Fosamax

Generic Name: Alendronate Sodium
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

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 ().

Introduction

Synthetic bisphosphonate; bone resorption inhibitor.^{1 2 3 4 a}

Uses for Fosamax

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.

Osteoporosis

Alendronate is used for prevention of osteoporosis in postmenopausal women^{1 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}

Corticosteroid-induced Osteoporosis

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

Paget’s Disease of Bone

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}

Fosamax Dosage and Administration

General

• 
  

  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

  
  

Administration

Oral Administration (Alendronate and Alendronate/Cholecalciferol)

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}

Dosage

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}

Adults

Osteoporosis

Prevention of Postmenopausal Osteoporosis

Oral

Alendronate 5 mg once daily or 35 mg once weekly.¹

Treatment of Osteoporosis

Oral

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

Corticosteroid-induced Osteoporosis

Prevention of Corticosteroid-induced Osteoporosis†

Oral

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

Treatment of Corticosteroid-induced Osteoporosis

Oral

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

Paget’s Disease of Bone

Oral

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

Special Populations

Renal Impairment

No dosage adjustment required in patients with mild to moderate impairment (Cl_cr 35–60 mL/minute); not recommended in patients with severe impairment (Cl_cr <35 mL/minute).^{1 a}

Geriatric Patients

No dosage adjustment required.^a

Cautions for Fosamax

Contraindications

• 
  

  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}

  
  

Warnings/Precautions

Warnings

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.

GI Effects

Possible severe adverse esophageal effects (e.g., esophagitis, esophageal ulcers, erosions, strictures, perforation).^{1 16 18 20 21 23 a} Monitor for any manifestations^{1 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}

General Precautions

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.

Diagnosis

Consider other possible causes of osteoporosis before beginning alendronate.^{1 a}

Metabolic Effects

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

Musculoskeletal Effects

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}

Use of Fixed Combinations

When alendronate is used in fixed combination with cholecalciferol, consider the cautions, precautions, and contraindications associated with cholecalciferol.^{a b}

Corticosteroid-induced Osteoporosis

Measure bone mineral density at initiation of therapy and after 6–12 months of concomitant use with corticosteroids.¹

Specific Populations

Pregnancy

Alendronate alone or in fixed combination with cholecalciferol: Category C.^{1 a}

Lactation

Not known whether alendronate is distributed into milk.^{1 a} Caution if used in nursing women.^{1 a}

Pediatric Use

Safety and efficacy not established.^{1 a}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.^{1 a}

Renal Impairment

Decreased clearance of alendronate likely.^{1 a} Use not recommended in patients with severe renal insufficiency (Cl_cr <35 mL/minute).^{1 a}

Common Adverse Effects

Abdominal pain.^{1 a}

Interactions for Fosamax

Antacids or Mineral Supplements Containing Divalent Cations

Potential decreased alendronate absorption when administered with divalent cations (e.g., calcium).^{1 a}

Other Oral Medications

Potential decreased alendronate absorption when administered concomitantly with other oral medications.^f Administer alendronate ≥30 minutes prior to other oral medications.^f

Specific Drugs

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

Fosamax Pharmacokinetics

Absorption

Bioavailability

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

Onset

Decrease in bone resorption rate evident as early as 1 month.^{1 a}

Food

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}

Distribution

Extent

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}

Plasma Protein Binding

Alendronate: Approximately 78%.^{1 a}

Elimination

Metabolism

No evidence of metabolism of alendronate.^{1 c}

Elimination Route

Urinary excretion is the sole means of elimination of alendronate.^{1 3 a b}

Half-life

Terminal half-life of alendronate >10 years, reflecting release from bone.^{1 2 3 4 11 a}

Special Populations

In patients with renal impairment, clearance of alendronate likely to be reduced.^{1 a} Somewhat greater accumulation in bone expected.^{1 a}

Stability

Storage

Oral

Tablets

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

Oral Solution

Alendronate: 15–30°C.¹ Do not freeze.¹

Actions

• 
  

  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}

  
  

Advice to Patients

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.)

  
  

Preparations

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

Alendronate Sodium

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

Alendronate Sodium and Cholecalciferol

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

Comparative Pricing

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

Disclaimer

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.

References

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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]

32. Adami S, Passeri M, Ortolani S et al. Effects of oral alendronate and intranasal salmon calcitonin on bone mass and biochemical markers of bone turnover in postmenopausal women with osteoporosis. Bone. 1995; 17:383-90. [PubMed 8573412]

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]

40. Maricic M. Early prevention vs late treatment for osteoporosis. Arch Intern Med. 1997; 157:2545-6. [IDIS 397757] [PubMed 9531221]

41. National Osteoporosis Foundation. Physician’s guide to prevention and treatment of osteoporosis. Washington, DC; 1998.

42. Cummings SR, Black DM, Thompson DE et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures. JAMA. 1998; 280:2077-82. [IDIS 416392] [PubMed 9875874]

43. Health Care Financing Administr

Neurotam

Neurotam may be available in the countries listed below.

Ingredient matches for Neurotam

Piracetam

Piracetam is reported as an ingredient of Neurotam in the following countries:

• Indonesia


• Myanmar

International Drug Name Search

Perfenazine CF

Perfenazine CF may be available in the countries listed below.

Ingredient matches for Perfenazine CF

Perphenazine

Perphenazine is reported as an ingredient of Perfenazine CF in the following countries:

• Netherlands

International Drug Name Search

ferrous fumarate, folic acid, and iron polysaccharide

Generic Name: ferrous fumarate, folic acid, and iron polysaccharide (FER us foo MAR ayt, FOH lik AS sid, I urn pol ee SAK uh ryd)

Brand Names: Tandem F

What is ferrous fumarate, folic acid, and iron polysaccharide?

This medication contains two different types of iron. You normally get iron from the foods you eat. In your body, iron becomes a part of your hemoglobin (HEEM o glo bin) and myoglobin (MY o glo bin). Hemoglobin carries oxygen through your blood to tissues and organs. Myoglobin helps your muscle cells store oxygen.

Folic acid helps your body produce and maintain new cells, and also helps prevent changes to DNA that may lead to cancer.

Ferrous fumarate, folic acid, and iron polysaccharide is used to treat iron deficiency anemia (a lack of red blood cells caused by having too little iron in the body).

Ferrous fumarate, folic acid, and iron polysaccharide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about ferrous fumarate, folic acid, and iron polysaccharide?

Before using this medication, tell your doctor if you have ulcerative colitis, enteritis, stomach ulcers, or similar stomach problems.

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of iron can be fatal, especially in a young child.

Symptoms of a ferrous fumarate, folic acid, and iron polysaccharide overdose may include nausea, vomiting, shallow breathing, weak pulse, pale skin, blue lips, extreme weakness, fainting, or death.

Do not give this medicine to a child younger than 12 years old.

What should I discuss with my health care provider before taking ferrous fumarate, folic acid, and iron polysaccharide?

Before using this medication, tell your doctor if you have ulcerative colitis, enteritis, stomach ulcers, or similar stomach problems.

If you have any of these conditions, you may not be able to use ferrous fumarate, folic acid, and iron polysaccharide, or you may need a dosage adjustment or special tests during treatment.

It is not known whether this medication could be harmful to an unborn baby. Tell your doctor if you become pregnant during treatment. It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 12 years old.

How should I take ferrous fumarate, folic acid, and iron polysaccharide?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor.

It is best to take this medication between meals or at bedtime. However, if the medicine upsets your stomach, you may take it just after a meal.

Store this medicine at room temperature away from moisture and heat.

See also: Ferrous fumarate, folic acid, and iron polysaccharide dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of iron can be fatal, especially in a young child.

Symptoms of a ferrous fumarate, folic acid, and iron polysaccharide overdose may include nausea, vomiting, shallow breathing, weak pulse, pale skin, blue lips, extreme weakness, fainting, or death.

What should I avoid while taking ferrous fumarate, folic acid, and iron polysaccharide?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Ferrous fumarate, folic acid, and iron polysaccharide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur such as:

• 
  

  loss of appetite;

  
  


• 
  

  diarrhea;

  
  


• 
  

  heartburn;

  
  


• 
  

  constipation;

  
  


• 
  

  black-colored stools; or

  
  


• 
  

  mild nausea or vomiting.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Ferrous fumarate, folic acid, and iron polysaccharide Dosing Information

Usual Adult Dose for Iron Deficiency Anemia:

1 capsule orally once a day between meals

Usual Pediatric Dose for Iron Deficiency Anemia:

>= 12 years: 1 capsule orally once a day between meals

What other drugs will affect ferrous fumarate, folic acid, and iron polysaccharide?

There may be other drugs that can affect ferrous fumarate, folic acid, and iron polysaccharide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More ferrous fumarate, folic acid, and iron polysaccharide resources

• Ferrous fumarate, folic acid, and iron polysaccharide Dosage
• Ferrous fumarate, folic acid, and iron polysaccharide Use in Pregnancy & Breastfeeding
• Ferrous fumarate, folic acid, and iron polysaccharide Drug Interactions
• Ferrous fumarate, folic acid, and iron polysaccharide Support Group
• 0 Reviews for Ferrous fumarate, folic acid, and iron polysaccharide - Add your own review/rating

Compare ferrous fumarate, folic acid, and iron polysaccharide with other medications

• Iron Deficiency Anemia

Where can I get more information?

• Your pharmacist has more information about ferrous fumarate, folic acid, and iron polysaccharide written for health professionals that you may read.

Seb-Prev Cream

sodium sulfacetamide

Dosage Form: cream
SEB-PREV™ CREAM (SODIUM SULFACETAMIDE 10%)

Seb-Prev Cream

(Sodium Sulfacetamide 10%)

Rx Only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

Seb-Prev Cream Description

Each gram of Seb-Prev™ Cream contains 100 mg of Sulfacetamide Sodium USP in a vehicle consisting of benzyl alcohol, cetyl alcohol, dimethicone, edetate disodium, emulsifying wax, glycerin, isopropyl myristate, monobasic sodium phosphate, PEG-8 stearate, propylene glycol monopalmitostearate, purified water and sodium thiosulfate.

Sulfacetamide sodium is C8H9N2NaO3S•H2O with a molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:

Sulfacetamide sodium is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform, and in ether.

Seb-Prev Cream - Clinical Pharmacology

Sulfacetamide sodium exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systemic absorption of Seb-Prev™ Cream when applied to the skin or scalp. However, significant absorption of sulfacetamide sodium through the skin has been reported.

The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sulfacetamide sodium are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

Indications and Usage for Seb-Prev Cream

Seb-Prev™ Cream is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Contraindications

Seb-Prev™ Cream is contraindicated in persons with known or suspected hypersensitivity to sulfonamides or to any of the ingredients of the product.

Warnings

Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sulfacetamide sodium topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.

Precautions

General

Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration, and cross hypersensitivity between different sulfonamides may occur. If Seb-Prev™ Cream produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded, or severely burned areas. Under these circumstances, potentially any of the adverse effects produced by the systemic administration of these agents could occur and appropriate observations and laboratory determinations should be performed.

Information For Patients

Patients should discontinue Seb-Prev™ Cream if the condition becomes worse, or if a rash develops in the area being treated or elsewhere. Seb-Prev™ Cream also should be discontinued promptly and the physician notified if any arthritis, fever, or sores in the mouth develop.

For external use only. Avoid contact with eyes and mucous membranes.

Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or poison control center immediately (seeOVERDOSAGE).

Drug Interactions

Seb-Prev™ Cream is incompatible with silver preparations.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies for carcinogenic potential have not been performed on Seb-Prev™ Cream to date. Studies on reproduction and fertility also have not been performed. One author detected chromosomal nondisjunction in the yeast, Saccharomyces cerevisiae, following application of sulfacetamide sodium. The significance of this finding to the topical use of sulfacetamide sodium in the human is unknown.

Pregnancy

Teratogenic effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Seb-Prev™ Cream. It also is not known whether Seb-Prev™ Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Seb-Prev™ Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Seb-Prev™ Cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children under the age of 12 years have not been established.

Adverse Reactions

Reports of irritation and hypersensitivity to sulfacetamide sodium are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sulfacetamide sodium, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome has been reported (see WARNINGS).

Overdosage

The oral LD50 of sulfacetamide in mice is 16.5 g/kg. The LD50 for topical administration of sulfacetamide has not been determined. Oral overdosage may cause nausea and vomiting. Large oral overdosage may cause hematuria, crystalluria, and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. In the event of overdosage, call a physician or poison control center; emergency treatment should be started immediately.

Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of eight to twelve fluid ounces of water. If emesis does not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Isotonic and one-half isotonic saline are the lavage solutions of choice. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and, therefore, may be valuable for their action in rapid dilution of bowel content. After emergency treatment, the patient should continue to be medically monitored.

Observe kidney function for up to 1 week and have the patient ingest copious amounts of fluid during this period. Mannitol infusions may be helpful at the first sign of oliguria. Alkalinization of the urine by ingestion of bicarbonate is very helpful in preventing crystallization of sulfa drug in the kidney.

Seb-Prev Cream Dosage and Administration

Seborrheic dermatitis including seborrhea sicca: Apply to affected areas twice daily (morning and evening), or as directed by your physician. Avoid contact with eyes or mucous membranes. Repeat application as described for eight to ten days. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of Seb-Prev™ Cream should be reinitiated as at the beginning of treatment.

Secondary cutaneous bacterial infections: Apply to affected areas twice daily for eight to ten days.

How is Seb-Prev Cream Supplied

Seb-Prev™ Cream is available as follows:

30 g tube (NDC 45802-954-94)

60 g tube (NDC 45802-954-96)

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

Occasionally, a slight yellowish discoloration may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration is readily removed by ordinary laundering without bleaches.

MANUFACTURED BY

STIEFEL LABORATORIES, INC.

CORAL GABLES, FL 33134

DISTRIBUTED BY

PERRIGO®

ALLEGAN, MI 49010

Rev. 10/07

82174

: 5L500 RC J1

Principal Display Panel - 30 g Carton

Seb-Prev™ Cream

(Sodium Sulfacetamide 10%)

For Dermatologic Use Only. Not for Ophthalmic Use.

Rx Only

Seb-Prev(tm) Cream - 30 g Carton

Principal Display Panel - 30 g Tube

Seb-Prev™ Cream

(Sodium Sulfacetamide 10%)

For Dermatologic Use Only. Not for Ophthalmic Use.

Rx Only

Seb-Prev(tm) Cream - 30 g Tube

Principal Display Panel - 60 g Carton

Seb-Prev™ Cream

(Sodium Sulfacetamide 10%)

For Dermatologic Use Only. Not for Ophthalmic Use.

Rx Only

Seb-Prev(tm) Cream - 60 g Carton

Principal Display Panel - 60 g Tube

Seb-Prev™ Cream

(Sodium Sulfacetamide 10%)

For Dermatologic Use Only. Not for Ophthalmic Use.

Rx Only

Seb-Prev(tm) Cream - 60 g Tube

PERRIGO SEB PREV  sodium sulfacetamide  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-954 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45802-954-94 1 TUBE In 1 CARTON contains a TUBE 1 30 g In 1 TUBE This package is contained within the CARTON (45802-954-94) 2 45802-954-96 1 TUBE In 1 CARTON contains a TUBE 2 60 g In 1 TUBE This package is contained within the CARTON (45802-954-96)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/07/2008

Labeler - Perrigo New York Inc (078846912)

Revised: 11/2009Perrigo New York Inc

More Seb-Prev Cream resources

• Seb-Prev Cream Side Effects (in more detail)
• Seb-Prev Cream Use in Pregnancy & Breastfeeding
• Seb-Prev Cream Support Group
• 0 Reviews for Seb-Prev - Add your own review/rating

Compare Seb-Prev Cream with other medications

• Seborrheic Dermatitis
• Secondary Cutaneous Bacterial Infections

Felbatol

Pronunciation: fel-BAM-ate
Generic Name: Felbamate
Brand Name: Felbatol

Because severe, even fatal, blood disorders (aplastic anemia, pancytopenia) and liver problems have occurred with the use of Felbatol, it should be used only in people with severe epilepsy and only after careful consideration. Aplastic anemia may occur even after the drug has been stopped. Felbatol is not recommended for use in patients who have liver problems. Stop using Felbatol and immediately notify your doctor if you have symptoms of infection such as fever, chills, or persistent sore throat, or if you have unusual bleeding or bruising, weakness, fatigue, dark urine, yellowing of the eyes or skin, or persistent stomach/abdominal pain. Your doctor will perform liver function tests before starting Felbatol and every 1 to 2 weeks while you are using Felbatol.

Felbatol is used for:

Treating certain types of seizures. It may be used alone or with other medicines.

Felbatol is an anticonvulsant. It works by controlling nerve impulses in the brain, which prevents or reduces some types of seizures.

Do NOT use Felbatol if:

• you are allergic to any ingredient in Felbatol or other carbamates


• you have a history of blood disorders, bone marrow depression, or liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Felbatol:

Some medical conditions may interact with Felbatol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney or liver problems


• if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Felbatol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Gabapentin because the actions and side effects of Felbatol may be increased


• Carbamazepine, hydantoins (eg, phenytoin), or phenobarbital because the effectiveness of Felbatol may be decreased


• Anticoagulants (eg, warfarin), hydantoins (eg, phenytoin), phenobarbital, or valproic acid because the actions and side effects of these medicines may be increased


• Hormonal contraceptives (eg, birth control pills) because their effectiveness may be decreased by Felbatol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Felbatol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Felbatol:

Use Felbatol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• After discussing this medication with your health care provider, you must read, initial, and sign a patient information/consent form before taking Felbatol. Do not sign the consent form if there is anything you do not understand.


• Felbatol may be taken with food if it upsets your stomach.


• Do not suddenly stop taking Felbatol. You may have an increased risk of side effects (eg, seizures). If you need to stop taking Felbatol or add a new medicine, your doctor will gradually lower your dose.


• Continue to use Felbatol even if you feel well. Do not miss any doses.


• If you miss a dose of Felbatol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Felbatol.

Important safety information:

• Felbatol may cause drowsiness, dizziness, or double vision. These effects may be worse if you take it with alcohol or certain medicines. Use Felbatol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Patients who take Felbatol may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Felbatol closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Felbatol. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Lab tests, including liver function tests and complete blood cell counts, may be performed while you use Felbatol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Felbatol with caution in the ELDERLY; they may be more sensitive to its effects.


• Felbatol should be used with extreme caution in certain CHILDREN; safety and effectiveness in these children have not been confirmed. Discuss with your doctor the risks and benefits of giving Felbatol to your child.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Felbatol while you are pregnant. Felbatol is found in breast milk. If you are or will be breast-feeding while you are using Felbatol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Felbatol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; fatigue; headache; indigestion; loss of appetite; mild stomach pain; nausea; trouble sleeping; vomiting; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of coordination; mouth sores; muscle pain; nervousness; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes); new or worsening seizures; red, swollen, blistered, or peeling skin; severe or persistent stomach pain; suicidal thoughts or actions; unusual bruising or bleeding; vision changes; weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Felbatol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fast heartbeat; upset stomach.

Proper storage of Felbatol:

Store Felbatol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Felbatol out of the reach of children and away from pets.

General information:

• If you have any questions about Felbatol, please talk with your doctor, pharmacist, or other health care provider.


• Felbatol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Felbatol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Felbatol resources

• Felbatol Side Effects (in more detail)
• Felbatol Dosage
• Felbatol Use in Pregnancy & Breastfeeding
• Drug Images
• Felbatol Drug Interactions
• Felbatol Support Group
• 3 Reviews for Felbatol - Add your own review/rating

• Felbatol Prescribing Information (FDA)


• Felbatol Advanced Consumer (Micromedex) - Includes Dosage Information


• Felbatol Concise Consumer Information (Cerner Multum)


• Felbatol Monograph (AHFS DI)


• Felbamate Prescribing Information (FDA)


• Felbamate Professional Patient Advice (Wolters Kluwer)

Compare Felbatol with other medications

• Epilepsy
• Lennox-Gastaut Syndrome

Gentamicina + Betametasone Ranbaxy

Gentamicina + Betametasone Ranbaxy may be available in the countries listed below.

Ingredient matches for Gentamicina + Betametasone Ranbaxy

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Gentamicina + Betametasone Ranbaxy in the following countries:

• Italy

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentamicina + Betametasone Ranbaxy in the following countries:

• Italy

International Drug Name Search