Pronunciation:.......... a-LEN-druh-nate SOH-dee-um

Drug class: Biphosphonate Derivative; Bone Metabolism Regulator
Generic available? No
Controlled substance? No

      Oral alendronate sodium is a bisphosphonate type of drug used to treat and prevent osteoporosis in postmenopausal women and treat Paget's disease. It works by decreasing bone breakdown in the body.
      This medication should be taken on the empty stomach. Do not eat or drink anything, especially dairy products such as milk or cheese, for at least 30 minutes before or after taking alendronate sodium. In addition, remain sitting or standing for 30 minutes after each dose.

FDA Approved Uses
      Used to prevent osteoporosis in postmenopausal women at risk for developing osteoporosis. Used in combination with calcium supplementation to treat osteoporosis in postmenopausal women who have a confirmed finding of low bone mass or who have a history of an osteoporotic fracture.
      Used to treat Paget's disease in those with alkaline phosphatase levels at least 2 times the normal limit, are symptomatic or are at risk for future complications from the disease.
      Used in the treatment steroid-induced osteoporosis.

Contraindications
      Any of the following may be reason to choose a different drug. Inform your doctor before starting therapy.

• Allergic to alendronate or biphosphonates
• Esophageal abnormalities
• Hypocalcemia
• Unable to stand or sit upright for 30 minutes after the dose.

Adults Under 60

• For prevention of osteoporosis: 5 mg every morning, 30 minutes before the first food, beverage or medication of the day. Take this medication with a full glass of water.
• For treatment of osteoporosis: 10 mg every morning, 30 minutes before the first food, beverage or medication of the day. Take this medication with a full glass of water.
• For treatment of Paget's disease: 40 mg every morning, 30 minutes before the first food, beverage or medication of the day, for 6 months. Then, your physician should reevaluate your therapy. Take this medication with a full glass of water.

Infants and Children
Safety and efficacy have not been established.

Maximum Dosage Recommendations

• For treatment and prevention of osteoporosis: 10 mg per day.
• For treatment of Paget's disease: 40 mg per day.

If You Miss a Dose
      Do not take the missed dose later in the day. Skip the dose and resume the usual schedule the following morning.

Storage
      Keep all medications out of the reach of children
      Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:

Common Symptoms

• Stomach pain

• Throat pain or irritation
• Difficulty swalllowing
• Esophageal ulcers
• Heartburn
• Skin rash
• Nausea
• Headache
• Gas
• Constipation or diarrhea
• Muscle pain
• Bloated feeling

• None expected

• Throat irritation
• Increased severity of heartburn
• Stomach cramps

• Hypersensitivity to calcitonin

Adults Under 60

• For Paget's disease: 200-400 units/day.
• For postmenopausal osteoporosis: 200 units/day.

Infants and Children
      The dosage is not established in this age group.

Maximum Dosage Recommendations
      Do not exceed the recommended doses, unless deemed necessary by your doctor.

If You Miss a Dose
      Use as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children
      Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:

• Common Symptoms
• Back pain
• Loss of appetite
• Diarrhea
• Nausea
• Rhinitis and discomfort symptoms in nose
• Flushing
• Edema (pedal edema)

• Frequent urination
• Dizziness

Contraindications
      Any of the following may be reason to choose a different drug. Inform your doctor before starting therapy.

• Allergic to estradiol or other estrogens
• Known or suspected pregnancy
• Undiagnosed abnormal genital bleeding
• Thrombophlebitis or thromboembolic disorders
• Known or suspected estrogen-dependent neoplasia

Adults Under 60
      Apply 1 transdermal system (delivering 50mcg daily) as directed by your physician and package label either once or twice weekly, depending on the product, with 3 weeks of the 4 week cycle. The adhesive side should be placed on a clean, dry area of skin. The system may be applied to the lower abdomen, the upper quadrant of the buttocks, or the outer aspect of the hip. Do not apply to the breasts. The sites of application should be rotated, with an interval of a minimum of 1 week until a site is repeated.

Adults 60 and Over
      Follow the adult dosage. This is used in postmenopausal women.

Storage
      Keep all medications out of the reach of children Store at room temperature.

Possible Side Effects
      You may experience the following side effects with the use of this drug:
Common Symptoms

• Tender, swollen breasts
• Swollen feet and ankles
• Weight gain

• Mental depression
• Nausea or Vomiting
• Vaginal candidiasis (infection of the vagina due to Candida)
• Stomach cramps or bloating
• Breakthrough vaginal bleeding
• Migraine headache
• Changes in sex drive
• Loss of appetite
• Diarrhea
• Hepatitis
• Pancreatitis

• Thromboembolism or thrombus formation

What to Do in Case of Overdose
      Overdose is unlikely to happen. If it does occur, dial 911 for emergency help or call your poison control center.

• Allergic to any estrogen
• Thrombophlebitis or thromboembolic disorders
• Liver disease
• Known or suspected pregnancy
• Estrogen-dependent cancer
• Undiagnosed vaginal bleeding

Adults Under 60

• For moderate to severe vasomotor symptoms and vulval and vaginal atrophy associated with menopause: The usual initial dose range is 0.625-1.25 mg per day, either continuously or cyclically, adjusted as needed to control the symptoms. Use the lowest effective dose and regimen that will control the symptoms, and maintain at the lowest effective dose.
• For female hypogonadism: 2.5-7.5 mg per day taken either continuously or cyclically.
• For primary ovarian failure or ovariectomy: 1.25 mg per day, either continuously or cyclically, adjusted to find the lowest effective maintenance dose.
• For palliation of breast cancer in appropriately selected men and women with metastatic disease: The suggested dose is at least 10 mg three times daily for at least 3 months.
• For palliation of advanced androgen-dependent prostate cancer: 1.25-2.5 mg taken by mouth 3 times per day. For prevention of osteoporosis: Start therapy as soon as possible after menopause, with 0.625 mg per day taken either continuously or cyclically.

Maximum Dosage Recommendations
      Do not exceed the recommended doses, unless deemed necessary by your doctor.

Usual Duration of Use
      Allow 1 to 4 months of use to assess the drug's effectiveness. Long term therapy may be indicated.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:
Common Symptoms

• Tender, swollen breasts
• Swollen feet and ankles
• Weight gain
• Less Common to Rare Symptoms
• Mental depression
• Nausea or Vomiting
• Vaginal candidiasis (infection of the vagina due to Candida)
• Stomach cramps or bloating
• Breakthrough vaginal bleeding
• Migraine headache
• Changes in sex drive
• Loss of appetite
• Diarrhea
• Hepatitis Pancreatitis

• Thromboembolism or thrombus formation

What to Do in Case of Overdose
      Dial 911 for emergency help or call your poison control center.

• Allergic to any component of this combination or any estrogen or progestin
• Active or history of thrombophlebitis or thromboembolic disorders
• Abnormal vaginal bleeding
• Severe liver function impairment
• Known or suspected pregnancy
• Known or suspected estrogen-dependent cancer History of stroke
• Elevated blood calcium levels associated with breast cancer or bone metastases

Adults Under 60
      Prempro: 0.625/2.5 mg or 5mg: taken 1 tablet by mouth once every day. This therapy consists of a single tablet containing 0.625 mg conjugated estrogens and either 2.5 mg or 5.0 mg medroxyprogesterone acetate. The 0.625/5.0 mg tablet may be used in those patients who need more progestin to stop the menstrual-like bleeding associated with estrogen.
      Premphase: This therapy consists of 2 different colored tablets. Take the maroon tablet by mouth everyday on days 1-14 of cycle, and take the light blue tablet on days 15 through 28. Each maroon tablet contains 0.625 mg conjugated estrogens and each light blue tablet contains 0.625 mg of conjugated estrogens and 5 mg medroxyprogesterone acetate. Repeat cycle every 28 days.

Adults 60 and Over
      Follow the adult dosage, unless directed otherwise by your physician.

Usual Duration of Use
      If used for treatment of menopausal symptoms, re-evaluation every 3-6 months is recommended to determine if therapy is still needed.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children
      Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:
Common Symptoms

• Nausea or vomiting
• Tender, swollen breasts
• Mild to moderate abdominal pain or cramping
• Breakthrough bleeding or spotting
• Withdrawal bleeding

• Swollen feet and ankles
• Loss of appetite
• Menstrual irregularities
• Hirsutism (excessive body or facial hair, especially in women)
• Edema (excessive accumulation of fluids in cells or tissues)
• Insomnia
• Vaginal candidiasis (infection of the vagina caused by Candida)
• Vaginal itching or irritation
• Bloating Diarrhea
• Tiredness Pancreatitis
• Hepatitis

• Thromboembolism or thrombus formation
• Profuse vaginal bleeding

• Acute overdose:
  • None expected
• Chronic overdose:
  • Dizziness
  • Leg cramps
  • Headache
  • Breast enlargement and discomfort
  • Fluid retention
  • Jaundice

Adults Under 60

• Secondary amenorrhea: 5-10 mg per day taken by mouth for 5-10 days, starting anytime, then stop.
• Dysfunctional uterine bleeding: 5-10 mg per day taken by mouth for 5-10 days, starting on the 16th or 21st days of the menstrual cycle.
• Induction of menstruation: 10 mg per day taken by mouth for 10 days, starting on the 16th day of the menstrual cycle.
• Withdrawal bleeding usually starts within 3-7 days after drug is discontinued.
• Reduction of endometrial hyperplasia in postmenopausal women taking 0.625 mg conjugated estrogens: 5 or 10 mg taken by mouth daily for 12 to 14 consecutive days per month, beginning on the first day of the cycle or the 16th day of the cycle.

Maximum Dosage Recommendations
      Do not exceed the recommended doses, unless deemed necessary by your doctor.

Usual Duration of Use
      Allow 2 to 3 menstrual cycles of use to assess the drug's effectiveness.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children
      Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:

Common Symptoms

• Headache
• Menstrual cycle changes
• Unusual tiredness or weakness
• Swollen feet or ankles
• Stomach pain
• Nervousness
• Changes in appetite or weight

• Decreased sex drive
• Insomnia
• Hot flashes
• Hirsutism (excessive body or facial hair, especially in women)
• Brown skin spots
• Hair loss
• Depression
• Vaginitis
• Thromboembolic phenomena (blood clots in a blood vessel)
• Jaundice (shows up as yellowish eyes or skin)
• Amenorrhea (abnormal or absence of menstrual function)
• Nausea
• Dizziness
• Pruritus (itching)
• Rash
• Urticaria (an itching attack, may be due to drug sensitivity)
• Tender breasts
• Bloating
• Breast pain
• Fever
• Acne
• Backache

• Anaphylaxis (severe allergic reaction)
• Thromboembolic disorder (formation of blood clots)

• Jaundice
• Headache
• Dizziness
• Fluid retention
• Breast discomfort or enlargement
• Amenorrhea
• Decreased libido

Adults Under 60

• 60 mg taken by mouth once daily without regard to meals.
• Take supplemental calcium and vitamin D if daily dietary intake is inadequate.

Infants and Children
      This drug is not used in this age group.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children
      Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.       You may experience the following side effects with the use of this drug:

Common Symptoms

• Leg cramps
• Sinusitis (inflammation of the lining of a sinus)
• Hot flashes
• Less Common to Rare Symptoms Chest pain
• Flatulence (gas)
• Fever
• Increased coughing
• Dyspepsia (upset stomach)
• Vaginitis (inflammation of the vagina)
• Sweating
• Myalgia (muscle pain)
• Rash
• Migraine
• Weight gain
• Peripheral edema (swelling of the hands, feet, ankles, due to fluid accumulation)
• Nausea or vomiting
• Depression

Possible Overdose Symptoms
      Overdosage has not been reported

What to Do in Case of Overdose
      In the event of a suspected overdose, dial 911 for emergency help or call your poison control center.

Adults Under 60
      400 mg taken by mouth with 6-8 ounces of plain water per day for a period of 3 months. Take doses on an empty stomach at least 2 hours before or 2 hours after a meal. After the 3 months of therapy, allow a 3 month period for reassessment. Data on retreatment, however, are not available.

Adults 60 and Over
      Follow the adult dosage.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children
      Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:
Common Symptoms

• None expected

• Hypocalcemia (low level of calcium)