Mycogynax Overdose

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What is the dose of your medication?

Consists of Chloramphenicol, Dexamethasone, Metronidazole, Nystatin

What happens if I overdose Chloramphenicol (Mycogynax)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Chloramphenicol (Mycogynax):

Chloramphenicol (Mycogynax) is usually handled and stored by a health care provider. If you are using Chloramphenicol (Mycogynax) at home, store Chloramphenicol (Mycogynax) as directed by your pharmacist or health care provider. Keep Chloramphenicol (Mycogynax) out of the reach of children and away from pets.

Overdose of Chloramphenicol (Mycogynax) in details

infoWhen a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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No information available.

Chloramphenicol (Mycogynax) warnings

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

In severe infections topical use of Chloramphenicol (Mycogynax) should be supplemented with appropriate systemic treatment.

Aplastic anaemia has, very rarely, followed topical use of Chloramphenicol (Mycogynax) eye drops and, whilst this hazard is an uncommon one, it should be borne in mind when the benefits of the use of Chloramphenicol (Mycogynax) are assessed.

Prolonged use should be avoided as it may increase the likelihood of sensitisation and the emergence of resistant organisms.

Chloramphenicol (Mycogynax) should be reserved for use only in infections for which it is specifically indicated.

Contact lenses should be removed during the period of treatment.

Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)

What should I discuss with my healthcare provider before taking Chloramphenicol (Mycogynax)?

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

Allergies

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

Pediatric

Gray syndrome may be especially likely to occur in children, who are usually more sensitive than adults to the effects of Chloramphenicol (Mycogynax). Report any of these effects to your health care professional: blue tone to the skin, changes in blood pressure or heart rate, eating problems, irregular breathing, passage of loose green stools, or stomach bloating with or without vomiting. Your health care professional should monitor blood levels of Chloramphenicol (Mycogynax) if possible.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of Chloramphenicol (Mycogynax) in the elderly with use in other age groups.

Breast Feeding

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

Interactions with Medicines

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

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

  • Citalopram
  • Voriconazole

Using Chloramphenicol (Mycogynax) with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ceftazidime
  • Chlorpropamide
  • Cyclosporine
  • Dicumarol
  • Fosphenytoin
  • Phenytoin
  • Rifampin
  • Rifapentine
  • Tacrolimus
  • Tetanus Toxoid
  • Tolbutamide

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

  • Opening in your ear drum—Chloramphenicol (Mycogynax) may cause unwanted effects if it goes past the ear drum into the middle ear
  • Sensitivity reaction to Chloramphenicol (Mycogynax)

Chloramphenicol (Mycogynax) precautions

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

The prolonged use of antibiotics may occasionally result in overgrowth of nonsusceptible organisms, including fungi. If new infections appear during medication or clinical improvement is not observed within 1 week, the drug should be discontinued and appropriate measures should be taken.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies have been conducted in animals or in humans to evaluate the carcinogenic potential or effects on fertility with Chloramphenicol (Mycogynax). However, there is some clinical evidence that aplastic anemia due to Chloramphenicol (Mycogynax) may be associated with subsequent development of leukemia.

Pregnancy

Pregnancy Category C. Chloramphenicol (Mycogynax) has been shown to be embryocidal and teratogenic in rat, mouse, rabbit and chicken embryos/fetuses. There are no adequate and well-controlled studies in pregnant women. Chloramphenicol (Mycogynax) has been shown to cross the placental barrier, but it is not known whether Chloramphenicol (Mycogynax) can cause fetal harm when administered to a pregnant woman. Chloramphenicol (Mycogynax) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Embryotoxic effects : Significantly lower numbers of live fetuses and an increase in the number of early embryonic resorptions occurred after pregnant rats were treated orally with 500 mg/kg (equivalent to 5800 times the recommended maximum daily adult topical ophthalmic dose) from days 5 to 15 of their pregnancy. Similar findings were seen with groups receiving higher oral doses (1000 mg/kg or 2000 mg/kg) at various dosing intervals. Female mice receiving 1000 mg/kg orally from days 6 to 12 of their pregnancy showed a significant increase in the number of resorptions. Female rabbits receiving the same oral dosing (1000 mg/kg) from days 8 to 11 had an increase in the number of resorptions of embryos without placentation. Chloramphenicol (Mycogynax) (2.5 mg) injected into chicken eggs resulted in a 20% embryo mortality rate one day after administration, which increased to 100% embryo mortality on the 11th day of incubation.

Teratogenicity : When given to female orally at 2000 mg/kg from days 6 to 8 of pregnancy, 36% of the fetuses exhibited either an omphalocele or an umbilical hernia, with costal fusions. Fetuses of the rats treated with 1000 mg/kg orally from days 7 to 12 of pregnancy or 2000 mg/kg from days 11 to 13, and of mice treated with 1000 mg/kg from days 6 to 12, had a higher incidence of missing ossification of the phalangeal nuclei of the forelegs and hindlegs; and of the 5th stemebra. This correlated with a decrease in the average weight of the fetuses. Rabbit fetuses displayed more frequent absence of the phalangeal nuclei of the forelegs than control when pregnant rabbits received 500 mg/kg orally on days 6 to 15 of pregnancy, More frequent missing ossification of the phalangeal nuclei of the forelegs and hindlegs and an increase in the number of unevenly ossified vertebrae was seen in the fetuses of rabbits when pregnant females were given 1000 mg/kg from days 6 to 9 of pregnancy.

Teratogenic effects of Chloramphenicol (Mycogynax) (0.5 mg when injected into chicken eggs, included malformations of the beak, eyes and legs.

Nursing Mothers

Chloramphenicol (Mycogynax) appears in human milk following oral administration of the drug. Systemic absorption of Chloramphenicol (Mycogynax) may occur when applied topically. Because of the potential for serious, adverse reactions in nursing infants from Chloramphenicol (Mycogynax), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy in pediatric patients below 1 year of age have not been established.

Geriatric Use

No overall difference in safety or effectiveness have been observed between elderly and younger, adult patients.

What happens if I overdose Dexamethasone (Mycogynax)?

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

Proper storage of Dexamethasone (Mycogynax) suspension:

Store Dexamethasone (Mycogynax) suspension at room temperature, between 46 and 80 degrees F (8 and 27 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dexamethasone (Mycogynax) suspension out of the reach of children and away from pets.

Overdose of Dexamethasone (Mycogynax) in details

infoWhen a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available, treatment is supportive and symptomatic.

The oral LD50 of Dexamethasone (Mycogynax) in female mice was 6.5 g/kg. The intravenous LD50 of Dexamethasone (Mycogynax) Sodium Phosphate in female mice was 794 mg/kg.

What should I avoid while taking Dexamethasone (Mycogynax)?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication such as Dexamethasone (Mycogynax).

Do not receive a "live" vaccine while using Dexamethasone (Mycogynax). The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, rotavirus, typhoid, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid drinking alcohol while you are taking Dexamethasone (Mycogynax).

Dexamethasone (Mycogynax) warnings

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

Serious Neurologic Adverse Reactions With Epidural Administration

Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.

In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroidinduced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Usage In Pregnancy

Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Average and large doses of cortisone or hydrocortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Patients with a stressed myocardium should be observed carefully and the drug administered slowly since premature ventricular contractions may occur with rapid administration. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially in high doses, because of possible hazards of neurological complications and lack of antibody response.

The use of Dexamethasone (Mycogynax)® Phosphate Injection (Dexamethasone (Mycogynax) sodium phosphate injection, USP) in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculosis regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.

Dexamethasone (Mycogynax)® Phosphate Injection contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

What should I discuss with my healthcare provider before taking Dexamethasone (Mycogynax)?

Some medical conditions may interact with Dexamethasone (Mycogynax) elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are scheduled for a vaccination with a live virus vaccine (eg, smallpox)
  • if you have an underactive thyroid, liver or kidney problems, diabetes, or ulcerative colitis
  • if you have heart problems, esophagitis, gastritis, stomach obstruction or perforation, or an ulcer
  • if you have a history of mental problems (eg, depression), glaucoma, cataracts, or other eye problems
  • if you have a herpes infection in your eye or any other type of infection (bacterial, fungal, or viral); have or recently had tuberculosis (TB) or tested positive for TB, measles, or chickenpox

Some MEDICINES MAY INTERACT with Dexamethasone (Mycogynax) elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Dexamethasone (Mycogynax) elixir's effectiveness
  • Clarithromycin, azole antifungals (eg, ketoconazole), steroidal contraceptives (eg, desogestrel), or troleandomycin because because weakness, confusion, muscle aches, joint pain, or low blood sugar, may occur
  • Methotrexate or ritodrine because the risk of their side effects may be increased by Dexamethasone (Mycogynax) elixir
  • Hydantoins (eg, phenytoin),mifepristone, or live vaccines because their effectiveness may be decreased by Dexamethasone (Mycogynax) elixir
  • Anticoagulants (eg, warfarin) or aspirin because their actions and side effects may be increased or decreased by Dexamethasone (Mycogynax) elixir

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

Dexamethasone (Mycogynax) precautions

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

FOR TOPICAL OPHTHALMIC USE ONLY. The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing.

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the contents. The preservative in Dexamethasone (Mycogynax)® (Dexamethasone (Mycogynax) ophthalmic suspension), benzalkonium chloride, may be absorbed by soft contact lenses. Dexamethasone (Mycogynax)® (Dexamethasone (Mycogynax) ophthalmic suspension) should not be administered while wearing soft contact lenses.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Dexamethasone (Mycogynax)® (Dexamethasone (Mycogynax) ophthalmic suspension).

Pregnancy

Pregnancy Category C. Dexamethasone (Mycogynax) has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.

In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.

There are no adequate or well-controlled studies in pregnant women. Dexamethasone (Mycogynax)® (Dexamethasone (Mycogynax) ophthalmic suspension) should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dexamethasone (Mycogynax)® (Dexamethasone (Mycogynax) ophthalmic suspension) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

What happens if I miss a dose of Dexamethasone (Mycogynax)?

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

Because you will receive Dexamethasone (Mycogynax) in a clinical setting, you are not likely to miss a dose.

What happens if I overdose Metronidazole (Mycogynax)?

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

Proper storage of Metronidazole (Mycogynax) emulsion:

Store Metronidazole (Mycogynax) emulsion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metronidazole (Mycogynax) emulsion out of the reach of children and away from pets.

Overdose of Metronidazole (Mycogynax) in details

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

Use of dosages of intravenous Metronidazole (Mycogynax) higher than those recommended has been reported. These include the use of 27 mg/kg three times a day for 20 days, and the use of 75 mg/kg as a single loading dose followed by 7.5 mg/kg maintenance doses. No adverse reactions were reported in either of the two cases.

Single oral dose of Metronidazole (Mycogynax), up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported included nausea, vomiting and ataxia.

Oral Metronidazole (Mycogynax) has been studied as a radiation sensitizer in the treatment of malignant tumors. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.

Treatment: There is no specific antidote for overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.

What should I avoid while taking Metronidazole (Mycogynax)?

Avoid getting this medication in your eyes, nose, or mouth. If it does get into any of these areas, rinse with plenty of cool water.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Avoid having sex until your vaginal infection has been completely treated and you have finished using the medication.

Avoid using other vaginal creams or douches at the same time as Metronidazole (Mycogynax) vaginal unless your doctor approves.

Avoid drinking alcohol while you are using Metronidazole (Mycogynax) vaginal.

Metronidazole (Mycogynax) warnings

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

Convulsive Seizures and Peripheral Neuropathy

Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with Metronidazole (Mycogynax). The appearance of abnormal neurologic signs demands the prompt discontinuation of Metronidazole (Mycogynax) (Metronidazole (Mycogynax)) therapy. Metronidazole (Mycogynax) should be administered with caution to patients with central nervous system diseases.

Patients with severe hepatic disease metabolize Metronidazole (Mycogynax) slowly, with resultant accumulation of Metronidazole (Mycogynax) and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously.

Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with Metronidazole (Mycogynax) (Metronidazole (Mycogynax)) and requires treatment with a candidacidal agent.

Prescribing Metronidazole (Mycogynax) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Laboratory tests

Metronidazole (Mycogynax) (Metronidazole (Mycogynax)) is a nitro-imidazole and should be used with caution in patients with evidence of or history of blood dys-crasia. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to metro-nidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended before and after therapy for trichomonia-sis and amebiasis, especially if a second course of therapy is necessary, and before and after therapy for anaerobic infections.

Carcinogenesis, mutagenesis, impairment of fertility

Metronidazole (Mycogynax) has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats.

Prominent among the effects in the mouse was the promotion of pulmonary tumorigenesis. This has been observed in all six reported studies in that species, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). At very high dose levels (approx. 500 mg/kg/day which is approximately 33 times the most frequently recommended human dose for a 50 kg adult based on mg/kg body weight) there was a statistically significant increase in the incidence of malignant liver tumors in males. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lym-phomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. All these effects are statistically significant.

Several long-term, oral-dosing studies in the rat have been completed. There were statistically significant increases in the incidence of various neo-plasms, particularly in mammary and hepatic tumors, among female rats administered metroni-dazole over those noted in the concurrent female control groups.

Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.

Although Metronidazole (Mycogynax) has shown mutagenic activity in a number of in vitro assay systems, studies in mammals (in vivo) have failed to demonstrate a potential for genetic damage.

Fertility studies have been performed in mice at doses up to six times the maximum recommended human dose based on mg/m² and have revealed no evidence of impaired fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category B. Metronidazole (Mycogynax) crosses the placental barrier and enters the fetal circulation rapidly. Reproduction studies have been performed in rats at doses up to five times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Metronidazole (Mycogynax). No fetotoxicity was observed when Metronidazole (Mycogynax) was administered orally to pregnant mice at 20 mg/kg/day, approximately one and a half times the most frequently recommended human dose (750 mg/day) based on mg/kg body weight; however in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. The relationship of these findings to the drug is unknown. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because Metronidazole (Mycogynax) is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Use of Metronidazole (Mycogynax) for trichomoniasis during pregnancy should be restricted to those in whom alternative treatment has been inadequate. Use of Metronidazole (Mycogynax) (Metronidazole (Mycogynax)) for trichomoniasis in pregnancy should be carefully evaluated because Metronidazole (Mycogynax) crosses the placental barrier and its effects on the human fetal organogenesis are not known.

Nursing mothers

Because of the potential for tumorigenicity, shown for Metronidazole (Mycogynax) in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance ofthe drug to the mother. Metronidazole (Mycogynax) is secreted in human milk in concentrations similar to those found in plasma.

Geriatric use

Decreased renal function does not alter the single-dose pharmacokinetics of metroni-dazole. However, plasma clearance of metronida-zole is decreased in patients with decreased liver function. Therefore, in elderly patients, monitoring of serum levels may be necessary to adjust the Metronidazole (Mycogynax) dosage accordingly.

Pediatric use

Safety and effectiveness in pediatric patients have not been established, except for the treatment of amebiasis.

What should I discuss with my healthcare provider before taking Metronidazole (Mycogynax)?

Some medical conditions may interact with Metronidazole (Mycogynax) emulsion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a central nervous system disease

Some MEDICINES MAY INTERACT with Metronidazole (Mycogynax) emulsion. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Barbiturates (eg, phenobarbital) because they may decrease Metronidazole (Mycogynax) emulsion's effectiveness
  • Aminoquinolines (eg, chloroquine), anticoagulants (eg, warfarin), busulfan, carbamazepine, cyclosporine, disulfiram, ergot alkaloids (eg, ergotamine), ethanol, fluorouracil, HIV protease inhibitors containing alcohol (eg, ritonavir), imatinib, lithium, macrolide immunosuppressants (eg, tacrolimus), or mitomycin because the risk of their side effects may be increased by Metronidazole (Mycogynax) emulsion
  • Amphotericin B or oral contraceptives (eg, birth control pills) because their effectiveness may be decreased by Metronidazole (Mycogynax) emulsion

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

Metronidazole (Mycogynax) precautions

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

Central and Peripheral Nervous System Effects

Use of oral or intravenous Metronidazole (Mycogynax) is associated with convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or parethesia of an extremity. Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) should be administered with caution to patients with central nervous system diseases. Discontinue Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) promptly if a patient develops abnormal neurologic signs.

Carcinogenicity in Animals

Metronidazole (Mycogynax) has been shown to be carcinogenic in mice and rats. Unnecessary use of Metronidazole (Mycogynax) should be avoided. Use of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) should be reserved for the treatment of bacterial vaginosis

Interference with Laboratory Tests

Metronidazole (Mycogynax) may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminostransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and glucose hexokinase. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide-adenine dinucleotides (NAD + NADH).

Interference is due to the similarity in absorbance peaks of NADH (340 nm) and Metronidazole (Mycogynax) (322 nm) at pH 7. Consider postponing chemistry laboratory tests to after treatment with Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel).

Patient Counseling Information

Interaction with Alcohol

Instruct the patient not to consume alcoholic beverages and preparations containing ethanol or propylene glycol during and for at least 3 days after treatment with Metronidazole (Mycogynax).

Drug Interactions

Instruct the patient not to use Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) if disulfiram had been used within the last two weeks, and to inform their healthcare provider if they are taking oral anticoagulants, or lithium.

Vaginal Intercourse and Use with Vaginal Products

Instruct the patient not to engage in vaginal intercourse, or use other vaginal products (such as tampons or douches) during treatment with Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel).

Fungal Vaginal Infections

Inform the patient that vaginal fungal infections can occur following use of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) and may require treatment with an antifungal drug.

Human Milk Feeding

Advise women that they may consider discontinuing milk feeding or pump and discard their milk during treatment and for 24 hours after the last dose of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel).

Accidental Exposure to the Eye

Inform the patient that Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) contains ingredients that may cause burning and irritation of the eye. In the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water and consult a healthcare provider.

Vaginal Irritation

Inform the patient to discontinue use and consult a healthcare provider if vaginal irritation occurs with use of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel).

Administration of Drug

Instruct the patient that Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel, 0.75%) is supplied with 5 vaginal applicators. For once daily dosing, one applicator should be used per dose. See DIRECTIONS FOR USE for complete instructions on how to use the product and the vaginal applicator.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Metronidazole (Mycogynax) has shown evidence of carcinogenic activity after chronic oral administration in mice and rats. Pulmonary tumors and lymphomas were reported in several oral mouse studies in which mice were dosed at 75 mg/kg and above (about 5 times the clinical human dose based on body surface area comparison). Malignant liver tumors were reported in male mice dosed at doses equivalent to a human dose of 41 mg/kg/day (33 times the recommended clinical dose based on body surface area comparisons). Chronic oral dosing of Metronidazole (Mycogynax) in rats at doses above 150 mg/kg (about 20 times the clinical human dose based on body surface area comparison) has resulted in mammary and hepatic tumors. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative. Although no life-time studies were performed to evaluate the carcinogenic potential of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel, 0.75%), published data have shown that intravaginal administration of Metronidazole (Mycogynax) to Wistar rats for 5 days, at doses 26 times the recommended human dose based on body surface area comparisons, has resulted in an increased frequency of micronuclei in rat vaginal mucosal cells.

Metronidazole (Mycogynax) has shown mutagenic activity in a number of in vitro assay systems. In addition, a dose dependent increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosome aberrations has been reported in one study of patients with Crohn's disease who were treated with 200 to 1200 mg/day of Metronidazole (Mycogynax) for 1 to 24 months. However, in a second study, no increase in chromosome aberrations was reported in patients with Crohn's disease who were treated with Metronidazole (Mycogynax) for 8 months.

Fertility studies have been performed in mice up to six times the recommended human oral dose (based on mg/m²) and have revealed no evidence of impaired fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category B

Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) should be used during pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women.

There are published data from case-control studies, cohort studies, and two meta-analyses that include more than 5000 pregnant women who used Metronidazole (Mycogynax) systemically during pregnancy. Many studies included first trimester exposures. One study showed an increased risk of cleft lip, with or without cleft palate, in infants exposed to Metronidazole (Mycogynax) in-utero; however, these findings were not confirmed. In addition, more than ten randomized, placebo-controlled clinical trials enrolled more than 5000 pregnant women to assess the use of systemic antibiotic treatment (including Metronidazole (Mycogynax)) for bacterial vaginosis on the incidence of preterm delivery. Most studies did not show an increased risk for congenital anomalies or other adverse fetal outcomes following Metronidazole (Mycogynax) exposure during pregnancy. Three studies conducted to assess the risk of infant cancer following systemic Metronidazole (Mycogynax) exposure during pregnancy did not show an increased risk; however, the ability of these studies to detect such a signal was limited.

Oral reproductive toxicity studies have been performed in mice at doses up to six times the recommended human dose based on body surface area comparisons and have revealed no evidence of impaired fertility or harm to the fetus. However, in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed.

Animal studies have shown that Metronidazole (Mycogynax) crosses the placental barrier and enters the fetal circulation rapidly. Because animal reproduction studies are not always predictive of human response, and because Metronidazole (Mycogynax) crosses the placental barrier and is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Caution should be exercised when Metronidazole (Mycogynax) is administered to a nursing woman. Following oral Metronidazole (Mycogynax) administration, concentrations of Metronidazole (Mycogynax) in human milk are similar to concentrations in plasma. Since some Metronidazole (Mycogynax) is systemically absorbed following vaginal administration of Metronidazole (Mycogynax), excretion in human milk is possible.

Because of the potential for tumorigenicity shown for Metronidazole (Mycogynax) in animal studies, a decision should be made whether to discontinue nursing or to discontinue Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel), taking into account the importance of the therapy to the mother. A nursing mother may choose to pump and discard her milk for the duration of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) therapy, and for 24 hours after therapy ends and feed her infant stored human milk or formula.

Pediatric Use

The safety and efficacy of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) in the treatment of bacterial vaginosis in post-menarchal females have been established on the extrapolation of clinical trial data from adult women. The safety and efficacy of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) in premenarchal females have not been established.

Geriatric Use

Clinical studies with Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) did not include sufficient numbers of subjects 65 years of age or older to determine whether they respond differently than younger subjects. Other reported clinical experience in using Metronidazole (Mycogynax) gel, 1% has not identified differences in responses between elderly and younger patients.

What happens if I miss a dose of Metronidazole (Mycogynax)?

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

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose Nystatin (Mycogynax)?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include diarrhea; high blood pressure; nausea; serious irregular heartbeat; vomiting; wheezing.

Proper storage of Nystatin (Mycogynax) suspension:

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

Overdose of Nystatin (Mycogynax) in details

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

Oral doses of Nystatin (Mycogynax) in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections.

What should I avoid while taking Nystatin (Mycogynax)?

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

Nystatin (Mycogynax) warnings

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

Patients using METROGELÒ (metronidazole gel) 1% should receive the following information and instructions:

1. This medication is to be used as directed.

2. It is for external use only.

3. Avoid contact with the eyes.

4. Cleanse affected area(s) before applying METROGELÒ (metronidazole gel) 1%.

5. This medication should not be used for any other condition than that for which it is prescribed.

6. Patients should report any adverse reaction to their physician.

What should I discuss with my healthcare provider before taking Nystatin (Mycogynax)?

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

Allergies

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

Pediatric

Although there is no specific information comparing use of topical Nystatin (Mycogynax) in children with use in other age groups, Nystatin (Mycogynax) is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical Nystatin (Mycogynax) in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Nystatin (Mycogynax) precautions

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

General

Nystatin (Mycogynax) cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of Nystatin (Mycogynax). No studies have been performed to determine the mutagenicity of Nystatin (Mycogynax) or the effects on male or female fertility.

Pregnancy

Teratogenic Effects

Category C

Animal reproduction studies have not been conducted with any Nystatin (Mycogynax) cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin (Mycogynax) cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether Nystatin (Mycogynax) is excreted in human milk. Caution should be exercised when Nystatin (Mycogynax) is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years.

Geriatric Use

Clinical studies with Nystatin (Mycogynax) cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

What happens if I miss a dose of Nystatin (Mycogynax)?

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

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



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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