ACTONEL ® - Risedronic acid

ACTONEL ® is a drug based on sodium risedronate.

THERAPEUTIC GROUP: Drugs affecting bone metabolism - Bisphosphonates

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications ACTONEL ® - Risedronic acid

ACTONEL ® is used both in the prevention and treatment of post menopausal and cortisone-induced osteoporosis, and of the related complications such as vertebral fractures and hip fractures.

Action mechanism ACTONEL ® - Risedronic acid

ACTONEL ® is a drug based on risedronic acid, an active ingredient belonging to the drug-therapeutic category of bisphosphonates.

These active ingredients are able to selectively reach the bone tissue, preferentially settling at the level of the hydroxyapatite crystals present in the areas of active bone resorption, sensibly modulating the normal bone turnover.

More precisely, through molecular mechanisms that are not yet fully characterized, risedronic acid can selectively inhibit the osteoriasorbent activity of osteoclasts while safeguarding the deponent activity of osteoblasts, thus ensuring a significant increase in bone mineral density.

Studies carried out and clinical efficacy

1. THE EFFECTIVENESS OF THE ADMINISTRATION OF RISEDRONATO / COLECALCIFEROL

The administration for 16 weeks of risedronate and colecalciferol in patients with osteoporosis was more effective than drug therapy with risedronic acid alone in improving bone mineral density.

2. INEFFECTIVE OSTEOPROTEGERIN AS A MARKER OF BONE METABOLISM

Work that rejects the possibility of using some biochemical parameters such as blood concentrations of osteoprotegerin as markers of bone metabolism improvement.

3. RISEDRONIC ACID AND COLONRECTAL CARCINOMA PREVENTION

Very interesting study that shows how exposure to bisphosphonates and in particular to risedronic acid may be associated with a reduction in the risk of developing colorectal carcinomas.

Method of use and dosage

ACTONEL ®

Risedronate sodium tablets 5, 30, 35 and 75 mg:

the dosage of ACTONEL ® must be established by the specialist doctor after having subjected the patient to a careful medical examination.

In light of the particular pharmacokinetic properties of risedronic acid, to optimize the absorption of this product, minimizing the side effects it is necessary that the tablet is ingested with a glass of water, avoiding the intake of food or drinks for following 30 minutes.

Furthermore it is advisable for the patient to maintain the upright position in the following minutes, in order to avoid unpleasant side effects on the esophageal mucosa.

Based on the dosing schedule proposed by the doctor and the type of dosage used, the tablet can be ingested daily or weekly.

Warnings ACTONEL ® - Risedronic acid

The use of bisphosphonates such as risedronic acid should be preceded by a careful medical examination and accompanied by periodic monitoring of the patient's state of health.

The biological efficacy of these drugs has proven to be useful in preventing pathological fractures associated with osteoporosis at the mainly vertebral level, while low is the protective action against femoral fractures.

The ingestion of ACTONEL ® could lead to the appearance of inflammation and oesophageal lesions, or the aggravation of local pathologies already present.

In case of previous hypocalcemia, the correction of the levels of this element, through appropriate cycles of integration with calcium and vitamin D, should be seriously considered before starting the pharmacological treatment with risedronic acid.

The increased risk of osteonecrosis of the jaw in patients taking ACTONEL ® should be seriously considered before any dental treatment and major surgery.

ACTONEL ® contains lactose therefore its use is not recommended in patients suffering from lactose intolerance, lactase enzyme deficiency or glucose-galactose malabsorption.

PREGNANCY AND BREASTFEEDING

The absence of clinical trials conducted on humans and the presence in the literature of works demonstrating the reproductive toxicity of risedronic acid when taken during pregnancy, extend the contraindications to the use of ACTONEL ® also to the gestational period and to the subsequent stage of lactation at the breast.

Interactions

Despite the fact that active ingredients whose contextual assumption is able to alter the normal pharmacokinetic properties of risedronic acid are not known at the moment, it is useful to remember that the concomitant ingestion of polyvalent oligolesities such as calcium, magnesium, iron or aluminum could reduce absorption. intestinal activity of this active ingredient.

Contraindications ACTONEL ® - Risedronic acid

ACTONEL ® is contraindicated in patients with hypocalcemia, reduced renal function and hypersensitivity to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

Despite the side effects described following the use of risedronic acid, they have proved clinically of little relevance and transient, so much so that it does not generally require the suspension of the ongoing therapy, the appearance of headache, constipation, dyspepsia, nausea, abdominal pain, diarrhea, muscle pain -Skeletal, dermatological hypersensitivity reactions have been reported with high frequency among users of ACTONEL ® .