Monday, 21 December 2009

Dibazol




Dibazol may be available in the countries listed below.


Ingredient matches for Dibazol



Bendazol

Bendazol is reported as an ingredient of Dibazol in the following countries:


  • Georgia

International Drug Name Search

Friday, 11 December 2009

Voltaren Colirio




Voltaren Colirio may be available in the countries listed below.


Ingredient matches for Voltaren Colirio



Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Voltaren Colirio in the following countries:


  • Spain

International Drug Name Search

Wednesday, 9 December 2009

Amisulprid dura




Amisulprid dura may be available in the countries listed below.


Ingredient matches for Amisulprid dura



Amisulpride

Amisulpride is reported as an ingredient of Amisulprid dura in the following countries:


  • Germany

International Drug Name Search

Monday, 23 November 2009

Epirubicina




Epirubicina may be available in the countries listed below.


Ingredient matches for Epirubicina



Epirubicin

Epirubicina (DCIT) is known as Epirubicin in the US.

International Drug Name Search

Glossary

DCITDenominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

oxymetazoline nasal


Generic Name: oxymetazoline nasal (ox ee me TAZ oh leen)

Brand names: Afrin, Afrin Nasal Sinus, Allerest 12 Hour Nasal Spray, Duramist Plus, Duration, Four-Way Nasal Spray, Genasal, Neo-Synephrine 12 Hour, Nostrilla, NRS Nasal, NTZ Long Acting Nasal, Oxyfrin, Oxymeta-12, Sinarest Nasal, Sinex Long-Acting, Twice-A-Day, ...show all 35 brand names.


What is oxymetazoline nasal?

Oxymetazoline is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. The nasal formulation acts directly on the blood vessels in your nasal tissues. Constriction of the blood vessels in your nose and sinuses leads to drainage of these areas and a decrease in congestion.


Oxymetazoline nasal is used to treat congestion associated with allergies, hay fever, sinus irritation, and the common cold.


Oxymetazoline nasal may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about oxymetazoline nasal?


Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.


Do not use more of this medication than is recommended on the package or by your doctor.

Who should not use oxymetazoline nasal?


Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. This could cause a very dangerous drug interaction with serious side effects.

Before taking this medication, tell your doctor if you have



  • high blood pressure;




  • any type of heart disease, hardening of the arteries, or irregular heart beats;




  • thyroid problems;




  • diabetes;




  • glaucoma or increased pressure in the eye;




  • an enlarged prostate or difficulty urinating; or




  • liver or kidney disease.



You may not be able to use oxymetazoline nasal, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.


It is not known whether oxymetazoline nasal will harm an unborn baby. Do not use oxymetazoline nasal without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of oxymetazoline nasal. Do not use this medication without first talking to your doctor if you are breast-feeding a baby. If you over 60 years of age, you may be more likely to experience side effects from oxymetazoline nasal. You may require a lower dose of this medication.

How should I use oxymetazoline nasal?


Use oxymetazoline nasal exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


To apply the nasal spray, keep your head upright, spray, then sniff hard for a few minutes after administering a dose.


To apply the nasal drops, lie on a bed on your back with your head hanging over the edge. Insert the drops and remain in this position for several minutes. Gently turn your head from side to side.


Do not allow the tip of the container to touch the inside of your nose or any other surface. This spreads the infection.


Also, to prevent the spread of infection, do not share this medication with anyone else.


Discard this medication bottle after use. Do not save it for reuse.


Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful. Oxymetazoline nasal should not be used more often than twice a day (every 12 hours).

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.


Store oxymetazoline nasal at room temperature away from moisture and heat.


What happens if I miss a dose?


Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of an oxymetazoline nasal overdose include extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.


What should I avoid while taking oxymetazoline nasal?


Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful.

Oxymetazoline nasal side effects


If you experience any of the following serious side effects, stop using oxymetazoline nasal and seek emergency medical attention:



  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);




  • seizures;




  • unusual behavior or hallucinations; or




  • an irregular or fast heartbeat.



More commonly, you may experience some sneezing or burning, stinging, dryness, or irritation of the nose. These side effects are usually mild and temporary.


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.


Oxymetazoline nasal Dosing Information


Usual Adult Dose for Nasal Congestion:

0.025% solution: 4 to 6 drops to each nostril twice daily as needed.

0.05% solution: 2 to 3 drops to each nostril twice daily as needed.

Usual Pediatric Dose for Nasal Congestion:

0.025% solution:
>= 2 years to 5 years: 2 to 3 drops to each nostril twice daily as needed.
6 years to 18 years: 4 to 6 drops to each nostril twice daily as needed.

0.05% solution:
>= 6 years to 18 years: 2 to 3 drops to each nostril twice daily as needed.

0.05% spray:
>= 6 years to 18 years: 1 to 2 sprays to each nostril twice daily as needed.


What other drugs will affect oxymetazoline nasal?


Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Although drug interactions between topical nasal decongestants and drugs taken by mouth are not expected, they can occur. Rarely, oxymetazoline nasal may interact with the following medicines:



  • furazolidone (Furoxone);




  • guanethidine (Ismelin);




  • indomethacin (Indocin);




  • methyldopa (Aldomet);




  • bromocriptine (Parlodel);




  • caffeine in cola, tea, coffee, chocolate and other products;




  • theophylline (Theo-Dur, Theochron, Theolair, others);



  • tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);

  • other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);

  • phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and

  • other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with oxymetazoline nasal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More oxymetazoline nasal resources


  • Oxymetazoline nasal Dosage
  • Oxymetazoline nasal Use in Pregnancy & Breastfeeding
  • Oxymetazoline nasal Drug Interactions
  • Oxymetazoline nasal Support Group
  • 12 Reviews for Oxymetazoline - Add your own review/rating


  • Afrin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Afrin Solution MedFacts Consumer Leaflet (Wolters Kluwer)



Compare oxymetazoline nasal with other medications


  • Nasal Congestion


Where can I get more information?


  • Your pharmacist has additional information about oxymetazoline nasal written for health professionals that you may read.


Sunday, 22 November 2009

Ostatac




Ostatac may be available in the countries listed below.


Ingredient matches for Ostatac



Ergocalciferol

Ergocalciferol is reported as an ingredient of Ostatac in the following countries:


  • Argentina

International Drug Name Search

Thursday, 19 November 2009

ratio-Sotalol




ratio-Sotalol may be available in the countries listed below.


Ingredient matches for ratio-Sotalol



Sotalol

Sotalol hydrochloride (a derivative of Sotalol) is reported as an ingredient of ratio-Sotalol in the following countries:


  • Canada

International Drug Name Search

Wednesday, 18 November 2009

Orphénadrine




Orphénadrine may be available in the countries listed below.


Ingredient matches for Orphénadrine



Orphenadrine

Orphénadrine (DCF) is known as Orphenadrine in the US.

International Drug Name Search

Glossary

DCFDénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Sunday, 15 November 2009

ratio-Minocycline




ratio-Minocycline may be available in the countries listed below.


Ingredient matches for ratio-Minocycline



Minocycline

Minocycline hydrochloride (a derivative of Minocycline) is reported as an ingredient of ratio-Minocycline in the following countries:


  • Canada

International Drug Name Search

Saturday, 14 November 2009

Didronel



etidronate disodium

Dosage Form: tablet
Didronel®

(etidronate disodium)

DESCRIPTION:


Didronel tablets contain 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. It 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, and starch.



CLINICAL PHARMACOLOGY:


Didronel 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.


Didronel 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.


Didronel 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.


Didronel 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 Didronel 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 Didronel 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.



Didronel 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 Didronel prevents or retards heterotopic ossification. There is no evidence Didronel affects mature heterotopic bone.



INDICATIONS AND USAGE:


Didronel is 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. Didronel is not approved for the treatment of osteoporosis.



Paget's Disease: Didronel is indicated for the treatment of symptomatic Paget's disease of bone. Didronel 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 1 year following cessation of therapy. The upper limit of this period has not been determined.


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



Heterotopic Ossification: Didronel is indicated in the prevention and treatment of heterotopic ossification following total hip replacement or due to spinal cord injury.


Didronel reduces the incidence of clinically important heterotopic bone by about two-thirds.


Among those patients who form heterotopic bone, Didronel retards the progression of immature lesions and reduces the severity by at least half. Follow-up data (at least 9 months posttherapy) suggest these benefits persist.


In total hip replacement patients, Didronel does not promote loosening of the prosthesis or impede trochanteric reattachment.


In spinal cord injury patients, Didronel does 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: Didronel, 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 Didronel 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 Didronel 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 (6-8 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 Didronel 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 Didronel 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.


Didronel 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 posttherapy. There is no experience to specifically guide treatment in patients with impaired renal function. Didronel 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 Didronel® I. V. Infusion (etidronate disodium) 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.


Didronel 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 posttherapy. 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 Didronel. 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 co-morbid disorders (e.g., periodontal and/or other pre-existing 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 postmarketing 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 Didronel therapy, may be especially prone to fracture.


Patients with predominantly lytic lesions should be monitored radiographically and biochemically to permit termination of Didronel 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 Didronel 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 versus oral) on this risk has not been studied.


There are no adequate and well-controlled studies in pregnant women. Didronel (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 Didronel is administered to a nursing woman.



Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Pediatric patients have been treated with Didronel, 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 Didronel 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, Didronel 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 Didronel 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 (versus 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 Postmarketing Experience: The worldwide postmarketing 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 Didronel 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 to 6000 mg (67 to 100 mg/kg) of Didronel 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 posttherapy.


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.



DOSAGE AND ADMINISTRATION:


Didronel should be taken as a single, oral dose. As with other bisphosphonates, it is recommended that Didronel 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 two 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) a Didronel-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). Didronel therapy should begin as soon as medically feasible following the injury, preferably prior to evidence of heterotopic ossification.



Retreatment has not been studied.



HOW SUPPLIED:


Didronel is available as 400-mg, white, scored, capsule-shaped tablets with "N E" on one face and "406" on the other.


        NDC 0149-0406-60         bottle of 60


Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)


[see USP Controlled Room Temperature]


Mfg. by:

Norwich Pharmaceuticals, Inc.

North Norwich, NY 13814

Dist. by:

Procter & Gamble Pharmaceuticals, Inc.

TM Owner, Cincinnati, OH 45202


REVISED DECEMBER 2009



PRINCIPAL DISPLAY PANEL - 200 mg Tablet Label


NDC 0149-0405-60

LIST 80040560


200 mg


Didronel®

(etidronate disodium)


60 Tablets


Rx Only


Procter & Gamble

PHARMACEUTICALS




PRINCIPAL DISPLAY PANEL - 400 mg Tablet Label


NDC 0149-0406-60

LIST 80040660


Rx Only


400 mg


Didronel®

(etidronate disodium)


60 Tablets


FPO

2D Data Matrix

& Human Readable










Didronel 
etidronate disodium  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0149-0405
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETIDRONATE DISODIUM (ETIDRONIC ACID)ETIDRONATE DISODIUM200 mg










Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 


















Product Characteristics
ColorWHITEScoreno score
ShapeRECTANGLESize12mm
FlavorImprint CodePG;402
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10149-0405-6060 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01783101/09/197704/30/2010







Didronel 
etidronate disodium  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0149-0406
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ETIDRONATE DISODIUM (ETIDRONIC ACID)ETIDRONATE DISODIUM400 mg










Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 


















Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize14mm
FlavorImprint CodeNE;406
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10149-0406-6060 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01783108/12/1983


Labeler - Procter & Gamble Pharmaceuticals, Inc. (016972051)









Establishment
NameAddressID/FEIOperations
Norwich Pharmaceuticals, Inc.132218731MANUFACTURE, ANALYSIS, PACK, LABEL
Revised: 01/2010Procter & Gamble Pharmaceuticals, Inc.




More Didronel resources


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


  • Didronel Monograph (AHFS DI)

  • Didronel Advanced Consumer (Micromedex) - Includes Dosage Information

  • Didronel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Didronel Consumer Overview



Compare Didronel with other medications


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

Friday, 13 November 2009

Amilin




Amilin may be available in the countries listed below.


Ingredient matches for Amilin



Amitriptyline

Amitriptyline hydrochloride (a derivative of Amitriptyline) is reported as an ingredient of Amilin in the following countries:


  • Bangladesh

  • Iceland

International Drug Name Search

Wednesday, 11 November 2009

Diamox



Generic Name: acetazolamide (a SEET a ZOLE a mide)

Brand Names: Diamox, Diamox Sequels


What is Diamox (acetazolamide)?

Acetazolamide is a carbonic anhydrase inhibitor. Carbonic anhydrase is a protein in your body. Acetazolamide reduces the activity of this protein.


Acetazolamide is used to treat glaucoma and to treat and to prevent acute mountain sickness (altitude sickness). It is also used as a part of some treatment plans for congestive heart failure and seizure disorders.


Acetazolamide may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Diamox (acetazolamide)?


Call your doctor immediately if you experience a sore throat, fever, unusual bleeding or bruising, tingling or tremors in your hands or feet, pain in your side or groin, or a rash. These symptoms could be early signs of a serious side effect.


Use caution when driving, operating machinery, or performing other hazardous activities. Acetazolamide may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Avoid prolonged exposure to sunlight. Acetazolamide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Who should not take Diamox (acetazolamide)?


Tell your doctor if you have ever had an allergic reaction to a sulfa-based drug such as sulfamethoxazole (e.g., Bactrim, Septra, Gantanol). Acetazolamide is also a sulfa-based drug, and you may have a similar reaction to it.


Before taking acetazolamide, tell your doctor if you



  • are on aspirin therapy,




  • have liver disease,




  • have kidney disease,




  • have heart disease,




  • have lung disease, or




  • have a hormonal disease.



You may not be able to take acetazolamide, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.


Acetazolamide is in the FDA pregnancy category C. This means that it is not known whether acetazolamide will harm an unborn baby. Do not take acetazolamide without first talking to your doctor if you are pregnant. Acetazolamide passes into breast milk. It is not known whether acetazolamide will affect a nursing infant. Do not take acetazolamide without first talking to your doctor if you are breast-feeding a baby.

How should I take Diamox (acetazolamide)?


Take acetazolamide exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water. Take acetazolamide with food if it upsets your stomach. Store acetazolamide at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of an acetazolamide overdose are not well known, but the following symptoms might be expected: drowsiness, decreased appetite, nausea, vomiting, dizziness, numbness or tingling, shaking, and ringing in the ears.


What should I avoid while taking Diamox (acetazolamide)?


Use caution when driving, operating machinery, or performing other hazardous activities. Acetazolamide may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Avoid prolonged exposure to sunlight. Acetazolamide may increase the sensitivity of your skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Diamox (acetazolamide) side effects


If you experience any of the following serious side effects, stop taking acetazolamide and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);




  • a sore throat or a fever;




  • unusual bleeding or bruising;




  • side or groin pain;




  • tingling or tremors in your hands or feet; or




  • a rash.



Other, less serious side effects may be more likely to occur. Continue to take acetazolamide and talk to your doctor if you experience



  • decreased appetite, nausea, vomiting, constipation, diarrhea, or changes in taste;




  • drowsiness, dizziness, fatigue, or weakness;




  • nervousness or mild tremor;




  • headache or confusion;




  • increased sensitivity of the skin to sunlight;




  • worsening gout;




  • loss of blood sugar control (if you are diabetic);




  • ringing in your ears or hearing problems; or




  • changes in your vision.



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 Diamox (acetazolamide)?


Before taking this medication, tell your doctor if you are taking any of the following medicines:



  • cyclosporine (Sandimmune). Cyclosporine may have more side effects if it is taken with acetazolamide.




  • primidone (Mysoline). Primidone may not be as effective if it is taken with acetazolamide, and seizure control may be reduced.




  • diflunisal (Dolobid). Diflunisal may increase both the activity and the side effects of acetazolamide.




  • aspirin, salsalate (Disalcid, Salflex, Salsitab, others), choline salicylate (Arthropan), magnesium salicylate (Doan's, Magan, Mobidin), and other aspirin-like products (salicylates). These medicines may also interact with acetazolamide, and special monitoring of your therapy may be necessary.




  • lithium (Lithobid, Eskalith, others). Acetazolamide may decrease the level of lithium in your blood. Special monitoring or a dosage adjustment may be necessary.



Drugs other than those listed here may also interact with acetazolamide. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More Diamox resources


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


  • Diamox Prescribing Information (FDA)

  • Diamox Monograph (AHFS DI)

  • Acetazolamide Prescribing Information (FDA)

  • Acetazolamide Professional Patient Advice (Wolters Kluwer)

  • Acetazolamide MedFacts Consumer Leaflet (Wolters Kluwer)

  • Diamox Sequels Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Diamox with other medications


  • Edema
  • Epilepsy
  • Glaucoma
  • Hydrocephalus
  • Mountain Sickness / Altitude Sickness
  • Pseudotumor Cerebri
  • Seizure Prevention


Where can I get more information?


  • Your pharmacist can provide more information about acetazolamide.

See also: Diamox side effects (in more detail)


Sunday, 8 November 2009

Rolac




Rolac may be available in the countries listed below.


Ingredient matches for Rolac



Ketorolac

Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Rolac in the following countries:


  • Bangladesh

  • Indonesia

International Drug Name Search

Saturday, 7 November 2009

Triple C




Triple C may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Triple C



Chlortetracycline

Chlortetracycline hydrochloride (a derivative of Chlortetracycline) is reported as an ingredient of Triple C in the following countries:


  • Australia

International Drug Name Search

Wednesday, 28 October 2009

Tavor




Tavor may be available in the countries listed below.


Ingredient matches for Tavor



Fluconazole

Fluconazole is reported as an ingredient of Tavor in the following countries:


  • Chile

  • Colombia

  • Ecuador

Lorazepam

Lorazepam is reported as an ingredient of Tavor in the following countries:


  • Germany

  • Greece

  • Italy

Oxybutynin

Oxybutynin hydrochloride (a derivative of Oxybutynin) is reported as an ingredient of Tavor in the following countries:


  • Mexico

Simvastatin

Simvastatin is reported as an ingredient of Tavor in the following countries:


  • Venezuela

International Drug Name Search

Tuesday, 13 October 2009

Zilversulfadiazine PCH




Zilversulfadiazine PCH may be available in the countries listed below.


Ingredient matches for Zilversulfadiazine PCH



Sulfadiazine

Sulfadiazine silver (a derivative of Sulfadiazine) is reported as an ingredient of Zilversulfadiazine PCH in the following countries:


  • Netherlands

International Drug Name Search

Wednesday, 7 October 2009

Zavedos




Zavedos may be available in the countries listed below.


UK matches:

  • Zavedos 5mg and 10mg Powder for Solution for Injection' (SPC)
  • Zavedos Capsules 5mg, 10mg and 25mg (SPC)
  • Zavedos Injection 10 mg (SPC)
  • Zavedos Injection 20 mg (SPC)
  • Zavedos Injection 5 mg (SPC)

Ingredient matches for Zavedos



Idarubicin

Idarubicin is reported as an ingredient of Zavedos in the following countries:


  • Chile

  • Ecuador

  • Ireland

  • Sri Lanka

  • Tunisia

Idarubicin hydrochloride (a derivative of Idarubicin) is reported as an ingredient of Zavedos in the following countries:


  • Argentina

  • Australia

  • Austria

  • Bahrain

  • Belgium

  • Bosnia & Herzegowina

  • Brazil

  • China

  • Croatia (Hrvatska)

  • Czech Republic

  • Denmark

  • Egypt

  • Estonia

  • Finland

  • France

  • Germany

  • Greece

  • Hong Kong

  • Hungary

  • Iceland

  • Iran

  • Iraq

  • Israel

  • Italy

  • Jordan

  • Kuwait

  • Latvia

  • Lebanon

  • Lithuania

  • Luxembourg

  • Malaysia

  • Netherlands

  • New Zealand

  • Norway

  • Oman

  • Peru

  • Philippines

  • Poland

  • Portugal

  • Qatar

  • Romania

  • Russian Federation

  • Saudi Arabia

  • Serbia

  • Singapore

  • Slovakia

  • Slovenia

  • South Africa

  • Spain

  • Sweden

  • Switzerland

  • Taiwan

  • Thailand

  • Turkey

  • United Arab Emirates

  • United Kingdom

  • Venezuela

International Drug Name Search

Glossary

SPC Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Friday, 2 October 2009

Atenoblock




Atenoblock may be available in the countries listed below.


Ingredient matches for Atenoblock



Atenolol

Atenolol is reported as an ingredient of Atenoblock in the following countries:


  • Argentina

International Drug Name Search

Wednesday, 23 September 2009

Loxinic




Loxinic may be available in the countries listed below.


Ingredient matches for Loxinic



Meloxicam

Meloxicam is reported as an ingredient of Loxinic in the following countries:


  • Indonesia

International Drug Name Search

Sunday, 20 September 2009

Donezepil Synthon




Donezepil Synthon may be available in the countries listed below.


Ingredient matches for Donezepil Synthon



Donepezil

Donepezil is reported as an ingredient of Donezepil Synthon in the following countries:


  • Slovakia

International Drug Name Search

Sunday, 13 September 2009

Unimax




Unimax may be available in the countries listed below.


Ingredient matches for Unimax



Felodipine

Felodipine is reported as an ingredient of Unimax in the following countries:


  • Germany

  • Switzerland

Ramipril

Ramipril is reported as an ingredient of Unimax in the following countries:


  • Germany

  • Switzerland

International Drug Name Search

Friday, 11 September 2009

Bendex




Bendex may be available in the countries listed below.


Ingredient matches for Bendex



Mebendazole

Mebendazole is reported as an ingredient of Bendex in the following countries:


  • Bangladesh

International Drug Name Search

Anvomer B6




Anvomer B6 may be available in the countries listed below.


Ingredient matches for Anvomer B6



Pyridoxine

Pyridoxine is reported as an ingredient of Anvomer B6 in the following countries:


  • Indonesia

International Drug Name Search

Thursday, 10 September 2009

Lennon-Warfarin




Lennon-Warfarin may be available in the countries listed below.


Ingredient matches for Lennon-Warfarin



Warfarin

Warfarin sodium salt (a derivative of Warfarin) is reported as an ingredient of Lennon-Warfarin in the following countries:


  • South Africa

International Drug Name Search

Wednesday, 9 September 2009

Furolix




Furolix may be available in the countries listed below.


Ingredient matches for Furolix



Furosemide

Furosemide is reported as an ingredient of Furolix in the following countries:


  • Tunisia

International Drug Name Search

Tuesday, 8 September 2009

Betadine Ophthalmic





Dosage Form: ophthalmic solution
Betadine® 5%

Sterile Ophthalmic

Prep Solution

(povidone-iodine ophthalmic solution)

(0.5% available iodine)

DESCRIPTION


Povidone-Iodine is a broad-spectrum microbicide with the chemical formulas:


2-pyrrolidinone, 1- ethenyl-, homopolymer, compound with iodine; 1-vinyl-2-pyrrolidinone polymer, compound with iodine. The structural formula is as follows:



BETADINE® 5% Sterile Ophthalmic Prep Solution contains 5% povidone-iodine (0.5% available iodine) as a sterile dark brown solution stabilized by glycerin. Inactive Ingredients: citric acid, glycerin, nonoxynol-9, sodium chloride, sodium hydroxide, and dibasic sodium phosphate.



CLINICAL PHARMACOLOGY


A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log10 reduction of 3.05 log10 units in total aerobes at 10 minutes following prepping the skin with BETADINE® 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58 log10 units after prepping with vehicle free of the iodine complex. This placebo-controlled study indicates a mean log10 reduction by the iodine complex compared with the control solution of 1.47 log10 units at 10 minutes and 1.79 log10 units at 45 minutes. The base-line mean aerobic bacterial count was 7,586 organisms per square cm.



INDICATIONS AND USAGE


BETADINE® 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).



CONTRAINDICATIONS


Do not use on individuals known to be sensitive to iodine, or other components of this product.



WARNINGS


FOR EXTERNAL USE ONLY. NOT FOR INTRAOCULAR INJECTION OR IRRIGATION.



PRECAUTIONS:



General


No studies are available in patients with thyroid disorders; therefore, caution is advised in using BETADINE® 5% Sterile Ophthalmic Prep Solution in these patients due to the possibility of iodine absorption.



Carcinogenesis, Mutagenesis, Impairment of Fertility


No long term studies in animals have been performed to evaluate the carcinogenic or mutagenic potential of povidone-iodine. One report of the mutagenic potential of povidone-iodine indicated that it was positive in a modification of the Ames S. typhimurium model, but these results could not be reproduced by another researcher. Another test using mouse lymphoma and Balb/3T3 cells showed that povidone-iodine has no significant mutagenic or transformation capabilities. Other data indicated that it does not produce mutagenic effects in mice or hamsters according to the dominant lethal test, micronucleus test, and chromosome analysis.



Pregnancy


Category C: Animal reproduction studies have not been conducted with BETADINE® 5% Sterile Ophthalmic Prep Solution. It is also not known whether BETADINE® 5% Sterile Ophthalmic Prep Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. BETADINE® 5% Sterile Ophthalmic Prep Solution should only be used on a pregnant woman if clearly needed.



Nursing Mothers


Because of the potential for serious adverse reactions in nursing infants from BETADINE® 5% Sterile Ophthalmic Prep Solution, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Safety and effectiveness in pediatric patients have not been established.



Geriatric Use


No overall differences in safety or effectiveness have been observed between elderly and younger patients.



ADVERSE REACTIONS


Local sensitivity has been exhibited by some individuals to povidone-iodine ophthalmic solution.



DOSAGE AND ADMINISTRATION


While the inner surface and contents of the immediate container (i.e. bottle) are sterile, the outer surface of the bottle is not sterile. The use of the bottle in a sterile field should be avoided.


BETADINE® 5% Sterile Ophthalmic Prep Solution is used as


follows:


1. Make sure container is intact before use. To open, COMPLETELY TWIST OFF TAB, do not pull off. Gently squeeze entire contents of bottle into a sterile prep cup.


2. Saturate sterile cotton-tipped applicator to prep lashes and lid margins using one or more applicators per lid; repeat once.


3. Saturate sterile prep sponge or other suitable material to prep lids, brow and cheek in a circular ever-expanding fashion until the entire field is covered; repeat prep three (3) times.


4. While separating the lids, irrigate the cornea, conjunctiva and palpebral fornices with BETADINE® 5% Sterile Ophthalmic Prep Solution using a sterile bulb syringe.


5. After the BETADINE® 5% Sterile Ophthalmic Prep Solution has been left in contact for two minutes, sterile saline solution in a bulb syringe should be used to flush the residual prep solution from the cornea, conjunctiva, and the palpebral fornices.



HOW SUPPLIED


BETADINE® 5% Sterile Ophthalmic Prep Solution is packaged under sterile conditions and supplied in 1 fl.oz. (30 mL) form sealed blue HDPE bottles (NDC #0065 0411 30). Twenty-four (24) bottles are packed in each shipper.


Store at 15-25°C (59-77°F).


Rx Only


Single use only


       


Manufactured for:


Alcon Laboratories, Inc.


Fort Worth, TX 76134


        


Manufactured by:


Catalent Pharma Solutions, LLC


Woodstock, IL 60098


      


BETADINE® is a registered trademark of The Purdue Frederick Company.


       


9002984-1007



Principal Display Panel


NDC 0065 0411 30


Betadine® 5%


Sterile Ophthalmic Prep Solution


(povidone-iodine


ophthalmic solution)


For Pre-Operative Prep and


Irrigation of the Ocular and


Periocular Surfaces


Flush eye thoroughly with


sterile saline solution after


each use.


Rx Only


1 Fl. Oz. (30 mL)


Alcon®











BETADINE 
povidone-iodine  solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0065-0411
Route of AdministrationOPHTHALMICDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE)IODINE5 mg  in 1 mL
















Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
NONOXYNOL-9 
SODIUM CHLORIDE 
SODIUM HYDROXIDE 
SODIUM PHOSPHATE, DIBASIC 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10065-0411-3030 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01863404/01/2000


Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)









Establishment
NameAddressID/FEIOperations
Catalent Pharma Solutions, LLC043911403MANUFACTURE
Revised: 07/2011Alcon Laboratories, Inc.

Wednesday, 2 September 2009

Pulmonary Fibrosis Medications


Definition of Pulmonary Fibrosis: Idiopathic pulmonary fibrosis involves scarring or thickening of tissues deep in the lung without a known cause.

Drugs associated with Pulmonary Fibrosis

The following drugs and medications are in some way related to, or used in the treatment of Pulmonary Fibrosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Pulmonary Fibrosis

  • Idiopathic Pulmonary Fibrosis (1 drug)





Drug List:

Friday, 28 August 2009

Atenolol Stada




Atenolol Stada may be available in the countries listed below.


Ingredient matches for Atenolol Stada



Atenolol

Atenolol is reported as an ingredient of Atenolol Stada in the following countries:


  • Austria

  • Germany

  • Vietnam

International Drug Name Search

Friday, 7 August 2009

Reprostom




Reprostom may be available in the countries listed below.


Ingredient matches for Reprostom



Finasteride

Finasteride is reported as an ingredient of Reprostom in the following countries:


  • Indonesia

International Drug Name Search

Monday, 3 August 2009

Noruxol




Noruxol may be available in the countries listed below.


Ingredient matches for Noruxol



Collagenase

Collagenase is reported as an ingredient of Noruxol in the following countries:


  • Italy

International Drug Name Search

Thursday, 23 July 2009

Min Nuo Bin




Min Nuo Bin may be available in the countries listed below.


Ingredient matches for Min Nuo Bin



Vinorelbine

Vinorelbine tartrate (a derivative of Vinorelbine) is reported as an ingredient of Min Nuo Bin in the following countries:


  • China

International Drug Name Search

Tuesday, 21 July 2009

Aristomol




Aristomol may be available in the countries listed below.


Ingredient matches for Aristomol



Timolol

Timolol maleate (a derivative of Timolol) is reported as an ingredient of Aristomol in the following countries:


  • Bangladesh

International Drug Name Search

Thursday, 9 July 2009

Cefepime Richet




Cefepime Richet may be available in the countries listed below.


Ingredient matches for Cefepime Richet



Cefepime

Cefepime Hydrochloride (a derivative of Cefepime) is reported as an ingredient of Cefepime Richet in the following countries:


  • Argentina

International Drug Name Search

Wednesday, 8 July 2009

Echnatol




Echnatol may be available in the countries listed below.


Ingredient matches for Echnatol



Cyclizine

Cyclizine hydrochloride (a derivative of Cyclizine) is reported as an ingredient of Echnatol in the following countries:


  • Austria

International Drug Name Search

Tuesday, 7 July 2009

Fluprostenol




In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0040666-16-8

Chemical Formula

C23-H29-F3-O6

Molecular Weight

458

Therapeutic Category

Prostaglandin analogue

Chemical Names

(±)-(Z)-7-[(1R*,2R*,3R*,5S*)-3,5-Dihydroxy-2-[(E,3R*)-3-hydroxy-4-[(α,α,α-trifluoro-m-tolyl)oxy]-1-butenyl]cyclopentyl]-5-heptenoic acid (WHO)

(Z)-7-[(1RS,2RS,3RS,5SR)-3,5-Dihydroxy-2-{(E,RS)-3-hydroxy-4-[3-(trifluormethyl)-phenoxy]but-1-en-1-yl}cyclopentyl]hept-5-ensäure (IUPAC)

Foreign Names

  • Fluprostenolum (Latin)
  • Fluprostenol (German)
  • Fluprosténol (French)
  • Fluprostenol (Spanish)

Generic Names

  • Fluprostenol (OS: BAN)
  • Fluprostenol Sodium (OS: BANM, USAN)
  • ICI 81008 (IS)

Brand Name

  • Equimate (veterinary use)
    Bayer Healthcare LLC, United States

International Drug Name Search

Glossary

BANBritish Approved Name
BANMBritish Approved Name (Modified)
IUPACInternational Union of Pure and Applied Chemistry
ISInofficial Synonym
OSOfficial Synonym
Rec.INNRecommended International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name
WHOWorld Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Friday, 3 July 2009

Cimal




Cimal may be available in the countries listed below.


Ingredient matches for Cimal



Citalopram

Citalopram is reported as an ingredient of Cimal in the following countries:


  • Ecuador

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Cimal in the following countries:


  • Chile

International Drug Name Search

Sulpiride G Gam




Sulpiride G Gam may be available in the countries listed below.


Ingredient matches for Sulpiride G Gam



Sulpiride

Sulpiride is reported as an ingredient of Sulpiride G Gam in the following countries:


  • France

International Drug Name Search

Wednesday, 24 June 2009

Ultramidol




Ultramidol may be available in the countries listed below.


Ingredient matches for Ultramidol



Bromazepam

Bromazepam is reported as an ingredient of Ultramidol in the following countries:


  • Portugal

International Drug Name Search

Sunday, 21 June 2009

Vérapamil




Vérapamil may be available in the countries listed below.


Ingredient matches for Vérapamil



Verapamil

Vérapamil (DCF) is known as Verapamil in the US.

International Drug Name Search

Glossary

DCFDénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Saturday, 20 June 2009

Selan




Selan may be available in the countries listed below.


Ingredient matches for Selan



Cefuroxime

Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Selan in the following countries:


  • Spain

International Drug Name Search

Thursday, 11 June 2009

Hidroclorotiazida Lch




Hidroclorotiazida Lch may be available in the countries listed below.


Ingredient matches for Hidroclorotiazida Lch



Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Hidroclorotiazida Lch in the following countries:


  • Chile

International Drug Name Search