Alendronate Pliva - instructions for use, dose, side effects, contraindications

Inhibitor of bone resorption. Refers to the group of bisphosphonates, being an analogue of natural pyrophosphate. Selective action is due to the high affinity of bisphosphonates to the mineral components of the bone.

Suppresses the activity of osteoclasts, thereby reducing the resorption of bone tissue. Restores a positive balance between resorption and bone repair. Increases the mineral density of the bones of the spine, pelvis, etc., promotes the formation of bone tissue with a normal histological structure.

Pharmacokinetics:

Absorbability after a single dose of 70 mg in the morning on an empty stomach 2 hours before breakfast is 0,64%, With a shortened interval between taking the drug and food: 0.46-0.39%. Such a decrease in absorption does not have a significant effect on the effectiveness of the drug. Simultaneous reception of coffee or orange juice reduces bioavailability by 60%.

Distribution: after ingestion, it is temporarily distributed in soft tissues, then quickly incorporated into bone tissue. The connection with plasma proteins is ~ 78%.

Metabolism: There is no data confirming the metabolism of alendronate in the human body.

Excretion:

Alendronate is excreted by the kidneys. The maximum saturation capacity of bone tissue in animals could not be determined by intravenous administration of a cumulative daily dose of 35 mg / kg. Despite the lack of evidence, with kidney disease, there is likely a reduction in alendronate excretion with increased accumulation in bone tissue. The half-life can be more than 10 years.

Indications:

Treatment of osteoporosis in postmenopausal women (reducing the risk of fractures in the spinal vertebrae and the head of the hip).

Contraindications:

Hypersensitivity to any of the components of the drug; abnormalities of the esophagus and other factors that impede the passage of the esophagus (achalasia, stricture, etc.); inability of the patient to remain in the vertical position for 30 minutes; hypocalcemia, severe chronic renal failure (creatinine clearance <35 mL / min); pregnancy, lactation; childhood; vitamin deficiency D; severe disturbances in mineral metabolism; intolerance to galactose, lactase deficiency, or glucose-galactose malabsorption.

Carefully:

Diseases of the digestive tract in the phase of exacerbation (dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer and duodenal ulcer, a serious gastrointestinal disease in the previous 12 months, for example, peptic ulcer, gastrointestinal bleeding, surgery, except for operations on the spastic gastric gatekeeper).

Pregnancy and lactation:

Pregnancy: in the absence of the necessary clinical experience, the use of alendronate during pregnancy is contraindicated.

Breastfeeding period: there is no data on penetration into breast milk; The intake of alendronate in the period of breastfeeding is contraindicated.

Dosing and Administration:

Recommended dose: 70 mg once a week. To ensure optimal absorption, the drug should be taken in the morning on an empty stomach, 2 hours (at least 30 minutes) before the first meal or liquid, squeezed with plain drinking water. Other drinks, including mineral, water, food, a number of drugs can worsen the absorption of alendronate.

To avoid local irritation of the oral mucosa and esophagus in the morning,immediately after getting up from bed, you should drink at least 200 ml of ordinary water, then take the pill without chewing and letting it dissolve in your mouth, within the next 30 minutes you can not accept the horizontal position of the body, after this time you should take breakfast. Do not take the pill in the morning before getting up from bed or in the evening after going to bed.

Elderly patients: dose adjustment is not required.

Renal insufficiency: if renal filtration is> 35 ml / min, dose adjustment is not required, in more severe stages of kidney failure, prescribing the drug is not recommended because of a lack of clinical experience.

Childhood: due to the lack of clinical data, the drug is not prescribed to children.

Side effects:

The following side effects are possible.

Frequent (not less than 1/100, less than 1/10):

Co hand gastrointestinal tract: abdominal pain, indigestion, constipation, diarrhea, flatulence, esophagus ulcer, dysphagia, heartburn.

From the side of the musculoskeletal system: Ostalgia, arthralgia, myalgia.

Co hand central nervous system: headache, irritability.

Infrequent (not less than 1/1000, less than 1/100):

Are common: itching, rash, erythema.

From the gastrointestinal tract: nausea, vomiting, gastritis, esophagitis, erosion of the esophagus, melena.

Rare (not less than 1/10000, less than 1/1000):

Are common: allergic reactions (hives, angiodema, Stevens-Johnson syndrome, toxic epidermal necrolysis); transient symptoms resembling a phase of acute reaction (myalgia, weakness, poor health, rarely - high body temperature) - most often develop at the beginning of treatment; rash; photosensitivity; hypocalcemia (often accompanied by predisposing factors).

From the gastrointestinal tract: narrowing of the esophagus, ulceration of the oropharynx, perforation of the upper gastrointestinal tract, ulcer, bleeding in the upper gastrointestinal tract, however, a causal relationship with the treatment has not been established.

On the part of organs feelings: uveitis, scleritis, episcleritis.

Muscles and bones: osteonecrosis. There are reports of osteonecrosis of the jaw in patients taking bisphosphonates.

Some cases of severe skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Laboratory indicators: temporary, weakly expressed asymptomatic hypocalcemia and hypophosphatemia.

With the use of Alendronate Pliva in a dosage of 10 mg / day, there was an asymptomatic decrease in the concentration of calcium and phosphate in the blood serum by approximately 18 and 10%, respectively. The degree of reduction is less than 2 and 0.65 mmol / l, respectively.

Overdose:

Symptoms: hypocalcemia, hypophosphatemia, side reactions from the upper parts of the digestive tract (heartburn, esophagitis, gastritis, ulcer). Specific treatment is not. It is recommended to take milk, antacids. To avoid irritation of the esophagus, do not induce vomiting, the patient should be placed in a vertical position (standing or sitting).

Interaction:

Calcium, antacids, some oral preparations affect the absorption of alendronate; medicines can be taken inside no earlier than 1 hour after taking alendronate.

Ranitidine increases bioavailability (clinical significance is unknown). Nonsteroidal anti-inflammatory drugs enhance the adverse effects of alendronic acid.

Special studies on drug interactions were not carried out, however, in patients with alendronate, patients taking other oral medications simultaneously participated.At the same time, they did not observe any side effects associated with the simultaneous administration of other drugs.

Special instructions:

Alendronate can cause local irritation of the mucous membranes of the upper gastrointestinal tract. In patients with acute diseases of the upper gastrointestinal tract (dysphagia, diseases of the esophagus, gastritis, duodenitis and peptic ulcer disease), as well as severe gastrointestinal diseases (especially during the previous year) - ulcerative colitis, gastrointestinal bleeding in acute form, surgical interventions in the area of the gastrointestinal tract (except for pyloroplasty), there may be a deterioration in the condition.

There are cases of adverse reactions from the esophagus (esophagitis, ulcer or erosion of the esophagus), sometimes occurring in severe form, requiring in-patient treatment, and complicated by the formation of stricture. Special attention should be paid to the fact that if the signs of esophageal irritation (dysphagia, retrosternal pain during swallowing, the appearance or deterioration of the course of heartburn) appear, the drug should be stopped and consult a doctor.The risk of esophageal involvement is higher in patients who do not follow the rules of taking the drug, or continue treatment in spite of the appearance of signs of esophageal irritation. It is extremely important to inform patients in a timely manner about the importance of adherence to the rules for taking the drug and to make sure that the patient understands this.

Patients should be warned that if they skip the next dose, the missed pill should be taken the next morning. Do not take two tablets in one day, then you need to return to the usual intake of 1 tablet per week on the originally selected day.

If there is a violation of the kidney function: there is no need to adjust the dose for patients with a coefficient of collar filtration (PAA) more than 35 ml / min. If this value is less than 35 ml / min, alendronate is not recommended.

It should take into account the causes of osteoporosis, not depending on the deficiency of estrogens and age characteristics.

Treatment with alendronate should be supplemented with calcium and vitamin intake D.

Treatment can begin only after the elimination of hypocalcemia, disorders of mineral and vitamin metabolism (eg, vitamin deficiency D).

The use of alendronate leads to an increase in the mineral salts content in the bone tissue, the process can be accompanied by an asymptomatic change in the levels of calcium and phosphorus. Ensuring appropriate intake of calcium and vitamin D It is especially important in case of treatment of a patient with glucocorticosteroid drugs. Treatment should be combined with a diet enriched with calcium salts.

The drug contains lactose, so it should not be taken to patients suffering from galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

There are reports of an osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis) in cancer patients receiving mainly intravenous bisphosphonates. Many of these patients also received chemotherapy and glucocorticosteroids. There are also reports of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates.

Prior to the appointment of bisphosphonate therapy to patients with concomitant risk factors (eg cancer, chemotherapy, radiation therapy, the use of glucocorticosteroid drugs,inadequate oral hygiene) it is necessary to undergo dental examination with concomitant preventive treatment of teeth.

Patients on treatment with bisphosphonates should avoid invasive dental procedures whenever possible. In patients who are on therapy with bisphosphonates, with developed osteonecrosis of the jaw, dental surgery can lead to deterioration. If surgical intervention is necessary, it should be taken into account that there is no data on the possibility of reducing the risk of developing an osteonecrosis of the jaw after the bisphosphonate has been discontinued.

The appointments and recommendations of the attending physician should be based on an individual assessment of the benefit / risk ratio for each patient.

Effect on the ability to drive transp. cf. and fur:

Not affects the ability to drive and perform work associated with a high risk of injury, but in the presence of adverse reactions from the body of vision, driving and working mechanisms are contraindicated until the complete disappearance of adverse reactions.

Form release / dosage:

Tablets of 70 mg.

Packaging:

4 tablets in a blister of PVC / PE / PVDC / aluminum foil.1 blister together with instructions for use are placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006735/08

Date of registration:18.08.2008

Expiration Date:Unlimited

The owner of the registration certificate:Pliva of Hrvatska dooPliva of Hrvatska doo Croatia

Manufacturer: & nbsp

PLIVA HRVATSKA, d.o.o. Croatia

Representation: & nbspPliva of Hvartska dooPliva of Hvartska doo

Information update date: & nbsp06.07.2017

Illustrated instructions

Instructions

Alendronate Pliva (Aledronate Pliva)