Itrotab 200 – 4 tablet

Itraconazole Information

Pronunciation

(i tra KOE na zole)

What is this drug used for?

• It is used to treat fungal infections.

Frequently reported side effects of this drug

• Abdominal pain

• Nausea

• Vomiting

• Diarrhea

• Lack of appetite

• Loss of strength and energy

• Fatigue

• Runny nose

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, seizures, lack of appetite, or severe nausea or vomiting.

• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit.

• Heart problems like cough or shortness of breath that is new or worse, swelling of the ankles or legs, abnormal heartbeat, weight gain of more than five pounds in 24 hours, dizziness, or passing out.

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin.

• Burning or numbness feeling

• Difficulty urinating

• Chest pain

• Severe headache

• Severe dizziness

• Passing out

• Chills

• Vision changes

• Confusion

• Edema

• Loss of sex drive

• Sexual dysfunction

• Hearing loss

• Trouble hearing

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

 

Medication Safety Issues
Sound-alike/look-alike issues:

Itraconazole may be confused with fluconazole, posaconazole, voriconazole

Sporanox may be confused with Suprax, Topamax

 

Product Availability

Onmel has been discontinued in the US for more than 1 year.

 

Storage and Stability

Capsule: Store at room temperature of 15°C to 25°C (59°F to 77°F). Protect from light and moisture.

Oral solution: Store at ≤25°C (77°F); do not freeze.

Tablet: Store at room temperature 15°C to 25°C (59°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light and moisture.

 

Adverse Reactions

Cardiovascular: Chest pain, edema, hypertension

Central nervous system: Abnormal dreams, anxiety, depression, dizziness, fatigue, headache, malaise, pain

Dermatologic: Diaphoresis, pruritus, skin rash

Endocrine & metabolic: Hypertriglyceridemia, hypokalemia

Gastrointestinal: Abdominal pain, aphthous stomatitis, constipation, diarrhea, dyspepsia, flatulence, gastritis, gastroenteritis, gastrointestinal disease, gingivitis, increased appetite, nausea, vomiting

Genitourinary: Cystitis, urinary tract infection

Hepatic: Abnormal hepatic function tests, increased liver enzymes

Infection: Herpes zoster

Neuromuscular & skeletal: Bursitis, myalgia, tremor

Respiratory: Cough, dyspnea, pharyngitis, pneumonia, rhinitis, sinusitis, upper respiratory tract infection

Miscellaneous: Fever

Rare but imporant or life-threatening: Abnormal urinalysis, acute generalized exanthematous pustulosis, adrenocortical insufficiency, albuminuria, alopecia, anaphylactoid reaction, anaphylaxis, angioedema, anorexia, arthralgia, blurred vision, cardiac arrhythmia, cardiac failure, chills, confusion, decreased libido, dehydration, diplopia, drowsiness, dysgeusia, dysphagia, erectile dysfunction, erythema multiforme, erythematous rash, exfoliative dermatitis, facial edema, gynecomastia, hearing loss, hematuria, hepatic failure, hepatitis, hepatotoxicity, hot flash, hyperbilirubinemia, hyperglycemia, hyperhidrosis, hyperkalemia, hypersensitivity angiitis, hypersensitivity reaction, hypoesthesia, hypomagnesemia, hypotension, impotence, increased blood urea nitrogen, increased creatine phosphokinase, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, insomnia, jaundice, left heart failure, leukopenia, menstrual disease, mucosal inflammation, neutropenia, orthostatic hypotension, pancreatitis, paresthesia, peripheral edema, peripheral neuropathy, pharyngolaryngeal pain, pollakiuria, pulmonary edema, renal insufficiency, rigors, serum sickness, sinus bradycardia, skin photosensitivity, Stevens-Johnson syndrome, tachycardia, thrombocytopenia, tinnitus, toxic epidermal necrolysis, urinary incontinence, urticaria, vasculitis, vertigo, voice disorder