Diclofenac Potassium for Oral Solution (Cambia)
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Diclofenac Potassium for Oral Solution (Cambia)

CAMBIA
(diclofenac potassium) for Oral Solution

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Risk

  • Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see WARNINGS AND PRECAUTIONS].
  • CAMBIA (diclofenac potassium for oral solution) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Gastrointestinal Risk

  • NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

CAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA (diclofenac potassium for oral solution) is available as a buffered soluble powder, designed to be mixed with water prior to oral administration.

CAMBIA (diclofenac potassium for oral solution) is a white to off-white, buffered, flavored, powder for oral solution packaged in individual unit dose packets [see HOW SUPPLIED].

The chemical name for diclofenac potassium is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight of diclofenac potassium is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structural formula:

CAMBIA
  (Diclofenac Potassium) Structural Formula Illustration

The inactive ingredients in CAMBIA (diclofenac potassium for oral solution) include: aspartame (equivalent to 25 mg phenylalanine), flavoring agents (anise and mint), glycerol behenate, mannitol, potassium bicarbonate, and saccharin sodium.

What are the possible side effects of diclofenac (Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor)?

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

Stop using diclofenac and call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain, urinating less than usual or not at...

Read All Potential Side Effects and See Pictures of Cambia »

What are the precautions when taking diclofenac potassium for oral solution (Cambia)?

Before taking diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), kidney disease, liver disease, growths in the nose (nasal polyps), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, stroke, swelling of the ankles/feet/hands,...

Read All Potential Precautions of Cambia »

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Acute Treatment of Migraine

CAMBIA (diclofenac potassium for oral solution) ™ (Diclofenac Potassium for Oral Solution) is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).

Important Limitations

  • CAMBIA (diclofenac potassium for oral solution) is not indicated for the prophylactic therapy of migraine.
  • The safety and effectiveness of CAMBIA (diclofenac potassium for oral solution) have not been established for cluster headache, which is present in an older, predominantly male population.

DOSAGE AND ADMINISTRATION

Acute Treatment of Migraine

Administer one packet (50 mg) of CAMBIA (diclofenac potassium for oral solution) ™ for the acute treatment of migraine. Empty the contents of one packet into a cup containing 1 to 2 ounces (30 to 60 mL) of water, mix well and drink immediately. Do not use liquids other than water.

Taking CAMBIA (diclofenac potassium for oral solution) with food may cause a reduction in effectiveness compared to taking CAMBIA (diclofenac potassium for oral solution) on an empty stomach [see CLINICAL PHARMACOLOGY].

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The safety and effectiveness of a second dose have not been established.

Interchangeability with Other Formulations of Diclofenac

Different formulations of oral diclofenac (e.g., CAMBIA (diclofenac potassium for oral solution) , diclofenac sodium enteric-coated tablets, diclofenac sodium extended-release tablets, or diclofenac potassium immediate-release tablets) may not be bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulation of diclofenac to CAMBIA (diclofenac potassium for oral solution) .

HOW SUPPLIED

Dosage Forms And Strengths

CAMBIA (diclofenac potassium for oral solution) is available in individual packets each designed to deliver a 50 mg dose when mixed in water.

CAMBIA™ 50 mg (Diclofenac Potassium for Oral Solution) is supplied as one or more sets of three perforated co-joined individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water.

CAMBIA (diclofenac potassium for oral solution) is a white to off-white, buffered, flavored, powder for oral solution packaged in individual unit dose packets.

Individual CAMBIA (diclofenac potassium for oral solution) ™ Packets - NDC 66869-513-01

Boxes of nine (9) CAMBIA (diclofenac potassium for oral solution) ™ Packets - NDC 66869-513-09

Store at 25°C (77°F) Excursions permitted from 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]

Manufactured by: MIPHARM S.p.A. Via Bernardo Quaranta, 12 20141 Milan, Italy. Manufactured for: Kowa Pharmaceuticals America, Inc. 530 Industrial Park Blvd. Montgomery, AL. Issued June 2009

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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

The most common adverse reactions reported with CAMBIA (diclofenac potassium for oral solution) are nausea and dizziness.

The most common adverse events resulting in discontinuation of patients following CAMBIA (diclofenac potassium for oral solution) dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%).

Clinical Studies Experience with CAMBIA (diclofenac potassium 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 CAMBIA (diclofenac potassium for oral solution) was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with CAMBIA (diclofenac potassium for oral solution) for a single migraine headache. Following treatment with diclofenac potassium (either CAMBIA or diclofenac potassium 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 CAMBIA (diclofenac potassium for oral solution) -treated patients) and more frequent with CAMBIA (diclofenac potassium for oral solution) than with placebo were nausea and dizziness (see Table 1).

Table 1: Treatment-Related Adverse Reactions with Incidence > 1% and Greater than Placebo in Studies 1 and 2 Combined

Disorder Event CAMBIA
N=634
Placebo
N=646
Gastrointestinal
  Nausea 3% 2%
Nervous System
  Dizziness 1% 0.5%

Adverse reactions reported with diclofenac and other NSAIDs

In patients taking diclofenac or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1%-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.

Read the Cambia (diclofenac potassium for oral solution) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Aspirin

When administered with aspirin, diclofenac potassium's protein binding is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of CAMBIA (diclofenac potassium for oral solution) and aspirin is not generally recommended because of the potential of increased adverse effects.

Anticoagulants

The effects of anticoagulants such as warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than that with use of either drug alone.

ACE Inhibitors

NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking CAMBIA (diclofenac potassium for oral solution) concomitantly with ACE inhibitors.

Diuretics

Clinical studies, as well as post-marketing observations, have shown that diclofenac potassium can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, observe patients closely for signs of renal failure as well as to assure diuretic efficacy [see WARNINGS AND PRECAUTIONS].

Lithium

NSAIDs have produced elevations of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. When CAMBIA (diclofenac potassium for oral solution) and lithium are administered concurrently, observe patients carefully for signs of lithium toxicity.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This indicates that NSAIDs may enhance the toxicity of methotrexate. Use caution when NSAIDs are administered concomitantly with methotrexate.

Cyclosporine

CAMBIA (diclofenac potassium for oral solution) , like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with CAMBIA (diclofenac potassium for oral solution) may increase cyclosporine's nephrotoxicity. Use caution when CAMBIA (diclofenac potassium for oral solution) is administered concomitantly with cyclosporine.

Inhibitors of Cytochrome P450 2C9

Diclofenac is metabolized predominantly by Cytochrome P-450 CYP2C9. Co-administration of medications that inhibit CYP2C9 may affect the pharmacokinetics of diclofenac [see CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

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, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Inform patients about the signs and 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 increases the risk of serious GI events [see WARNINGS AND PRECAUTIONS].

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following coronary artery bypass graft (CABG) surgery found an increased incidence of myocardial infarction and stroke [see CONTRAINDICATIONS].

Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation

NSAIDs, including CAMBIA (diclofenac potassium for oral solution) , can cause serious gastrointestinal (GI) adverse events such as inflammation, bleeding, ulceration, and perforation of the 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 occur in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. These trends continue with longer duration of use, thus increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term NSAID therapy is not without risk.

Prescribe NSAIDs, including CAMBIA (diclofenac potassium for oral solution) , with extreme caution in patients with a prior history of ulcer disease or GI bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold risk for developing a GI bleed than patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients, and therefore special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, use the lowest effective dose for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during CAMBIA (diclofenac potassium for oral solution) therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the CAMBIA (diclofenac potassium for oral solution) until a serious GI adverse event is ruled out. For high risk patients, alternative therapies that do not include NSAIDs should be considered.

Hepatic Effects

Elevations of one or more liver tests may occur during therapy with CAMBIA (diclofenac potassium for oral solution) . These laboratory abnormalities may progress, may persist, or may only be transient with continued therapy. Borderline elevations (less than 3 times the upper limit of the normal [ULN] range) or greater elevations of transaminases occurred in about 15% of diclofenac-treated patients . Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury.

In clinical trials, 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 treatment (ALT was not measured in all studies). In an open-label, controlled trial of 3,700 patients treated for 2–6 months, patients were monitored 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 the 3,700 patients and included marked elevations ( > 8 times the ULN) in about 1% of the 3,700 patients. In this open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3–8 times the ULN), and marked ( > 8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs.. Almost all meaningful elevations in transaminases were detected before patients became symptomatic.

Abnormal tests occurred during the first 2 months of therapy with 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.

Measure transaminases (ALT and AST) 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.), discontinue CAMBIA (diclofenac potassium for oral solution) immediately.

To minimize the possibility that hepatic injury will become severe between transaminase measurements, 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), and the appropriate action patients should take if these signs and symptoms appear.

To minimize the potential risk for an adverse liver-related event in patients treated with CAMBIA (diclofenac potassium for oral solution) , use the lowest effective dose for the shortest duration possible. Exercise caution when prescribing CAMBIA (diclofenac potassium for oral solution) with concomitant drugs that are known to be potentially hepatotoxic (e.g. acetaminophen, certain antibiotics, antiepileptics). Caution patients to avoid taking nonprescription acetaminophen-containing products while using CAMBIA (diclofenac potassium for oral solution) .

Hypertension

NSAIDs, including CAMBIA (diclofenac potassium for oral solution) , can lead to new onset or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Use NSAIDs, including CAMBIA (diclofenac potassium for oral solution) , with caution in patients with hypertension. Monitor blood pressure closely during the initiation of NSAID treatment and throughout the course of therapy.

Patients taking ACE inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. Use CAMBIA (diclofenac potassium for oral solution) with caution in patients with fluid retention or heart failure.

Renal Effects

Use caution when initiating treatment with CAMBIA (diclofenac potassium for oral solution) in patients with considerable dehydration.

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, heart failure, liver dysfunction, those taking diuretics or ACE inhibitors, 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 CAMBIA (diclofenac potassium for oral solution) in patients with advanced renal disease. Therefore, treatment with CAMBIA (diclofenac potassium for oral solution) is not recommended in patients with advanced renal disease. If CAMBIA (diclofenac potassium for oral solution) therapy must be initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to CAMBIA (diclofenac potassium for oral solution) . CAMBIA (diclofenac potassium for oral solution) is contraindicated in patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. [see CONTRAINDICATIONS].

Serious Skin Reactions

NSAIDs, including CAMBIA (diclofenac potassium for oral solution) , 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 manifestations and to discontinue CAMBIA (diclofenac potassium for oral solution) at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

CAMBIA (diclofenac potassium for oral solution) can cause fetal harm when administered to a pregnant woman. Starting at 30 weeks gestation, CAMBIA (diclofenac potassium for oral solution) and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. If this drug is used during this time period in pregnancy, the patient should be apprised of the potential hazard to a fetus [See Use in Special Populations].

Masking of Inflammation and Fever

The pharmacological activity of NSAIDs in reducing inflammation and possibly fever may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Hematologic Effects

Anemia may occur in patients receiving NSAIDs. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. In patients on long-term therapy with NSAIDs, including CAMBIA (diclofenac potassium for oral solution) , check hemoglobin or hematocrit if they exhibit any signs or symptoms of anemia or blood loss.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible. Carefully monitor patients treated with CAMBIA (diclofenac potassium for oral solution) who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants.

Use in Patients with Pre-existing Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross-reactivity, including bronchospasm, between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, CAMBIA (diclofenac potassium for oral solution) is contraindicated in patients with this form of aspirin sensitivity and should be used with caution in all patients with preexisting asthma.

Monitoring

Because serious GI ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding.

For patients on long-term treatment with NSAIDs, including CAMBIA (diclofenac potassium for oral solution) , periodically perform a CBC and chemistry profile. Discontinue CAMBIA (diclofenac potassium for oral solution) if abnormal liver tests or renal tests persist or worsen.

Phenylketonurics

CAMBIA (diclofenac potassium for oral solution) contains aspartame equivalent to phenylalanine 25 mg per packet.

Patient Counseling Information

Inform patients of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and instruct them to read the Medication Guide prior to using CAMBIA [see Medication Guide].

Cardiovascular Effects

CAMBIA (diclofenac potassium for oral solution) , like other NSAIDS, may cause serious CV events, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, advise patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and to ask for medical advice when observing any indicative sign or symptoms. Inform patients of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Gastrointestinal Effects

CAMBIA (diclofenac potassium for oral solution) , like other NSAIDS, can cause GI discomfort and more serious GI adverse events such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, advise patients to be alert for the signs and symptoms of ulcerations and bleeding, and to ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Inform patients of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flulike” symptoms). Instruct patients to stop therapy with CAMBIA (diclofenac potassium for oral solution) and seek immediate medical therapy if any of these occur [see WARNINGS AND PRECAUTIONS].

Weight Gain and Edema

Advise patients to promptly report to their physicians signs or symptoms of unexplained weight gain or edema during treatment with CAMBIA (diclofenac potassium for oral solution) [see WARNINGS AND PRECAUTIONS].

Anaphylactoid Reactions

Inform patients of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see WARNINGS AND PRECAUTIONS].

Adverse Skin Reactions

CAMBIA (diclofenac potassium for oral solution) , like other NSAIDS, can cause serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrosis (TEN), which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, advise patients to be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and to ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop CAMBIA (diclofenac potassium for oral solution) immediately if they develop any type of rash and to contact their physicians as soon as possible [see WARNINGS AND PRECAUTIONS].

Effects During Pregnancy

Starting at 30 weeks gestation, CAMBIA (diclofenac potassium for oral solution) and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur [see Use in Specific Populations].

Phenylketonurics

CAMBIA (diclofenac potassium for oral solution) packets contain aspartame equivalent to phenylalanine 25 mg per packet.

Non-clinical Studies

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term carcinogenicity studies in rats given diclofenac sodium up to 2 mg/kg/day (less than the recommended human dose [RHD] of 50 mg/day on a body surface area [mg/m2] basis) have revealed no significant increases in tumor incidence. There was a slight increase in benign mammary fibroadenomas in mid-dose treated (0.5 mg/kg/day or 3 mg/m2/day ) female rats (high-dose females had excessive mortality), but the increase was not significant for this common rat tumor. A 2-year carcinogenicity study conducted in mice employing diclofenac sodium at doses up to 0.3 mg/kg/day (less than the RHD on a mg/m2 basis) in males and 1 m/kg/day (less than the RHD on a mg/m2 basis) in females did not reveal any oncogenic potential.

Diclofenac sodium was not genotoxic in in vitro (reverse mutation in bacteria [Ames], mouse lymphoma tk) or in in vivo (including dominant lethal and male germinal epithelial chromosomal aberration in Chinese hamster) assays.

Diclofenac sodium administered to male and female rats at 4 mg/kg/day (less than the RHD on a mg/m2 basis) did not affect fertility.

Use In Specific Populations

Pregnancy

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

Starting at 30 weeks gestation, CAMBIA (diclofenac potassium for oral solution) , and other NSAIDS, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur [see WARNINGS AND PRECAUTIONS]. There are no adequate and well controlled studies in pregnant women.

Prior to 30 weeks gestation, CAMBIA (diclofenac potassium for oral solution) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Reproductive studies have been performed in mice given diclofenac sodium (up to 20 mg/kg/day, 2 times the recommended human dose [RHD] of 50 mg/day on a body surface area [mg/m2 basis), and in rats and rabbits given diclofenac sodium (up to 10 mg/kg/day; 2 [rats] and 4 [rabbits] times the RHD on a mg/m2 basis) and have revealed no evidence of teratogenicity despite the induction of maternal toxicity and fetal toxicity. In rats, maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival.

Labor and Delivery

The effects of CAMBIA (diclofenac potassium for oral solution) on labor and delivery in pregnant women are unknown. In rat studies, maternal exposure to NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, increased the incidence of dystocia, delayed parturition, and decreased pup survival.

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 CAMBIA (diclofenac potassium for oral solution) , 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

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of CAMBIA (diclofenac potassium for oral solution) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Elderly patients are at increased risk for serious GI adverse events.

Diclofenac is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when using CAMBIA (diclofenac potassium for oral solution) in the elderly.

Hepatic Impairment

Because hepatic metabolism accounts for almost 100% of diclofenac elimination, patients with hepatic impairment should be considered for treatment with CAMBIA (diclofenac potassium for oral solution) only if the benefits outweigh the risks. There is insufficient information available to support dosing recommendations for CAMBIA in patients with hepatic insufficiency. [see CLINICAL PHARMACOLOGY].

Renal Impairment

No information is available from controlled clinical studies regarding the use of CAMBIA (diclofenac potassium for oral solution) in patients with advanced renal disease. Therefore, treatment with CAMBIA (diclofenac potassium for oral solution) is not recommended in patients with advanced renal disease. If CAMBIA (diclofenac potassium for oral solution) therapy must be initiated, close monitoring of the patient's renal function is advisable.

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

CONTRAINDICATIONS

  • CAMBIA (diclofenac potassium for oral solution) is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to diclofenac [see WARNINGS AND PRECAUTIONS].
  • CAMBIA (diclofenac potassium 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 [see WARNINGS AND PRECAUTIONS].
  • CAMBIA (diclofenac potassium for oral solution) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

CAMBIA (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug (NSAID). The mechanism of action of CAMBIA (diclofenac potassium for oral solution) , like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition.

Pharmacokinetics

Absorption: Diclofenac is 100% absorbed after oral administration compared to intravenous administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available. In fasting volunteers, measurable plasma levels were observed within 5 minutes of dosing with CAMBIA (diclofenac potassium for oral solution) . Peak plasma levels were achieved at approximately 0.25 hour in fasting normal volunteers, with a range of 0.17 to 0.67 hours. High fat food had no significant effect on the extent of diclofenac absorption, but there was a reduction in peak plasma levels of approximately 70% after a high fat meal. Decreased Cmax may be associated to decreased effectiveness.

Distribution: The apparent volume of distribution (V/F) of diclofenac potassium is 1.3 L/kg.

Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Serum protein binding is constant over the concentration range (0.15-105 µg/mL) achieved with recommended doses.

Metabolism: Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy diclofenac. The major diclofenac metabolite, 4'-hydroxydiclofenac, has very weak pharmacologic activity. The formation of 4'-hydroxy diclofenac is primarily mediated by CPY2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CPY2C8 may also play a role in diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy and 3'-hydroxy- diclofenac. In patients with renal impairment, peak concentrations of metabolites 4'-hydroxy-and 5- hydroxydiclofenac were approximately 50% and 4% of the parent compound after single oral dosing compared to 27% and 1% in normal healthy subjects.

Excretion: Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Little or no free unchanged diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites. Because renal elimination is not a significant pathway of elimination for unchanged diclofenac, dosing adjustment in patients with mild to moderate renal dysfunction is not necessary. The terminal half-life of unchanged diclofenac is approximately 2 hours.

Special Populations

Race: There are no pharmacokinetic differences due to race.

Hepatic Impairment: The liver metabolizes almost 100% of diclofenac; there is insufficient information available to support dosing recommendations for CAMBIA (diclofenac potassium for oral solution) in patients with hepatic insufficiency (5.3, 8.6)

Renal Impairment: In patients with renal impairment (inulin clearance 60-90, 30-60, and < 30 mL/min; N=6 in each group), AUC values and elimination rate were comparable to those in healthy subjects.

Clinical Studies

The efficacy of CAMBIA (diclofenac potassium for oral solution) in the acute treatment of migraine headache was demonstrated in two randomized, double-blind, placebo-controlled trials.

Patients enrolled in these two trials were predominantly female (85%) and white (86%), with a mean age of 40 years (range: 18 to 65). Patients were instructed to treat a migraine of moderate to severe pain with 1 dose of study medication. Patients evaluated their headache pain 2 hours later. Associated symptoms of nausea, photophobia, and phonophobia were also evaluated. In addition, the proportion of patients who were “sustained pain free”, defined as a reduction in headache severity from moderate or severe pain to no pain at 2 hours post-dose without a return of mild, moderate, or severe pain and no use of rescue medication for 24 hours post-dose, was also evaluated. In these studies, the percentage of patients achieving pain freedom 2 hours after treatment and sustained pain freedom from 2 to 24 hours post-dose was significantly greater in patients who received CAMBIA (diclofenac potassium for oral solution) compared with those who received placebo (see Table 2). The percentage of patients achieving pain relief 2 hours after treatment (defined as a reduction in headache severity from moderate or severe pain to mild or no pain) was also significantly greater in patients who received CAMBIA (diclofenac potassium for oral solution) compared with those who received placebo (see Table 2)

Table 2: Percentage of Patients With 2-Hour Pain Freedom, Sustained Pain Freedom 2-24 hours, and 2 Hour Pain Relief Following Treatment

Study 1 CAMBIA (n=265) Placebo (n=257)
2-Hour Pain Free 24% 13%
2-24h Sustained Pain Free 22% 10%
2-Hour Pain Relief 48% 27%
Study 2 CAMBIA (n=343) Placebo (n=347)
2-Hour Pain Free 25% 10%
2-24h Sustained Pain Free 19% 7%
2-Hour Pain Relief 65% 41%

The estimated probability of achieving migraine headache pain freedom within 2 hours following treatment with CAMBIA (diclofenac potassium for oral solution) is shown in Figure 1.

Figure 1. Percentage of Patients With Initial Headache Pain Freedom Within 2 Hours

Percentage of Patients With Initial Headache Pain Freedom Within 2 Hours - Illustration

There was a decreased incidence of nausea, photophobia and phonophobia following administration of CAMBIA (diclofenac potassium for oral solution) , compared to placebo. The efficacy and safety of CAMBIA (diclofenac potassium for oral solution) was unaffected by age or gender of the patient.

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

MEDICATION GUIDE

CAMBIA
(diclofenac potassium for oral solution)

Read the Patient Information that comes with CAMBIA (diclofenac potassium for oral solution) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about CAMBIA (diclofenac potassium for oral solution) ?

CAMBIA (diclofenac potassium for oral solution) , which contains diclofenac, (a non-steroidal anti-inflammatory drug or NSAID), may increase your chance of a heart attack or stroke that can lead to death. This chance is higher:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines, such as CAMBIA (diclofenac potassium for oral solution) , should never be used right before or after a heart surgery called a “coronary artery bypass graft” (CABG).

NSAID medicines, such as CAMBIA (diclofenac potassium for oral solution) , can cause ulcers and bleeding in your stomach and intestines at any time during treatment.

Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • the use of medicines called steroid hormones (corticosteroids) and blood thinners (anticoagulants)
  • longer or regular use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

CAMBIA (diclofenac potassium for oral solution) should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What is CAMBIA (diclofenac potassium for oral solution) ?

CAMBIA (diclofenac potassium for oral solution) is a prescription medicine used to treat migraine attacks in adults. It does not prevent or lessen the number of migraines you have, and it is not for other types of headaches. CAMBIA contains diclofenac potassium (a NonSteroidal Anti-Inflammatory Drugs or NSAID).

How should I take CAMBIA (diclofenac potassium for oral solution) ?

Take CAMBIA (diclofenac potassium for oral solution) exactly as your healthcare provider tells you to take it.

Take 1 dose of CAMBIA (diclofenac potassium for oral solution) to treat your migraine headache:

  • remove one single dose packet from a set of three packets
  • open packet only when you are ready to use it
  • empty contents of packet into 1 to 2 ounces (2 to 4 tablespoons) of water
  • mix well and drink the water and powder mixture
  • throw away empty packet in a safe place and out of the reach of children
  • taking CAMBIA (diclofenac potassium for oral solution) with food may cause a reduction in effectiveness compared to taking Cambia (diclofenac potassium for oral solution) on an empty stomach
  • do not take more CAMBIA (diclofenac potassium for oral solution) than directed by your healthcare provider. In case of overdose, get medical help or contact a Poison Control Center right away.

Who should not take CAMBIA (diclofenac potassium for oral solution) ?

Do not take Cambia (diclofenac potassium for oral solution) :

  • right before or after heart bypass surgery. See “What is the most important information I should know about Cambia (diclofenac potassium for oral solution) ?”
  • if you have or have had an asthma attack, hives, or other allergic reaction with aspirin, diclofenac, or any other NSAID medicine.

Before you take CAMBIA (diclofenac potassium for oral solution) , tell your healthcare provider about all your medical conditions, including if you:

  • have a history of stomach ulcer or bleeding in your stomach or intestines
  • have kidney or liver problems
  • have any allergies to any medicines
  • have chest pain, shortness of breath, irregular heartbeats
  • are pregnant, think you might be pregnant, or are trying to become pregnant. Cambia (diclofenac potassium for oral solution) should not be used by pregnant women, especially during the last 3 months of pregnancy unless directed by your healthcare provider to do so. Cambia (diclofenac potassium for oral solution) may cause problems in your unborn child or complications during your delivery.
  • are breastfeeding or plan to breast-feed. It is not known if CAMBIA (diclofenac potassium for oral solution) passes into your breast milk. You and your doctor should decide if you will take CAMBIA (diclofenac potassium for oral solution) or breast feed. You should not do both.
  • have a headache that is different from your usual migraine

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

CAMBIA (diclofenac potassium for oral solution) and other medicines may affect each other causing side effects. CAMBIA (diclofenac potassium for oral solution) may affect the way other medicines work, and other medicines may affect how CAMBIA (diclofenac potassium for oral solution) works.

Especially tell your doctor if you take

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

What are the possible side effects of CAMBIA (diclofenac potassium for oral solution) ?

Serious side effects include:

  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including life-threatening liver failure
  • asthma attacks in people who have asthma

Get emergency help right away if you have any of the following symptoms of heart attack or stroke:

  • shortness of breath or trouble breathing
  • chest pain
  • swelling of your face or throat
  • weakness in one part or one side of your body
  • slurred speech

Common side effects include:

Stop CAMBIA (diclofenac potassium for oral solution) and call your healthcare provider right away if you have any of the following symptoms:

  • nausea that seems out of proportion to your migraine
  • stomach pain
  • sudden or severe pain in your belly
  • vomit blood
  • blood in your bowel movement or it is black and sticky like tar
  • itching
  • skin rash or blisters with fever
  • yellow skin or eyes
  • swelling of your arms and legs, hands and feet
  • unusual weight gain
  • more tired or weaker than usual
  • flu-like symptoms

Tell your healthcare provider if you have any side effects that bother you or do not go away.

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CAMBIA (diclofenac potassium for oral solution) ?

  • Store CAMBIA (diclofenac potassium for oral solution) in a dry place at room temperature between 59° to 86°F (15° to 30°C).
  • Keep CAMBIA (diclofenac potassium for oral solution) and all medicines out of reach of children.

General information about CAMBIA (diclofenac potassium for oral solution)

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CAMBIA (diclofenac potassium for oral solution) for a condition for which it was not prescribed.
  • Do not give CAMBIA (diclofenac potassium for oral solution) to other people, even if they have the same problem you have. It may harm them.
  • This Medication Guide contains the most important information about CAMBIA (diclofenac potassium for oral solution) . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information written for healthcare professionals.
  • For more information call Kowa Pharmaceuticals America, Inc. at 1-877-334-3464 (weekdays 9 AM to 5 PM EST) or through our web site at: www.kowapharma.com.

What are the ingredients in CAMBIA?

Active ingredients: diclofenac potassium

Inactive ingredients: aspartame (equivalent to 25 mg phenylalanine), flavoring agents (anise and mint), glyceryl behenate, mannitol, potassium bicarbonate, and saccharin sodium.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

MEDICATION GUIDE

CAMBIA
(diclofenac potassium for oral solution)

Read the Patient Information that comes with CAMBIA (diclofenac potassium for oral solution) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about CAMBIA (diclofenac potassium for oral solution) ?

CAMBIA (diclofenac potassium for oral solution) , which contains diclofenac, (a non-steroidal anti-inflammatory drug or NSAID), may increase your chance of a heart attack or stroke that can lead to death. This chance is higher:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines, such as CAMBIA (diclofenac potassium for oral solution) , should never be used right before or after a heart surgery called a “coronary artery bypass graft” (CABG).

NSAID medicines, such as CAMBIA (diclofenac potassium for oral solution) , can cause ulcers and bleeding in your stomach and intestines at any time during treatment.

Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • the use of medicines called steroid hormones (corticosteroids) and blood thinners (anticoagulants)
  • longer or regular use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

CAMBIA (diclofenac potassium for oral solution) should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What is CAMBIA (diclofenac potassium for oral solution) ?

CAMBIA (diclofenac potassium for oral solution) is a prescription medicine used to treat migraine attacks in adults. It does not prevent or lessen the number of migraines you have, and it is not for other types of headaches. CAMBIA contains diclofenac potassium (a NonSteroidal Anti-Inflammatory Drugs or NSAID).

How should I take CAMBIA (diclofenac potassium for oral solution) ?

Take CAMBIA (diclofenac potassium for oral solution) exactly as your healthcare provider tells you to take it.

Take 1 dose of CAMBIA (diclofenac potassium for oral solution) to treat your migraine headache:

  • remove one single dose packet from a set of three packets
  • open packet only when you are ready to use it
  • empty contents of packet into 1 to 2 ounces (2 to 4 tablespoons) of water
  • mix well and drink the water and powder mixture
  • throw away empty packet in a safe place and out of the reach of children
  • taking CAMBIA (diclofenac potassium for oral solution) with food may cause a reduction in effectiveness compared to taking Cambia (diclofenac potassium for oral solution) on an empty stomach
  • do not take more CAMBIA (diclofenac potassium for oral solution) than directed by your healthcare provider. In case of overdose, get medical help or contact a Poison Control Center right away.

Who should not take CAMBIA (diclofenac potassium for oral solution) ?

Do not take Cambia (diclofenac potassium for oral solution) :

  • right before or after heart bypass surgery. See “What is the most important information I should know about Cambia (diclofenac potassium for oral solution) ?”
  • if you have or have had an asthma attack, hives, or other allergic reaction with aspirin, diclofenac, or any other NSAID medicine.

Before you take CAMBIA (diclofenac potassium for oral solution) , tell your healthcare provider about all your medical conditions, including if you:

  • have a history of stomach ulcer or bleeding in your stomach or intestines
  • have kidney or liver problems
  • have any allergies to any medicines
  • have chest pain, shortness of breath, irregular heartbeats
  • are pregnant, think you might be pregnant, or are trying to become pregnant. Cambia (diclofenac potassium for oral solution) should not be used by pregnant women, especially during the last 3 months of pregnancy unless directed by your healthcare provider to do so. Cambia (diclofenac potassium for oral solution) may cause problems in your unborn child or complications during your delivery.
  • are breastfeeding or plan to breast-feed. It is not known if CAMBIA (diclofenac potassium for oral solution) passes into your breast milk. You and your doctor should decide if you will take CAMBIA (diclofenac potassium for oral solution) or breast feed. You should not do both.
  • have a headache that is different from your usual migraine

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

CAMBIA (diclofenac potassium for oral solution) and other medicines may affect each other causing side effects. CAMBIA (diclofenac potassium for oral solution) may affect the way other medicines work, and other medicines may affect how CAMBIA (diclofenac potassium for oral solution) works.

Especially tell your doctor if you take

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

What are the possible side effects of CAMBIA (diclofenac potassium for oral solution) ?

Serious side effects include:

  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including life-threatening liver failure
  • asthma attacks in people who have asthma

Get emergency help right away if you have any of the following symptoms of heart attack or stroke:

  • shortness of breath or trouble breathing
  • chest pain
  • swelling of your face or throat
  • weakness in one part or one side of your body
  • slurred speech

Common side effects include:

Stop CAMBIA (diclofenac potassium for oral solution) and call your healthcare provider right away if you have any of the following symptoms:

  • nausea that seems out of proportion to your migraine
  • stomach pain
  • sudden or severe pain in your belly
  • vomit blood
  • blood in your bowel movement or it is black and sticky like tar
  • itching
  • skin rash or blisters with fever
  • yellow skin or eyes
  • swelling of your arms and legs, hands and feet
  • unusual weight gain
  • more tired or weaker than usual
  • flu-like symptoms

Tell your healthcare provider if you have any side effects that bother you or do not go away.

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CAMBIA (diclofenac potassium for oral solution) ?

  • Store CAMBIA (diclofenac potassium for oral solution) in a dry place at room temperature between 59° to 86°F (15° to 30°C).
  • Keep CAMBIA (diclofenac potassium for oral solution) and all medicines out of reach of children.

General information about CAMBIA (diclofenac potassium for oral solution)

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CAMBIA (diclofenac potassium for oral solution) for a condition for which it was not prescribed.
  • Do not give CAMBIA (diclofenac potassium for oral solution) to other people, even if they have the same problem you have. It may harm them.
  • This Medication Guide contains the most important information about CAMBIA (diclofenac potassium for oral solution) . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information written for healthcare professionals.
  • For more information call Kowa Pharmaceuticals America, Inc. at 1-877-334-3464 (weekdays 9 AM to 5 PM EST) or through our web site at: www.kowapharma.com.

What are the ingredients in CAMBIA?

Active ingredients: diclofenac potassium

Inactive ingredients: aspartame (equivalent to 25 mg phenylalanine), flavoring agents (anise and mint), glyceryl behenate, mannitol, potassium bicarbonate, and saccharin sodium.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Cambia Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DICLOFENAC POWDER PACKETS - ORAL

(dye-KLOE-fen-ak)

COMMON BRAND NAME(S): Cambia

WARNING: Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG).

This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning at any time while taking this drug. Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.)

Stop taking diclofenac and get medical help right away if you notice any of the following rare but serious side effects: bloody or black/tarry stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, slurred speech, sudden vision changes.

Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.

USES: Diclofenac is used to relieve pain from various conditions. This form of diclofenac is used to treat migraine headaches. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking diclofenac 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. Empty the contents of one packet into a cup containing 1 to 2 ounces (30 to 60 milliliters) of water. Mix well and drink all of it right away. Do not mix with any liquid other than water. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. However, if you take this medication with a meal high in fat, it may not work as well.

There are different brands and forms of this medication available. Because different forms do not have the same effects at equal strengths, do not switch forms of diclofenac unless your doctor tells you to.

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. Do not increase your dose or take it more often than prescribed.

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 persists or worsens.

Disclaimer

Cambia Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, constipation, diarrhea, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/pounding heartbeat, hearing changes (such as ringing in the ears), persistent/severe headache, sudden/unexplained weight gain, swelling of the hands/feet, unusual tiredness, vision changes (such as blurred vision).

Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Cambia (diclofenac potassium for oral solution) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), blood disorders (such as anemia, bleeding/clotting problems), kidney disease, liver disease, growths in the nose (nasal polyps), heart disease (such as congestive heart failure, previous heart attack), high blood pressure, stroke, swelling of the ankles/feet/hands, throat/stomach/intestinal problems (such as bleeding, ulcers).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

This medicine may cause stomach/intestinal bleeding. Daily use of alcohol or tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially stomach/intestinal bleeding.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Cambia Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: methotrexate, probenecid, high blood pressure drugs (including ACE inhibitors such as captopril, lisinopril and angiotensin II receptor blockers such as losartan, valsartan), other medications that may affect the kidneys (including cidofovir, cyclosporine, tenofovir, "water pills"/diuretics such as furosemide, hydrochlorothiazide, triamterene).

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Some affected drugs include anti-platelet drugs such as clopidogrel, "blood thinners" such as enoxaparin/warfarin, bisphosphonates such as alendronate, corticosteroids such as prednisone, SSRI antidepressants such as fluoxetine/sertraline, among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include lithium, pemetrexed, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, vomit that looks like coffee grounds, extreme drowsiness, slow/shallow breathing.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress, or to check for side effects. Ask your doctor for more details.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised February 2012. Copyright(c) 2012 First Databank, Inc.

Cambia Patient Information Including Side Effects

Brand Names: Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor

Generic Name: diclofenac (Pronunciation: dye KLOE fen ak)

What is diclofenac (Cambia)?

Diclofenac is a non steroidal anti inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain inflammation.

Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis.

Diclofenac powder (Cambia) is used to treat a migraine headache attack. Do not use this medication to treat a cluster headache.

Cambia will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

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

Cataflam 50 mg

round, beige, imprinted with CATAFLAM, 50

Diclofenac 100 mg ER-TEV

round, pink, imprinted with 93, 1041

Diclofenac 50 mg-GG

round, brown, imprinted with GG 759

Diclofenac 75 mg-GG

round, peach, imprinted with GG 739

Diclofenac Potassium 50 mg-APO

round, brown, imprinted with APO, DP 50

Diclofenac Potassium 50 mg-MYL

round, white, imprinted with M D5

Diclofenac Potassium 50 mg-TEV

round, orange, imprinted with 93 948

Diclofenac Sodium 100 mg ER-MYL

round, yellow, imprinted with M 355

Diclofenac Sodium 100 mg-WAT

round, pink, imprinted with DX41

Diclofenac Sodium 25 mg-GG

round, yellow, imprinted with GG 737

Diclofenac Sodium 50 mg-ROX

round, white, imprinted with 54 592

Diclofenac Sodium 50 mg-WAT

round, white, imprinted with WATSON 338

Diclofenac Sodium 75 mg-WAT

round, white, imprinted with WATSON 339

Diclofenac XR 100 mg-GG

round, brown, imprinted with GG 904

Voltaren 75 mg

triangular, peach, imprinted with Voltaren 75

Voltaren XR 100 mg

round, pink, imprinted with Voltaren XR, 100

What are the possible side effects of diclofenac (Cambia)?

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

Stop using diclofenac and call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain, urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); 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.

Less serious side effects may include:

  • upset stomach, mild heartburn or stomach pain, diarrhea, constipation bloating, gas;
  • dizziness, headache, nervousness;
  • skin itching or rash;
  • blurred vision; or
  • ringing in your ears.

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.

Read the Cambia (diclofenac potassium for oral solution) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about diclofenac (Cambia)?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use diclofenac just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diclofenac, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Ask a doctor or pharmacist before using any cold, allergy, or other pain medicine. Medicines similar to diclofenac are contained in many combination medicines. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Side Effects Centers

Cambia Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking diclofenac (Cambia)?

Do not use diclofenac just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking diclofenac, especially in older adults.

You should not use this medication if you are allergic to diclofenac, or if you have a history of allergic reaction to aspirin or other NSAIDs.

To make sure you can safely take diclofenac, tell your doctor if you have any of these other conditions:

  • a history of heart attack, stroke, or blood clot;
  • heart disease, congestive heart failure, high blood pressure;
  • a history of stomach ulcers or bleeding;
  • liver or kidney disease,
  • asthma;
  • polyps in your nose;
  • a bleeding or blood clotting disorder; or
  • if you smoke.

FDA pregnancy category D. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking diclofenac during the last 3 months of pregnancy may harm the unborn baby. Do not take diclofenac during pregnancy unless your doctor has told you to.

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

Do not give this medicine to a child younger than 18 years old without medical advice.

How should I take diclofenac (Cambia)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

If you switch brands of diclofenac, your dose needs may change. Follow your doctor's instructions about how much medicine to take.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Dissolve the diclofenac powder (Cambia) with 1 to 2 ounces of water. Do not use any other type of liquid. Stir this mixture and drink all of it right away. Diclofenac powder works best if you take it on an empty stomach.

Call your doctor if your headache does not completely go away after taking Cambia. Do not take a second dose of diclofenac powder without your doctor's advice.

Do not crush, chew, or break an enteric-coated pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating.

If you use this medication long-term, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

Side Effects Centers

Cambia Patient Information including If I Miss a Dose

What happens if I miss a dose (Cambia)?

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 (Cambia)?

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

Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, and fainting.

What should I avoid while taking diclofenac (Cambia)?

Ask a doctor or pharmacist before using any cold, allergy, or other pain medicine. Medicines similar to diclofenac are contained in many combination medicines. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid exposure to sunlight or tanning beds. Diclofenac 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 diclofenac (Cambia)?

Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all other medications you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • isoniazid (for treating tuberculosis);
  • lithium (Eskalith, Lithobid);
  • methotrexate (Rheumatrex, Trexall);
  • pronbenecid (Benemid);
  • rifampin (Rifadin, Rifater, Rifamate);
  • secobarbital (Seconal);
  • sertraline (Zoloft);
  • sulfamethoxazole (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);
  • teniposide (Vumon);
  • zafirlukast (Accolate);
  • a diuretic (water pill) such as furosemide (Lasix).
  • steroids (prednisone and others);
  • antifungal medication such as fluconazole (Diflucan) or voriconazole (Vfend);
  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), indomethacin (Indocin), meloxicam (Mobic), and others;
  • cholesterol-lowering medicine such as fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, TriCor, Triglide), fluvastatin (Lescol), or lovastatin (Mevacor, Altoprev, Advicor); or
  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

This list is not complete and other drugs may interact with diclofenac. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about diclofenac.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.01. Revision date: 8/30/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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