Alendronate Sodium (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING


How Supplied
Alendronate Sodium Tablets USP, 10 mg are white to off-white, circular, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘18’ on the other side.
Bottles of 30 NDC 16714-631-01
Bottles of 100 NDC 16714-631-02
10 x 10 Unit-dose Tablets NDC 16714-631-11
Alendronate Sodium Tablets USP, 35 mg are white to off-white, oval shaped, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘19’ on the other side.
Unit-of-use blister package of 4 NDC 16714-632-01
Unit-of-use blister package of 20 NDC 16714-632-02
10 x 10 Unit-dose Tablets NDC 16714-632-11
Alendronate Sodium Tablets USP, 70 mg are white to off-white, oval shaped, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘21’ on the other side.
Unit-of-use blister package of 4 NDC 16714-633-01
Unit-of-use blister package of 20 NDC 16714-633-02
10 x 10 Unit-dose Tablets NDC 16714-633-11
Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Store in a well-closed container.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Instruct patients to read the Medication Guide before starting therapy with alendronate sodium and to reread it each time the prescription is renewed.

17.1 Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium and vitamin D, if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as cigarette smoking and/or excessive alcohol consumption, if these factors exist.

17.2 Dosing Instructions

Instruct patients that the expected benefits of alendronate sodium may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing with orange juice or coffee has been shown to markedly reduce the absorption of alendronate sodium [see Clinical Pharmacology (12.3)].
Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal ulceration.
Instruct patients to swallow each tablet of alendronate sodium with a full glass of water (6 to 8 ounces) to facilitate delivery to the stomach and thus reduce the potential for esophageal irritation.
Instruct patients not to lie down for at least 30 minutes and until after their first food of the day.
Instruct patients not to take alendronate sodium at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems.
Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking alendronate sodium and consult their physician.
If patients miss a dose of once weekly alendronate sodium, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
Medication Guides available at www.northstarrxllc.com/products or call 1-800-206-7821.
Manufactured for: Northstar Rx LLC
Memphis, TN 38141.
Manufactured by: Aurobindo Pharma Limited
Hyderabad-500 090, India.
M.L.No.: 19/HD/AP/95/F/RRevised: 10/2019

MEDICATION GUIDE

Alendronate Sodium Tablets, USP
(a len’ droe nate soe’ dee um)
Read the Medication Guide that comes with alendronate sodium tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about alendronate sodium tablets.

What is the most important information I should know about alendronate sodium tablets?
Alendronate sodium tablets c an cause serious side effects including:

  1. Esophagus problems
  2. Low calcium levels in your blood (hypocalcemia)
  3. Bone, joint, or muscle pain
  4. Severe jaw bone problems (osteonecrosis)
  5. Unusual thigh bone fractures

1. Esophagus problems.
Some people who take alendronate sodium tablets m ay develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.

  • It is important that you take alendronate sodium tablets exactly as prescribed to help lower your chance of getting esophagus problems. (See the section “How should I take alendronate sodium tablets?”)
  • Stop taking alendronate sodium tablets and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

2. Low calcium levels in your blood (hypocalcemia).
Alendronate sodium tablets may lower the calcium levels in your blood. If you have low blood calcium before you start taking alendronate sodium tablets, they may get worse during treatment. Your low blood calcium must be treated before you take alendronate sodium tablets. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:

  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes, or around your mouth

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take alendronate sodium tablets. Take calcium and vitamin D as your doctor tells you to.
3. Bone, joint, or muscle pain.
Some people who take alendronate sodium tablets develop severe bone, joint, or muscle pain.
4. Severe jaw bone problems (osteonecrosis).
Severe jaw bone problems may happen when you take alendronate sodium tablets. Your doctor should examine your mouth before you start alendronate sodium tablets. Your doctor may tell you to see your dentist before you start alendronate sodium tablets. It is important for you to practice good mouth care during treatment with alendronate sodium tablets.
5. Unusual thigh bone fractures.
Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.
Call your doctor right away if you have any of these side effects.
What are alendronate sodium tablets?

Alendronate sodium tablets are a prescription medicine used to:

  • Treat or prevent osteoporosis in women after menopause. It helps reduce the chance of having a hip or spinal fracture (break).
  • Increase bone mass in men with osteoporosis.
  • Treat osteoporosis in either men or women who are taking corticosteroid medicines.
  • Treat certain men and women who have Paget’s disease of the bone.

It is not known how long alendronate sodium tablets work for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if alendronate sodium tablets are still right for you.
Alendronate sodium tablets are not for use in children.
Who should not take alendronate sodium tablets?

Do not take alendronate sodium tablets i f you:

  • Have certain problems with your esophagus, the tube that connects your mouth with your stomach
  • Cannot stand or sit upright for at least 30 minutes
  • Have low levels of calcium in your blood
  • Are allergic to alendronate sodium tablets or any of their ingredients. A list of ingredients is at the end of this leaflet.


What should I tell my doctor before taking alendronate sodium tablets?

Before you start
alendronate sodium tablets, be sure to talk to your doctor if you:

  • Have problems with swallowing
  • Have stomach or digestive problems
  • Have low blood calcium
  • Plan to have dental surgery or teeth removed
  • Have kidney problems
  • Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
  • Are pregnant, trying to become pregnant or suspect that you are pregnant. If you become pregnant while taking alendronate sodium tablets, stop taking them and contact your doctor. It is not known if alendronate sodium tablets can harm your unborn baby.

  • Are breast-feeding or plan to breast-feed. It is not known if alendronate sodium passes into your milk and may harm your baby.

Especially tell your doctor if you take:

  • antacids
  • aspirin
  • Nonsteroidal Anti-Inflammatory (NSAID) medicines


Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how alendronate sodium tablets work.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

How should I take alendronate sodium tablets?

  • Take alendronate sodium tablets exactly as your doctor tells you.
  • Alendronate sodium tablets work only if taken on an empty stomach.
  • Take alendronate sodium tablets, after you get up for the day and before taking your first food, drink, or other medicine.
  • Take alendronate sodium tablets while you are sitting or standing.
  • Do not chew or suck on a tablet of alendronate sodium.
  • Swallow alendronate sodium tablet with a full glass (6 to 8 oz) of plain water only.
  • Do not take alendronate sodium tablets with mineral water, coffee, tea, soda, or juice.
  • If you take Alendronate Daily:
    • Take 1 alendronate tablet one time a day, every day after you get up for the day and before taking your first food, drink, or other medicine.
  • If you take Once Weekly alendronate sodium tablets:
    • Choose the day of the week that best fits your schedule.
    • Take 1 dose of alendronate sodium tablet every week on your chosen day after you get up for the day and before taking your first food, drink, or other medicine.

After swallowing alendronate sodium tablet, wait at least 30 minutes:

  • Before you lie down. You may sit, stand or walk, and do normal activities like reading.
  • Before you take your first food or drink except for plain water.
  • Before you take other medicines, including antacids, calcium, and other supplements and vitamins.

Do not lie down for at least 30 minutes after you take alendronate sodium tablets a nd after you eat your first food of the day.
If you miss a dose of alendronate sodium tablets, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.
If you take too much alendronate sodium, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of alendronate sodium tablets?

Alendronate sodium tablets may cause serious side effects.

  • See “What is the most important information I should know about alendronate sodium tablets?”

The most common side effects of alendronate sodium tablets are:

  • Stomach area (abdominal) pain
  • Heartburn
  • Constipation
  • Diarrhea
  • Upset stomach
  • Pain in your bones, joints, or muscles
  • Nausea

You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat.
Worsening of asthma has been reported.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of alendronate sodium tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store alendronate sodium tablets?

  • Store alendronate sodium tablets at room temperature, 20° to 25°C (68° to 77°F).
  • Keep alendronate sodium tablets in a tightly closed container.

Keep alendronate sodium tablets a nd all medicines out of the reach of children.
General information about the safe and effective use of alendronate sodium tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use alendronate sodium tablets for a condition for which it was not prescribed. Do not give alendronate sodium tablets to other people, even if they have the same symptoms you have. They may harm them.
This Medication Guide summarizes the most important information about alendronate sodium tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about alendronate sodium tablets that is written for health professionals. For more information, call Northstar Rx LLC at 1-800-206-7821.
What are the ingredients in alendronate sodium tablets?

Active ingredient: alendronate monosodium salt trihydrate
Inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication Guides available at www.northstarrxllc.com/products or call 1-800-206-7821.
Manufactured for: Northstar Rx LLC
Memphis, TN 38141.
Manufactured by: Aurobindo Pharma Limited
Hyderabad-500 090, India.
M.L.No.: 19/HD/AP/95/F/R
Revised: 10/2019

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