Infaser

Infaser tablet also contains the following excipients: Core: Magnesium stearate, povidone, anhydrous colloidal silica, sodium starch glycollate, maize starch, calcium phosphate.

Sugar Coating: Microcrystalline cellulose, polyethylene glycol 8000, red iron oxide (E172) and titanium dioxide (E171) (dispersed Anstead), povidone, talc, sucrose.

Polish: Polyethylene glycol 8000, sucrose.

Imprint: Brown printing ink for 25 mg and white for 50 mg.

Infaser is potassium-[0-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate.

In Infaser, the sodium ion of Infaser sodium (Voltaren) has been replaced by a potassium ion.

Carefully consider the potential benefits and risks of Infaser tablets and other treatment options before deciding to use Infaser tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Infaser tablets are indicated:

Treating migraine headache.

Infaser powder packets is an NSAID. Exactly how it works is not known. It may work by blocking certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Carefully consider the potential benefits and risks of Infaser tablets and other treatment options before deciding to use Infaser tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Infaser tablets, the dose and frequency should be adjusted to suit an individual patient's needs.

For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg t.i.d. With experience, physicians may find that in some patients an initial dose of 100 mg of Infaser tablets, followed by 50 mg doses, will provide better relief.

For the relief of osteoarthritis the recommended dosage is 100 to 150 mg/day in divided doses, 50 mg b.i.d. or t.i.d.

For the relief of rheumatoid arthritis the recommended dosage is 150 to 200 mg/day in divided doses, 50 mg t.i.d. or q.i.d.

Different formulations of Infaser [Infaser sodium enteric-coated tablets; Infaser sodium extended-release tablets; Infaser tablets] are not necessarily bioequivalent even if the milligram strength is the same.

See also:
What is the most important information I should know about Infaser?

Infaser for

Oral Solution is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to Infaser.

Infaser for

Oral Solution is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

Infaser for

Oral Solution is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

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

• Infaser powder packets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Infaser powder packets refilled.
• Do not open a packet of Infaser powder packets until you are ready to take a dose.
• To use Infaser powder packets, mix the contents of 1 packet with 2 to 4 tablespoons (30 to 60 mL) water. Do not use a liquid other than water. Mix well and drink right away. Do not store the mixed medicine for future use.
• Infaser powder packets may be taken with food if it upsets your stomach. Taking it with food may make it less effective. 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.
• Only 1 dose of Infaser powder packets is required. If you miss your dose of Infaser powder packets and you still have a migraine, take it as soon as you remember.

Ask your health care provider any questions you may have about how to use Infaser powder packets.

Infaser is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

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.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat gout attacks.

How to use Infaser

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

Take this medication by mouth 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. To prevent stomach upset, take this medication with food, milk, or an antacid.

There are different brands and forms of this medication available. Because different brands deliver different amounts of medication, do not switch brands of Infaser without your doctor's permission and directions.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To minimize side effect risks (such as stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often than prescribed. For chronic conditions such as arthritis, continue taking it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.

For certain conditions (such as arthritis), it may take up to 2 weeks of regular use before the full benefits of this drug take effect.

If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Tell your doctor if your condition worsens.

See also:
What other drugs will affect Infaser?

Not to be given IV to patients who are receiving other NSAIDs or anticoagulants including low dose heparin. Renal function may be worsened when used with ciclosporin or triamterene. Altered absorption when given with sucralfate, colestyramine or colestipol. Ophthalmic application of Infaser may reduce the efficacy of ophthalmic acetylcholine and carbachol. Increased risk of GI ulceration and bleeding when used with corticosteroids, aspirin or anticoagulants.

Potentially Fatal: Increases blood levels of digoxin, lithium and methotrexate. Potentiate potassium-sparing diuretics.

Food Interaction

Slow absorption of enteric-coated tab when given with food.

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

The following serious adverse reactions are discussed elsewhere in the labeling:

• Cardiovascular thrombotic events
• Gastrointestinal effects
• Hepatic effects
• Hypertension
• Congestive Heart Failure and Edema
• Renal Effects
• Anaphylactoid Reactions
• Serious Skin Reactions

The most common adverse reactions reported with Infaser for

Oral Solution are nausea and dizziness.

The most common adverse events resulting in discontinuation of patients following Infaser for

Oral Solution dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%).

Clinical Studies Experience With Infaser for

Oral Solution

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of a single dose of Infaser for

Oral Solution was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with Infaser for

Oral Solution for a single migraine headache. Following treatment with Infaser (either Infaser for

Oral Solution or Infaser immediate-release tablets [as a control]), 5 subjects (0.8%) withdrew from the studies; following placebo exposure, 1 subject (0.2%) withdrew. No withdrawals were due to a serious reaction.

The most common adverse reactions (i.e., that occurred in 1% or more of Infaser for

Oral Solution -treated patients) and more frequent with Infaser for

Oral Solution than with placebo were nausea and dizziness.

Adverse Reactions Reported With Infaser and Other NSAIDs

In patients taking Infaser or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1% to 10% of patients are: GI reactions (including abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers [gastric/duodenal], and vomiting), abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.

Additional adverse reactions reported in patients taking NSAIDs include occasionally:

Body as a Whole: Fever, infection, sepsis

Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope

Digestive System: Dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice

Hemic and Lymphatic System: Ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia

Metabolic and Nutritional: Weight changes

Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo

Respiratory System: Asthma, dyspnea

Skin and Appendages: Alopecia, photosensitivity, sweating increased

Special Senses: Blurred vision

Urogenital System: Cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure

Other adverse reactions in patients taking NSAIDs, which occur rarely, are:

Body as a Whole: Anaphylactic reactions, appetite changes, death

Cardiovascular System: Arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis

Digestive System: Colitis, eructation, liver failure, pancreatitis

Hemic and Lymphatic System: Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia

Metabolic and Nutritional: Hyperglycemia

Nervous System: Convulsions, coma, hallucinations, meningitis

Respiratory System: Respiratory depression, pneumonia

Skin and Appendages: Angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria

Special Senses: Conjunctivitis, hearing impairment