Mycogynax Overdose

Rating: 3.3 - 3 review(s)
What is the dose of your medication?
sponsored

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

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

No information available.

Chloramphenicol (Mycogynax) warnings

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

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.

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.

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:

Chloramphenicol (Mycogynax) precautions

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

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) may be harmful if swallowed.

Proper storage of Dexamethasone (Mycogynax):

Store Dexamethasone (Mycogynax) 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) out of the reach of children and away from pets.

Overdose of Dexamethasone (Mycogynax) in details

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

For

Oral Administration

The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated.

It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains, and adequate clinical response is reached.

Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions of exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of Dexamethasone (Mycogynax) for a week followed by 4 to 12 mg every other day for one month have been shown to be effective.

In pediatric patients, the initial dose of Dexamethasone (Mycogynax) may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).

For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids:

Dexamethasone (Mycogynax), 1.5 Methylprednisolone, 8

Prednisone, 10 Triamcinolone, 8

Prednisolone, 10 Betamethasone, 1.5

Hydrocortisone, 40 Paramethasone, 4

Cortisone, 50

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

In acute, self-limited allergic disorders or acute exacerbations of chronic allergic disorders, the following dosage schedule combining parenteral and oral therapy is suggested:

Dexamethasone (Mycogynax) sodium phosphate injection, 4 mg per ml

First Day

1 or 2 ml, intramuscularly

Dexamethasone (Mycogynax) tablets, 0.75 mg

Second Day

4 tablets in two divided doses

Third Day

4 tablets in two divided doses

Fourth Day

2 tablets in two divided doses

Fifth Day

1 tablet

Sixth Day

1 tablet

Seventh Day

No treatment

Eighth Day

Follow-up visit

This schedule is designed to ensure adequate therapy during acute episodes, while minimizing the risk of overdosage in chronic cases.

In cerebral edema, Dexamethasone (Mycogynax) sodium phosphate injection is generally administered initially in dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with either Dexamethasone (Mycogynax) sodium phosphate injection or Dexamethasone (Mycogynax) tablets in a dosage of 2 mg two or three times daily may be effective.

Dexamethasone (Mycogynax) Suppression Tests

1. Tests for Cushing’s syndrome

Give 1.0 mg of Dexamethasone (Mycogynax) orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of Dexamethasone (Mycogynax) orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

2. Test to distinguish Cushing’s syndrome due to pituitary ACTH excess from Cushing’s syndrome due to other causes.

Give 2.0 mg of Dexamethasone (Mycogynax) orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

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

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

Alterations in Endocrine Function

Corticosteroids, such as Dexamethasone (Mycogynax), can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients receiving Dexamethasone (Mycogynax) for adrenal insufficiency after corticosteroid withdrawal and Cushing’s syndrome and hyperglycemia while receiving corticosteroids. In addition, patients with hypopituitarism, primary adrenal insufficiency, or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at risk for adverse endocrine events.

Risk of Adrenal Insufficiency Following Corticosteroid Withdrawal

Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression, with the potential for the development of secondary adrenal insufficiency after withdrawal of corticosteroid treatment. Acute adrenal insufficiency can occur if glucocorticoids are withdrawn abruptly and can be fatal. The degree and duration of adrenocortical insufficiently produced is variable among patients and depends on the dose, frequency, and duration of glucocorticoid therapy. The risk may be reduced by gradually tapering the corticosteroid dose when withdrawing treatment. This insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstituted. For patients already taking corticosteroids during times of stress, the dosage may have to be increased.

A steroid “withdrawal syndrome”, seemingly unrelated to adrenocortical insufficiency, may also occur following abrupt discontinuance of corticosteroids. This syndrome includes symptoms such as: anorexia, nausea, vomiting, lethargy, headache, fever, joint pain, desquamation, myalgia, and/or weight loss. These effects are thought to be due to the sudden change in glucocorticoid concentration rather than to low corticosteroid levels.

Cushing’s Syndrome

Cushing’s syndrome (hypercortisolism) may occur with prolonged exposure to exogenous corticosteroids, including Dexamethasone (Mycogynax). Symptoms include hypertension, truncal obesity and thinning of the limbs, purple striae, facial rounding, facial plethora, muscle weakness, easy and frequent bruising with thin fragile skin, posterior neck fat deposition, osteopenia, acne, amenorrhea, hirsutism and psychiatric abnormalities. Using the lowest dose of corticosteroid for the shortest duration possible may reduce the risk.

Hyperglycemia

Corticosteroids can increase blood glucose, worsen pre-existing diabetes, and predispose those on long-term therapy to diabetes mellitus, and may reduce the effect of the antidiabetic drugs. Monitor blood glucose at regular intervals. For patients with hyperglycemia, anti-diabetic treatment should be initiated or adjusted accordingly.

Considerations for Use in Patients with Altered Thyroid Function

Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate a dose adjustment of the corticosteroid. When concomitant administration of corticosteroids and levothyroxine is required, administration of corticosteroid should precede the initiation of levothyroxine therapy to avoid adrenal crisis.

Pheochromocytoma Crisis

There have been reports of pheochromocytoma crisis, which can be fatal, after administration of systemic corticosteroids. In patients with suspected or identified pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering Dexamethasone (Mycogynax).

Immunosuppression and Increased Risk of Infections

Corticosteroids, including Dexamethasone (Mycogynax), suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic.

Corticosteroids reduce resistance to new infections, exacerbate existing infections, increase the risk of disseminated infections, increase the risk of reactivation or exacerbation of latent infections, and mask some signs of infection. These infections can be severe, and at times fatal. The degree to which the dose, route, and duration of corticosteroid administration correlates with the specific risks of infection is not well characterized; however, the rate of occurrence of infectious complications increases with increasing doses of corticosteroids.

Monitor for the development of infection and consider withdrawal of Dexamethasone (Mycogynax) or reduction of the dose of corticosteroids as needed.

Varicella Zoster and Measles Viral Infections

Chickenpox caused by Varicella Zoster virus and measles can have a serious or even fatal course in non-immune children or adult on corticosteroids, including Dexamethasone (Mycogynax). In patients who have not had these diseases, particular care should be taken to avoid exposure. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with immune globulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered.

Hepatitis B Virus Reactivation

Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers undergoing treatment with immunosuppressive drugs including corticosteroids. Reactivation can also occur in patients who appear to have resolved hepatitis B infection.

Fungal Infections

Dexamethasone (Mycogynax) is contraindicated in patients with systemic fungal infections. Corticosteroids may exacerbate systemic fungal infections. For patients on chronic corticosteroids who have developed systemic fungal infections, withdrawal of corticosteroids or reduction of the dose of corticosteroids is recommended.

The following infections have been reported during the use of corticosteroids to treat other conditions that Dexamethasone (Mycogynax) is not indicated for:

Amebiasis

Corticosteroids may activate latent amebiasis. Rule out latent amebiasis or active amebiasis before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea.

Strongyloides Infestation

In patients with known or suspected Strongyloides (threadworm) infestation, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. For patients on Dexamethasone (Mycogynax) who develop known or suspected Strongyloides (threadworm) infection, withdrawal of corticosteroids or reduction of the dose of corticosteroids is recommended.

Tuberculosis

The use of corticosteroids in active tuberculosis should generally be limited to cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous 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.

Cerebral Malaria

Corticosteroids should not be used in cerebral malaria.

Alterations in Cardiovascular/Renal Function

Corticosteroids, including Dexamethasone (Mycogynax), can cause elevation of blood pressure, salt, and water retention, and increased excretion of potassium and calcium. Monitor blood pressure and assess for signs and symptoms of volume overload. Monitor serum potassium levels. Dietary salt restriction and potassium supplementation may be necessary. Dexamethasone (Mycogynax) should be used with caution in patients with congestive heart failure.

Literature reports suggest an association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with Dexamethasone (Mycogynax) should be used with great caution in these patients.

Venous and Arterial Thromboembolism

Thromboembolism is a known adverse reaction of Dexamethasone (Mycogynax), including Dexamethasone (Mycogynax). The risk for venous and arterial thromboembolism increases significantly when Dexamethasone (Mycogynax) is administered with anti-myeloma products (e.g., thalidomide, lenalidomide, pomalidomide, and carfilzomib). Refer to the Prescribing Information of these anti-myeloma products for information about the risk of venous and arterial thromboembolism.

Consider thromboprophylaxis based on an assessment of individual patients’ underlying risk factors and the anti-myeloma drugs. Agents that also may increase the risk of thromboembolism should be used with caution in patients with multiple myeloma receiving combination regimens of Dexamethasone (Mycogynax) and anti-myeloma products.

Vaccination

Avoid administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids for the treatment of multiple myeloma. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted.

Ophthalmic Effects

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 bacteria, fungi, or viruses. Consider referral to an ophthalmologist for patients who develop ocular symptoms or use corticosteroid-containing products for more than 6 weeks. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in patients with active ocular herpes simplex.

Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Gastrointestinal Perforation

There is an increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis.

Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked in patients receiving corticosteroids. Avoid corticosteroids if there is a possibility of impending perforation, abscess, or other pyrogenic infections; diverticulitis; fresh intestinal anastomoses; or active or latent peptic ulcer.

Osteoporosis

Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone, secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating Dexamethasone (Mycogynax) therapy.

Myopathy

An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.

Behavioral and Mood Disturbances

Potentially severe psychiatric adverse reactions may occur with systemic corticosteroids, including Dexamethasone (Mycogynax). Symptoms typically emerge within a few days or weeks of starting treatment and may be dose-related. These reactions may improve after either dose reduction or withdrawal, although pharmacologic treatment may be necessary. Psychiatric adverse reactions usually involve hypomanic or manic symptoms (e.g., euphoria, insomnia, mood swings) during treatment and depressive episodes after discontinuation of treatment. Inform patients and caregivers of the potential for behavioral and mood changes and encourage them to seek medical attention if psychiatric symptoms develop, especially if depressed mood or suicidal ideation is suspected.

Kaposi's Sarcoma

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy to treat other chronic conditions for which Dexamethasone (Mycogynax) is not indicated. Discontinuation of corticosteroids may result in clinical improvement.

Dexamethasone (Mycogynax) in Combination with Anti-Myeloma Products

Dexamethasone (Mycogynax) is administered in combination regimens with anti-myeloma products; please refer to the Prescribing Information of these products for additional information.

Embryo-Fetal Toxicity

Based on findings from clinical and animal reproduction studies, corticosteroids, including Dexamethasone (Mycogynax), can cause fetal harm when administered to a pregnant woman. Dexamethasone (Mycogynax) administration to pregnant women has resulted in adverse effects on fetal growth, skeletal development/osteogenesis and low birth weight with prolonged use. Dexamethasone (Mycogynax) administration to pregnant animals during organogenesis resulted in structural abnormalities, embryo-fetal mortality, functional impairment, and alterations to growth at doses equivalent to or below the recommended doses.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Dexamethasone (Mycogynax) and for at least one month after the last dose.

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

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

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dexamethasone (Mycogynax) 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

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

Intravitreal Injection-related Effects

Intravitreal injections, including those with Dexamethasone (Mycogynax)®, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection.

Steroid-related Effects

Use of corticosteroids including Dexamethasone (Mycogynax)® may produce posterior subcapsular cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No adequate studies in animals have been conducted to determine whether Dexamethasone (Mycogynax)® (Dexamethasone (Mycogynax) intravitreal implant) has the potential for carcinogenesis.

Although no adequate studies have been conducted to determine the mutagenic potential of Dexamethasone (Mycogynax)®, Dexamethasone (Mycogynax) has been shown to have no mutagenic effects in bacterial and mammalian cells in vitro or in the in vivo mouse micronucleus test.

Adequate fertility studies have not been conducted in animals.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Risk Summary

There are no adequate and well-controlled studies with Dexamethasone (Mycogynax)® in pregnant women.

Animal reproduction studies using topical ocular administration of Dexamethasone (Mycogynax) were conducted in mice and rabbits. Cleft palate and embryofetal death in mice and malformations of the intestines and kidneys in rabbits were observed. Dexamethasone (Mycogynax)® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal Data

Topical ocular administration of 0.15% Dexamethasone (Mycogynax) (0.375 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in mice. A dose of 0.375 mg/kg/day in the mouse is approximately 3 times an Dexamethasone (Mycogynax)® injection in humans (0.7 mg Dexamethasone (Mycogynax)) on a mg/m² basis. In rabbits, topical ocular administration of 0.1% Dexamethasone (Mycogynax) throughout organogenesis (0.13 mg/kg/day, on gestational day 6 followed by 0.20 mg/kg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A dose of 0.13 mg/kg/day in the rabbit is approximately 4 times an Dexamethasone (Mycogynax)® injection in humans (0.7 mg Dexamethasone (Mycogynax)) on a mg/m² basis.

Nursing Mothers

Systemically administered corticosteroids are present in human milk and can suppress growth and interfere with endogenous corticosteroid production. The systemic concentration of Dexamethasone (Mycogynax) following intravitreal treatment with Dexamethasone (Mycogynax)® is low. It is not known whether intravitreal treatment with Dexamethasone (Mycogynax)® could result in sufficient systemic absorption to produce detectable quantities in human milk. Exercise caution when Dexamethasone (Mycogynax)® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Dexamethasone (Mycogynax)® 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)?

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

Since Dexamethasone (Mycogynax) intravitreal is given as an implant by a healthcare professional, you will not be on a frequent dosing schedule.

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) may be harmful if swallowed.

Proper storage of Metronidazole (Mycogynax):

Store Metronidazole (Mycogynax) 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) out of the reach of children and away from pets.

Overdose of Metronidazole (Mycogynax) in details

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

Use of dosages of intravenous metronidazole 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, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported included nausea, vomiting and ataxia.

Oral metronidazole 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)?

Do not drink alcohol while you are taking metronidazole and for at least 3 days after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

Check the labels of any medicines or food products you use to make sure they do not contain alcohol.

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

Metronidazole (Mycogynax) warnings

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

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. The appearance of abnormal neurologic signs demands the prompt discontinuation of Metronidazole (metronidazole) therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole 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 (metronidazole) and requires treatment with a candidacidal agent.

Prescribing Metronidazole 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 (metronidazole) 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 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 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 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. No fetotoxicity was observed when metronidazole 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 is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Use of Metronidazole for trichomoniasis during pregnancy should be restricted to those in whom alternative treatment has been inadequate. Use of Metronidazole (metronidazole) for trichomoniasis in pregnancy should be carefully evaluated because metronidazole 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 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 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 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). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Metronidazole (Mycogynax) 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

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

Metronidazole Vaginal Gel affords minimal peak serum levels and systemic exposure (AUCs) of metronidazole compared to 500 mg oral metronidazole dosing. Although these lower levels of exposure are less likely to produce the common reactions seen with oral metronidazole, the possibility of these and other reactions cannot be excluded presently. Data from well-controlled trials directly comparing metronidazole administered orally to metronidazole administered vaginally are not available.

General:

Patients with severe hepatic disease metabolize metronidazole slowly. This results in the accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, Metronidazole Vaginal Gel should be administered cautiously.

Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with Metronidazole Vaginal Gel. Approximately 6-10% of patients treated with Metronidazole Vaginal Gel developed symptomatic Candida vaginitis during or immediately after therapy.

Disulfiram-like reaction to alcohol has been reported with oral metronidazole, thus the possibility of such a reaction occurring while on Metronidazole Vaginal Gel therapy cannot be excluded.

Metronidazole 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.

Information for the Patient:

The patient should be cautioned about drinking alcohol while being treated with Metronidazole Vaginal Gel. While blood levels are significantly lower with Metronidazole Vaginal Gel than with usual doses of oral metronidazole, a possible interaction with alcohol cannot be excluded.

The patient should be instructed not to engage in vaginal intercourse during treatment with this product.

Drug Interactions:

Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when Metronidazole Vaginal Gel is prescribed for patients on this type of anticoagulant therapy.

In patients stabilized on relatively high doses of lithium, short-term oral metronidazole therapy has been associated with elevation of serum lithium levels and, in a few cases, signs of lithium toxicity.

Use of cimetidine with oral metronidazole may prolong the half-life and decrease plasma clearance of metronidazole.

Drug/Laboratory Test Interactions:

Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (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 (322 nm) at pH 7.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Metronidazole 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 (approximately 500 mg/kg/day), 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 lymphomas 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 neoplasms, particularly in mammary and hepatic tumors, among female rats administered metronidazole over those noted in the concurrent female control groups. Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.

These studies have not been conducted with 0.75% Metronidazole Vaginal Gel, which would result in significantly lower systemic blood levels than those obtained with oral formulations.

Although metronidazole 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 up to six times the recommended human oral dose (based on mg/m2) and have revealed no evidence of impaired fertility.

Pregnancy: Teratogenic Effects:

Pregnancy Category B

There has been no experience to date with the use of Metronidazole Vaginal Gel in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant mice at six times the recommended human dose (based on mg/m2); 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 is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers:

Specific studies of metronidazole levels in human milk following intravaginally administered metronidazole have not been performed. However, metronidazole is secreted in human milk in concentrations similar to those found in plasma following oral administration of metronidazole.

Because of the potential for tumorigenicity shown for metronidazole in mouse and rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in children have not been established.

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

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

Use the 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):

Store Nystatin (Mycogynax) 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) out of the reach of children and away from pets.

Overdose of Nystatin (Mycogynax) in details

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

Oral doses of nystatin 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)?

There are no restrictions on foods, beverages, or activities during treatment with nystatin unless your doctor directs otherwise.

Nystatin (Mycogynax) warnings

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

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, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to nystatin 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 in children with use in other age groups, nystatin 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 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

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

General

Nystatin (Mycogynax) 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. No studies have been performed to determine the mutagenicity of nystatin or the effects on male or female fertility.

Pregnancy

Teratogenic Effects

Category C

Animal reproduction studies have not been conducted with any Nystatin (Mycogynax). 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) 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 is excreted in human milk. Caution should be exercised when nystatin 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) 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)?

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

Take the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.



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).

Reviews

Consumer reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 28 here

Information checked by Dr. Sachin Kumar, MD Pharmacology

| Privacy Policy
This site does not supply any medicines. It contains prices for information purposes only.
© 2003 - 2024 ndrugs.com All Rights Reserved