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Buy No Prescription Cheap Nizoral (Ketoconazole) 200mg

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Ketoconazole is authorised in the world under the following brand names: Extina, Fungarest, Fungoral, Ketoderm, Ketoisdin, Ketozole, Nizoral, Nizoral a-D, Nizoral a-D Shampoo, Nizoral Cream, Nizoral Shampoo, Orifungal, Orifungal M, Panfungol, Sebazole.

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Ketoconazole: Cautions

GI Effects

The most frequent adverse reactions to ketoconazole are nausea and/or vomiting which have been reported in 3-10% of patients receiving the drug. Abdominal pain, constipation, flatulence, GI bleeding, and diarrhea have also been reported in 1% or less of patients receiving the drug. Adverse GI effects appear to be dose related, are reported less frequently when ketoconazole is administered with food, and usually subside with continued therapy with the drug.

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Hepatic Effects

Transient increases in serum AST (SGOT), ALT (SGPT), and alkaline phosphatase concentrations have been reported during ketoconazole therapy. Hepatotoxicity, which may be hepatocellular (in most cases), cholestatic, or a mixed pattern of injury, has been reported rarely.

Although ketoconazole-induced hepatotoxicity usually is reversible following discontinuance of the drug, recovery may take several months and rarely death has occurred. Symptomatic hepatotoxicity usually is apparent within the first few months of ketoconazole therapy, but occasionally may be apparent within the first week of therapy.

Most cases of hepatotoxicity have been reported in patients receiving the drug for tinea unguium (onychomycosis), and many others were receiving the drug for chronic, refractory dermatophytoses. Several cases of ketoconazole-induced hepatitis have been reported in children.

Endocrine and Metabolic

Effects Bilateral gynecomastia with breast tenderness has occurred in some men during therapy with ketoconazole. In some patients, gynecomastia and breast pain abated after several weeks of continued therapy with ketoconazole. In other patients, gynecomastia persisted until the drug was discontinued.

Limited data suggest that gynecomastia occurs because ketoconazole decreases serum testosterone concentrations and to a lesser extent serum estradiol concentrations, resulting in an increased estradiol:testosterone ratio. Although it has been suggested that gynecomastia may be caused by a direct effect on breast tissue since serum hormone concentrations were normal in several patients, ketoconazole only transiently inhibits testosterone synthesis and testosterone concentrations may have returned to baseline values depending on when the serum samples were obtained.

Ketoconazole may inhibit cortisol synthesis, particularly in patients receiving relatively high daily dosages or divided daily dosing of the drug. The adrenocortical response to corticotropin (ACTH) may be at least transiently diminished and a reduction in urinary free and serum cortisol concentrations may occur during therapy with the drug; however, adrenocortical insufficiency has been reported only rarely. In clinical trials in Europe in patients receiving high-dose (i.e., 1.2 g daily) ketoconazole therapy for metastatic prostatic carcinoma, death occurred within 2 weeks after initiating therapy with the drug in 3% of patients.

Although these deaths could not be attributed definitely to the drug, in part because of the serious nature of the underlying disease, the possibility exists that ketoconazole-induced adrenocortical insufficiency may have been a contributing factor in some patients. When adrenocortical hypofunction does occur in patients receiving ketoconazole, the condition generally is reversible following discontinuance of the drug but rarely may be persistent.

Although the clinical importance is unclear, a transient decrease (of approximately 20% of pretreatment concentrations) in serum cholesterol concentrations and alterations in serum triglyceride concentrations (e.g., hypertriglyceridemia) have been reported in a few patients during ketoconazole therapy.

Dermatologic and Sensitivity Reactions

Pruritus has been reported in about 2% of patients receiving ketoconazole. Rash, dermatitis, purpura, and urticaria have been reported in less than 1% of patients receiving ketoconazole, and in some cases these effects may have been manifestations of a hypersensitivity reaction to the drug. Anaphylactic reactions occurring after the first dose of ketoconazole have been reported rarely.

Nervous System Effects

Headache, dizziness, somnolence, lethargy, asthenia, nervousness, insomnia, abnormal dreams, photophobia, and paresthesia have been reported in less than 1% of patients receiving ketoconazole. Neuropsychiatric disturbances, including suicidal tendencies and severe depression, have occurred rarely in patients receiving ketoconazole.

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Cardiovascular Effects

Hypertension has been reported in several patients receiving high-dose (e.g., 400 mg every 6-8 hours) ketoconazole therapy for metastatic prostatic carcinoma. Although not clearly established, it has been suggested that ketoconazole-induced increases in mineralocorticoid activity may have caused the increase in blood pressure observed in these patients.

Other Adverse Effects

Arthralgia, fever and chills, dyspnea, hemolytic anemia, tinnitus, impotence, changes in sweat patterns, thrombocytopenia, leukopenia, alopecia, and signs of increased intracranial pressure including bulging fontanelles and papilledema have also occurred in less than 1% of patients receiving ketoconazole. Fragility and fractures of long bones have occurred in female rats following daily oral administration of ketoconazole doses of 80 mg/kg or more for 3-6 months; these effects did not occur with daily doses of 20 mg/kg or less. Limited studies have not demonstrated these effects on the metacarpals or ribs of dogs, and these effects have not been reported in humans to date.

Precautions and Contraindications

Ketoconazole has been associated with hepatotoxicity, which rarely has resulted in death. Patients receiving the drug should be informed of the risk of hepatotoxicity and should be instructed to report any signs or symptoms of possible hepatic dysfunction (e.g., unusual fatigue, anorexia, nausea and/or vomiting, jaundice, dark urine, pale feces) to their physician. Patients receiving the drug should be closely monitored clinically and biochemically.

Liver function tests, including determinations of serum AST (SGOT), ALT (SGPT), alkaline phosphatase, Gamma-glutamyltransferase (b-glutamyltranspeptidase, GGT, GGTP), and bilirubin, should be performed prior to initiation of ketoconazole therapy and frequently (e.g., biweekly during the first 2 months of therapy and monthly or bimonthly thereafter) during therapy, particularly in patients receiving prolonged therapy or other potentially hepatotoxic drugs and in those with a history of hepatic disease. Minor, asymptomatic elevations in liver function test results may return to pretreatment concentrations during continued therapy with ketoconazole.

However, if liver function test results are substantially elevated or if such abnormalities persist, worsen, or are accompanied by other manifestations of hepatic dysfunction, ketoconazole therapy should be discontinued. The possibility that ketoconazole may depress adrenocortical function should be considered, particularly in patients receiving relatively high dosages of the drug. (See Cautions: Endocrine and Metabolic Effects.) Similarly, the possibility that the drug may reduce serum testosterone concentrations should be considered. To minimize the risk of these endocrine effects, the manufacturer states that the recommended dosage (i.e., 200-400 mg daily in adults) should be followed closely. Ketoconazole is contraindicated in patients with known hypersensitivity to the drug.

Pediatric Precautions

Ketoconazole has not been systematically studied in children of any age, and there is essentially no information to date on use of the drug in children younger than 2 years of age. Although ketoconazole has been used in a limited number of children older than 2 years of age, the drug should be used in pediatric patients only when the potential benefits justify the possible risks.

Mutagenicity and Carcinogenicity

In vitro studies using ketoconazole in a microbial system (i.e., Ames test) have not shown the drug to be mutagenic. In addition, there was no evidence of mutagenicity in any stage of germ cell development in a dominant lethal mutation test in mice who received single oral doses of ketoconazole as high as 80 mg/kg. There was no evidence of ketoconazole-induced carcinogenicity in a long-term feeding study in mice and rats.

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Pregnancy, Fertitlity and Lactation

Ketoconazole has caused webbing of the feet or the absence of toes in the fetus when given orally to pregnant rats in daily doses of 80 mg/kg (10 times the maximum recommended human oral dosage). The drug has also been embryotoxic in rats when given during the first trimester of pregnancy and has caused dystocia in rats when given during the third trimester of pregnancy.

Although these effects may be a reflection of the particular sensitivity of female rats to ketoconazole (maternal toxicity), there are no adequate and controlled studies to date using ketoconazole in pregnant women.

Ketoconazole should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Oligospermia and, rarely, azoospermia have been reported in adult males receiving ketoconazole dosages greater than 400 mg daily. Although oligospermia has not been reported to date in patients receiving lower dosages, sperm counts have been obtained infrequently in such patients. Because ketoconazole is probably distributed into human milk, lactating women receiving the drug should not breast-feed.

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Synonyms of Ketoconazole:

2%, Ketocanazole, Ketoconazol, Ketoconazol [INN-Spanish], Ketoconazole, Ketoconazole [Usan:Ban:Inn:Jan], Ketoconazolum [INN-Latin]

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