Ostalon Kaltsy-D

Осталон Кальций-Д Drug photo

The description is actual on 01.04.2015

  • Latin name: Ostalon Calcium-D
  • ATH code: M05BB05
  • Active ingredient: Kolekaltsiferol (Colecalciferolum), Alendronovaya acid (Acidum alendronicum)
  • Producer: GEDEON RICHTER (Hungary)

Structure

The first tablet from a drug set Ostalon Kaltsy-D includes 70 mg of alendronovy acid.

Additional substances: microcrystallic cellulose, silicon dioxide, magnesium stearate, sodium of a kroskarmelloz. Structure of a cover: microcrystallic cellulose, macrogoal 8000, karraginan.

The second tablet from a drug set Ostalon Kaltsy-D includes 10 mkg of a kolekaltsiferol and 600 mg of calcium.
Additional substances: the hydrogenated oil of soybeans, D, L-α-токоферол, gelatin, sucrose, corn starch, polysorbate 80, maltodextrin, kopovidon, microcrystallic cellulose, magnesium stearate, krospovidon. Structure of a cover: sepifilm yellow 4202 (macrogoal, gipromelloz, talc, dye yellow iron oxide, titan dioxide).

Release form

White biconvex tablets of a round form with an engraving of "M14" (contain alendronovy acid). Four tablets in the blister.

Fulvous tablets of oblong shape with a notch on one party (contain kolekaltsiferol and calcium), there is a white kernel inside. Fourteen tablets in the blister.

28 tablets (containing alendronovy acid) in two blisters and 4 tablets (containing kolekaltsiferol and calcium) in one blister; three specified blisters in a pack from paper.

84 tablets (containing alendronovy acid) in six blisters and 12 tablets (containing kolekaltsiferol and calcium) in three blisters; nine specified blisters in a pack from paper.

Pharmacological action

Blocks a bone resorption and normalizes calcium - phosphorus balance.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Osteoresorption blocker at osteoporosis. Active agent is bisfosfonaty, artificial analog of the pyrophosphate organizing a hydroxyapatite of bones.

Being specific non-hormonal inhibitor of osteoclasts, brakes a resorption of tissue of bones, but its forming does not influence. Stimulates bone formation, normalizes positive balance of a resorption and reparation of a bone. Increases the mineral density of a bone tissue, promotes forming of its normal structure and structure.

Calcium the carbonate includes calcium – an important element of electrolytic balance. It is necessary for normal reduction of muscles, transfer of nervous impulses and work of coagulant system of blood. Calcium is to the main inorganic components of a bone tissue, to 99% of the general calcium of an organism is in a bone tissue.

Vitamin D strengthens intestinal absorption of phosphates and calcium, regulates their allocation by kidneys, and also normalizes concentration of calcium in blood.

Pharmacokinetics of alendronovy acid

After the drug use once inside on an empty stomach in the morning absorption reaches 0,64%; at a break between the use of drug and food less than 2 hours – 0,45-0,4%. However similar weakening of absorption significantly does not influence effect of drug. Joint reception of orange juice or coffee lowers bioavailability for 60%.

Active agent at first gets into soft tissues, and then is actively built in bone tissues. Reaction with blood proteins makes 78%. It is not metabolized. The substance which is not built in a bone quickly is removed by kidneys.

Calcium carbonate pharmacokinetics

About 30-50% of orally entered medicine are absorbed in a small bowel. Absorption of calcium amplifies at its deficit and use of a diet with the lowered content of calcium. In blood about 45% of this substance are in a complex with proteins.

Pharmacokinetics of a kolekaltsiferol

Bioavailability at reception with alendronovy acid approaches bioavailability at the isolated reception. To 20% other quantity — with a stake is output with urine.

Indications to use

  • Therapy of osteoporosis in a postmenopause (reduction of risk of changes of a head of a coxofemoral bone or vertebrae).
  • Therapy of osteoporosis at men (reduction of risk of changes of a head of a coxofemoral bone or pelvic bones).
  • Therapy of osteoporosis against long use of glucocorticosteroids.

Contraindications

For alendronovy acid

  • Hypocalcemia.
  • Anomalies of development of a gullet and others, the reducing passability of a gullet, factors.
  • Chronic insufficiency of work of kidneys.
  • The expressed frustration of a mineral exchange.
  • Lack of vitamin D.
  • Inability of the patient to be in vertical position or sitting within half an hour.
  • Hypersensitivity to drug components.
  • Children's age.
  • Pregnancy or lactation.

For a combination of a kolekaltsiferol and calcium carbonate

It is necessary to apply with care Ostalon at diseases of the digestive system in an aggravation phase (gullet diseases, a duodenitis, gastritis, an ulcer).

Side effects

  • Frustration from digestion: dyspepsia, abdominal pains, lock, meteorism, diarrhea, gullet ulcer, abdominal distention, dysphagy, heartburn, vomiting, nausea, gastritis, gullet erosion, esophagitis, melena, oropharyngeal ulcer, esophageal stenosis, perforation, bleeding.
  • Frustration from the musculoskeletal device: ostalgiya, mialgiya, arthralgia.
  • Frustration from nervous activity: irritability, headache.
  • Frustration from touch bodies: sclerite, uveitis.
  • Dermatological frustration: rash, dermahemia, itch, photosensitization.
  • Frustration from a metabolism: hypocalcemia, hypophosphatemia.
  • Allergic reactions: Stephens-Johnson's syndrome, Quincke's disease, small tortoiseshell, toxic epidermal necrolysis.
  • Other frustration: weakness, mialgiya, feeling sick, rash, symptomless hypocalcemia, photosensitization, hyperthermia.

Application instruction of Ostalon (Way and dosage)

The instruction to Kaltsy-D3 orders to take a pill with alendronovy acid on 1 piece weekly. For improvement of absorbability they are used on an empty stomach in the morning in 2 hours prior to reception of food or liquid, washing down with water. Other drinks, food, some medicines are capable to worsen absorption of an alendronat.

For prevention of local irritation of a mucous mouth and a gullet it is recommended in the morning, directly after rise to accept not less than 200 ml of water, and then – a tablet, without allowing it to be dissolved and without chewing. Within the following half an hour it is forbidden to accept horizontal position. It is also forbidden to accept drug before rise from a bed (morning) or before backfilling (evening).

Tablets with kolekaltsiferoly and calcium carbonate accept inside on 1 piece daily, after a dinner or a lunch, washing down with water. The tablet should not be chewed. In day of the use of alendronovy acid medicine should be taken only 3 hours later after use of alendronovy acid.

It is not required from elderly patients of change of a dosage of drug. At clearance of creatinine over 35 ml a minute of change of a dose are also not required.

Overdose

Overdose signs: hypophosphatemia, hypocalcemia, heartburn, esophagitis, ulcer, gastritis, hypercalcemia, anorexia, thirst, vomiting, nausea, abdominal pains, lock, fatigue, weakness, polyuria, ostealgias, giperkaltsiuriyeya, giperkreatininemiya, arrhythmia. At long use emergence of calcification of fabrics is not excluded.

Overdose treatment: the use of milk and antacids is recommended. For prevention of irritation of a gullet it is forbidden to cause vomiting, it is necessary to accept vertical position.

Interaction

Antacids, kaltsiysoderzhashchy means, food, some drugs for oral administration, drinks influence absorption of an alendronat therefore medicines can be accepted inside 1 hour later after Ostalon's use.

Ranitidine is capable to increase bioavailability of drug.

Anti-inflammatory nonsteroid drugs strengthen undesirable effects of drug Ostalon.

Thiazide diuretics reduce calcium removal. Because of increase in risk of emergence of a hypercalcemia concentration of calcium in blood should be controlled periodically during all course of therapy by thiazide diuretics.

Glucocorticosteroids reduce calcium absorption. At treatment by glucocorticosteroids need of increase in a dosage of a kolekaltsiferol and calcium carbonate can appear.

Sharing with ion-exchange resins can reduce vitamin D absorption.

Use of a kolekaltsiferol and calcium carbonate along with Tetracycline is authorized or in 2 hours prior to the Tetracycline use, or 5-6 hours later later.

The combination of a kolekaltsiferol and calcium carbonate increases toxic effects of cardiac glycosides. Patients need to carry out control of level of calcium and an ECG.

Oxalic acid slows down calcium absorption. The patient should not apply the tablets including a combination of a kolekaltsiferol and calcium carbonate within 2 hours after the use of foodstuff with rich with oxalic acid.

At joint purpose of sodium fluoride, a kolekaltsiferol and calcium carbonate, the interval between reception of the specified drugs has to be not less than three hours.

Terms of sale

According to the recipe.

Storage conditions

To store at the room temperature. To protect from children.

Period of validity

2 years.

Special instructions

Drug can cause local irritation of mucous digestive organs. The course of diseases of a digestive tract can be aggravated during treatment with drug Ostalon.

It is necessary to warn the patient that at the admission of one dose of medicine, the passed pill needs to be taken next day in the morning. But it is strictly forbidden to take two pill per day.

It is authorized to begin treatment only after stopping of disturbances of a mineral exchange, a hypocalcemia and gipovitaminoz. Use of an alendronat causes increase in concentration of mineral salts in tissues of bones, can accompany this process asymptomatic change of concentration of phosphorus and calcium. Ensuring sufficient intake of vitamin D and calcium especially important at joint therapy of the patient of a glyukotikosteroidama.

It is recommended to combine treatment with the diet rich with calcium salts.

For avoidance of overdose it is necessary to consider intake of vitamin D from other sources.

Does not influence ability to driving of motor transport.

Analogs

Alendronat, Alendrokern, Alendronat Pliva, Lindron, Alental, Ostealen, Strongos, Osterepar, Foroza, Tevanat, Fosamaks.

Zdravzona

  • Ostalon calcium-d set of the tablet N28+4Chemedica AG
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Section: For joints
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Education: Graduated from the Vitebsk state medical university majoring in "Surgery". At university headed Council of students' scientific society. Professional development in 2010 - in "Oncology" and in 2011 - in "A mammology, visual forms of oncology".

Experience: Work in an all-medical network 3 years the surgeon (The Vitebsk hospital of an emergency medical service, Lioznensky TsRB) and in combination the regional oncologist and the traumatologist. Work farm the representative within a year in the Rubicon company.

Provided 3 improvement suggestions on the subject "Optimization of an Antibioticotherapia depending on Species Composition of Microflora", 2 works took prizes in a republican competition review of student's scientific works (1 and 3 categories).
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