Nizoral is a weak double base substance that dissolves and is absorbed in the acidic Wednesday. The maximum concentration ketokonazola plasma approximately 3.5 µg/ml achieved through 1-2 hours after single oral administration of 200 mg of the drug at the time of delivery.
Oral drug bioavailability is maximal when the pill at the time of delivery. The absorption of Nizoral is lower in patients with decreased stomach acidity, for example of persons who take medicines known as antacids (for example, aluminum hydrochloride) and drugs that suppress the formation of gastric juice (e.g., H2 blockers gistaminovykh receptors, Proton pump inhibitors) or in individuals with ahlorgidriej associated with certain diseases (see section Special instructions
“and the section” Medicinal vzaimodejsviâ The absorption of Nizoral in applying it on an empty stomach increases for these individuals admission ketokonazola with acidic beverages (such as nedietičeskaâ Cola). If the drug administration preceded the application of omeprazole, a Proton pump inhibitor, the bioavailability of Nizoral in his prandial at a dose of 200 mg decreased to 17% of bioavailability when applying one Nizoral. If the drug administration preceded the application of omeprazole, but preparation took with nedietičeskoj Cola, bioavailability was 65% of bioavailability when applying one Nizoral.
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In vitro binding to plasma proteins, primarily with the al′buminovoj faction is 99%. Nizoral is widely distributed in the body, but only a small part of the preparation penetrates into spinnomozgovu liquid.
After absorption from the gastrointestinal tract, Nizoral is metabolized in the liver with the formation of a large number of active metabolites. In vitro studies demonstrated that CYP3A4 is the principal enzyme involved in the metabolism of Nizoral. The main routes of metabolism are oxidation and cleavage of imidazol′nogo and piperazinovogo rings, oxidative o-dealkilirovanie and aromatic hydroxylation. Nizoral is not an inducer own metabolism.
Withdrawal of blood plasma is two-phase: during the first half-life of 10:00, and later 2:00-8:00.
About 13% dose presented with urine, of which 2 to 4% of unchanged drug substance. The drug is excreted mainly jelchew in the gastrointestinal tract, with about 57% of the drug excreted in the faeces.
Special patient groups
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Patients with hepatic or renal failure Pharmacokinetics
Nizoral in patients with hepatic or renal failure does not differ materially from pharmacokinetics in healthy individuals.
Kids Nizoral is a synthetic imidazole dioxolane derivative having fungicidal or mikostatičeskim action against dermophytes yeast (Candida, Torulopsis, Malassezia, Cryptococcus) dimorfnah mushrooms and higher fungi (èumicetov). Less sensitive to the effects of Nizoral: Aspergillus spp., Sporothrix schenckii, some Dermatiaceae, Mucor spp. and other fikomicety, except the Entomophthorales. Nizoral inhibits biosynthesis ergosterola in fungi and alters the composition of the other lipid components in membranes. Clinical research and the study of drug interactions showed that when taking the drug at a dose of 200 mg 2 times daily for 3-7 days there may be a slight increase in the QT interval: average maximum increase QT interval to 6-12 msec was observed after 1-4 hours after taking the drug Nizoral, when concentration ketokonazola plasma reached maximum values. However, this increase in the QT interval is considered not clinically meaningful.
When the therapeutic dose of 200 mg once a day may be a transient reduction of testosterone concentration in blood plasma. The concentration of testosterone returned to the original level within 12:00 am after taking Nizoral. During long-term therapy using this dosage, the concentration of testosterone usually differs slightly from the control.
Nizoral in a daily dose of 400 mg and above caused a reduction of “kortizolovogo” response to ACTH stimulation for volunteers. Indications for use
Infections of the skin, scalp and mucous membranes caused by dermatofitami and/or yeast in cases where topical treatment is not applicable due to the large size of the affected areas, considerable depth of defeat, as well as in the absence of the effect of previously conducted local treatment: dermatofitia Pityriasis Versicolor Folliculitis caused by fungi of the genus Malassezia chronic candidiasis mucous membranes and skin tumours
candidiasis of the mouth and pharynx and esophageal candidiasis chronic recurrent vaginal candidiasis
Systemic fungal infection parakokcidioidoz histoplasmosis kokcidioidoz Blastomycosis
Because of the risk of Hepatotoxicity, Nizoral pills should only be used in cases where the potential benefits outweigh the potential harm, taking into account the availability of local medicinal Nizoral and other drugs. Dosage and administration
Product Nizoral is inside, at the time of delivery for better absorption.
Infections of the skin, scalp and mucous membranes caused by dermatofitami and/or yeast and systemic infections:
-One tablet (200 mg) once a day at meal times. When receiving specified doses of improvement does not occur, the dose should be increased twice (400 mg once a day).
-Vaginal candidiasis: two tablets (400 mg) once a day at meal times.
Children over 3 years:
-weighing from 15 to 30 kg: Paul-pills (100 mg) once a day, at meal times;
-weighing more than 30 kg: dosage specified for adults.
Average duration of treatment:
-vaginal candidiasis-5 days
skin mikozy caused by dermatophytes is approximately 4 weeks
-Pityriasis Versicolor-10 days
-skin and oral candidiasis caused by Candida is 2-3 weeks
-fungal scalp-1-2 months
-parakokcidiodomikoz, gistoplazmoz, kokcidiodomikoz-duration of treatment is 6 months Below are listed the side effects observed with frequency 1.0% in patients with superficial and deep Mycosis taking Nizoral:
nausea, stomach pain, diarrhea, liver
Side effects observed with a frequency of 1.0% in patients with surface and deep Mycosis taking Nizoral:
-pain in the upper abdomen, vomiting, dyspepsia, constipation, dry mouth, dysgeusia, bloating, discoloration of the tongue, hepatitis, jaundice
-dizziness, paresthesia, somnolence, anxiety, insomnia, anxiety, fatigue, weakness
-alcohol intolerance, Hyperlipidemia, anorexia, increased appetite,
-the menstrual cycle
-alopecia, Dermatitis, Erythema, mul′tifornaâ Erythema, itching, rash, allergic skin rashes, Xeroderma Pigmentosum, “tides” of blood
-decrease in the number of platelets
-fever, peripheral edema, fever