Maxlen-70 Mega We Care medicine prevents and treats osteoporosis, reduces the risk of fractures (1 blister x 4 tablets)
Dosage form Box of 1 blister x 4 tablets
Specifications Alendronic Acid
Ingredient
Thành phần cho 1 viên
| Composition information | Content |
| Alendronic Acid | 70mg |
Uses
indicated
Sodium alendronat trihydrate, the main active ingredient of Maxlen-70, is a bisphosphonate that inhibits bone resorption through the cell cancel without affecting bone formation. Prelise clinical research shows that Alendronat is given to places with real destruction. Alendronat inhibits the active cancellation of the cell but does not affect the mobilization/participation of the cell cancellation. Bone quality is formed during the time of using alendronat.
pharmacokinetics
absorption and bioavailability:
Compared to intravenous doses, alendronate's bioavailability is taken in women about 0.64% at 5 - 70 mg dose, taken in the morning of hunger and 2 hours before breakfast. Born is about 0.46 % and 0.39 % when taking Alendronat before breakfast 1 hour and 30 minutes.
Distribution:
Plasma concentration in plasma after drinking is very low, not detected (
Metabolism:
Metabolism has no evidence that alendronate is metabolized in animals and humans.
Elimination:
In humans, the sale time is estimated to be over 10 years, corresponding to the release of Alendronat from the bone. In rabbits, Alendronat is not eliminated through the kidney's acid or basic transportation system, so it does not anticipate the level of affecting the elimination of other drugs because this system is in humans.
Before taking Maxlen-70 Mega We Care medicine prevents and treats osteoporosis, reduces the risk of fractures (1 blister x 4 tablets)
How to use
To be fully absorbed to note:
Must take maxlen - 70 at least 30 minutes before eating, taking or taking the first medicine for the day with normal water. Other drinks (including mineral water), food and some drugs can reduce the absorption of alendronat.
To put the drug down to the stomach easily to reduce the risk of adverse irritation/ adverse effects on the spot and esophagus. Maxlen-70 must be taken with a full cup of water in the morning when waking up (at least 200ml or 7FL.Oz).
Patients should not chew or leave the pill to dissolve in the mouth to avoid mouth ulcers - throat.
Patients should not be within at least 30 minutes after taking the drug and until the first time of eating the day.
Do not take maxlen-70 before going to bed or are lying in bed when you wake up. Patients need to supplement calcium and vitamin D if the diet is not enough.
Dosage
Dosage recommended: Take 1 tablet of 70 mg, once a week.
In elderly patients: In clinical studies, there is no difference in the safety and effectiveness of Alendronat related to age. Therefore, there is no need to adjust the dose in the elderly.
In patients with renal impairment: No dose adjustment in patients with GFR is over 35 ml/min. Do not use alendronat for patients with renal failure with GFR less than 35 ml/min because there is no clinical experience on this issue.
In children: Alendronat has not been studied in children, so it is not used for these cases.
maxlen-70, a single dose of 70 mg in the week has not been studied in detail in the treatment of osteoporosis caused by glucocorticoid.What to do when using overdose?
There is no special information about the overdose treatment of Alendronat. It is necessary to drink milk or antacids to combine with Alendronat. Due to the risk of esophageal irritation, do not cause vomiting and need to keep patients in a completely vertical position.
What to do when you forget 1 dose? Do not take two capsules at the same time but continue to take one capsules per week on the original selected day.
Side Effects
The following are unwanted effects that have been reported. [Common (~ 1/100, immune system disorders
Rape: sensitive reaction, including urticaria and angiography.
Disorders of metabolism and nutrition:
Rare: Symptoms of blood calcium, often associated with existing diseases.
Central neurological disorders:
Common: headache.eye disorders:
Rare: Eythitis, Macal inflammation, Thuong Thuong Mac.
digestive disorders:
Common: abdominal pain, indigestion, constipation, diarrhea, flatulence, esophageal ulcer, difficulty swallowing, bloating, heartburn.Less: nausea, vomiting, gastritis, esophagus, mouth ulcers - throat, perforation, ulcer, gastrointestinal bleeding.
Skin and subcutaneous disorders:
Uncommon: ban, erythema, itching.
Special cases are very rare: the skin reaction including Stevens Johnson syndrome and poisoned epidermal necrosis.
Musculoskeletal, connective tissue and bone disorders:
Common: musculoskeletal pain.
Rare: Jaw bone necrosis has been reported in patients using bisphosphonate.
Notice immediately to the doctor or pharmacist about unwanted effects when using medicine .
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Be cautious when used
Alendronate can cause in place of the gastrointestinal tract mucosa. Due to the worsening disease, it is necessary to be cautious when using alendronat for patients with the above gastrointestinal problems such as difficulty swallowing, esophagus, gastric ulcer, duodenum or a new history (within 1 year) serious gastrointestinal diseases, such as ulcers in the digestive system, digestive bleeding, digestive bleeding surgery, gastrointestinal surgery.
There have been reports on harmful effects in the esophagus (some severe cases of hospitalization), such as esophagitis, esophageal ulcers and esophageal sliding, rarely leading to stenosis in patients treated with alendronat. Therefore, physicians need to be wary of any signs or symptoms that signal the esophageal reaction and patients should be instructed to stop drinking alendronat and notify the physician immediately if there is symptom of irritation of the esophagus, such as difficulty swallowing, swallowing pain, pain behind the sternum, heartburn appears or worse.
The risk of serious harmful reactions to the esophagus is greater in the patient who drinks alendronat improperly and/or continues to use Alendronat after there are suspected symptoms of esophageal irritation. Therefore, providing sufficient information for patients so that they understand the instructions of the dosage, the usage is very important (see the dose and how to use). It is necessary to tell patients if they do not follow these instructions, the risk of harmful effects on the esophagus may increase. Although there is no increased risk in clinical tests, there have been some rare reports (after bringing the drug to the market) to stomach and duodenal ulcers, some severe and complicated cases. However, the cause of cause and effect has not been identified.
There have been reports on the case of jaw bone necrosis due to tooth extraction and/ or local infection (including bone marrow) in patients with cancer being treated, including when injecting venous biPhosphonate for the first time.
Some patients are using chemotherapy and corticosteroids. Jaw bone necrosis has also been reported in patients with osteoporosis using biphosphonate.
In patients with many risk factors (such as cancer, chemotherapy, radiation, corticosteroids, poor dental hygiene) should be examined before using bisphosphonate. During treatment, patients should not do any procedure that affects the teeth. In patients with progressive jaw bone necrosis using bisphosphonate, tooth surgery can worsen the disease. In the case of teeth tips, no documents show that the suspension of using bisphosphonate will reduce the risk of jaw bone necrosis.
The treating doctor should guide patients to plan on the risk and benefits of each patient.
Bone pain, joints and/ or muscles have been reported in patients using bisphosphonat. After bringing the drug to the market, rarely experienced heavy side effects and/or is no longer able to cure. The time starting to see symptoms may vary from 1 day to several months after taking the drug. Most cases are completely cured after stopping the medication. However, it can return when taking that drug or other bisphosphonat.
In case the patient forgets a maxlen-70 dose of type once a week, take a tablet in the morning immediately after discovering. Do not take two capsules at the same time but continue to take one capsules per week on the original selected day.
Do not use maxlen-70 for patients with renal failure with GFR below 35 ml/min.
It is necessary to consider the causes of osteoporosis other than the deficiency of estrogen and aging. Must adjust the condition of lowering blood calcium before starting with Alendronate (see "contraindicated"). Other mineral metabolic disorders (for example, vitamin D deficiency and parathyroid deficit) also need to be actively treated. Monitor blood calcium and symptoms of blood calcium lower in these patients during treatment with Maxlen-70. Because alendronate has the effect of increasing bone minerals, it can lead to hypocalcemia and blood phosphate. This condition is usually mild and does not cause symptoms. However, there has been a report on hypocalcemia, sometimes severe and often occurring in patients with existing diseases (for example, underlying the parathyroid gland, deficiency of vitamin D and poor calcium absorption). Ensure the amount of calcium and vitamin D put into the body is very important in patients using glucocorticoids.
The effect of drugs on driving and operating machinery
There is no report on the effect of the drug on the ability to drive and operate machinery.
Use drugs for women during pregnancy and lactation
Pregnant women:
Alendronat has not been studied in pregnant women, so it is not used for these cases.
breastfeeding women:
It is unknown whether alendronat is excreted in breast milk, so it is not used for these cases.
Drug interaction
If used at the same time, foods and drinks (including mineral water), calcium supplements, acid -reducing drugs (antacids) and other oral medications may affect the absorption of alendronat. Therefore, patients have to wait at least 30 minutes after taking Alendronat to take other drugs.
There is no interaction with other clinical significance for predicted. In clinical trials, some patients use estrogen (vaginal placement, subcutaneous or drinking) simultaneously with alendronat. There is no evidence of harmful interaction.
Special interactive studies have not been conducted. In Alendronat clinical studies used in combination with a range of conventional prescription drugs, there is no evidence of clinical harmful interactions.
Storage
Store in cool dry places, below 30 ° C. Avoid light and damp.
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