DH-Alenbe Plus 70mg/2800iu Hasan treat osteoporosis (2 blisters x 2 tablets)

Dosage form Box of 2 blisters x 2 tablets
Specifications Alendronic Acid, Cholecalciferol
Ingredient Osteoporosis, osteoporosis in men

Ingredient

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Composition information	Content
Alendronic Acid	70mg
Cholecalciferol	2800iu

Uses

Indications

DH-Alenbe Plus 70mg/2800iu Hasan is indicated in the following cases:

Treatment of osteoporosis in menopausal women, increasing the vol

Alendronate sodium (alendronic acid) is a bisphosphonate acting as a strong inhibitor and inhibit the bone elimination through the intermediary to cancel the cell. Bisphosphonate are similar synthetic substances Pyrophosphate are linked to hydroxyapatite in bone.

Alendronat is a bisphosphonate that in animal studies, has a priority characteristic characteristic of bone pepper, especially under the cell cancel and inhibits bone resorption due to the cancellation of the cell, without direct effect in bone formation. Because bones and bone resorption go hand in hand, bone formation also decreased, but less than bone resorption, leading to gradual increase in bone mass.

During the use of alendronat, normal bones are formed and attached to the bone mold and there, the drug will no longer activate pharmacological.

colecalciferol (vitamin D3):

Cholecalciferol (Vitamin D3) is a secondosterol, a natural precursor of calcitriol hormone regulating calcium (1.25-dihydroxyvitamin D3).

Vitamin D3 is created in the skin due to the optical conversion from 7-dehydrocholesterol to Vitamin D3 money with ultraviolet light. When the sun is not enough, vitamin D3 will be essential nutrients. Vitamin D3 is required for normal bone formation. Vitamin D deficiency will increase when not exposed to sunlight and lack of nutritional supplements.

Vitamin D deficiency is related to negative balance of calcium, bone loss and increased the risk of fractures. In serious cases, vitamin D deficiency will cause secondary energy to the parathyroid gland, lower blood phosphate, muscle weakness near the point of clinging and bone puree, moreover also increases the risk of falling and fractures in people with osteoporosis.

Dynamic pharmacology

sodium alendronate trihydrate

absorption:

Compared to an intravenous, medium -sized oral abuse standard for women of 0.64% at a dose of 5 - 70 mg. Drink after 1 fast fast and 2 hours before a standard breakfast. Food, especially products containing calcium or other chemotherapy ions reduce drug absorption.

Birth is about 0.46% and 0.39%, respectively when taking Alendronat 1 hour and 30 minutes before the standard breakfast. In the study of osteoporosis, Alendronat works until it is taken at least 30 minutes before the first meal of the day. Birth is negligible when drinking Alendronat with or within 2 hours after breakfast coffee and orange juice reduces the bioavailability of Alendronat about 60%.

Distribution:

Pre -clinical studies show that after 1 mg/kg. Alendronat transiently distributed in soft tissues but then redistributed to the bone or excreted through the urine. The integral distribution in the average stable state is at least 28 liters, in the Alendronat people binding about 78% with plasma proteins

Metabolism:

There is no evidence that alendronat is metabolized in humans

Era:

After an intravenous injection of 10 mg. The renal clearance of the alendronate is 71 ml/min. Plasma drug concentration decreased by more than 95% within 6 hours after static injection in humans, the sale time of the drug was estimated at more than 10 years, reflecting the release of alendronat from the skeleton.

Cholocalciferol (Vitamin D3)

Absorption: Vitamm D is well absorbed through the gastrointestinal tract. Necessary bile for absorption of Vitaimin D in the intestine. Because vitamin D is soluble in lipid, it is concentrated in the micro -body and is absorbed in the lymphatic system (about 80% of oral vitamins)

Distribution: Vitamin D and metabolites linked to Alpha Globulin specific Cholecalciferol Procedure Fast Previsive distribution in the liver and transformed into the main reserve of 25-hydroxycholcalciferot. A smaller amount distributed in muscle tissue and adipose tissue in the form of intact molecules then release gradually into the circulatory system.

Metabolism: cholecalciferol is hydroxylation in the liver forming 25-hydroxycholeciferol (calcificationiol), then continues to be hydroxylation in the kidneys and forming metabolites of 1.25- dihydroxolololeciferol (calcitriol) and derivatives of 1,24,25- trihydroxycholeciferol.

Elimination: Vitamin D and its metabolites are excreted mainly through bile and feces, small amounts appear in urine. The sale time of 25-hydroxy metabolites in the blood is about 10 days to 3 weeks and the semi-exhaust time of metabolic 1.25-hydroxy metabolites is about 4-6 hours.

Pharmacokinetics on some special clinical subjects

Patients with renal failure without clinical data on patients with renal impairment, however, does not exclude the possibility that the elimination process of Alendronate may be impaired in patients with physical impairment similar to pre -clinical studies. Therefore, it is possible to increase the accumulation of alendronat in bones in patients with renal failure.

Before taking DH-Alenbe Plus 70mg/2800iu Hasan treat osteoporosis (2 blisters x 2 tablets)

How to use

oral oral medication, oral as directed by a doctor or pharmacist. Ask the doctor or pharmacist if you are not sure about how to take the drug.

The instructions below carefully:

Choose the most favorite day of the week, take a pill every week on the selected day.

Four guidelines (2), (3), (4), (5) below are especially important, you should follow to help the pill can get down to the stomach quickly and minimize the potential of irritation of the esophagus (the tube between the mouth and the stomach).

(2): After waking up the day and before using any other food, drinks or medicine, taking DH-Alenbe Plus 70mg/2800iu Hasan with a full cup of water (at least 200 ml) (do not use mineral water (including carbonated water or not gasoline), tea, coffee, fruit juice or milk). Do not chew, suck, grind or leave the tablet to dissolve in the mouth.

(3): Do not lie down, keeping the vertical position (sitting, standing or walking) for at least 30 minutes after taking the pills. Do not lie until you finish the first meal of the day.

(4): Do not take medicine at bedtime or before waking up during the day.

(5): If symptoms of difficulty swallowing, pain when swallowing, chest pain, heartburn or heartburn is worse, stop taking the medication and immediately notify the treating doctor.

(6): After taking the medication, wait at least 30 minutes before eating, taking or taking other medications of the day, including antacids, supplementary supplements and vitamins. Dh-Alenbe Plus 70mg/2800iu Hasan is only effective when your stomach is empty.

Dosage

Doses recommended only 1 single tablet Dh-Alenbe Plus 70mg/2800iu Hasan or DH-Alenbe Plus 70 mg/5600iu per week.

For special patients: liver failure, kidney failure, elderly people, children should pay special attention to adjust the dose. Details can refer to the user manual accompanied by the product.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose? Take a full cup of milk and notify the doctor for treatment. Do not try to vomit and do not lie down.

What to do when forgetting 1 dose? Instruct patients to take one capsule the next morning after remembering. Patients should not take 2 tablets to take the same day, but start a week like the original schedule.

Side Effects

When using DH-Alenbe Plus 70mg/2800iu Hasan, you may experience unwanted effects (ADR).

Notify your doctor immediately if you experience any of the following unwanted effects, the symptoms may become serious and you may need acute bacterial treatment:

Common (can affect 1 - 10 people in 100 people):

Heartburn, difficulty swallowing, pain after swallowing.

Hypersensitivity reactions like urticaria. swelling of the face.

Tongue lips and/or throat, which can cause shortness of breath or difficulty swallowing. Serious skin reaction.

Pain in the mouth and/or ham, swelling or ignoring the oral mucosa, numbness or heavy feeling in the jaw bone, the wobbly teeth can be signs of jaw bone necrosis (often related to local infections and tooth extraction), immediately report to your doctor or dentist if you suffer any of the above symptoms.

Abnormal femur fracture, especially in patients treating long -term osteoporosis. Contact your doctor if you have pain, weakness or discomfort in the thigh. hips or groin because this can be an early sign of the risk of femur fracture.

Severe muscular pain.

Other undesirable effects

Very common (can affect more than 1 person of 10 people):

musculoskeletal pain, sometimes worse pain.

swelling of joints, abdominal pain, stomach difficulty feeling or belching after eating, constipation, diarrhea, bloating or bloating, hair loss, itching, headache, eyes, fatigue. Swelling in the legs and arms.

Nausea, vomiting, irritation or esophagitis or stomach.

Symptoms of lower blood calcium include cramps or muscle contraction and or tingling sensation in the fingers or around the mouth), stomach ulcers (sometimes severe or bleeding), esophageal stenosis, worse rash with light, mouth ulcers

very rare (can affect less than 1 person of 100,000 people):

Notify your doctor if you have an ear pain, there is a secretion from the ear, and or an ear infection.

If you encounter any unwanted effects, including unwanted effects, which are not listed in this section, notify your doctor or pharmacist.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

DH-Alenbe Plus 70mg/2800iu Hasan is contraindicated in the following cases:

Hypersensitivity to bisphosphonate, vitamin D or any ingredient of the drug.

Esophageal deformities or elements that slow the removal of esophagus such as narrow and center space.

Inability to stand or sit upright for at least 30 minutes.

Hypercalcemia.

Be cautious when using

Alendronat can cause events in the esophagus such as esophagitis, esophageal ulcer, esophageal slip, sometimes with bleeding, so you need to be alert to all signs or symptoms of esophageal reactions (difficulty swallowing, swallowing pain or burning behind the breast bone).

Report immediately to the doctor and stop the medication when there are appearance on the risk of severe esophageal complications in patients right after taking alendronat or not taking pills with enough water and/ or continuing to take Alendronat after seeing symptoms of esophageal irritation. Therefore, the use of drugs in accordance with the instructions of the doctor or pharmacist is very important.

You should have a dental examination before treatment with DH-Alenbe Plus. Another important thing is that you need to maintain clean oral hygiene and have a habit of checking your teeth during the treatment with DH-ALENBE Plus. Report immediately to your doctor or dentist if you encounter any problems about your teeth or mouth such as pain or swelling.

There have been reports on not typical femoral fractures in some patients using the bisphosphonate group. Notify your doctor when you have pain in the thigh, hip or groin during treatment with Dh-Alenbe Plus.

DH-ALENBE Plus preparations contain lactose, do not use the drug if you are diagnosed with diseases in tolerance of some types of sugar.

The ability to drive and operate machinery

DH-Alenbe Plus can cause dizziness, blurred vision or severe musculoskeletal manifestations, although not everyone has the above effects. If happening to you, do not drive, operate machines, work on high or other dangerous jobs.

Pregnancy

Dh-Alenbe Plus is only nailed for women after menopause, not suitable for use in pregnant women. Do not use Dh-Alenbe Plus if you are pregnant, suspect you are pregnant.

Breastfeeding period

DH-Alenbe Plus is only nailed for women after menopause, not suitable for use in breastfeeding women should not use Dh-Alenbe Plus if you are breastfeeding.

Interactive drugs

Calcium supplements, antacids or oral medications containing polymerization cations can reduce the absorption of alendronat. So take other drugs at least 30 minutes after taking Alendronat.

Aspirin: In clinical research, the incidence of unwanted effects in the gastrointestinal tract increases in patients who use simultaneously containing aspirin with alendronal larger than 10mg/day.

Non -steroid anti -inflammatory drugs (NSAID): Alendronat can be used in patients using NSAIDs, however, NSAIDs often cause gastrointestinal irritation, so the kidneys need to be simultaneously used with alendronate.

olestra, mineral oil, orlistat bile acid -binding drugs (cholestyramin, colestipol): can reduce the absorption of vitamin D, the supplementation of vitamin D if considered.

Anti -convulsions, cimetidine and thiazid diuretics: can increase vitamin D. Supplementation of vitamin D should be considered.

Storage

Where dry, less than 300C, avoid light.

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