Mycogynax Actions

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Consists of Chloramphenicol, Dexamethasone, Metronidazole, Nystatin

Actions of Chloramphenicol (Mycogynax) in details

infoThe 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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Description: Chloramphenicol (Mycogynax) inhibits bacterial protein synthesis by binding to 50s subunit of the bacterial ribosome, thus preventing peptide bond formation by peptidyl transferase. It has both bacteriostatic and bactericidal action against H. influenzae, N. meningitidis and S. pneumoniae.

Duration: Typhoid: 8-10 days; meningitis: 7-10 days; brain abscess: Up to 4 wk.

Pharmacokinetics:

Absorption: Readily absorbed with peak plasma concentrations after 1 or 2 hr (oral).

Distribution: Distributed widely into tissues and fluids, CSF (up to 50% even in the absence of meningitis), eye (aqueous and vitreous humours); crosses the placenta and enters the breast milk. Protein-binding: 60%.

Metabolism: Hydrolysed to the free drug in the GI tract (palmitate); liver by conjugation with glucuronic acid, lungs and kidneys after parenteral admin (sodium succinate).

Excretion: Via the urine (30% as unchanged before hydrolysis, 5-10% of an oral dose), via the bile (3%), via the faeces (1% as inactive form); 1.5-4 hr (elimination half-life).

How should I take Chloramphenicol (Mycogynax)?

For patients using the eye drop form of Chloramphenicol (Mycogynax):

  • Although the bottle may not be full, it contains exactly the amount of medicine your doctor ordered.
  • To use:
    • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to come into contact with the infection.
    • If you think you did not get the drop of medicine into your eye properly, use another drop.
    • To keep the medicine as germ-free as possible, do not touch the applicator tip or dropper to any surface (including the eye). Also, keep the container tightly closed.

To use the eye ointment form of Chloramphenicol (Mycogynax):

  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately 1/3-inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.
  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using Chloramphenicol (Mycogynax) eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your infection completely, keep using Chloramphenicol (Mycogynax) for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using Chloramphenicol (Mycogynax) too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of Chloramphenicol (Mycogynax) 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 Chloramphenicol (Mycogynax). 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.

  • For eye infection:
    • For ophthalmic ointment dosage form:
      • Adults and children—Use every three hours.
    • For ophthalmic solution (eye drops) dosage form:
      • Adults and children—One drop every one to four hours.

Missed Dose

If you miss a dose of Chloramphenicol (Mycogynax), 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.

Chloramphenicol (Mycogynax) administration

infoAdministration 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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Should be taken on an empty stomach. Take on an empty stomach 1 hr before or 2 hr after meals.

Chloramphenicol (Mycogynax) pharmacology

infoPharmacokinetics 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.

Chloramphenicol (Mycogynax) administered orally is absorbed rapidly from the intestinal tract. In controlled studies in adult volunteers using the recommended dosage of 50 mg/kg/day, a dosage of 1 g every 6 hours for 8 doses was given. Using the microbiological assay method, the average peak serum level was 11.2 mcg/mL one hour after the first dose. A cumulative effect gave a peak rise to 18.4 mcg/mL after the fifth dose of 1 g. Mean serum levels ranged from 8 to 14 mcg/mL over the 48-hour period. Total urinary excretion of Chloramphenicol (Mycogynax) in these studies ranged from a low of 68% to a high of 99% over a three-day period. From 8% to 12% of the antibiotic excreted is in the form of free Chloramphenicol (Mycogynax); the remainder consists of microbiologically inactive metabolites, principally the conjugate with glucuronic acid. Since the glucuronide is excreted rapidly, most Chloramphenicol (Mycogynax) detected in the blood is in the microbiologically active free form. Despite the small proportion of unchanged drug excreted in the urine, the concentration of free Chloramphenicol (Mycogynax) is relatively high, amounting to several hundred mcg/mL in patients receiving divided doses of 50 mg/kg/day. Small amounts of active drug are found in bile and feces. Chloramphenicol (Mycogynax) diffuses rapidly, but its distribution is not uniform. Highest concentrations are found in liver and kidney, and lowest concentrations are found in brain and cerebrospinal fluid. Chloramphenicol (Mycogynax) enters cerebrospinal fluid even in the absence of meningeal inflammation, appearing in concentrations about half of those found in the blood. Measurable levels are also detected in pleural and in ascitic fluids, saliva, milk, and in the aqueous and vitreous humors. Transport across the placental barrier occurs with somewhat lower concentration in cord blood of neonates than in maternal blood.

Microbiology

Chloramphenicol (Mycogynax) is a broad-spectrum antibiotic originally isolated from Streptomyces venezuelae. It inhibits bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribsomes. In vitro, Chloramphenicol (Mycogynax) exerts mainly a bacteriostatic effect on a wide range of gram-negative and gram-positive bacteria. Bacteriological studies should be performed to determine the causative organisms and their susceptibilities to Chloramphenicol (Mycogynax).

Chloramphenicol (Mycogynax) has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Aerobic gram-negative microorganisms

Haemophilus influenzae

Salmonella species, including Salmonella typhi

Other microorganisms

Lymphogranuloma-psittacosis group

Rickettsia

Susceptibility Testing Methods

Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method1,3 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of Chloramphenicol (Mycogynax) powder. The MIC values should be interpreted according to the following criteria:

For testing extraintestinal isolates of Salmonella species:
MIC (µg/mL) Interpretation
< 8 Susceptible (S)
16 Intermediate (I)
> 32 Resistant (R)
For testing Haemophilus influenzaea:
MIC (µg/mL) Interpretation
< 2 Susceptible (S)
4 Intermediate (I)
> 8 Resistant (R)

aThese MIC interpretative standards are applicable only to broth microdilution susceptibility tests with Haemophilus influenzae using Haemophilus Test Medium (HTM)1.

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” 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 high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard Chloramphenicol (Mycogynax) powder should provide the following MIC values:

Microorganism MIC (µg/mL)
Escherichia coli ATCC 25922 2-8
Haemophilus influenzaeb ATCC 49247 0.25-1

bThis MIC quality control range is applicable to only Haemophilus influenzae ATCC 49247 tested by broth microdilution procedure using Haemophilus Test Medium (HTM)1.

Diffusion Techniques: Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30µg Chloramphenicol (Mycogynax) to test the susceptibilty of microorgansims to Chloramphenicol (Mycogynax).

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 30-µg Chloramphenicol (Mycogynax) disk should be interpreted according to the following criteria:

For testing extraintestinal isolates of Salmonella species:
Zone Diameter (mm) Interpretation
> 18 Susceptible (S)
13-17 Intermediate (I)
< 12 Resistant (R)
For testing Haemophilus influenzaec:
Zone Diameter Interpretation
≥ 29 Susceptible (S)
26-28 Intermediate (I)
< 25 Resistant (R)

CThese zone diameter interpretative standards are applicable only to susceptibility tests performed by disk diffusion with Haemophilus influenzae using Haemophilus Test Medium (HTM)2.

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. For the diffusion technique, the 30µg Chloramphenicol (Mycogynax) disk should provide the following zone diameters in these laboratory test quality control strains:

Microorgansim Zone diameter (mm)
Escherichia coli ATCC 25922 21-27
Haemophilus influenzaed ATCC 49247 31-40

dThese zone diameter quality control limits are applicable to only Haemophilus influenzae ATCC 49247 tested by a disk diffusion method using Haemophilus Test Medium (HTM)2.

Actions of Dexamethasone (Mycogynax) in details

infoThe 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: Pharmacodynamics: Tablet/Forte Tablet: Dexamethasone (Mycogynax) is a highly potent and long-acting glucocorticoid whose main pharmacological actions include general effects on metabolism, water and electrolyte imbalance; negative feedback effect on the hypothalamus and pituitary; anti-inflammatory and immunosuppressive effects.

It has negligible sodium-retaining properties and has powerful anti-inflammatory and immunosuppressive effects.

Pharmacokinetics: Tablet/Forte Tablet: Dexamethasone (Mycogynax) is well absorbed orally. Peak plasma levels are reached between 1-2 hrs after ingestion. The area under the curve (AUC), volume of distribution, plasma clearance and maximum plasma concentration are not dose-dependent but vary by a factor of about 0.6-0.7 after oral doses of 0.5-1.5 mg. The systemic bioavailability of Dexamethasone (Mycogynax) is approximately 90% and the mean plasma t½ of is 3.6±0.9 hr.

Dexamethasone (Mycogynax)'s plasma t½ is shortened in chronic renal failure and simultaneous use of other drugs eg, rifampicin, phenobarbital and phenytoin. Phenytoin decreases the oral bioavailability of Dexamethasone (Mycogynax) by over 50%; plasma t½ is shortened and mean plasma clearance increased to approximately 3 times the normal.

Metabolic clearance is reduced and plasma t½ is prolonged in patients with liver disease. Dexamethasone (Mycogynax) is cleared more rapidly from the circulation of the fetus and neonate than in the mother.

Up to 77% of Dexamethasone (Mycogynax) is bound to plasma proteins. Percentage binding of Dexamethasone (Mycogynax), unlike that of cortisol, remains practically unchanged with increasing steroid concentrations.

Dexamethasone (Mycogynax)'s metabolism in the liver is slow and limited and 60% of the administered dose is excreted in the urine within 24 hrs largely as unconjugated steroids.

How should I take Dexamethasone (Mycogynax)?

Take Dexamethasone (Mycogynax) exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

The Dexamethasone (Mycogynax) Intensol™ solution is a concentrated liquid. Measure the concentrated liquid with the special oral dropper that comes with the package. The liquid should be added to water, juice, soda or a soda-like beverage, applesauce, or pudding. Stir the mixture well and drink or eat it right away. Do not store the mixture for future use.

If you use Dexamethasone (Mycogynax) for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

Dosing

The dose of Dexamethasone (Mycogynax) 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 Dexamethasone (Mycogynax). 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.

  • For oral dosage forms (solution, tablets):
    • Dose depends on medical condition:
      • Adults—At first, 0.75 to 9 milligrams (mg) per day. Your doctor may adjust your dose as needed.
      • Children—Dose is based on body weight and must be determined by your doctor. At first, 0.02 to 0.3 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day. Your doctor may adjust your dose as needed.

Missed Dose

If you miss a dose of Dexamethasone (Mycogynax), take 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. Do not double doses.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused Dexamethasone (Mycogynax) Intensol™ solution 90 days after the bottle is opened for the first time.

Dexamethasone (Mycogynax) administration

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

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

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.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Dexamethasone (Mycogynax).

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

Wear a medical alert tag or carry an ID card stating that you take Dexamethasone (Mycogynax). Any medical care provider who treats you should know that you are using steroid medication.

Store at room temperature away from moisture and heat.

Dexamethasone (Mycogynax) pharmacology

infoPharmacokinetics 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.

Glucocorticoids such as Dexamethasone (Mycogynax) can inhibit leukocyte infiltration at the site of inflammation, interfere with mediators of inflammatory response, and suppress humoral immune responses. The antiinflammatory actions of glucocorticoids are thought to involve phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Dexamethasone (Mycogynax) reduces inflammatory reaction by limiting the capillary dilatation and permeability of the vascular structures. These compounds restrict the accumulation of polymorphonuclear leukocytes and macrophages and reduce the release of vasoactive kinins. Recent research suggests that corticosteroids may inhibit the release of arachidonic acid from phospholipids, thereby reducing the formation of prostaglandins. Dexamethasone (Mycogynax) is a glucocorticoid receptor agonist. On binding, the corticoreceptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing an increase or decrease in expression of specific target genes, including suppression of IL2 (interleukin 2) expression.

Actions of Metronidazole (Mycogynax) in details

infoThe 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: Metronidazole (Mycogynax) is a synthetic antibacterial compound. Disposition of Metronidazole (Mycogynax) in the body is similar for both oral and intravenous dosage forms, with an average elimination half-life in healthy humans of eight hours.

The major route of elimination of Metronidazole (Mycogynax) and its metabolites is via the urine (60-80% of the dose), with fecal excretion accounting for 6-15% of the dose. The metabolites that appear in the urine result primarily from side-chain oxidation [1-(β-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-yl-acetic acid] and glucuronide conjugation, with unchanged Metronidazole (Mycogynax) accounting for approximately 20% of the total. Renal clearance of Metronidazole (Mycogynax) is approximately 10 mL/min/1.73 m2.

Metronidazole (Mycogynax) is the major component appearing in the plasma, with lesser quantities of the 2-hydroxymethyl metabolite also being present. Less than 20% of the circulating Metronidazole (Mycogynax) is bound to plasma proteins. Both the parent compound and the metabolite possess in vitro bactericidal activity against most strains of anaerobic bacteria.

Metronidazole (Mycogynax) appears in cerebrospinal fluid, saliva and breast milk in concentrations similar to those found in plasma. Bactericidal concentrations of Metronidazole (Mycogynax) have also been detected in pus from hepatic abscesses.

Plasma concentration of Metronidazole (Mycogynax) are proportional to the administered dose. An eight hour intravenous infusion of 100-4,000 mg of Metronidazole (Mycogynax) in normal subjects showed a linear relationship between dose and peak plasma concentration.

In patients treated with intravenous Metronidazole (Mycogynax), using a dosing regimen of 15 mg/kg loading dose followed six hours later by 7.5 mg/kg every six hours, peak steady-state plasma concentrations of Metronidazole (Mycogynax) averaged 25 mcg/mL with trough (minimum) concentrations averaging 18 mcg/mL.

Decreased renal function does not alter the single-dose pharmacokinetics of Metronidazole (Mycogynax). However, plasma clearance of Metronidazole (Mycogynax) is decreased in patients with decreased liver function.

In one study newborn infants appeared to demonstrate diminished capacity to eliminate Metronidazole (Mycogynax). The elimination half-life, measured during the first three days of life, was inversely related to gestational age. In infants whose gestational ages were between 28 and 40 weeks, the corresponding elimination half-lives ranged from 10.9 to 22.5 hours.

Microbiology: Metronidazole (Mycogynax) is active in vitro against most obligate anaerobes, but does not appear to possess any clinically relevant activity against facultative anaerobes or obligate aerobes. Against susceptible organisms, Metronidazole (Mycogynax) is generally bactericidal at concentrations equal to or slightly higher than the minimal inhibitory concentrations. Metronidazole (Mycogynax) has been shown to have in vitro and clinical activity against the following organisms: Anaerobic Gram-Negative Bacilli, Including: Bacteroides species, including the Bacteroides fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Fusobacterium species.

Anaerobic Gram-Positive Bacilli, Including: Clostridium species and susceptible strains of Eubacterium.

Anaerobic Gram-Positive Cocci, Including: Peptococcus species, Peptostreptococcus species.

How should I take Metronidazole (Mycogynax)?

Do not use Metronidazole (Mycogynax) in or near the eyes. Watering of the eyes may occur when the medicine is used too close to the eyes.

If Metronidazole (Mycogynax) does get into your eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

Before applying Metronidazole (Mycogynax), thoroughly wash the affected area(s) with a mild, nonirritating cleanser, rinse well, and gently pat dry.

To use:

  • After washing the affected area(s), apply Metronidazole (Mycogynax) with your fingertips.
  • Apply and rub in a thin film of medicine, using enough to cover the affected area(s) lightly. You should apply the medicine to the whole area usually affected by rosacea, not just to the pimples themselves.
  • Wash the medicine off your hands.

To help keep your rosacea under control, keep using Metronidazole (Mycogynax) for the full time of treatment. You may have to continue using Metronidazole (Mycogynax) every day for 9 weeks or longer. Do not miss any doses.

Dosing

The dose of Metronidazole (Mycogynax) 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 Metronidazole (Mycogynax). 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.

  • For topical dosage forms (cream, gel, and lotion):
    • For rosacea:
      • Adults—Apply to the affected area(s) of skin two times a day, morning and evening, for nine weeks.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of Metronidazole (Mycogynax), 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.

Metronidazole (Mycogynax) administration

infoAdministration 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 this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Wash your hands before and after using this medication.

Insert the cream into your vagina using the applicator as directed.

Your medication may come with disposable applicators. Use each applicator for only 1 day and then throw it away. If you use the medication twice daily, wash and rinse the applicator after your morning dose and use it again for your evening dose. Then throw it away and use a new applicator the next day.

Use Metronidazole (Mycogynax) vaginal for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.

If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that Metronidazole (Mycogynax) will not treat.

You may need to use a sanitary napkin during treatment, but do not use a tampon.

Metronidazole (Mycogynax) vaginal can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using this medication.

Store Metronidazole (Mycogynax) vaginal at room temperature away from moisture or heat. Do not allow it to freeze.

Metronidazole (Mycogynax) pharmacology

infoPharmacokinetics 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.

Normal Subjects:

Following a single, intravaginal 5 gram dose of Metronidazole (Mycogynax) Vaginal Gel (equivalent to 37.5 mg of Metronidazole (Mycogynax)) to 12 normal subjects, a mean maximum serum Metronidazole (Mycogynax) concentration of 237 ng/mL was reported (range: 152 to 368 ng/mL). This is approximately 2% of the mean maximum serum Metronidazole (Mycogynax) concentration reported in the same subjects administered a single, oral 500 mg dose of Metronidazole (Mycogynax) (mean Cmax = 12,785 ng/mL, range: 10,013 to 17,400 ng/mL). These peak concentrations were obtained in 6 to 12 hours after dosing with Metronidazole (Mycogynax) Vaginal Gel and 1 to 3 hours after dosing with oral Metronidazole (Mycogynax).

The extent of exposure [area under the curve (AUC)] of Metronidazole (Mycogynax), when administered as a single intravaginal 5 gram dose of Metronidazole (Mycogynax) Vaginal Gel (equivalent to 37.5 mg of Metronidazole (Mycogynax)), was approximately 4% of the AUC of a single oral 500 mg dose of Metronidazole (Mycogynax) (4977 ng-hr/mL and approximately 125,000 ng-hr/mL, respectively).

Dose-adjusted comparisons of AUCs demonstrated that, on a mg to mg comparison basis, the absorption of Metronidazole (Mycogynax), when administered vaginally, was approximately half that of an equivalent oral dosage.

Patients with Bacterial Vaginosis:

Following single and multiple 5 gram doses of Metronidazole (Mycogynax) Vaginal Gel to 4 patients with bacterial vaginosis, a mean maximum serum Metronidazole (Mycogynax) concentration of 214 ng/mL on day 1 and 294 ng/mL (range: 228 to 349 ng/mL) on day five were reported. Steady state Metronidazole (Mycogynax) serum concentrations following oral dosages of 400 to 500 mg BID have been reported to range from 6,000 to 20,000 ng/mL.

Microbiology:

The intracellular targets of action of Metronidazole (Mycogynax) on anaerobes are largely unknown. The 5-nitro group of Metronidazole (Mycogynax) is reduced by metabolically active anaerobes, and studies have demonstrated that the reduced form of the drug interacts with bacterial DNA. However, it is not clear whether interaction with DNA alone is an important component in the bactericidal action of Metronidazole (Mycogynax) on anaerobic organisms.

Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis.

Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens, Gardnerella vaginalis, Mobiluncus spp., and Mycoplasma hominis, has not been defined. Nonetheless, Metronidazole (Mycogynax) is an antimicrobial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

Bacteroides spp.

Gardnerella vaginalis

Mobiluncus spp.

Peptostreptococcus spp.

Actions of Nystatin (Mycogynax) in details

infoThe 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.

Description: Nystatin (Mycogynax) interferes w/ the cell wall permeability by binding to sterols, chiefly ergosterol, in the fungal cell membrane, thus allowing leakage of cellular contents.

Onset: Symptomatic relief of candidiasis: 24-72 hr.

Pharmacokinetics:

Absorption: Poorly absorbed from the GI tract; not absorbed through the skin or mucous membrane when applied topically.

Excretion: Via faeces, as unchanged drug.

How should I take Nystatin (Mycogynax)?

Topical Nystatin (Mycogynax) should not be used in the eyes.

Apply enough Nystatin (Mycogynax) to cover the affected area.

For patients using the powder form of Nystatin (Mycogynax) on the feet:

  • Sprinkle the powder between the toes, on the feet, and in socks and shoes.

The use of any kind of occlusive dressing (airtight covering, such as kitchen plastic wrap) over Nystatin (Mycogynax) may increase the chance of irritation. Therefore, do not bandage, wrap, or apply any occlusive dressing over Nystatin (Mycogynax) unless directed to do so by your doctor. When using Nystatin (Mycogynax) on the diaper area of children, avoid tight-fitting diapers and plastic pants.

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

Dosing

The dose of Nystatin (Mycogynax) 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 Nystatin (Mycogynax). 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.

  • For topical dosage forms (cream or ointment):
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two times a day.
  • For topical dosage form (powder):
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two or three times a day.

Missed Dose

If you miss a dose of Nystatin (Mycogynax), take 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. Do not double doses.

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.

Nystatin (Mycogynax) administration

infoAdministration 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.

Do not use Nystatin (Mycogynax) topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Clean and dry the skin before you apply Nystatin (Mycogynax) topical.

Do not cover treated skin with bandages or dressings that do not allow air circulation unless your doctor tells you to.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using Nystatin (Mycogynax) topical.

Do not share this medication with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat.

Nystatin (Mycogynax) pharmacology

infoPharmacokinetics 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.

Pharmacokinetics

Nystatin (Mycogynax) Cream USP is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin (Mycogynax) is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsisglabrata, Tricophytonrubrum, T. mentagrophytes.

Nystatin (Mycogynax) acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of Nystatin (Mycogynax), Candida albicans does not develop resistance to Nystatin (Mycogynax). Generally, resistance to Nystatin (Mycogynax) does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with Nystatin (Mycogynax) and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.

Nystatin (Mycogynax) exhibits no appreciable activity against bacteria, protozoa, or viruses.



References

  1. DailyMed. "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE: 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. "DEXAMETHASONE: 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. "CHLORAMPHENICOL: 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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Information checked by Dr. Sachin Kumar, MD Pharmacology

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