Vivlodex

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

You may take meloxicam with or without food.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If a child is taking this medication, tell your doctor if the child has any changes in weight. Meloxicam doses are based on weight in children.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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

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.

Serious side effects have been reported with Vivlodex including:

• Cardiovascular thrombotic events. Vivlodex can increase your risk of cardiovascular and heart diseases such as strokes and myocardial infarctions, which can lead to death. Tell your doctor if you have a history of heart disease.
• Gastrointestinal effects. Vivlodex can cause digestive tract problems such as ulcers, bleeding, inflammation, and perforations (small holes). Tell your doctor if you have a history of digestive problems, or if you smoke or frequently drink alcohol. Alert your doctor if you take anticoagulants (blood-thinners) or corticosteroids such as prednisone.
• Hepatic events. Vivlodex c­­an cause damage to the liver and increase liver tests. Tell your doctor if you have a history of liver disease.
• Hypertension. Vivlodex may raise your blood pressure. Tell your doctor if you have a history of high blood pressure or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Congestive heart failure and edema. Vivlodex can increase the chance of congestive heart failure, fluid retention, and weight gain.
• Renal effects. Kidney damage can result from the use of Vivlodex. Tell your doctor if you have a history of kidney disease or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Hypersensitivity reaction. An allergic reaction to Vivlodex can occur. Symptoms of a hypersensitivity reaction include:
  • hives
  • rash
  • difficulty breathing or swallowing
  • itching
  • swelling
• Adverse skin reactions. Vivlodex can lead to dangerous skin reactions. Symptoms of a skin reaction include:
  • rash
  • red, itchy, or scaly skin
  • blisters
  • fever
• Pregnancy. Vivlodex should not be taken past the 30th week of pregnancy.

Vivlodex can cause dizziness. Do not drive or operate heavy machinery until you know how Vivlodex affects you.

Do not take Vivlodex if you:

• are allergic to meloxicam (the active ingredient in Vivlodex)
• have a history of asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs
• will have or have recently had coronary (heart) surgery

If you take too much Vivlodex, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

You may take meloxicam with or without food.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

If a child is taking this medication, tell your doctor if the child has any changes in weight. Meloxicam doses are based on weight in children.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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

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

Avoid taking aspirin while you are taking meloxicam.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to meloxicam. 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.

Meloxicam is an nonsteroidal anti-inflammatory drug (NSAID) used to relieve the symptoms of arthritis (juvenile rheumatoid arthritis, osteoarthritis, and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will only help you as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Arm, back, or jaw pain
• bleeding gums
• bloating
• blood in the urine
• blurred vision
• burning upper abdominal or stomach pain
• canker sores
• chest tightness or heaviness
• chills
• cloudy urine
• cough
• cramping
• dark urine
• decreased frequency or amount of urine
• difficult or labored breathing
• dilated neck veins
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• general tiredness and weakness
• headache
• hives or welts
• increased blood pressure
• increased sensitivity of the skin to sunlight
• increased thirst
• irregular breathing
• itching, redness, or other discoloration of the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• lower side or back pain
• noisy breathing
• pain or discomfort in the arms, jaw, back, or neck
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red or purple spots on the skin
• pounding in the ears
• redness, soreness, or itching skin
• seizures
• severe and continuing nausea
• severe sunburn
• shakiness in the legs, arms, hands, or feet
• skin blisters
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• sores, welting, or blisters
• stomach bloating, burning, cramping, tenderness, or pain
• sweating
• swelling or puffiness of the face
• swollen glands
• trembling or shaking of the hands or feet
• trouble breathing
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• watery or bloody diarrhea
• weight gain or loss
• yellow eyes or skin

• Area rash
• blistering, peeling, or loosening of the skin
• bloody or black, tarry stools
• clay-colored stools
• cold, clammy skin
• continuing vomiting
• cough or hoarseness
• cracks in the skin
• difficulty with swallowing
• fast, weak pulse
• fever with or without chills
• greatly decreased frequency of urination or amount of urine
• joint or muscle pain
• lightheadedness
• loss of heat from the body
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• severe stomach pain
• tightness in the chest
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds

• Difficulty with speaking
• double vision
• inability to move the arms, legs, or facial muscles
• inability to speak
• pains in the chest, groin or legs, especially the calves
• severe headaches of sudden onset
• slow speech
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blue lips, fingernails, or skin
• convulsions (seizures)
• pain in the chest, upper stomach, or throat
• severe stomach pain
• skin rash
• slow or fast heartbeat
• swelling around the eyes, face, lips, or tongue
• weight gain (rapid)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• gas
• heartburn
• indigestion

• Abdominal or stomach pain
• abnormal dreaming
• anxiety
• appetite increased
• bad, unusual, or unpleasant after taste
• belching
• bloated or full feeling
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• change in taste
• changes in vision
• confusion
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased urination
• discharge
• discouragement
• dry mouth
• excess air or gas in the stomach
• excessive tearing
• feeling of constant movement of self or surroundings
• feeling sad or empty
• general feeling of discomfort or illness
• hair loss
• hearing loss
• hot flushes
• irritability
• loss of interest or pleasure
• nausea or vomiting
• nervousness
• pain or burning in the throat
• rapid breathing
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• sensation of spinning
• sleepiness
• stomach upset
• sunken eyes
• tenderness in the stomach area
• thinning of the hair
• thirst
• tiredness
• trouble concentrating
• trouble sleeping
• wrinkled skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• It is used to treat arthritis.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to meloxicam or any other part of Vivlodex.
• If you have an allergy to aspirin or NSAIDs.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
• If you are having trouble getting pregnant or you are having your fertility checked.
• If you are pregnant or may be pregnant. Do not take this medicine if you are in the third trimester of pregnancy. You may also need to avoid Vivlodex at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this medicine during pregnancy.
• If you are taking any other NSAID.
• If you are taking a salicylate drug like aspirin.
• If you are taking pemetrexed.
• If the patient is a child who weighs less than 132 pounds (60 kilograms).

This is not a list of all drugs or health problems that interact with Vivlodex.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Vivlodex (meloxicam) capsules: 5 mg – light pink body with a dark blue cap (imprinted IP-205 on the body and 5 mg on the cap in white ink).

Vivlodex (meloxicam) capsules: 10 mg – pink body and a dark blue cap (imprinted IP-206 on the body and 10 mg on the cap in white ink).

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

Cardiovascular Thrombotic Events

Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2)].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop Vivlodex and seek immediate medical therapy [see Warnings and Precautions (5.3)].

Heart Failure and Edema

Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.5)].

Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4), Warnings and Precautions (5.7)].

Serious Skin Reactions

Advise patients to stop Vivlodex immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [see Warnings and Precautions (5.9)].

Fetal Toxicity

Inform pregnant women to avoid use of Vivlodex and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [see Warnings and Precautions (5.10), Use in Specific Populations (8.1)].

Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of Vivlodex with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2), Drug Interactions (7)]. Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia.

Use of NSAIDs and Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with Vivlodex until they talk to their healthcare provider [see Drug Interactions (7)].

Manufactured (under license from iCeutica Pty Ltd.) for and Distributed by:
Iroko Pharmaceuticals, LLC
Philadelphia, PA 19112

Copyright 2015 Iroko Pharmaceuticals, LLC

ALL RIGHTS RESERVED

Issued: October/2015

Applies to meloxicam: oral capsule, oral suspension, oral tablet

General

The most frequently reported side effects were diarrhea, upper respiratory tract infections, dyspepsia, nausea, abdominal discomfort, and influenza-like symptoms.[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea
Common (1% to 10%): Abdominal discomfort, gastrointestinal (GI) irritation, aggravated dyspepsia, eructation, gastroesophageal reflux disease, upper abdominal pain
Uncommon (0.1% to 1%): Occult or macroscopic GI hemorrhage, gastritis, stomatitis
Rare (0.01% to 0.1%): Colitis, gastroduodenal ulcer, esophagitis
Very rare (less than 0.01%): GI perforation
Frequency not reported: Dry mouth, duodenal ulcer, gastric ulcer, gastritis, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative[Ref]

Cardiovascular

Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Flushing
Rare (less than 0.1%): Palpitations
Frequency not reported: Hot flushes, angina pectoris, cardiac failure, hypotension, myocardial infarction, vasculitis, arrhythmia, palpitation, tachycardia, shock, cardiac failure[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, carpel tunnel syndrome
Uncommon (0.1% to 1%): Somnolence
Frequency not reported: Syncope, convulsions, paresthesia, tremor, taste perversion[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, upper respiratory tract infection, coughing, nasopharyngitis, bronchitis, sinusitis, laryngitis, pleuritic pain, dyspnea, rhinitis
Rare (less than 0.1%): Asthma
Frequency not reported: Bronchospasm[Ref]

Other

Common (1% to 10%): Accident household, edema, fall, influenza-like symptoms, pain, peripheral edema, gravitational edema, fatigue, ear disorder, vertigo, fall
Frequency not reported: Face edema, fever, malaise, weight decreased, weight increased, tinnitus
Postmarketing reports: Meningitis[Ref]

Hematologic

Common (1% to 10%): Anemia
Rare (0.01% to 0.1%): Blood count abnormal, leukopenia, thrombocytopenia
Very rare (less than 0.01%): Agranulocytosis[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, erythematous rash, maculopapular rash, hyperhidrosis, purpura
Uncommon (0.1% to 1%): Angioedema
Rare (0.01% to 0.1%): Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Very rare (less than 0.01%): Dermatitis bullous, erythema multiforme
Frequency not reported: Alopecia, bullous eruption, exfoliative dermatitis, photosensitivity reaction, sweating increased[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity
Uncommon (0.1% to 1%): Allergic reactions
Frequency not reported: Anaphylactoid reaction[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, aggravated arthralgia, joint crepitation, joint effusion, joint swelling, back pain, osteoarthritis, pain in extremity, arthritis, bursitis, muscle spasms, myalgia, rheumatoid arthritis[Ref]

Genitourinary

Common (1% to 10%): Micturition frequency, urinary tract infection, hematuria
Frequency not reported: Acute urinary retention[Ref]

Hepatic

Uncommon (0.1% to 1%): Liver function disorder, ALT increased, AST increased, bilirubinemia
Very rare (less than 0.01%): Hepatitis
Frequency not reported: GGT increased, jaundice, liver failure[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Rare (less than 0.1%): Nightmares, mood alterations
Frequency not reported: Abnormal dreaming, anxiety, confusion, depression, nervousness, disorientation[Ref]

Renal

Very rare (less than 0.01%): Acute renal failure, papillary necrosis, acute tubular necrosis
Frequency not reported: Albuminuria, BUN increased, creatinine increased, interstitial nephritis, renal failure[Ref]

Metabolic

Common (1% to 10%): Dehydration, appetite increased
Uncommon (0.1% to 1%): Sodium retention, hyperkalemia, water retention[Ref]

Ocular

Common (1% to 10%): Cataract
Rare (less than 0.1%): Visual disturbances, conjunctivitis, blurred vision
Frequency not reported: Abnormal vision[Ref]

Some side effects of Vivlodex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.