Ibuprofeno L.CH.

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Ibuprofen

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Orapred

prednisolone sodium phosphate

Dosage Form: oral solution
Orapred®

(prednisolone sodium phosphate oral solution)

Rx only

Orapred Description

Orapred Solution is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of Orapred contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base) in a palatable, aqueous vehicle.

Inactive Ingredients: Orapred Solution equivalent to 15 mg prednisolone per 5 mL contains the following inactive ingredients: alcohol 2%, fructose, glycerin, monoammonium glycyrrhizinate, povidone, sodium benzoate, sorbitol, and flavor. Orapred may contain citric acid and/or sodium hydroxide for pH adjustment.

Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is pregna-1, 4-diene-3,20-dione, 11, 17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11β)-. The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its chemical structure is:

Pharmacological Category: Glucocorticoid

Orapred - Clinical Pharmacology

Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Prednisolone is a synthetic adrenocortical steroid drug with predominantly glucocorticoid properties. Some of these properties reproduce the physiological actions of endogenous glucocorticosteroids, but others do not necessarily reflect any of the adrenal hormones' normal functions; they are seen only after administration of large therapeutic doses of the drug. The pharmacological effects of prednisolone which are due to its glucocorticoid properties include: promotion of gluconeogenesis; increased deposition of glycogen in the liver; inhibition of the utilization of glucose; anti-insulin activity; increased catabolism of protein; increased lipolysis; stimulation of fat synthesis and storage; increased glomerular filtration rate and resulting increase in urinary excretion of urate (creatinine excretion remains unchanged); and increased calcium excretion.

Depressed production of eosinophils and lymphocytes occurs, but erythropoiesis and production of polymorphonuclear leukocytes are stimulated. Inflammatory processes (edema, fibrin deposition, capillary dilatation, migration of leukocytes and phagocytosis) and the later stages of wound healing (capillary proliferation, deposition of collagen, cicatrization) are inhibited.

Prednisolone can stimulate secretion of various components of gastric juice. Suppression of the production of corticotropin may lead to suppression of endogenous corticosteroids. Prednisolone has slight mineralocorticoid activity, whereby entry of sodium into cells and loss of intracellular potassium is stimulated. This is particularly evident in the kidney, where rapid ion exchange leads to sodium retention and hypertension.

Prednisolone is rapidly and well absorbed from the gastrointestinal tract following oral administration. Orapred Solution produces a 14% higher peak plasma level of prednisolone which occurs 20% faster than that seen with tablets. Prednisolone is 70-90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine as sulfate and glucuronide conjugates.

The systemic availability, metabolism and elimination of prednisolone after administration of single weight-based doses (0.8 mg/kg) of intravenous (IV) prednisolone and oral prednisone were reported in a small study of 19 young (23 to 34 years) and 12 elderly (65 to 89 years) subjects. Results showed that the systemic availability of total and unbound prednisolone, as well as interconversion between prednisolone and prednisone were independent of age. The mean unbound fraction of predisolone was higher, and the steady-state volume of distribution (Vss) of unbound prednisolone was reduced in elderly patients. Plasma prednisolone concentrations were higher in elderly subjects, and the higher AUCs of total and unbound prednisolone were most likely reflective of an impaired metabolic clearance, evidenced by reduced fractional urinary clearance of 6β-hydroxyprednisolone. Despite these findings of higher total and unbound prednisolone concentrations, elderly subjects had higher AUCs of cortisol, suggesting that the elderly population is less sensitive to suppression of endogenous cortisol or their capacity for hepatic inactivation of cortisol is diminished.

Indications and Usage for Orapred

Orapred Solution is indicated in the following conditions:

1. Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.

2. Dermatologic Diseases

Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides.

3. Edematous States

To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia.

4. Endocrine Disorders

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis.

5. Gastrointestinal Diseases

To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis.

6. Hematologic Disorders

Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia.

7. Neoplastic Diseases

For the treatment of acute leukemia and aggressive lymphomas in adults and children.

8. Nervous System

Acute exacerbations of multiple sclerosis.

9. Ophthalmic Diseases

Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia.

10. Respiratory Diseases

Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under "Allergic States"), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia.

11. Rheumatic Disorders

As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren's syndrome, relapsing polychondritis, and certain cases of vasculitis.

12. Miscellaneous

Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); Trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).

Contraindications

Systemic fungal infections.

Hypersensitivity to the drug or any of its components.

Warnings

General

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated.

Cardio-renal

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Endocrine

Corticosteroids can produce reversible hypothalamicpituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.

Infections (General)

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen including viral, bacterial, fungal, protozoan or helminthic infection, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect humoral or cellular immunity, or neutrophil function. These infections may be mild to severe, and, with increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of infection after it has already started.

Infections (Viral)

Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents should be considered.

Ophthalmic

Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex.

Special pathogens

Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Candida, Mycobacterium, Ameba, Toxoplasma, Pneumocystis, Cryptococcus, Nocardia, etc.

Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.

Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Corticosteroids should not be used in cerebral malaria.

Tuberculosis

The use of prednisolone in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy these patients should receive chemoprophylaxis.

Vaccination

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered, however, the response to such vaccines can not be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.

Precautions

General

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis.

Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Cardio-renal

As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with hypertension, congestive heart failure, or renal insufficiency.

Endocrine

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

Gastrointestinal

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection: diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer.

Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.

Musculoskeletal

Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (i.e., postmenopausal women) before initiating corticosteroid therapy.

Neuro-psychiatric

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)

An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Ophthalmic

Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Information For Patients

Patients should be warned not to discontinue the use of Orapred abruptly or without medical supervision, to advise any medical attendants that they are taking it and to seek medical advice at once should they develop fever or other signs of infection.

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Drug Interactions

Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of Orapred be increased.

Increased activity of both cyclosporin and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

Estrogens may decrease the hepatic metabolism of certain corticosteroids thereby increasing their effect.

Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to an increased risk of corticosteroid side effects.

Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

Concomitant use of aspirin (or other non-steroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.

When corticosteroids are administered concomitantly with potassium-depleting agents (i.e., diuretics, amphotericin-B), patients should be observed closely for development of hypokalemia. Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.

Due to inhibition of antibody response, patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. If possible, routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued.

Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

Corticosteroids may suppress reactions to skin tests.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Prednisolone has been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which prednisolone has been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well controlled studies in pregnant women. Orapred should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Orapred is administered to a nursing woman.

Pediatric Use

The efficacy and safety of prednisolone in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age). However, some of these conclusions and other indications for pediatric use of corticosteroid, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

The adverse effects of prednisolone in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Children who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in children than some commonly used tests of HPA axis function. The linear growth of children treated with corticosteroids by any route should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of other treatment alternatives. In order to minimize the potential growth effects of corticosteroids, children should be titrated to the lowest effective dose.

Geriatric Use

Clinical studies of prednisolone sodium phosphate oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with prednisolone sodium phosphate has not identified differences in responses between the elderly and younger patients. However, the incidence of corticosteroid-induced side effects may be increased in geriatric patients and appear to be dose-related. Osteoporosis is the most frequently encountered complication, which occurs at a higher incidence rate in corticosteroid-treated geriatric patients as compared to younger populations and in age-matched controls. Losses of bone mineral density appear to be greatest early on in the course of treatment and may recover over time after steroid withdrawal or use of lower doses (i.e., ≤5 mg/day). Prednisolone doses of 7.5 mg/day or higher have been associated with an increased relative risk of both vertebral and nonvertebral fractures, even in the presence of higher bone density compared to patients with involutional osteoporosis.

Routine screening of geriatric patients, including regular assessments of bone mineral density and institution of fracture prevention strategies, along with regular review of Orapred indication should be undertaken to minimize complications and keep the Orapred dose at the lowest acceptable level. Co-administration of bisphosphonates has been shown to retard the rate of bone loss in corticosteroid-treated males and postmenopausal females, and these agents are recommended in the prevention and treatment of corticosteroid-induced osteoporosis.

It has been reported that equivalent weight-based doses yield higher total and unbound prednisolone plasma concentrations and reduced renal and non-renal clearance in elderly patients compared to younger populations. However, it is not clear whether dosing reductions would be necessary in elderly patients, since these pharmacokinetic alterations may be offset by age-related differences in responsiveness of target organs and/or less pronounced suppression of adrenal release of cortisol. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, 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 in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY).

Adverse Reactions

(listed alphabetically under each subsection):

Cardiovascular: Hypertrophic cardiomyopathy in premature infants.

Dermatologic: Facial erythema; increased sweating; impaired wound healing; may suppress reactions to skin tests; petechiae and ecchymoses; thin fragile skin; urticaria; edema.

Endocrine: Decreased carbohydrate tolerance; development of cushingoid state; hirsutism; increased requirements for insulin or oral hypoglycemic agents in diabetic patients; manifestations of latent diabetes mellitus; menstrual irregularities; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; suppression of growth in children.

Fluid and Electrolyte Disturbances: Congestive heart failure in susceptible patients; fluid retention; hypertension; hypokalemic alkalosis; potassium loss; sodium retention.

Gastrointestinal: Abdominal distention; elevation in serum liver enzyme levels (usually reversible upon discontinuation); pancreatitis; peptic ulcer with possible perforation and hemorrhage; ulcerative esophagitis.

Metabolic: Negative nitrogen balance due to protein catabolism.

Musculoskeletal: Aseptic necrosis of femoral and humeral heads; loss of muscle mass; muscle weakness; osteoporosis; pathologic fracture of long bones; steroid myopathy; tendon rupture; vertebral compression fractures.

Neurological: Convulsions; headache; increased intracranial pressure with papilledema (pseudotumor cerebri), usually following discontinuation of treatment; psychic disorders; vertigo.

Ophthalmic: Exophthalmos; glaucoma; increased intraocular pressure; posterior subcapsular cataracts.

Other: Increased appetite; malaise; nausea; weight gain.

Overdosage

The effects of accidental ingestion of large quantities of prednisolone over a very short period of time have not been reported, but prolonged use of the drug can produce mental symptoms, moon face, abnormal fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency. Hepatomegaly and abdominal distention have been observed in children.

Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy the dosage of prednisolone may be reduced only temporarily, or alternate day treatment may be introduced.

Orapred Dosage and Administration

The initial dose of Orapred may vary from 1.67 mL to 20 mL (5 to 60 mg prednisolone base) per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time, there is a lack of satisfactory clinical response, Orapred should be discontinued and the patient placed on other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Orapred for a period of time consistent with the patient's condition. If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for one month have been shown to be effective.

In pediatric patients, the initial dose of Orapred may vary depending on the specific disease entity being treated. The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m2bsa/day).

The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m2/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m2/day.

The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses. It is further recommended that short course, or "burst" therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

For the purpose of comparison, 5 mL of Orapred (20.2 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids:

Cortisone, 75	Triamcinolone, 12
Hydrocortisone, 60	Paramethasone, 6
Prednisolone, 15	Betamethasone, 2.25
Prednisone, 15	Dexamethasone, 2.25
Methylprednisolone, 12

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

How is Orapred Supplied

Each 5 mL (teaspoonful) of grape flavored solution contains 20.2 mg prednisolone sodium phosphate (15 mg prednisolone base).

Available as:

NDC 59630-710-08 8 fl oz (237 mL) bottle

NDC 59630-710-10 10 pk of 2/3 fl oz (20 mL) bottles - Institutional Pack

Dispense in tight, light-resistant glass or PET plastic containers as defined in USP.

Store refrigerated, 2-8°C (36-46°F)

Keep tightly closed and out of the reach of children.

Rx only

ORS-PI-02 Rev. 05/09

Manufactured for Sciele Pharma, Inc.

Atlanta, GA 30328

by Lyne Laboratories, Inc., Brockton, MA 02301

To report SUSPECTED ADVERSE EVENTS,

contact Sciele Pharma, Inc. at

1-800-849-9707 ext. 1454 or FDA at 1-800-

FDA-1088 or www.fda.gov/medwatch.

Sciele™

Pharma, Inc.

A SHIONOGI COMPANY

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Label

NDC 59630-710-10

Equivalent to prednisolone

15 mg/5 mL

Orapred®

(prednisolone sodium phosphate

oral solution)

Rx only

For Institutional Use Only

Store refrigerated, 2-8°C (36-46°F)

20 mL (2/3 fl oz)

ORS-IL-02

Rev. 05/09

Orapred  prednisolone sodium phosphate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 59630-710 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE) PREDNISOLONE SODIUM PHOSPHATE 15 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL   FRUCTOSE   POVIDONE   SODIUM BENZOATE   SORBITOL   CITRIC ACID MONOHYDRATE   SODIUM HYDROXIDE

Product Characteristics Color YELLOW (pale yellow) Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 59630-710-10 10 BOTTLE In 1 TRAY contains a BOTTLE, GLASS 1 20 mL In 1 BOTTLE, GLASS This package is contained within the TRAY (59630-710-10) 2 59630-710-08 237 mL In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075117	12/14/2000

Labeler - Shionogi Pharma, Inc. (802728477)

Revised: 02/2010Shionogi Pharma, Inc.

More Orapred resources

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

• Orapred Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Orapred Consumer Overview


• Orapred Advanced Consumer (Micromedex) - Includes Dosage Information


• Flo-Pred Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Flo-Pred Consumer Overview


• Millipred DP MedFacts Consumer Leaflet (Wolters Kluwer)


• Orapred ODT MedFacts Consumer Leaflet (Wolters Kluwer)


• PediaPred Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Prednisolone Professional Patient Advice (Wolters Kluwer)


• Prednisolone Monograph (AHFS DI)


• Prednisolone MedFacts Consumer Leaflet (Wolters Kluwer)


• Prednisolone Acetate eent Monograph (AHFS DI)


• Prelone Syrup MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Orapred with other medications

• Asthma, acute
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• Inflammatory Conditions
• Multiple Sclerosis
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• Pemphigoid
• Pemphigus

Gazix

Gazix may be available in the countries listed below.

Ingredient matches for Gazix

Dimeticone

Dimeticone is reported as an ingredient of Gazix in the following countries:

• Oman

International Drug Name Search

Tampyrine

Tampyrine may be available in the countries listed below.

Ingredient matches for Tampyrine

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Tampyrine in the following countries:

• Luxembourg

International Drug Name Search

Gingicain D

Gingicain D may be available in the countries listed below.

Ingredient matches for Gingicain D

Benzalkonium Chloride

Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Gingicain D in the following countries:

• Germany

Tetracaine

Tetracaine is reported as an ingredient of Gingicain D in the following countries:

• Germany

International Drug Name Search

Zesun

Zesun may be available in the countries listed below.

Ingredient matches for Zesun

Timepidium Bromide

Timepidium Bromide is reported as an ingredient of Zesun in the following countries:

• Japan

International Drug Name Search

Bricanyl SA

Bricanyl SA may be available in the countries listed below.

Ingredient matches for Bricanyl SA

Terbutaline

Terbutaline sulfate (a derivative of Terbutaline) is reported as an ingredient of Bricanyl SA in the following countries:

• Ireland

International Drug Name Search

Tensapril

Tensapril may be available in the countries listed below.

Ingredient matches for Tensapril

Enalapril

Enalapril is reported as an ingredient of Tensapril in the following countries:

• Romania

International Drug Name Search

Anopyrin

Anopyrin may be available in the countries listed below.

Ingredient matches for Anopyrin

Aspirin

Acetylsalicylic Acid is reported as an ingredient of Anopyrin in the following countries:

• Bulgaria


• Czech Republic


• Slovakia

International Drug Name Search

Amantadin-Serag

Amantadin-Serag may be available in the countries listed below.

Ingredient matches for Amantadin-Serag

Amantadine

Amantadine sulfate (a derivative of Amantadine) is reported as an ingredient of Amantadin-Serag in the following countries:

• Germany

International Drug Name Search

Lopraxer

Lopraxer may be available in the countries listed below.

Ingredient matches for Lopraxer

Citalopram

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

• Greece

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

• Greece

International Drug Name Search

BetaTan Suspension

Pronunciation: BROME-fen-IR-a-meen/KAR-bay-ta-PEN-tane/FEN-il-EF-rin
Generic Name: Brompheniramine/Carbetapentane/Phenylephrine
Brand Name: Examples include V-Cof and Vazotan

BetaTan Suspension is used for:

Relieving symptoms of sinus congestion, pressure, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

BetaTan Suspension is an antihistamine, decongestant, and cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use BetaTan Suspension if:

• you are allergic to any ingredient in BetaTan Suspension


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using BetaTan Suspension:

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

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


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


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


• if you have a fast, slow, or irregular heartbeat


• if you have a history of asthma; lung problems (eg, emphysema); adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; phenylketonuria; or an overactive thyroid


• if you are very drowsy, sedated, or are confined to a bed or chair

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of BetaTan Suspension's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by BetaTan Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by BetaTan Suspension

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

How to use BetaTan Suspension:

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

• Take BetaTan Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


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

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

Important safety information:

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


• Do not drink alcohol while you are using BetaTan Suspension.


• Do not take diet or appetite control medicines while you use BetaTan Suspension unless your doctor tells you to.


• BetaTan Suspension has brompheniramine and phenylephrine in it. Before you start any new medicine, check the label to see if it has brompheniramine and phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or take BetaTan Suspension for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.


• BetaTan Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to BetaTan Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• BetaTan Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking BetaTan Suspension for a few days before the tests.


• Tell your doctor or dentist that you take BetaTan Suspension before you receive any medical or dental care, emergency care, or surgery.


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


• Caution is advised when using BetaTan Suspension in CHILDREN; they may be more sensitive to its effects.


• BetaTan Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using BetaTan Suspension while you are pregnant. It is not known if BetaTan Suspension is found in breast milk. Do not breast-feed while taking BetaTan Suspension.

Possible side effects of BetaTan Suspension:

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

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

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

See also: BetaTan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of BetaTan Suspension:

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

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More BetaTan resources

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

Compare BetaTan with other medications

• Cold Symptoms
• Cough and Nasal Congestion
• Hay Fever

Elizyme

Elizyme may be available in the countries listed below.

Ingredient matches for Elizyme

Lysozyme

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

• Japan

International Drug Name Search

Hepavital

Hepavital may be available in the countries listed below.

Ingredient matches for Hepavital

Silibinin

Silibinin is reported as an ingredient of Hepavital in the following countries:

• Dominican Republic

International Drug Name Search

Sulphadiazine

Sulphadiazine may be available in the countries listed below.

Ingredient matches for Sulphadiazine

Sulfadiazine

Sulfadiazine is reported as an ingredient of Sulphadiazine in the following countries:

• Australia

International Drug Name Search

Kefol

Kefol may be available in the countries listed below.

Ingredient matches for Kefol

Cefazolin

Cefazolin sodium salt (a derivative of Cefazolin) is reported as an ingredient of Kefol in the following countries:

• Spain

International Drug Name Search

Tilosina

Tilosina may be available in the countries listed below.

Ingredient matches for Tilosina

Tylosin

Tilosina (DCIT) is also known as Tylosin (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Glemaz

Glemaz may be available in the countries listed below.

Ingredient matches for Glemaz

Glimepiride

Glimepiride is reported as an ingredient of Glemaz in the following countries:

• Argentina


• Chile


• Peru


• Russian Federation

International Drug Name Search

Lansoprazol Focus

Lansoprazol Focus may be available in the countries listed below.

Ingredient matches for Lansoprazol Focus

Lansoprazole

Lansoprazole is reported as an ingredient of Lansoprazol Focus in the following countries:

• Netherlands

International Drug Name Search

Dolomax

Dolomax may be available in the countries listed below.

Ingredient matches for Dolomax

Ibuprofen

Ibuprofen is reported as an ingredient of Dolomax in the following countries:

• Peru

Ketoprofen

Ketoprofen is reported as an ingredient of Dolomax in the following countries:

• Colombia


• Venezuela

International Drug Name Search

Aratan

Aratan may be available in the countries listed below.

Ingredient matches for Aratan

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Aratan in the following countries:

• Chile


• Peru

International Drug Name Search

Bearberry

Pronunciation: Not applicable.
Generic Name: Bearberry
Brand Name: Generics only. No brands available.

Bearberry is used for:

Aiding in urination and preventing the growth of bacteria in the urinary tract.It has also been used in women as a menstrual remedy. It may also be used as an astringent and may have other uses. Check with your pharmacist for more details regarding the particular brand you use.

Bearberry is an herbal product. It works by killing bacteria in the urinary tract.

Do NOT use Bearberry if:

• you are allergic to any ingredient in Bearberry


• you have stomach irritation or kidney disease


• you are pregnant or breast-feeding

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

Before using Bearberry:

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

• if you are planning to become pregnant


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


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

Some MEDICINES MAY INTERACT with Bearberry. However, no specific interactions are known at this time.

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

How to use Bearberry:

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

• Dosing depends on the use and the source of the product.


• Use as directed on the package, unless instructed otherwise by your doctor.


• If you miss taking a dose of Bearberry for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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

Important safety information:

• Your urine may turn a greenish color while you are taking bearberry. This is normal and should not be cause for alarm. If your doctor orders a urine sample while you are taking bearberry, be sure to tell your doctor and the lab technicians why your urine may be green.


• Check with your doctor before you begin taking any new medicine, either prescription or over-the-counter, including vitamin C (ascorbic acid).


• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.


• Use Bearberry with caution in CHILDREN.


• PREGNANCY and BREAST-FEEDING: Do not use this product if you are pregnant. Do not breast-feed while you are taking this product.

Possible side effects of Bearberry:

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

Green urine; nausea; stomach discomfort.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; irregular heartbeat; muscle cramps; ringing in the ears; seizures; slightly bluish, grayish, slate-like, or dark purple discoloration of the skin; vomiting.

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

See also: Bearberry side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include loss of consciousness; ringing in the ears; seizures; vomiting.

Proper storage of Bearberry:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Bearberry out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Bearberry resources

• Bearberry Side Effects (in more detail)
• Bearberry Support Group
• 0 Reviews · Be the first to review/rate this drug

Tetralan

Tetralan may be available in the countries listed below.

Ingredient matches for Tetralan

Tetracycline

Tetracycline is reported as an ingredient of Tetralan in the following countries:

• Peru

International Drug Name Search

Metopirone

In the US, Metopirone (metyrapone systemic) is a member of the following drug classes: adrenal corticosteroid inhibitors, in vivo diagnostic biologicals.

US matches:

• Metopirone

UK matches:

• Metopirone Capsules 250 mg (SPC)

Ingredient matches for Metopirone

Metyrapone

Metyrapone is reported as an ingredient of Metopirone in the following countries:

• Australia


• Greece


• Ireland


• Israel


• New Zealand


• United Kingdom


• United States

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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

Courage

Courage may be available in the countries listed below.

Ingredient matches for Courage

Fluoxetine

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

• Indonesia

International Drug Name Search

Verin

Verin may be available in the countries listed below.

Ingredient matches for Verin

Tipepidine

Tipepidine hibenzate (a derivative of Tipepidine) is reported as an ingredient of Verin in the following countries:

• Taiwan

International Drug Name Search

Amlodowin

Amlodowin may be available in the countries listed below.

Ingredient matches for Amlodowin

Amlodipine

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

• Hungary

International Drug Name Search

Gusperimus Hydrochloride

Gusperimus Hydrochloride may be available in the countries listed below.

Ingredient matches for Gusperimus Hydrochloride

Gusperimus

Gusperimus Hydrochloride (JAN) is also known as Gusperimus (Rec.INN)

International Drug Name Search

Glossary

JAN	Japanese Accepted Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Corvasal intracoronaire

Corvasal intracoronaire may be available in the countries listed below.

Ingredient matches for Corvasal intracoronaire

Linsidomine

Linsidomine hydrochloride (a derivative of Linsidomine) is reported as an ingredient of Corvasal intracoronaire in the following countries:

• France

International Drug Name Search

Gino-Lotremine

Gino-Lotremine may be available in the countries listed below.

Ingredient matches for Gino-Lotremine

Clotrimazole

Clotrimazole is reported as an ingredient of Gino-Lotremine in the following countries:

• Portugal

International Drug Name Search

Banex

Generic Name: guaifenesin/phenylephrine/phenylpropanolamine (gwye FEN e sin/fen ill EFF rin/fen ill proe pa NOLE a meen)

Brand Names: Ami-Tex, Banex, Dura-Gest, Duratex, Enomine, Entex, Fentex, Guaifenex, Phenylfenesin, Quintex

What is Banex (guaifenesin/phenylephrine/phenylpropanolamine)?

Guaifenesin is an expectorant. It is used to break up congestion and mucous to ease breathing. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose, and throat), and increases the removal of mucous.

Phenylpropanolamine and phenylephrine are decongestants. They constrict (shrink) blood vessels (veins and arteries), which reduces the swelling of mucous membranes in areas such as the nose and sinuses.

Guaifenesin/phenylephrine/phenylpropanolamine is used to treat the symptoms of the common cold and of infections of your sinuses, your lungs, and your throat.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Guaifenesin/phenylephrine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Banex (guaifenesin/phenylephrine/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Drink plenty of extra fluids while taking this medication. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

Who should not take Banex (guaifenesin/phenylephrine/phenylpropanolamine)?

Do not take guaifenesin/phenylephrine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  high blood pressure or any other type of heart disease,

  
  


• 
  

  diabetes,

  
  


• 
  

  a peripheral vascular disorder (poor circulation),

  
  


• 
  

  glaucoma or increased pressure in the eyes,

  
  


• 
  

  an overactive thyroid, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

You may not be able to take guaifenesin/phenylephrine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Guaifenesin/phenylephrine/phenylpropanolamine is in the FDA pregnancy category C. This means that it is not known whether guaifenesin/phenylephrine/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Guaifenesin/phenylephrine/phenylpropanolamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from guaifenesin/phenylephrine/phenylpropanolamine. You may require a lower dose of this medication. Guaifenesin/phenylephrine/phenylpropanolamine has not been approved for use by children younger than 6 years of age.

How should I take Banex (guaifenesin/phenylephrine/phenylpropanolamine)?

Take guaifenesin/phenylephrine/phenylpropanolamine 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 guaifenesin/phenylephrine/phenylpropanolamine with food if stomach upset occurs. Do not crush or chew the tablets. Swallow them whole or break them in half where they are scored to make them easier to swallow if needed.

To ensure that you get a correct dose, measure the liquid form of guaifenesin/phenylephrine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Store guaifenesin/phenylephrine/phenylpropanolamine 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 the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a guaifenesin/phenylephrine/phenylpropanolamine overdose include vomiting, high blood pressure (headache, red face, blurred vision), an irregular heartbeat, and numbness of the fingers or toes.

What should I avoid while taking Banex (guaifenesin/phenylephrine/phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Guaifenesin/phenylephrine/phenylpropanolamine may cause dizziness. If you experience dizziness, avoid these activities.

Banex (guaifenesin/phenylephrine/phenylpropanolamine) side effects

No serious side effects from guaifenesin/phenylephrine/phenylpropanolamine are expected. Stop taking guaifenesin/phenylephrine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

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

• 
  

  dizziness or headache;

  
  


• 
  

  nervousness, restlessness, or insomnia;

  
  


• 
  

  nausea or stomach upset; or

  
  


• 
  

  difficulty urinating.

  
  

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.

What other drugs will affect Banex (guaifenesin/phenylephrine/phenylpropanolamine)?

Do not take guaifenesin/phenylephrine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Heart medications such as methyldopa (Aldomet), reserpine (Serpalan, Serpasil), and guanethidine (Ismelin) may have decreased effects. Talk to your doctor before taking guaifenesin/phenylephrine/phenylpropanolamine.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking guaifenesin/phenylephrine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain guaifenesin, phenylephrine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with guaifenesin/phenylephrine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

More Banex resources

• Banex Drug Interactions
• Banex Support Group
• 0 Reviews for Banex - Add your own review/rating

• Entacapone Monograph (AHFS DI)


• Guaifenex Consumer Overview

Compare Banex with other medications

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• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist has additional information about guaifenesin/phenylephrine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Guaifenesin/phenylephrine/phenylpropanolamine is available with a prescription under the brand names Entex and Dura-Gest. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

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  Entex, 200 mg of guaifenesin, 5 mg of phenylephrine, and 45 mg of phenylpropanolamine--orange/white capsules

  
  


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  Entex Liquid, 100 mg of guaifenesin, 5 mg of phenylephrine, and 20 mg of phenylpropanolamine with 5% alcohol per 5 mL (1 teaspoon)-- orange-colored liquid

  
  


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  Dura-Gest, 200 mg of guaifenesin, 5 mg of phenylephrine, and 45 mg of phenylpropanolamine--gray/white capsules