Naflax

Each tablet contains Naproxen 200 mg and sodium 20 mg. It also contains the following inactive ingredients: Povidone, microcrystalline cellulose, talc, magnesium stearate, purified water and Opadry (blue) in the coating. It is lactose- and gluten-free.

The sodium content of Naflax is low, similar to a slice of wheat bread.

Carefully consider the potential benefits and risks of Naflax, EC-Naflax or Naflax Suspension and other treatment options before deciding to use Naflax, EC-Naflax or Naflax Suspension. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Naflax as Naflax, EC-Naflax or Naflax Suspension is indicated:

• For the relief of the signs and symptoms of rheumatoid arthritis
• For the relief of the signs and symptoms of osteoarthritis
• For the relief of the signs and symptoms of ankylosing spondylitis
• For the relief of the signs and symptoms of juvenile arthritis

Naflax as Naflax Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

Naflax as Naflax and Naflax Suspension is also indicated:

• For relief of the signs and symptoms of tendonitis
• For relief of the signs and symptoms of bursitis
• For relief of the signs and symptoms of acute gout
• For the management of pain
• For the management of primary dysmenorrhea

EC-Naflax is not recommended for initial treatment of acute pain because the absorption of Naflax is delayed compared to absorption from other Naflax-containing products.

Naflax is a nonsteroidal anti-inflammatory drug (NSAID). Naflax works by reducing hormones that cause inflammation and pain in the body.

Naflax is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

The delayed-release or extended-release tablets are slower-acting forms of Naflax that are used only for treating chronic conditions such as arthritis or ankylosing spondylitis. These forms of Naflax will not work fast enough to treat acute pain.

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

Usual Adult Dose for Ankylosing Spondylitis:

Initial: 250 mg to 500 mg (Naflax) or 275 mg to 550 mg (Naflax sodium) orally twice a day. The initial dose for Naflax sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naflax) or 1650 mg (Naflax sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naflax sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Osteoarthritis:

Initial: 250 mg to 500 mg (Naflax) or 275 mg to 550 mg (Naflax sodium) orally twice a day. The initial dose for Naflax sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naflax) or 1650 mg (Naflax sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naflax sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Rheumatoid Arthritis:

Initial: 250 mg to 500 mg (Naflax) or 275 mg to 550 mg (Naflax sodium) orally twice a day. The initial dose for Naflax sodium controlled-release is two 375 mg tablets (750 mg) orally once a day, one 750 mg tablet orally once a day, or two 500 mg tablets (1000 mg) orally once a day.

Maintenance: May be increased to a daily maximum of 1500 mg (Naflax) or 1650 mg (Naflax sodium) in 2 divided doses, for limited periods up to 6 months. In patients who tolerate lower doses well, the dose of Naflax sodium controlled-release may be increased to two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) orally once a day for limited periods.

Usual Adult Dose for Acute Gout:

750 mg (Naflax) or 825 mg (Naflax sodium) orally one time, followed by 250 mg (Naflax) or 275 mg (Naflax sodium) every 8 hours until the gouty attack has resolved, usually 2 to 3 days. The recommended dose of Naflax sodium controlled-release is two to three 500 mg tablets (1000 to 1500 mg) orally on the first day, followed by two 500 mg tablets (1000 mg) orally daily until the attack has subsided.

Usual Adult Dose for Bursitis:

550 mg Naflax sodium orally once, followed by 550 mg Naflax sodium every 12 hours, or 275 mg (Naflax sodium)/250 mg (Naflax) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naflax sodium or 1000 mg Naflax. The recommended initial dose of Naflax sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Tendonitis:

550 mg Naflax sodium orally once, followed by 550 mg Naflax sodium every 12 hours, or 275 mg (Naflax sodium)/250 mg (Naflax) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naflax sodium or 1000 mg Naflax. The recommended initial dose of Naflax sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Dysmenorrhea:

550 mg Naflax sodium orally once, followed by 550 mg Naflax sodium every 12 hours, or 275 mg (Naflax sodium)/250 mg (Naflax) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naflax sodium or 1000 mg Naflax.

Over-the-counter preparation: Naflax sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.

The recommended initial dose of Naflax sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Adult Dose for Pain:

550 mg Naflax sodium orally once, followed by 550 mg Naflax sodium every 12 hours, or 275 mg (Naflax sodium)/250 mg (Naflax) every 6 to 8 hours as needed. Titrate to a maximum daily dose of 1100 mg Naflax sodium or 1000 mg Naflax.

Over-the-counter preparation: Naflax sodium 220 mg orally every 8 hours as needed. Do not exceed 2 caplets in any 8- to 12-hour period.

The recommended initial dose of Naflax sodium controlled-release is two 500 mg tablets (1000 mg) orally once a day. For patients requiring greater analgesic benefit, two 750 mg tablets (1500 mg) or three 500 mg tablets (1500 mg) may be used for a limited period. Thereafter, the total daily dose should not exceed two 500 mg tablets (1000 mg).

Usual Geriatric Dose for Pain:

Over-the-counter preparation - 220 mg (Naflax sodium) orally every 12 hours or 250 mg (Naflax) orally every 8 hours as needed.

Usual Pediatric Dose for Fever:

Dosage guidelines are based on Naflax:

Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.

Usual Pediatric Dose for Pain:

Dosage guidelines are based on Naflax:

Greater than 2 years: 2.5 to 10 mg/kg/dose. Maximum daily dose is 10 mg/kg, given every 8 to 12 hours.

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

Dosage guidelines are based on Naflax:

Greater than or equal to 2 years: 5 mg/kg orally twice a day. Maximum dose: 1000 mg/day.

Смотрите также:
Какую самую важную информацию я должен знать о Нафлаксе?

Суспензия нафлакса, EC-нафлакса и нафлакса противопоказана пациентам с известной гиперчувствительностью к нафлаксу и нафлаксу натрия.

Naflax, EC-Naflax и Naflax Суспензия не следует назначать пациентам, которые испытали астму, крапивницу или аллергические реакции после приема аспирина или других НПВП. У таких пациентов были зарегистрированы тяжелые, редко смертельные, анафилактические реакции на НПВП.

Нафлакс, EC-Naflax и Naflax Суспензия противопоказаны для лечения периоперационной боли при операции по шунтированию коронарной артерии (CABG).

Use Naflax sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Naflax sustained-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naflax sustained-release tablets refilled.
• Swallow Naflax sustained-release tablets whole. Do not break, crush, or chew before swallowing.
• Take Naflax sustained-release tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
• Take Naflax sustained-release tablets with a full glass of water (8 oz [240 mL]) as directed by your doctor.
• If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with Naflax sustained-release tablets.
• If you miss a dose of Naflax sustained-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Naflax sustained-release tablets.

Naflax is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness from arthritis. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation.

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

This form of Naflax is absorbed slowly and should not be used for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist about using a different form of this drug or other medications for quick relief of pain.

How to use EC-Naflax

Read the Medication Guide provided by your pharmacist before you start using Naflax and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice daily with or without food. Swallow this medication whole. Do not break, crush, or chew the tablets. Doing so can release the drug too quickly, increasing the risk of side effects. Take this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug.

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this drug more often than directed. For ongoing conditions such as arthritis, continue taking this medication as directed by your doctor.

For certain conditions (such as arthritis), it may take up to two weeks of taking this drug regularly until you get the full benefit.

Tell your doctor if your condition does not improve or if it worsens.

Смотрите также:
Какие другие лекарства повлияют на Нафлакса?

Использование НПВП у пациентов, которые получают ингибиторы АПФ, может усиливать почечные заболевания.

In vitro исследования показали, что анион Naflax из-за его сродства к белку может вытеснять из своих сайтов связывания другие лекарства, которые также связаны с альбумином.

Теоретически, сам анион Нафлакса также может быть смещен. Краткосрочные контролируемые исследования не показали, что прием препарата значительно влияет на время протромбина при введении людям на антикоагулянтах типа кумарина. Тем не менее, следует соблюдать осторожность, поскольку взаимодействия наблюдались с другими нестероидными агентами этого класса. Аналогичным образом, пациенты, получающие препарат и гидантоин, сульфонамид или сульфонилмочевина, должны наблюдаться на наличие признаков токсичности для этих препаратов.

Одновременный прием Нафлакса и аспирина не рекомендуется, поскольку Нафлакс вытесняется из сайтов связывания во время одновременного приема аспирина, что приводит к снижению концентрации в плазме и пиковым уровням в плазме.

Сообщалось, что натрийуретический эффект фуросемида ингибируется некоторыми препаратами этого класса. Также сообщалось о ингибировании почечного клиренса лития, что приводит к увеличению концентрации лития в плазме. DL Naflax и другие НПВП могут снижать антигипертензивный эффект пропранолола и других бета-блокаторов.

При одновременном назначении с пробенецидом повышается уровень анионной плазмы нафлакса и значительно продлевается период полувыведения из плазмы.

Следует соблюдать осторожность, если Нафлакс вводится одновременно с метотрексатом. Сообщалось, что DL Naflax, Naflax натрия и другие НПВП снижают канальцевую секрецию метотрексата на животных моделях, что может повысить токсичность метотрексата.

Наркотиков / Лабораторных Тестовых Взаимодействий

DL Naflax может уменьшить агрегацию тромбоцитов и продлить время кровотечения. Этот эффект следует учитывать при определении времени кровотечения. Введение Naflax может привести к увеличению мочеиспускания для 17-кетогенных стероидов из-за взаимодействия между препаратом и / или его метаболитами с м-динитробензеном, используемым в этом анализе. Хотя измерения 17-гидроксикортикостероидов (тест Портера-Сильбера), по-видимому, не изменяются артефактно, предлагается временно прекратить терапию нафлаксом за 72 часа до проведения тестов на функцию надпочечников, если будет использоваться тест Портера-Сильбера.

DL Naflax может мешать некоторым мочевым анализам 5-гидроксииндолеуксусной кислоты (5HIAA).

See also:
What are the possible side effects of Naflax?

Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below. In general, reactions in patients treated chronically were reported 2 to 10 times more frequently than they were in short-term studies in the 962 patients treated for mild to moderate pain or for dysmenorrhea. The most frequent complaints reported related to the gastrointestinal tract.

A clinical study found gastrointestinal reactions to be more frequent and more severe in rheumatoid arthritis patients taking daily doses of 1500 mg Naflax compared to those taking 750 mg Naflax.

In controlled clinical trials with about 80 pediatric patients and in well-monitored, open-label studies with about 400 pediatric patients with juvenile arthritis treated with Naflax, the incidence of rash and prolonged bleeding times were increased, the incidence of gastrointestinal and central nervous system reactions were about the same, and the incidence of other reactions were lower in pediatric patients than in adults.

In patients taking Naflax in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal (GI) Experiences, including: heartburn*, abdominal pain*, nausea*, constipation*, diarrhea, dyspepsia, stomatitis

Central Nervous System: headache*, dizziness*, drowsiness*, lightheadedness, vertigo

Dermatologic: pruritus (itching)*, skin eruptions*, ecchymoses*, sweating, purpura

Special Senses: tinnitus*, visual disturbances, hearing disturbances

Cardiovascular: edema*, palpitations

General: dyspnea*, thirst

*Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.

In patients taking NSAIDs, the following adverse experiences have also been reported in approximately 1% to 10% of patients.

Gastrointestinal (GI) Experiences, including: flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting

General: abnormal renal function, anemia, elevated liver enzymes, increased bleeding time, rashes

The following are additional adverse experiences reported in <1% of patients taking Naflax during clinical trials and through postmarketing reports. Those adverse reactions observed through postmarketing reports are italicized.

Body as a Whole: anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia (chills and fever)

Cardiovascular: congestive heart failure, vasculitis, hypertension, pulmonary edema

Gastrointestinal: inflammation, bleeding (sometimes fatal, particularly in the elderly), ulceration, perforation and obstruction of the upper and lower gatrointestinal tract. Esophagitis, stomatitis, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn’s disease)

Hepatobiliary: jaundice, abnormal liver function tests, hepatitis (some causes have been fatal)

Hemic and Lymphatic: eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia

Metabolic and Nutritional: hyperglycemia, hypoglycemia

Nervous System: inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, convulsions

Respiratory: eosinophilic pneumonitis, asthma

Dermatologic: alopecia, urticaria, skin rashes, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematoses, Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa. If skin fragility, blistering or other symptoms suggestive of pseudoporphyria occur, treatment should be discontinued and the patient monitored.

Special Senses: hearing impairment, corneal opacity, papillitis, retrobulbar optic neuritis, papilledema

Urogenital: glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, raised serum creatinine

Reproduction (Female): infertility

In patients taking NSAIDs, the following adverse experiences have also been reported in <1% of patients.

Body as a Whole: fever, infection, sepsis, anaphylactic reactions, appetite changes, death

Cardiovascular: hypertension, tachycardia, syncope, arrhythmia, hypotension, myocardial infarction

Gastrointestinal: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, glossitis, eructation

Hepatobiliary: hepatitis, liver failure

Hemic and Lymphatic: rectal bleeding, lymphadenopathy, pancytopenia

Metabolic and Nutritional: weight changes

Nervous System: anxiety, asthenia, confusion, nervousness, paresthesia, somnolence, tremors, convulsions, coma, hallucinations

Respiratory: asthma, respiratory depression, pneumonia

Dermatologic: exfoliative dermatitis

Special Senses: blurred vision, conjunctivitis

Urogenital: cystitis, dysuria, oliguria/polyuria, proteinuri