Itraconazole 100/200mg Capsules, 200/400mg Sustained Release Tablets
IndicationsItraconazole Capsule/Tablet is indicated for the treatment of following conditions:
- Dermatological/Ophthalmological Indications:
- Pityriasis Versicolor
- Oral Candidiasis
- Fungal Keratitis
- Onychomycosis, caused by Dermatophytes and/or Yeasts.
- Gynecological Indications:
- Vulvovaginal candidiasis
- Systemic Mycoses:
- Systemic Aspergillosis and Candidiasis
- Cryptococcosis (including Cryptococcal Meningitis)
- Paracoccidioidomycosis and
- Other rarely occurring systemic or topical mycoses
- Itraconazole capsules/tablets are contraindicated in patients with known hypersensitivity to Itraconazole or to any of the excipients.
- Co-administration of following drugs is contraindicated with Itraconazole Tablets:
- Astemizole, Bepridil, Cisapride, Dofetilide, Levacetylmethadol (Levomethadyl), Mizolastine, Pimozide, Quinidine, Sertindole and Terfenadine are contraindicated with Itraconazole since co-administration may result in increased plasma concentration of these substances, which can lead to QT prolongation and rare occurrences of torsade de pointes.
- CYP3A4 metabolized HMG-CoA reductase inhibitors such as Lovastatin and Simvastatin
- Triazolam and Oral Midazolam
- Ergot Alkaloids such as Dihydroergotamine, Ergometrine (Ergonovine), Ergotamine and Methylergometrine (Methylergonovine)
- Itraconazole Capsules/Tablets should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life threatening or other serious infections.
- Itraconazole Capsules/Tablets must not be used during pregnancy (except for life threatening cases).
- The incidence and type of adverse reaction vary depending on usage and route of administration:
- Cardiovascular: Hypertension (3%), Orthostatic Hypotension, Vasculitis (1%), CHF (Post marketing).
- CNS: Headache (10% ), Anxiety, Depression, Fatigue, Malaise (3%), Abnormal Dreaming, Asthenia, Hypesthesia, Paresthesia, Peripheral Neuropathy (Post marketing)
- Dermatologic: Rash (9%), Pruritus (5%), Increased Sweating (4%), Skin Disorder (2%), Alopecia, Erythema Multiforme, Exfoliative Dermatitis, Leukocytoclastic Vasculitis, Photosensitivity, Stevens-Johnson Syndrome, Urticaria (Post marketing).
- ENT: Gingivitis (3%), Pharyngitis (2%), Dysphagia, Tinnitus, Vision Abnormal (Less than 2%), Transient or Permanent Hearing Loss, Visual Disturbances including Blurred Vision and Diplopia (Post marketing).
- GI: Diarrhoea, Nausea (11%), Vomiting (7%), Abdominal Pain (6%), GI Disorders (4%), Constipation, Ulcerative Stomatitis (3%), Dyspepsia, Flatulence, Hemorrhoids, Taste Perversion (less than 2%), Anorexia (1%), Dysgeusia, Pancreatitis (Post marketing).
- Genitourinary: Gynecomastia, Hematuria, Male Breast Pain (less than 2%), Albuminuria, Impotence (1%), Erectile Dysfunction, Menstrual Disorder, Pollakiuria, Urinary Incontinence (Post marketing).
- Hematologic-Lymphatic: Leukopenia, Neutropenia, Thrombocytopenia (Post marketing).
- Hepatic: Elevated Liver Enzymes (4%), Abnormal Hepatic Function (3%), Hepatotoxicity; Liver Failure, Hepatitis, Reversible Increases in Hepatic Enzymes, Serious Hepatotoxicity (including Acute Liver Failure) (Post marketing).
- Hypersensitivity: Anaphylactic/allergic Reactions, Anaphylaxis, Angioneurotic Edema(Post marketing).
- Metabolic-Nutritional: Edema (4%), Hypertriglyceridemia (3%); Hypokalemia (2%), Adrenal Insufficiency, Dehydration, Weight Decrease (less than 2%), Pulmonary Edema (Post marketing).
- Musculoskeletal: Bursitis (3%), Back Pain, Myalgia, Rigors (less than 2%), Arthralgia (Post marketing).
- Respiratory: Coughing (4%), Dyspenia, Increased Sputum (3%), Pneumonia, Sinusitis (2%), Upper Respiratory Tract infection (less than 2%).
Itrabond 100 mg Capsules are available as hard gelatin capsules containing itraconazole pellets in 1x7's capsule pack.
Itrabond 200 mg Capsules are available as hard gelatin capsules containing itraconazole pellets in 1x7's capsule pack.
Itrabond 200 mg SR is available as Sustained Release Tablets in 1 x 4 tablet pack.
Itrabond 400 mg SR is available as Sustained Release Tablets in 1 x 4 tablet pack.