Onmel Oral Tablet 200Mg Drug Medication Dosage Information
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ONMEL: Oral tablet (200mg)

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What is this Medicine?

ITRACONAZOLE (i tra KO na zole) is an antifungal medicine. It is used to treat certain kinds of fungal or yeast infections.

In-Depth Information

ONMEL 200mg Tablet

NDC: 002591420
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Aspergillosis Prophylaxis, Onychomycosis, Mucocutaneous Candidiasis

Sometimes used for but not FDA approved for the following conditions:
Meningitis, Sporotrichosis, Microsporidiosis, Candidiasis, Cryptococcosis Prophylaxis, Cryptococcosis, Candidiasis Prophylaxis, Tinea Capitis, Tinea Pedis, Penicilliosis Prophylaxis, Vulvovaginal Candidiasis Prophylaxis, Coccidioidomycosis, Histoplasmosis Prophylaxis, Penicilliosis, Tinea Corporis, Vulvovaginal Candidiasis, Coccidioidomycosis Prophylaxis

Storage Information
Protect from light
Store between 59 to 77 degrees F, excursions permitted to 59 to 86 degrees F
Protect from moisture
ONMEL 200mg Tablet

Reported Side Effects for ONMEL 200mg Tablet

Infection Incidence:
<8.0%*
Severity: MILD
Onset: DELAYED
Blood In The Urine Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Difficulty Swallowing Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Ringing In Ears Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Mouth Ulcers Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Itching Incidence:
<5.0%*
Severity: MILD
Onset: RAPID
Sore Throat Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Muscle Pain Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Metallic Taste Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Gynecomastia Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Weakness Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Deafness Incidence:
<3.3%*
Severity: SEVERE
Onset: DELAYED
Long Qt Syndrome Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Irregular Periods Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Rhinitis Incidence:
<9.0%*
Severity: MILD
Onset: EARLY
Gas Incidence:
<4.0%*
Severity: MILD
Onset: EARLY
Swelling Incidence:
<4.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
<4.0%*
Severity: MILD
Onset: EARLY
Visual Impairment Incidence:
<2.0%*
Severity: SEVERE
Onset: EARLY
Dehydration Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Weight Loss Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Low Steroid Hormones Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Inability To Sleep Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Low Potassium Levels Incidence:
<8.0%*
Severity: MODERATE
Onset: DELAYED
Hemorrhoids Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Hot Flashes Incidence:
<2.0%*
Severity: MODERATE
Onset: EARLY
Decreased Sexual Desire Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Drowsiness Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Depression Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Impotence (erectile Dysfunction) Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
Tired Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Balance Problems Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Slow Heart Beat Incidence:
1.0%*
Severity: SEVERE
Onset: RAPID
Postural Low Blood Pressure Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
Decreased Appetite Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Low Blood Pressure Incidence:
1.0%*
Severity: MODERATE
Onset: RAPID
Cough Incidence:
1.2-4.0%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
1.2-4.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
1.7-11.0%*
Severity: MILD
Onset: EARLY
Stomach Pain Incidence:
1.7-6.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
1.7-11.0%*
Severity: MILD
Onset: EARLY
Causing To Be Hungry Incidence:
2.0%*
Severity: MILD
Onset: DELAYED
Constipation Incidence:
2.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Shaking Incidence:
2.0%*
Severity: MILD
Onset: EARLY
Sinus Infection Incidence:
2.0-7.0%*
Severity: MILD
Onset: DELAYED
Nightmares Incidence:
2.0%*
Severity: MILD
Onset: EARLY
High Blood Pressure Incidence:
2.0-3.0%*
Severity: MODERATE
Onset: EARLY
Shortness Of Breath Incidence:
2.0-3.0%*
Severity: MODERATE
Onset: EARLY
Fever Incidence:
2.0-7.0%*
Severity: MILD
Onset: EARLY
Inflamed Stomach Incidence:
2.0%*
Severity: MODERATE
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
2.9-4.0%*
Severity: MODERATE
Onset: DELAYED
Nervousness Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Bladder Infection Incidence:
3.0%*
Severity: MODERATE
Onset: DELAYED
Gum Inflammation Incidence:
3.0%*
Severity: MILD
Onset: DELAYED
Skin Rash Incidence:
3.0-9.0%*
Severity: MILD
Onset: EARLY
Excessive Sweating Incidence:
3.0-4.0%*
Severity: MILD
Onset: DELAYED
High Triglycerides Incidence:
3.0%*
Severity: MODERATE
Onset: DELAYED
Chest Pain Incidence:
3.0%*
Severity: MODERATE
Onset: EARLY
Vomiting Incidence:
5.0-7.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for ONMEL 200mg Tablet

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Moderate Lifestyle Interaction
Food and ONMEL 200mg Tablet(Itraconazole)
Food and Itraconazole(Itraconazole)
Itraconazole oral solution should be taken without food, while Itraconazole capsules should be taken with a full meal.
Moderate Lifestyle Interaction
Marijuana and ONMEL 200mg Tablet(Itraconazole)
Marijuana and Itraconazole(Itraconazole)
Itraconazole can theoretically decrease the elimination of Marijuana, Medical from the body. Side effects from Marijuana, Medical may worsen if you take Itraconazole. You may feel drowsy or more tired. Do not drive or operate machinery until you know how these drugs affect you. Contact your health care provider immediately if you notice slurred speech, confusion, increases heart rate, or palpitations while taking Marijuana, Medical.
Minor Lifestyle Interaction
Grapefruit juice and ONMEL 200mg Tablet(Itraconazole)
Grapefruit juice and Itraconazole(Itraconazole)
It is best not to change your usual intake of grapefruit juice while taking Itraconazole. Grapefruit juice may decrease the actions of Itraconazole.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


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