Нептазан инструкция по применению цена

Generic name: methazolamide [ meth-a-ZOLE-a-mide ]
Drug class: Carbonic anhydrase inhibitors

What is Neptazane?

Neptazane reduces the activity of a protein in your body called carbonic anhydrase. Blocking this protein can help reduce the amount of fluid in the eye, which decreases pressure inside the eye.

Neptazane is used to lower pressure inside the eye (intraocular pressure) in people with certain types of glaucoma.

Neptazane is also used as a diuretic («water pill») in people with congestive heart failure, to reduce the build-up of fluid in the body. This build-up is called edema.

Neptazane is also used to treat certain types of seizures, and to treat or prevent altitude sickness.

Neptazane may also be used for purposes not listed in this medication guide.

Neptazane side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Neptazane may cause serious side effects. Call your doctor at once if you have:

• blood in urine or stools;

• a seizure (convulsions);

• loss of movement in any part of your body;

• a blood cell disorder—sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, pale skin, feeling tired or short of breath, rapid heart rate, nosebleeds, bleeding gums;

• liver problems—nausea, upper stomach pain or swelling, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of metabolic acidosis—confusion, vomiting, lack of energy, irregular heartbeats;

• signs of a kidney stone—pain in your side or lower back, blood in your urine, painful or difficult urination; or

• severe skin reaction—fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of Neptazane may include:

• nausea, vomiting, loss of appetite, diarrhea;

• numbness or tingling, especially in your arms and legs;

• drowsiness, confusion;

• hearing problems, ringing in your ears;

• increased urination; or

• altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

You should not use Neptazane if you have cirrhosis, severe liver or kidney disease, an electrolyte imbalance, adrenal gland failure, or an allergy to Neptazane or sulfa drugs.

Before taking this medicine

You should not use Neptazane if you are allergic to it, or if you have:

• severe liver disease, or cirrhosis;

• severe kidney disease;

• an electrolyte imbalance (such as acidosis or low levels of potassium or sodium in your blood);

• adrenal gland failure; or

• an allergy to sulfa drugs.

To make sure Neptazane is safe for you, tell your doctor if you have:

• severe breathing problems;

• angle closure glaucoma; or

• if you also take aspirin in high doses.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether methazolamide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Neptazane is not approved for use by anyone younger than 18 years old.

How should I take Neptazane?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use Neptazane in larger or smaller amounts or for longer than recommended.

While using Neptazane, you may need frequent blood tests.

Neptazane may be only part of a complete treatment program that may also include other medications. Follow your doctor’s instructions very closely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Neptazane?

Neptazane may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Neptazane can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect Neptazane?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• steroid medicine (prednisone, dexamethasone, and others).

This list is not complete. Other drugs may interact with methazolamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 7.01.

Тазан — инструкция по применению

Синонимы, аналоги

Статьи

Регистрационный номер

ЛП-003620

Торговое наименование препарата

Тазан®

Международное непатентованное наименование

Глюкозамин + Хондроитина сульфат

Лекарственная форма

Таблетки, покрытые пленочной оболочкой

Состав

На 1 таблетку:

Описание

Двояковыпуклые таблетки овальной формы, покрытые плёночной оболочкой от белого до почти белого цвета. Допускается шероховатость поверхности таблеток.

Фармакотерапевтическая группа

репарации тканей стимулятор

Код АТХ

M01AX

Фармакодинамика:

Стимулирует регенерацию хрящевой ткани. Глюкозамин и хондроитин сульфат принимают участие в синтезе соединительной ткани, способствуя предотвращению процессов разрушения хряща и стимулируя регенерацию ткани. Введение экзогенного глюкозамина усиливает выработку хрящевого матрикса и обеспечивает неспецифическую защиту от химического повреждения хряща.

Глюкозамин в виде сульфатной соли является предшественником гексозамина, а сульфат-анион необходим для синтеза гликозаминогликанов. Другой возможной функцией глюкозамина является защита поврежденного хряща от метаболического разрушения, вызываемого нестероидными противовоспалительными препаратами и глюкокортикостероидными, а также собственное умеренное противовоспалительное действие.

Хондроитин сульфат независимо от того, всасывается ли он в интактной форме или же в виде отдельных компонентов, служит дополнительным субстратом для образования здорового хрящевого матрикса. Стимулирует образование гиалуронона, синтез протеогликанов и коллагена типа II, а также защищает гиалуронон от ферментативного расщепления (путем подавления активности гиалуронидазы) и от повреждающего действия свободных радикалов; поддерживает вязкость синовиальной жидкости, стимулирует механизмы репарации хряща. При лечении остеоартроза облегчает симптомы заболевания и уменьшает потребность в нестероидных противовоспалительных препаратах.

Фармакокинетика:

Глюкозамин: биодоступность при пероральном приеме — 25% (эффект «первого прохождения» через печень). Распределяется в тканях: наибольшие концентрации обнаруживаются в печени, почках и суставном хряще. Около 30 % принятой дозы длительно персистирует в костной и мышечной ткани. Выводится преимущественно почками в неизмененном виде; частично — кишечником. Период полувыведения — 68 ч.

Хондроитин сульфат: при приеме внутрь однократно в дозе 0,8 г (или 2 раза в сутки в дозе 0,4 г) концентрация в плазме возрастает на протяжении 24 ч. Абсолютная биодоступность — 12%. Около 10 и 20% принятой дозы абсорбируется в виде высокомолекулярных и низкомолекулярных производных соответственно. Кажущийся объем распределения — около 0,44 мл/г. Метаболизируется посредством десульфирования. Выводится почками. Период полувыведения — 310 мин.

Показания:

Остеоартроз I-III ст.

Противопоказания:

Гиперчувствительность к компонентам препарата, детский возраст до 15 лет, выраженное нарушение функции почек, беременность и период грудного вскармливания.

С осторожностью:

Кровотечения, склонность к кровоточивости, сахарный диабет, бронхиальная астма.

Беременность и лактация:

При беременности и в период грудного вскармливания (лактации) препарат противопоказан.

Способ применения и дозы:

Внутрь.

Взрослым и детям старше 15 лет: по 2 таблетки 2 раза в день в течение трёх первых недель; по 2 таблетки 1 раз в день в течение последующих недель и месяцев.

Устойчивый лечебный эффект достигается при приёме препарата не менее 6 месяцев.

Побочные эффекты:

Классификация предполагаемой частоты побочных явлений: часто — 1/100 назначений (1-10%), очень редко — менее 1/10000 назначений (менее 0,01%, включая отдельные случаи).

Часто — нарушение функции желудочно-кишечного тракта (боли в эпигастрии, метеоризм, диарея или запор), головокружение, кожные аллергические реакции, головная боль, боль в ногах и периферические отеки, сонливость, бессонница, тахикардия.

Очень редко — аллергические реакции.

Передозировка:

Симптомы: случаи передозировки неизвестны.

Лечение: промывание желудка, симптоматическая терапия.

Взаимодействие:

Повышает абсорбцию тетрациклинов, уменьшает действие полусинтетических пенициллинов и глюкозамина.

Препарат совместим с нестероидными противовоспалительными препаратами и глюкокортикостероидными.

Возможно усиление действия антикоагулянтов, антиагрегантов, фибринолитиков.

Особые указания:

При появлении нежелательных эффектов со стороны желудочно-кишечного тракта дозу препарата следует уменьшить в 2 раза, а при отсутствии улучшения — отменить препарат.

При отсутствии клинического эффекта после лечебного курса 8 таблеток в сутки в течение 4 недель следует решить вопрос об уточнении диагноза.

Влияние на способность управлять транспортными средствами и механизмами:

Требуется соблюдение осторожности при управлении транспортными средствами и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.

Форма выпуска/дозировка:

Таблетки, покрытые плёночной оболочкой, 250 мг + 250 мг.

Упаковка:

По 5, 15 таблеток в контурную ячейковую упаковку.

По 30, 60 или 90 таблеток в банки полимерные.

Каждую банку, 6, 12 или 18 контурных ячейковых упаковок по 5 таблеток или 2, 4 или 6 контурных ячейковых упаковок по 15 таблеток с инструкцией по медицинскому применению помещают в пачку из картона.

Условия хранения:

В защищённом от света месте, при температуре не выше 25 °С.

Хранить в местах, недоступных для детей.

Срок годности:

3 года.

Не использовать по истечении срока годности, указанного на упаковке.

Условия отпуска

Без рецепта

Производитель

Открытое акционерное общество «Акционерное Курганское общество медицинских препаратов и изделий «Синтез» (ОАО «Синтез»), 640008, Курганская обл., г. Курган, проспект Конституции, д. 7, Россия

Владелец регистрационного удостоверения/организация, принимающая претензии потребителей:

ООО «МС-ВИТА»

Комментарии

(видны только специалистам, верифицированным редакцией МЕДИ РУ)

Fera Pharmaceuticals

NEPTAZANE
Methazolamide Tablets USP25 mg and 50 mg

FULL PRESCRIBING INFORMATION: CONTENTS*

• NEPTAZANE DESCRIPTION
• CLINICAL PHARMACOLOGY
• NEPTAZANE INDICATIONS AND USAGE
• NEPTAZANE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
  • Information for patients
  • Laboratory tests
  • Drug interactions
  • Carcinogenesis, mutagenesis, impairment of fertility
  • Pregnancy
  • Nursing mothers
  • Pediatric use
• NEPTAZANE ADVERSE REACTIONS
• OVERDOSAGE
• NEPTAZANE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 25 mg 90 COUNT BOTTLE
• PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 50 mg 90 COUNT BOTTLE

FULL PRESCRIBING INFORMATION

NEPTAZANE DESCRIPTION

Methazolamide, a sulfonamide derivative, is a white crystalline powder, weakly acidic, slightly soluble in water, alcohol and acetone. The chemical name for methazolamide is: N-[5-(aminosulfonyl)-3-methyl-1,3,4-thiadiazo1-2(3H)-ylidene]-acetamide and it has the following structural formula:

C5H8N4O3S2 236.26

Each tablet, for oral administration, contains 25 mg or 50 mg methazolamide. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate (powder), and microcrystalline cellulose.

CLINICAL PHARMACOLOGY

Methazolamide is a potent inhibitor of carbonic anhydrase.

Methazolamide is well absorbed from the gastrointestinal tract. Peak plasma concentrations are observed 1 to 2 hours after dosing. In a multiple-dose, pharmacokinetic study, administration of methazolamide 25 mg bid, 50 mg bid, and 100 mg bid demonstrated a linear relationship between plasma methazolamide levels and methazolamide dose. Peak plasma concentrations (C_max) for the 25 mg, 50 mg and 100 mg bid regimens were 2.5 mcg/mL, 5.1 mcg/mL, and 10.7 mcg/mL, respectively. The area under the plasma concentration-time curves (AUC) was 1130 mcg.min/mL, 2571 mcg.min/mL, and 5418 mcg.min/mL for the 25 mg, 50 mg, and 100 mg dosage regimens, respectively.

Methazolamide is distributed throughout the body including the plasma, cerebrospinal fluid, aqueous humor of the eye, red blood cells, bile and extra-cellular fluid. The mean apparent volume of distribution (V_area/F) ranges from 17 L to 23 L. Approximately 55% is bound to plasma proteins. The steady-state methazolamide red blood cell:plasma ratio varies with dose and was found to be 27:1, 16:1, and 10:1 following the administration of methazolamide 25 mg bid, 50 mg bid, and 100 mg bid, respectively.

The mean steady-state plasma elimination half-life for methazolamide is approximately 14 hours. At steady-state, approximately 25% of the dose is recovered unchanged in the urine over the dosing interval. Renal clearance accounts for 20% to 25% of the total clearance of drug. After repeated bid-tid dosing, methazolamide accumulates to steady-state concentrations in 7 days.

Methazolamide’s inhibitory action on carbonic anhydrase decreases the secretion of aqueous humor and results in a decrease in intraocular pressure. The onset of the decrease in intraocular pressure generally occurs within 2 to 4 hours, has a peak effect in 6 to 8 hours and a total duration of 10 to 18 hours.

Methazolamide is a sulfonamide derivative; however, it does not have any clinically significant antimicrobial properties. Although methazolamide achieves a high concentration in the cerebrospinal fluid, it is not considered an effective anticonvulsant.

Methazolamide has a weak and transient diuretic effect; therefore, use results in an increase in urinary volume, with excretion of sodium, potassium, and chloride. The drug should not be used as a diuretic. Inhibition of renal bicarbonate reabsorption produces an alkaline urine. Plasma bicarbonate decreases, and a relative, transient metabolic acidosis may occur due to a disequilibrium in carbon dioxide transport in the red cell. Urinary citrate excretion is decreased by approximately 40% after doses of 100 mg every 8 hours. Uric acid output has been shown to decrease 36% in the first 24 hour period.

NEPTAZANE INDICATIONS AND USAGE

NEPTAZANE^TM is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.

NEPTAZANE CONTRAINDICATIONS

Methazolamide therapy is contraindicated in situations in which sodium and/or potassium serum levels are depressed, in cases of marked kidney or liver disease or dysfunction, in adrenal gland failure, and in hyperchloremic acidosis. In patients with cirrhosis, use may precipitate the development of hepatic encephalopathy.

Long-term administration of methazolamide is contraindicated in patients with angle-closure glaucoma, since organic closure of the angle may occur in spite of lowered intraocular pressure.

WARNINGS

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration.

If hypersensitivity or other serious reactions occur, the use of this drug should be discontinued.

Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly, as anorexia, tachypnea, lethargy, coma, and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors.

PRECAUTIONS

General

Potassium excretion is increased initially upon administration of methazolamide and in patients with cirrhosis or hepatic insufficiency could precipitate a hepatic coma.

In patients with pulmonary obstruction or emphysema, where alveolar ventilation may be impaired, methazolamide should be used with caution because it may precipitate or aggravate acidosis.

Information for patients

Adverse reactions common to all sulfonamide derivatives may occur: anaphylaxis, fever, rash (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), crystalluria, renal calculus, bone marrow depression, thrombocytopenic purpura, hemolytic anemia, leukopenia, pancytopenia, and agranulocytosis. Precaution is advised for early detection of such reactions, and the drug should be discontinued and appropriate therapy instituted.

Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly.

Laboratory tests

To monitor for hematologic reactions common to all sulfonamides, it is recommended that a baseline CBC and platelet count be obtained on patients prior to initiating methazolamide therapy and at regular intervals during therapy. If significant changes occur, early discontinuance and institution of appropriate therapy are important. Periodic monitoring of serum electrolytes is also recommended.

Drug interactions

Methazolamide should be used with caution in patients on steroid therapy because of the potential for developing hypokalemia.

Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly, as anorexia, tachypnea, lethargy, coma and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors (see WARNINGS).

Carcinogenesis, mutagenesis, impairment of fertility

Long-term studies in animals to evaluate the carcinogenic potential of methazolamide and its effect on fertility have not been conducted. Methazolamide was not mutagenic in the Ames bacterial test.

Pregnancy

Teratogenic effects

Pregnancy category C

Methazolamide has been shown to be teratogenic (skeletal anomalies) in rats when given in doses approximately 40 times the human dose. There are no adequate and well controlled studies in pregnant women. Methazolamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from methazolamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

The safety and effectiveness of methazolamide in children have not been established.

NEPTAZANE ADVERSE REACTIONS

Adverse reactions, occurring most often early in therapy, include paresthesias, particularly a “tingling” feeling in the extremities; hearing dysfunction or tinnitus; fatigue; malaise; loss of appetite; taste alteration; gastrointestinal disturbances such as nausea, vomiting, and diarrhea; polyuria; and occasional instances of drowsiness and confusion.

Metabolic acidosis and electrolyte imbalance may occur.

Transient myopia has been reported. This condition invariably subsides upon diminution or discontinuance of the medication.

Other occasional adverse reactions include urticaria, melena, hematuria, glycosuria, hepatic insufficiency, flaccid paralysis, photosensitivity, convulsions, and, rarely, crystalluria and renal calculi. Also see PRECAUTIONS: Information for patients for possible reactions common to sulfonamide derivatives. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS).

OVERDOSAGE

No data are available regarding methazolamide overdosage in humans as no cases of acute poisoning with this drug have been reported. Animal data suggest that even a high dose of methazolamide is nontoxic. No specific antidote is known. Treatment should be symptomatic and supportive.

Electrolyte imbalance, development of an acidotic state, and central nervous system effects might be expected to occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

Supportive measures may be required to restore electrolyte and pH balance.

NEPTAZANE DOSAGE AND ADMINISTRATION

The effective therapeutic dose administered varies from 50 mg to 100 mg two or three times daily. The drug may be used concomitantly with miotic and osmotic agents.

HOW SUPPLIED

NEPTAZANE^TM (methazolamide tablets USP, 25 mg) are round, white tablets, debossed “EFF” on one side and “21” on the other side and are supplied in bottles of 90, NDC 48102-014-90.

NEPTAZANE^TM (methazolamide tablets USP, 50 mg) are round, white, scored tablets debossed “EFF” on one side and “20” on the other side and are supplied in bottles of 90, NDC 48102-015-90.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Rx only

 .

Manufactured for:

Fera Pharmaceuticals, LLC

Locust Valley, NY 11560

Code 617J00

Rev. 04/10

Neptazane is a ^TM of Fera Pharmaceuticals.

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 25 mg 90 COUNT BOTTLE

NDC 48102-014-90

NEPTAZANE^TM

Methazolamide Tablets USP

25 mg

Rx only

90 TABLETS

FERA^TM

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 50 mg 90 COUNT BOTTLE

NDC 48102-015-90

NEPTAZANE^TM

Methazolamide Tablets USP

50 mg

Rx only

90 TABLETS

FERA^TM