Ibandronic acid tabs 150mg #1

Ibandronic acid user manual

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Composition

The tablet contains the active ingredient Ibandronic acid (2.5 mg or 150 mg), as well as additional ingredients: povidone, silicon dioxide, anhydrous colloid, lactose monohydrate, stearic acid, crospovidone, MCC. The tablet shell consists of titanium dioxide, hypromellose, talc, macrogol 6000. Ibandronic acid IV in the composition contains the active substance ibandronic acid (3 mg), as well as auxiliary ingredients: sodium chloride, sodium acetate trihydrate, acid acetic ice, water.

Form of issue

The medicine Ibandronic acid is manufactured in the form of tablets and a solution for intravenous administration.
    Tablets of 2.5 mg cover the film membrane, they are slightly biconvex, oval, have a white or slightly white color. On one side of the tablet is engraved "I T", on the other hand - "L 3". Tablets containing 2.5 mg ibandronic acid, blistere 14 pcs., In the bundle two blisters.
    Ibandronic acid 150 mg tablets cover the film membrane, they are oblong, oval, have a white or slightly white color. On one side of the tablet is engraved "BNVA", on the other hand - "150". Tablets containing 150 mg ibandronic acid, blistere 1 or 3 pcs., In a bundle one blister.
    The drug in the form of a solution is a colorless transparent liquid. It is contained in a special syringe tube of 3 ml, the kit also includes a sterile needle. The syringe is placed in a cardboard box.

pharmachologic effect

The ibandronic acid component is a highly active bisphosphonate containing nitrogen. This substance is an inhibitor of bone resorption and osteoclast activity. Under its influence, the destruction of the bone is prevented, which is caused by blockade of the function of the sexual glands, retinoids, and tumors.
The agent does not disrupt the process of bone mineralization and does not affect the replenishment of the osteoclast pool. The active ingredient selectively affects the bone tissue, which is due to its significant affinity for hydroxyapatite, which is the mineral matrix of the bone.
The active component of Ibandronic acid's medication stops bone resorption and does not directly affect the process of bone tissue formation. When taking drugs during the menopause, there is a decrease in the rate of bone tissue renewal to the level observed in the reproductive age. As a result, there is a general increase in bone mass, bone collagen degradation decreases, and the incidence of fractures decreases.
Due to the high activity of the drug and a wide therapeutic range, flexible dosing and the intermittent administration of Ibandronic acid with a long period without treatment are acceptable.

Pharmacokinetics and pharmacodynamics

There was no direct dependence of the action of ibandronic acid on the concentration of the component in the plasma.
After oral intake, rapid absorption of ibandronic acid is noted, absorption occurs in the upper gastrointestinal tract. A dose-dependent increase in the concentration of the active substance in the plasma is noted. The highest concentration is achieved 0.5-2 hours after the drug was taken on an empty stomach. The level of absolute bioavailability is 0.6%. At reception with meal the process of absorption is broken, it is possible to wash down tablets pure water. With simultaneous intake of food, the level of bioavailability is reduced by 90%. When using the drug 1 hour before meals, the level of bioavailability does not decrease.
After the substance enters the bloodstream, it quickly binds to the bone tissue or is removed from the body. Approximately 40-50% of the substance that circulates in the blood, penetrates into the bone tissue and accumulates.
With blood proteins binds to 85% with oral intake and 85-87% - when taking Ibandronic acid in / in.
There is no evidence that the active substance is metabolized.
Approximately half the dose binds to the bone tissue, the part that remains unbound is excreted unchanged in the urine.
The elimination half-life for tablets 2.5 mg is 10-60 hours, for Ibandronic acid 150 mg and for iv solution 10-72 hours. After oral administration 8 hours later and 3 hours after IV introduction, the concentration of the active substance decreases to 10%.

Indications for use

Tablets and Ibandronic acid injections are indicated for use in preventing fractures in women with postmenopausal osteoporosis in order to reduce the fragility of bones.

Contraindications

The preparation Ibandronic acid in all forms is contraindicated in such cases:
    high sensitivity to the ingredients of drugs;
    hypocalcemia (must be eliminated before treatment starts).
Contraindications for Ibandronic acid 2.5 mg and IV solution:
    pregnancy and breastfeeding;
    age of the patient under 18 (tablets);
    impaired renal function in severe form (solution).
Assign the drug with caution in acute conditions in the stomach and esophagus, duodenitis, Barrett's esophagus, dysphagia, gastritis.

Side effects

In the process of treatment, a number of side effects common to all forms of Ibandronic acid's medicine may appear:
    digestive system: gastritis, dyspepsia, diarrhea;
    nervous system: dizziness, headaches;
    skin: a rash;
    allergic manifestations: urticaria, angioedema;
    other manifestations: influenza-like syndrome, in very rare cases - osteonecrosis of the jaw.
Side effects with Ibandronic acid tablets:
    digestive system: duodenitis, ulcer or stricture of the esophagus, esophagitis;
    general manifestations: a state of weakness, pain in the back.
Side effects with Ibandronic acid 150 mg tablets:
    digestive system: dysphagia, vomiting, nausea, abdominal pain, reflux, flatulence;
    musculoskeletal system: muscle spasm, stiffness of muscles.
Side effects when using Ibandronic acid IV:
    a short decrease in the level of calcium in the blood;
    digestive system: gastroenteritis, constipation;
    osteo-muscular system: osteoarthritis, pain in the limbs, bones;
    nervous system: depression, insomnia;
    common manifestations: reactions at the injection site, weakness, phlebitis, thrombophlebitis, cystitis, nasopharyngitis, bronchitis, urinary tract infections, scleritis, upper respiratory tract infections, hypertension, uveitis, hypercholesterolemia.

Instructions for use Ibandronic acid (Method and dosage)

Ibandronic acid tablets, instructions for use

The drug in the form of tablets should be taken orally, washed down with water (a full glass), in a standing or sitting position. Drink mineral water because it contains a large amount of calcium. After taking the pill for 60 minutes you can not go to bed. Do not dissolve or chew the pill, as the risk of ulcers on the esophagus increases.

Ibandronic acid 2.5 mg should be taken once a day for one tablet. This should be done 1 hour before the first meal of the day.

Ibandronic acid 150 mg should be taken 1 tablet once a month. The pill should be taken on the same day. If the next appointment was missed, you need to drink the pill right away, as soon as possible. Next, you need to follow the schedule prescribed by the doctor. It is strictly forbidden to take two tablets 150 mg per week.

Solution Ibandronic acid, instructions for use

Used only for intravenous use. Do not allow the medication to enter the surrounding tissue. For injection use those needles that come with a syringe tube. It is shown to administer intravenously 3 mg bolus (the administration lasts 15-30 s) once every three months. Additionally, calcium and vitamin D are indicated.
If the injection was missed, you need to enter it as soon as possible. Further, the administration of the agent is continued 3 months after the last administration. You can not inject a drug more than once every three months.
During the treatment period, it is important to monitor the content of phosphorus, magnesium, calcium in the serum, as well as control of kidney function.

Overdose

When an overdose of tablets in the patient may be noted esophagitis, gastritis, hypocalcemia, dyspepsia, heartburn, hypophosphatemia, ulcer.
For the purpose of binding ibandronic acid, it is necessary to take antacids, milk. Do not induce vomiting, as there is a risk of irritation of the esophagus. You need to stay in the standing position.
When an overdose of the solution for intravenous administration is likely to develop hypophosphatemia, hypocalcemia, hypomagnesemia. The administration of gluconate of calcium, potassium or magnesium sulfate and sodium phosphate is shown. Dialysis is not effective.

Interaction

The interaction of Ibandronic acid tablets can be noted in such cases:
    Absorption of the active substance Ibandronic acid can disrupt the intake of calcium-containing products, as well as products containing iron, magnesium, aluminum. After oral administration, they can be taken no sooner than 1 hour later. Similarly, you need to take food supplements containing these minerals.
    The use of bisphosphonates and NSAIDs may provoke irritation of the gastrointestinal mucosa. This combination should be practiced very carefully.
    Intravenous administration of ranitidine increases the bioavailability level of ibandronic acid by 20%.
The interaction of the Ibandronic acid solution can be noted in such cases:
    The solution is incompatible with solutions that contain calcium, as well as with other solutions for intravenous administration.

Storage conditions

Keep all forms of the drug at a temperature of up to 30 ° C. Keep away from children.
You can store the medicine for 2 years. After the expiration of the specified period, do not apply.

special instructions

Before using Ibandronic acid's medication, all risk factors for fracture and postmenopausal osteoporosis should be considered.
Before the application of the drug, it is necessary to correct all the violations of the electrolyte balance, as well as the metabolism of bone tissue, in particular hypocalcemia. To this end, the patient is prescribed a sufficient amount of vitamin D. It is important that during the period of treatment with Ibandronic acid the patient received enough calcium and vitamin D.
When taking drugs, oral side effects are usually mild or moderate. The manifestation of influenza-like syndrome can be observed after the first dose, it passes without correction of the dosage of the drug.
It is important to take into account all recommendations for taking medication to avoid side effects in the form of ulcers, swallowing disorders, esophagitis. If these symptoms occur, you need to stop treatment and consult a doctor.
Before each injection, you need to monitor serum creatinine.
Cases of osteonecrosis of the jaw in the appointment of bisphosphonates against the background of cancer. The risk of such manifestations increases the surgical intervention for the treatment of dental diseases.

Children

It is not practiced for patients under 18 years of age.

In pregnancy and lactation

There is no experience of clinical use of the drug in pregnant women and in patients during lactation.

Reviews of Ibandronic acid

Users leave different reviews on the web. The negative point, in their opinion, is the high cost of the drug, and patients also note that the drug causes side effects. But many users who underwent a course of treatment report that the condition of bone tissue has improved much.
In the process of discussing the drug Ibandronic acid, doctors' opinions are also different. But in general, they evaluate the effect of the drug positively.