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Alendronate

(a len' droe nate)

PCI  - Contraindicated in pregnancy

LCI  - Contraindicated in lactation

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |
Indication & Dosage

Disease indications

Osteopetrosis
Adult: 10 mg daily or 70 mg once wkly.

Paget's disease of bone
Adult: 40 mg daily for 6 mth; may be repeated if necessary after 6-mth post-treatment evaluation period. 
Oral
Prophylaxis of postmenopausal osteoporosis
Adult: 5 mg once daily or 35 mg once wkly.

CrCl (ml/min) Dosage Recommendation
<35 Not recommended.

Corticosteroid-induced osteoporosis
Adult: Treatment and prevention: 5 mg daily; may increase to 10 mg daily in women who do not receive HRT.

Special Populations: Do not take Alendronate with mineral water, coffee, tea or juice, and at bedtime or before rising. Stand or sit upright for at least 30 min and do not lie down until after breakfast.
Administration Should be taken on an empty stomach. Take w/ a full glass of plain water at least ½ hr before the 1st food/drink/medication of the day & remain in sitting/upright position for at least ½ hr. Swallow whole, do not chew/crush.
Overdosage Symptoms may include hypocalcaemia, hypophosphataemia and upper GI adverse events, such as upset stomach, heartburn, esophagitis, gastritis or ulcer. Milk or antacids should be given to bind alendronate. Should not induce vomiting due to the risk of oesophageal irritation. Patient should remain fully upright. Dialysis would not be beneficial.
Contraindications Hypocalcaemia; oesophageal abnormalities and factors which delay oesophageal emptying; severe renal impairment; hypersensitivity; inability to stand or sit upright for ≥30 min. Pregnancy, lactation.
Special Precautions Upper GI disorders (discontinue if symptoms worsen); history of ulcers, active GI bleeding. Correct vitamin D and calcium deficiency before starting therapy. To be taken half an hr before breakfast and remain upright for at least 30 minutes after admin. Not recommended for use in patients with CrCl <35 ml/min.
Adverse Drug Reactions Oesophagitis, oesophageal ulcers and erosions, dysphagia, heartburn, retrosternal pain, abdominal pain, distension, diarrhoea, constipation, flatulence, headache, rash, erythema, musculoskeletal pain, transient decreases in serum phosphate.
Drug Interactions Concomitant iron, calcium supplements and antacids hinder alendronate absorption. Concomitant aspirin or NSAIDs may increase the incidence of adverse GI effects.
Food Interaction Food, mineral water, coffee, tea and juice interfere with absorption of alendronate.
Pregnancy Category (US FDA) Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Pharmacology Alendronic acid reduces bone resorption by inhibiting the action of osteoclasts.
Absorption: Poorly absorbed from the GIT (oral); reduced by food.
Distribution: Protein-binding: 78%
Excretion: Urine (50%); remainder is sequestered to bone.
ATC Classification M05BA04 - alendronic acid; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

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Brand/Product Info


Total Products : 2  
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
ALENDON Beximco Pharmaceuticals Ltd Alendronic Acid 70 mg Tablet 30's: 750.00 MRP
BONEMASS D Incepta Pharmaceuticals Limited Alendronate monosodium trihydrate USP equivalent to 70mg Alendronic acid and Colecalciferol BP 70mcg equivalent to 2800 IU Tablet 10x1's: 300.00 MRP

Gen. MedInfo

 

Why is Alendronate prescribed?

 

Alendronate is used to treat and prevent osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (''change of life,'' end of menstrual periods) and to treat osteoporosis in men. Alendronate is also used to treat osteoporosis in men and women who are taking corticosteroids (a type of medication that may cause osteoporosis in some patients). Alendronate is also used to treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Alendronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).

Colecalciferol is a vitamin D supplement. Your body needs vitamin D in order to improve absorption of calcium. Both vitamin D and calcium are important to build strong bones and teeth.
Taken together, Alendronate Sodium + Colecalciferol help to make your bones stronger.

How should Alendronate be used?

Alendronate comes as a tablet and a solution (liquid) to take by mouth. The solution is usually taken on an empty stomach once a week in the morning. The 5-mg and 10-mg tablets are usually taken on an empty stomach once a day in the morning, and the 35-mg and 70-mg tablets are usually taken on an empty stomach once a week in the morning. The 40-mg tablets are usually taken once a day in the morning for six months to treat Paget's disease of bone. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alendronate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Alendronate may not work properly and may damage the esophagus (tube between the mouth and stomach) or cause sores in the mouth if it is not taken according to the following instructions. Tell your doctor if you do not understand, you do not think you will remember, or you are unable to follow these instructions:

  • You must take alendronate just after you get out of bed in the morning, before you eat or drink anything. Never take alendronate at bedtime or before you wake up and get out of bed for the day.

  • Swallow alendronate tablets with a full glass (6 to 8 ounces [180 to 240 mL]) of plain water. Drink at least a quarter of a cup (2 ounces [60 mL]) of plain water after you take alendronate solution. Never take alendronate tablets or solution with tea, coffee, juice, milk, mineral water, sparkling water, or any liquid other than plain water.

  • Swallow the tablets whole; do not split, chew or crush them. Do not suck on the tablets.

  • After you take alendronate, do not eat, drink, or take any other medications (including vitamins or antacids) for at least 30 minutes. Do not lie down for at least 30 minutes after you take alendronate. Sit upright or stand upright until at least 30 minutes have passed and you have eaten your first food of the day.

Alendronate controls osteoporosis and Paget's disease of bone but does not cure these conditions. It may take 3 months or longer before your bone density begins to increase. Alendronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take alendronate even if you feel well. Do not stop taking alendronate without talking to your doctor, but talk to your doctor from time to time about whether you still need to take alendronate.

What to do if I have forgotten to take Alendronate?

If you miss a dose of once-daily alendronate, do not take it later in the day. Skip the missed dose and take one dose the next morning as usual. If you miss a dose of once-weekly alendronate, take one dose the morning after you remember. Then return to taking one dose once each week on your regularly scheduled day. Never take a double dose to make up for a missed one, and never take more than one dose in one day.

 

When to not use Alendronate?

Tell your doctor if you are pregnant. Do not take Alendronate if you are pregnant. Alendronate+Colecalciferol can cause harm to the unborn baby. Use effective birth control methods while being treated with Alendronate.

Alert your doctor if you are breastfeeding. Do not breastfeed while being treated with Alendronate.

Alert your doctor if you:

- cannot sit or stand upright for at least 30 minutes
- have low levels of calcium in your blood
- have difficulty swallowing
- have diseases of the gullet (food pipe)

Do not take Alendronate at bedtime or before getting up for the day.

What special precautions to follow?

Before taking alendronate,

  • tell your doctor if you are allergic to alendronate or any other medications.
  • tell your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen; cancer chemotherapy; or oral steroids such as dexamethasone, methylprednisolone, and prednisone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • if you are taking any other medications including supplements, vitamins, or antacids by mouth, take them at least 30 minutes after you take alendronate.
  • tell your doctor if you are unable to sit upright or stand upright for at least 30 minutes and if you have or have ever had a low level of calcium in your blood or any problems with your esophagus. Your doctor may tell you that you should not take alendronate.
  • tell your doctor if are undergoing radiation therapy and if you have or have ever had anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); a low level of vitamin D in your body; difficulty swallowing; heartburn; ulcers or other stomach problems;cancer; any type of infection, especially in your mouth; problems with your mouth, teeth, or gums; any condition that stops your blood from clotting normally; or dental or kidney disease.
  • tell your doctor if you are pregnant or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future, because alendronate may remain in your body for years after you stop taking it. Call your doctor if you become pregnant during or after your treatment.
  • you should know that alendronate may cause serious problems with your jaw, especially if you have dental surgery or treatment while you are taking the medication. A dentist should examine your teeth and perform any needed treatments before you start to take alendronate. Be sure to brush your teeth and clean your mouth properly while you are taking alendronate. Talk to your doctor before having any dental treatments while you are taking Alendronate.
  • you should know that alendronate may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first take alendronate. Although this type of pain may begin after you have taken alendronate for some time, it is important for you and your doctor to realize that it may be caused by alendronate. Call your doctor right away if you experience severe pain at any time during your treatment with alendronate. Your doctor may tell you to stop taking alendronate and your pain may go away after you stop taking the medication.
  • talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.
What side effects could I experience?

Alendronate /Alendronate + Colecalciferol may cause side effects. There may be irritation or ulcers in your gullet. To minimise this problem, drink a full glass of plain water with the tablet. Ensure that you wait at least 30 minutes before lying down after taking your medicine.

Other common side effects of Alendronate include flu-like symptoms, heartburn (reflux), indigestion, nausea, vomiting, bloating, flatulence (wind), constipation or diarrhoea, headache, stomach pain, back pain, as well as pain of the muscle, bone or joints.

Tell your doctor if any of these symptoms are severe or do not go away.

Other side effects are less common but may be more serious. You may need immediate medical attention. Alert your doctor immediately if you develop any of these symptoms:

- difficulty swallowing
- severe heartburn (reflux)
- severe gastric pain
- chest pain
- eye pain or loss of vision
- allergic reactions such as severe or persistent rash, swelling of the face, breathlessness

What special dietary instructions to follow?

You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking alendronate. Your doctor will tell you which foods and drinks are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.

How to store Alendronate? Store in a cool, dry place away from the reach of children. Medicines must be used before expiry date mentioned.

This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. 

| See FDA approved Prescribing Information from Brand Manufacturer |    Manufacturer's 
     
| Latest mph edition: Jan 2014 |
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*Trademark name & prescribing information are the property of their respective Manufacturers.

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