Apo-Ibuprofen

Apo-Ibuprofen

ibuprofen

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Contents
Ibuprofen.
Description
Each tablet contains ibuprofen 200 mg or 400 mg, respectively.
All strengths are gluten and tartrazine-free.
Indications/Uses
For the treatment of rheumatoid arthritis and osteoarthritis.
For the relief of mild to moderate pain accompanied by inflammation in conditions such as musculo-skeletal trauma and post-dental extraction.
For the relief of pain associated with dysmenorrhea.
Dosage/Direction for Use
Adults: Rheumatoid arthritis and osteoarthritis: 1200 mg initial daily dose administered in 3 or 4 divided doses. Depending on the therapeutic response the dose may be adjusted downward or upward keeping the 3 or 4 times a day dosage schedule. The daily dose should not exceed 2400 mg. Maintenance therapy, once maximum response is obtained, varies usually between 800 to 1200 mg/day.
For mild to moderate pain associated with inflammation, dysmenorrhea: 400 mg repeated as required every 4 to 6 hours. The daily dosage should not exceed 2400 mg.
Children: Due to lack of clinical experience, Ibuprofen is not indicated in children under 12.
Overdosage
Symptoms and Treatment: The following cases of overdosage have been reported. A 19 month old child, 1.5 hours after the ingestion of 7 to 10 tablets of Ibuprofen 400 mg, presented apnea, cyanosis and responded only to painful stimuli. After treatment with oxygen, sodium bicarbonate, infusion of dextrose and normal saline, the child was responsive and 12 hours after ingestion appeared completely recovered. Blood levels of ibuprofen reached 102.9 μg/mL 8.5 hours after the accident.
Two other children weighing approximately 10 kg, had taken an estimated 120 mg/kg. There were no signs of acute intoxication or late sequelae. In one child, the Ibuprofen blood level at 90 minutes after ingestion was 700 µg/mL.
A 19 years old male who had taken 8000 mg of Ibuprofen over a period of a few hours complained of dizziness, and nystagmus was observed. After hospitalization, hydration and 3 days bed rest, he recovered without sequelae.
In cases of acute overdosage, the stomach should be emptied by vomiting or lavage.
Because the drug is acidic and is excreted in the urine it is theoretically beneficial to administer alkali and induce diuresis.
Contraindications
Ibuprofen should not be used in patients who have previously exhibited hypersensitivity to it, or in individuals with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to ASA or other nonsteroidal anti-inflammatory agents (see Warnings).
Ibuprofen should not be used in patients with active peptic ulcer, in pediatric patients, pregnant woman and nursing mothers because its safety in such patients has not been established. Ibuprofen has been shown to inhibit prostaglandin synthesis and release, an action which has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals, when nonsteroidal anti-inflammatory drugs were administered late in pregnancy.
Warnings
Anaphylactoid reactions have occurred in patients with known ASA hypersensitivity (see Contraindications).
Peptic ulceration and gastrointestinal bleeding, sometimes severe, have been reported in patients receiving Ibuprofen. Peptic ulceration, perforation, or severe gastrointestinal bleeding can have a fatal outcome and although a few such reports have been received with Ibuprofen, a cause and effect relationship has not been established. Ibuprofen should be given under close supervision to patients with a history of upper gastrointestinal tract disease.
Special Precautions
Blurred, diminished vision, scotomata, and changes in color vision have been reported. Medication should be discontinued if there is any evidence of abnormal ocular manifestation. Patients presenting these changes should be followed up by an ophthalmologist.
Fluid retention and edema have been reported in association with Ibuprofen and the drug should be used cautiously in patients with a history of cardiac decompensation or renal disease.
Ibuprofen, like other nonsteroidal anti-inflammatory agents, can inhibit platelet aggregation but the effect is quantitatively less than that seen with ASA.
Ibuprofen has been shown to prolong bleeding time (but within normal range) in normal subjects. Because this prolonged bleeding effect may be exaggerated in patients with underlying hemostatic defects, Ibuprofen should be used with caution in patients with intrinsic coagulation defects and those on anticoagulant therapy.
When Ibuprofen is added to the treatment program of patients who have been on prolonged corticosteroid therapy and a decision is made to reduce or discontinue this treatment, this should be done gradually to avoid exacerbation of disease or adrenal insufficiency. Patients receiving Ibuprofen should be instructed to report to their physicians any gastrointestinal manifestations, ocular symptoms, skin rash, weight gain or edema.
Aseptic meningitis has been reported in connection with Ibuprofen therapy in patients with systemic lupus erythematosus. Such patients may also develop hypersensitivity reactions to Ibuprofen, such as fever, rash or abnormal function, more often than those with other disorders. Caution should therefore be exercised when considering Ibuprofen therapy for patients with systemic lupus erythematosus.
Non-selective NSAIDs may be associated with a small increase in the absolute risk of cardiovascular events (e.g. myocardial infarction and stroke), especially when used at high doses for long-term treatment.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2,400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1,200 mg/day) is associated with an increased risk of arterial thrombotic events, particularly myocardial infarction. All NSAIDs should be prescribed at the lowest effective dose and the duration of treatment should be periodically reviewed and kept as short as possible. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
All NSAIDs should not be used perioperatively in patients who have recently undergone coronary artery bypass graft (CABG) surgery and revascularization procedures.
Use In Pregnancy & Lactation
Ibuprofen should not be used in patients with active peptic ulcer, in pediatric patients, pregnant woman and nursing mothers because its safety in such patients has not been established. Ibuprofen has been shown to inhibit prostaglandin synthesis and release, an action which has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals, when nonsteroidal anti-inflammatory drugs were administered late in pregnancy.
Adverse Reactions
Gastrointestinal: The most frequently encountered adverse reactions following Ibuprofen administration involve the gastrointestinal tract. Nausea, heartburn, epigastric pain (3 to 9%); vomiting, diarrhea, constipation, abdominal cramps or pain, dyspepsia, bloating or flatulence (1 to 3%); gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, hepatitis, jaundice, abnormal liver function (SGOT, serum bilirubin and alkaline phosphatase) (less than 1%).
CNS: Dizziness (3 to 9%); headache, nervousness (1 to 3%); depression, insomnia (less than 1%). Paresthesias, hallucinations and dream abnormalities have been reported in conjunction with Ibuprofen treatment.
Special Senses: Tinnitus (1 to 3%); amblyopia (blurred and/or diminished vision, scotomata and/or change in color vision) (less than 1%). Any patient with eye complaints during Ibuprofen therapy should have an ophthalmological examination (see Precautions).
Conjunctivitis, diplopia and optic neuritis have been reported but causal relationship with Ibuprofen administration has not been established.
Skin: Rash (including maculopapular type) (3 to 9%); pruritus (1 to 3%); vesiculobullous eruptions, urticaria, erythema multiforme (less than 1%). Alopecia and Stevens-Johnson syndrome have been reported but causal relationship with Ibuprofen administration has not been established.
Hematologic: Leukopenia and decreases in hemoglobin and hematocrit (less than 1%). Rare cases of hemolytic anemia, thrombocytopenia, granulocytopenia and bleeding episodes (purpura, epistaxis, hematuria, menorrhagia) have been reported in conjunction with Ibuprofen administration.
Metabolic: Edema, fluid retention (1 to 3%). Fluid retention generally responds promptly to drug discontinuation (see Precautions).
Cardiovascular: Congestive heart failure in patients with marginal cardiac function, elevated blood pressure (less than 1%). Rare cases of arrhythmias (sinus tachycardia, sinus bradycardia, palpitations) have been reported.
Renal: Rare cases of decreased creatinine clearance, polyuria and azotemia have been reported in conjunction with Ibuprofen treatment, as well as a case of renal papillary necrosis of uncertain etiology.
Endocrine: Rare cases of gynecomastia and hypoglycemic reactions have been reported in conjunction with Ibuprofen administration.
Allergic: Anaphylaxis (see Contraindications) (less than 1%). Fever, serum sickness and lupus erythematosus have been rarely reported in connection with Ibuprofen administration.
Drug Interactions
Coumarin Type Anticoagulants: Several short-term controlled studies failed to show that Ibuprofen affects significantly prothrombin time or a variety of other clotting factors when administered to patients on coumarin-type anticoagulants. However, bleeding has been reported when ibuprofen and other nonsteroidal anti-inflammatory agents have been administered to patients on coumarin-type anticoagulants and therefore, Ibuprofen should be used cautiously in such cases.
ASA: As with other products containing NSAIDs, concomitant administration of ibuprofen and acetylsalicylic acid/aspirin is not generally recommended because of the potential of increased adverse effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid/aspirin on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of ibuprofen 400 mg were taken within 8 h before or within 30 min after immediate release aspirin dosing (81 mg), a decreased effect of acetylsalicylic acid/aspirin on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid/aspirin cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use.
Caution For Usage
Incompatibilities: None Known.
Storage
Store in a cool, dry place. Protect from light.
ATC Classification
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
FC tab 200 mg (yellow, round, identified APO 200) x 1,000's. 400 mg (orange, round, identifies APO 400) x 100's.
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