> TRADENAME (Established name which should always include dosage form)
> Strength
>
> **DESCRIPTION**
>
> TRADENAME \[established name\] is a member of the ???????? group of
> nonsteroidal anti‑inflammatory drugs (NSAIDs). Each \[color
> description\] tablet/capsule contains \[common name\] for oral
> administration. \[Common name is a racemic mixture of \[+\] S‑ and
> \[-\] R‑enantiomers.\] It is a \[description of the chemical substance
> in accordance with the USP, BP or Merck Index\].
>
> The chemical name is ????????. The molecular weight is ?????. Its
> molecular formula is ??? and it has the following structural formula:
>
> \[structure\]
>
> The inactive ingredients in TRADENAME include: (list of inactive
> ingredients).
>
> **CLINICAL PHARMACOLOGY**
>
> **Pharmacodynamics**
>
> TRADENAME is a nonsteroidal anti‑inflammatory drug (NSAID) that
> exhibits anti‑inflammatory, analgesic, and antipyretic activities in
> animal models. The mechanism of action of TRADENAME, like that of
> other NSAIDs, is not completely understood but may be related to
> prostaglandin synthetase inhibition.
>
> **Pharmacokinetics**
>
> ***Absorption***
>
> TRADENAME is ??% absorbed after oral administration \[as compared to
> IV; as compared to solution; or as measured by urinary recovery\] (see
> Table 1). \[TRADENAME\'s low bioavailability is due to ????\]. Food
> (has a, has no) significant effect on {the rate (and) the extent} of
> TRADENAME absorption. \[(The {extent {and} rate} of TRADENAME
> absorption is (decreased, increased) ??% when given with food.) There
> is no significant food effect if the drug is given at least hours
> (before, after) meals.)\] {The antacids A,B,C (and) Drugs X,Y,Z} have
> also been shown (to, not to) significantly (increase, decrease) the
> {extent (and) rate} of TRADENAME absorption \[and concomitant use with
> TRADENAME is contraindicated.\]
>
> TABLE 1.

+-----------------------+----------------------+-----------------------+
| > PK Parameters       | > Normal Healthy     | > Important Special   |
|                       | > Adults             |                       |
+-----------------------+----------------------+-----------------------+
|                       | > (Age Range) \[N =  | > Population(s)       |
|                       | > \]                 |                       |
+-----------------------+----------------------+-----------------------+
|                       |                      | > (Gender, Age,       |
+-----------------------+----------------------+-----------------------+
|                       |                      | > Ethnic group,       |
|                       |                      | > Disease)            |
+-----------------------+----------------------+-----------------------+
|                       |                      | > \[N= \]             |
+-----------------------+----------------------+-----------------------+
| > Absolute            | > Mean (C.V.). and   | > Separate-Column for |
| > Bioavailability     | > 95%                |                       |
+-----------------------+----------------------+-----------------------+
| > (if known)          | > C. I.              | > each important      |
+-----------------------+----------------------+-----------------------+
|                       |                      | > population          |
+-----------------------+----------------------+-----------------------+
| > Tmax                |                      |                       |
+-----------------------+----------------------+-----------------------+
| > Oral Clearance      |                      |                       |
+-----------------------+----------------------+-----------------------+
| > (CL/F )             |                      |                       |
+-----------------------+----------------------+-----------------------+
| > Renal Clearance     |                      |                       |
+-----------------------+----------------------+-----------------------+
| > Apparent Volume of  |                      |                       |
+-----------------------+----------------------+-----------------------+
| > Distribution (V/F,  |                      |                       |
| > Vss/F)              |                      |                       |
+-----------------------+----------------------+-----------------------+
| > {Effective,         | > Separate Row for   |                       |
| > Terminal,           | > each               |                       |
+-----------------------+----------------------+-----------------------+
| > Distribution}       |                      |                       |
| > Half-life           |                      |                       |
+-----------------------+----------------------+-----------------------+

> ***Distribution***
>
> The apparent volume of distribution (Vss/F) of DRUG SUBSTANCE is
> approximately ??? L/kg. DRUG SUBSTANCE is ?? ‑ ?? % bound to plasma
> proteins, primarily to {albumin, glycoproteins, lipoproteins, etc.}.
> Plasma protein binding (is constant, increases, decreases) over the
> concentration range ( ?? ‑ ?? *µ*g/mL) achieved with recommended doses
> \[resulting in increasing free/total ratios with increasing total drug
> concentration\]. \[DRUG SUBSTANCE penetrates into red blood cells with
> a blood/plasma ratio = ?.?\] \[DRUG SUBSTANCE penetrates the
> {blood‑brain, placental} barrier(s) to ? % (see **PRECAUTIONS**).\]
> DRUG SUBSTANCE (is, is not) \[expected to be\] excreted in human milk
> \[based on its physical‑chemical properties\]. \[The nursing infant
> dose would be approximately ? mg/day.)
>
> ***Metabolism***
>
> ?? (number) DRUG SUBSTANCE metabolites have been identified in human
> plasma and urine. \[Several metabolites remain to be identified\]. The
> metabolites include W, X, Y and Z. On chronic dosing, metabolite(s)
> {W, X, Y, Z} (accumulate, do not accumulate) in the plasma of patients
> with normal renal function. Increased plasma levels of metabolite(s)
> {W,X,Y,Z} are observed in patients with renal dysfunction.
> \[Concentrations of metabolite(s) X and Y are approximately ? % of the
> parent compound at steady‑state.\] Studies utilizing human liver
> (microsomes, slices) have demonstrated that cytochrome P~450~ plays an
> important role in DRUG SUBSTANCE metabolism. These *in vitro* findings
> are consistent with the clinical observation that DRUG SUBSTANCE
> metabolism is (increased, reduced) in (smokers, subjects receiving
> DRUG Q). \[Metabolites X and Y undergo further (glucuronidation,
> sulfation) followed by biliary excretion, enterohepatic circulation
> and partial elimination in the feces.\]
>
> DRUG SUBSTANCE\'s metabolites (have, do not have) significant
> pharmacologic activity. \[The major metabolite, W, has been evaluated
> along with DRUG SUBSTANCE in receptor binding studies and *in vivo*
> animal models and has a demonstrated (activity, potency) of
> approximately ? % of the parent drug.\] \[A statement of the rationale
> for the potency estimate should be included, if available.\]
>
> ***Excretion***
>
> Approximately ? % of a TRADENAME dose is excreted unchanged in the
> urine, with ? % of the dose excreted into the urine as parent drug
> plus metabolites. Because renal elimination (is, is not) a significant
> pathway of elimination, dosing adjustment in patients with mild to
> moderate renal dysfunction (is, is not) necessary. The half-life
> (t~1/2~) is ?. In patients with severe renal dysfunction or undergoing
> hemodialysis or continuous ambulatory peritoneal dialysis (CAPD),
> dosing (must, does not need to) be modified. \[Since DRUG SUBSTANCE is
> actively secreted in the urine via the (acid, base) pathway,
> concomitant use of other drugs which are substrates such as (????) for
> this pathway may result in a decrease in DRUG SUBSTANCE renal
> clearance and subsequent increase in plasma levels\].
>
> **Special Populations**
>
> ***Pediatric***
>
> TRADENAME (has, has not) been investigated in pediatric patients ??
> yrs of age. \[Clearance, t~1/2~, {is, is not, are, are not}
> (different, decreased, increased) approximately ? % as compared to the
> adult population.\]
>
> ***Race***
>
> Pharmacokinetics differences due to race (have, have not been)
> identified. \[Because the slow metabolize isozyme of Cytochrome P~450~
> is more prevalent in {Asians, Afro‑Americans, Hispanics, Eskimos,
> American Indians, etc.}, (lower, higher) doses should be used in
> initiating TRADENAME therapy within (this, these) racial group(s).\]
>
> ***Hepatic Insufficiency***
>
> Hepatic metabolism accounts for ? % of TRADENAME elimination, so
> patients with {acute (and) chronic} hepatic disease (may, do not)
> require reduced doses of TRADENAME compared to patients with normal
> hepatic function. \[DRUG SUBSTANCE plasma protein binding may decrease
> in liver disease due to reduced serum albumin (\< ? mg%).\]
>
> ***Renal Insufficiency***
>
> TRADENAME pharmacokinetics (has, has not) been investigated in
> subjects with renal insufficiency. DRUG SUBSTANCE renal clearance
> decreased proportionally with creatinine clearance (CrCI), \[but since
> only ? % of DRUG SUBSTANCE is excreted unchanged in the urine, the
> decrease in total body clearance becomes clinically important in those
> subjects with CrCl \< ? mL/min\]. DRUG SUBSTANCE (is, is not)
> significantly removed from the blood in patients undergoing
> {hemodialysis, CAPD}. DRUG SUBSTANCE plasma protein binding may
> decrease in patients with severe renal deficiency.\]
>
> **CLINICAL STUDIES**
>
> **INDICATIONS AND USAGE**
>
> TRADENAME is indicated:
>
> { ● For reduction of fever \[in patients age ??\].

-   For relief of mild to moderate pain \[in patients age ??\].

-   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.

-   For treatment of primary dysmenorrhea.

-   For acute or long‑term use in the relief of signs and symptoms of
    the

> following:
>
> 1\. Ankylosing spondylitis
>
> 2\. Acute painful shoulder (Acute subacromial bursitis/supraspinatus
> tendinitis)
>
> 3\. Acute gouty arthritis
>
> Put in the product specific indication(s)}
>
> **CONTRAINDICATIONS**
>
> TRADENAME is contraindicated in patients with known hypersensitivity
> to GENERIC NAME. TRADENAME 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
> **WARNINGS ‑ Anaphylactoid Reactions**, and **PRECAUTIONS ‑
> Preexisting Asthma**).
>
> **WARNINGS**
>
> **Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and
> Perforation**
>
> Serious gastrointestinal toxicity, such as inflammation, bleeding,
> ulceration, and perforation of the stomach, small intestine or large
> intestine, can occur at any time, with or without warning symptoms, in
> patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs).
> Minor upper gastrointestinal problems, such as dyspepsia, are common
> and may also occur at any time during NSAID therapy. Therefore,
> physicians and patients should remain alert for ulceration and
> bleeding, even in the absence of previous GI tract symptoms. Patients
> should be informed about the signs and/or symptoms of serious GI
> toxicity and the steps to take if they occur. The utility of periodic
> laboratory monitoring has not been demonstrated, nor has it been
> adequately assessed. Only one in five patients, who develop a serious
> upper GI adverse event on NSAID therapy, is symptomatic. It has been
> demonstrated that upper GI ulcers, gross bleeding or perforation,
> caused by NSAIDs, appear to 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 thus, increasing the likelihood of
> developing a serious GI event at some time during the course of
> therapy. However, even short term therapy is not without risk.
>
> NSAIDs should be prescribed with extreme caution in those with a prior
> history of ulcer disease or gastrointestinal bleeding. 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,
> the lowest effective dose should be used for the shortest possible
> duration.** For high risk patients, alternate therapies that do not
> involve NSAIDs should be considered.
>
> Studies have shown that patients with a *prior history of peptic ulcer
> disease andlor gastrointestinal bleeding* and who use NSAIDs, have a
> greater than 10-fold risk for developing a GI bleed than patients with
> neither of these risk factors. In addition to a past history of ulcer
> disease, pharmacoepidemiological studies have identified several other
> co-therapies or co-morbid conditions that may increase the risk for GI
> bleeding such as: treatment with oral corticosteroids, treatment with
> anticoagulants, longer duration of NSAID therapy, smoking, alcoholism,
> older age, and poor general health status.
>
> **Anaphylactoid Reactions**
>
> As with other NSAIDs, anaphylactoid reactions may occur in patients
> without known prior exposure to TRADENAME. TRAIDENAME should not be
> given to 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 and PRECAUTIONS - Preexisting Asthma**). Emergency
> help should be sought in cases where an anaphylactoid reaction occurs.
>
> **Advanced Renal Disease**
>
> In cases with advanced kidney disease, treatment with TRADENAME is not
> recommended. If NSAID therapy, however, must be initiated, close
> monitoring of the patient\'s kidney function is advisable (see
> **PRECAUTIONS - Renal Effects**).
>
> **Pregnancy**
>
> In late pregnancy, as with other NSAIDs, TRADENAME should be avoided
> because it may cause premature closure of the ductus arteriosus.
>
> **PRECAUTIONS**
>
> **General**
>
> TRADENAME 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 TRADENAME in reducing \[fever and\]
> inflammation may diminish the utility of these diagnostic signs in
> detecting complications of presumed noninfectious, painful conditions.
>
> ***Hepatic Effects***
>
> Borderline elevations of one or more liver tests may occur in up to
> 15% of patients taking NSAIDs including TRADENAME. These laboratory
> abnormalities may progress, may remain unchanged, or may be transient
> with continuing therapy. Notable elevations of ALT or AST
> (approximately three or more times the upper limit of normal) have
> been reported in approximately 1% of patients in clinical trials with
> NSAIDs. In addition, rare cases of severe hepatic reactions, including
> jaundice and fatal fulminant hepatitis, liver necrosis and hepatic
> failure, some of them with fatal outcomes have been reported.
>
> A patient with symptoms and/or signs suggesting liver dysfunction, or
> in whom an abnormal liver test has occurred, should be evaluated for
> evidence of the development of a more severe hepatic reaction while on
> therapy with TRADENAME. If clinical signs and symptoms consistent with
> liver disease develop, or if systemic manifestations occur (e.g.,
> eosinophilia, rash, etc.), TRADENAME should be discontinued.
>
> ***Renal Effects***
>
> Caution should be used when initiating treatment with TRADENAME in
> patients with considerable dehydration. It is advisable to rehydrate
> patients first and then start therapy with TRADENAME. Caution is also
> recommended in patients with pre-existing kidney disease (see
> **WARNINGS - Advanced Renal Disease**).
>
> As with other NSAIDs, long-term administration of TRADENAME has
> resulted in renal papillary necrosis and other renal medullary
> changes. Renal toxicity has also been seen in patients in which renal
> prostaglandins have a compensatory role in the maintenance of renal
> perfusion. In these patients, administration of a nonsteroidal
> anti-inflammatory drug may cause a dose-dependant 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 and ACE inhibitors,
> and the elderly. Discontinuation of nonsteroidal anti-inflammatory
> drug therapy is usually followed by recovery to the pretreatment
> state.
>
> \[TRADENAME metabolites are eliminated primarily by the kidneys. The
> extent to which the metabolites may accumulate in patients with renal
> failure has not been studied. As with other NSAIDs, metabolites of
> which are excreted by the kidney, patients with significantly impaired
> renal function should be more closely monitored.\]
>
> ***Hematological Effects***
>
> Anemia is sometimes seen in patients receiving NSAIDs, including
> TRADENAME. This may be due to fluid retention, GI loss, or an
> incompletely described effect upon erythropoiesis. Patients on
> long-term treatment with NSAIDs, including TRADENAME, should have
> their hemoglobin or hematocrit checked if they exhibit any signs or
> symptoms of anemia.
>
> All drugs which inhibit the biosynthesis of prostaglandins may
> interfere to some extent with platelet function and vascular responses
> to bleeding.
>
> NSAIDs inhibit platelet aggregation and have been shown to prolong
> bleeding time in some patients. Unlike aspirin, their effect on
> platelet function is quantitatively less, of shorter duration, and
> reversible. TRADENAME does not generally affect platelet counts,
> prothrombin time (PT), or partial thromboplastin time (PTT). Patients
> receiving TRADENAME who may be adversely affected by alterations in
> platelet function, such as those with coagulation disorders or
> patients receiving anticoagulants, should be carefully monitored.
>
> ***Fluid Retention and Edema***
>
> Fluid retention and edema have been observed in some patients taking
> NSAIDs. Therefore as with other NSAIDs, TRADENAME should be used with
> caution in patients with fluid retention, hypertension, or heart
> failure.
>
> ***Preexisting 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 nonsteroidal
> anti‑inflammatory drugs has been reported in such aspirin‑sensitive
> patients, TRADENAME should not be administered to patients with this
> form of aspirin sensitivity and should be used with caution in
> patients with preexisting asthma.
>
> **Information for Patients**
>
> TRADENAME, like other drugs of its class, can cause discomfort and,
> rarely, more serious side effects, such as gastrointestinal bleeding,
> which may result in hospitalization and even fatal outcomes. Although
> serious GI tract ulcerations and bleeding can occur without warning
> symptoms, patients should be alert for the signs and symptoms of
> ulcerations and bleeding, and should ask for medical advice when
> observing any indicative sign or symptoms. Patients should be apprised
> of the importance of this follow-up (see **WARNINGS, Risk of
> Gastrointestinal Ulceration, Bleeding and Perforation**).
>
> Patient should report to their physicians signs or symptoms of
> gastrointestinal ulceration or bleeding, skin rash, weight gain, or
> edema.
>
> Patients should be informed of the warning signs and symptoms of
> hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice,
> right upper quadrant tenderness, and \"flu-like\" symptoms). If these
> occur, patients should be instructed to stop therapy and seek
> immediate medical therapy.
>
> Patients should also be instructed to seek immediate emergency help in
> the case of an anaphylactoid reaction (see **WARNINGS**).
>
> In late pregnancy, as with other NSAIDs, TRADENAME should be avoided
> because it will cause premature closure of the ductus arteriosus.
>
> **Laboratory Tests**
>
> Patients on long-term treatment with NSAIDs, should have their CBC and
> a chemistry profile checked periodically. If clinical signs and
> symptoms consistent with liver or renal disease develop, systemic
> manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal
> liver tests persist or worsen, TRADENAME should be discontinued.
>
> **Drug Interactions**
>
> ***Aspirin***
>
> \[When TRADENAME is administered with aspirin, its protein binding is
> reduced, although the clearance of free TRADENAME is not altered. The
> clinical significance of this interaction is not known; however,\] as
> with other NSAIDs, concomitant administration of GENERIC NAME and
> aspirin is not generally recommended because of the potential of
> increased adverse effects.
>
> ***Methotrexate***
>
> 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.
>
> ***ACE-inhibitors***
>
> 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.
>
> ***Furosemide***
>
> Clinical studies, as well as post marketing observations, have shown
> that TRADENAME 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 signs
> of renal failure (see **PRECAUTIONS, Renal Effects**), as well as to
> assure diuretic efficacy.
>
> ***Lithium***
>
> 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.
>
> ***Warfarin***
>
> 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 users of either drug alone.
>
> **Drug/Laboratory Test Interactions** *Only if positive interactions
> have been observed. \[See 201.57(f)(4)(ii)\]*
>
> **Carcinogenesis, Mutagenesis, Impairment of Fertility** *Usually only
> if significant findings have been observed. \[See 201.57(f)(5)\]*
>
> **Pregnancy**
>
> ***Teratogenic Effects: Pregnancy Category C***
>
> Reproductive studies conducted in rats and rabbits have not
> demonstrated evidence of developmental abnormalities. However, animal
> reproduction studies are not always predictive of human response.
> There are no adequate and well-controlled studies in pregnant women.
>
> ***Nonteratogenic Effects***
>
> Because of the known effects of nonsteroidal anti-inflammatory drugs
> on the fetal cardiovascular system (closure of ductus arteriosus), use
> during pregnancy (particularly late pregnancy) should be avoided.
>
> **Labor and Delivery**
>
> In rat studies with NSAIDs, as with other drugs known to inhibit
> prostaglandin synthesis, an increased incidence of dystocia, delayed
> parturition, and decreased pup survival occurred. The effects of
> TRADENAME on labor and delivery in pregnant women are unknown.
>
> **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 TRADENAME, 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 below the age of ???
> \[have, have not\] been established.
>
> **Geriatric Use**
>
> As with any NSAIDs, caution should be exercised in treating the
> elderly (65 years and older).
>
> **ADVERSE REACTIONS**
>
> In patients taking TRADENAME or other NSAIDs, the most frequently
> reported adverse experiences occurring in approximately 1 -10% of
> patients are:
>
> gastrointestinal experiences including: abdominal pain, constipation,
> diarrhea , dyspepsia flatulence, gross bleeding/perforation,
> heartburn, nausea, GI ulcers (gastric/duodenal), vomiting;
>
> abnormal renal function, anemia, dizziness, edema, elevated liver
> enzymes, headaches, increased bleeding time, pruritus, rashes,
> tinnitus
>
> Additional adverse experiences reported occasionally include:
>
> 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;
>
> Hermic 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, pruritus, sweat;
>
> Special senses - blurred vision;
>
> Urogenital system ‑ cystitis, dysuria, hematuria, interstitial
> nephritis, oliguria/polyuria, proteinuria, renal failure.
>
> Other adverse reactions, which occur rarely are:
>
> Body as a whole - anaphylactic reactions, appetite changes, death;
>
> Cardiovascular system - arrhythmia, hypotension, myocardial
> infarction, palpitations, vasculitis;
>
> Digestive system - 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 - respiratory depression, pneumonia;
>
> Skin and appendages - angioedema, toxic epidermal necrosis, erythema
> multiforma, exfoliative dermatitis, Stevens Johnson syndrome,
> urticaria;
>
> Special senses - conjunctivitis, hearing impairment.
>
> **OVERDOSAGE**
>
> Symptoms following acute NSAIDs 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 NSAIDs 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.
>
> **DOSAGE AND ADMINISTRATION**
>
> As with other NSAIDs, the lowest dose should be sought for each
> patient. Therefore, after observing the response to initial therapy
> with TRADENAME, the dose and frequency should be adjusted to suit an
> individual patient\'s needs.
>
> For the relief of ????, the recommended dose is ??? mg given orally ??
> times per day.
>
> \[Different dose strengths and formulations \[i.e., capsules, tablets,
> suspensions\] of the drug are not necessarily bioequivalent. This
> difference should be taken into consideration when changing
> {formulation (type, strength)}.\]
>
> **HOW SUPPLIED**
>
> (For each potency, the following in tabular format as follows:)
>
> Dosage, description (e.g., shape, color, scoring, etc.)
>
> Size 1 NDC \#
>
> Size 2 NDC \#
>
> Size 3 NDC \#
>
> (Special handling and storage conditions)
>
> Caution: Federal law prohibits dispensing without prescription.
>
> The date, identified as such, of the most recent revision of the
> labeling.
>
> Name and place of business of the manufacturer, packer, and/or
> distributor as required.
>
> Revised 12/19/96