Mycogynax Side effects

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Consists of Chloramphenicol, Dexamethasone, Metronidazole, Nystatin

What are the possible side effects of Chloramphenicol (Mycogynax)?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking Chloramphenicol (Mycogynax) and get emergency help immediately if any of the following effects occur:

Rare - in babies only

  • Bloated stomach
  • drowsiness
  • gray skin color
  • low body temperature
  • uneven breathing
  • unresponsiveness

Check with your doctor immediately if any of the following side effects occur:

Less common

  • Pale skin
  • sore throat and fever
  • unusual bleeding or bruising
  • unusual tiredness or weakness (the above side effects may also occur up to weeks or months after you stop taking Chloramphenicol (Mycogynax))
Rare
  • Confusion, delirium, or headache
  • eye pain, blurred vision, or loss of vision
  • numbness, tingling, burning pain, or weakness in the hands or feet
  • skin rash, fever, or difficulty in breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Diarrhea
  • nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.

Side effects of Chloramphenicol (Mycogynax) in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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1. Blood Dyscrasias

The most serious adverse effect of Chloramphenicol (Mycogynax) is bone marrow depression. Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of Chloramphenicol (Mycogynax). An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplastic or hypoplasia. Peripherally, pancytopenia is most often observed, but in a small number of cases only one or two of the three major cell types (erythrocytes, leukocytes, platelets) may be depressed.

A reversible type of bone marrow depression, which is dose related, may occur. This type of marrow depression is characterized by vacuolization of the erythroid cells, reduction of reticulocytes and leukopenia, and responds promptly to the withdrawal of Chloramphenicol (Mycogynax).

An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding 1) the size of the population at risk, 2) the total number of drug-associated dyscrasias, and 3) the total number of non-drug associated dyscrasias.

In a report to the California State Assembly by the California Medical Association and the State Department of Public Health in January 1967, the risk of fatal aplastic anemia was estimated at 1:24,200 to 1:40,500 based on two dosage levels.

There have been reports of aplastic anemia attributed to Chloramphenicol (Mycogynax) which later terminated in leukemia.

Paroxysmal nocturnal hemoglobinuria has been reported.

2. Gastrointestinal Reactions

Nausea, vomiting, glossitis and stomatitis, diarrhea and enterocolitis may occur in low incidence.

3. Neurotoxic Reactions

Headache, mild depression, mental confusion, and delirium have been described in patients receiving Chloramphenicol (Mycogynax). Optic and peripheral neuritis have been reported, usually following long-term therapy. If this occurs, the drug should be promptly withdrawn.

4. Hypersensitivity Reactions

Fever, macular and vesicular rashes, angioedema, urticaria, and anaphylaxis may occur. Herxheimer’s reactions have occurred during therapy for typhoid fever.

5. "Gray Syndrome"

Toxic reactions including fatalities have occurred in the premature and neonate; the signs and symptoms associated with these reactions have been referred to as the “gray syndrome.” One case of gray syndrome has been reported in a neonate born to a mother having received Chloramphenicol (Mycogynax) during labor. One case has been reported in a 3-month-old infant. The following summarizes the clinical and laboratory studies that have been made on these patients:

a) In most cases therapy with Chloramphenicol (Mycogynax) had been instituted within the first 48 hours of life.

b) Symptoms first appeared after 3 to 4 days of continued treatment with high doses of Chloramphenicol (Mycogynax).

c) The symptoms appeared in the following order:

(1) abdominal distension with or without emesis;

(2) progressive pallid cyanosis;

(3) vasomotor collapse, frequently accompanied by irregular respiration;

(4) death within a few hours of onset of these symptoms.

d) The progression of symptoms from onset to exitus was accelerated with higher dose schedules.

e)Preliminary blood serum level studies revealed unusually high concentrations of Chloramphenicol (Mycogynax) (over 90 mcg/mL after repeated doses).

f) Termination of therapy upon early evidence of the associated symptomatology frequently reversed the process with complete recovery.

What is the most important information I should know about Chloramphenicol (Mycogynax)?

  • Do not exceed the recommended dose or use Chloramphenicol (Mycogynax) for longer than prescribed without checking with your doctor.
  • Chloramphenicol (Mycogynax) is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold).
  • It is important to use Chloramphenicol (Mycogynax) for the full course of treatment. Failure to do so may decrease the effectiveness of Chloramphenicol (Mycogynax) and increase the risk that the bacteria will no longer be sensitive to Chloramphenicol (Mycogynax) and will not be able to be treated by this or certain other antibiotics in the future.
  • Long-term or repeated use of Chloramphenicol (Mycogynax) may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
  • If symptoms of "gray syndrome" (swelling of the abdomen, pale or blue skin color, vomiting, shock, difficulty breathing, refusal to suck, loose green stools, limp muscles, low temperature) occur in a newborn or infant, contact your doctor. Death may occur within hours of the onset of symptoms. Stopping use of Chloramphenicol (Mycogynax) when symptoms first appear increases the chance for a complete recovery.
  • Chloramphenicol (Mycogynax) may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
  • Chloramphenicol (Mycogynax) may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
  • Diabetes patients - Chloramphenicol (Mycogynax) may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • LAB TESTS, including complete blood cell counts, may be performed to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Chloramphenicol (Mycogynax) with extreme caution in CHILDREN younger than 1 year of age. Safety and effectiveness in this age group have not been confirmed.
  • Use Chloramphenicol (Mycogynax) with extreme caution in CHILDREN younger than 10 years of age who have diarrhea or a stomach or bowel infection.
  • Use Chloramphenicol (Mycogynax) with extreme caution in premature and full-term INFANTS because they may be more sensitive to the effects of Chloramphenicol (Mycogynax), especially the risk of "gray syndrome."
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Chloramphenicol (Mycogynax), discuss with your doctor the benefits and risks of using Chloramphenicol (Mycogynax) during pregnancy. Chloramphenicol (Mycogynax) should be used with extreme caution during full-term pregnancy and labor because the fetus may experience severe side effects. Chloramphenicol (Mycogynax) is excreted in breast milk. Do not breast-feed while taking Chloramphenicol (Mycogynax).

Chloramphenicol (Mycogynax) contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Chloramphenicol (Mycogynax) Lotion is contraindicated for premature neonates because their skin may be more permeable than full term infants and their liver enzymes may not be sufficiently developed. It is also contraindicated for patients with Norwegian (crusted) scabies due to possible increased absorption. It is also contraindicated for patients with known seizure disorders and for individuals with a known sensitivity to the product or any of its components.

What are the possible side effects of Dexamethasone (Mycogynax)?

Get emergency medical help if you have any of these signs of an allergic reaction to Dexamethasone (Mycogynax): hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • problems with your vision;

  • swelling, rapid weight gain, feeling short of breath;

  • severe depression, unusual thoughts or behavior, seizure (convulsions);

  • bloody or tarry stools, coughing up blood;

  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious Dexamethasone (Mycogynax) side effects may include:

  • sleep problems (insomnia), mood changes;

  • acne, dry skin, thinning skin, bruising or discoloration;

  • slow wound healing;

  • increased sweating;

  • headache, dizziness, spinning sensation;

  • nausea, stomach pain, bloating;

  • muscle weakness; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Dexamethasone (Mycogynax) in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Applies to Dexamethasone (Mycogynax): oral elixir, oral solution, oral tablet

Along with its needed effects, Dexamethasone (Mycogynax) (the active ingredient contained in Dexamethasone (Mycogynax)) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking Dexamethasone (Mycogynax):

More common

  • Aggression
  • agitation
  • anxiety
  • blurred vision
  • decrease in the amount of urine
  • dizziness
  • fast, slow, pounding, or irregular heartbeat or pulse
  • headache
  • irritability
  • mental depression
  • mood changes
  • nervousness
  • noisy, rattling breathing
  • numbness or tingling in the arms or legs
  • pounding in the ears
  • shortness of breath
  • swelling of the fingers, hands, feet, or lower legs
  • trouble thinking, speaking, or walking
  • troubled breathing at rest
  • weight gain
Incidence not known
  • Abdominal cramping and/or burning (severe)
  • abdominal pain
  • backache
  • bloody, black, or tarry stools
  • cough or hoarseness
  • darkening of skin
  • decrease in height
  • decreased vision
  • diarrhea
  • dry mouth
  • eye pain
  • eye tearing
  • facial hair growth in females
  • fainting
  • fatigue
  • fever or chills
  • flushed, dry skin
  • fractures
  • fruit-like breath odor
  • full or round face, neck, or trunk
  • heartburn and/or indigestion (severe and continuous)
  • increased hunger
  • increased thirst
  • increased urination
  • loss of appetite
  • loss of sexual desire or ability
  • lower back or side pain
  • menstrual irregularities
  • muscle pain or tenderness
  • muscle wasting or weakness
  • nausea
  • pain in back, ribs, arms, or legs
  • painful or difficult urination
  • skin rash
  • sleeplessness
  • sweating
  • trouble healing
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • vision changes
  • vomiting
  • vomiting of material that looks like coffee grounds

Some side effects of Dexamethasone (Mycogynax) may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Increased appetite
Incidence not known
  • Abnormal fat deposits on the face, neck, and trunk
  • acne
  • dry scalp
  • lightening of normal skin color
  • red face
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • swelling of the stomach area
  • thinning of the scalp hair

For Healthcare Professionals

Applies to Dexamethasone (Mycogynax): compounding powder, inhalation aerosol with adapter, injectable solution, injectable suspension, intravenous solution, oral concentrate, oral liquid, oral tablet

General

The most commonly occurring side effects have included alteration in glucose tolerance, behavioral and mood changes, increased appetite, and weight gain; the incidence generally correlates with dosage, timing of administration, and duration of treatment.

Immunologic

Frequency not reported: Opportunistic infection, exacerbation of latent infections, decreased resistance to infection, immunosuppression, candidiasis, chicken pox (varicella)

Other

Frequency not reported: Vertigo, abnormal fat deposits, malaise, sterile abscess, impaired healing, fatigue, malaise

Respiratory

Frequency not reported: Hiccups, pulmonary edema

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Dexamethasone (Mycogynax) (Dexamethasone (Mycogynax))." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc), Huntsville, AL.

3. "Product Information. Dexamethasone (Mycogynax) Sodium Phosphate (Dexamethasone (Mycogynax))." West-Ward Pharmaceutical Corporation, Eatontown, NJ.

4. Sechi GP, Piras MR, Demurtas A, Tanca S, Rosati G "Dexamethasone (Mycogynax)-induced schizoaffective-like state in multiple sclerosis: prophylaxis and treatment with carbamazepine." Clin Neuropharmacol 10 (1987): 453-7

5. "Product Information. Decadron (Dexamethasone (Mycogynax))." Merck & Co, Inc, West Point, PA.

6. Carroll BJ, Schroeder K, Mukhopadhyay S, Greden JF, Feinberg M, Ritchie J, Tarika J "Plasma Dexamethasone (Mycogynax) concentrations and cortisol suppression response in patients with endogenous depression." J Clin Endocrinol Metab 51 (1980): 433-7

7. Jaime Vazquez J "Persistent hiccup as a side-effect of Dexamethasone (Mycogynax) treatment." Hum Exp Toxicol 12 (1993): 52

8. Kanwar AJ, Kaur S, Dhar S, Ghosh S "Hiccup--a side-effect of pulse therapy." Dermatology 187 (1993): 279

9. Fadul CE, Lemann W, Thaler HT, Posner JB "Perforation of the gastrointestinal tract in patients receiving steroids for neurologic disease." Neurology 38 (1988): 348-52

10. McDonnell M, Evans N "Upper and lower gastrointestinal complications with Dexamethasone (Mycogynax) despite H2 antagonists." J Paediatr Child Health 31 (1995): 152-4

11. Whitmore SE "Dexamethasone (Mycogynax) injection-induced generalized dermatitis." Br J Dermatol 131 (1994): 296-7

12. Ludvik B, Clodi M, Kautzky-Willer A, Capek M, Hartter E, Pacini G, Prager R "Effect of Dexamethasone (Mycogynax) on insulin sensitivity, islet amyloid polypeptide and insulin secretion in humans." Diabetologia 36 (1993): 84-7

13. New MI, Peterson RE, Saenger P, Levine LS "Evidence for an unidentified ACTH-induced steroid hormone causing hypertension." J Clin Endocrinol Metab 43 (1976): 1283-93

14. Tsoi WW "Cushing's syndrome caused by analgesic/Dexamethasone (Mycogynax) preparation." Ann Pharmacother 28 (1994): 1411

15. Spenney JG, Eure CA, Kreisberg RA "Hyperglycemic, hyperosmolar, nonketoacidotic diabetes. A complication of steroid and immunosupressive therapy." Diabetes 18 (1969): 107-10

16. Francois J "Corticosteroid glaucoma." Ann Ophthalmol 9 (1977): 1075-80

17. Godel V, Regenbogen L, Stein R "On the mechanism of corticosteroid-induced ocular hypertension." Ann Ophthalmol 10 (1978): 191-6

18. Bluming AZ, Zeegen P "Cataracts induced by intermittent Decadron used as an antiemetic." J Clin Oncol 4 (1986): 221-3

19. Kobayashi Y, Akaishi K, Nishio T, Kobayashi Y, Kimura Y "Posterior subcapsular cataract in nephrotic children receiving steroid therapy." Am J Dis Child 128 (1974): 671-3

20. Schmidt GB, Meier MA, Sadove MS "Sudden appearance of cardiac arrhythmias after Dexamethasone (Mycogynax)." JAMA 221 (1972): 1402-4

21. Rao G, Zikria EA, Miller WH, Samadani SR, Ford WB "Cardiac arrhythmias after Dexamethasone (Mycogynax)." JAMA 222 (1972): 1185

Some side effects of Dexamethasone (Mycogynax) may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

What is the most important information I should know about Dexamethasone (Mycogynax)?

  • Dexamethasone (Mycogynax) may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Tell your doctor or dentist that you take Dexamethasone (Mycogynax) before you receive any medical or dental care, emergency care, or surgery.
  • Dexamethasone (Mycogynax) may cause an elevation in blood pressure, salt and water retention, and increased potassium loss. You may need to restrict the use of salt and take a calcium supplement.
  • Dexamethasone (Mycogynax) can cause calcium loss and promote the development of osteoporosis. Take adequate calcium and vitamin D supplements.
  • Diabetes patients - Dexamethasone (Mycogynax) may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests may be performed while you use Dexamethasone (Mycogynax). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Caution is advised when using Dexamethasone (Mycogynax) in CHILDREN; because they may be more sensitive to its effects.
  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Dexamethasone (Mycogynax).
  • PREGNANCY and BREAST-FEEDING: It is not known if Dexamethasone (Mycogynax) can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dexamethasone (Mycogynax) while you are pregnant. Dexamethasone (Mycogynax) is found in breast milk. Do not breast-feed while taking Dexamethasone (Mycogynax).

Dexamethasone (Mycogynax) contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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You should not use this medication if you are allergic to Dexamethasone (Mycogynax), or if you have a fungal infection anywhere in your body.

Before taking Dexamethasone (Mycogynax), tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

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

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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.

Do not receive a "live" vaccine while you are taking Dexamethasone (Mycogynax). Vaccines may not work as well while you are taking a steroid.

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

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

What are the possible side effects of Metronidazole (Mycogynax)?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Itching in the vagina
  • pain during sexual intercourse
  • thick, white vaginal discharge with no odor or with a mild odor
Less common
  • Abdominal or stomach cramping or pain
  • burning on urination or need to urinate more often
  • burning or irritation of penis of sexual partner
  • itching, stinging, or redness of the genital area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Diarrhea
  • dizziness or lightheadedness
  • dryness of the mouth
  • feeling of a furry tongue
  • headache
  • loss of appetite
  • metallic taste or other change in taste sensation
  • nausea
  • vomiting

Metronidazole (Mycogynax) may cause your urine to become dark. This is harmless and will go away when you stop using Metronidazole (Mycogynax).

After you stop using Metronidazole (Mycogynax), it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Any vaginal or genital irritation or itching
  • pain during sexual intercourse
  • thick, white vaginal discharge not present before treatment, with no odor or with a mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.

Side effects of Metronidazole (Mycogynax) in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

Clinical Trials Experience

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

The data described below reflect exposure to Metronidazole (Mycogynax) compared to another formulation of vaginal Metronidazole (Mycogynax) in 220 women in a single trial. The population was non-pregnant females (age range 18 to 72 years, the mean was 33 years +/- 11 years) with bacterial vaginosis. The racial demographic of those enrolled was 71 (32%) of White, 143 (65%) of Black, 3 (1%) of Hispanic, 2 (1%) of Asian, and 1 (0%) of other. Patients administered an applicator full of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) intravaginally once daily at bedtime for 5 days.

There were no deaths or serious adverse reactions related to drug therapy in the clinical trial. Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) was discontinued in 5 patients (2.3%) due to adverse reactions.

The incidence of all adverse reactions in Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) -treated patients was 42% (92/220). Adverse reactions occurring in ≥ 1% of patients were: fungal infection* (12%), headache (7%), pruritus (6%), abdominal pain (5%), nausea (3%), dysmenorrhea (3%), pharyngitis (2%), rash (1%), infection (1%), diarrhea (1%), breast pain (1%), and metrorrhagia (1%).

* Known or previously unrecognized vaginal candidiasis may present more prominent symptoms during therapy with Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel). Approximately 10% of patients treated with Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) developed Candida vaginitis during or immediately after therapy.

Additional uncommon events, reported by < 1% of those women treated with Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) included:

General: allergic reaction, back pain, flu syndrome, mucous membrane disorder, pain

Gastrointestinal: anorexia, constipation, dyspepsia, flatulence, gingivitis, vomiting

Nervous System: depression, dizziness, insomnia

Respiratory System: asthma, rhinitis

Skin and Appendages: acne, sweating, urticaria

Urogenital System: breast enlargement, dysuria, female lactation, labial edema, leucorrhea, menorrhagia, pyleonephritis, salpingitis, urinary frequency, urinary tract infection, vaginitis, vulvovaginal disorder

Other Metronidazole (Mycogynax) Formulations

Other Vaginal Formulations

Other reactions that have been reported in association with the use of other formulations of Metronidazole (Mycogynax) vaginal gel include: unusual taste and decreased appetite.

Topical (Dermal) Formulations

Other reactions that have been reported in association with the use of topical (dermal) formulations of Metronidazole (Mycogynax) include skin irritation, transient skin erythema, and mild skin dryness and burning. None of these adverse reactions exceeded an incidence of 2% of patients.

Oral and

Parenteral Formulations

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of Metronidazole (Mycogynax):

Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.

Nervous System: The most serious adverse reactions reported in patients treated with Metronidazole (Mycogynax) have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. In addition, patients have reported syncope, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia.

Gastrointestinal: Abdominal discomfort, nausea, vomiting, diarrhea, an unpleasant metallic taste, anorexia, epigastric distress, abdominal cramping, constipation, “furry” tongue, glossitis, stomatitis, pancreatitis, and modification of taste of alcoholic beverages.

Genitourinary: Overgrowth of Candida in the vagina, dyspareunia, decreased libido, proctitis.

Hematopoietic: Reversible neutropenia, reversible thrombocytopenia.

Hypersensitivity Reactions: Urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.

Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure, darkened urine.

What is the most important information I should know about Metronidazole (Mycogynax)?

  • Metronidazole (Mycogynax) capsules may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Metronidazole (Mycogynax) capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or take any products containing alcohol or propylene glycol while you are taking Metronidazole (Mycogynax) capsules and for at least 3 days after the last dose. Drinking alcohol or taking products with alcohol or propylene glycol may cause stomach cramps, nausea, vomiting, headaches, and flushing.
  • Metronidazole (Mycogynax) capsules only works against bacteria; it does not treat viral infections (eg, the common cold).
  • Be sure to use Metronidazole (Mycogynax) capsules for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Long-term or repeated use of Metronidazole (Mycogynax) capsules may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Some patients have developed persistent nerve problems (peripheral neuropathy) after taking Metronidazole (Mycogynax) capsules for a long period of time. Tell your doctor right away if you develop signs of nerve problems (eg, numbness; tingling; burning of the arms, hands, legs, feet). Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Metronidazole (Mycogynax) capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Metronidazole (Mycogynax) capsules.
  • Lab tests, including liver function and white blood cell counts, may be performed while you use Metronidazole (Mycogynax) capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Metronidazole (Mycogynax) capsules with caution in the ELDERLY; they may be more sensitive to its effects.
  • Metronidazole (Mycogynax) capsules should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metronidazole (Mycogynax) capsules while you are pregnant. Certain patients should not use Metronidazole (Mycogynax) capsules during the first 3 months of pregnancy. Metronidazole (Mycogynax) capsules is found in breast milk. Do not breast-feed while taking Metronidazole (Mycogynax) capsules.

Metronidazole (Mycogynax) contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

Hypersensitivity

The use of Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) is contraindicated in patients with a history of hypersensitivity to Metronidazole (Mycogynax), other nitroimidazole derivatives, or parabens. Reported reactions include urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains.

Psychotic Reaction with Disulfiram

Use of oral Metronidazole (Mycogynax) is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel) to patients who have taken disulfiram within the last two weeks.

Interaction with Alcohol

Use of oral Metronidazole (Mycogynax) is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue alcohol consumption during and for at least three days after therapy with Metronidazole (Mycogynax) (Metronidazole (Mycogynax) vaginal gel).

What are the possible side effects of Nystatin (Mycogynax)?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

  • Vaginal burning or itching not present before use of Nystatin (Mycogynax)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.

Side effects of Nystatin (Mycogynax) in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

Applies to Nystatin (Mycogynax): oral capsule, oral suspension, oral tablet

In addition to its needed effects, some unwanted effects may be caused by Nystatin (Mycogynax) (the active ingredient contained in Nystatin (Mycogynax)). In the event that any of these side effects do occur, they may require medical attention.

Minor Side Effects

Some of the side effects that can occur with Nystatin (Mycogynax) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

  • Diarrhea
  • nausea or vomiting
  • stomach pain

What is the most important information I should know about Nystatin (Mycogynax)?

  • Practice good oral hygiene, including proper care of dentures, while you are taking Nystatin (Mycogynax) suspension.
  • Be sure to use Nystatin (Mycogynax) suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Diabetes patients - Nystatin (Mycogynax) suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nystatin (Mycogynax) suspension while you are pregnant. It is not known if Nystatin (Mycogynax) suspension is found in breast milk. If you are or will be breast-feeding while you use Nystatin (Mycogynax) suspension, check with your doctor. Discuss any possible risks to your baby.

Nystatin (Mycogynax) contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

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

Nystatin (Mycogynax) topical (for the skin) is not for use to treat a vaginal yeast infection.

Avoid getting this medication in your eyes or mouth. If this does happen, rinse with water.

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

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

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

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

The results of a survey conducted on ndrugs.com for Mycogynax are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Mycogynax. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

2 consumers reported side effects

Did you experience side effects while taking Mycogynax drug?
According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Mycogynax drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
Users%
It has side effects1
50.0%
No side effects1
50.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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