Higesic-P (Higesic-P) is a nonsteroidal anti-inflammatory drug (NSAID). Higesic-P works by reducing hormones that cause inflammation and pain in the body.
Higesic-P is used to treat mild to moderate pain, osteoarthritis, or rheumatoid arthritis.
Higesic-P may also be used for purposes not listed in this medication guide.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or Higesic-P is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of Higesic-P. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Carefully consider the potential benefits and risks of Higesic-P Extended-Release Tablets and other treatment options before deciding to use Higesic-P Extended-Release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Higesic-P Extended-Release Tablets are indicated:
For relief of signs and symptoms of juvenile arthritis
For relief of the signs and symptoms of rheumatoid arthritis
For relief of the signs and symptoms of osteoarthritis
How should I use Higesic-P?
Use Higesic-P extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Higesic-P extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Higesic-P extended-release tablets refilled.
Take Higesic-P extended-release tablets by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
Swallow Higesic-P extended-release tablets whole. Do not break, crush, or chew before swallowing.
Take Higesic-P extended-release tablets with a full glass of water (8 oz/240 mL) as directed by your doctor.
If you miss a dose of Higesic-P extended-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about the proper use of Higesic-P extended-release tablets.
Uses of Higesic-P in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Higesic-P is used to relieve painful conditions of the bone, joints and soft tissues such as inflammatory arthritis (rheumatoid arthritis) and advanced osteoarthritis.
Higesic-P is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties. Its therapeutic effects are due to its ability to inhibit prostaglandin synthesis. It is indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis.
Generic name: Higesic-P
Dosage form: Capsules and Tablets
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Carefully consider the potential benefits and risks of Higesic-P and other treatment options before deciding to use Higesic-P. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Higesic-P, the dose and frequency should be adjusted to suit an individual patient's needs. As with other NSAIDs, the lowest dose and longest dosing interval should be sought for each patient. Therefore, after observing the response to initial therapy with Higesic-P, the dose and frequency should be adjusted to suit an individual patient's needs.
Dosage adjustment of Higesic-P is generally not required in patients with mild to moderate renal impairment. Higesic-P should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function.
The recommended total daily dose of Higesic-P for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of Higesic-P greater than 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.
Osteoarthritis and Rheumatoid Arthritis
The recommended starting dose of Higesic-P for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.
In chronic conditions, a therapeutic response to therapy with Higesic-P is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
The concomitant administration of antacids has no apparent effect on the extent of absorption of Higesic-P. However, antacids can decrease the peak concentration reached by 15% to 20% but have no detectable effect on the time-to-peak.
When Higesic-P is administered with aspirin, its protein binding is reduced, although the clearance of free Higesic-P is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Higesic-P and aspirin is not generally recommended because of the potential of increased adverse effects.
Cyclosporine, Digoxin, Methotrexate
Higesic-P, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs leading to elevated serum levels of cyclosporine, digoxin, methotrexate, and increase toxicity. Nephrotoxicity associated with cyclosporine may also be enhanced. Patients receiving these drugs who are given Higesic-P, or any other NSAID, and particularly those patients with altered renal function, should be observed for the development of the specific toxicities of these drugs. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Higesic-P has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide. Nevertheless, clinical studies, as well as post marketing observations have shown that Higesic-P 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, the patient should be observed closely for sings of renal failure, as well as to assure diuretic efficacy.
Higesic-P has no apparent pharmacokinetic interaction when administered with glyburide.
NSAIDs have produced an elevation 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. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Phenylbutazone causes increase (by about 80%) in the free fraction of Higesic-P. Although in vivo studies have not been done to see if Higesic-P clearance is changed by coadministration of phylbutazone, it is not recommended that they be coadministered.
Higesic-P has no apparent pharmacokinetic interaction when administered with phenytoin.
The effects of 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 of users of either drug alone. Short-term pharmacokinetic studies have demonstrated that concomitant administration of warfarin and Higesic-P results in reduced protein binding of warfarin, but there was no change in the clearance of free warfarin. There was no significant difference in the pharmacodynamic effect of warfarin administered alone and warfarin administered with Higesic-P as measured by prothrombin time. Thus, concomitant therapy with warfarin and Higesic-P should not require dosage adjustment of either drug. However, caution should be exercised because there have been a few spontaneous reports of prolonged prothrombin times, with or without bleeding, in Higesic-P-treated patients receiving concomitant warfarin therapy.
Drug/Laboratory Test Interactions
The urine of patients who take Higesic-P can give a false-positive reaction for urinary bilirubin (urobilin) due to the presence of phenolic metabolites of Higesic-P. Diagnostic dip-stick methodology, used to detect ketone bodies in urine, has resulted in false-positive findings in some patients treated with Higesic-P. Generally, this phenomenon has not been associated with other clinically significant events. No dose relationship has been observed.
Higesic-P treatment is associated with a small decrease in serum uric acid levels. In clinical trials, mean decreases of 1 to 2 mg/dL were observed in arthritic patients receiving Higesic-P (600 mg to 1000 mg/day) after 4 weeks of therapy. These levels then remained stable for up to 1 year of therapy.
A total of 1552 patients were exposed to Higesic-P Extended-Release Tablets in controlled clinical studies of at least 4 weeks in length and using daily doses in the range of 400 to 1200 mg. In the tabulations below, adverse event rates are generally categorized based on the incidence of events in the first 30 days of treatment with Higesic-P Extended-Release Tablets. As with other NSAIDs, the cumulative adverse event rates may increase significantly over time with extended therapy.
In patients taking NSAIDs, including Higesic-P Extended-Release Tablets, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: gastrointestinal experiences including:
Adverse events that were observed in < 1% of patients in the first 30 days of treatment with Higesic-P Extended-Release Tablets in clinical trials.
GI ulcers (gastric/duodenal)*
other events including:
abnormal renal function*
elevated liver enzymes*
increased bleeding time*
Additional NSAID Adverse Experiences Reported Occasionally with NSAIDs or Higesic-P Extended-Release Tablets Include
Body as a whole - allergic reaction, anaphylactic/anaphylactoid reactions (including shock), chills, fever, sepsis
Cardiovascular system - congestive heart failure, flushing, palpitations, tachycardia, syncope, vasculitis (including necrotizing and allergic)
This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Higesic-P. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking Higesic-P. Older adults may have an even greater risk of these serious gastrointestinal side effects.
Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Higesic-P (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.
Do not drink alcohol while taking Higesic-P. Alcohol can increase the risk of stomach bleeding caused by Higesic-P.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Higesic-P can make your skin more sensitive to sunlight and sunburn may result.
DailyMed. "ETODOLAC: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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