the Trade name
the International unlicensed
name Alendronovaya acid
the Dosage form
of the Tablet of 70 mg
One tablet contains
active agent of acid alendronovy (in the form of sodium of the alendronat of trihydrate) 70 mg,
excipients: lactose anhydrous, cellulose microcrystalline, sodium of a kroskarmelloz, magnesium stearate.
of the Tablet of round shape, white color
the Drugs affecting structure and a mineralization of bones. Bisfosfonata.
The ATX M05BA04 code
Pharmacokinetics Reception properties of alendronovy acid just before, in time or after a meal leads to reduction of bioavailability. At reception with coffee or orange juice the bioavailability of the alendronat of sodium decreases approximately by 60%.
It is temporarily distributed in soft tissues, then quickly redistributed in a bone or removed with urine. The average volume of distribution in a condition of equilibrium concentration at the person is about 28 l. After intake in therapeutic doses concentration of the alendronat in blood plasma usually below the smallest concentration which is giving in to definition (less than 5 ng/ml). Linking with proteins of plasma makes about 78%.
It is not metabolized.
It is removed mainly by kidneys. T½, in a final phase can make more than 10 years that is connected with release of active agent from bones.
of Londromaks – non-hormonal specific inhibitor of an osteoklastichesky bone resorption. Treats to group of bisfosfonat, is an analog of a natural pyrophosphate. Selection action is caused by high affinity of bisfosfonat to mineral components of a bone.
Suppresses activity of osteoclasts. Stimulates bone formation, restores positive balance between a resorption and recovery of a bone, progressively increases the mineral density of bones (regulates phosphorus-calcium exchange), promotes forming of a normal bone tissue with normal histologic structure.
– treatment of osteoporosis at women in a postmenopause for the purpose of prevention
of changes, including fractures of a hip and compression
– treatment of osteoporosis at men for the purpose of prevention of changes.
A route of administration and doses
of the Regulation of Admission
of the drug Londromaks it is necessary to accept a minimum in 30 min. prior to the first meal, drink or drugs, washing down only with plain water. Other drinks (including mineral water), food and some drugs can reduce drug absorption.
For simplification of receipt in a stomach and reduction of irritation of a gullet a pill should be taken in the morning right after rise from a bed, washing down with a glass of water, not chewing and not rassasyvy them in a mouth because of possible formation of ulcers in an oral cavity and a drink. After that patients should not lay down at least within 30 min. Londromaks should not be accepted before going to bed or before rise from a bed.
For treatment of osteoporosis at women and men drug is appointed on 70 mg once a week.
For patients of advanced age, patients with a slight or moderate renal failure (ml/min. KK=35 – 60) of dose adjustment are not required.
– a headache
– an abdominal pain, dyspepsia, a constipation, diarrhea, a meteorism, gullet ulcers, a dysphagy, an abdominal distension, an eructation
– skeletno muscular pain (bones, muscles or joints)
it is not frequent
– nausea, vomiting, gastritis, an esophagitis, gullet erosion, a melena
– rash, an itching, an erythema
– a uveitis, a sclerite, an episcleritis
– a gullet stricture, oropharyngeal expressions, perforation, an ulcer bleeding from upper digestive tract
– severe skeletal and muscular pain (bones, muscles or joints), puffiness of joints
– reactions of hypersensitivity, including urticaria and a Quincke’s disease
– a symptomatic hypocalcemia
the Passing symptoms, such, as in a sharp phase of reaction (myalgia, an indisposition and in rare instances fever), usually in connection with an initiation of treatment. Skin rash in connection with photosensitivity.
– perforation of a gullet
– heavy skin reactions, including Stephens’s syndrome of Johnson and a toxic epidermal necrolysis
– a jaw osteonecrosis
Influence on laboratory indicators: the asymptomatic weak and passing decrease in calcium and phosphorus in blood serum up to 10-18%
of the Contraindication
– hypersensitivity to active agent or any of drug components
– anomalies from a gullet and other factors which are slowing down depletions of a gullet, such as stricture or achalasia, dysphagy, the gullet diseases, gastritis, duodenitis or ulcers, or cases which is recently postponed (within the last year) a serious disease of digestive tract, such as stomach ulcers, acute gastrointestinal bleeding, surgical intervention on upper parts of digestive tract, but not pyloroplasty
– a renal failure with clearance of creatinine is lower 35ml/mines
– lack of an opportunity to stand or sit directly during as to a minimum is 30 minutes after reception
– the damage of a gullet which is slowing down it depletion (including narrowing or an achalasia)
– a hypocalcemia
– pregnancy and the period of a lactation
– children’s age up to 18 years
the Medicinal interactions
Are the probability of disturbance of absorption of Londromaks at simultaneous use with calcium drugs (including nutritional supplements) and antacids. Therefore, the interval between Londromaks’s reception and other medicines has to make not less than 30 min.
At combined use of Londromaks and gormonozameshchayushchy therapy (also plusmn, progestin is oestrogenic) safety and shipping of combination therapy correspond to that at use of each of these drugs separately.
Intravenous use of ranitidine increases bioavailability twice.
Non-steroidal anti-inflammatory drugs (NPVS) strengthen a gastrotoksichnost.
At emergence of symptoms of damage of a GIT (for example, pain when swallowing or behind a breast, emergence or strengthening of heartburn) it is necessary to stop administration of drug and to consult the doctor.
Risk of development of heavy side reactions from a gullet increases at patients who violate Regulations of Admission of drug therefore the patient has to conform to Regulations of Admission of drug accurately.
With care it is necessary to appoint Londromaks to patients with exacerbation of diseases of upper parts of a GIT (dysphagy, gullet diseases, gastritis, a duodenitis, ulcers) in connection with possible irritant action of drug to a mucous membrane and deterioration in a course of a basic disease.
At the accidental admission of administration of drug in a dosage it is necessary to take 1 pill in the morning of the next day once a week. It is not necessary to take 2 pill in 1 day, but in the subsequent it is necessary to continue to accept on 1 tablet in that day of the week which was chosen for reception from the very beginning of treatment.
Prior to treatment by Londromaks it is necessary to normalize calcium content in blood and to compensate a lack of vitamin D.
Because Londromaks increases the content of mineral substances in bones, small asymptomatic decrease in level of calcium and phosphates in serum can take place (including at the patients receiving glucocorticoid means (GKS) at which absorption of calcium can be reduced).
Patients should accept nutritional supplements, calciferous and vitamin D if intake of these substances with food is not enough.
Londromaks patients are not recommended to appoint with a renal failure of heavy degree (KK & lt, 35 ml/min.).
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to drive the car and to work with mechanisms.
Symptoms: a hypocalcemia, a hypophosphatemia, the undesirable phenomena from an upper part of the digestive tract (DT), including dyspepsia, heartburn, an esophagitis, gastritis, stomach ulcers and a gullet.
Treatment: the patient should take milk or antacids for binding of the alendronat. For prevention of irritation of a gullet it is not necessary to cause vomiting. Patients have to keep vertical position. Data on specific therapy are not available.
The form of release and packing
On 4 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in the dry place protected from light at a temperature not over 25C.
To store out of children’s reach!
not to apply a period of storage after an expiration date.
To develop prescription status According to the prescription