole Dosage

Generic name: MICONAZOLE 50mg

Dosage form: buccal tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Basic Dosing Information

The recommended dosing schedule for Miconazole is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days.

Administration Instructions

Miconazole should be applied in the morning, after brushing the teeth. The tablet should be applied with dry hands. The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. The tablet is round on one side for comfort, but either side of the tablet can be applied to the gum.

Once applied, Miconazole stays in position and gradually dissolves. [ See Clinical Pharmacology (12.3)] Subsequent applications of Miconazole should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away any remaining tablet material. In addition,

More about Miconazole (miconazole)

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Miconazole interactions

See also:
What other drugs will affect Miconazole?

Interaction with other medicinal products and other forms of interaction: When using any concomitant medication, the corresponding label should be consulted for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolized by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects.

Drugs which should not be used during treatment with miconazole:

Oral miconazole is contraindicated with the co-administration of the following drugs that are subject to metabolism by CYP3A4 : Substrates known to prolong QT-interval eg, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine; ergot alkaloids; HMG-CoA reductase inhibitors eg, simvastatin and lovastatin; triazolam and oral midazolam.

When co-administered with oral miconazole, the following drugs should be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse effects. If necessary, their dosage should be reduced and when appropriate, plasma levels monitored: Others:

Oral hypoglycemics (CYP2C9), phenytoin (CYP2C9), carbamazepine, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.

Drugs subject to metabolism by CYP2C9 :

Oral anticoagulants eg, warfarin; oral hypoglycemics eg, sulfonylureas; phenytoin.

Other drugs subject to metabolism by CYP3A4: HIV protease inhibitors eg, saquinavir; certain antineoplastic agents eg, vinca alkaloids, busulfan and docetaxel; certain calcium channel blockers eg, dihydropyridines and verapamil; certain immunosuppressive agents: cyclosporine, tacrolimus, sirolimus (rapamycin); others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostasol, disopyramide, ebastin, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil and trimetrexate.

Miconazole side effects

See also:
What are the possible side effects of Miconazole?

The following serious adverse drug reactions are discussed in detail in other sections of labeling:

Clinical Trial Experience

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

The overall safety of Miconazole was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects.

HIV Infected Patients

Two trials were conducted in immunocompromised HIV infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 Miconazole, 287 control) and one non-comparative trial (N = 25).

In the randomized, double blind trial (Study 1), 290 HIV infected subjects used Miconazole once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are presented in Table 1.

Table 1 Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of HIV-Infected Patients in the Controlled Clinical Trial

Adverse Reaction

(MedDRA v 9.1 System Organ Class and Preferred Term)

Miconazole

N = 290 (%)

Clotrimazole

troches

N = 287 (%)

Patients with any adverse reaction during the study

158 (54.5)

146 (50.9)

Gastrointestinal disorders

25.9

23.7

Diarrhea

9.0

8.0

Nausea

6.6

7.7

Vomiting

3.8

3.1

Dry mouth

2.8

1.7

Abdominal pain upper

1.7

2.8

Infections and infestations

15.9

17.1

Upper respiratory infection

2.1

2.4

Gastroenteritis

1.4

2.8

Nervous system disorders

13.1

8.4

Headache

7.6

6.6

Ageusia

2.4

0.3

Blood and lymphatic disorders

6.9

8.4

Anemia

2.8

1.7

Lymphopenia

1.7

2.1

Neutropenia

0.7

2.1

General disorders and administration site conditions

6.6

8.0

Fatigue

2.8

2.1

Pain

1.0

2.8

Respiratory/thoracic

5.2

7.7

Cough

2.8

1.7

Pharyngeal pain

0.7

2.4

Investigations

5.5

6.3

Increased GGT

1.0

2.8

Overall local adverse reactions, including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritis, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and altered taste, were reported by 35 (12.1%) patients who received miconazole buccal tablet compared to 27 (9.4%) patients who received clotrimazole troches.

Head and Neck Cancer Patients

In the randomized, open-label comparative trial of oropharyngeal candidiasis in patients with head and neck cancer who had received radiation therapy (Study 2), 147 patients used Miconazole once daily for 14 days and 147 patients used 125 mg of miconazole oral gel four times daily for 14 days. Adverse reactions occurring in ≥2% of patients in either arm are listed in Table 2.

Table 2: Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of Patients with Head and Neck Cancer who had Received Radiation Therapy (Controlled Clinical Trial)
Adverse Reaction

(MedDRA v 9.1 System Organ Class and Preferred Term)

Miconazole

N = 147 (%)

Miconazole gel

N = 147 (%)

Patients with at least one adverse reaction 30 (20.4) 32 (21.8)
Gastrointestinal disorders 8.8 13.6
Abdominal pain, upper 2.7 2.0

Oral discomfort

1.4 2.7
Nausea 0.7 2.7
Vomiting 0.7 2.0
Glossodynia 0 2.0
Nervous system disorders 5.4 1.4
Dysgeusia 4.1 0
Skin and subcutaneous 3.4 0.7
Pruritus 2.0 0.7

Overall local adverse reactions, including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, and application site discomfort or pain, were experienced by 14 (9.5%) patients who used Miconazole compared to 16 (10.9%) patients who used miconazole gel.

Overall Miconazole Safety Experience In Patients and Healthy Subjects

Adverse reactions reported in the overall safety database of 480 subjects who received miconazole buccal tablet is listed in Table 3.

Table 3 Adverse Reactions Reported in ≥ 2% of Patients and Healthy Subjects who Received Miconazole in Clinical Trials
Adverse reaction

(MedDRA v 9.1 System Organ Class and Preferred Term)

Miconazole

N = 480 (%)

Patients with at least one AE 209 (43.5)
Gastrointestinal disorders 20.6
Diarrhea 6.0
Nausea 4.6
Abdominal pain upper 2.5
Vomiting 2.5
Infections and infestations 11.9
Nervous system disorders 10.6
Headache 5.0
Dysgeusia 2.9

Discontinuation of Miconazole due to adverse drug reactions occurred in 0.6% overall.

Miconazole contraindications

See also:
What is the most important information I should know about Miconazole?

Patients with any kind of liver disease; hypersensitivity to any of the ingredients of Daktarin

Oral Gel.

The effects and/or side effects of many prescription medications, when taken with Daktarin

Oral Gel, can be increased. Hence, patients taking or about to take any other medications, must consult the doctor or pharmacist before starting Daktarin

Oral Gel therapy.

Use in infants: Daktarin

Oral Gel is contraindicated in infants <6 months because of the risk of choking.

Active ingredient matches for Betamethasone valerate/gentamicin/Miconazole:

Betamethasone valerate/gentamicin/Miconazole


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. "GENTAMICIN 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. DailyMed. "BETAMETHASONE: 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).

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