Alendronate Sodium (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Alendronate Sodium Oral Solution

70 mg oral solution is supplied as a clear, colorless to pale pink solution with a raspberry flavor.

NDC 0054-0282 -59 unit-of-use cartons of 4 single-dose bottles containing 75 mL each

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze.

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 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 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 [see Clinical Pharmacology (12.3)].

Instruct patients to drink at least 2 ounces (a quarter of a cup) of water after taking alendronate oral solution, to facilitate gastric emptying.

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 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 and consult their physician.

If patients miss a dose of once weekly alendronate, 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.

Distr. by: Hikma

Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

C50000243/01
Revised September 2020

Medication Guide

ONCE WEEKLY
Alendronate Sodium Oral Solution

(a len’ droe nate soe’ dee um)

Rx only

Read the Medication Guide that comes with Alendronate Sodium Oral Solution before you start taking it 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 Oral Solution.

What is the most important information I should know about Alendronate Sodium Oral Solution?

Alendronate Sodium Oral Solution can 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 Oral Solution may 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 Oral Solution exactly as prescribed to help lower your chance of getting esophagus problems. (See the section “How should I take once weekly Alendronate Sodium Oral Solution sodium oral solution?”)
Stop taking Alendronate Sodium Oral Solution 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 Oral Solution may lower the calcium levels in your blood. If you have low blood calcium before you start taking Alendronate Sodium Oral Solution, it may get worse during treatment. Your low blood calcium must be treated before you take Alendronate Sodium Oral Solution. 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. Take calcium and vitamin D as your doctor tells you to.

3. Bone, joint, or muscle pain.

Some people who take Alendronate Sodium Oral Solution develop severe bone, joint, or muscle pain.

4. Severe jaw bone problems (osteonecrosis).

Severe jaw bone problems may happen when you take Alendronate Sodium Oral Solution. Your doctor should examine your mouth before you start Alendronate Sodium Oral Solution. Your doctor may tell you to see your dentist before you start Alendronate Sodium Oral Solution. It is important for you to practice good mouth care during treatment with Alendronate Sodium Oral Solution.

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 is Alendronate Sodium Oral Solution?

Alendronate Sodium Oral Solution is a prescription medicine used to:

Treat 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.

It is not known how long alendronate works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if Alendronate Sodium Oral Solution is still right for you.

Alendronate Sodium Oral Solution is not for use in children.

Who should not take Alendronate Sodium Oral Solution?

Do not take Alendronate Sodium Oral Solution if 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 Oral Solution or any of its ingredients. A list of ingredients is at the end of this leaflet.

What should I tell my doctor before taking Alendronate Sodium Oral Solution?

Before you start Alendronate Sodium Oral Solution, 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 Oral Solution, stop taking it and contact your doctor. It is not known if Alendronate Sodium Oral Solution can harm your unborn baby.
Are breast-feeding or plan to breast-feed. It is not known if Alendronate Sodium Oral Solution 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 Oral Solution works.

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 once weekly Alendronate Sodium Oral Solution?

Take Alendronate Sodium Oral Solution exactly as your doctor tells you.
Alendronate Sodium Oral Solution works only if taken on an empty stomach.
Take Alendronate Sodium Oral Solution after you get up for the day and before taking your first food, drink, or other medicine.
Take Alendronate Sodium Oral Solution while you are sitting or standing.
Do not take Alendronate Sodium Oral Solution with mineral water, coffee, tea, soda, or juice.
Choose the day of the week that best fits your schedule.
Take 1 dose of Alendronate Sodium Oral Solution every week on your chosen day after you get up for the day and before taking your first food, drink, or other medicine.

Do not lie down for at least 30 minutes after you take Alendronate Sodium Oral Solution and after you eat your first food of the day.

If you miss a dose of Alendronate Sodium Oral Solution, 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 Oral Solution, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of Alendronate Sodium Oral Solution?

Alendronate Sodium Oral Solution may cause serious side effects.

See “What is the most important information I should know about Alendronate Sodium Oral Solution?”

The most common side effects of Alendronate Sodium Oral Solution 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 Oral Solution. 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 Oral Solution?

Store Alendronate Sodium Oral Solution at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze.
Keep Alendronate Sodium Oral Solution in a tightly closed container.

Keep Alendronate Sodium Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of Alendronate Sodium Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Alendronate Sodium Oral Solution for a condition for which it was not prescribed. Do not give Alendronate Sodium Oral Solution to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Alendronate Sodium Oral Solution. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Alendronate Sodium Oral Solution that is written for health professionals. For more information, go to: call 1-800-962-8364 (toll-free).

What are the ingredients in Alendronate Sodium Oral Solution?

Active ingredient: alendronate sodium

Inactive ingredients: citric acid (anhydrous), methylparaben, propylparaben, purified water, raspberry blend, saccharin sodium and sodium citrate

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distr. by: Hikma

Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

C50000243/01 Revised September 2020

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