Etidronate

Dosage Form: tablet

Etidronate Description

Etidronate disodium tablets, USP contain either 200 mg or 400 mg of Etidronate disodium, the disodium salt of (1-hydroxyethylidene) diphosphonic acid, for oral administration. This compound, also known as EHDP, regulates bone metabolism. Etidronate disodium, USP is a white powder, highly soluble in water, with a molecular weight of 250 and the following structural formula:

Inactive ingredients: Each tablet contains magnesium stearate, microcrystalline cellulose, pregelatinized starch and starch (corn).

Etidronate - Clinical Pharmacology

Etidronate disodium acts primarily on bone. It can inhibit the formation, growth, and dissolution of hydroxyapatite crystals and their amorphous precursors by chemisorption to calcium phosphate surfaces. Inhibition of crystal resorption occurs at lower doses than are required to inhibit crystal growth. Both effects increase as the dose increases.

Etidronate disodium is not metabolized. The amount of drug absorbed after an oral dose is approximately 3%. In normal subjects, plasma half-life (t1/2) of Etidronate, based on non-compartmental pharmacokinetics is 1 to 6 hours. Within 24 hours, approximately half the absorbed dose is excreted in urine; the remainder is distributed to bone compartments from which it is slowly eliminated. Animal studies have yielded bone clearance estimates up to 165 days. In humans, the residence time on bone may vary due to such factors as specific metabolic condition and bone type. Unabsorbed drug is excreted intact in the feces. Preclinical studies indicate Etidronate disodium does not cross the blood-brain barrier.

Etidronate disodium therapy does not adversely affect serum levels of parathyroid hormone or calcium.

Paget’s Disease

Paget’s disease of bone (osteitis deformans) is an idiopathic, progressive disease characterized by abnormal and accelerated bone metabolism in one or more bones. Signs and symptoms may include bone pain and/or deformity, neurologic disorders, elevated cardiac output and other vascular disorders, and increased serum alkaline phosphatase and/or urinary hydroxyproline levels. Bone fractures are common in patients with Paget’s disease.

Etidronate disodium slows accelerated bone turnover (resorption and accretion) in pagetic lesions and, to a lesser extent, in normal bone. This has been demonstrated histologically, scintigraphically, biochemically, and through calcium kinetic and balance studies. Reduced bone turnover is often accompanied by symptomatic improvement, including reduced bone pain. Also, the incidence of pagetic fractures may be reduced and elevated cardiac output and other vascular disorders may be improved by Etidronate disodium therapy.

Heterotopic Ossification

Heterotopic ossification, also referred to as myositis ossificans (circumscripta, progressiva or traumatica), ectopic calcification, periarticular ossification, or paraosteoarthropathy, is characterized by metaplastic osteogenesis. It usually presents with signs of localized inflammation or pain, elevated skin temperature, and redness. When tissues near joints are involved, functional loss may also be present.

Heterotopic ossification may occur for no known reason as in myositis ossificans progressiva or may follow a wide variety of surgical, occupational, and sports trauma (e.g., hip arthroplasty, spinal cord injury, head injury, burns, and severe thigh bruises). Heterotopic ossification has also been observed in non-traumatic conditions (e.g., infections of the central nervous system, peripheral neuropathy, tetanus, biliary cirrhosis, Peyronie’s disease, as well as in association with a variety of benign and malignant neoplasms).

Clinical trials have demonstrated the efficacy of Etidronate disodium in heterotopic ossification following total hip replacement or due to spinal cord injury.

• Heterotopic ossification complicating total hip replacement typically develops radiographically 3 to 8 weeks postoperatively in the pericapsular area of the affected hip joint. The overall incidence is about 50%; about one-third of these cases are clinically significant.


• Heterotopic ossification due to spinal cord injury typically develops radiographically 1 to 4 months after injury. It occurs below the level of injury, usually at major joints. The overall incidence is about 40%; about one-half of these cases are clinically significant.

Etidronate disodium chemisorbs to calcium hydroxyapatite crystals and their amorphous precursors, blocking the aggregation, growth, and mineralization of these crystals. This is thought to be the mechanism by which Etidronate disodium prevents or retards heterotopic ossification. There is no evidence Etidronate disodium affects mature heterotopic bone.

Indications and Usage for Etidronate

Etidronate disodium tablets are indicated for the treatment of symptomatic Paget’s disease of bone and in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury. Etidronate disodium tablets are not approved for the treatment of osteoporosis.

Paget’s Disease

Etidronate disodium tablets are indicated for the treatment of symptomatic Paget’s disease of bone. Etidronate disodium therapy usually arrests or significantly impedes the disease process as evidenced by:

• Symptomatic relief, including decreased pain and/or increased mobility (experienced by 3 out of 5 patients).


• Reductions in serum alkaline phosphatase and urinary hydroxyproline levels (30% or more in 4 out of 5 patients).


• Histomorphometry showing reduced numbers of osteoclasts and osteoblasts, and more lamellar bone formation.


• Bone scans showing reduced radionuclide uptake at pagetic lesions.

In addition, reductions in pagetically elevated cardiac output and skin temperature have been observed in some patients.

In many patients, the disease process will be suppressed for a period of at least one year following cessation of therapy. The upper limit of this period has not been determined.

The effects of the Etidronate disodium treatment in patients with asymptomatic Paget’s disease have not been studied. However, Etidronate disodium treatment of such patients may be warranted if extensive involvement threatens irreversible neurologic damage, major joints, or major weight-bearing bones.

Heterotopic Ossification

Etidronate disodium tablets are indicated in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury.

Etidronate disodium tablets reduce the incidence of clinically important heterotopic bone by about two-thirds. Among those patients who form heterotopic bone, Etidronate disodium tablets retard the progression of immature lesions and reduces the severity by at least half. Follow-up data (at least 9 months post-therapy) suggests these benefits persist.

In total hip replacement patients, Etidronate disodium tablets do not promote loosening of the prosthesis or impede trochanteric reattachment.

In spinal cord injury patients, Etidronate disodium tablets do not inhibit fracture healing or stabilization of the spine.

Contraindications

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.


• Known hypersensitivity to Etidronate disodium or in patients with clinically overt osteomalacia.

Warnings

General

Upper Gastrointestinal Adverse Reactions

Etidronate disodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Etidronate disodium  is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Etidronate disodium  and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6 to 8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE AND ADMINISTRATION). In patients who cannot comply with dosing instructions due to mental disability, therapy with Etidronate disodium  should be used under appropriate supervision.

There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.

Paget’s Disease

In Paget’s patients the response to therapy may be of slow onset and continue for months after Etidronate disodium therapy is discontinued. Dosage should not be increased prematurely. A 90-day drug-free interval should be provided between courses of therapy.

Heterotopic Ossification

No specific warnings.

Precautions

General

Patients should maintain an adequate nutritional status, particularly an adequate intake of calcium and vitamin D.

Therapy has been withheld from some patients with enterocolitis since diarrhea may be experienced, particularly at higher doses.

Etidronate disodium is not metabolized and is excreted intact via the kidney. Hyperphosphatemia may occur at doses of 10 to 20 mg/kg/day, apparently as a result of drug-related increases in tubular reabsorption of phosphate. Serum phosphate levels generally return to normal 2 to 4 weeks post-therapy. There is no experience to specifically guide treatment in patients with impaired renal function. Etidronate disodium dosage should be reduced when reductions in glomerular filtration rates are present. Patients with renal impairment should be closely monitored. In approximately 10% of patients in clinical trials of Etidronate disodium I.V. infusion, for hypercalcemia of malignancy, occasional, mild-to-moderate abnormalities in renal function (increases of > 0.5 mg/dL serum creatinine) were observed during or immediately after treatment.

Etidronate disodium suppresses bone turnover, and may retard mineralization of osteoid laid down during the bone accretion process. These effects are dose and time dependent. Osteoid, which may accumulate noticeably at doses of 10 to 20 mg/kg/day, mineralizes normally post-therapy. In patients with fractures, especially of long bones, it may be advisable to delay or interrupt treatment until callus is evident.

Osteonecrosis of the Jaw (ONJ)

ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Etidronate sodium. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids), poor oral hygiene, and comorbid disorders (e.g., periodontal and/or other preexisting dental disease, anemia, coagulopathy, infection, ill-fitting dentures).

For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.

Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.

Musculoskeletal Pain

In post-marketing experience, there have been infrequent reports of severe and occasionally incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates (see ADVERSE REACTIONS). The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping medication. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.

Paget’s Disease

In Paget’s patients, treatment regimens exceeding the recommended (see DOSAGE AND ADMINISTRATION) daily maximum dose of 20 mg/kg or continuous administration of medication for periods greater than 6 months may be associated with osteomalacia and an increased risk of fracture.

Long bones predominantly affected by lytic lesions, particularly in those patients unresponsive to Etidronate disodium therapy, may be especially prone to fracture.

Patients with predominantly lytic lesions should be monitored radiographically and biochemically to permit termination of Etidronate disodium in those patients unresponsive to treatment.

Drug Interactions

There have been isolated reports of patients experiencing increases in their prothrombin times when Etidronate was added to warfarin therapy. The majority of these reports concerned variable elevations in prothrombin times without clinically significant sequelae. Although the relevance of these reports and any mechanism of coagulation alterations is unclear, patients on warfarin should have their prothrombin time monitored.

Carcinogenesis

Long-term studies in rats have indicated that Etidronate disodium is not carcinogenic.

Pregnancy

Teratogenic Effects

Pregnancy Category C

In teratology and developmental toxicity studies conducted in rats and rabbits treated with dosages of up to 100 mg/kg (5 to 20 times the clinical dose), no adverse or teratogenic effects have been observed in the offspring. Etidronate disodium has been shown to cause skeletal abnormalities in rats when given at oral dose levels of 300 mg/kg (15 to 60 times the human dose). Other effects on the offspring (including decreased live births) are at dosages that cause significant toxicity in the parent generation and are 25 to 200 times the human dose. The skeletal effects are thought to be the result of the pharmacological effects of the drug on bone.

Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over periods of weeks to years. The amount of bisphosphonate incorporation into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous vs. oral) on this risk has not been studied.

There are no adequate and well controlled studies in pregnant women. Etidronate disodium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 Etidronate disodium is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Pediatric patients have been treated with Etidronate disodium, at doses recommended for adults, to prevent heterotopic ossifications or soft tissue calcifications. A rachitic syndrome has been reported infrequently at doses of 10 mg/kg/day and more for prolonged periods approaching or exceeding a year. The epiphyseal radiologic changes associated with retarded mineralization of new osteoid and cartilage, and occasional symptoms reported, have been reversible when medication is discontinued.

Geriatric Use

Clinical studies of Etidronate disodium did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. As stated in PRECAUTIONS, Etidronate disodium dosage should be reduced when reductions in glomerular filtration rates are present. In addition, patients with renal impairment should be closely monitored.

Adverse Reactions

The incidence of gastrointestinal complaints (diarrhea, nausea) is the same for Etidronate disodium at 5 mg/kg/day as for placebo, about 1 patient in 15. At 10 to 20 mg/kg/day the incidence may increase to 2 or 3 in 10. These complaints are often alleviated by dividing the total daily dose.

Paget’s Disease

In Paget’s patients, increased or recurrent bone pain at pagetic sites, and/or the onset of pain at previously asymptomatic sites has been reported. At 5 mg/kg/day about 1 patient in 10 (vs. 1 in 15 in the placebo group) report these phenomena. At higher doses the incidence rises to about 2 in 10. When therapy continues, pain resolves in some patients but persists in others.

Heterotopic Ossification

No specific adverse reactions.

Worldwide Post-Marketing Experience

The worldwide post-marketing experience for Etidronate disodium reflects its use in the following approved indications: Paget’s disease, heterotopic ossification, and hypercalcemia of malignancy. It also reflects the use of Etidronate disodium for osteoporosis where approved in countries outside the US. Other adverse events that have been reported and were thought to be possibly related to Etidronate disodium include the following: alopecia; arthropathies, including arthralgia and arthritis; bone fracture; esophagitis; glossitis; hypersensitivity reactions, including angioedema, follicular eruption, macular rash, maculopapular rash, pruritus, Stevens-Johnson Syndrome, and urticaria; osteomalacia; neuropsychiatric events, including amnesia, confusion, depression and hallucination; and paresthesias.

In patients receiving Etidronate disodium, there have been rare reports of agranulocytosis, pancytopenia, and a report of leukopenia with recurrence on rechallenge. In addition, there have been rare reports of exacerbation of asthma. Exacerbation of existing peptic ulcer disease including perforation has been reported rarely.

In osteoporosis clinical trials, headache, gastritis, leg cramps, and arthralgia occurred at a significantly greater incidence in patients who received Etidronate as compared with those who received placebo.

Overdosage

Clinical experience with acute Etidronate disodium overdosage is extremely limited. Decreases in serum calcium following substantial overdosage may be expected in some patients. Signs and symptoms of hypocalcemia also may occur in some of these patients. Some patients may develop vomiting. In one event, an 18 year old female who ingested an estimated single dose of 4000 mg to 6000 mg (67 to 100 mg/kg) of Etidronate disodium was reported to be mildly hypocalcemic (7.52 mg/dL) and experienced paresthesia of the fingers. Hypocalcemia resolved 6 hours after lavage and treatment with intravenous calcium gluconate. A 92 year old female who accidentally received 1600 mg of Etidronate disodium per day for 3.5 days experienced marked diarrhea and required treatment for electrolyte imbalance. Orally administered Etidronate disodium may cause hematologic abnormalities in some patients (see ADVERSE REACTIONS).

Etidronate disodium suppresses bone turnover and may retard mineralization of osteoid laid down during the bone accretion process. These effects are dose and time dependent. Osteoid which may accumulate noticeably at doses of 10 to 20 mg/kg/day of chronic, continuous dosing mineralizes normally post-therapy.

Prolonged continuous treatment (chronic overdosage) has been reported to cause nephrotic syndrome and fracture.

Gastric lavage may remove unabsorbed drug. Standard procedures for treating hypocalcemia, including the administration of Ca++ intravenously, would be expected to restore physiologic amounts of ionized calcium and relieve signs and symptoms of hypocalcemia. Such treatment has been effective.

Etidronate Dosage and Administration

Etidronate disodium tablets should be taken as a single, oral dose. As with other bisphosphonates, it is recommended that Etidronate disodium tablets  should be swallowed with a full glass of water (6 to 8 oz). Patients should not lie down after taking the medication. However, should gastrointestinal discomfort occur, the dose may be divided. To maximize absorption, patients should avoid taking the following items within 2 hours of dosing:

• Food, especially food high in calcium, such as milk or milk products.


• Vitamins with mineral supplements or antacids which are high in metals such as calcium, iron, magnesium, or aluminum.

Paget’s Disease

Initial Treatment Regimens

5 to 10 mg/kg/day, not to exceed 6 months or 11 to 20 mg/kg/day, not to exceed 3 months.

The recommended initial dose is 5 mg/kg/day for a period not to exceed 6 months. Doses above 10 mg/kg/day should be reserved for when 1) lower doses are ineffective or 2) there is an overriding need to suppress rapid bone turnover (especially when irreversible neurologic damage is possible) or reduce elevated cardiac output. Doses in excess of 20 mg/kg/day are not recommended.

Retreatment Guidelines

Retreatment should be initiated only after 1) an Etidronate disodium-free period of at least 90 days and 2) there is biochemical, symptomatic or other evidence of active disease process. It is advisable to monitor patients every 3 to 6 months although some patients may go drug free for extended periods. Retreatment regimens are the same as for initial treatment. For most patients the original dose will be adequate for retreatment. If not, consideration should be given to increasing the dose within the recommended guidelines.

Heterotopic Ossification

The following treatment regimens have been shown to be effective:

• Total Hip Replacement Patients: 20 mg/kg/day for 1 month before and 3 months after surgery (4 months total).


• Spinal Cord Injured Patients: 20 mg/kg/day for 2 weeks followed by 10 mg/kg/day for 10 weeks (12 weeks total). Etidronate disodium therapy should begin as soon as medically feasible following the injury, preferably prior to evidence of heterotopic ossification.

Retreatment has not been studied.

How is Etidronate Supplied

Etidronate Disodium Tablets, USP are available containing 200 mg or 400 mg of Etidronate disodium, USP.

The 200 mg tablets are white rectangular-shaped tablets with ED 200 on one side and G on the other side. They are available as follows:

NDC 0378-3286-91

Bottles of 60

The 400 mg tablets are white capsule-shaped tablets with ED 400 on one side and G on the other side. They are available as follows:

NDC 0378-3288-91

Bottles of 60

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Avoid excessive heat (over 104°F or 40°C).

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured in Australia by:

ALPHAPHARM PTY LTD

15 Garnet St.

Carole Park QLD 4300

Australia

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

REVISED AUGUST 2010

ETDN:R5

PRINCIPAL DISPLAY PANEL - 200 mg

NDC 0378-3286-91

Etidronate

DISODIUM

TABLETS, USP

200 mg

60 TABLETS (Rx only)

Each tablet contains:

Etidronate

disodium, USP . . . . . 200 mg

Dispense in a tight, light-resistant

container as defined in the USP

using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication

out of the reach of children.

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room

Temperature.]

Avoid excessive heat (over 104°F

or 40°C).

Usual Dosage: See accompanying

prescribing information.

Manufactured in Australia by:

ALPHAPHARM PTY LTD

15 Garnet St.

Carole Park QLD 4300

Australia

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

RM3286D1

PRINCIPAL DISPLAY PANEL - 400 mg

NDC 0378-3288-91

Etidronate

DISODIUM

TABLETS, USP

400 mg

60 TABLETS (Rx only)

Each tablet contains:

Etidronate

disodium, USP . . . . . 400 mg

Dispense in a tight, light-resistant

container as defined in the USP

using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication

out of the reach of children.

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room

Temperature.]

Avoid excessive heat (over 104°F

or 40°C).

Usual Dosage: See accompanying

prescribing information.

Manufactured in Australia by:

ALPHAPHARM PTY LTD

15 Garnet St.

Carole Park QLD 4300

Australia

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

RM3288D1

Etidronate DISODIUM  Etidronate disodium  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0378-3286 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Etidronate DISODIUM (ETIDRONIC ACID) Etidronate DISODIUM 200 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN

Product Characteristics Color WHITE Score no score Shape RECTANGLE Size 12mm Flavor Imprint Code ED;200;G Contains

Packaging # NDC Package Description Multilevel Packaging 1 0378-3286-91 60  In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075800	10/24/2011

Etidronate DISODIUM  Etidronate disodium  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0378-3288 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Etidronate DISODIUM (ETIDRONIC ACID) Etidronate DISODIUM 400 mg

Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STARCH, CORN

Product Characteristics Color WHITE Score no score Shape OVAL (capsule-shaped) Size 16mm Flavor Imprint Code ED;400;G Contains

Packaging # NDC Package Description Multilevel Packaging 1 0378-3288-91 60  In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075800	10/24/2011

Labeler - Mylan Pharmaceuticals Inc. (059295980)

Revised: 08/2010Mylan Pharmaceuticals Inc.

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Compare Etidronate with other medications

• Heterotopic Ossification, Spinal Cord Injury
• Heterotopic Ossification, Total Hip Arthroplasty
• Hypercalcemia of Malignancy
• Osteoporosis
• Paget's Disease

Pinxav

Generic Name: zinc oxide topical (ZINK OX ide)

Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin

What is Pinxav (zinc oxide topical)?

Zinc oxide is a mineral.

Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.

Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.

Zinc oxide topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Pinxav (zinc oxide topical)?

You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.

What should I discuss with my health care provider before using Pinxav (zinc oxide topical)?

You should not use this medication if you are allergic to zinc, dimethicone, lanolin, cod liver oil, petroleum jelly, parabens, mineral oil, or wax.

Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.

It is not known whether zinc oxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

How should I use Pinxav (zinc oxide topical)?

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.

Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.

To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.

To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.

Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.

When using the powder form of this medicine, pour the powder slowly to avoid a large puff into the air. Do not allow a baby to handle a powder bottle during use. Always close the lid after using the powder.

Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting a rectal suppository.

Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

Stop using this medication and call your doctor if your condition does not improve within 7 days of treatment. Store at room temperature away from moisture and heat. Keep the tube cap tightly closed when not in use. You may store zinc oxide rectal suppositories in a refrigerator to prevent melting.

What happens if I miss a dose?

Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Pinxav (zinc oxide topical)?

Avoid getting this medication in your mouth or eyes. If this does happen, rinse with water right away. Do not use zinc oxide topical on deep skin wounds or severe burns. Get medical attention for more severe skin irritation or injury.

Pinxav (zinc oxide topical) 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. Stop using zinc oxide rectal suppositories if you have rectal bleeding or continued pain.

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.

What other drugs will affect Pinxav (zinc oxide topical)?

Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.

There may be other drugs that can interact with zinc oxide topical or rectal suppositories. 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.

More Pinxav resources

• Pinxav Side Effects (in more detail)
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• Pinxav Support Group
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Compare Pinxav with other medications

• Anal Itching
• Dermatologic Lesion

Where can I get more information?

• Your pharmacist can provide more information about zinc oxide topical.

See also: Pinxav side effects (in more detail)

Flexbumin

albumin human

Dosage Form: injection
Flexbumin 25% Albumin (Human), USP, 25% Solution in GALAXY single-dose container

Flexbumin Description

Flexbumin 25%, Albumin (Human), 25% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration.  Each 100 ml contains 25 g of albumin and was prepared from human venous plasma using the Cohn cold ethanol fractionation process.  Source material for fractionation may be obtained from another U.S. licensed manufacturer.  It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with  N-acetyltryptophan and sodium caprylate.  The sodium content is 145 ± 15 mEq/L.  This solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. 

Flexbumin 25%, Albumin (Human), 25% Solution is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.

The likelihood of the presence of viable hepatitis viruses has been minimized by heating the product for 10 hours at 60°C.  This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.1-3

The GALAXY plastic container is fabricated from a specially designed multilayered plastic (PL 2501).  Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period.  The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

Flexbumin - Clinical Pharmacology

Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating the volume of circulating blood.4-6  Albumin is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6

Flexbumin 25%, Albumin (Human), 25% Solution is osmotically equivalent to approximately five times its volume of human plasma.  When injected intravenously, 25% albumin will draw about 3.5 times its volume of additional fluid into the circulation within 15 minutes, except when the patient is markedly dehydrated.  This extra fluid reduces hemoconcentration and blood viscosity.  The degree and duration of volume expansion depends upon the initial blood volume.  With patients treated for diminished blood volume, the effect of infused albumin may persist for many hours; however, in patients with normal volume, the duration will be shorter.7,8

Total body albumin is estimated to be 350 g for a 70 kg man and is distributed throughout the extracellular compartments; more than 60% is located in the extravascular fluid compartment.  The half-life of albumin is 15 to 20 days with a turnover of approximately 15 g per day.5

The minimum plasma albumin level necessary to prevent or reverse peripheral edema is unknown.  Some investigators recommend that plasma albumin levels be maintained at approximately 2.5 g/dL.  This concentration provides a plasma oncotic value of 20 mm Hg.4

Flexbumin 25%, Albumin (Human) 25% Solution is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 ± 0.5°C for 10 - 11 hours.  This process accomplishes both purification of albumin and reduction of viruses.

In vitro studies, demonstrate that the manufacturing process for Flexbumin 25%, Albumin (Human), 25% Solution provides for significant viral reduction.  These viral reduction studies, summarized in Table 1, demonstrate viral clearance during the manufacturing process for Flexbumin 25%, Albumin (Human), 25% Solution using human immunodeficiency virus, type 1 (HIV-1) both as a target virus and as model virus for HIV-2 and other enveloped RNA viruses; bovine viral diarrheal virus (BVDV), a model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); West Nile Virus (WNV), a target virus and model for other similar enveloped RNA viruses; pseudorabies virus (PRV), a model for other enveloped DNA viruses such as hepatitis B virus (HBV);  mice minute virus (MMV), models for non-lipid enveloped DNA viruses such as human parvovirus B 1912; and hepatitis A virus (HAV), a target virus and a model for other non-lipid enveloped RNA viruses.

These studies indicate that specific steps in the manufacture of Flexbumin 25%, Albumin (Human), 25% Solution are capable of eliminating/inactivating a wide range of relevant and model viruses.  Since the mechanism of virus elimination/inactivation at specific process steps is different, the overall manufacturing process of Flexbumin 25%, Albumin (Human), 25% Solution is robust in reducing viral load.

TABLE 1 Summary of Viral Reduction Factor for Each Virus and Processing Step
* Other Abumin fractionation process steps (processing of cryo-poor plasma to Fraction I+II+III/II+III supernatant and processing of Fraction V suspension to Cuno 90LP filtrate) showed significant virus reduction capacity in in vitro viral clearance studies. These process steps also contribute to the overall viral clearance robustness of the manufacturing process. However, since the mechanism of virus removal is similar to that of this particular process step, the viral inactivation data from other steps were not used in the calculation of the Mean Cumulative Reduction Factor. † n.d. = not determined ‡ Recent scientific data suggest that the actual human parvovirus B19 (B19V), is far more effectively inactivated by pasteurization than indicated by model virus data12.
Process Step	Viral Reduction Factor (log10)
	Lipid Enveloped				Non-Lipid Enveloped
	HIV-1	Flaviviridae		PRV	HAV	Parvoviridae
		BVDV	WNV			MMV
Processing of Fraction I+II+III/II + III supernatant to Fraction IV4 Cuno 70C filtrate*	> 4.9	> 4.8	> 5.7	>5.5	>4.5	3.0
Pasteurization	> 7.8	> 6.5	n.d.†	> 7.4	3.2	1.6‡
Mean Cumulative Reduction Factor	> 12.7	> 11.3	> 5.7	> 12.9	> 7.7	4.6

Indications and Usage for Flexbumin

1. Hypovolemia

Hypovolemia is a possible indication for Flexbumin 25%, Albumin (Human), 25% Solution. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation.  It is most effective with patients who are well hydrated.


When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 25% albumin is preferable to 5% protein solutions.4,6   However, in the absence of adequate or excessive hydration, 5% protein solutions should be used or 25% albumin should be diluted with crystalloid.


Although crystalloid solutions and colloid-containing plasma substitutes can be used in emergency treatment of shock, Albumin (Human) has a prolonged intravascular half-life.9  When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible.

2. Hypoalbuminemia

A.  General

Hypoalbuminemia is another possible indication for use of Flexbumin 25%, Albumin (Human), 25% Solution.  Hypoalbuminemia can result from one or more of the following:5

(1)    Inadequate production (malnutrition, burns, major injury, infections, etc.)

(2)    Excessive catabolism (burns, major injury, pancreatitis, etc.)

(3)    Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)

(4)    Redistribution within the body (major surgery, various inflammatory conditions, etc.)

When albumin deficit is the result of excessive protein loss, the effect of administration of albumin will be temporary unless the underlying disorder is reversed.  In most cases, increased nutritional replacement of amino acids and/or protein with concurrent treatment of the underlying disorder will restore normal plasma albumin levels more effectively than albumin solutions.  Occasionally hypoalbuminemia accompanying severe injuries, infections or pancreatitis cannot be quickly reversed and nutritional supplements may fail to restore serum albumin levels.  In these cases, Flexbumin 25%, Albumin (Human), 25% Solution might be a useful therapeutic adjunct.

B.   Burns

An optimum regimen for the use of albumin, electrolytes and fluid in the early treatment of burns has not been established, however, in conjunction with appropriate crystalloid therapy, Flexbumin 25%, Albumin (Human), 25% Solution may be indicated for treatment of oncotic deficits after the initial 24 hour period following extensive burns and to replace the protein loss which accompanies any severe burn.4,6

C.   Adult Respiratory Distress Syndrome (ARDS)

A characteristic of ARDS is a hypoproteinemic state, which may be causally related to the interstitial pulmonary edema.  Although uncertainty exists concerning the precise indication of albumin infusion in these patients, if there is a pulmonary overload accompanied by hypoalbuminemia, 25% albumin solution may have a therapeutic effect when used with a diuretic.4

D.   Nephrosis

Flexbumin 25%, Albumin (Human), 25% Solution may be a useful aid in treating edema in patients with severe nephrosis who are receiving steroids and/or diuretics.

3. Cardiopulmonary Bypass Surgery

Flexbumin 25%, Albumin (Human), 25% Solution has been recommended prior to or during cardiopulmonary bypass surgery, although no clear data exist indicating its advantage over crystalloid solutions. 4,6,10

4. Hemolytic Disease of the Newborn (HDN)

Flexbumin 25%, Albumin (Human), 25% Solution may be administered in an attempt to bind and detoxify unconjugated bilirubin in infants with severe HDN.

There is no valid reason for use of albumin as an intravenous nutrient.

CONTRAINDICATONS

A history of allergic reactions to albumin is a specific contraindication to the use of this product.  Flexbumin 25%, Albumin (Human), 25% Solution is also contraindicated in severely anemic patients and in patients with cardiac failure.

Warnings

Do not use if turbid.  Do not begin administration more than 4 hours after the container has been entered.  Discard unused portion.

There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent for Flexbumin 25%, Albumin (Human), 25% Solution.  Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.

Flexbumin 25%, Albumin (Human), 25% Solution is made from human plasma.  Products made from human plasma may contain infectious agents, such as viruses, that can cause disease.  The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses (See Description).  Despite these measures, such products can still potentially transmit disease.  Based on effective donor screening and product manufacturing processes, albumin carries an extremely remote risk for transmission of viral diseases.  A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.  ALL infections thought by a physician possibly to have been transmitted by this product, should be reported by the physician, or other healthcare provider to Baxter Healthcare Corporation at 1-800-423-2862.  The physician should discuss the risks and benefits of this product with the patient.

Precautions

Flexbumin 25%, Albumin (Human), 25% Solution must be administered intravenously at a rate not to exceed 1ml/min to patients with normal blood volume.  More rapid administration might cause circulatory overload and pulmonary edema.

A rise in blood pressure after 25% albumin infusion necessitates careful observation of the injured or post-operative patient in order to detect and treat severed blood vessels that may not have bled at a lower blood pressure.

Pregnancy-Category C

Animal reproduction studies have not been conducted with Flexbumin 25%, Albumin (Human), 25% Solution.  It is not known whether Flexbumin 25%, Albumin (Human), 25% Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  Flexbumin 25%, Albumin (Human), 25% Solution should be given to a pregnant woman only if clearly needed.

Pediatric Use

The safety of albumin solutions has been demonstrated in children provided the dose is appropriate for body weight, however, the safety of Flexbumin 25%, Albumin (Human), 25% Solution has not been evaluated in pediatric patients.

Adverse Reactions

Untoward reactions to Flexbumin 25%, Albumin (Human), 25% Solution are extremely rare, although nausea, fever, chills or urticaria may occasionally occur.  Such symptoms usually disappear when the infusion is slowed or stopped for a short period of time.

Flexbumin Dosage and Administration

Flexbumin 25%, Albumin (Human), 25% Solution must be administered intravenously.  This solution may be administered in conjunction with or combined with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate.  The addition of four volumes of normal saline or 5% glucose to 1 volume of Flexbumin 25%, Albumin (Human), 25% Solution gives a solution, which is approximately isotonic and isosmotic with citrated plasma.

Albumin solutions should not be mixed with protein hydrolysates or solutions containing alcohol.

Recommended Dosages

1.   Hypovolemic Shock

The dosage of Flexbumin 25%, Albumin (Human), 25% Solution must be individualized.  As a guideline, the initial treatment should be in the range of 100 to 200 ml for adults and 2.5 to 5 ml per kilogram body weight for children.  This may be repeated after 15 to 30 minutes, if the response is not adequate.  For patients with significant plasma volume deficits, albumin replacement is best administered in the form of 5% Albumin (Human).

Upon administration of additional albumin or if hemorrhage has occurred, hemodilution and a relative anemia will follow.  This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.

2.   Burns

The optimal therapeutic regimen for administration of crystalloid and colloid solutions after extensive burns has not been established.  When Flexbumin 25%, Albumin (Human), 25% Solution is administered after the first 24 hours following burns, the dose should be determined according to the patient’s condition and response to treatment.

3.    Hypoalbuminemia

Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude.  This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.  When using patient’s serum albumin concentration to estimate the deficit, the body albumin compartment should be calculated to be 80 to100 ml per kg of body weight.5,6  Daily dose should not exceed 2 g of albumin per kilogram of body weight.

4.   Hemolytic Disease of the Newborn

Flexbumin 25%, Albumin (Human), 25% Solution may be administered prior to or during exchange transfusion in a dose of 1 g per kilogram body weight.11

Preparation of Administration

Check the GALAXY container for minute leaks prior to use by squeezing the bag firmly.  If leaks are found, discard solution as sterility may be impaired.  Do not add supplementary medication.  Do not use unless solution is clear and seal is intact.

CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

Preparation for administration:

1.    Suspend container from eyelet support.

2.    Remove plastic protector from outlet port at bottom of container.

3.    Attach administration set.  Refer to complete directions accompanying set.  Make certain that the administration set contains an adequate filter.

How is Flexbumin Supplied

Flexbumin 25%, Albumin (Human), 25% Solution is supplied in 50 ml (NDC 0944-0493-01) and 100 ml (NDC 0944-0493-02) in single dose GALAXY plastic container (PL 2501).

STORAGE

Store Flexbumin 25%, Albumin (Human), 25% Solution at room temperature, not to exceed 30°C (86°F).  Protect from freezing.

REFERENCES

1.  Gellis SS, Neefe JR, Stokes J Jr, et al: Chemical, clinical and immunological studies on the products of human plasma fractionation.  XXXVI.  Inactivation of the virus of homologous serum hepatitis in solutions of normal human serum albumin by means of heat.  J Clin Invest 27:239-244, 1948

2.  Gerety RJ, Aronson DL: Plasma derivatives and viral hepatitis.  Transfusion 22:347‑351, 1982

3.  Murray R, Diefenbach WCL, Geller H, et al: Problem of reducing danger of serum hepatitis from blood and blood products.  NY State J Med 55:1145-1150, 1955

4.  Tullis JL: Albumin 1.  Background and use, and 2.  Guidelines for clinical use. JAMA 237:355-360, 460-463, 1977

5.  Peters T Jr: Serum albumi, in The Plasma Proteins, 2nd ed, Vol 1.  Putnam FW (ed).  New York, Academic Press, 1975, pp 133-181

6.  Finlayson JS: Albumin products.  Semin Thromb Hemostas. 6:85-120, 1980

7.  Janeway CA, Berenberg W, Hutchins G: Indications and uses of blood, blood derivatives and blood substitutes.  Med Clin N Amer 29:1069-1094, 1945

8.  Janeway CA, Gibson ST, Woodruff LM, et al: Chemical, clinical and immunological studies on the products of human plasma fractionation.  VII.  Concentrated human serum albumin.  J Clin Invest 23:465-490, 1944

9.  Shoemaker WC, Schluchter M, Hopkins JA, el at: Comparison of the relative effectiveness of colloids and crystalloids in emergency resuscitation.  Am J Surg 142:73-83, 1981.

10. Lowenstein E, Hallowell P, Bland JHL: Use of colloid and crystalloid solutions in open heart surgery: Physiological basis and clinical results in, Proceedings of the Workshop on Albumin.  Sgouris JT, Rene A (eds).  DHEW Publication No. (NIH) 76-925, Washington, DC, US Government Printing Office, 1976, pp 195-210

11. Tsao YC, Yu VYH: Albumin in management of neonatal hyperbilirubinaemia.  Arch Dis Childhood 47:250-256, 1972

12. J. Blumel et al., Inactivation of Parvovirus B19 During Pasteurization of Human Serum Albumin.  Transfusion 42: 1011-1018, 2002

To enroll in the confidential industry-wide Patient Notification System, call 1-888-UPDATE U (1-888-873-2838).

Baxter, Flexbumin and GALAXY are trademarks of Baxter International Inc.

Baxter Healthcare Corporation

Westlake Village, CA 91362  USA

U.S. License No. 140

Flexbumin   25% albumin human  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0944-0493 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Albumin human (Albumin human) Albumin human 0.25 g  in 1 mL

Inactive Ingredients Ingredient Name Strength acetyltryptophan   Sodium caprylate

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0944-0493-01 50 mL In 1 BAG None 2 0944-0493-02 100 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	bla101452	01/06/2006

Labeler - Baxter Healthcare Corporation (123412376)

Establishment
Name	Address	ID/FEI	Operations
Baxter Healthcare Corporation		194684502	manufacture

Revised: 06/2007Baxter Healthcare Corporation

More Flexbumin resources

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

• Flexbumin Consumer Overview


• Albumin Human Monograph (AHFS DI)


• Albuminar-25


• Albuminar-5


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Compare Flexbumin with other medications

• Burns, External
• Hypoproteinemia
• Pancreatitis
• Peritonitis
• Postoperative Albumin Loss
• Shock

Euglucon

Generic Name: glyburide (Oral route)

GLYE-bure-ide

Commonly used brand name(s)

In the U.S.

• Diabeta


• Glycron


• Glynase Pres-Tab


• Micronase

In Canada

• Euglucon

Available Dosage Forms:

• Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: 2nd Generation Sulfonylurea

Uses For Euglucon

Glyburide is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Glyburide belongs to a class of medicines called sulfonylureas. It causes your pancreas to release more insulin into the blood stream. This medicine may be used alone or with another oral medicine such as metformin.

This medicine is available only with your doctor's prescription.

Before Using Euglucon

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:

Allergies

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of glyburide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glyburide in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment in the dose for patients receiving glyburide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bosentan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Disopyramide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Aceclofenac


• Acemetacin


• Alclofenac


• Alprenolol


• Apazone


• Aspirin


• Atenolol


• Benoxaprofen


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bromfenac


• Bucindolol


• Bufexamac


• Carprofen


• Carteolol


• Carvedilol


• Celiprolol


• Clarithromycin


• Clometacin


• Clonixin


• Clorgyline


• Colesevelam


• Cyclosporine


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dilevalol


• Dipyrone


• Droxicam


• Esmolol


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Fenugreek


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gemfibrozil


• Glucomannan


• Ibuprofen


• Indomethacin


• Indoprofen


• Iproniazid


• Isocarboxazid


• Isoxicam


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nialamide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxprenolol


• Oxyphenbutazone


• Pargyline


• Penbutolol


• Phenelzine


• Phenylbutazone


• Pindolol


• Pirazolac


• Piroxicam


• Pirprofen


• Procarbazine


• Propranolol


• Propyphenazone


• Proquazone


• Psyllium


• Rifampin


• Rifapentine


• Selegiline


• Sotalol


• Sulfamethoxazole


• Sulindac


• Suprofen


• Talinolol


• Tenidap


• Tenoxicam


• Tertatolol


• Tiaprofenic Acid


• Timolol


• Tolmetin


• Toloxatone


• Tranylcypromine


• Voriconazole


• Warfarin


• Zomepirac

Interactions with Food/Tobacco/Alcohol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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:

• Alcohol intoxication or


• Underactive adrenal glands or


• Underactive pituitary gland or


• Undernourished condition or


• Weakened physical condition or


• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking glyburide.

• Diabetic ketoacidosis (ketones in the blood) or


• Type I diabetes—Should not be used in patients with these conditions.

• Fever or


• Infection or


• Surgery or


• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (a blood disorder) in patients with this condition.

• Heart disease—Use with caution. May make this condition worse.

• Kidney disease or


• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of glyburide

This section provides information on the proper use of a number of products that contain glyburide. It may not be specific to Euglucon. Please read with care.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

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.

• For type 2 diabetes:
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 2.5 to 5 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (micronized tablets):
    
    • Adults—At first, 1.5 to 3 milligrams (mg) once a day taken with breakfast or the first main meal. Your doctor may adjust your dose if needed. The dose is usually not more than 12 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

Storage

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.

Precautions While Using Euglucon

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.


• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.

Check with your doctor right away if you start having chest pain or discomfort; nausea; pain or discomfort in arms, jaw, back, or neck; shortness of breath; sweating; or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, including a heart attack.

Too much glyburide can cause low blood sugar (hypoglycemia) when it is used under certain conditions. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly and call someone on your health care team right away when you need advice.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Do not take this medicine if you are also using bosentan (Tracleer®). Also, make sure your doctor knows about all other medicines you are using for diabetes, including insulin.

Euglucon Side Effects

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:

Less common

• Difficulty with swallowing


• dizziness


• fast heartbeat


• hives


• itching


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Rare

• Abdominal or stomach pain


• chills


• clay-colored stools


• dark urine


• diarrhea


• fever


• headache


• light-colored stools


• loss of appetite


• nausea and vomiting


• rash


• unpleasant breath odor


• upper right abdominal pain


• vomiting of blood


• yellow eyes and skin

Incidence not known

• Agitation


• back, leg, or stomach pains


• bleeding gums


• blood in the urine or stools


• bloody, black, or tarry stools


• blurred vision


• change in near or distance vision


• chest pain


• coma


• confusion


• convulsions


• cough or hoarseness


• decreased urine output


• depression


• difficulty in focusing eyes


• difficulty with breathing


• fast or irregular heartbeat


• fluid-filled skin blisters


• general body swelling


• high fever


• hostility


• increased thirst


• irritability


• itching of the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lethargy


• lower back or side pain


• muscle pain or cramps


• muscle twitching


• nosebleeds


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• rapid weight gain


• seizures


• sensitivity to the sun


• skin thinness


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stupor


• swelling of the face, ankles, or hands


• swollen or painful glands


• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety


• cold sweats


• cool, pale skin


• increased hunger


• nervousness


• nightmares


• shakiness


• slurred speech

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:

Less common

• Indigestion


• passing of gas

Incidence not known

• Difficulty with moving


• itching


• joint pain


• redness or other discoloration of the skin


• severe sunburn


• swollen joints

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: Euglucon side effects (in more detail)

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More Euglucon resources

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

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