Itraconazole Capsules
Itraconazole Information
Product Code 10147-1700 Company Name Patriot Pharmaceuticals Dosage From CAPSULE Strength 100 mg Active Ingredient ITRACONAZOLE
Itraconazole (Itraconazole)
Itraconazole (Itraconazole) Description
Itraconazole (Itraconazole) is a synthetic triazole antifungal agent. Itraconazole (Itraconazole) is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature:
(±)-1-[(*)--butyl]-4-[-[4-[-[[(2*,4*)-2-(2,4-dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ-1,2,4-triazolin-5-one mixture with (±)-1-[(*)--butyl]-4-[-[4-[-[[(2*,4*)-2-(2,4-dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ-1,2,4-triazolin-5-one
or
(±)-1-[()--butyl]-4-[-[4-[-[[(2,4)-2-(2,4-dichlorophenyl)-2-(1-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-Δ-1,2,4-triazolin-5-one
Itraconazole (Itraconazole) has a molecular formula of CHClNO and a molecular weight of 705.64. It is a white to slightly yellowish powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pH 8.1.
Itraconazole (Itraconazole) Capsules contain 100 mg of Itraconazole (Itraconazole) coated on sugar spheres. Inactive ingredients are hard gelatin capsule, hypromellose, polyethylene glycol (PEG) 20,000, starch, sucrose, titanium dioxide, FD&C Blue No. 1, FD&C Blue No. 2, D&C Red No. 22 and D&C Red No. 28.
Itraconazole (Itraconazole) Clinical Pharmacology
NOTE: The plasma concentrations reported below were measured by high-performance liquid chromatography (HPLC) specific for Itraconazole (Itraconazole) . When Itraconazole (Itraconazole) in plasma is measured by a bioassay, values reported are approximately 3.3 times higher than those obtained by HPLC due to the presence of the bioactive metabolite, hydroxyItraconazole (Itraconazole) . (See.)
The pharmacokinetics of Itraconazole (Itraconazole) after intravenous administration and its absolute oral bioavailability from an oral solution were studied in a randomized crossover study in 6 healthy male volunteers. The observed absolute oral bioavailability of Itraconazole (Itraconazole) was 55%.
The oral bioavailability of Itraconazole (Itraconazole) is maximal when Itraconazole (Itraconazole) Capsules are taken with a full meal. The pharmacokinetics of Itraconazole (Itraconazole) were studied in 6 healthy male volunteers who received, in a crossover design, single 100-mg doses of Itraconazole (Itraconazole) as a polyethylene glycol capsule, with or without a full meal. The same 6 volunteers also received 50 mg or 200 mg with a full meal in a crossover design. In this study, only Itraconazole (Itraconazole) plasma concentrations were measured. The respective pharmacokinetic parameters for Itraconazole (Itraconazole) are presented in the table below:
Doubling the Itraconazole (Itraconazole) dose results in approximately a three-fold increase in the Itraconazole (Itraconazole) plasma concentrations.
Values given in the table below represent data from a crossover pharmacokinetics study in which 27 healthy male volunteers each took a single 200-mg dose of Itraconazole (Itraconazole) Capsules with or without a full meal:
Absorption of Itraconazole (Itraconazole) under fasted conditions in individuals with relative or absolute achlorhydria, such as patients with AIDS or volunteers taking gastric acid secretion suppressors (e.g., H receptor antagonists), was increased when Itraconazole (Itraconazole) Capsules were administered with a cola beverage. Eighteen men with AIDS received single 200-mg doses of Itraconazole (Itraconazole) Capsules under fasted conditions with 8 ounces of water or 8 ounces of a cola beverage in a crossover design. The absorption of Itraconazole (Itraconazole) was increased when Itraconazole (Itraconazole) Capsules were coadministered with a cola beverage, with AUC and C increasing 75% ± 121% and 95% ± 128%, respectively.
Thirty healthy men received single 200-mg doses of Itraconazole (Itraconazole) Capsules under fasted conditions either 1) with water; 2) with water, after ranitidine 150 mg b.i.d. for 3 days; or 3) with cola, after ranitidine 150 mg b.i.d. for 3 days. When Itraconazole (Itraconazole) Capsules were administered after ranitidine pretreatment, Itraconazole (Itraconazole) was absorbed to a lesser extent than when Itraconazole (Itraconazole) Capsules were administered alone, with decreases in AUC and C of 39% ± 37% and 42% ± 39%, respectively. When Itraconazole (Itraconazole) Capsules were administered with cola after ranitidine pretreatment, Itraconazole (Itraconazole) absorption was comparable to that observed when Itraconazole (Itraconazole) Capsules were administered alone. (See.)
Steady-state concentrations were reached within 15 days following oral doses of 50 mg to 400 mg daily. Values given in the table below are data at steady-state from a pharmacokinetics study in which 27 healthy male volunteers took 200-mg Itraconazole (Itraconazole) Capsules b.i.d. (with a full meal) for 15 days:
The plasma protein binding of Itraconazole (Itraconazole) is 99.8% and that of hydroxyItraconazole (Itraconazole) is 99.5%. Following intravenous administration, the volume of distribution of Itraconazole (Itraconazole) averaged 796 ± 185 liters.
Itraconazole (Itraconazole) is metabolized predominately by the cytochrome P450 3A4 isoenzyme system (CYP3A4), resulting in the formation of several metabolites, including hydroxyItraconazole (Itraconazole) , the major metabolite. Results of a pharmacokinetics study suggest that Itraconazole (Itraconazole) may undergo saturable metabolism with multiple dosing. Fecal excretion of the parent drug varies between 3–18% of the dose. Renal excretion of the parent drug is less than 0.03% of the dose. About 40% of the dose is excreted as inactive metabolites in the urine. No single excreted metabolite represents more than 5% of a dose. Itraconazole (Itraconazole) total plasma clearance averaged 381 ± 95 mL/minute following intravenous administration. (Seeandfor more information.)
Itraconazole (Itraconazole) Microbiology
In vitro
Itraconazole (Itraconazole) exhibitsactivity againstand. Itraconazole (Itraconazole) also exhibits varyingactivity againstspecies,, and otherspecies.
The bioactive metabolite, hydroxyItraconazole (Itraconazole) , has not been evaluated againstspp.,spp. andspp. Correlation between minimum inhibitory concentration (MIC) resultsand clinical outcome has yet to be established for azole antifungal agents.
Itraconazole (Itraconazole) administered orally was active in a variety of animal models of fungal infection using standard laboratory strains of fungi. Fungistatic activity has been demonstrated against disseminated fungal infections caused by, and
Itraconazole (Itraconazole) administered at 2.5 mg/kg and 5 mg/kg via the oral and parenteral routes increased survival rates and sterilized organ systems in normal and immunosuppressed guinea pigs with disseminatedinfections. Oral Itraconazole (Itraconazole) administered daily at 40 mg/kg and 80 mg/kg increased survival rates in normal rabbits with disseminated disease and in immunosuppressed rats with pulmonaryinfection, respectively. Itraconazole (Itraconazole) has demonstrated antifungal activity in a variety of animal models infected withand otherspecies.
Isolates from several fungal species with decreased susceptibility to Itraconazole (Itraconazole) have been isolatedand from patients receiving prolonged therapy.
Severalstudies have reported that some fungal clinical isolates, includingspecies, with reduced susceptibility to one azole antifungal agent may also be less susceptible to other azole derivatives. The finding of cross-resistance is dependent on a number of factors, including the species evaluated, its clinical history, the particular azole compounds compared, and the type of susceptibility test that is performed. The relevance of thesesusceptibility data to clinical outcome remains to be elucidated.
Itraconazole (Itraconazole) is not active against(e.g.,spp.,pp.,spp. andspp.),spp.,spp. andspp.
Studies (bothand) suggest that the activity of amphotericin B may be suppressed by prior azole antifungal therapy. As with other azoles, Itraconazole (Itraconazole) inhibits the C-demethylation step in the synthesis of ergosterol, a cell wall component of fungi. Ergosterol is the active site for amphotericin B. In one study the antifungal activity of amphotericin B againstinfections in mice was inhibited by ketoconazole therapy. The clinical significance of test results obtained in this study is unknown.
Itraconazole (Itraconazole) Indications And Usage
Itraconazole (Itraconazole) Capsules are indicated for the treatment of the following fungal infections in patients:
Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly.
Itraconazole (Itraconazole) Capsules are also indicated for the treatment of the following fungal infections in patients:
Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
(See,,, andfor more information.)
Itraconazole (Itraconazole) Contraindications
Concomitant administration of Itraconazole (Itraconazole) and certain drugs metabolized by the cytochrome P450 3A4 isoenzyme system (CYP3A4) may result in increased plasma concentrations of those drugs, leading to potentially serious and/or life-threatening adverse events. Cisapride, oral midazolam, nisoldipine, pimozide, quinidine, dofetilide, triazolam and levacetylmethadol (levomethadyl) are contraindicated with Itraconazole (Itraconazole) . HMG CoA-reductase inhibitors metabolized by CYP3A4, such as lovastatin and simvastatin, are also contraindicated with Itraconazole (Itraconazole) . Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) are contraindicated with Itraconazole (Itraconazole) . (See, and.)
Itraconazole (Itraconazole) should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy.
Itraconazole (Itraconazole) is contraindicated for patients who have shown hypersensitivity to Itraconazole (Itraconazole) or its excipients. There is no information regarding cross-hypersensitivity between Itraconazole (Itraconazole) and other azole antifungal agents. Caution should be used when prescribing Itraconazole (Itraconazole) to patients with hypersensitivity to other azoles.
Itraconazole (Itraconazole) Warnings
Itraconazole (Itraconazole) Capsules and SPORANOX (Itraconazole (Itraconazole) ) Oral Solution should not be used interchangeably. This is because drug exposure is greater with the Oral Solution than with the Capsules when the same dose of drug is given. In addition, the topical effects of mucosal exposure may be different between the two formulations. Only the Oral Solution has been demonstrated effective for oral and/or esophageal candidiasis.
Itraconazole (Itraconazole) has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition, and some of these cases developed within the first week of treatment. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. Continued Itraconazole (Itraconazole) use or reinstitution of treatment with Itraconazole (Itraconazole) is strongly discouraged unless there is a serious or life-threatening situation where the expected benefit exceeds the risk. (Seeand.)
Itraconazole (Itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF
For patients with risk factors for congestive heart failure, physicians should carefully review the risks and benefits of Itraconazole (Itraconazole) therapy. These risk factors include cardiac disease such as ischemic and valvular disease; significant pulmonary disease such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of CHF, should be treated with caution, and should be monitored for signs and symptoms of CHF during treatment. If signs or symptoms of CHF appear during administration of Itraconazole (Itraconazole) Capsules, discontinue administration.
Itraconazole (Itraconazole) has been shown to have a negative inotropic effect. When Itraconazole (Itraconazole) was administered intravenously to anesthetized dogs, a dose-related negative inotropic effect was documented. In a healthy volunteer study of SPORANOX (Itraconazole (Itraconazole) ) Injection (intravenous infusion), transient, asymptomatic decreases in left ventricular ejection fraction were observed using gated SPECT imaging; these resolved before the next infusion, 12 hours later.
Itraconazole (Itraconazole) has been associated with reports of congestive heart failure. In post-marketing experience, heart failure was more frequently reported in patients receiving a total daily dose of 400 mg although there were also cases reported among those receiving lower total daily doses.
Calcium channel blockers can have negative inotropic effects which may be additive to those of Itraconazole (Itraconazole) . In addition, Itraconazole (Itraconazole) can inhibit the metabolism of calcium channel blockers. Therefore, caution should be used when co-administering Itraconazole (Itraconazole) and calcium channel blockers due to an increased risk of CHF. Concomitant administration of Itraconazole (Itraconazole) and nisoldipine is contraindicated.
Cases of CHF, peripheral edema, and pulmonary edema have been reported in the post-marketing period among patients being treated for onychomycosis and/or systemic fungal infections. (See,,, andfor more information.)
Itraconazole (Itraconazole) Precautions
Itraconazole (Itraconazole) Capsules should be administered after a full meal. (See.)
Under fasted conditions, Itraconazole (Itraconazole) absorption was decreased in the presence of decreased gastric acidity. The absorption of Itraconazole (Itraconazole) may be decreased with the concomitant administration of antacids or gastric acid secretion suppressors. Studies conducted under fasted conditions demonstrated that administration with 8 ounces of a cola beverage resulted in increased absorption of Itraconazole (Itraconazole) in AIDS patients with relative or absolute achlorhydria. This increase relative to the effects of a full meal is unknown. (See.)
Itraconazole (Itraconazole) showed no evidence of carcinogenicity potential in mice treated orally for 23 months at dosage levels up to 80 mg/kg/day (approximately 10× the maximum recommended human dose [MRHD]). Male rats treated with 25 mg/kg/day (3.1× MRHD) had a slightly increased incidence of soft tissue sarcoma. These sarcomas may have been a consequence of hypercholesterolemia, which is a response of rats, but not dogs or humans, to chronic Itraconazole (Itraconazole) administration. Female rats treated with 50 mg/kg/day (6.25× MRHD) had an increased incidence of squamous cell carcinoma of the lung (2/50) as compared to the untreated group. Although the occurrence of squamous cell carcinoma in the lung is extremely uncommon in untreated rats, the increase in this study was not statistically significant.
Itraconazole (Itraconazole) produced no mutagenic effects when assayed in DNA repair test (unscheduled DNA synthesis) in primary rat hepatocytes, in Ames tests with(6 strains) and, in the mouse lymphoma gene mutation tests, in a sex-linked recessive lethal mutation () test, in chromosome aberration tests in human lymphocytes, in a cell transformation test with C3H/10T½ C18 mouse embryo fibroblasts cells, in a dominant lethal mutation test in male and female mice, and in micronucleus tests in mice and rats.
Itraconazole (Itraconazole) did not affect the fertility of male or female rats treated orally with dosage levels of up to 40 mg/kg/day (5× MRHD), even though parental toxicity was present at this dosage level. More severe signs of parental toxicity, including death, were present in the next higher dosage level, 160 mg/kg/day (20× MRHD).
The efficacy and safety of Itraconazole (Itraconazole) have not been established in pediatric patients. No pharmacokinetic data on Itraconazole (Itraconazole) Capsules are available in children. A small number of patients ages 3 to 16 years have been treated with 100 mg/day of Itraconazole (Itraconazole) Capsules for systemic fungal infections, and no serious unexpected adverse events have been reported. SPORANOX (Itraconazole (Itraconazole) ) Oral Solution (5 mg/kg/day) has been administered to pediatric patients (N=26; ages 6 months to 12 years) for 2 weeks and no serious unexpected adverse events were reported.
The long-term effects of Itraconazole (Itraconazole) on bone growth in children are unknown. In three toxicology studies using rats, Itraconazole (Itraconazole) induced bone defects at dosage levels as low as 20 mg/kg/day (2.5× MRHD). The induced defects included reduced bone plate activity, thinning of the zona compacta of the large bones, and increased bone fragility. At a dosage level of 80 mg/kg/day (10× MRHD) over 1 year or 160 mg/kg/day (20× MRHD) for 6 months, Itraconazole (Itraconazole) induced small tooth pulp with hypocellular appearance in some rats. No such bone toxicity has been reported in adult patients.
Itraconazole (Itraconazole) Adverse Reactions
Itraconazole (Itraconazole) has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of Itraconazole (Itraconazole) use should be reassessed. (Seeandand.)
Adverse event data were derived from 602 patients treated for systemic fungal disease in U.S. clinical trials who were immunocompromised or receiving multiple concomitant medications. Treatment was discontinued in 10.5% of patients due to adverse events. The median duration before discontinuation of therapy was 81 days (range: 2 to 776 days). The table lists adverse events reported by at least 1% of patients.
Adverse events infrequently reported in all studies included constipation, gastritis, depression, insomnia, tinnitus, menstrual disorder, adrenal insufficiency, gynecomastia, and male breast pain.
Patients in these trials were on a continuous dosing regimen of 200 mg once daily for 12 consecutive weeks.
The following adverse events led to temporary or permanent discontinuation of therapy.
The following adverse events occurred with an incidence of greater than or equal to 1% (N=112): headache: 10%; rhinitis: 9%; upper respiratory tract infection: 8%; sinusitis, injury: 7%; diarrhea, dyspepsia, flatulence, abdominal pain, dizziness, rash: 4%; cystitis, urinary tract infection, liver function abnormality, myalgia, nausea: 3%; appetite increased, constipation, gastritis, gastroenteritis, pharyngitis, asthenia, fever, pain, tremor, herpes zoster, abnormal dreaming: 2%.
Patients in these trials were on a pulse regimen consisting of two 1-week treatment periods of 200 mg twice daily, separated by a 3-week period without drug.
The following adverse events led to temporary or permanent discontinuation of therapy.
The following adverse events occurred with an incidence of greater than or equal to 1% (N=37): headache: 8%; pruritus, nausea, rhinitis: 5%; rash, bursitis, anxiety, depression, constipation, abdominal pain, dyspepsia, ulcerative stomatitis, gingivitis, hypertriglyceridemia, sinusitis, fatigue, malaise, pain, injury: 3%.
Adverse drug reactions that have been identified during post-approval use of Itraconazole (Itraconazole) (all formulations) are listed in the table below. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
There is limited information on the use of Itraconazole (Itraconazole) during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with Itraconazole (Itraconazole) has not been established. (See,,, andfor more information.)
Itraconazole (Itraconazole) Overdosage
Itraconazole (Itraconazole) is not removed by dialysis. In the event of accidental overdosage, supportive measures, including gastric lavage with sodium bicarbonate, should be employed.
Limited data exist on the outcomes of patients ingesting high doses of Itraconazole (Itraconazole) . In patients taking either 1000 mg of SPORANOX (Itraconazole (Itraconazole) ) Oral Solution or up to 3000 mg of Itraconazole (Itraconazole) Capsules, the adverse event profile was similar to that observed at recommended doses.
Itraconazole (Itraconazole) Dosage And Administration
Itraconazole (Itraconazole) Capsules should be taken with a full meal to ensure maximal absorption.
Itraconazole (Itraconazole) Capsules are a different preparation than SPORANOX (Itraconazole (Itraconazole) ) Oral Solution and should not be used interchangeably.
Itraconazole (Itraconazole) How Supplied
Itraconazole (Itraconazole) Capsules are available containing 100 mg of Itraconazole (Itraconazole) , with a blue opaque cap and pink transparent body, imprinted with "PP 100." The capsules are supplied in bottles of 30 capsules (NDC 10147-1700-3) and in thecontaining 7 blister packs × 4 capsules each (NDC 10147-1700-7).
Itraconazole (Itraconazole)
Itraconazole (Itraconazole) Patient Information
Itraconazole (Itraconazole) is used to treat fungal nail infections. However, Itraconazole (Itraconazole) is not for everyone.(See "?" below.)
If you have had heart, lung, liver, kidney or other serious health problems, ask your doctor if it is safe for you to take Itraconazole (Itraconazole) .
Anyone can have a fungal nail infection, but it is usually found in adults. When a fungus infects the tip or sides of a nail, the infected part of the nail may turn yellow or brown. If not treated, the fungus may spread under the nail towards the cuticle. If the fungus spreads, more of the nail may change color, may become thick or brittle, and the tip of the nail may become raised. In some patients, this can cause pain and discomfort.
Itraconazole (Itraconazole) is a prescription medicine used to treat fungal infections of the toenails and fingernails. It is also used to treat some types of fungal infections in other areas of your body. We do not know if Itraconazole (Itraconazole) works in children with fungal nail infections or if it is safe for children to take.
Itraconazole (Itraconazole) comes in the form of capsules and liquid (oral solution). The capsule and liquid forms work differently, so you should not use one in place of the other. This Patient Information discusses only the capsule form of Itraconazole (Itraconazole) . You will get these capsules in a medicine bottle or an Itraconazole (Itraconazole) . Thecontains 28 capsules for treatment of your fungal nail infection.
Itraconazole (Itraconazole) goes into your bloodstream and travels to the source of the infection underneath the nail so that it can fight the infection there. Improved nails may not be obvious for several months after the treatment period is finished because it usually takes about 6 months to grow a new fingernail and 12 months to grow a new toenail.
Itraconazole (Itraconazole) is not for everyone. Your doctor will decide if Itraconazole (Itraconazole) is the right treatment for you.
Tell your doctor and pharmacist the name of all the prescription and non-prescription medicines you are taking, including dietary supplements and herbal remedies. Also tell your doctor about any other medical conditions you have had, especially heart, lung, liver or kidney conditions.
Taking Itraconazole (Itraconazole) with certain other medicines could lead to serious or life-threatening medical problems. For example, taking fentanyl, a strong opioid narcotic pain medicine, with Itraconazole (Itraconazole) could cause serious side effects, including trouble breathing, that may be life-threatening. Tell your doctor and pharmacist the name of all the prescription and non-prescription medicines you are taking. Your doctor will decide if Itraconazole (Itraconazole) is the right treatment for you.
Never take Itraconazole (Itraconazole) if you have a fungal nail infection and are pregnant or planning to become pregnant within 2 months after you have finished your treatment.
If you are able to become pregnant, you should use effective birth control during Itraconazole (Itraconazole) treatment and for 2 months after finishing treatment. Ask your doctor about effective types of birth control.
If you are breast-feeding, talk with your doctor about whether you should take Itraconazole (Itraconazole) .
Always take Itraconazole (Itraconazole) Capsules during or right after a full meal.
Your doctor will decide the right dose for you. Depending on your infection, you will take Itraconazole (Itraconazole) once a day for 12 weeks, or twice a day for 1 week in a "pulse" dosing schedule. You will receive either a bottle of capsules or a. Do not skip any doses. Be sure to finish all your Itraconazole (Itraconazole) as prescribed by your doctor.
If you have ever had liver problems, your doctor should do a blood test to check your condition. If you haven't had liver problems, your doctor may recommend blood tests to check the condition of your liver because patients taking Itraconazole (Itraconazole) can develop liver problems.
If you forget to take or miss doses of Itraconazole (Itraconazole) , ask your doctor what you should do with the missed doses.
If you use the, you will take Itraconazole (Itraconazole) for 1 week and then take no Itraconazole (Itraconazole) for the next 3 weeks before repeating the 1-week treatment. This is called "pulse dosing." The Itraconazole (Itraconazole) contains enough medicine for one "pulse" (1 week of treatment).
The Itraconazole (Itraconazole) comes with special instructions. It contains 7 pouches-one for each day of treatment. Inside each pouch is a card containing 4 capsules. Looking at the back of the card, fold it back along the dashed line and peel away the backing so that you can remove 2 capsules.
The most common side effects that cause people to stop treatment either for a short time or completely include: skin rash, high triglyceride test results, high liver test results, and digestive system problems (such as nausea, bloating, and diarrhea).
Additional possible side effects include upset stomach, vomiting, abdominal pain, constipation, headache, fever, inflammation of the pancreas, menstrual disorders, erectile dysfunction, dizziness, muscle weakness or pain, painful joints, unpleasant taste, or hair loss. These are not all the side effects of Itraconazole (Itraconazole) . Your doctor or pharmacist can give you a more complete list.
If you think you took too much Itraconazole (Itraconazole) , call your doctor or local poison control center, or go to the nearest hospital emergency room right away.
Keep all medicines, including Itraconazole (Itraconazole) , out of the reach of children.
Store Itraconazole (Itraconazole) Capsules and theat room temperature in a dry place away from light.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Itraconazole (Itraconazole) for a condition for which it was not prescribed. Do not give Itraconazole (Itraconazole) to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Itraconazole (Itraconazole) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Itraconazole (Itraconazole) that is written for health professionals or you can call 1-800-667-8570.
This patient information has been approved by the U.S. Food and Drug Administration.
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Printed in USA
Revised June 2011
Manufactured by:JOLLC, Gurabo, Puerto Rico 00778
Manufactured for:Patriot Pharmaceuticals, LLCHorsham, PA 19044
Itraconazole (Itraconazole) Principal Display Panel - Mg Carton
Store at controlled room temperature15°-25°C (59°-77°F).
Protect from light and moisture.
Keep out of reach of children.
Rx only
Capsule contents manufactured by:Janssen Pharmaceutica N.V.Olen Belgium
Manufactured by:JOLLCGurabo, Puerto Rico 00778
Manufactured for:Patriot Pharmaceuticals, LLCHorsham, PA 19044
