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Alendra Tablets

Alendra Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
- Treatment and prophylaxis of osteoporosis in postmenopausal women for the prevention of fractures, including those of hip and spine (vertebral compression fractures).
- Treatment of osteoporosis in men for the prevention of fractures.
- Treatment and prophylaxis of glucocorticoid-induced osteoporosis;

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
The following gastrointestinal adverse reactions can appear:
Heartburn, nausea, vomiting, acid eructation, epigastric pain, dyspepsia, dysphagia, meteorism, abdominal swelling, constipation, diarrhoea, melena; rarely- oesophagitis, oesophageal erosions and oesophageal ulcers; in isolated cases stenosis and oesophagus perforation, oropharynx ulcers, gastric ulcer and duodenal ulcer were observed.

In single cases the following allergic reactions may occur:
skin rash, hyperaemia, itch, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria and in isolated cases – angioneurotic edema.
In some patients who took the preparation there were noted asymptomatic hypocalcemia and hypophosphatemia, headache, myalgia, sometimes – uveitis, scleritis or episcleritis.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

The absorption of Alendronate is decreased in case of concomitant usage with calcium supplement (including food supplements) and antacids. An interval between the preparation intake and other per oral drugs usage must be not less than 1 hour.
Combined usage of Sodium Alendronate and hormone replacement therapy (estrogens + progesterones) caused more bone weight increase and more significant bone rosorption decrease in comparison with the individual usage of the first and second treatment metods.
NSAIDs increase gastrointestinal action of Sodium Alendronate.
Increase of hypocalcaemia is possible during simultaneous Sodium Alendronate usage with glucocorticoids can because they suppress the vitamin D activity that results in decrease of absorption of calcium and its more active excretion.
It is recommended to be on guard in case of usage of Alendronate with aminoglycosides, which decrease calcium level in serum for a long time.
The usage of thiazides, which decrease the calcium elimination with urine, can interfere with the calcium decreasing effect of Alendronate in the treatment of malignant hypercalcemia treatment.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms:
Hypocalcaemia, hypophosphatemia, stomach upset, heartburn, oesophagitis, gastritis or gastric ulcer.
Treatment. Milk or antacids should be given to bind alendronate. Due to risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:


Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description

COMPOSITION:
Active substance:
Alendronic acid;
1 tablet contains Sodium Alendronate, equivalent to Alendronic acid 10 mg or 70 mg.
Additional ingredients: Microcrystalline cellulose, Lactose monohydrate, Croscarmellose sodium, Magnesium stearate, Colloidal anhydrous silica.

Indications and dosage.

INDICATIONS:
- Treatment and prophylaxis of osteoporosis in postmenopausal women for the prevention of fractures, including those of hip and spine (vertebral compression fractures).
- Treatment of osteoporosis in men for the prevention of fractures.
- Treatment and prophylaxis of glucocorticoid-induced osteoporosis;


DOSAGE:
The medicine should be taken immediately on getting up, swallowing the tablet as whole and without chewing or dissolving, with full glass of water only for at least 30 min before your first meal, water or other drugs of a day. Other beverages, food or drugs can decrease the absorption of alendronate. One should never lie down for at least 30 min and until after your first food of a day to decrease an irritant action on oesophagus. Do not take the drug before going to bed or before getting up or lying down in horizontal position after taking the drug. Failure to follow this instruction may increase the risk of oesophageal side effects.
In addition to the drug treatment it is recommended to change a way of life for patients with osteoporosis – to stop smoking, to limit taking alcohol, to do exercises, to stick to calcium diet.
The recommended dose for osteoporosis treatment in postmenopausal women and menn is 1 tablet (10 mg) per a day or 1 tablet (70 mg) per a week. It is also prescribed with calcium supplements in dose 0.5 g of calcium per a day. The treatment lasts for a long time – for years. The recommended dose for osteoporosis prophylaxis in postmenopausal women is 5 mg per a day. For the treatment and prophylaxis of glucocorticoid-induced osteoporosis in men and women the recommended dosage is 5 mg once per a day, except for postmenopausal women not receiving estrogens, for which the recommended dosage is 10 mg once per a day. Appropriate pharmaceutical form and dosage of the preparation should be used during administration of the dosage of 5 mg.

Side effects and drug interactions.

ADVERSE REACTIONS:
The following gastrointestinal adverse reactions can appear:
Heartburn, nausea, vomiting, acid eructation, epigastric pain, dyspepsia, dysphagia, meteorism, abdominal swelling, constipation, diarrhoea, melena; rarely- oesophagitis, oesophageal erosions and oesophageal ulcers; in isolated cases stenosis and oesophagus perforation, oropharynx ulcers, gastric ulcer and duodenal ulcer were observed.

In single cases the following allergic reactions may occur:
Skin rash, hyperaemia, itch, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria and in isolated cases – angioneurotic edema.
In some patients who took the preparation there were noted asymptomatic hypocalcemia and hypophosphatemia, headache, myalgia, sometimes – uveitis, scleritis or episcleritis.

Drug interactions:
The absorption of Alendronate is decreased in case of concomitant usage with calcium supplement (including food supplements) and antacids. An interval between the preparation intake and other per oral drugs usage must be not less than 1 hour.
Combined usage of Sodium Alendronate and hormone replacement therapy (estrogens + progesterones) caused more bone weight increase and more significant bone rosorption decrease in comparison with the individual usage of the first and second treatment metods.
NSAIDs increase gastrointestinal action of Sodium Alendronate.
Increase of hypocalcaemia is possible during simultaneous Sodium Alendronate usage with glucocorticoids can because they suppress the vitamin D activity that results in decrease of absorption of calcium and its more active excretion.
It is recommended to be on guard in case of usage of Alendronate with aminoglycosides, which decrease calcium level in serum for a long time. The usage of thiazides, which decrease the calcium elimination with urine, can interfere with the calcium decreasing effect of Alendronate in the treatment of malignant hypercalcemia treatment.

Warnings and precautions

Pregnancy and lactation:
It is contraindicated.
Children:
Contraindicated to children under 18 years old.

PRECAUTIONS:
⇒ Take the medicine as soon as you get up for the day 30 min before your first meal in sitting or standing position only.

⇒ Drink full glass of plain water after Alendra® tablet because any other beverage will decrease absorption of this drug (Do not use mineral water).

⇒ Do not chew or dissolve the tablets because of risk of oropharynx ulceration.

⇒ Do not lie down for at least 30 min after taking the medicine (do not take this drug if you are not in sitting or upright standing position for 30 min). Taking medicine in lying position or at bedtime increases the risk of oesophagus development (mucous coat esophagitis).

⇒ Interval between taking Sodium Alendronate and other medicine taken per oral should not be less than 1 hour.

⇒ The drug should be carefully used in patients with acute upper gastrointestinal diseases (dysphagia, oesophagus diseases, gastritis, duodenitis, and ulcers) because of possible irritant action of Alendra® on mucus.

⇒ Treatment by the preparation should be combined with calcium-fortified diet. Patients should receive additionally about 0.5 g of calcium per a day, except in the cases of hypercalcemia (malignant or medicament) treatment.

⇒ The calcium supplements and the products contained calcium should not be taken for 1 – 2 hours after intake of Alendronate, because calcium delays Alendronate (and other bisphosphonates) absorption from intestine.

⇒ In case of once a week dosage schedule, choose the day of week which best fits your schedule. Every week, take one tablets on the same day of week which you have chosen. ⇒ If you miss a dose, take only one tablet in the next morning after you remember. Do not take two tablets on the same day. Then use the drug as usual – take next one tablet the day you have chosen according your schedule of the treatment.

In case of appearance of oesophagus disease symptoms (such as complications or pain upon swallowing, chest pain, new or worsening heartburn) you should stop the preparation usage and make an additional examination).

Before the beginning of the therapy by Alendra® patients with hypocalcaemia and other mineral metabolism disorders (such as vitamin D deficiency) should get appropriate treatment because level of serum calcium and phosphates may decrease during the Alendronate treatment.

The usage of Alendronate can be combined with supplemental vitamin D.
There is no need to correct the dosage for elderly patients and patients with renal insufficiency from mild to moderate (creatinin clearance from 35 to 60 ml/min).

Ability to influence reaction velocity while driving or operating any other mechanisms.

There are no data concerning the influence of Alendra® on ability to drive car and other machines.

Overdosage and Contraindications

Overdose:
Symptoms:
Hypocalcaemia, hypophosphatemia, stomach upset, heartburn, oesophagitis, gastritis or gastric ulcer.
Treatment. Milk or antacids should be given to bind alendronate. Due to risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Ability to influence reaction velocity while driving or operating any other mechanisms.
There are no data concerning the influence of Alendra® on ability to drive car and other machines.

CONTRAINDICATIONS:
Hypersensitivity to Sodium Alendronate or other drug ingredient; inability to stand or sit upright for at least 30 min after drug intake; hypocalcemia; oesophagus involvement, which delay oesophageal empting, such as stricture or achalasia of oesophagus; severe renal insufficiency (creatinine clearance < 35 ml/min); concomitant usage with other bisphosphonates; pregnancy and lactation period; children under 18 years old.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:
Pharmacodynamics. Sodium Alendronate is one of the aminobisphosphonates group. It is a synthetic analogue of nature pyrophosphate. It inhibits precipitation of calcium phosphate, blocks its transformation into hydroxyapatite, delays the aggregation of apatite crystals with formation of bigger crystals and accelerates resolution of these crystals. Selective action is caused by high affinity of bisphosphonates and mineral components of bone. It acts as effective non-hormonal specific inhibitor of osteoclast mediated bone resorption. Accurate mechanisms of this process are not still cleared up. It promotes positive balance of resorption and bone renovation.
It increases a mineral density of the spine, pelvic and other bones, promotes the formation of bone tissue with normal histological structure. It prevents new bone fractures. It decreases the calcium level in serum as a result of inhibition of bone resorption and decrease of calcium release from bone tissue. The preparation action of calcium decrease, mediated as a result of osteoclast inhibition, is observed in1 – 2 days.
Pharmacocinetics. 25% of Sodium Alendronate is absorbed gastro intestinal tract.
Absolute bioavailability of tablets (from 5 to 10 mg) has taken an empty stomach before 2 hours to a meal is 0.64% (for wpmen) and 0.59% (for men). Bioavailability decreases (approximately on 40%) in Alendronate intake before half an hour – hour before usual breakfast. Alendronate bioavailability is small while its usage with a meal or during two hours after a meal. Simultaneous usage of Alendronate with other beverages (including mineral water, coffee, Orange juice) decreases its bioaviability to 60%. Trials conducted on laboratory rats show that in intravenous introduction of the drug in dosage 1 mg/kg Alendronate is temporarily distributed in soft tissues and then quickly is redistributed.
Very small amount <1% of ingested from, therefore, it is very important to follow the instruction regarding how to take the tablets. The half of absorbed dose is mainly eliminated unchanged through kidneys over 72 hours, and the rest is sequestered in bone tissues for a long time and is eliminated extremely slowly as a result of strong bonding with bone tissue. Half-excretion period of Alendronate from bones is several years.
Approximately 78% of Alendronate binds with plasma proteins and is not metabolized. The preparation concentration in plasma is small (less than 5 ng/ml) and is decreasing to 95% during 6 hours after intravenous infusion. After single oral introduction of 10 mg of Alendronate its renal clearance was 71 ml/min and systemic clearance did not exceed 200 ml/min.

PHARMACEUTICAL CHARACTERISTICS:
General physico-chemical properties:
round, biconvex, white or nearly white tablets (10 mg) or oval, biconvex, white or nearly white tablets (70 mg).
Shelf-life:
3 years.

Storage:
Keep it out of reach of children, in dry place at a temperature vot more 25°C.
Package:
Tablets (10 mg). There are 10 tablets in blister, there are 3 blisters in a carton box № 30 (10x3). Tablets 70 mg. There are 4 tablets in blister, each blister is in a carton envelop № 4.

Conditions of supply:
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780