Prastera

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Overview

What is Prastera?

Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77° C and is very slightly soluble in water (< 1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone . The structural formula is represented below:

What does Prastera look like?

What are the available doses of Prastera?

200mg oral softgel capsules supplied in a convenience package with ibuprofen oral tablets 400mg. (§)

What should I talk to my health care provider before I take Prastera?

How should I use Prastera?

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

Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis .

Ibuprofen tablets are indicated for relief of mild to moderate pain.

Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.

Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.

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

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

Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk.

Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease

Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.

The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.

The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See for effects of food on rate of absorption).

The availability of four tablet strengths facilitates dosage adjustment.

In chronic conditions , a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week 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.

Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.

In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.

What interacts with Prastera?

Sorry No Records found

What are the warnings of Prastera?

Sorry No Records found

What are the precautions of Prastera?

Sorry No Records found

What are the side effects of Prastera?

Sorry No records found

What should I look out for while using Prastera?

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen.

Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria , or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see , and ).

Ibuprofen tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft ( CABG ) surgery (see ).

What might happen if I take too much Prastera?

Approximately 1½ hours after the reported ingestion of from 7 to 10 ibuprofen tablets (400 mg), a 19-month old child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic , responding only to painful stimuli. This type of stimulus, however, was sufficient to induce respiration . Oxygen and parenteral fluids were given; a greenish-yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen . Two hours after ingestion the child's condition seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting from 5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By four hours post-ingestion she could be aroused easily, sit by herself and respond to spoken commands. Blood level of ibuprofen was 102.9 μg/mL approximately 8½ hours after accidental ingestion. At 12 hours she appeared to be completely recovered.

In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequelae . Blood level in one child 90 minutes after ingestion was 700 μg/mL — about 10 times the peak levels seen in absorption-excretion studies.

A 19-year old male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness , and nystagmus was noted. After hospitalization, parenteral hydration and three days bed rest, he recovered with no reported sequelae.

In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis . In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen tablets.

How should I store and handle Prastera?

Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5 (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for:Health Science Funding, LLCMorristown, NJ 07960 USA Manufactured by:Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14 Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5 (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for:Health Science Funding, LLCMorristown, NJ 07960 USA Manufactured by:Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14 Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5 (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for:Health Science Funding, LLCMorristown, NJ 07960 USA Manufactured by:Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14 Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5 (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for:Health Science Funding, LLCMorristown, NJ 07960 USA Manufactured by:Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14 Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5 (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for:Health Science Funding, LLCMorristown, NJ 07960 USA Manufactured by:Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14 Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5 (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for:Health Science Funding, LLCMorristown, NJ 07960 USA Manufactured by:Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14 Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5 (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for:Health Science Funding, LLCMorristown, NJ 07960 USA Manufactured by:Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14 Ibuprofen tablets are available in the following strengths: 400 mg (white to off white, round, biconvex, film coated tablets debossed with ‘121' on one side and plain on other side) Blister strips of 5 (NDC 55607-400-10) Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only Manufactured for:Health Science Funding, LLCMorristown, NJ 07960 USA Manufactured by:Marksans Pharma Ltd. Verna, Goa-403 722, India Iss. 03/14

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Ibuprofen tablets contain ibuprofen which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition.

In clinical studies in patients with rheumatoid arthritis and osteoarthritis , ibuprofen tablets have been shown to be comparable to aspirin in controlling pain and inflammation and to be associated with a statistically significant reduction in the milder gastrointestinal side effects (see ). Ibuprofen tablets may be well tolerated in some patients who have had gastrointestinal side effects with aspirin, but these patients when treated with ibuprofen tablets should be carefully followed for signs and symptoms of gastrointestinal ulceration and bleeding. Although it is not definitely known whether ibuprofen tablets causes less peptic ulceration than aspirin, in one study involving 885 patients with rheumatoid arthritis treated for up to one year, there were no reports of gastric ulceration with ibuprofen tablets whereas frank ulceration was reported in 13 patients in the aspirin group (statistically significant p< .001).

Gastroscopic studies at varying doses show an increased tendency toward gastric irritation at higher doses. However, at comparable doses, gastric irritation is approximately half that seen with aspirin. Studies using 51Cr-tagged red cells indicate that fecal blood loss associated with ibuprofen tablets in doses up to 2400 mg daily did not exceed the normal range, and was significantly less than that seen in aspirin-treated patients.

In clinical studies in patients with rheumatoid arthritis, ibuprofen tablets have been shown to be comparable to indomethacin in controlling the signs and symptoms of disease activity and to be associated with a statistically significant reduction of the milder gastrointestinal (see ) and CNS side effects.

Ibuprofen tablets may be used in combination with gold salts and/or corticosteroids.

Controlled studies have demonstrated that ibuprofen tablets are a more effective analgesic than propoxyphene for the relief of episiotomy pain, pain following dental extraction procedures, and for the relief of the symptoms of primary dysmenorrhea.

In patients with primary dysmenorrhea, ibuprofen tablets have been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce resting and active intrauterine pressure, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia .

The ibuprofen in ibuprofen tablets is rapidly absorbed. Peak serum ibuprofen levels are generally attained one to two hours after administration. With single doses up to 800 mg, a linear relationship exists between amount of drug administered and the integrated area under the serum drug concentration vs time curve. Above 800 mg, however, the area under the curve increases less than proportional to increases in dose. There is no evidence of drug accumulation or enzyme induction.

The administration of ibuprofen tablets either under fasting conditions or immediately before meals yields quite similar serum ibuprofen concentration-time profiles. When ibuprofen tablets are administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the extent of absorption. The bioavailability of the drug is minimally altered by the presence of food.

A bioavailability study has shown that there was no interference with the absorption of ibuprofen when ibuprofen tablets were given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide.

Ibuprofen is rapidly metabolized and eliminated in the urine . The excretion of ibuprofen is virtually complete 24 hours after the last dose. The serum half-life is 1.8 to 2.0 hours.

Studies have shown that following ingestion of the drug, 45%to 79%of the dose was recovered in the urine within 24 hours as metabolite A (25%), (+)-2-[p-(2hydroxymethyl-propyl) phenyl] propionic acid and metabolite B (37%), (+)-2-[p-(2carboxypropyl)phenyl] propionic acid; the percentages of free and conjugated ibuprofen were approximately 1%and 14%, respectively.

Non-Clinical Toxicology

Ibuprofen tablets are contraindicated in patients with known hypersensitivity to Ibuprofen.

Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria , or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see , and ).

Ibuprofen tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft ( CABG ) surgery (see ).

Drug Interactions

General Precautions

Ibuprofen tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

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

The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal . In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4%to 16%.

In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients.

Adverse reactions observed during controlled clinical trials at an incidence greater than 1%are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.

Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with ibuprofen tablets has not been established.

Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis . The increases in incidence were slight and still within the ranges reported in the table.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Disclaimer:

Overview

What is Prastera?

What does Prastera look like?

What are the available doses of Prastera?

What should I talk to my health care provider before I take Prastera?

How should I use Prastera?

What interacts with Prastera?

What are the warnings of Prastera?

What are the precautions of Prastera?

What are the side effects of Prastera?

What should I look out for while using Prastera?

What might happen if I take too much Prastera?

How should I store and handle Prastera?

Clinical Information

Chemical Structure

Clinical Pharmacology

Non-Clinical Toxicology

Reference

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Prastera

Overview

What is Prastera?

What does Prastera look like?

What are the available doses of Prastera?

What should I talk to my health care provider before I take Prastera?

How should I use Prastera?

What interacts with Prastera?

What are the warnings of Prastera?

What are the precautions of Prastera?

What are the side effects of Prastera?

What should I look out for while using Prastera?

What might happen if I take too much Prastera?

How should I store and handle Prastera?

Clinical Information

Chemical Structure

Clinical Pharmacology

Non-Clinical Toxicology

Reference

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

Review

Rate this treatment and share your opinion

Helpful tips to write a good review:

Reason for Taking This Treatment

Click the stars to rate this treatment

Effectiveness (required)

Ease of Use (required)

Satisfaction (required)

Write a brief description of your experience with this treatment:

Optional Information

User Reviews & Ratings - losartan oral

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Overall User Ratings

User Reviews Learn about User Reviews

Related to losartan oral

Professional

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User Reviews
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