Pexol

Pexol may be available in the countries listed below.

Ingredient matches for Pexol

Pentoxifylline

Pentoxifylline is reported as an ingredient of Pexol in the following countries:

• Peru

International Drug Name Search

Poloxalene

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

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0009003-11-6

Therapeutic Category

Laxative

Chemical Name

Oxirane, methyl-, polymer with oxirane, block

Foreign Names

• Poloxalenum (Latin)
• Poloxalen (German)
• Poloxalène (French)
• Poloxaleno (Spanish)

Generic Names

• Poloxalene (OS: USAN, BAN)
• SKF 18 667 (IS)
• Poloxalene (PH: USP 32)

Brand Names

• Bloat Guard (veterinary use)
  Agrimin, United Kingdom; Pfizer Animal Health, United States; Phibro Animal Health, United States



• Easylix Bloat Guard (veterinary use)
  Ridley, United States



• Purina (veterinary use)
  Virbac, United States



• Therabloat (veterinary use)
  Pfizer Animal Health, United States

International Drug Name Search

Glossary

BAN	British Approved Name
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Baycadron

dexamethasone

Dosage Form: elixir
Baycadron™ ELIXIR

(Dexamethasone Elixir, USP

0.5 mg/5 mL)

Baycadron Description

Each 5 mL (teaspoonful) contains:

Dexamethasone, USP……….……….…………………………. 0.5 mg

Also contains:

Benzoic Acid, USP……………………………………………….. 0.1%

  (as preservative)

Alcohol……………………………………………………………. 5.1%

Inactive Ingredients: Artificial Raspberry Flavor; Citric Acid, USP; FD&C Red No. 40; Liquid Sugar; Propylene Glycol, USP and Purified Water, USP. It may also contain Sodium Citrate, USP.

Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.

Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water. The molecular weight is 392.47. It is designated chemically as 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. The molecular formula is C22H29FO5 and the structural formula is:

Baycadron - Clinical Pharmacology

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

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

Indications and Usage for Baycadron

1. 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

 

Nonsuppurative thyroiditis

 

Hypercalcemia associated with cancer

2. 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

 

Post-traumatic osteoarthritis

 

Synovitis of osteoarthritis

 

Epicondylitis

3. Collagen Diseases

During an exacerbation or as maintenance therapy in selected cases of:

 

Systemic lupus erythematosus

 

Acute rheumatic carditis

4. Dermatologic Diseases

 

Pemphigus

 

Bullous dermatitis herpetiformis

 

Severe erythema multiforme (Stevens-Johnson syndrome)

 

Exfoliative dermatitis

 

Mycosis fungoides

 

Severe psoriasis

 

Severe seborrheic dermatitis

5. Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

 

Seasonal or perennial allergic rhinitis

 

Bronchial asthma

 

Contact dermatitis

 

Atopic dermatitis

 

Serum sickness

 

Drug hypersensitivity reactions

6. Ophthalmic Diseases

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as:

 

Allergic conjunctivitis

 

Keratitis

 

Allergic corneal marginal ulcers

 

Herpes zoster ophthalmicus

 

Iritis and iridocyclitis

 

Chorioretinitis

 

Anterior segment inflammation

 

Diffuse posterior uveitis and choroiditis

 

Optic neuritis

 

Sympathetic ophthalmia

7. Respiratory Diseases

 

Symptomatic sarcoidosis

 

Loeffler's syndrome not manageable by other means

 

Berylliosis

 

Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

 

Aspiration pneumonitis

8. Hematologic Disorders

 

Idiopathic thrombocytopenic purpura in adults

 

Secondary thrombocytopenia in adults

 

Acquired (autoimmune) hemolytic anemia

 

Erythroblastopenia (RBC anemia)

 

Congenital (erythroid) hypoplastic anemia

9. Neoplastic Diseases

For palliative management of:

 

Leukemia and lymphomas in adults

 

Acute leukemia of childhood

10. Edematous States

To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus

11. Gastrointestinal Diseases

To tide the patient over a critical period of the disease in:

 

Ulcerative colitis

 

Regional enteritis

12. Miscellaneous

 

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy

 

Trichinosis with neurologic or myocardial involvement

13. Diagnostic testing of adrenocortical hyperfunction

Contraindications

 

Systemic fungal infections

 

Hypersensitivity to this product

Warnings

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

Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and 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. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false-negative results.

In cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding.

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 any patient with unexplained diarrhea.

Prolonged 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 fungi or viruses.

Usage in Pregnancy

Since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. Mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

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.

Administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. If inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have 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 affects 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 chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

The use of Baycadron™ Elixir 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.

Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Precautions

Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.

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

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

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.

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.

Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

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, renal insufficiency, hypertension, osteoporosis and myasthenia gravis. Fat embolism has been reported as a possible complication of hypercortisonism.

When large doses are given, some authorities advise that corticosteroids be taken with meals and antacids taken between meals to help to prevent peptic ulcer.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Steroids may increase or decrease motility and number of spermatozoa in some patients.

Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage. These interactions may interfere with dexamethasone suppression tests which should be interpreted with caution during administration of these drugs.

False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.

The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies.

When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.

Information for Patients

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.

Adverse Reactions

Fluid and Electrolyte Disturbances:

 

Sodium retention

 

Fluid retention

 

Congestive heart failure in susceptible patients

 

Potassium loss

 

Hypokalemic alkalosis

 

Hypertension

Musculoskeletal:

 

Muscle weakness

 

Steroid myopathy

 

Loss of muscle mass

 

Osteoporosis

 

Vertebral compression fractures

 

Aseptic necrosis of femoral and humeral heads

 

Pathologic fracture of long bones

 

Tendon rupture

Gastrointestinal:

 

Peptic ulcer with possible perforation and hemorrhage

 

Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease

 

Pancreatitis

 

Abdominal distention

 

Ulcerative esophagitis

Dermatologic:

 

Impaired wound healing

 

Thin fragile skin

 

Petechiae and ecchymoses

 

Erythema

 

Increased sweating

 

May suppress reactions to skin tests

 

Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema

Neurologic:

 

Convulsions

 

Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment

 

Vertigo

 

Headache

 

Psychic Disturbances

Endocrine:

 

Menstrual irregularities

 

Development of cushingoid state

 

Suppression of growth in children

 

Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness

 

Decreased carbohydrate tolerance

 

Manifestations of latent diabetes mellitus

 

Increased requirements for insulin or oral hypoglycemic agents in diabetes

 

Hirsutism

Ophthalmic:

 

Posterior subcapsular cataracts

 

Increased intraocular pressure

 

Glaucoma

 

Exophthalmos

Metabolic:

 

Negative nitrogen balance due to protein catabolism

Cardiovascular:

 

Myocardial rupture following recent myocardial infarction (See WARNINGS)

Other:

 

Hypersensitivity

 

Thromboembolism

 

Weight gain

 

Increased appetite

 

Nausea

 

Malaise

 

Hiccups

Overdosage

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.

The oral LD50 of dexamethasone in female mice was 6.5 g/kg.

Baycadron Dosage and Administration

For oral administration

DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.

The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.75 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient's response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue Baycadron™ Elixir and transfer the patient to other therapy.

After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.

Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily.

If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually.

The following milligram equivalents facilitate changing to Baycadron™ Elixir from other glucocorticoids:

Baycadron™ ELIXIR	METHYLPREDNISOLONE AND TRIAMCINOLONE	PREDNISOLONE AND PREDNISONE	HYDROCORTISONE	CORTISONE
0.75 mg =	4 mg =	5 mg =	20 mg =	25 mg

Dexamethasone suppression tests

1. Tests for Cushing's syndrome.
   
   Give 1 mg of Dexamethasone orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning.
   
   For greater accuracy, give 0.5 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.


2. Test to distinguish Cushing's syndrome due to pituitary ACTH excess from Cushing's syndrome due to other causes.
   
   Give 2 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

How is Baycadron Supplied

Baycadron™ Elixir (Dexamethasone Elixir, USP 0.5 mg/5 mL) is supplied as a clear, red, raspberry-flavored liquid in the following size:

8 fl oz (No Dropper) (237 mL)

RECOMMENDED STORAGE

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

KEEP TIGHTLY CLOSED

AVOID FREEZING

Dispense in a tight container as defined in the USP.

Rx Only

Product No.: 8810

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

28810

ISS. 12-08

PRINCIPAL DISPLAY PANEL - 30 mL Bottle

WOCKHARDT

NDC 64679-810-30

Baycadron™

ELIXIR

(Dexamethasone Elixir,

USP 0.5 mg/5 mL)

PROFESSIONAL SAMPLE –

NOT FOR RESALE

Rx Only

NET: 1 fl oz (30 mL)

Baycadron  dexamethasone  elixir

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64679-810 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexamethasone (Dexamethasone) Dexamethasone 0.5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength raw sugar   propylene glycol   benzoic acid   alcohol   Anhydrous Citric Acid   FD&C red no. 40   water   sodium citrate   citric acid monohydrate

Product Characteristics Color RED (Clear) Score      Shape Size Flavor RASPBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64679-810-08 30 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088254	07/27/1983

Labeler - Wockhardt USA, LLC (170508365)

Revised: 07/2009Wockhardt USA, LLC

More Baycadron resources

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

• Baycadron Concise Consumer Information (Cerner Multum)


• Dexamethasone Professional Patient Advice (Wolters Kluwer)


• Dexamethasone Monograph (AHFS DI)


• Cortastat injection Concise Consumer Information (Cerner Multum)


• Decadron Advanced Consumer (Micromedex) - Includes Dosage Information


• Decadron MedFacts Consumer Leaflet (Wolters Kluwer)


• Dexamethasone Sodium Phosphate eent Monograph (AHFS DI)

Compare Baycadron with other medications

• Addison's Disease
• Adrenal Insufficiency
• Adrenocortical Insufficiency
• Adrenogenital Syndrome
• Ankylosing Spondylitis
• Aspiration Pneumonia
• Asthma
• Asthma, acute
• Atopic Dermatitis
• Bronchopulmonary Dysplasia
• Bursitis
• Cerebral Edema
• Chorioretinitis
• Croup
• Cushing's Syndrome
• Dermatitis Herpetiformis
• Eczema
• Epicondylitis, Tennis Elbow
• Erythroblastopenia
• Evan's Syndrome
• Gouty Arthritis
• Hay Fever
• Hemolytic Anemia
• Hypercalcemia of Malignancy
• Idiopathic Thrombocytopenic Purpura
• Inflammatory Bowel Disease
• Inflammatory Conditions
• Iridocyclitis
• Iritis
• Juvenile Rheumatoid Arthritis
• Keratitis
• Leukemia
• Loeffler's Syndrome
• Lymphoma
• Meningitis, Haemophilus influenzae
• Meningitis, Listeriosis
• Meningitis, Meningococcal
• Meningitis, Pneumococcal
• Mountain Sickness / Altitude Sickness
• Multiple Myeloma
• Multiple Sclerosis
• Mycosis Fungoides
• Nausea/Vomiting, Chemotherapy Induced
• Neurosarcoidosis
• Pemphigus
• Psoriatic Arthritis
• Pulmonary Tuberculosis
• Rheumatoid Arthritis
• Sarcoidosis
• Seborrheic Dermatitis
• Shock
• Synovitis
• Systemic Lupus Erythematosus
• Thrombocytopenia
• Toxic Epidermal Necrolysis
• Tuberculous Meningitis
• Ulcerative Colitis
• Uveitis, Posterior

Supirocin

Supirocin may be available in the countries listed below.

Ingredient matches for Supirocin

Mupirocin

Mupirocin is reported as an ingredient of Supirocin in the following countries:

• Oman


• Sri Lanka

International Drug Name Search

Omeprazol Medinfar

Omeprazol Medinfar may be available in the countries listed below.

Ingredient matches for Omeprazol Medinfar

Omeprazole

Omeprazole is reported as an ingredient of Omeprazol Medinfar in the following countries:

• Portugal

International Drug Name Search

Acépromazine

Acépromazine may be available in the countries listed below.

Ingredient matches for Acépromazine

Acepromazine

Acépromazine (DCF) is also known as Acepromazine (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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

Lansoprazol AAA

Lansoprazol AAA may be available in the countries listed below.

Ingredient matches for Lansoprazol AAA

Lansoprazole

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

• Germany

International Drug Name Search

Drotebanol

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0003176-03-2

Chemical Formula

C19-H27-N-O4

Molecular Weight

333

Therapeutic Categories

Cough suppressant

Opioid analgesic

Chemical Name

Morphinan-6,14-diol, 3,4-dimethoxy-17-methyl-, (6ß)-

Foreign Names

• Drotebanolum (Latin)
• Drotebanol (German)
• Drotébanol (French)
• Drotebanol (Spanish)

Generic Names

• Drotebanol (OS: BAN)
• Drotébanol (OS: DCF)
• Drotebanolo (OS: DCIT)
• Oxymethebanol (IS)
• RAM 327 (IS)

Brand Name

• Metebanyl
  Daiichi Sankyo, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

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