Voltfast 50mg инструкция на русском по применению

Состав 

• диклофенак калия  -50 мг .

Форма выпуска 

Порошок для приготовления раствора для приема внутрь от белого до светло-желтого цвета, однородный, со специфическим запахом; восстановленный раствор слегка опалесцирующий, со специфическим запахом. 

Фармакологическое действие 

НПВС. Вольтарен Рапид® содержит диклофенак калия, оказывающий выраженное анальгезирующее, противовоспалительное и жаропонижающее действие. 

Показание к применению 

Для краткосрочного лечения следующих острых состояний: 

• посттравматическая боль, воспаление и отек, например, вследствие повреждения связок; 
• послеоперационная боль, воспаление и отек, например, после стоматологических или ортопедических оперативных вмешательств; 
• боль и/или воспаление, сопровождающие гинекологические заболевания, например, первичную дисменорею или аднексит; 
• приступы мигрени; 
• болевые синдромы со стороны позвоночника; 
• ревматические заболевания внесуставных мягких тканей; 
• в качестве вспомогательного средства при инфекционно-воспалительных заболеваниях уха, горла и носа, например, при фаринготонзиллите, отите, сопровождающихся выраженной болью и воспалением. 

В соответствии с общепринятыми подходами к лечению инфекционно-воспалительных заболеваний необходимо также применять этиотропные средства. Изолированное повышение температуры не является показанием к применению препарата Вольтарен Рапид®. 

Способ применения и дозы 

Порошок для приготовления раствора для приема внутрь предпочтительно принимать перед едой. Содержимое саше следует растворить, помешивая, в стакане воды (негазированной). Раствор может оставаться слегка мутным, но это не влияет на эффективность препарата. 

• Для взрослых рекомендуемая начальная доза препарата составляет 100-150 мг/сут. В случае умеренной выраженности симптомов обычно бывает достаточно применения в суточной дозе  50-100 мг в форме порошка для приготовления раствора для приема внутрь. Суточную дозу следует делить на 3 приема для порошка для приготовления раствора. Максимальная суточная доза препарата не должна превышать 150 мг/сут. 
• При первичной дисменорее суточную дозу для всех лекарственных форм Вольтарена Рапид® следует подбирать индивидуально; обычно она составляет 50-150 мг. Начальная доза — 50-100 мг; при необходимости в течение нескольких менструальных циклов дозу можно повысить до 200 мг/сут. Прием препарата следует начинать при появлении первых симптомов. В зависимости от динамики клинических симптомов лечение можно продолжать в течение нескольких дней. 
• При приступе мигрени начальная доза для всех лекарственных форм Вольтарена Рапид® составляет 50 мг. Препарат следует принимать при первых симптомах приближающегося приступа. В случаях, когда в течение 2 ч после приема первой дозы не происходит облегчения боли, возможен повторный прием препарата в дозе 50 мг. В дальнейшем через каждые 4-6 ч возможен дополнительный прием Вольтарена Рапид® в дозе 50 мг. Суммарная доза препарата не должна превышать 200 мг/сут (в течение не более 2 дней). Эффективность Вольтарена Рапид® при лечении приступов мигрени у детей и подростков не установлена. 
• Детям и подросткам старше 14 лет Вольтарен Рапид® в форме таблеток, покрытых оболочкой, назначают в суточной дозе 75-100 мг; в форме порошка для приготовления раствора для приема внутрь — в суточной дозе 50-100 мг (из расчета 0.5-2 мг/кг массы тела в сут; для лечения ревматоидного артрита суточная доза может быть максимально увеличена до 3 мг/кг). Суточную дозу следует делить на 2-3 приема приема для таблеток, покрытых оболочкой, и на 3 приема для порошка для приготовления раствора. Максимальная суточная доза препарата не должна превышать 150 мг/сут. Вольтарен Рапид® не следует применять у детей и подростков младше 14 лет. При необходимости лечения данной категории больных Вольтарен можно назначать в суппозиториях 12.5 или 25 мг. 

Противопоказания 

• обострение язвенных поражений желудка и кишечника, кровотечения, перфорации; 
• воспалительные заболевания кишечника (болезнь Крона, язвенный колит) в фазе обострения; 
• тяжелая печеночная недостаточность; 
• почечная недостаточность тяжелой степени (КК менее 30 мл/мин); 
• тяжелая сердечная недостаточность; 
• пациенты, страдающие приступами бронхиальной астмы, крапивницей или острым ринитом, которые провоцируются приемом ацетилсалициловой кислотой или другими НПВС; 
• III триместр беременности; 
• фенилкетонурия (т.к. Вольтарен Рапид® в форме порошка содержит источник фенилаланина); 
• повышенная чувствительность к компонентам препарата. 

Не рекомендуется применять в период лактации (грудного вскармливания), у детей в возрасте до 14 лет (в связи с трудностью дозирования препарата). 

Особые указания 

При применении препарата Вольтарен Рапид®, как и других НПВС, необходимо тщательное медицинское наблюдение за пациентами с язвенным поражением желудка или кишечника, язвенный колит, болезнь Крона, с нарушениями функции печени в анамнезе или за больными, предъявляющими жалобы, указывающие на заболевания ЖКТ. Риск развития желудочно-кишечного кровотечения возрастает при увеличении дозы НПВС или при наличие язвенного анамнеза, особенно кровотечений и перфорации язвы у пациентов пожилого возраста. Следует соблюдать особую осторожность при применении препарата Вольтарен Рапид® у пациентов, получающих препараты, увеличивающие риск желудочно-кишечных кровотечений: системные кортикостероиды, антикоагулянты, антиагреганты или селективные ингибиторы обратного захвата серотонина. При применении всех НПВС отмечались кровотечения или изъязвления/перфорации желудочно-кишечного тракта, в ряде случаев со смертельным исходом, у пациентов с симптомами-предшественниками и желудочно-кишечными заболеваниями в анамнезе или без них. У пациентов пожилого возраста подобные осложнения могут иметь серьезные последствия. При развитии у пациентов на фоне применения Вольтарен Рапид® кровотечений или изъязвлений ЖКТ препарат следует отменить. Для снижения токсического действия на ЖКТ препарат следует назначать в минимальной эффективной дозе. Пациентам с повышенным риском развития желудочно-кишечных осложнений, а также больным, получающим терапию низкими дозами ацетилсалициловой кислоты (аспирина), следует принимать гастропротекторы (ингибиторы протоновой помпы или мизопростол). Пациентам с язвенным анамнезом, особенно пожилым, необходимо сообщать врачу обо всех необычных абдоминальных симптомах. Следует соблюдать осторожность при применении Вольтарена Рапид® у пациентов пожилого возраста. Это особенно актуально у ослабленных или имеющих низкую массу тела пожилых людей; им рекомендуется назначать препарат в минимальной эффективной дозе. 

С осторожностью следует назначать Вольтарен Рапид® пациентам с печеночной порфирией, т.к. препарат может провоцировать приступы порфирии. Поскольку простагландины играют важную роль в поддержании почечного кровотока, особая осторожность требуется при лечении пациентов с нарушениями функции сердца или почек, с артериальной гипертензией, при лечении пациентов пожилого возраста, получающих диуретики или другие препараты, влияющие на функцию почек, а также пациентов со значительным уменьшением объема внеклеточной жидкости любой этиологии, например, в периоды до и после массивных хирургических вмешательств. При длительном лечении Вольтареном Рапид® рекомендуется проводить контроль функции почек у пациентов с артериальной гипертензией, нарушениями функции сердца или почек, пожилых больных, получающих диуретики или другие препараты, влияющие на почечную функцию, а также у больных со значительным уменьшением ОЦК любой этиологии, например, в период до и после массивных хирургических вмешательств. После прекращения терапии препаратом обычно отмечается нормализация показателей почечной функции до исходного уровня. При применении Вольтарена Рапид® и других НПВС наблюдались отдельные случаи развития тяжелых дерматологических и аллергических реакций: эксфолиативного дерматита, синдрома Стивенса-Джонсона, токсического эпидермального некролиза редко со смертельным исходом. Наибольшие риск и частота развития тяжелых дерматологических реакций отмечается в первый месяц лечения препаратом. При развитии у пациентов, получающих диклофенак, кожной сыпи, поражения слизистых или других симптомов гиперчувствительности препарат должен быть отменен. В редких случаях у пациентов, не страдающих аллергией на диклофенак, при применении Вольтарена Рапид® и других НПВС отмечались анафилактические/анафилактоидные реакции. 

Обострение астмы (непереносимость НПВС/астма, провоцируемая приемом НПВС), отек Квинке и крапивница наиболее часто отмечаются у пациентов, страдающих бронхиальной астмой, сезонным аллергическим ринитом, носовыми полипами, хронической обструктивной болезнью легких или хроническими инфекционными заболеваниями дыхательных путей (особенно связанными с аллергических ринитоподобными симптомами). У данной группы пациентов, а также у больных с аллергией на другие препараты (сыпь, зуд или крапивница) при назначении Вольтарена Рапид® следует соблюдать особую осторожность (готовность к проведению реанимационных мероприятий). Поскольку в период применения Вольтарена Рапид®, также, как и других НПВС, может отмечаться повышение уровня одного или нескольких печеночных ферментов, при длительной терапии препаратом, в качестве меры предосторожности, показан контроль функции печени. При сохранении и прогрессировании нарушений печеночной функции или возникновении признаков заболеваний печени, или других симптомов (например, эозинофилии, сыпи и т.п.), прием Вольтарена Рапид® необходимо отменить. Следует иметь в виду, что гепатит на фоне применения Вольтарена Рапид® может развиваться без продромальных явлений. Поскольку при совместном применении Вольтарена Рапид® с другими НПВС отмечается увеличение частоты нежелательных побочных явлений при отсутствии улучшения терапевтического ответа, не следует назначать препарат вместе и другими НПВС, включая селективные ингибиторы ЦОГ-2. Противовоспалительное действие препарата и других НПВС, может затруднять диагностику инфекционных процессов. Вольтарен Рапид®, так же, как и другие НПВС, может временно ингибировать агрегацию тромбоцитов. Поэтому у пациентов с нарушениями гемостаза необходим тщательный контроль соответствующих лабораторных показателей. При длительном применении Вольтарена Рапид®, как и других НПВС, показан систематический контроль картины периферической крови. 

Условия хранения 

Препарат следует хранить в недоступном для детей, сухом месте при температуре не выше 25°С. Срок годности — 2 года. 

Примечание 

Препарат отпускается по рецепту. 

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events.

Status Post Coronary Artery Bypass Graft (CABG) Surgery

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG.

Post-MI Patients

Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.

Avoid the use of Voltfast in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Voltfast is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Gastrointestinal Bleeding, Ulceration, And Perforation

NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.

Risk Factors For GI Bleeding, Ulceration, And Perforation

Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status. Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.

Strategies to Minimize the GI Risks in NSAID-treated patients:

• Use the lowest effective dosage for the shortest possible duration.
• Avoid administration of more than one NSAID at a time.
• Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For  such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs.
• Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy.
• If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue Voltfast until a serious GI adverse event is ruled out.
• In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding.

Hepatotoxicity

In clinical trials of oral diclofenac containing products, meaningful elevations (i.e., more than 3 times the ULN) of AST (SGOT) occurred in about 2% of approximately 5,700 patients at some time during diclofenac treatment (ALT was not measured in all studies).

In a large, open-label, controlled trial of 3,700 patients treated with oral diclofenac for 2 — 6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of 3,700 patients and included marked elevations (greater than 8 times the ULN) in about 1% of the 3,700 patients. In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3 to 8 times the ULN), and marked (greater than 8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.

Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with oral diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of NSAID therapy, but can occur at any time during treatment with diclofenac.

Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

In a European retrospective population-based, case-controlled study, 10 cases of oral diclofenac associated drug-induced liver injury with current use compared with non-use of diclofenac were associated with a statistically significant 4-fold adjusted odds ratio of liver injury. In this particular study, based on an overall number of 10 cases of liver injury associated with diclofenac, the adjusted odds ratio increased further with female gender, doses of 150 mg or more, and duration of use for more than 90 days.

Physicians should measure transaminases at baseline and periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. However, severe hepatic reactions can occur at any time during treatment with diclofenac.

If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), Voltfast should be discontinued immediately.

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue Voltfast immediately, and perform a clinical evaluation of the patient.

To minimize the potential risk for an adverse liver-related event in patients treated with Voltfast, use the lowest effective dose for the shortest duration possible. Exercise caution when prescribing Voltfast with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, antibiotics, antiepileptics).

Hypertension

NSAIDs, including Voltfast, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.

Heart Failure And Edema

The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.

Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]).

Avoid the use of Voltfast in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If Voltfast is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Renal Toxicity And Hyperkalemia

Renal Toxicity

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

No information is available from controlled clinical studies regarding the use of Voltfast in patients with advanced renal disease. The renal effects of Voltfast may hasten the progression of renal dysfunction in patients with preexisting renal disease.

Correct volume status in dehydrated or hypovolemic patients prior to initiating Voltfast. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of Voltfast. Avoid the use of Voltfast in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. If Voltfast is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

Hyperkalemia

Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.

Anaphylactic Reactions

Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to diclofenac and in patients with aspirin-sensitive asthma.

Seek emergency help if an anaphylactic reaction occurs.

Exacerbation Of Asthma Related To Aspirin Sensitivity

A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, Voltfast is contraindicated in patients with this form of aspirin sensitivity. When Voltfast is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.

Serious Skin Reactions

NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of Voltfast at the first appearance of skin rash or any other sign of hypersensitivity. Voltfast is contraindicated in patients with previous serious skin reactions to NSAIDs.

Do not apply Voltfast to open skin wounds, infections, inflammations, or exfoliative dermatitis, as it may affect absorption and tolerability of the drug.

Premature Closure Of Fetal Ductus Arteriosus

Diclofenac may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Voltfast, in pregnant women starting at 30 weeks of gestation (third trimester).

Hematologic Toxicity

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with Voltfast has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.

NSAIDs, including Voltfast, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding.

Masking Of Inflammation And Fever

The pharmacological activity of Voltfast in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

Laboratory Monitoring

Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically.

Sun Exposure

Instruct patients to avoid exposure to natural or artificial sunlight on treated knee(s) because studies in animals indicated topical diclofenac treatment resulted in an earlier onset of ultraviolet light-induced skin tumors. The potential effects of Voltfast on skin response to ultraviolet damage in humans are not known.

Eye Exposure

Avoid contact of Voltfast with eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.

Oral Nonsteroidal Anti-Inflammatory Drugs

Concomitant use of oral NSAIDs with Voltfast 1.5% resulted in a higher rate of rectal hemorrhage, more frequent abnormal creatinine, urea and hemoglobin. Therefore, do not use combination therapy with Voltfast and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with Voltfast and periodically during the course of ongoing therapy.

Cardiovascular Thrombotic Events

Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately.

Gastrointestinal Bleeding, Ulceration, And Perforation

Advise patients to report symptoms of ulceration and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding.

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop Voltfast and seek immediate medical therapy.

Heart Failure And Edema

Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur.

Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur.

Serious Skin Reactions

Advise patients to stop Voltfast immediately if they develop any type of rash and contact their health care provider as soon as possible.

Female Fertility

Advise females of reproductive potential who desire pregnancy that NSAIDs, including Voltfast, may be associated with a reversible delay in ovulation

Fetal Toxicity

Inform pregnant women to avoid use of Voltfast and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus.

Avoid Concomitant Use Of NSAIDs

Inform patients that the concomitant use of Voltfast with other NSAIDs or salicylates (e.g.,diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy. Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.

Use of NSAIDs And Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with Voltfast until they talk to their healthcare provider.

Eye Exposure

Instruct patients to avoid contact of Voltfast with the eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.

Prevention Of Secondary Exposure

Instruct patients to avoid skin-to-skin contact between other people and the knee(s) to which Voltfast was applied until the knee(s) is completely dry.

Special Application Instructions

Instruct patients not to apply Voltfast to open skin wounds, infections, inflammations, or exfoliative dermatitis, as it may affect absorption and reduce tolerability of the drug.

Instruct patients to wait until the area treated with Voltfast is completely dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication.

Instruct patients to minimize or avoid exposure of treated knee(s) to natural or artificial sunlight.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Carcinogenicity studies in mice and rats administered diclofenac sodium as a dietary constituent for 2 years resulted in no significant increases in tumor incidence at doses up to 2 mg/kg/day approximately 0.85 and 1.7 times, respectively, the maximum recommended human topical dose of Voltfast (based on apparent bioavailability and body surface area comparison).

In a dermal carcinogenicity study conducted in albino mice, daily topical applications of diclofenac sodium for two years at concentrations up to 0.035% diclofenac sodium (a 57-fold lower diclofenac sodium concentration than present in Voltfast) did not increase neoplasm incidence.

In a photococarcinogenicity study conducted in hairless mice, topical application of diclofenac sodium at doses up to 0.035% diclofenac sodium (a 57-fold lower diclofenac sodium concentration than present in Voltfast) resulted in an earlier median time of onset of tumors.

Mutagenesis

Diclofenac was not mutagenic or clastogenic in a battery of genotoxicity tests that included the bacterial reverse mutation assay, in vitro mouse lymphoma point mutation assay, chromosomal aberration studies in Chinese hamster ovarian cells in vitro, and in vivo rat chromosomal aberration assay of bone marrow cells.

Impairment Of Fertility

Fertility studies have not been conducted with Voltfast. Diclofenac sodium administered to male and female rats at doses up to 4 mg/kg/day (approximately 3.4 times the MRHD of Voltfast based on apparent bioavailability and body surface area comparison) did not affect fertility. Studies conducted in rats found no effect of dermally applied DMSO on fertility, reproductive performance, or offspring performance.

Use In Specific Populations

Pregnancy

Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation

Risk Summary

Use of NSAIDs, including Voltfast, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including Voltfast, in pregnant women starting at 30 weeks of gestation (third trimester).

There are no adequate and well-controlled studies of Voltfast in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. Published reproductive and developmental studies of dimethyl sulfoxide (DMSO, the solvent used in Voltfast) are equivocal as to potential teratogenicity. In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 0.6, 0.6, and 1.3 times, respectively, the maximum recommended human dose (MRHD) of Voltfast, despite the presence of maternal and fetal toxicity at these doses. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as diclofenac resulted in increased pre- and post-implantation loss.

Clinical Considerations

Labor or Delivery

There are no studies on the effects of Voltfast during labor or delivery. In animal studies, NSAIDs, including diclofenac inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Data

Animal data

Reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day (approximately 0.6 times the maximum recommended human dose [MRHD] of Voltfast, 162 mg/day, based on body surface area (BSA) comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day (approximately 0.6 and 1.3-times, respectively, the MRHD based on BSA comparison). Published reproductive and developmental studies of dimethyl sulfoxide (DMSO, the solvent used in Voltfast) are equivocal as to potential teratogenicity. In rats, maternally toxic doses of diclofenac were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival.

Lactation

Risk Summary

Based on available data, diclofenac may be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CATAFLAM and any potential adverse effects on the breastfed infant from the CATAFLAM or from the underlying maternal condition.

Data

One woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day. Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period).

Females And Males Of Reproductive Potential

Infertility

Females

Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including Voltfast, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including Voltfast, in women who have difficulties conceiving or who are undergoing investigation of infertility.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects.

Of the 911 patients treated with Voltfast 1.5% in seven controlled, Phase 3 clinical trials, 444 subjects were 65 years of age and over. There was no age-related difference in the incidence of adverse events. Of the 793 patients treated with Voltfast 1.5% in one open-labeled safety trial, 334 subjects were 65 years of age and over including 107 subjects 75 and over. There was no difference in the incidence of adverse events with long-term exposure to Voltfast 1.5% for this elderly population.

Вольтарен (таблетки): инструкция по применению

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Содержание

1. Состав лекарственного препарата
2. Описание внешнего вида, запаха, вкуса
3. Фармакотерапевтическая группа
4. Показания к применению
5. Противопоказания
6. Необходимые меры предосторожности при применении
7. Взаимодействия с другими лекарственными препаратами
8. Специальные предупреждения
9. Беременность и период лактации
10. Особенности влияния препарата на способность управлять транспортным средством или потенциально опасными механизмами
11. Рекомендации по применению
12. Побочное действие
13. Форма выпуска и упаковка
14. Срок хранения
15. Условия хранения
16. Условия отпуска из аптек

Состав лекарственного препарата

Одна таблетка содержит
активное вещество — диклофенак натрия 50 мг,
вспомогательные вещества: крахмал кукурузный, лактозы моногидрат, натрия крахмала гликолят (тип А), целлюлоза микрокристаллическая (Avicel PH 102), кремния диоксид коллоидный безводный (Aerosil 200), повидон К30, магния стеарат,
состав оболочки: гипромеллоза, тальк, железа оксид желтый (Е172), титана диоксид (Е171), макроголглицерол гидроксистеарат (полиоксилированное 40 гидрогенизированное касторовое масло) (Cremophor RH 40), железа оксид красный 17266 (Е 172), 30% дисперсия сополимера метакриловая кислота — этилакрилат (1:1)/сополимер метакриловая кислота (Eudragit L 30 D-55), макрогол 8000 (полиэтиленгликоль 8000), силиконовая пеноудаляющая эмульсия SE2.

Описание внешнего вида, запаха, вкуса

Таблетки круглой формы, с двояковыпуклой поверхностью, покрытые оболочкой, светло-коричневого цвета, с фаской, гравировкой «CG» на одной стороне и «GT» на другой стороне.

Фармакотерапевтическая группа

Костно-мышечная система. Противовоспалительные и противоревматические препараты. Противовоспалительные и противоревматические препараты, нестероидные. Уксусной кислоты производные и родственные соединения. Диклофенак.
Код АТХ М01АВ05

Показания к применению

— воспалительные и дегенеративные формы ревматических заболеваний: ревматоидный артрит, ювенильный ревматоидный артрит, остеоартрит, спондилоартрит, анкилозирующий спондилит (болезнь Бехтерева), болевые синдромы при заболеваниях позвоночника ревматического происхождения
— острые приступы подагры
— посттравматические и послеоперационные болевые синдромы
— гинекологические заболевания, сопровождающиеся болевым синдромом и воспалением (например, первичная дисменорея и аднексит)
— в составе комплексной терапии при тяжелых воспалительных заболеваниях уха, горла и носа, протекающих с выраженным болевым синдромом (например, фарингит, тонзиллит, отит)

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

The contents of the sachet should be dissolved with stirring in a glass of natural (non-carbonated) water. The solution may remain slightly opalescent, but this should not influence the efficacy of the preparation. The solution should be swallowed preferably before meals.

Adults

The recommended initial daily dosage is 100-150mg. In milder cases, 50-100mg daily are usually sufficient. The daily dosage should generally be divided up to 3 doses.

In primary dysmenorrhoea the daily dosage should be individually adjusted and is generally 50-150mg. Initially a dose of 50-100mg should be given and, if necessary, raised in the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started upon appearance of the first symptoms and, depending on the symptomatology, continued for a few days.

In migraine an initial dose of 50mg should be taken at the first signs of an impending attack. In cases where pain relief within 2 hours after the first dose is not sufficient, a further dose of 50mg may be taken. If needed, further doses of 50mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200mg per day.

Children and adolescents

Voltfast 50mg powder for oral solution is not recommended for use in children and adolescents below 14 years of age. For treatment in children and adolescents below 14 years of age, oral drops and suppositories of diclofenac 12.5mg are available.

For adolescents aged 14 years and over, 50 to 100mg daily are usually sufficient, given as 1 to 2 divided doses.

The maximum daily dose of 150mg should not be exceeded.

The use of Voltfast 50mg powder for oral solution in migraine attacks has not been established in children and adolescents.

Older people (Patients aged 65 or above)

Although the pharmacokinetics of Votlfast are not impaired to any clinically relevant extent in elderly patients, non-steroidal anti-inflammatory drugs should be used with particular caution in frail elderly patients or those with a low body weight. In particular, it is recommended that the lowest effective dosage be used in these patients (see Section 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or if intolerance occurs.

Renal impairment

Diclofenac is contraindicated in patients with severe renal impairment (see section 4.3).

No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made.

Caution is advised when administering diclofenac to patients with mild to moderate renal impairment (see section 4.3 and 4.4).

Hepatic impairment

Diclofenac is contraindicated in patients with severe hepatic impairment (see section 4.3).

No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made.

Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment (see section 4.3 and 4.4).