Alti-Piroxicam

Name: Alti-Piroxicam

Before Using Alti-Piroxicam

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of piroxicam in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of piroxicam in the elderly. However, elderly patients may be more sensitive to the stomach side effects (eg, ulcers, bleeding) of piroxicam than younger adults, and are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving piroxicam.

Pregnancy

Pregnancy Category Explanation
1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Amiloride
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Balsalazide
  • Bemiparin
  • Bendroflumethiazide
  • Benzthiazide
  • Betamethasone
  • Betrixaban
  • Bismuth Subsalicylate
  • Bivalirudin
  • Bromfenac
  • Budesonide
  • Bufexamac
  • Bumetanide
  • Cangrelor
  • Celecoxib
  • Ceritinib
  • Certoparin
  • Chlorothiazide
  • Chlorthalidone
  • Choline Magnesium Trisalicylate
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clomipramine
  • Clonixin
  • Clopamide
  • Clopidogrel
  • Cortisone
  • Cyclopenthiazide
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Deflazacort
  • Desipramine
  • Desirudin
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diazoxide
  • Dibenzepin
  • Diclofenac
  • Dicumarol
  • Diflunisal
  • Digoxin
  • Dipyridamole
  • Dipyrone
  • Dothiepin
  • Doxepin
  • Droxicam
  • Duloxetine
  • Edoxaban
  • Enoxaparin
  • Eplerenone
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Feverfew
  • Floctafenine
  • Flufenamic Acid
  • Fluocortolone
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Furosemide
  • Ginkgo
  • Gossypol
  • Heparin
  • Hydrochlorothiazide
  • Hydrocortisone
  • Hydroflumethiazide
  • Ibuprofen
  • Iloprost
  • Imipramine
  • Indapamide
  • Indomethacin
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Lithium
  • Lofepramine
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Magnesium Salicylate
  • Meadowsweet
  • Meclofenamate
  • Mefenamic Acid
  • Melitracen
  • Meloxicam
  • Mesalamine
  • Methotrexate
  • Methyclothiazide
  • Methylprednisolone
  • Metolazone
  • Milnacipran
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Nortriptyline
  • Olsalazine
  • Opipramol
  • Oxaprozin
  • Oxyphenbutazone
  • Paramethasone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Phenyl Salicylate
  • Piketoprofen
  • Piroxicam
  • Polythiazide
  • Pralatrexate
  • Prasugrel
  • Prednisolone
  • Prednisone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C
  • Protriptyline
  • Reboxetine
  • Reviparin
  • Rivaroxaban
  • Rofecoxib
  • Salicylamide
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sibutramine
  • Sodium Salicylate
  • Spironolactone
  • Sulfasalazine
  • Sulindac
  • Tacrolimus
  • Tenoxicam
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Treprostinil
  • Triamterene
  • Trichlormethiazide
  • Trimipramine
  • Trolamine Salicylate
  • Valdecoxib
  • Venlafaxine
  • Vilazodone
  • Vorapaxar
  • Vortioxetine
  • Warfarin
  • Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Alacepril
  • Anisindione
  • Atenolol
  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Betaxolol
  • Bisoprolol
  • Candesartan
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cilazapril
  • Delapril
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Esmolol
  • Fosinopril
  • Imidapril
  • Irbesartan
  • Labetalol
  • Levobunolol
  • Lisinopril
  • Losartan
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Olmesartan
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Practolol
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Telmisartan
  • Temocapril
  • Timolol
  • Trandolapril
  • Valsartan
  • Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Bleeding problems or
  • Blood clots or
  • Congestive heart failure or
  • Dehydration or
  • Edema (fluid retention or body swelling) or
  • Heart attack, recent or
  • Heart or blood vessel disease or
  • Hyperkalemia (high levels of potassium in the blood) or
  • Hypertension (high blood pressure) or
  • Kidney disease or
  • Liver disease or
  • Stomach or intestinal ulcers or bleeding, history of or
  • Stroke, history of—Use with caution. May make these conditions worse.
  • Aspirin-sensitive asthma, history of or
  • Aspirin sensitivity, history of or
  • Kidney disease, severe—Should not be used in patients with these conditions.
  • Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

Proper Use of piroxicam

This section provides information on the proper use of a number of products that contain piroxicam. It may not be specific to Alti-Piroxicam. Please read with care.

For safe and effective use of this medicine, do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Using too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not crush, break, or chew it.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within 1 week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For osteoarthritis and rheumatoid arthritis:
      • Adults—20 milligrams (mg) once a day or 10 mg two times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In Summary

More frequently reported side effects include: heartburn, nausea, and prolonged bleeding time. See below for a comprehensive list of adverse effects.

Usual Adult Dose for Osteoarthritis

Recommended dose: 20 mg orally once a day

Comments:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
-Due to the long half-life, there is a progressive response to treatment over several weeks; the effect of therapy should not be assessed for 2 weeks.

Use: For the relief of signs and symptoms of osteoarthritis.

Precautions

US BOXED WARNINGS: CARDIOVASCULAR RISK AND GASTROINTESTINAL RISK:
-Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use and in patients with CV disease or risk factors for CV disease.
-This drug is contraindicated for the treatment of per-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
-NSAIDs cause an increased 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 a greater risk for serious GI events.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Piroxicam Identification

Substance Name

Piroxicam

CAS Registry Number

36322-90-4

Drug Class

Analgesic Agents

Nonsteroidal Antiinflammatory Agents

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