Mykozem

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Mykozem uses

Mykozem consists of Undecylenic Acid, Urea, Zinc Stearate.

Undecylenic Acid:



Drug Facts

Active Ingredients Purpose
Mykozem (Undecylenic Acid) Acid 2% Antifungal
Zinc Undecylenate 20% Antifungal

Uses

  • Cures most athlete's foot, jock itch & ringworm
  • Relieves itching, burning, cracking, and discomfort which accompany these conditions

Warning

  • For external use only.
  • Not for diaper rash
  • When using this product avoid contact with eyes and mucous membrane.
  • Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Stop use and ask a doctor if

  • Irritation occurs
  • There is no improvement within 4 weeks of treatment for athlete's foot and ringworm and 2 weeks of treatment for jock itch discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN.

In case of accidental ingestion seek professional assistance or contact a poison control center right away.

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Directions

  • Clean affected area and dry thoroughly.
  • Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor.
  • For athlete's foot pay special attention to the space between the toes. Wear well fitting, ventilated shoes and change shoes & socks at least once a day.
  • For athlete's foot and ringworm, use daily for 4 weeks
  • For jock itch use daily for 2 weeks.
  • Supervise Children in use of this product.
  • Product not effective in the scalp or nails.

Other Information

Store at 59° - 86° F

Other ingredients

talc

SANAFITIL®

ANTIFUNGAL

POWDER

  • Treats most Athlete's foot, Jock itch & Ringworm

NET WEIGHT / PESO

NETO : 2 OZ (57 g)

Urea:



FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, LIPS OR MUCOUS MEMBRANES.

DESCRIPTION: Mykozem (Urea) Nail Stick 50% is a keratolytic solution, which is gentle yet potent, tissue softener for nails. Each mL of Mykozem (Urea) Nail Stick 50% contains 50% Mykozem (Urea) along with acrylates copolymer, carbomer, cetyl alcohol, disodium EDTA, dl-alphatocophery acetate, glycerin, lactic acid, linoleic acid, mineral oil, PEG-6, polysorbate 60, purified water, sodium hydroxide solution, stearic acid, titanium dioxide, zinc undecylenate.

Mykozem (Urea) is a diamide of carbonic acid with the following chemical structure:

Chemical Structure

CLINICAL

Pharmacology: Mykozem (Urea) gently dissolves the intracellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Mykozem (Urea) also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

PHARMACOKINETICS: The mechanism of action of topically applied Mykozem (Urea) is not yet known.

INDICATIONS AND USES: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Mykozem (Urea) is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized, and ingrown nails.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

WARNINGS: FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips, inside the mouth/nose, and the vaginal/groin area. Consult your physician for directions about any areas of types of skin to apply or not apply the product. Tell your doctor if your condition persists or worsens.

PRECAUTIONS: This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however there are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Mykozem (Urea) Nail Stick 50% should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mykozem (Urea) Nail Stick 50% is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Call your doctor for medical advice about side effects.

DOSAGE AND ADMINISTRATION: Use this product as directed, and regularly, to achieve maximum benefit. Follow all directions on the product package and prescription label. If you are uncertain about any of the information, consult your doctor or pharmacist. Apply to the affected areas of the skin/nails, twice a day or as directed by your doctor. Rub in well until absorbed. As the product dries, the level of Mykozem (Urea) increases as the level of moisture decreases, allowing some of the Mykozem (Urea) to crystallize (white color). The product will work properly whether or not the Mykozem (Urea) can be seen on the surface. Wash hands after applying unless you are treating the hands.

HOW SUPPLIED: Mykozem (Urea) Nail Stick 50% is supplied in a carton containing 6 nail sticks (2.4 mL each = 2.7 g each) NDC 42808-0205-15.

Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing.

How to Dispense Mykozem (Urea) Nail Stick 50% from the Container: Shake before use. Remove the cap, applicator side up. Holding the container with one hand, rotate the bottom dispensing dial counterclockwise. As the dial is rotated you will hear a clicking sound, which indicates that the product is being dispensed on the applicator. Rotate until the gel is visibly and apply as needed. After use, place the cap firmly on the container and when not in use keep the product tightly capped.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0205-15-205-00

Iss:6/11

Zinc Stearate:


INDICATIONS AND USAGE

Mykozem (Zinc Stearate) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Mykozem (Zinc Stearate) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Mykozem (Zinc Stearate) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Mykozem (Zinc Stearate) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Mykozem (Zinc Stearate) from a bolus injection. Administration of Mykozem (Zinc Stearate) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Mykozem (Zinc Stearate) are suggested as a guideline for subsequent Mykozem (Zinc Stearate) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Mykozem 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mykozem (Zinc Stearate) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Mykozem chloride. It is also not known whether Mykozem (Zinc Stearate) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mykozem (Zinc Stearate) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Mykozem (Zinc Stearate) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Mykozem (Zinc Stearate) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Mykozem (Zinc Stearate) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Mykozem (Zinc Stearate) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Mykozem (Zinc Stearate) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Mykozem (Zinc Stearate) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Mykozem (Zinc Stearate) toxicity.

DOSAGE AND ADMINISTRATION

Mykozem (Zinc Stearate) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Mykozem (Zinc Stearate) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Mykozem (Zinc Stearate).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Mykozem (Zinc Stearate) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004


© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Mykozem (Zinc Stearate)

1 mg/mL

Mykozem (Zinc Stearate) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

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Mykozem pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Mykozem available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Mykozem destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Mykozem Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Mykozem pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."HONGO CURA MS (UNDECYLENIC ACID) SPRAY [KRAMER LABORATORIES]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."UREA (UREA ) EMULSION [EXACT-RX, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."UREA: 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/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Mykozem?

Depending on the reaction of the Mykozem after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mykozem not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Mykozem addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Mykozem, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Mykozem consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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