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עמוד הבית / איבופן 600 / מידע מעלון לרופא

איבופן 600 IBUFEN 600 (IBUPROFEN)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

קפליות : CAPLETS

Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to about 1.5%. It is assumed that the risk increases with increased dose and duration of therapy.

In animals, the administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses and embryo/foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

• Use of NSAIDs, including Ibufen 600, at about 20 weeks gestation or later in pregnancy may cause foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
• These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
• There have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation.
• Use of NSAIDs should be limited at 20 weeks gestation or later in pregnancy. If the NSAID effectiveness is considered to outweigh the risk to the foetus and the treatment is necessary at 20 weeks gestation or later, limit Ibufen 600 use to the lowest effective dose and shortest duration possible.
• Consider ultrasound monitoring of amniotic fluid if Ibufen 600 treatment at maximum daily dose extends beyond 5 days. Discontinue Ibufen 600 if oligohydramnios or ductus arteriosus constriction occur and follow up according to clinical practice.


During the third trimester of pregnancy, all prostaglandin synthesis inhibitors 
• may expose the foetus to:
-   cardiopulmonary toxicity (premature constriction / closure of the ductus arteriosus and pulmonary hypertension);
-   Renal dysfunction (see above);
• may expose the mother and the neonate at the end of pregnancy, to: -   possible prolongation of bleeding time, an anti-aggregating effect which may occur even with very low doses.
-   inhibition of uterine contractions resulting in delayed or prolonged process of childbirth.

Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.

Breast-feeding
The active ingredient ibuprofen and its metabolites pass into breast milk in low concentrations only. As adverse effects for the infant are not known, an interruption in lactation is usually not indicated during short-time use of ibuprofen. However, if a longer duration of treatment or higher doses are prescribed, early ablactation should be considered.

Fertility
The use of Ibufen 600 may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Ibufen 600 should be considered.

שימוש לפי פנקס קופ''ח כללית 1994 Rheumatoid arthritis & osteoarthritis, mild to moderate pain, dysmenorrhea
תאריך הכללה מקורי בסל 01/01/1995
הגבלות תרופה שאושרה לשימוש כללי בקופ'ח

בעל רישום

DEXCEL LTD, ISRAEL

רישום

040 23 26009 00

מחיר

0 ₪

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לתרופה במאגר משרד הבריאות

איבופן 600

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