Ibuprofen

                           Ibuprofen 



PHARMACEUTICAL FORM AND FORMULATION:

 Each TABLET contains: Ibuprofen ................... 400 mg 
                                         Excipient, c.b.p. 1 tablet


INDICATIONS:

IBUPROFEN is an analgesic and anti-inflammatory used for the treatment of painful conditions, accompanied by significant inflammation such as mild rheumatoid arthritis and musculoskeletal disorders (osteoarthritis, lumbago, bursitis, tendinitis, painful shoulder, sprains, sprains, etc.). It is used for the treatment of moderate pain in the postoperative period, dental pain, postepisiotomy, primary dysmenorrhea, headache.


CONTRAINDICATIONS: The use in pregnant or lactating women is not recommended. Its use is not recommended for children under 12 years of age. It will not be administered when there is known sensitivity to the substance or to acetylsalicylic acid.


RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION: It should not be used in pregnancy or lactation, since there are reports that it can cause prolonged pregnancy due to inhibition of delivery, the ductus arteriosus can be closed antepartum causing neonatal primary pulmonary hypertension, as well as hypercoagulability and hyperbilirubinemia have been presented in neonates


SECONDARY AND ADVERSE REACTIONS: In 10 to 15% of patients the administration of IBUPROFENO has been suspended due to intolerance to the substance. From 5 to 15% present data of gastrointestinal intolerance, the most common being epigastralgia, nausea, heartburn, fullness sensation in the gastrointestinal tract, hidden loss of blood is infrequent. Other secondary reactions reported are thrombocytopenia skin rashes, headache, dizziness and blurred vision, in some cases toxic amblyopia, fluid retention and edema. It is advisable to suspend the drug in patients with ocular alterations. Other effects reported with the use of IBUPROFENO are diarrhea, constipation; In asthmatic patients, airway obstruction due to fluid retention has been reported, congestive heart failure or pulmonary edema may occur in patients with borderline cardiac function.


DRUG INTERACTIONS AND OTHER GENDER: Should be administered with caution in patients being treated with derivatives of coumarin, due to its high degree of binding with plasma albumin can displace oral hypoglycemic agents and warfarin, so that it is It is important to assess the dosages of the latter when they are administered together. It can reduce the diuretic and natriuretic effects of furosemide as well as the antihypertensive effects of thiazides, beta-blockers, prazosin and captopril, possibly by inhibiting the synthesis of prostaglandins in the kidneys. 

PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, TERATOGENESIS AND ON FERTILITY: There are no reports of mutagenesis or alterations in fertility with the use of IBUPROFENO and it has not been shown to have carcinogenic action.


DOSAGE AND ROUTE OF ADMINISTRATION: The administration of IBUPROFENO is oral. It is possible to administer daily doses of up to 3,200 mg in divided doses for the treatment of rheumatoid arthritis and osteoarthritis, even though the usual total dose is 1,200 to 1,800 mg, it is also possible to reduce the dose for maintenance purposes for mild pain to moderate, especially in primary dysmenorrhoea the usual dose is 400 mg every 4 to 6 hours as necessary, it can be ingested with milk or food to minimize gastrointestinal side effects. In general, doses of 200 to 400 mg are recommended every 6 hours.


 MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION: Patients who present ocular alterations by the use of IBUPROFENO even at therapeutic doses should immediately suspend its use; in case of accidental or voluntary overdose intake it is advisable to gastric emptying, administration of alkaline substances that neutralize it, as it is an acid, and assess the administration of activated charcoal to avoid drug absorption. In addition to monitoring the patient and keeping it under continuous observation.


RECOMMENDATIONS ON STORAGE: Keep in a fresh and dry place.