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ARAVA® (leflunomide) is a pyrimidine synthesis inhibitor

ARAVA® (leflunomide) is used for:

Reducing signs and symptoms of rheumatoid arthritis. It is also used to improve physical function and to prevent the development of structural damage to the joints.

ARAVA® (leflunomide) is a pyrimidine synthesis inhibitor. It is thought to work by blocking certain enzymes responsible for abnormal tissue development or growth.

Do NOT use ARAVA® (leflunomide) if:

• you are allergic to any ingredient in Leflunomide
• you are pregnant or planning to become pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using ARAVA® (leflunomide):

Some medical conditions may interact with Leflunomide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a weakened immune system, blood or bone marrow disorders, an infection, or have recently received a vaccination
• if you have hepatitis B or C or other liver problems, kidney problems, or drink alcoholic beverages

Some MEDICINES MAY INTERACT with Leflunomide. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cholestyramine because the effectiveness of Leflunomide may be decreased
• Methotrexate or rifampin because side effects, including liver toxicity, headache, and muscle pains, may occur
• Anticoagulants (eg, warfarin) because side effects, including risk of bleeding, may be increased by Leflunomide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Leflunomide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Leflunomide :

Use Leflunomide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Leflunomide may be taken with or without food.
• It may take 4 weeks or more to notice any improvement while taking Leflunomide.
• If you miss a dose of Leflunomide , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and 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 Leflunomide.

Important safety information:

• Drinking alcohol while you are taking Leflunomide may increase the risk of liver problems. Talk with your doctor before drinking alcohol while taking Leflunomide.
• Avoid receiving vaccines while taking Leflunomide.
• Contact your doctor immediately if you develop a skin rash, small blisters over a large portion of the body, or lesions around the eyes, mouth, or throat.
• LAB TESTS, including liver function, may be performed to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments.
• Leflunomide is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• Leflunomide may cause birth defects in children of men taking Leflunomide at the time of conception. Discuss the use of reliable birth control methods (eg, condoms) with your doctor or pharmacist while taking Leflunomide. Talk with your health care provider about stopping Leflunomide if you and your female partner are planning for parenthood.
• PREGNANCY and BREAST-FEEDING: Leflunomide may cause harm to the fetus. Leflunomide must not be used during pregnancy, or by women who are able to become pregnant unless they are using reliable forms of birth control. A negative pregnancy test must be obtained before the start of treatment with Leflunomide. Contact your health care provider at once if your menstrual flow is delayed or if you suspect that you are pregnant. After completing therapy, women of childbearing potential who plan to become pregnant must undergo a procedure to flush any remaining medicine out of the body system. It is unknown if Leflunomide is excreted in breast milk. Do not breast-feed while taking Leflunomide.

Possible side effects of Leflunomide :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; bronchitis; diarrhea; dizziness; dry skin; hair loss; headache; increased cough; indigestion; joint disorder; loss of appetite; muscle aches; nausea; runny nose; sinus infection; upper respiratory tract infection; urinary tract infection; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering or peeling skin; blisters on the inside of eyes, nose, or mouth; chest pain; dark urine; easy bruising/bleeding; feelings of numbness or tingling; fever; infection; muscle cramps, including leg cramps; pale skin; pale stools; sore throat; stomach pain; unusual tiredness; vomiting; yellowing of the eyes or skin.

Arcoxia Etoricoxib

Etoricoxib Information:

Arcoxia (Etoricoxib) is the newset of the COX-II inhibitors released onto the market by Merck Frosst. Arcoxia (Etoricoxib) can be used to treat acute gouty arthritis, osteoarthirtis and other conditions as determined by your doctor.

Arcoxia (Etoricoxib) is administered orally and may be taken with or without food. The onset of Arcoxia (Etoricoxib) effect may be faster when Arcoxia (Etoricoxib) is administered without food. This should be considered when rapid symptomatic relief is needed. Osteoarthritis: The recommended dose of Arcoxia (Etoricoxib) is 60 mg once daily. Rheumatoid arthritis- The recommended dose is 90 mg once daily. Acute gouty arthritis- The recommended dose of Arcoxia (Etoricoxib) is 120 mg once daily. In clinical trials for acute gouty arthritis, Arcoxia (Etoricoxib) was given for 8 days. Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore, the dose for each indication is the maximum recommended dose.

ARCOXIA (Etoricoxib) is contra-indicated in:
- patients with known hypersensitivity to etoricoxib or to any of the excipients of this medicinal product
- patients with active peptic ulceration or gastro-intestinal (GI) bleeding
- patients with severe hepatic dysfunction (Child-Pugh score>9)
- patients with estimated creatinine clearance <30 ml/min
- patients who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
- pregnancy and lactation (see 4.6 'Pregnancy and lactation' and 5.3 'Preclinical safety data')
- children and adolescents under 16 years of age
- patients with inflammatory bowel disease
- patients with severe congestive heart failure.

Etoricoxib Side Effects:

Information about Arcoxia Side Effects:
In clinical trials, Arcoxia (etoricoxib) was evaluated for safety in approximately 4800 individuals, including approximately 3400 patients with OA, RA or chronic low back pain (approximately 600 patients with OA or RA were treated for one year or longer).

In clinical studies the following undesirable Arcoxia side effects were reported at an incidence greater than placebo in patients with OA, RA or chronic low back pain treated with etoricoxib 60 mg or 90 mg for up to 12 weeks: [Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare ( <1/10,000)]

Arcoxia side effects include: Uncommon Arcoxia Side Effects:gastro-enteritis, upper respiratory infection, urinary tract infection.
Immune system disorder Arcoxia Side Effects:
Very rare Arcoxia Side Effects:drug hypersensitivity.
Metabolism and nutrition disorders Arcoxia Side Effects:
Uncommon Arcoxia Side Effects: appetite increase or decrease, oedema/fluid retention, weight gain.
Psychiatric disorders Arcoxia Side Effects:
Uncommon Arcoxia Side Effects: anxiety, depression, mental acuity decreased.
Nervous system disorder:
Common Arcoxia Side Effects: dizziness, headache.
Uncommon Arcoxia Side Effects: dysgeusia, insomnia, paraesthesia/hypaesthesia, somnolence.
Eye disorders:
Uncommon Arcoxia Side Effects: blurred vision.
Ear and labyrinth disorders:
Uncommon: tinnitus.
Cardiac disorders:
Uncommon Arcoxia Side Effects: congestive heart failure, non-specific ECG changes.
Very rare Arcoxia Side Effects: myocardial infarction.
Vascular disorders:
Uncommon Arcoxia Side Effects: flushing, hypertension.
Very rare Arcoxia Side Effects: cerebrovascular accident.
Respiratory, thoracic and mediastinal disorders:
Uncommon Arcoxia Side Effects: cough, dyspnoea, epistaxis.
Gastro-intestinal disorders:
Common Arcoxia Side Effects: gastro-intestinal disorders (e.g. abdominal pain, flatulence, heartburn), diarrhoea, dyspepsia, epigastric discomfort, nausea.
Uncommon Arcoxia Side Effects: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting.
Very Rare Arcoxia Side Effects: gastro-intestinal perforation and bleeding.
Skin and subcutaneous tissue disorders:
Uncommon Arcoxia Side Effects: ecchymosis, facial oedema, pruritus, rash.
Musculoskeletal, connective tissue and bone disorders:
Uncommon Arcoxia Side Effects: muscular cramp/spasm, musculoskeletal pain/stiffness.
Renal and urinary disorders Arcoxia Side Effects:
Uncommon Arcoxia Side Effects: proteinuria.
General disorders and administration site conditions:
Common Arcoxia Side Effects: asthenia/fatigue, flu-like disease.
Uncommon Arcoxia Side Effects: chest pain.
Investigations:
CommonArcoxia Side Effects: ALT increased, AST increased.
Uncommon Arcoxia Side Effects: blood urea nitrogen increased, creatine phosphokinase increased, haematocrit decreased, haemoglobin decreased, hyperkalaemia, leukocytes decreased, platelets decreased, serum creatinine increased, uric acid increased.

Arcoxia comes from a class of drugs that is similar to Vioxx (Rofecoxib), Celebrex (Celecoxib, Bextra (Valdecoxib) and Mobic (Meloxicam).