Mohero CR

Mohero CR may be available in the countries listed below.

Ingredient matches for Mohero CR

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Mohero CR in the following countries:

• Vietnam

International Drug Name Search

Capronol

Capronol may be available in the countries listed below.

Ingredient matches for Capronol

Propranolol

Propranolol is reported as an ingredient of Capronol in the following countries:

• Peru

International Drug Name Search

Dermex

Dermex may be available in the countries listed below.

Ingredient matches for Dermex

Clobetasol

Clobetasol 17α-propionate (a derivative of Clobetasol) is reported as an ingredient of Dermex in the following countries:

• Bangladesh

International Drug Name Search

Cartens

Cartens may be available in the countries listed below.

Ingredient matches for Cartens

Carteolol

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

• Argentina

International Drug Name Search

Neosampoon

Neosampoon may be available in the countries listed below.

Ingredient matches for Neosampoon

Menfegol

Menfegol is reported as an ingredient of Neosampoon in the following countries:

• Taiwan

International Drug Name Search

Diprophyllinum

Diprophyllinum may be available in the countries listed below.

Ingredient matches for Diprophyllinum

Diprophylline

Diprophylline is reported as an ingredient of Diprophyllinum in the following countries:

• Poland

International Drug Name Search

Indapamid

Indapamid may be available in the countries listed below.

Ingredient matches for Indapamid

Indapamide

Indapamide is reported as an ingredient of Indapamid in the following countries:

• Georgia


• Romania


• Russian Federation


• Serbia

International Drug Name Search

Mirtazapina Merck

Mirtazapina Merck may be available in the countries listed below.

Ingredient matches for Mirtazapina Merck

Mirtazapine

Mirtazapine is reported as an ingredient of Mirtazapina Merck in the following countries:

• Portugal


• Spain

International Drug Name Search

Inhibitron

Inhibitron may be available in the countries listed below.

Ingredient matches for Inhibitron

Omeprazole

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

• Dominican Republic


• El Salvador


• Guatemala


• Mexico


• Panama

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

• Dominican Republic


• El Salvador


• Guatemala


• Mexico


• Panama

International Drug Name Search

Bediatil Forte

Bediatil Forte may be available in the countries listed below.

Ingredient matches for Bediatil Forte

Ibuprofen

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

• Chile

International Drug Name Search

Revellex

Revellex may be available in the countries listed below.

Ingredient matches for Revellex

Infliximab

Infliximab is reported as an ingredient of Revellex in the following countries:

• South Africa

International Drug Name Search

Lipopress

Lipopress may be available in the countries listed below.

Ingredient matches for Lipopress

Simvastatin

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

• Greece

International Drug Name Search

Vicks

Ingredient matches for Vicks

Dextromethorphan

Dextromethorphan is reported as an ingredient of Vicks in the following countries:

• Switzerland

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

• France


• Switzerland


• United States

Guaifenesin

Guaifenesin is reported as an ingredient of Vicks in the following countries:

• France

Pentoxyverine

Pentoxyverine citrate (a derivative of Pentoxyverine) is reported as an ingredient of Vicks in the following countries:

• France

International Drug Name Search

Vitasol AD3EC

Vitasol AD3EC may be available in the countries listed below.

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

Ingredient matches for Vitasol AD3EC

Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Vitasol AD3EC in the following countries:

• Austria

Colecalciferol

Colecalciferol is reported as an ingredient of Vitasol AD3EC in the following countries:

• Austria

Retinol

Retinol palmitate (a derivative of Retinol) is reported as an ingredient of Vitasol AD3EC in the following countries:

• Austria

Tocopherol, α-

Tocopherol, α- is reported as an ingredient of Vitasol AD3EC in the following countries:

• Austria

International Drug Name Search

Bismuth Subsalicylate Suspension

Bismuth Subsalicylate Suspension

INDICATIONS

A palatable oral suspension

for use as an aid in controlling

simple diarrhea in cattle, horses, dogs

and cats.

CAUTION

This product contains salicylate;

do not administer with other salicylate

containing products, such as

aspirin.

Bismuth Subsalicylate Suspension Dosage and Administration

SHAKE WELL BEFORE USING.

Administer orally.

Dogs and Cats- 1 to 3 tablespoonfuls

every 1-3 hours.

Calves and Foals- 3 to 4 ounces every 2-

3 hours.

Horses and Cattle- 6-10 ounces every 2-

3 hours.

warning

KEEP OUT OF REACH OF CHILDREN

If diarrhea persists after

using this product for 2 days, consult

veterinarian.

AHL Bismuth Subsalicylate Suspension

Anti-Diarrheal

Palatable Oral Suspension

For Animal Use Only

NET WT. 3.78L (128 fl oz) (1 gal)

Distributed by:

American Animal Health, Inc.

1401 Joel East Road • Fort Worth, TX 76140

1-800-272-8338

Bottle Label Image

Bottle Label Image

Bismuth Subsalicylate Suspension  bimumth subsalicylate suspension  suspension

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 66818-020 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bismuth Subsalicylate (Bismuth Subsalicylate) Bismuth Subsalicylate 0.0175 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66818-020-01 3780 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		06/26/2008

Labeler - American Animal Health, Inc. (102617875)

Registrant - American Animal Health, Inc (102617875)

Establishment
Name	Address	ID/FEI	Operations
American Pharmaceuticals and Cosmetics, Inc.		038023805	manufacture

Revised: 07/2009American Animal Health, Inc.

More Bismuth Subsalicylate Suspension resources

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

Compare Bismuth Subsalicylate Suspension with other medications

• Diarrhea
• Diarrhea, Chronic
• Helicobacter Pylori Infection
• Indigestion
• Lymphocytic Colitis

Ursolan

Ursolan may be available in the countries listed below.

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

Ingredient matches for Ursolan

Ichthammol

Ichthammol is reported as an ingredient of Ursolan in the following countries:

• Germany

International Drug Name Search

Clarilind

Clarilind may be available in the countries listed below.

Ingredient matches for Clarilind

Clarithromycin

Clarithromycin is reported as an ingredient of Clarilind in the following countries:

• Germany

International Drug Name Search

Dytide

Dytide may be available in the countries listed below.

Ingredient matches for Dytide

Benzthiazide

Benzthiazide is reported as an ingredient of Dytide in the following countries:

• United Kingdom

Hydrochlorothiazide

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

• Germany

Triamterene

Triamterene is reported as an ingredient of Dytide in the following countries:

• Germany


• United Kingdom

International Drug Name Search

Alnok

Alnok may be available in the countries listed below.

Ingredient matches for Alnok

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Alnok in the following countries:

• Denmark

International Drug Name Search

Trigain

Trigain may be available in the countries listed below.

Ingredient matches for Trigain

Cinchocaine

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

• Japan

Salicylic Acid

Salicylic Acid sodium (a derivative of Salicylic Acid) is reported as an ingredient of Trigain in the following countries:

• Japan

International Drug Name Search

Fucidin-Hydrocortison

Fucidin-Hydrocortison may be available in the countries listed below.

Ingredient matches for Fucidin-Hydrocortison

Fusidic Acid

Fusidic Acid is reported as an ingredient of Fucidin-Hydrocortison in the following countries:

• Denmark


• Finland


• Sweden

Fusidic Acid hemihydrate (a derivative of Fusidic Acid) is reported as an ingredient of Fucidin-Hydrocortison in the following countries:

• Norway

Hydrocortisone

Hydrocortisone is reported as an ingredient of Fucidin-Hydrocortison in the following countries:

• Denmark

Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Fucidin-Hydrocortison in the following countries:

• Finland

International Drug Name Search

Kop

Kop may be available in the countries listed below.

Ingredient matches for Kop

Ketoprofen

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

• Bangladesh

International Drug Name Search

Folan

Folan may be available in the countries listed below.

Ingredient matches for Folan

Folic Acid

Folic Acid is reported as an ingredient of Folan in the following countries:

• Serbia

International Drug Name Search

ReFacto

In the US, ReFacto (antihemophilic factor systemic) is a member of the drug class miscellaneous coagulation modifiers and is used to treat Hemophilia A.

US matches:

• Refacto recombinant


• Refacto

UK matches:

• ReFacto AF
• ReFacto AF (SPC)

Ingredient matches for ReFacto

Coagulation Factor VIII , Human (rDNA)

Coagulation Factor VIII , Human (rDNA) Moroctocog Alfa (a derivative of Coagulation Factor VIII , Human (rDNA)) is reported as an ingredient of ReFacto in the following countries:

• Australia


• Austria


• Belgium


• Czech Republic


• Denmark


• Finland


• France


• Germany


• Greece


• Hungary


• Iceland


• Italy


• Luxembourg


• Netherlands


• New Zealand


• Norway


• Portugal


• Slovakia


• Slovenia


• Spain


• 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.

Benzoyl Peroxide Wash

Dosage Form: topical liquid
Benzoyl Peroxide Wash 2.5%, 5% and 10%

Rx Only

Benzoyl Peroxide Wash Description

Benzoyl Peroxide Wash 2.5%, 5% and 10% are topical preparations containing benzoyl peroxide as the active ingredient.

Benzoyl Peroxide Wash 2.5%, 5% and 10% each contain: 2.5%, 5% and 10% benzoyl peroxide, respectively, in a lathering base formulated with acrylates copolymer, carbomer homopolymer type C, edetate disodium, glycerin, imidurea, purified water, sodium hydroxide, sodium C14-16 olefin sulfonate. May contain citric acid to adjust pH.

The structural formula of benzoyl peroxide is:

Benzoyl Peroxide Wash - Clinical Pharmacology

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne.

Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

Indications and Usage for Benzoyl Peroxide Wash

Benzoyl Peroxide Wash 2.5%, 5% and 10% are indicated for use in the topical treatment of mild to moderate acne vulgaris. Benzoyl Peroxide Wash 2.5%, 5% and 10% may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.

Contraindications

Benzoyl Peroxide Wash 2.5%, 5% and 10% should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.

Precautions

General -

For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.

Pregnancy:

Teratogenic Effects:

Pregnancy category C -

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

Nursing Mothers -

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use -

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

Adverse Reactions

Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.

Benzoyl Peroxide Wash Dosage and Administration

Shake well before using. It is recommended that therapy be initiated with Benzoyl Peroxide Wash 2.5%, washing the affected areas once a day during the first week, and twice a day thereafter as tolerated. Wet skin areas to be treated; apply Benzoyl Peroxide Wash, work to a full lather, rinse thoroughly and pat dry. Frequency of use should be adjusted to obtain the desired clinical response. Therapy with Benzoyl Peroxide Wash 5% or 10% may be initiated in patients who demonstrate accommodation to Benzoyl Peroxide Wash 2.5%.

Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.

How is Benzoyl Peroxide Wash Supplied

Benzoyl Peroxide Wash 2.5%, 5% and 10% are available as follows:

Benzoyl Peroxide Wash 2.5%

8 oz plastic bottle (NDC 45802-907-34)

Benzoyl Peroxide Wash 5%

4 oz plastic bottle (NDC 45802-913-26)

5 oz plastic bottle (NDC 45802-913-01)

8 oz plastic bottle (NDC 45802-913-34)

Benzoyl Peroxide Wash 10%

5 oz plastic bottle (NDC 45802-918-01)

8 oz plastic bottle (NDC 45802-918-34)

STORAGE

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

Manufactured by

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

Rev. 12/10

305263

: 0V500 RC J3

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

Benzoyl Peroxide Wash 10%

For Topical Use Only

Benzoyl Peroxide Wash 10% Front Label

Benzoyl Peroxide Wash 10% Back Label

BENZOYL PEROXIDE  benzoyl peroxide  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45802-918 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 10 g  in 100 g

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C   EDETATE DISODIUM   GLYCERIN   IMIDUREA   WATER   SODIUM HYDROXIDE   SODIUM C14-16 OLEFIN SULFONATE   CITRIC ACID MONOHYDRATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45802-918-34 227 g In 1 BOTTLE, GLASS None 2 45802-918-01 142 g In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		05/19/2008

Labeler - Perrigo New York Inc (078846912)

Revised: 09/2011Perrigo New York Inc

More Benzoyl Peroxide Wash resources

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

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• Benzac AC Wash MedFacts Consumer Leaflet (Wolters Kluwer)


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• Triazolam Monograph (AHFS DI)

Compare Benzoyl Peroxide Wash with other medications

• Acne
• Perioral Dermatitis

Glimedoc

Glimedoc may be available in the countries listed below.

Ingredient matches for Glimedoc

Glimepiride

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

• Germany

International Drug Name Search

Acebel-P

Acebel-P may be available in the countries listed below.

Ingredient matches for Acebel-P

Aceclofenac

Aceclofenac is reported as an ingredient of Acebel-P in the following countries:

• India

Paracetamol

Paracetamol is reported as an ingredient of Acebel-P in the following countries:

• India

International Drug Name Search

Fasimec

Fasimec may be available in the countries listed below.

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

Ingredient matches for Fasimec

Abamectin

Abamectin is reported as an ingredient of Fasimec in the following countries:

• Australia


• New Zealand

Ivermectin

Ivermectin is reported as an ingredient of Fasimec in the following countries:

• Australia

Triclabendazole

Triclabendazole is reported as an ingredient of Fasimec in the following countries:

• Australia


• New Zealand

International Drug Name Search

Amiodaron Cf

Amiodaron Cf may be available in the countries listed below.

Ingredient matches for Amiodaron Cf

Amiodarone

Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Amiodaron Cf in the following countries:

• Netherlands

International Drug Name Search

Timolux

Timolux may be available in the countries listed below.

Ingredient matches for Timolux

Timolol

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

• Italy

International Drug Name Search

Vextra

Vextra may be available in the countries listed below.

Ingredient matches for Vextra

Valdecoxib

Valdecoxib is reported as an ingredient of Vextra in the following countries:

• Bangladesh

International Drug Name Search

Tim-Ophtal

Tim-Ophtal may be available in the countries listed below.

Ingredient matches for Tim-Ophtal

Timolol

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

• Germany


• Indonesia

International Drug Name Search

UTP Opalia

UTP Opalia may be available in the countries listed below.

Ingredient matches for UTP Opalia

Uridine 5'-Triphosphate

Uridine 5'-Triphosphate is reported as an ingredient of UTP Opalia in the following countries:

• Tunisia

International Drug Name Search

Famotidina Cinfa

Famotidina Cinfa may be available in the countries listed below.

Ingredient matches for Famotidina Cinfa

Famotidine

Famotidine is reported as an ingredient of Famotidina Cinfa in the following countries:

• Spain

International Drug Name Search

Naxopren

Naxopren may be available in the countries listed below.

Ingredient matches for Naxopren

Naproxen

Naproxen is reported as an ingredient of Naxopren in the following countries:

• Finland

International Drug Name Search

Ovidrel

Generic Name: Choriogonadotropin Alfa
Class: Gonadotropins
ATC Class: G03GA08
VA Class: HS900
Chemical Name: Gonadotropin, chorionic (human α-subunit protein moiety reduced), complex with chorionic gonadotropin (human β-subunit protein moiety reduced)
Molecular Formula: C₄₃₇H₆₈₂N₁₂₂O₁₃₄S₁₃
CAS Number: 177073-44-8

Introduction

Gonad-stimulating hormone; biosynthetic (recombinant DNA-derived) form of human chorionic gonadotropin (hCG).¹

Uses for Ovidrel

Female Infertility

Used in conjunction with other infertility agents (e.g., gonadotropin-releasing hormone agonist, FSH) for induction of final follicular maturation and early luteinization in ovulatory, infertile women during assisted reproductive technology (ART) programs.^{1 2 3 6 7 8 9}

Use in patients with tubal obstruction only if participating in ART programs.¹

Choriogonadotropin alfa (r-hCG) is equivalent to urinary-derived hCG with regard to number of oocytes recovered, fertilized oocytes or embryos, and live births.^{1 2 3}

Used in conjunction with follicle-stimulating agent to induce ovulation in anovulatory, infertile women in whom anovulation is functional and not due to primary ovarian failure.^{1 4 5 h}

Choriogonadotropin alfa (r-hCG) is similar to urinary-derived hCG with regard to ovulation rates.^{1 h}

Ovidrel Dosage and Administration

General

• 
  

  Should be prescribed only by clinicians experienced in infertility treatment and who are familiar with cautions, precautions, and contraindications associated with such therapy.^{1 4 5}

  
  


• 
  

  Prior to treatment initiation with choriogonadotropin alfa, perform a thorough gynecologic and endocrinologic evaluation; assess pelvic anatomy and rule out early pregnancy, primary ovarian failure (as indicated by increased serum concentrations of FSH and LH and low serum estrogen concentrations), and neoplasms.^{1 4 5 6 7 c} (See Contraindications under Cautions.) Perform a thorough diagnostic evaluation in patients who demonstrate abnormal uterine bleeding and other signs of endometrial abnormalities.^{1 4} (See Contraindications under Cautions.) Evaluate partner’s infertility.^{1 4 5 6 h}

  
  


• 
  

  When ultrasound assessment and serum estradiol concentrations show sufficient follicular maturation, administer choriogonadotropin alfa 1 day after last dose of follicle-stimulating agent to complete final follicular maturation and induce ovulation.^{1 4 5}

  
  


• 
  

  Withhold further follicle-stimulating therapy and delay or withhold choriogonadotropin alfa if ovaries show an excessive response to treatment with gonadotropins because of increased risk of ovarian hyperstimulation syndrome (OHSS).^{1 4 5 6 i j} (See Ovarian Hyperstimulation Syndrome under Cautions.)

  
  


• 
  

  Encourage daily sexual intercourse beginning 1 day prior to administration of choriogonadotropin alfa until ovulation occurs (as determined by rise in basal body temperature, increase in serum progesterone concentrations, and menstruation following shift in basal body temperature).^l (See Adequate Patient Evaluation and Monitoring under Cautions.)

  
  


• 
  

  Examine ovaries by ultrasound for persistent cysts, particularly when attempts at stimulation of ovulation follow immediately after unsuccessful stimulated cycle.^{6 9}

  
  

Administration

Sub-Q Administration

Administer by sub-Q injection, generally into abdomen using commercially available prefilled syringe;¹ may be self-administered by patient.^{1 c}

Dosage

Adults

Female Infertility

ART

Sub-Q

250 mcg, given 1 day following last dose of follicle-stimulating agent.^{1 2 3} (See General under Dosage and Administration.)

Ovulation Induction

Sub-Q

250 mcg, given 1 day following last dose of follicle-stimulating agent.^{1 h} (See General under Dosage and Administration.)

If stimulation of ovulation is unsuccessful, adjust dosage of follicle-stimulating agent administered in subsequent cycles based on woman’s response in preceding cycle.^{6 9}

Prescribing Limits

Adults

Female Infertility

Sub-Q

Maximum 500-mcg single dose studied in clinical trials.^f

Cautions for Ovidrel

Contraindications

• 
  

  Known hypersensitivity to human chorionic gonadotropin preparations (including urinary-derived hCG) or any ingredient in formulation.^{1 c}

  
  


• 
  

  Primary ovarian failure.^{1 c}

  
  


• 
  

  Uncontrolled thyroid or adrenal dysfunction.^{1 c}

  
  


• 
  

  Uncontrolled organic intracranial lesions (e.g., pituitary neoplasms).^{1 c}

  
  


• 
  

  Abnormal intrauterine or vaginal bleeding of undetermined origin.^{1 c}

  
  


• 
  

  Ovarian cysts or enlargement of undetermined origin.^{1 c}

  
  


• 
  

  Sex-hormone-dependent neoplasms of reproductive tract and accessory organs.^{1 c}

  
  


• 
  

  Pregnancy.^{1 c}

  
  

Warnings/Precautions

Warnings

Ovarian Enlargement

Risk of mild to moderate uncomplicated ovarian enlargement; may be accompanied by abdominal distention and/or pain, but generally regresses without treatment within 2–3 weeks.¹ Careful monitoring of ovarian response recommended.¹

If ovaries are abnormally enlarged during controlled ovarian stimulation, withhold choriogonadotropin alfa during current course of therapy to minimize risk of OHSS.^{1 4 5 6 j} (See Ovarian Hyperstimulation Syndrome under Cautions.)

Ovarian Hyperstimulation Syndrome

Risk of potentially severe OHSS, characterized by apparent dramatic increase in vascular permeability that may result in rapid accumulation of fluid in peritoneal cavity, thorax, and potentially, pericardium.^{1 i j}

May progress rapidly (within 24 hours to several days).¹ Initial manifestations include severe pelvic pain, nausea, vomiting, and weight gain.^{1 i} Other symptoms include abdominal pain/distention, diarrhea, severe ovarian enlargement, dyspnea, and oliguria.^{1 j} Hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events may occur.^{1 i j}

Transient liver function test abnormalities, which may be accompanied by morphologic changes (as detected by liver biopsy), reported.^{1 i j}

Occurs most often after completion of gonadotropin therapy, reaching maximum severity after 7–10 days; usually resolves spontaneously with onset of menses.^{1 i} Monitor patients for ≥2 weeks after hCG administration.^{1 l} OHSS may be more severe and protracted if pregnancy occurs.^{1 i}

If severe OHSS develops, discontinue therapy, hospitalize patient, and consult clinician experienced in management of OHSS or fluid and electrolyte imbalances.^{1 i}

Multiple Births

Multiple ovulations resulting in multiple gestations reported in 30.9 or 13.3% of women during ART programs or ovulation induction, respectively.¹

Risk of multiple births correlates with number of embryos transferred.^{1 6}

Thromboembolism

Potential for arterial thromboembolism exists.¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; exclude pregnancy before initiating treatment.^d

Animal studies indicate adverse effects on pregnancy outcomes and/or labor.^d (See Contraindications under Cautions.)

General Precautions

Adequate Patient Evaluation and Monitoring

Administer only under supervision of qualified clinicians experienced in fertility disorders and interpretation of indices of ovulation.¹

Monitor follicular development (e.g., using transvaginal ultrasound, serum estradiol concentrations) to correctly identify follicular maturation, determine timing of choriogonadotropin alfa administration, detect ovarian enlargement, and minimize risks of OHSS and multiple gestation.^{1 4 5}

Obtain clinical confirmation of ovulation from direct and indirect indices of progesterone production, including rise in basal body temperature, an increase in serum progesterone concentrations, and menstruation following shift in basal body temperature.^{1 2 6 7} Sonographic evidence of ovulation includes findings of fluid in cul-de-sac, ovarian stigmata, collapsed follicle, and secretory endometrium.¹

Specific Populations

Pregnancy

Category X.¹ (See Fetal/Neonatal Morbidity and Mortality and also Contraindications under Cautions.)

Lactation

Not known whether choriogonadotropin alfa is distributed into milk.¹ Use caution.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

Safety and efficacy not established.¹

Hepatic Impairment

Safety and efficacy not established.¹

Renal Impairment

Safety and efficacy not established.¹

Common Adverse Effects

ART: Injection site reactions (i.e., pain, bruising),^{1 2 3 f} abdominal pain,¹ nausea,¹ vomiting,¹ postoperative pain.¹

Ovulation induction: Injection site reactions (i.e., pain, inflammation, bruising, other injection site reaction),^{1 h} ovarian cysts,¹ ovarian hyperstimulation,^{1 h} abdominal pain.¹

Interactions for Ovidrel

No formal drug interaction studies to date.¹

Laboratory Tests

Test	Interaction	Comments
Radioimmunoassays for gonadotropins	Possible cross-reaction with radioimmunoassays for gonadotropins, particularly LH1	Individual laboratories should establish degree of cross-reactivity with their gonadotropin assay1 When requesting gonadotropin concentration determinations, inform laboratory of choriogonadotropin alfa therapy1

Ovidrel Pharmacokinetics

Absorption

Bioavailability

Following sub-Q administration, absolute bioavailability is 40%.^{1 b} Peak serum concentrations attained in 12–24 hours; detectable in serum for 10 days.^{1 d e h}

Onset

Following midcycle administration, peak stimulation of luteal-phase progesterone production (as indicated by serum progesterone concentrations) occurs in approximately 5–7 days.^{e h} (See Actions.)

Duration

Following midcycle administration, stimulation of luteal-phase progesterone production persists for approximately 10 days.^{e h}

Distribution

Extent

Median apparent volume of distribution is 21.4 L in women undergoing in vitro fertilization.¹

Elimination

Metabolism

Urinary-derived hCG extensively metabolized, principally in the liver and kidneys, to active metabolites; urinary-derived choriogonadotropin alfa (r-hCG) exhibits similar pharmacokinetics as hCG.^{a k}

Elimination Route

Excreted in urine principally as metabolites.^a

Half-life

Biphasic; median terminal half-life is 29.2 hours in women undergoing in vitro fertilization.¹

Special Populations

Pharmacokinetics not evaluated in patients with renal or hepatic impairment.¹

Stability

Storage

Parenteral

Injection

2–8°C until dispensed.¹ Once dispensed, refrigerate prefilled syringe at 2–8°C, but may be stored at ≤25°C for ≤30 days; protect from light.^{1 c} Discard unused portion.¹

ActionsActions

• 
  

  A recombinant DNA-derived form of hCG prepared from genetically modified mammalian (Chinese hamster ovary) cells.^{1 2}

  
  


• 
  

  An analog of LH; has physicochemical, immunologic, and biologic activities comparable to those of urinary-derived hCG.^{1 2}

  
  


• 
  

  Substitutes for the endogenous LH surge responsible for ovulation and stimulates late maturation of the ovarian follicle, resumption of oocytic meiosis, and initiation of rupture of the preovulatory ovarian follicle.^{1 2 3 f} Spontaneous midcycle LH surges are inconsistent during controlled ovarian stimulation.^g

  
  


• 
  

  Induces and maintains corpus luteum (as evidenced by increased serum progesterone concentrations).^{1 2 3 e f}

  
  

Advice to Patients

• 
  

  Importance of informing patient of potential adverse effects (e.g., OHSS, multiple gestation).^{1 c}

  
  


• 
  

  Importance of discussing duration of treatment and required monitoring procedures.¹

  
  


• 
  

  Importance of patients informing clinician if severe pain or bloating in abdominal or pelvic area, severe upset stomach, vomiting, or weight gain occurs.^c

  
  


• 
  

  Importance of patient informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^c

  
  


• 
  

  Importance of women informing their clinician if they plan to breast-feed.^c

  
  


• 
  

  Importance of informing patient of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Choriogonadotropin Alfa

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use only	257.5 mcg/0.515 mL (delivers 250 mcg)	Ovidrel (available as a 0.515-mL, disposable prefilled syringe)	Serono

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions June 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Serono Inc. Ovidrel (choriogonadotropin alfa) injection prescribing information. Randolph, MA; 2004 Jan.

2. European Recombinant Human Chorionic Gonadotropin Study Group. Induction of final follicular maturation and early luteinization in women undergoing induction for assisted reproduction treatment—recombinant HCG versus urinary HCG. Hum Reprod. 2000; 15:1446-51. [PubMed 10875887]

3. Driscoll GL, Tyler JP, Hanagan JT et al. A prospective, randomized, controlled, double-blind, double-dummy comparison of recombinant and urinary HCG for inducing oocyte maturation and follicular luteinization in ovarian stimulation. Hum Reprod. 2000; 15:1305-10. [PubMed 10831560]

4. Serono Laboratories Inc. Gonal-F (follitropin alfa) for injection prescribing information. Randolph, MA; 1997 Sep.

5. Organon. Follistim (follitropin beta) for injection prescribing information. West Orange, NJ; 1997 Sep.

6. Practice Committee, American Society of Reproductive Medicine. Induction of ovarian follicle development and ovulation with exogenous gonadotropins. A technical bulletin. Birmingham, AL; 1998. From ASRM website.

7. Institute for Clinical Systems Improvement. Diagnosis and management of infertility. Bloomington, MN; 2000 July. From the ICSI website.

8. Yoshida TM. Infertility update: use of assisted reproductive technology. J Am Pharm Assoc. 1999; 39:65-72.

9. Serono Inc: Personal communication.

a. Norman RJ, Buchholz MM, Somogyi AA et al. hCGβ core fragment is a metabolite of hCG: evidence from infusion of recombinant hCG. J Endocrinol. 2000; 164:299-305. [PubMed 10694369]

b. Trinchard-Lugan I, Khan A, Porchet HC et al. Pharmacokinetics and pharmacodynamics of recombinant human chorionic gonadotropin in healthy male and female volunteers. Reprod Biomed Online. 2002; 4:106-15.

c. EMD Serono. Ovidrel (choriogonadotropin alfa) prefilled syringe FAQ's. Rockland, MA; 2007. Available from website. Accessed 2007 Nov 27.

d. Serono Inc. Ovidrel (choriogonadotropin alfa) injection prescribing information. Rockland MA; 2006 Jul.

e. Beckers NGM, Macklon NS, Eijkemans MJ et al. Nonsupplemented luteal phase characteristics after the administration of recombinant human chorionic gonadotropin, recombinant luteinizing hormone, or gonadotropin-releasing hormone (GnRH) agonist to induce final oocyte maturation in in vitro fertilization patients after ovarian stimulation with recombinant follicle-stimulating hormone and GnRH antagonist cotreatment. J Clin Endocrinol Metab. 2003; 88:4186-92. [PubMed 12970285]

f. Chan CCW, Ng EHY, Tang OS et al. A prospective, randomized, double-blind study to compare two doses of recombinant human chorionic gonadotropin in inducing final oocyte maturity and the hormonal profile during the luteal phase. J Clin Endocrinol Metab. 2005; 90:3933-8. [PubMed 15870129]

g. European Recombinant LH Study Group. Recombinant human leuteinizing hormone is as effective as, but safer than, urinary human choriogonadotropin in inducing final follicular maturation and ovulation in in vitro fertilization procedures: results of a multicenter double-blind study. J Clin Endocrinol Metab. 2001; 86:2607-18. [PubMed 11397861]

h. International Recombinant Human Chorionic Gonadotropin Study Group. Induction of ovulation in World Health Organization group II anovulatory women undergoing follicular stimulation with recombinant human follicle-stimulating hormone: a comparison of recombinant human chorionic gonadotropin (rHCG) and urinary HCG. Fertil Steril. 2001; 75:1111-8. [PubMed 11384635]

i. Practice Committee, American Society of Reproductive Medicine. Ovarian hyperstimulation syndrome. An educational bulletin. Fertil Steril. 2006; 86:S178-83. [PubMed 17055817]

j. Delvigne A, Rozenberg S. Epidemiology and prevention of ovarian hyperstimulation syndrome (OHSS): a review. Hum Reprod Update. 2002; 8:559-77. [PubMed 12498425]

k. Stenman U, Tiitinen A, Alfthan H et al. The classification, functions and clinical use of different isoforms of HCG. Hum Reprod Update. 2006; 12:769-84. [PubMed 16877746]

l. EMD Serono Laboratories Inc. Gonal-F (follitropin alfa) for injection prescribing information. Randolph, MA; 2005 Aug.

m. AHFS drug information 2007. McEvoy GK, ed. Choriogonadotropin Alfa. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3115-6.

More Ovidrel resources

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

• Ovidrel Prescribing Information (FDA)


• Ovidrel MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovidrel Advanced Consumer (Micromedex) - Includes Dosage Information


• Hcg Consumer Overview


• Novarel MedFacts Consumer Leaflet (Wolters Kluwer)


• Novarel Prescribing Information (FDA)


• Pregnyl Prescribing Information (FDA)

Compare Ovidrel with other medications

• Female Infertility
• Hypogonadism, Male
• Ovulation Induction
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• 
  Manufacturer: BOEHRINGER INGELHEIM
  
  Approval date: October 24, 1996
  
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Has a generic version of Combivent been approved?

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Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Combivent. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

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Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
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  Patent 5,603,918
  Issued: February 18, 1997
  Inventor(s): McNamara; Daniel
  Assignee(s): Boehringer Ingelheim Pharmaceuticals, Inc.
  The present invention is concerned with an aerosol formulation which contains an effective amount of a pharmaceutically acceptable salt of ipratropium and an effective amount of a pharmaceutically acceptable salt of albuterol in combination with an effective amount of soya lecithin as a suspending agent and a propellant.
  
  Patent expiration dates:
  
  
  • June 9, 2015
    
  
  

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