OPTINATE ® - Risedronic acid

OPTINATE ® 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 OPTINATE ® - Risedronic acid

OPTINATE ® is indicated for the prevention and treatment of osteoporosis secondary to menopause and cortisone therapy.

Mechanism of action OPTINATE ® - Risedronic acid

Risedronic acid is a bisphosphonate particularly used in the clinical setting for the prevention and treatment of post-menopausal osteoporosis and the main complications such as vertebral fractures.

Its therapeutic action is due to its capacity, once taken orally and absorbed at the intestinal level despite the very poor bioavailability, to concentrate in the sites of bone resorption, and probably inhibit the activity of osteoclasts and the related osteolysis process.

This selective action, which spares osteoblasts and the process of neo-deposition of bone matrix, therefore allows to increase bone mineral density, reducing the risk of pathological fractures.

Studies carried out and clinical efficacy

1. BONE MINERAL DENSITY AND FRACTURE RISK

An interesting study that shows how the increase in bone turnover markers and bone mineral density can best reflect the reduction in the risk of bone fractures associated with treatment with risedronic acid.

2. MOLECULAR ACTION MECHANISMS

Experimental study that seeks to characterize the molecular mechanisms underlying the osteoprotective effect of bisphosphonates. The selective action on the activity of osteoclasts seems to be the main biological characteristic today.

3. RISEDRONIC ACID AND PHARMACOTHERAPY OF PROSTATIC CARCINOMA

Treatment with risedronate during the first 6 months of pharmacological treatment of prostate cancer could prevent bone loss following the molecular action of the luteinizing hormone release hormone agonists.

Method of use and dosage

OPTINATE ®

Risedronate sodium 5, 35 and 75 mg tablets:

the dosing schedule related to the intake of risedronic acid strictly depends on the type of dosage used, being able to essentially opt for taking one 5 mg tablet per day, one 35 mg tablet per week or one 75 mg tablet taken consecutively for 2 days a month.

Regardless of the frequency of administration it is necessary to remember to take the drug on an empty stomach avoiding the ingestion of food and liquids in the following 30 minutes, in order to optimize the intestinal absorption of the active ingredient, and to keep the station upright for the same time to avoid the appearance of side effects on the esophageal mucosa.

OPTINATE ® warnings - Risedronic acid

The treatment with risedronic acid must necessarily be supervised by an expert doctor, in order to appropriately assess the therapeutic efficacy and the possible appearance of collateral effects potentially dangerous for the patient's health.

It is useful to remember that the data in the literature show an efficacy of this active principle in the prevention of vertebral fractures associated with osteoporosis, while the incidence of femoral fractures is unfortunately unchanged.

Before or during treatment with OPTINATE ® it could be indicated to make an integration with calcium and vitamin D in order to preserve the correct blood concentrations of this element or to correct them if they were compromised.

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

OPTINATE ® 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 intake of OPTINATE ® is contraindicated during pregnancy and lactation given the presence in the literature of experimental studies demonstrating the potential toxic effects of risedronic acid on the health of the fetus.

Interactions

At the moment there are no studies able to demonstrate the presence of active ingredients capable of interfering with the normal pharmacokinetic and pharmacodynamic properties of risedronic acid.

However, it is important to reiterate that the simultaneous ingestion of food or drinks, especially if characterized by a high content of polycationic elements, could significantly reduce the intestinal absorption of the sodium risedronate.

Contraindications OPTINATE ® - Risedronic acid

OPTINATE ® 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

Taking OPTINATE ® could cause side effects such as headache, constipation, dyspepsia, nausea, abdominal pain, diarrhea, musculoskeletal pain, gastro-oesophageal irritation and dermatological hypersensitivity reactions.

In most cases the aforementioned adverse reactions have proved to be devoid of particular clinical and transient interest, so much so that therapy suspension is required only in exceptional cases.