The following drugs and medications are in some way related to, or used in the treatment of Anticholinesterase Poisoning. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Class: Bone Resorption Inhibitors
VA Class: HS900
Chemical Name: (4-Amino-1-hydroxybutylidene)bis-phosphonic acid, monosodium salt, trihydrate
Molecular Formula: C4H13NO7P2•3H2O•Na
CAS Number: 121268-17-5
Brands: Fosamax, Fosamax Plus D
Special Alerts:
[Posted 07/21/2011] ISSUE: FDA notified healthcare professionals and patients about its ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus. FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer. There are insufficient data to recommend endoscopic screening of asymptomatic patients. FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available.
BACKGROUND: Oral bisphosphonates are commonly used for the prevention and treatment of osteoporosis as well as to treat other bone diseases such as Paget’s disease. There have been conflicting findings from studies evaluating the risk of esophageal cancer. Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates. See the Data Summary in the Drug Safety Communication for additional details at: .
RECOMMENDATION: Patients should talk with their healthcare professional about the benefits and risks of taking oral bisphosphonates and how long they should expect to take them. Patients should talk with their healthcare professional if they develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when swallowing. Patients should be instructed to carefully follow the directions for use of the oral bisphosphonate drug they are prescribed. For more information visit the FDA website at: and .
[Posted 10/13/2010] ISSUE: FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels approved to treat osteoporosis, including alendronate (Fosamax), alendronate with cholecalciferol (Fosamax Plus D), risedronate (Actonel and Atelvia), risedronate with calcium carbonate (Actonel with Calcium), ibandronate (Boniva), tiludronate (Skelid), and zoledronic acid (Reclast) and their generic products. A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription.
BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.
RECOMMENDATIONS: Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. For more information visit the FDA website at: and .
[Posted 03/11/2010] FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further.
FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates.
Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications. For more information visit the FDA website at: and .
[Posted 11/12/2008] FDA issued an update to the Agency’s review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication. For more information visit the FDA website at: , and .
REMS:
FDA approved a REMS for alendronate to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
Synthetic bisphosphonate; bone resorption inhibitor.1 2 3 4 a
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Alendronate is used for prevention of osteoporosis in postmenopausal women1 24 25 with risk factors for development of osteoporosis.1 41 46 47 50 51 52 53 62 Risk factors include premature ovarian failure; family history of osteoporosis; small, slim body frame; endocrine disorders (e.g., thyrotoxicosis, hyperparathyroidism, Cushing’s syndrome, hyperprolactinemia, insulin-dependent diabetes mellitus); cigarette smoking; excessive alcohol use; sedentary lifestyle; low body weight; moderately low body mass; low dietary calcium intake; or Caucasian or Asian race.1 41 46 47 50 51 52 53 62
Alendronate is used alone or in fixed combination with cholecalciferol (vitamin D3) for treatment of osteoporosis in postmenopausal women.1 2 3 5 6 7 8 10 11 12 13 a
Alendronate is used alone or in fixed combination with cholecalciferol for treatment of osteoporosis in men.1 66 70 a
Alendronate/cholecalciferol fixed combination is not recommended for treatment of vitamin D deficiency.a e
Alendronate has been used concomitantly with hormone replacement therapy.1 68 69
Alendronate is used for treatment of corticosteroid-induced osteoporosis in patients receiving corticosteroids (daily dosage ≥5–7.5 mg of prednisone).1 57 58 73 78
Alendronate is used for prevention of corticosteroid-induced osteoporosis† in patients receiving corticosteroid therapy (daily dosage ≥5 mg of prednisone).57 58 73 78
American College of Rheumatology considers patients receiving ≥5 mg prednisone daily for ≥3 months at risk for bone loss.78 Recommends bisphosphonate therapy for all long-term corticosteroid-treated men, premenopausal women (with caution), and postmenopausal women with or without hormone replacement therapy (combined estrogen and progestin therapy).78
Alendronate is used for treatment of moderate to severe Paget’s disease of bone (osteitis deformans) in patients with serum alkaline phosphatase concentrations ≥ twice ULN or who are symptomatic or at risk for future complications.1 15
Use adjunctively with other measures (e.g., diet, weight-bearing exercise, physical therapy, reduction in smoking, alcohol use) to retard further bone loss.1 41 45 78 a e
Supplemental calcium and vitamin D recommended if daily dietary intake is inadequate, particularly in patients with Paget’s disease of bone or receiving corticosteroids.1 1 a e
Supplemental vitamin D recommended in patients at increased risk for vitamin D insufficiency (e.g., >70 years of age, nursing home bound, chronically ill, with GI malabsorption syndrome) if necessary.a (See Metabolic Effects under Cautions.)
Recommended intake of vitamin D is 400–800 units daily; once-weekly dose of alendronate/cholecalciferol fixed-combination preparation containing cholecalciferol 2800 or 5600 units provides the equivalent of 400 or 800 units, respectively, of vitamin D daily.a
Administer tablet orally upon arising with a full glass (180–240 mL) of plain water at least 30 minutes before first food, beverage, or other orally administered drug of the day.1 1 a (See Food under Pharmacokinetics.)
Drink at least 60 mL (2 oz., a quarter of a cup) of water after taking the oral solution to facilitate gastric emptying.1
Administer in an upright position (sitting or standing).1 a Avoid lying down for at least 30 minutes following administration and until after the first food of the day.1 a (See GI Effects under Cautions.)
Avoid administering at bedtime or before arising for the day.1 20 a
Do not suck or chew tablets; potential oropharyngeal irritation.20 1 a e
Avoid any other medications, including calcium supplements or antacids, for 30 minutes after alendronate is administered.1 a (See Antacids or Mineral Supplements Containing Divalent Cations under Interactions.)
If a weekly dose is missed, administer missed dose the morning after it is remembered, followed by resumption of the regular weekly schedule.1 a However, do not take two 70-mg tablets on the same day.1 a
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Available as alendronate sodium; dosage expressed in terms of alendronate.1 a
Alendronate 5 mg once daily or 35 mg once weekly.1
Alendronate 10 mg once daily or 70 mg once weekly in men and postmenopausal women.1
Alendronate/cholecalciferol fixed-combination: Usually, alendronate 70 mg and cholecalciferol 5600 units once weekly in men and postmenopausal women.a Alternatively, alendronate 70 mg and cholecalciferol 2800 units once weekly.a
Alendronate 5 mg once daily in postmenopausal women receiving hormone replacement therapy (HRT), premenopausal women, and men.73 78
Alendronate 10 mg once daily in postmenopausal women not receiving HRT.78
Continue alendronate as long as patient continues to receive corticosteroid therapy.78
Alendronate 5 mg once daily in postmenopausal women receiving HRT, premenopausal women, and men.1 73 78
Alendronate 10 mg once daily in postmenopausal women not receiving HRT.1 78
Continue alendronate as long as patient continues to receive corticosteroid therapy.78
Alendronate 40 mg once daily for 6 months.1
Consider retreatment after a 6-month posttreatment evaluation period if relapse occurs (i.e., increased serum alkaline phosphatase concentration) or if initial treatment failed to normalize serum alkaline phosphatase concentrations.1
No dosage adjustment required in patients with mild to moderate impairment (Clcr 35–60 mL/minute); not recommended in patients with severe impairment (Clcr <35 mL/minute).1 a
No dosage adjustment required.a
Esophageal abnormalities that delay esophageal emptying (e.g., stricture, achalasia).1 20 21 23 a
Patients at increased risk of aspiration should not receive alendronate oral solution.1
Inability to stand or sit upright for at least 30 minutes.1 20 21 23 a
Hypocalcemia.1 a
Known hypersensitivity to alendronate or any ingredient in the formulation.1 a
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Possible severe adverse esophageal effects (e.g., esophagitis, esophageal ulcers, erosions, strictures, perforation).1 16 18 20 21 23 a Monitor for any manifestations1 16 18 20 21 23 a and discontinue if dysphagia, odynophagia, new or worsening heartburn, or retrosternal pain occurs.1 20 23 a
Cautious use recommended in patients with history of upper GI disease (e.g., dysphagia, esophageal diseases, gastritis, duodenitis, ulcers).1 20 23 a Gastric and duodenal ulcers (some severe and with complications) reported in postmarketing surveillance.1 a
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Consider other possible causes of osteoporosis before beginning alendronate.1 a
Possible asymptomatic decreases in serum calcium and phosphate concentrations, particularly in patients with Paget’s disease and in those receiving corticosteroids; ensure adequate calcium and vitamin D intake.1 a
Correct hypocalcemia and other disorders affecting mineral metabolism (e.g., vitamin D deficiency) before initiation of alendronate therapy;1 a administer supplemental calcium and vitamin D if daily dietary intake is inadequate.1 26 27 28 29 38 46 47 48 51 52 53 Monitor serum calcium and monitor for symptoms of hypocalcemia during therapy.a
Fixed combination of alendronate and cholecalciferol (vitamin D3) is not recommended for treatment of vitamin D deficiency (i.e., 25-hydroxyvitamin D concentration <9 ng/mL).a Patients at risk for vitamin D insufficiency (e.g., GI malabsorption syndromes) may require higher doses of vitamin D supplementation; consider measurement of 25-hydroxyvitamin D.a
Vitamin D3 supplementation may increase risk of hypercalcemia and/or hypercalciuria in patients with diseases associated with unregulated overproduction of 1,25-dihydroxyvitamin D (e.g., leukemia, lymphoma, sarcoidosis).a Monitor urine and serum calcium in these patients.a
Severe and occasionally incapacitating bone, joint, and/or muscle pain, especially in postmenopausal women, has been reported in postmarketing surveillance.a f Time to onset varied from 1 day to several months after treatment initiation.a f If severe symptoms occur, discontinue drug.a Such pain improves following discontinuance, but may recur upon subsequent rechallenge with the same drug or another bisphosphonate.a f
Osteonecrosis of the jaw has been reported principally in cancer patients receiving IV bisphosphonates.a f Most cases were associated with tooth extraction and/or local infection, often with delayed healing, but some cases occurred in patients with postmenopausal osteoporosis receiving oral therapy.a f Known risk factors include cancer, chemotherapy, radiation therapy, corticosteroids, poor oral hygiene, preexisting dental disease, anemia, coagulopathy, and infection.a f
If osteonecrosis of the jaw develops, consult an oral surgeon for treatment.a f Dental surgery may exacerbate condition.a f
In patients requiring dental procedures, no data are available to suggest whether discontinuance of therapy prior to procedure reduces the risk of osteonecrosis of the jaw.a f Base management of patients requiring dental treatment on an individual assessment of risks and benefits.a f
When alendronate is used in fixed combination with cholecalciferol, consider the cautions, precautions, and contraindications associated with cholecalciferol.a b
Measure bone mineral density at initiation of therapy and after 6–12 months of concomitant use with corticosteroids.1
Alendronate alone or in fixed combination with cholecalciferol: Category C.1 a
Not known whether alendronate is distributed into milk.1 a Caution if used in nursing women.1 a
Safety and efficacy not established.1 a
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 a
Decreased clearance of alendronate likely.1 a Use not recommended in patients with severe renal insufficiency (Clcr <35 mL/minute).1 a
Abdominal pain.1 a
Potential decreased alendronate absorption when administered with divalent cations (e.g., calcium).1 a
Potential decreased alendronate absorption when administered concomitantly with other oral medications.f Administer alendronate ≥30 minutes prior to other oral medications.f
Drug | Interaction | Comments |
|---|---|---|
Antacids (calcium) | May interfere with absorption of alendronatea | Wait at least ≥30 minutes after taking alendronate before taking any other oral medicationsa |
Hormone replacement therapy (estrogens; estrogens and progestins) | Potential increased effects on bone mineral density1 68 69 | |
NSAIAs (e.g., aspirin) | Aspirin increased GI toxicity in clinical studies; no increase in toxicity with concomitant NSAIAs in one study1 a | Use caution1 a |
Prednisone | No change in alendronate bioavailability1 a | |
Ranitidine | IV ranitidine doubled alendronate bioavailability1 a |
Oral bioavailability of alendronate in women and men is 0.64 and 0.59%, respectively.1 a
Bioavailability of alendronate sodium tablets and oral solution equivalent.1
Bioavailability of conventional tablets and fixed-combination tablets containing cholecalciferol (2800 and 5600 units) equivalent.a
Decrease in bone resorption rate evident as early as 1 month.1 a
Alendronate bioavailability decreased by 40% when administered 0.5–1 hour prior to a meal, and by 60% when administered with coffee or orange juice.1 a Bioavailability is negligible whether administered with or up to 2 hours after a meal.1 a
Alendronate is widely distributed after oral administration.c Subsequently, redistributes rapidly to skeletal tissues.c a Mean steady-state volume of distribution, exclusive of bone, is ≥28 L.1 a c
Alendronate: Approximately 78%.1 a
No evidence of metabolism of alendronate.1 c
Urinary excretion is the sole means of elimination of alendronate.1 3 a b
Terminal half-life of alendronate >10 years, reflecting release from bone.1 2 3 4 11 a
In patients with renal impairment, clearance of alendronate likely to be reduced.1 a Somewhat greater accumulation in bone expected.1 a
Alendronate: Tight containers at 15–30°C.1
Alendronate/cholecalciferol fixed combination: 20–25°C (may be exposed to 15–30°C).a Keep tablets in sealed blisters until immediately before use.a Protect from moisture and light.a
Alendronate: 15–30°C.1 Do not freeze.1
Alendronate incorporates into bone and selectively inhibits osteoclast-mediated bone resorption in a dose-dependent manner.1 2 3 4 5 8 9 10
Alendronate increases bone mineral density.1 8 24 58 66 69 70 72 73 74 78 a
Pharmacologically inactive while incorporated into bone matrix.1 2 3 4 11 a Continuous administration required for activity.1 2 3 4 11 a
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of providing a copy of the manufacturer’s patient information.1 17 20 21 23 a
Importance of correct administration (e.g., avoiding foods and beverages other than plain water, not lying down for ≥30 minutes following administration, avoiding administering at bedtime or before arising for the day).1 20 a e
Importance of swallowing tablets whole, without chewing or sucking.20 a e
Importance of discontinuing and informing clinician if symptoms of esophageal disease (e.g., difficulty or pain on swallowing; retrosternal, abdominal or esophageal pain; new or worsening heartburn) develop.1 20 23 a e
Importance of adhering to recommended lifestyle modifications (e.g., weight-bearing exercise, calcium and vitamin D consumption, avoidance of excessive cigarette smoking and/or alcohol consumption).1 a e
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 a
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 a
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Alendronate (Fosamax) for the treatment of Paget’s disease of bone is available only through Paget’s Patient Support Program with Pharma Care Specialty Pharmacy (800-238-7828 ext. 58197) distribution system for the 40-mg dosage regimen.d
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Solution | 70 mg/75 mL (of alendronate) | Fosamax | Merck |
Tablets | 5 mg (of alendronate) | Fosamax | Merck | |
10 mg (of alendronate) | Fosamax | Merck | ||
35 mg (of alendronate) | Fosamax | Merck | ||
40 mg (of alendronate) | Fosamax | Merck | ||
70 mg (of alendronate) | Fosamax | Merck |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 70 mg (of alendronate) and Cholecalciferol 2800 units | Fosamax Plus D | Merck |
70 mg (of alendronate) and Cholecalciferol 5600 units | Fosamax Plus D | Merck |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Alendronate Sodium 10MG Tablets (TEVA PHARMACEUTICALS USA): 100/$240.00 or 300/$679.95
Alendronate Sodium 40MG Tablets (TEVA PHARMACEUTICALS USA): 30/$179.99 or 90/$489.95
Alendronate Sodium 5MG Tablets (TEVA PHARMACEUTICALS USA): 100/$255.98 or 300/$729.91
Alendronate Sodium 70MG Tablets (TEVA PHARMACEUTICALS USA): 4/$13.99 or 12/$20.99
Alendronate Sodium 70MG Tablets (TEVA PHARMACEUTICALS USA): 20/$29.99 or 60/$69.97
Fosamax 10MG Tablets (MERCK SHARP & DOHME): 30/$95.12 or 90/$262.94
Fosamax 35MG Tablets (MERCK SHARP & DOHME): 4/$87.66 or 12/$252.29
Fosamax 5MG Tablets (MERCK SHARP & DOHME): 30/$91.92 or 90/$265.31
Fosamax 70MG Tablets (MERCK SHARP & DOHME): 4/$101.99 or 12/$288.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. Merck. Fosamax (alendronate sodium) tablets prescribing information. West Point, PA; 2004 Apr.
2. Inzerillo MT, Caspi A. Alendronate: an investigational agent for the prevention and treatment of osteoporosis. P & T. 1994; 19:851-2.
3. Kanis JA, Gertz BJ, Singer F et al. Rationale for the use of alendronate in osteoporosis. Osteoporos Int. 1995; 5:1-13. [PubMed 7703618]
4. Gertz BJ, Holland SD, Kline WF et al. Clinical pharmacology of alendronate sodium. Osteoporos Int. 1993; 3(Suppl 3):513-6.
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8. Chesnut CH III, McClung MR, Ensrud KE et al. Alendronate treatment of the postmenopausal osteoporotic woman: effect of multiple dosages on bone mass and bone remodeling. Am J Med. 1995; 99:144-52. [IDIS 352248] [PubMed 7625419]
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10. Harris ST, Gertz BJ, Genant HK et al. The effect of short term treatment with alendronate on vertebral density and biochemical markers of bone remodeling in early postmenopausal women. J Clin Endocrinol Metab. 1993; 76:1399-1406. [IDIS 316327] [PubMed 8501142]
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13. O’Doherty DP, Gertz BJ, Tindale W et al. Effects of five daily 1 h infusions of alendronate in Paget’s disease of bone. J Bone Miner Res. 1992; 7:81-7. [PubMed 1549961]
14. Krane SM. Paget’s disease of bone. In: Isselbacher KJ, Braunwald E, Wilson JD et al, eds. Harrison’s principles of internal medicine. 13th ed. New York: McGraw Hill Company; 1994:2190-3.
15. Singer FR. Paget’s disease of bone (osteitis deformans). In: Wyngaarden JB, Smith LH, Bennett JC, eds. Cecil’s textbook of medicine. 19th ed. Philadelphia: WB Saunders Company; 1992:1431-3.
16. Rosen CJ, Kessenich CR. Comparative clinical pharmacology and therapeutic use of bisphosphonates in metabolic bone diseases. Drugs. 1996; 51:537-51. [PubMed 8706593]
17. Adami S, Zamberlan N. Adverse effects of bisphosphonates: a comparative review. Drug Safety. 1996; 14:158-70. [PubMed 8934578]
18. Maconi G, Porro GB. Multiple ulcerative esophagitis caused by alendronate. Am J Gastroenterol. 1995; 90:1889-90. [IDIS 354658] [PubMed 7572919]
19. Riggs BL. Osteoporosis. In: Wyngaarden JB, Smith LH Jr, Bennett JC, eds. Cecil textbook of medicine. 19th ed. Philadelphia: WB Saunders Company; 1992:1426-31.
20. De Groen PC, Lubbe DF, Hirsch LJ et al. Esophagitis associated with the use of alendronate. N Engl J Med. 1996; 335:1016-21. [IDIS 372987] [PubMed 8793925]
21. Castell DO. “Pill esophagitis”—the case of alendronate. N Engl J Med. 1996; 335:1058-9. [IDIS 372990] [PubMed 8793934]
22. Liberman UA, Hirsch LJ. Esophagitis and alendronate. N Engl J Med. 1996; 335:1069-70. [IDIS 372999] [PubMed 8801453]
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24. McClung M, Clemmesen B, Daifotis A et al. Alendronate prevents postmenopausal bone loss in women without osteoporosis: a double-blind, randomized, controlled trial. Ann Intern Med. 1998; 128:253-61. [IDIS 401674] [PubMed 9471927]
25. Hosking D, Chilvers CED, Christiansen C et al. Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. N Engl J Med. 1998; 338:485-92. [IDIS 400119] [PubMed 9443925]
26. Wood AJJ. Treatment of postmenopausal osteoporosis. N Engl J Med. 1998; 338:736-46. [IDIS 402219] [PubMed 9494151]
27. Committee on Educational Bulletins of the American College of Obstetricians and Gynecologists. ACOG Educational Bulletin: osteoporosis. Obstet Gynecol. 1998; 91:1-9. [IDIS 403501] [PubMed 9464711]
28. Heaney RP. Bone mass, bone loss, and osteoporosis prophylaxis. Ann Intern Med. 1998; 128:313-4. [IDIS 401677] [PubMed 9471936]
29. Seeman E. Osteoporosis: trials and tribulations. Am J Med. 1997; 103:74-89S. [PubMed 9236490]
30. Liberman UA, Weiss SR, Bröli J et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med. 1995; 333:1437-43. [IDIS 357030] [PubMed 7477143]
31. Tucci JR, Tonino RP, Emkey RD et al. Effect of three years of oral alendronate treatment in postmenopausal women with osteoporosis. Am J Med. 1996; 101:488-501. [IDIS 377583] [PubMed 8948272]
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33. Devogelaer JP, Broll H, Correa-Rotter R et al. Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis. Bone. 1996; 18:141-50. [PubMed 8833208]
34. Karpf DB, Shapiro DR, Seeman E et al. Prevention of nonvertebral fractures by alendronate: a meta-analysis. JAMA. 1997; 277: 1159-64. [IDIS 382850] [PubMed 9087473]
35. Bone HG, Downs RW Jr, Tucci JR et al. for the Alendroante Elderly Osteoporosis Study Centers. Dose-response relationships for alendronate treatment in osteoporotic elderly women. J Clin Endocrinol Metab. 1997; 82:265-74. [IDIS 377943] [PubMed 8989272]
36. Black DM, Cummings SR, Karpf DB et al. for the Fracture Intervention Trial Research Group. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Lancet. 1996; 348:1535-41. [IDIS 377967] [PubMed 8950879]
37. Merck, West Point, PA: Personal communication.
38. Castelo-Branco C. Management of osteoporosis: an overview. Drugs Aging. 1998; 12(Suppl 1):25-32. [PubMed 9673863]
39. Jeal W, Barradell LB, McTavish D. Alendronate: a review of its pharmacological properties and therapeutic efficacy in postmenopausal osteoporosis. Drugs. 1997; 53:415-34. [PubMed 9074843]
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41. National Osteoporosis Foundation. Physician’s guide to prevention and treatment of osteoporosis. Washington, DC; 1998.
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Generic Name: fluocinolone (Topical application route)
floo-oh-SIN-oh-lone a-SEET-oh-nide
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Corticosteroid, Intermediate
Pharmacologic Class: Fluocinolone
Fluocinolone topical is used to relieve redness, itching, swelling, or other discomfort caused by skin conditions. Fluocinolone scalp oil is used to treat psoriasis of the scalp, and fluocinolone shampoo for seborrheic dermatitis of the scalp. This medicine is a corticosteroid (cortisone-like medicine or steroid).
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluocinolone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the body oil form, safety and efficacy in children 3 months of age and younger have not been established.
No information is available on the relationship of age to the effects of fluocinolone topical in geriatric patients.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain fluocinolone. It may not be specific to Synalar Mild. Please read with care.
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.
This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.
To use cream, ointment, solution, and body oil:
To use shampoo:
To use scalp oil:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.
Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Synalar side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Betadine VC Kit 10% w/v.
Povidone Iodine USP 10% w/v.
Solution.
As a vaginal cleanser in the treatment of vaginitis due to candidal, trichomonal, non-specific or mixed infections and for pre-operative preparation of the vagina.
For intravaginal use. Adults and the elderly: Once a day (preferably in the morning) for a 14 day period, including days of menstruation. The Betadine VC Concentrate should be diluted 1:10 using the measuring cap, and used according to the patient instruction leaflet provided. The applicators should only be used for the administration of the diluted VC Kit solution. This product may be used in combination with Betadine Vaginal Pessaries. Children: Contra-indicated for use in pre-pubertal children.
Known or suspected iodine hypersensitivity. Regular use is contra-indicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).
Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.
Absorption of iodine from povidone iodine through either intact or broken skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.
Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption of iodine on foetal thyroid function and development.
None known.
If local irritation, redness or swelling develops, discontinue treatment. Iodine is absorbed from the vagina and following prolonged use, thyroid dysfunction may develop. The product may be spermicidal and should not be used when conception is desired.
Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.
Povidone iodine is a complex of iodine which retains the broad spectrum germicidal activity of elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.
Betadine VC Concentrate is applied topically to the affected area.
None stated.
Nonoxynol 9; Fleuroma Bouquet 477; purified water.
Compatibility with barrier contraceptives has not been established. Therefore this product should not be used with such methods of contraception as their reliability may be affected.
36 months.
Store at or below 25oC.
Carton containing a white polypropylene container with a white polypropylene wadless cap containing 250ml Betadine VC Concentrate, an empty turquoise low density polypropylene squeeze bottle and a vaginal applicator.
None stated.
Seton Healthcare Group plc, Tubiton House, Oldham, OL1 3HS.
PL 0223/0020.
28th April 1993 / 17th November 1998.
April 2003.
Monomax SR 40 mg & 60 mg Capsules
isosorbide mononitrate
Monomax SR Modified-release Capsules contain isosorbide mononitrate which belongs to
a group of medicines called nitrates that act on the cardiovascular system (the heart and
blood vessels). Monomax has been given to you by your doctor or pharmacist to reduce
the frequency of your anginal attacks (chest pains). They are called modified-release
capsules because they are manufactured in a way that allows the isosorbide mononitrate
to be released and slowly absorbed by your body over a period of several hours.
In angina, isosorbide mononitrate works by opening up the arteries supplying the heart
muscle and this allows more blood and oxygen to reach the muscle, decreasing the
chances of angina (chest pains) occurring when extra strain is placed upon the heart.
Before starting treatment, please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained without a prescription.
If you have to go to a doctor, dentist or hospital for any reason, tell them that you are
taking Monomax.
In particular, tell your doctor or pharmacist if you are taking:
Taking these types of medicines with Monomax can increase the risk of low blood
pressure occurring, especially if you are elderly.
Do not take sildenafil, used for the treatment of erectile dysfunction at the
same time as Monomax. If taken at the same time it could cause a severe fall in
blood pressure resulting in collapse, unconciousness and may be fatal.
If you drink alcohol while you are taking Monomax it can increase the risk of low blood
pressure occurring, especially if you are elderly.
Do not take Monomax if you are pregnant, trying to become pregnant or are breast-feeding.
If you feel faint, dizzy or light headed when you stand up or move suddenly after taking
Monomax, then do not drive or operate machinery.
Monomax contains lactose monohydrate and sucrose. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before taking
this medicinal product.
Always take Monomax exactly as your doctor or pharmacist has told you to. You should
check with your doctor or pharmacist if you are not sure.
The label on the carton will tell you how many capsules you should take and when. It is
very important that you take your capsules regularly. Do not stop treatment even if
you feel better unless told to do so by your doctor.
Monomax is formulated so that you only have to take your capsules once a day. It is
important that you take your capsules at the same time each day, preferably in the
morning. Your capsule must be swallowed whole with a glass of water. Do not break or
chew your capsules.
Adults and the elderly: the usual dose is 40 mg or 60 mg once a day. Your doctor may decide to increase your dose to a maximum of 120 mg of Monomax once a day.
If you are elderly and suffer from low blood pressure, liver or kidney disease, your doctor
may prescribe a lower dose for you to take.
Do not stop taking your medicine until your doctor tells you.
Children must not take this medicine.
If you accidentally take more Monomax than you should, contact your nearest casualty
department or tell your doctor or pharmacist immediately. Remember to take the pack
and any remaining capsules with you.
Do not worry. Simply leave out that dose completely and then take your next dose at
the right time. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
Like all medicines, Monomax can cause side effects, although not everyone gets them.
If you experience a headache when you first start taking your capsules, contact your
doctor or pharmacist immediately. Your doctor or pharmacist may need to adjust your
dose.
The following side effects do not usually last long and are most likely to occur when you
first start to take your medicine or if your dose has been increased. If they continue or if
you are worried, contact your doctor or pharmacist immediately:
Also, some people experience:
If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
Monomax SR 40 mg and 60 mg Modified-release Capsules are white with “ISMN SR” and
“40” or “60” printed on the capsule in black ink respectively. They are available in blister
packs of 28 capsules.
The Marketing Authorisation holder and manufacturer is:
Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last approved in 08/2009
01811 V2/CP0028/2
A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.
Glycopeptide antibiotics inhibit bacterial cell wall formation by inhibiting peptidoglycan synthesis. They are used for treating methicillin-resistant staphylococcus aureus (MRSA) infections and enterococcal infections, which are resistant to beta-lactams and other antibiotics. They are also used in cases where there is allergy to beta-lactams.
Medical conditions associated with glycopeptide antibiotics:
Generic Name: chlorpheniramine, dextromethorphan, and pseudoephedrine (klor feh NEER a meen, dex tro meh THOR fan, and soo doe eh FEH drin)
Brand Names: AccuHist PDX Drops, Atuss DS, Children's NyQuil, Creomulsion Cough/Cold/Allergy, Creomulsion Pediatric, Dicel DM, Dicel DM Chewables, Entre-S, Esocor P, Kidcare Cough and Cold, M-End DM, Mesehist DM, Neutrahist PDX Drops, Nyquil Child Cough and Cold, Pediatric Cough & Cold Medicine, Rescon-DM, Robitussin Pediatric Night Relief, Robitussin PM Cough & Cold, Triaminic Cold and Cough, Triaminic Multi-Sympton, Triaminic Night Time, Triaminic Softchew Cold and Cough, Triaminic-D Multi-Symptom Cold, Vicks 44M Pediatric, Vicks Pediatric Formula 44M
Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.
Chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist before taking this medicine if you have heart disease, high blood pressure, kidney disease, diabetes, glaucoma, a thyroid disorder, emphysema or bronchitis, an enlarged prostate, or urination problems.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
heart disease or high blood pressure;
kidney disease;
diabetes;
glaucoma;
a thyroid disorder;
emphysema or chronic bronchitis;
an enlarged prostate; or
problems with urination.
Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
The chewable tablet should be chewed before you swallow it.
This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease sweating and you may be more prone to heat stroke.
Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeats;
slow, shallow breathing;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, or nervousness;
urinating less than usual or not at all;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
dry mouth, nose, or throat;
mild stomach pain, constipation;
blurred vision;
dizziness, drowsiness, mild headache;
sleep problems (insomnia);
feeling restless or excited (especially in children);
problems with memory or concentration; or
flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ask a doctor or pharmacist if it is safe for you to use chlorpheniramine, dextromethorphan, and pseudoephedrine if you are also using any of the following drugs:
glycopyrrolate (Robinul);
mepenzolate (Cantil);
atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
a diuretic (water pill), or blood pressure medicine;
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or
salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others.
This list is not complete and other drugs may interact with chlorpheniramine, dextromethorphan, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Creomulsion Cough/Cold/Allergy side effects (in more detail)
