Last update April 15, 2024

Безафибрат

Likely Compatibility

Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.

Bezafibrate, like other fibrates, is a fibric acid derivative that lowers elevated triglyceride levels by increasing the activity of lipases that catabolize triglyceride-rich lipoproteins and decreasing LDL cholesterol levels. It also increases those of HDL cholesterol (AEMPS 2014, Actavis 2013, Miller 1998). Oral administration 3 times daily (once daily in its retard form).

At the date of last update we found no published data in relation to lactation.

Its pharmacokinetic data (very high percentage of protein binding and moderately high molecular weight and volume of distribution) make its passage into milk unlikely.

Cholesterol levels are normally increased (by 40%) during pregnancy and lactation in healthy women (Lawrence 2016 p590). Milk cholesterol numbers are very stable even in hypercholesterolemic women and are not severely affected by diet or the mother's nutritional status, leading to the assumption that milk cholesterol is synthesized, at least in part, in the mammary gland (Lawrence 2016, p 289-90). Its normal concentration in breast milk varies from 30 mg/dL in colostrum to 10 - 20 mg/dL in mature milk. (Lawrence 2016 p98, 105 and 767)

It is unlikely that fibrates are capable of altering the lipid composition of milk.

If a fibrate is administered during lactation, it is advisable to choose those with a shorter half-life: Bezafibrate, Gemfibrozil.

Cholesterol is necessary for the development of brain tissue, myelination of nerves and is the basis of many enzymes. Breastfed infants have higher plasma cholesterol levels than those fed artificial formulas and this would protect them against the consequences of hypercholesterolemia in adulthood. (Lawrence 2016 p108)

Infants fed formula substitutes ("artificial milks") do not receive cholesterol in their diet, as these products do not contain cholesterol (Lawrence 2016 p 109 and 215). The amount of cholesterol in breast milk that would remain after the hypothetical cholesterol reduction produced by the medication taken by the mother would still be much higher than that provided by the artificial formulas. (Holmsen 2017)

Discontinuing drug treatment of non-severe hyperlipidemias during the breastfeeding period is not likely to alter the long-term outcome of the disease, especially when breastfeeding can be considered therapeutic. (Lawrence 2016, p. 393)

It seems wise to advise mothers with severe hyperlipidemias to continue medication during lactation. Mothers with moderately high triglyceride and/or cholesterol levels can discontinue drug treatment during the lactation period by monitoring their low density lipoproteins (LDL) and triglyceride levels.

It is advisable to follow a lipid-lowering diet and to practice regular physical activity daily, at least half an hour a day.

For considerations on the appropriateness of lipid-lowering treatment during lactation see Maternal hyperlipidemia, hypercholesterolemia, hypertriglyceridemia.


See below the information of this related product:

Alternatives

  • Colesevelam Hydrochloride (Safe substance and/or breastfeeding is the best option.)
  • Colestipol Hydrochloride (Safe substance and/or breastfeeding is the best option.)
  • Colestyramine (Safe substance and/or breastfeeding is the best option.)
  • Ezetimibe (Safe substance and/or breastfeeding is the best option.)
  • Gemfibrozil (Fairly safe. Mild or unlikely adverse effects. Compatible under certain circumstances. Follow-up recommended. Read Commentary.)
  • Pravastatin Sodium (Safe substance and/or breastfeeding is the best option.)
  • Rosuvastatin Calcium (Safe substance and/or breastfeeding is the best option.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Безафибрат is Bezafibrate in Cyrillic.

Is written in other languages:

Group

Безафибрат belongs to this group or family:

Tradenames

Main tradenames from several countries containing Безафибрат in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 70 - 100 %
Molecular weight 362 daltons
Protein Binding 94 - 96 %
VD 0.24 l/Kg
pKa 3.83 -
Tmax 3 - 4 hours
1 - 2 (retard: 2 - 4) hours

References

  1. Holmsen ST, Bakkebø T, Seferowicz M, Retterstøl K. Statins and breastfeeding in familial hypercholesterolaemia. Tidsskr Nor Laegeforen. 2017 May 23;137(10):686-687. Abstract Full text (link to original source)
  2. Lawrence RA, Lawrence RM. Breastfeeding. A guide for the medical profession. Eighth Edition. Philadelphia: Elsevier; 2016
  3. AEMPS. Bezafibrato. Ficha técnica. 2014 Full text (in our servers)
  4. Actavis. Bezafibrate. Drug Summary. 2013 Full text (in our servers)
  5. Miller DB, Spence JD. Clinical pharmacokinetics of fibric acid derivatives (fibrates). Clin Pharmacokinet. 1998 Abstract

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