Micogen B Actions

How times a day do you take this medicine?
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Consists of Betamethasone, gentamicin, miconazole

Actions of Betamethasone (Micogen B) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology:

Topical corticosteroids, such as Betamethasone (Micogen B) dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic and vasoconstrictive actions. While the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation, such as prostaglandins and leukotrienes, by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

While topical corticosteroids can be absorbed from normal intact skin, dermal inflammation and/or other dermatologic disease processes may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

In patients with psoriasis, application of 14 grams per day (7 grams twice daily) of Betamethasone (Micogen B) Cream for eight days produced depressed adrenocortical hormonal levels in plasma. Shortly after treatment cessation, adrenal output returned to normal. Application of 7 grams per day (once daily or 3.5 grams twice daily) of Betamethasone (Micogen B) Cream for one, two or three weeks produced hypothalamic-pituitary-adrenal (HPA) axis suppression in patients with psoriasis or atopic dermatitis. Suppression of HPA axis in these patients was usually mild to moderate, transient, and returned to normal during treatment or shortly after treatment cessation.

At 14 grams per day for nine days, Betamethasone (Micogen B) Ointment was shown to depress plasma cortisol levels following repeated applications to diseased skin in patients with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 grams per day (applied as 3.5 grams twice daily), Betamethasone (Micogen B) Ointment was shown to cause minimal inhibition of the HPA axis when applied for two to three weeks in normal patients and in patients with psoriasis and eczematous disorders. With 6 to 7 grams of Betamethasone (Micogen B) Ointment applied once daily for three weeks, no significant inhibition of the HPA axis was observed in patients with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels.

After dermal absorption, topical corticosteroids enter pharmacokinetic pathways similar to those of systemically administered corticosteroids. In varying degrees, corticosteroids are bound to plasma proteins. They are metabolized primarily in the liver and excreted by the kidneys. Some topical corticosteroids and their metabolites undergo biliary excretion.

Toxicology: Preclinical Information: Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of Betamethasone (Micogen B) dipropionate or the effect on fertility of topically applied corticosteroids.

Betamethasone (Micogen B) dipropionate was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone.

Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg respectively, resulted in dose related increases in fetal resorptions in the rabbits and mice.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Betamethasone (Micogen B) dipropionate has been shown to be fetotoxic (increased incidence of resorptions) and teratogenic in rabbits when given by the intramuscular route at doses of 0.015 and 0.05 mg/kg. This dose is approximately 26 times the human topical dose of Betamethasone (Micogen B) assuming human percutaneous absorption of approximately 3% and the use in a 70 kg person of 7 g per day. The abnormalities observed included umbilical hernias (0.015 and 0.05 mg/kg), cephalocele and cleft palate (0.05 mg/kg); an increased incidence of resorptions also was observed at both dose levels. Other corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels and some corticosteroids have been teratogenic after dermal application.

How should I take Betamethasone (Micogen B)?

A nurse or other trained health professional will give you Betamethasone (Micogen B) sodium phosphate and Betamethasone (Micogen B) acetate. It may be given as a shot into a muscle, joint, or skin, or as a shot into a lesion on your skin.

You may need to be on a salt-restricted diet or take potassium supplements when you receive Betamethasone (Micogen B) sodium phosphate and Betamethasone (Micogen B) acetate. Talk to your doctor if you have concerns.

Betamethasone (Micogen B) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

Measure the liquid form of Betamethasone (Micogen B) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Betamethasone (Micogen B).

Do not stop using Betamethasone (Micogen B) suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication.

Store Betamethasone (Micogen B) at room temperature away from moisture and heat.

Betamethasone (Micogen B) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.
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Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Betamethasone (Micogen B) dipropionate lotion (augmented), 0.05% in corticosteroid responsive dermatoses is unknown.

Pharmacodynamics

Vasoconstrictor Assay

Trials performed with Betamethasone (Micogen B) dipropionate lotion (augmented), 0.05% indicate that it is in the super-high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

Pharmacokinetics

No pharmacokinetic trials have been conducted with Betamethasone (Micogen B) dipropionate lotion (augmented), 0.05%.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Actions of Gentamicin (Micogen B) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacotherapeutic Group: Aminoglycoside antibiotic.

Pharmacokinetics: Gentamicin (Micogen B) is rapidly absorbed after IM injection and peak serum levels are usually achieved within 30-90 min and are measurable for 6-8 hrs. Following parenteral administration, Gentamicin (Micogen B) can be detected in tissues and body fluids. Following absorption, Gentamicin (Micogen B) is widely distributed into body fluid including ascitic, pericardial, pleural, synovial and abscess fluids. Concentration in bile is low. Gentamicin (Micogen B) is excreted almost entirely by renal glomerular filtration, hence the t½ of the drug is prolonged in the presence of renal failure. Adjustments in the frequency of administration of Gentamicin (Micogen B) are necessary to allow for the degree of renal failure. The serum t½ of Gentamicin (Micogen B) is approximately 2-3 hrs in adults with normal renal function. It is prolonged in patients with impaired renal function and in premature or newborn infants.

Microbiology: Gentamicin (Micogen B) is bactericidal and acts by inhibiting protein synthesis in susceptible bacteria. Cell death results. It is active against a wide range of pathogenic gram-negative organisms including Escherichia coli, Pseudomonas aeruginosa, Proteus sp (both indole-positive and -negative), Klebsiella, Enterobacter and Serratia spp. It is also active against some gram-positive organisms eg, Staphylococcus sp (including methicillin- and penicillin-resistant strains). In vitro, Gentamicin (Micogen B) is also active against Salmonella and Shigella. Some species have demonstrated resistance to aminoglycosides including Streptococcus pneumoniae and anaerobic organisms eg, Bacteroides or Clostridium spp.

How should I take Gentamicin (Micogen B)?

For patients using the eye drop form of Gentamicin (Micogen B):

For patients using the eye ointment form of Gentamicin (Micogen B):

To help clear up your infection completely, keep using Gentamicin (Micogen B) for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of Gentamicin (Micogen B) will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Gentamicin (Micogen B). If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of Gentamicin (Micogen B), apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Gentamicin (Micogen B) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.

IM: Administer by deep IM route if possible.

IV: Infuse over 30 to 120 minutes.

Some penicillins (eg, carbenicillin, ticarcillin, and piperacillin) have been shown to inactivate aminoglycosides in vitro. This has been observed to a greater extent with tobramycin and Gentamicin (Micogen B), while amikacin has shown greater stability against inactivation. Concurrent use of these agents may pose a risk of reduced antibacterial efficacy in vivo, particularly in the setting of profound renal impairment. However, definitive clinical evidence is lacking. If combination penicillin/aminoglycoside therapy is desired in a patient with renal dysfunction, separation of doses (if feasible), and routine monitoring of aminoglycoside levels, CBC, and clinical response should be considered.

Intraventricular (off-label route): Use preservative-free preparations only. When administered through a ventricular drain, clamp drain for 15 to 60 minutes before opening the drain to allow Gentamicin (Micogen B) to equilibrate in the cerebrospinal fluid (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).

Gentamicin (Micogen B) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

After intramuscular administration of Gentamicin (Micogen B) Sulfate, peak serum concentrations usually occur between 30 to 60 minutes and serum levels are measurable for 6 to 8 hours. When Gentamicin (Micogen B) is administered by intravenous infusion over a two-hour period, the serum concentrations are similar to those obtained by intramuscular administration.

In patients with normal renal function, peak serum concentrations of Gentamicin (Micogen B) (mcg/mL) are usually up to four times the single intramuscular dose (mg/kg); for example, a 1 mg/kg injection in adults may be expected to result in a peak serum concentration up to 4 mcg/mL; a 1.5 mg/kg dose may produce levels up to 6 mcg/mL. While some variation is to be expected due to a number of variables such as age, body temperature, surface area and physiologic differences, the individual patient given the same dose tends to have similar levels in repeated determinations. Gentamicin (Micogen B) administered at 1 mg/kg every eight hours for the usual 7- to 10-day treatment period to patients with normal renal function does not accumulate in the serum.

Gentamicin (Micogen B), like all aminoglycosides, may accumulate in the serum and tissues of patients treated with higher doses and for prolonged periods, particularly in the presence of impaired renal function. In adult patients, treatment with Gentamicin (Micogen B) dosages of 4 mg/kg/day or higher for seven to ten days may result in a slight, progressive rise in both peak and trough concentrations. In patients with impaired renal function, Gentamicin (Micogen B) is cleared from the body more slowly than in patients with normal renal function. The more severe the impairment, the slower the clearance.

Dosage must be adjusted.

Since Gentamicin (Micogen B) is distributed in extracellular fluid, peak serum concentrations may be lower than usual in adult patients who have a large volume of this fluid. Serum concentrations of Gentamicin (Micogen B) in febrile patients may be lower than those in afebrile patients given the same dose. When body temperature returns to normal, serum concentrations of the drug may rise. Febrile and anemic states may be associated with a shorter than usual serum half-life. (Dosage adjustment is usually not necessary.) In severely burned patients, the half-life may be significantly decreased and resulting serum concentrations may be lower than anticipated from the mg/kg dose.

Protein binding studies have indicated that the degree of Gentamicin (Micogen B) binding is low, depending upon the methods used for testing, this may be between 0 and 30%.

After initial administration to patients with normal renal function, generally 70% or more of the Gentamicin (Micogen B) dose is recoverable in the urine in 24 hours; concentrations in urine above 100 mcg/mL may be achieved. Little, if any metabolic transformation occurs; the drug is excreted principally by glomerular filtration. After several days of treatment, the amount of Gentamicin (Micogen B) excreted in the urine approaches the daily dose administered. As with other aminoglycosides, a small amount of the Gentamicin (Micogen B) dose may be retained in the tissues, especially in the kidneys. Minute quantities of aminoglycosides have been detected in the urine weeks after drug administration was discontinued. Renal clearance of Gentamicin (Micogen B) is similar to that of endogenous creatinine.

In patients with marked impairment of renal function, there is a decrease in the concentration of aminoglycosides in urine and in their penetration into defective renal parenchyma. This decreased drug excretion, together with the potential nephrotoxicity of aminoglycosides, should be considered when treating such patients who have urinary tract infections.

Probenecid does not affect renal tubular transport of Gentamicin (Micogen B).

The endogenous creatinine clearance rate and the serum creatinine level have a high correlation with the half-life of Gentamicin (Micogen B) in serum. Results of these tests may serve as guides for adjusting dosage in patients with renal impairment.

Following parenteral administration, Gentamicin (Micogen B) can be detected in serum, lymph, tissues, sputum, and in pleural, synovial, and peritoneal fluids. Concentrations in renal cortex sometimes may be eight times higher than the usual serum levels. Concentrations in bile, in general, have been low and have suggested minimal biliary excretion. Gentamicin (Micogen B) crosses the peritoneal as well as the placental membranes. Since aminoglycosides diffuse poorly into the subarachnoid space after parenteral administration, concentrations of Gentamicin (Micogen B) in cerebrospinal fluid are often low and dependent upon dose, rate of penetration and degree of meningeal inflammation. There is minimal penetration of Gentamicin (Micogen B) into ocular tissues following intramuscular or intravenous administration.

Microbiology

Mechanism of Action

Gentamicin (Micogen B), an aminoglycoside, binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. It is bactericidal in vitro against Gram-positive and Gram-negative bacteria.

Mechanism of Resistance

Bacterial resistance to Gentamicin (Micogen B) is generally developed slowly. Bacteria resistant to one aminoglycoside may be resistant to one or more other aminoglycosides. The following bacteria are usually resistant to the aminoglycosides, including Gentamicin (Micogen B): most streptococcal species (including Streptococcus pneumoniae and the Group D streptococci), most enterococcal species (including Enterococcus faecalis, E. faecium, and E. durans), and anaerobic organisms, such as Bacteroides species and Clostridium species.

Aminoglycosides are known to be not effective against Salmonella and Shigella species in patients. Therefore, in vitro susceptibility test results should not be reported.

Interactions with Other Antimicrobials

In vitro studies show that an aminoglycoside combined with an antibiotic that interferes with cell wall synthesis may act synergistically against some enterococcal strains. The combination of Gentamicin (Micogen B) and penicillin G has a synergistic bactericidal effect against strains of Enterococcus faecalis, E. faecium and E. durans. An enhanced killing effect against many of these strains has also been shown in vitro with combinations of Gentamicin (Micogen B) and ampicillin, carbenicillin, nafcillin or oxacillin.

The combined effect of Gentamicin (Micogen B) and carbenicillin is synergistic for many strains of Pseudomonas aeruginosa. In vitro synergism against other Gram-negative organisms has been shown with combinations of Gentamicin (Micogen B) and cephalosporins.

Gentamicin (Micogen B) may be active against clinical isolates of bacteria resistant to other aminoglycosides.

Antibacterial Activity

Gentamicin (Micogen B) has been shown to be active against most of the following bacteria, both in vitro and in clinical infections.

Gram-Positive Bacteria

Staphylococcus species

Gram-Negative Bacteria

Citrobacter species

Enterobacter species

Escherichia coli

Klebsiella species

Proteus species

Serratia species

Pseudomonas aeruginosa

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide cumulative results of the in vitro susceptibility tests for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antimicrobial drug for treatment.

Dilution technique

Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method.1, 3 Standardized procedures are based on a dilution method (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of Gentamicin (Micogen B) powder. The MIC values should be interpreted according to the criteria provided in.

Diffusion technique

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method. The standardized procedure requires the use of standardized inoculum concentrations and paper disks impregnated with 10 mcg of Gentamicin (Micogen B).2, 3 The disk diffusion values should be interpreted according to the criteria provided in.

A report of Susceptible (S) indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentration usually achievable at the infection site necessary to inhibit growth of the pathogen. A report of Intermediate (I) indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of the drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test.1, 2, 3 Standard Gentamicin (Micogen B) powder should provide the following range of MIC values provided in. For the diffusion technique using the 10-mcg Gentamicin (Micogen B) disk the criteria provided in should be achieved.

Actions of Miconazole (Micogen B) in details

The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.

Pharmacology: Pharmacodynamics: Miconazole (Micogen B) contains miconazole nitrate, an imidazole derivative antifungal drug. Miconazole nitrate has a broad spectrum of activity and is particularly effective against pathogenic fungi and yeasts including Candida albicans. In addition, it is effective against gram-positive bacteria.

Miconazole nitrate shows its effect during ergosterol synthesis present on cell cytoplasmic membrane. Miconazole nitrate changes permeability of mycotic cell Candida species in vitro and inhibits the glucose consumption of the cell.

Pharmacokinetics: Absorption: Miconazole persists in the vagina for up to 72 hrs after a single dose. Systemic absorption of miconazole after intravaginal administration is limited, with a bioavailability of 1-2% following intravaginal administration of a 1.2 g dose. Plasma concentrations of miconazole are measurable within 2 hrs of administration in some subjects, with maximal levels seen 12-24 hrs after administration. Plasma concentrations decline slowly, thereafter and were still measurable in most subjects 96 hrs post-dose. Absorption of miconazole nitrate by the intravaginal route is very low (approximately 1.4% of dose).

Distribution: Following the insertion of vaginal suppository containing miconazole nitrate 1.2 g in a single dose, the average maximum serum concentration is 10.4 mcg/L, and the elimination half-life (t½) is 56.8 hrs. The average serum concentration-time curve has been calculated to be 967 mcg/L/hr. Protein-binding ratio is between 90% and 93%.

Biotransformation: It is metabolized in liver microsomally. There are no active metabolites. The major metabolite formed by oxidative-N-dealkylation is 2,4-diclorophenile-1 H imidazole ethanol and secondary metabolite is oxidative 2,4-dicloromandelic acid by O-dealkylation.

Elimination: Half-life is 24 hrs. Less than 1% is excreted in the urine. Approximately 50%, is usually excreted with feces as unchanged drug.

How should I take Miconazole (Micogen B)?

Keep miconazole away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

To use the aerosol solution form of miconazole:

To use the powder form of miconazole:

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over miconazole. To do so may cause irritation of the skin. Do not apply an occlusive dressing over miconazole unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using miconazole for the full time of treatment, even if your condition has improved. Do not miss any doses.

Dosing

The dose of miconazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of miconazole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed Dose

If you miss a dose of miconazole, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep miconazole inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Miconazole (Micogen B) administration

Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Miconazole buccal is used each morning for 14 days in a row. Follow your doctor's instructions.

Brush your teeth before putting in a buccal tablet. Make sure your hands are dry before handling the tablet.

Place the rounded side of the tablet against your upper gum near your back teeth. Close your mouth and press your finger gently against the side of your cheek for 30 seconds to make sure the tablet stays in place.

Leave the tablet in place until the next morning. Switch the sides of your mouth each morning when using a new tablet.

If any pieces of the tablet remain in your mouth the next morning, rinse your mouth with water before using a new tablet.

Do not crush, chew, or break a miconazole buccal tablet. Do not swallow the tablet whole.

You may eat and drink normally while the tablet is in place, but avoid chewing gum.

During the first 6 hours after placing a buccal tablet in your mouth, if the tablet comes loose try putting it back into place. If it still comes loose, put in a new tablet. If you accidentally swallow a tablet within the first 6 hours of wearing time, drink a full glass of water and put in a new tablet.

After the first 6 hours, if a tablet comes loose or you accidentally swallow it, do not put in a new tablet. Wait until it is time for your next dose to put in a new tablet.

Store at room temperature away from moisture and heat.

Miconazole (Micogen B) pharmacology

Pharmacokinetics of a drug can be defined as what body does to the drug after it is taken. The therapeutic result of the medicine depends upon the Pharmacokinetics of the drug. It deals with the time taken for the drug to be absorbed, metabolized, the process and chemical reactions involved in metabolism and about the excretion of the drug. All these factors are essential to deciding on the efficacy of the drug. Based on these pharmacokinetic principles, the ingredients, the Pharmaceutical company decides dose and route of administration. The concentration of the drug at the site of action which is proportional to therapeutic result inside the body depends on various pharmacokinetic reactions that occur in the body.

Mechanism of Action

Miconazole is an antifungal drug [ see Clinical Pharmacology (12.4)].

Pharmacokinetics

Absorption and Distribution

Salivary

Single dose application of Miconazole (Micogen B) containing 50 mg of miconazole to the buccal mucosa of 18 healthy volunteers provided mean maximum salivary concentrations of 15 mcg/mL at 7 hours after application of the tablet. This provided an average saliva exposure to miconazole estimated from the AUC (0-24h) of 55.23 mcg⋅h/mL. The pharmacokinetic parameters of miconazole in the saliva of healthy volunteers are provided in Table 4.

Table 4: Pharmacokinetic (PK) Parameters of Miconazole in Saliva Following Application of a Single Miconazole (Micogen B) 50 mg Tablet in Healthy Volunteers (N = 18)
*
Median
Salivary PK

Parameters (N = 18)

Mean ± SD

(Min - Max)

AUC0-24h (mcg-h/mL) 55.2 ± 35.1

(0.5 – 128.3)

Cmax (mcg/mL) 15.1 ± 16.2

(0.5 – 64.8)

Tmax (hour) 7*

(2.0 – 24.1)

In healthy volunteers, the duration of buccal adhesion was on average 15 hours following a single dose application of Miconazole (Micogen B) 50 mg.

Plasma

Plasma concentrations of miconazole were below the lower limit of quantification (0.4 mcg/mL) in 157/162 (97%) samples from healthy volunteers following single-dose application of Miconazole (Micogen B) 50 mg. Measurable plasma concentrations ranged from 0.5 to 0.83 mcg/mL.

Plasma concentrations of miconazole evaluated after 7 days of treatment in 40 HIV-positive patients were all below the limit of quantification (0.1 mcg/mL).

Metabolism and Excretion

Most of the absorbed miconazole is metabolized by the liver with less than 1% of the administered dose found unchanged in urine. In healthy volunteers, the terminal half-life is 24 hours following systemic administration. There are no active metabolites of miconazole.

Food Effect

There was no formal food effect study conducted with Miconazole (Micogen B); however, in clinical studies patients were allowed to eat and drink while taking Miconazole (Micogen B).

Microbiology

Mechanism of Action

Miconazole inhibits the enzyme cytochrome P450 14α-demethylase which leads to inhibition of ergosterol synthesis, an essential component of the fungal cell membrane. Miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes, increasing the amount of reactive oxygen species within the cell.

Activity in vitro and in vivo

Miconazole is active against Candida albicans, C. parapsilosis, and C. tropicalis. Correlation between minimum inhibitory concentration (MIC) results in vitro and clinical outcome has yet to be established.

Drug Resistance

In vitro studies have shown that some Candida strains that demonstrate reduced susceptibility to one antifungal azole may also exhibit reduced susceptibility to other azoles suggesting cross-resistance.

Clinically relevant resistance to systemically utilized triazoles may occur in Candida species. Resistance may occur by multiple mechanisms such as changes in amino acids and/or in the regulation of the target enzyme and of a variety of efflux pump proteins. Multiple mechanisms may co-exist in the same isolate. Resistance breakpoints, correlating in vitro activity with clinical efficacy, have not been established for 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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