Inmunoprin

Inmunoprin may be available in the countries listed below.

Ingredient matches for Inmunoprin

Thalidomide

Thalidomide is reported as an ingredient of Inmunoprin in the following countries:

• Chile


• Colombia


• Mexico

International Drug Name Search

Femsel

Femsel may be available in the countries listed below.

Ingredient matches for Femsel

Tibolone

Tibolone is reported as an ingredient of Femsel in the following countries:

• Venezuela

International Drug Name Search

Apo-Clonazepam

Apo-Clonazepam may be available in the countries listed below.

Ingredient matches for Apo-Clonazepam

Clonazepam

Clonazepam is reported as an ingredient of Apo-Clonazepam in the following countries:

• Canada


• Guyana

International Drug Name Search

Bovatec

Dosage Form: FOR ANIMAL USE ONLY
Bovatec®

Liquid 20

Type A Medicated Article

Brand of lasalocid

CATTLE: For improved feed efficiency and increased rate of weight gain when used in medicated feeds for cattle fed in confinement for slaughter. For increased rate of weight gain when used in medicated feeds for pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).

For control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs.

SHEEP: For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva and E. intricata in sheep maintained in confinement.

Each pound contains 90.7 grams (20%) of lasalocid (as lasalocid sodium activity) in a carrier suitable for incorporation in liquid feed supplements.

IMPORTANT: Handling Information - Must be thoroughly mixed in feeds before use. When mixing and handling lasalocid liquid premix, use protective clothing and impervious gloves. Avoid contact with eyes. Operators should wash hands thoroughly with soap and water after handling.

MIXING DIRECTIONS

This product should be incorporated into liquid feed supplements:

(1)

Agitate Bovatec Liquid 20 before use.

(2)

Supplements with suspending agent(s) should be in a pH range of 4 - 8 and maintain physical stability for up to three months with a viscosity not less than 300 cps.

(3)

Conventional liquid supplements should be in a pH range of 4 - 8.

 

For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

 

For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(4)

The following is provided as a guide in determining the quantity of Bovatec Liquid 20 (Type A Medicated Article) to be added in preparing liquid feed supplements (LFS). Preparation of intermediate liquid premix is not recommended.

* 6.13 gm lasalocid per fluid ounce (Bovatec Liquid 20 specific gravity is 1.035)
LFS TO BE FED UNDILUTED As a Type C Medicated Feed - Hand-Fed or Top Dressed
Amount of LFS to be fed (lbs/head/day)	To achieve a lasalocid intake of (mg/head/day)	Bovatec Liquid 20 per ton LFS
		pounds	fluid ounces*
0.5	15	0.66	9.8
0.5	60	2.65	39.2
0.5	70	3.09	45.7
0.5	200	8.82	130.5
0.5	300	13.23	195.8
0.5	360	15.88	234.9
1.0	15	0.33	4.9
1.0	60	1.32	19.6
1.0	70	1.54	22.8
1.0	200	4.41	65.3
1.0	300	6.62	97.9
1.0	360	7.94	117.5
LFS TO BE DILUTED As a Type B Medicated Feed - Mixed into a Feed
Amount of LFS to be added to final feed (lbs/ton)	Lasalocid in final feed (grams/ton)	Bovatec Liquid 20 per Ton LFS
		pounds	fluid ounces*
100	10	2.21	32.6
100	25	5.51	81.6
100	30	6.62	97.9
150	10	1.47	21.8
150	25	3.68	54.4
150	30	4.41	65.3
200	10	1.10	16.3
200	25	2.76	40.8
200	30	3.31	48.9

DO NOT FEED UNDILUTED

USE DIRECTIONS

Species	Dose	Indications for use
Feedlot Cattle	10-30 grams lasalocid per ton of total ration (90% dry matter)	For improved feed efficiency in cattle being fed in confinement for slaughter, feed continuously to provide not less than 100 mg nor more than 360 mg per head per day.
	25-30 grams lasalocid per ton of total ration (90% dry matter)	For improved feed efficiency and increased rate of weight gain in cattle being fed in confinement for slaughter, feed continuously to provide not less than 250 mg nor more than 360 mg per head per day.
Pasture Cattle – slaughter, stocker, feeder cattle, and dairy and beef replacement heifers	60-300 mg lasalocid per head/day	For increased rate of weight gain. The drug must be contained in at least 1 pound of feed and fed continuously on a daily basis.
	60-300 mg lasalocid per head/day	For increased rate of weight gain, feed continuously on a free-choice basis. (Manufacture of Type C free-choice feeds from this product requires a Medicated Feed License Application approved by FDA.)
		Daily lasalocid intakes in excess of 200 mg per head per day have not been shown to be more effective than 200 mg lasalocid per head per day.
		NOTE: Coccidiosis may occur when young pasture cattle are comingled with adult cattle passing coccidial oocysts.
Cattle	1 mg lasalocid per 2.2 lbs body weight/day	For control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs. Hand feed continuously to provide not more than 360 mg per day.
Sheep	20-30 grams lasalocid per ton of total ration (90% dry matter)	For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva, and E. intricata in sheep maintained in confinement. Feed continuously to provide not less than 15 mg nor more than 70 mg per head per day depending on body weight.

CAUTION: Animal Safety - Do not allow horses or other equines access to premixes or supplements containing lasalocid, as ingestion may be fatal. The safety of lasalocid in unapproved species has not been established. Feeding undiluted or mixing errors resulting in excessive concentrations of lasalocid could be fatal to cattle and sheep.

Warning

A withdrawal period has not been established for this product in pre-ruminating calves.

Do not use in calves to be processed for veal.

DO NOT FEED UNDILUTED

Net Wt. 50 Lb. (22.68 kg)

NADA 96-298, Approved by FDA. Not for human use.

See side panel for use directions

Made in U.S.A.

Trademarks registered

by Alpharma Inc.

710347 0910

List No. 710127

Alpharma Inc.

Bridgewater, New Jersey 08807

PRINCIPAL DISPLAY PANEL - 50 lb Drum

List No. 710127

Control

Expires:

Bovatec®

Liquid 20

Type A Medicated Article

Brand of lasalocid

CATTLE: For improved feed efficiency and increased rate of weight gain when used in

medicated feeds for cattle fed in confinement for slaughter. For increased rate of weight

gain when used in medicated feeds for pasture cattle (slaughter, stocker, feeder cattle, and

dairy and beef replacement heifers).

For control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs.

SHEEP: For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis

(E. ninakohlyakimovae), E. parva and E. intricata in sheep maintained in confinement.

Each pound contains 90.7 grams (20%) of lasalocid (as lasalocid sodium activity)

in a carrier suitable for incorporation in liquid feed supplements.

IMPORTANT: Handling Information - Must be thoroughly mixed in feeds before use.

When mixing and handling lasalocid liquid premix, use protective clothing and impervious

gloves. Avoid contact with eyes. Operators should wash

hands thoroughly with soap and water after handling.

DO NOT FEED UNDILUTED

Net Wt. 50 Lb. (22.68 kg)

NADA 96-298, Approved by FDA. Not for human use.

See side panel for use directions

Alpharma®

Alpharma Inc.

Bridgewater, New Jersey 08807

Take Time

Observe Label

Directions

Made in U.S.A.

Trademarks registered

by Alpharma Inc.

710347 0910

Bovatec 20  lasalocid sodium  liquid

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 46573-459 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lasalocid Sodium (Lasalocid) Lasalocid Sodium 90.7 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Off-White to Yellow) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46573-459-06 22.68 kg In 1 DRUM None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA096298	01/01/2009

Labeler - Alpharma Inc. Animal Health (070954094)

Revised: 11/2009Alpharma Inc. Animal Health

Oributol

Oributol may be available in the countries listed below.

Ingredient matches for Oributol

Ethambutol

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

• Finland

International Drug Name Search

BroveX CBX

Pronunciation: BROME-fen-IR-a-meen/KOE-deen
Generic Name: Brompheniramine/Codeine
Brand Name: Examples include BroveX CB and BroveX CBX

BroveX CBX is used for:

Relieving 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.

BroveX CBX is an antihistamine and narcotic cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use BroveX CBX if:

• you are allergic to any ingredient in BroveX CBX or any other codeine- or morphine-related medicine


• you have severe high blood pressure, severe heart blood vessel disease, angle-closure glaucoma, or peptic ulcers


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or if 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 BroveX CBX:

Some medical conditions may interact with BroveX CBX. 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 heart blood vessel problems, irregular heartbeat, or any other heart problems (eg, cor pulmonale)


• if you have a history of high blood pressure; diabetes; liver or kidney problems; stroke; glaucoma or increased pressure in the eye; a blockage of your bladder, stomach, or bowels; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or thyroid problems


• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)


• if you have very poor health or a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior


• if you are taking medicine for high blood pressure or depression

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

• Anticholinergics (eg, scopolamine) because serious bowel motility problem (paralytic ileus) may occur


• Cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of BroveX CBX's side effects


• Narcotic pain medicines (eg, hydrocodone) because the risk of their side effects may be increased by BroveX CBX


• Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease BroveX CBX's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if BroveX CBX 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 BroveX CBX:

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

• Take BroveX CBX by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of BroveX CBX, 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 BroveX CBX.

Important safety information:

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


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using BroveX CBX; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• BroveX CBX may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• BroveX CBX has brompheniramine in it. Before you start any new medicine, check the label to see if it has brompheniramine 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 use for longer than prescribed without checking with your doctor.


• Do not use BroveX CBX for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• If your cough or other symptoms persist for more than 5 days, come back, or if you also have fever, rash, or persistent headache, check with your doctor.


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


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


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


• Use BroveX CBX with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using BroveX CBX in CHILDREN; they may be more sensitive to its effects, especially excitability.


• BroveX CBX should not be used in CHILDREN younger than 6 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 BroveX CBX while you are pregnant. Do not take BroveX CBX if you are in the third trimester of pregnancy. It is not known if BroveX CBX is found in breast milk. Do not breast-feed while taking BroveX CBX.

When used for long periods of time or at high doses, BroveX CBX may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if BroveX CBX stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking BroveX CBX. This is known as DEPENDENCE or addiction.

If you suddenly stop taking BroveX CBX, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; trouble sleeping.

Possible side effects of BroveX CBX:

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; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; thickening of mucus secretions; upset stomach; vomiting.

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); blurred vision, double vision, or other vision changes; confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; loss of coordination; mood or mental changes; nervousness; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness.

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: BroveX CBX 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; shallow breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of BroveX CBX:

Store BroveX CBX at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep BroveX CBX out of the reach of children and away from pets.

General information:

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


• BroveX CBX 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 BroveX CBX. 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 BroveX CBX resources

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

Compare BroveX CBX with other medications

• Cold Symptoms
• Cough
• Rhinorrhea

Bicalutamide

FULL PRESCRIBING INFORMATION

1. INDICATIONS AND USAGE

Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.

Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].

2. DOSAGE AND ADMINISTRATION

The recommended dose for Bicalutamide tablets therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that Bicalutamide tablets be taken at the same time each day. Treatment with Bicalutamide tablets should be started at the same time as treatment with an LHRH analog.

Dosage Adjustment in Renal Impairment

No dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations (8.7)].

Dosage Adjustment in Hepatic Impairment

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of Bicalutamide no dosage adjustment is necessary [see Use in Specific Populations (8.6)].

3. DOSAGE FORMS AND STRENGTHS

Bicalutamide Tablets, 50 mg for oral administration are white to off-white, round, biconvex, film-coated tablets, debossed with ZE 57 on one side and plain on other side.

4. CONTRAINDICATIONS

Hypersensitivity

Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported [see ADVERSE REACTIONS (6.2)].

Women

Bicalutamide has no indication for women, and should not be used in this population.

Pregnancy

Bicalutamide may cause fetal harm when administered to a pregnant woman. Bicalutamide is contraindicated in women, including those who are or may become pregnant. There are no studies in pregnant women using Bicalutamide. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be appraised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].

5. WARNINGS AND PRECAUTIONS

Hepatitis

Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported post-marketing in association with the use of Bicalutamide. Hepatotoxicity in these reports generally occurred within the first three to four months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of Bicalutamide patients in controlled clinical trials.

Serum transaminase levels should be measured prior to starting treatment with Bicalutamide, at regular intervals for the first four months of treatment, and periodically thereafter. If clinical symptoms or signs suggestive of liver dysfunction occur (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, "flu-like" symptoms, dark urine, jaundice, or right upper quadrant tenderness), the serum transaminases, in particular the serum ALT, should be measured immediately. If at any time a patient has jaundice, or their ALT rises above two times the upper limit of normal, Bicalutamide should be immediately discontinued with close follow-up of liver function.

Gynecomastia and Breast Pain

In clinical trials with Bicalutamide 150 mg as a single agent for prostate cancer, gynecomastia and breast pain have been reported in up to 38% and 39% of patients, respectively.

Glucose Tolerance

A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycemic control in those with preexisting diabetes. Consideration should therefore be given to monitoring blood glucose in patients receiving Bicalutamide in combination with LHRH agonists.

Laboratory Tests

Regular assessments of serum Prostate Specific Antigen (PSA) may be helpful in monitoring the patient’s response. If PSA levels rise during Bicalutamide therapy, the patient should be evaluated for clinical progression. For patients who have objective progression of disease together with an elevated PSA, a treatment-free period of antiandrogen, while continuing the LHRH analog, may be considered.

6. ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

In patients with advanced prostate cancer treated with Bicalutamide in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%).

In the multicenter, double-blind, controlled clinical trial comparing Bicalutamide 50 mg once daily with flutamide 250 mg three times a day, each in combination with an LHRH analog, the following adverse reactions with an incidence of 5% or greater, regardless of causality, have been reported.

Table 1 Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality

Body System      Adverse Reaction	Treatment Group
	Number of Patients (%)
	Bicalutamide Plus LHRH Analogue (n=401)	Flutamide Plus LHRH Analogue (n=407)
* Increased liver enzyme test includes increases in AST, ALT or both. † Anemia includes anemia, hypochronic-and iron deficiency anemia.
Body as a Whole
Pain (General)	142 (35)	127 (31)
Back Pain	102 (25)	105 (26)
Asthenia	89 (22)	87 (21)
Pelvic Pain	85 (21)	70 (17)
Infection	71 (18)	57 (14)
Abdominal Pain	46 (11)	46 (11)
Chest Pain	34 (8)	34 (8)
Headache	29 (7)	27 (7)
Flu Syndrome	28 (7)	30 (7)
Cardiovascular
Hot Flashes	211 (53)	217 (53)
Hypertension	34 (8)	29 (7)
Digestive
Constipation	87 (22)	69 (17)
Nausea	62 (15)	58 (14)
Diarrhea	49 (12)	107 (26)
Increased Liver Enzyme Test*	30 (7)	46 (11)
Dyspepsia	30 (7)	23 (6)
Flatulence	26 (6)	22 (5)
Anorexia	25 (6)	29 (7)
Vomiting	24 (6)	32 (8)
Hemic and Lymphatic
Anemia†	45 (11)	53 (13)
Metabolic and Nutritional
Peripheral Edema	53 (13)	42 (10)
Weight Loss	30 (7)	39 (10)
Hyperglycemia	26 (6)	27 (7)
Alkaline Phosphatase Increased	22 (5)	24 (6)
Weight Gain	22 (5)	18 (4)
Muscoloskeletal
Bone Pain	37 (9)	43 (11)
Myasthenia	27 (7)	19 (5)
Arthritis	21 (5)	29 (7)
Pathological Fracture	17 (4)	32 (8)
Nervous System
Dizziness	41 (10)	35 (9)
Paresthesia	31 (8)	40 (10)
Insomnia	27 (7)	39 (10)
Anxiety	20 (5)	9 (2)
Depression	16 (4)	33 (8)
Respiratory System
Dyspnea	51 (13)	32 (8)
Cough Increased	33 (8)	24 (6)
Pharyngitis	32 (8)	23 (6)
Bronchitis	24 (6)	22 (3)
Pneumonia	18 (4)	19 (5)
Rhinitis	15 (4)	22 (5)
Skin and Appendages
Rash	35 (9)	30 (7)
Sweating	25 (6)	20 (5)
Urogenital
Nocturia	49 (12)	55 (14)
Hematuria	48 (12)	26 (6)
Urinary Tract Infection	35 (9)	36 (9)
Gynecomastia	36 (9)	30 (7)
Impotence	27 (7)	35 (9)
Breast Pain	23 (6)	15 (4)
Urinary Frequency	23 (6)	29 (7)
Urinary  Retention	20 (5)	14 (3)
Urinary Impaired	19 (5)	15 (4)
Urinary Incontinence	15 (4)	32 (8)

Other adverse reactions (greater than or equal to 2%, but less than 5%) reported in the Bicalutamide-LHRH analog treatment group are listed below by body system and are in order of decreasing frequency within each body system regardless of causality.

Body as a Whole:

Neoplasm; Neck Pain; Fever; Chills; Sepsis; Hernia; Cyst

Cardiovascular:

Angina Pectoris; Congestive Heart Failure; Myocardial Infarct; Heart Arrest; Coronary Artery Disorder; Syncope

Digestive:

Melena; Rectal Hemorrhage; Dry Mouth; Dysphagia; Gastrointestinal Disorder; Periodontal Abscess; Gastrointestinal Carcinoma

Metabolic and Nutritional:

Edema; BUN Increased; Creatinine Increased; Dehydration; Gout; Hypercholesteremia

Musculoskeletal:

Myalgia; Leg Cramps

Nervous:

Hypertonia; Confusion; Somnolence; Libido Decreased; Neuropathy; Nervousness

Respiratory:

Lung Disorder; Asthma; Epistaxis; Sinusitis

Skin and Appendages:

Dry Skin; Alopecia; Pruritus; Herpes Zoster; Skin Carcinoma; Skin Disorder

Special Senses:

Cataract specified

Urogenital:

Dysuria; Urinary Urgency; Hydronephrosis; Urinary Tract Disorder

Abnormal Laboratory Test Values

Laboratory abnormalities including elevated AST, ALT, bilirubin, BUN, and creatinine and decreased hemoglobin and white cell count have been reported in both Bicalutamide-LHRH analog treated and flutamide-LHRH analog treated patients.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Bicalutamide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Uncommon cases of hypersensitivity reactions, including angioneurotic edema and urticaria have been seen [see CONTRAINDICATIONS (4.1)]. Cases of interstitial lung disease (some fatal), including interstitial pneumonitis and pulmonary fibrosis, have been reported with Bicalutamide. Interstitial lung disease has been reported most often at doses greater than 50 mg. A few cases of fatal hepatic failure have been reported.

Reduction in glucose tolerance, manifesting as diabetes or a loss of glycemic control in those with pre-existing diabetes, has been reported during treatment with LHRH agonists.

7. DRUG INTERACTIONS

Clinical studies have not shown any drug interactions between Bicalutamide and LHRH analogs (goserelin or leuprolide). There is no evidence that Bicalutamide induces hepatic enzymes.

In vitro studies have shown that R-Bicalutamide is an inhibitor of CYP 3A4 with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Clinical studies have shown that with co-administration of Bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5 fold (for Cmax) and 1.9 fold (for AUC). Hence, caution should be exercised when Bicalutamide is co-administered with CYP 3A4 substrates.

In vitro protein-binding studies have shown that Bicalutamide can displace coumarin anticoagulants from binding sites. Prothrombin times should be closely monitored in patients already receiving coumarin anticoagulants who are started on Bicalutamide and adjustment of the anticoagulant dose may be necessary.

8. USE IN SPECIFIC POPULATIONS

Pregnancy

PREGNANCY CATEGORY X [see CONTRAINDICATIONS (4.3)].

Based on its mechanism of action, Bicalutamide may cause fetal harm when administered to a pregnant woman. Bicalutamide is contraindicated in women, including those who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

While there are no human data on the use of Bicalutamide in pregnancy and Bicalutamide is not for use in women, it is important to know that maternal use of an androgen receptor inhibitor could affect development of the fetus.

In animal reproduction studies, male offspring of rats receiving doses of 10 mg/kg/day (approximately 2/3 of clinical exposure at the recommended dose) and above, were observed to have reduced anogenital distance and hypospadias. These pharmacological effects have been observed with other antiandrogens. No other teratogenic effects were observed in rabbits receiving doses up to 200 mg/kg/day (approximately 1/3 of clinical exposure at the recommended dose) or rats receiving doses up to 250 mg/kg/day (approximately 2 times the clinical exposure at the recommended dose).

Nursing Mothers

Bicalutamide is not indicated for use in women.

Pediatric Use

The safety and effectiveness of Bicalutamide in pediatric patients have not been established.

Labeling describing pediatric clinical studies for Bicalutamide is approved for AstraZeneca Pharmaceuticals LP's Bicalutamide tablet. However, due to AstraZeneca Pharmaceuticals LP's marketing exclusivity rights, a description of those clinical studies is not approved for this Bicalutamide labeling.

Geriatric Use

In two studies in patients given 50 or 150 mg daily, no significant relationship between age and steady-state levels of total Bicalutamide or the active R-enantiomer has been shown.

Hepatic Impairment

Bicalutamide should be used with caution in patients with moderate-to-severe hepatic impairment. Bicalutamide is extensively metabolized by the liver. Limited data in subjects with severe hepatic impairment suggest that excretion of Bicalutamide may be delayed and could lead to further accumulation. Periodic liver function tests should be considered for hepatic-impaired patients on long-term therapy [see WARNINGS AND PRECAUTIONS (5.1)].

No clinically significant difference in the pharmacokinetics of either enantiomer of Bicalutamide was noted in patients with mild-to-moderate hepatic disease as compared to healthy controls. However, the half-life of the R-enantiomer was increased approximately 76% (5.9 and 10.4 days for normal and impaired patients, respectively) in patients with severe liver disease (n=4).

Renal Impairment

Renal impairment (as measured by creatinine clearance) had no significant effect on the elimination of total Bicalutamide or the active R-enantiomer.

Women

Bicalutamide has not been studied in women.

10. OVERDOSAGE

Long-term clinical trials have been conducted with dosages up to 200 mg of Bicalutamide daily and these dosages have been well tolerated. A single dose of Bicalutamide that results in symptoms of an overdose considered to be life threatening has not been established.

There is no specific antidote; treatment of an overdose should be symptomatic.

In the management of an overdose with Bicalutamide, vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since Bicalutamide is highly protein bound and is extensively metabolized. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

11. DESCRIPTION

Bicalutamide Tablets contain 50 mg of Bicalutamide, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N [4 cyano-3-(trifluoromethy])phenyl]-3-[(4-fluorophenyl) sulfonyl]-2-hydroxy- 2-methyl-,(+-). The structural and molecular formulas are:

Bicalutamide, USP has a molecular weight of 430.37. The pKa’ is approximately 12. Bicalutamide is a white to off-white powder which is practically insoluble in water at 37°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran.

Bicalutamide is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of Bicalutamide; the S-enantiomer is essentially inactive.

Each Bicalutamide tablet intended for oral administration contains 50 mg of Bicalutamide. In addition each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.

12. CLINICAL PHARMACOLOGY

Mechanism of Action

Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.

When Bicalutamide is combined with luteinizing hormone releasing hormone (LHRH) analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with Bicalutamide as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted.

In a subset of patients who have been treated with Bicalutamide and an LHRH agonist, and who discontinue Bicalutamide therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.

Pharmacokinetics

Absorption

Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown. Co-administration of Bicalutamide with food has no clinically significant effect on rate or extent of absorption.

Distribution

Bicalutamide is highly protein-bound (96%) [see DRUG INTERACTIONS (7)].

Metabolism/Elimination

Bicalutamide undergoes stereospecific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation. Both the parent and metabolite glucuronides are eliminated in the urine and feces. The S-enantiomer is rapidly cleared relative to the R-enantiomer, with the R-enantiomer accounting for about 99% of total steady-state plasma levels.

Pharmacokinetics of the active enantiomer of Bicalutamide in normal males and patients with prostate cancer are presented in Table 2.

Parameter	Mean	Standard Deviation
Normal Males (n=30)
Apparent Oral Clearance (L/hr)	0.320	0.103
Single Dose Peak Concentration (mcg/mL)	0.768	0.178
Single Dose Time to Peak	31.3	14.6
Concentration (hours)
Half-life (days)	5.8	2.29
Patients with Prostate Cancer (n=40)
Css (mcg/mL)	8.939	3.504

13. NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year oral carcinogenicity studies were conducted in both male and female rats and mice at doses of 5, 15 or 75 mg/kg/day of Bicalutamide. A variety of tumor target organ effects were identified and were attributed to the antiandrogenicity of Bicalutamide, namely, testicular benign interstitial (Leydig) cell tumors in male rats at all dose levels (the steady-state plasma concentration with the 5 mg/kg/day dose is approximately 2/3 human therapeutic concentrations*) and uterine adenocarcinoma in female rats at 75 mg/kg/day (approximately 1 1/2 times the human therapeutic concentrations*). There is no evidence of Leydig cell hyperplasia in patients; uterine tumors are not relevant to the indicated patient population.

A small increase in the incidence of hepatocellular carcinoma in male mice given 75 mg/kg/day of Bicalutamide (approximately 4 times human therapeutic concentrations*) and an increased incidence of benign thyroid follicular cell adenomas in rats given 5 mg/kg/day (approximately 2/3 human therapeutic concentrations*) and above were recorded. These neoplastic changes were progressions of non-neoplastic changes related to hepatic enzyme induction observed in animal toxicity studies. Enzyme induction has not been observed following Bicalutamide administration in man. There were no tumorigenic effects suggestive of genotoxic carcinogenesis.

A comprehensive battery of both in vitro and in vivo genotoxicity tests (yeast gene conversion, Ames, E. coli, CHO/HGPRT, human lymphocyte cytogenetic, mouse micronucleus, and rat bone marrow cytogenetic tests) has demonstrated that Bicalutamide does not have genotoxic activity.

Administration of Bicalutamide may lead to inhibition of spermatogenesis. The long-term effects of Bicalutamide on male fertility have not been studied.

In male rats dosed at 250 mg/kg/day (approximately 2 times human therapeutic concentrations*), the precoital interval and time to successful mating were increased in the first pairing but no effects on fertility following successful mating were seen. These effects were reversed by 7 weeks after the end of an 11-week period of dosing.

No effects on female rats dosed at 10, 50 and 250 mg/kg/day (approximately 2/3, 1 and 2 times human therapeutic concentrations, respectively*) or their female offspring were observed. Administration of Bicalutamide to pregnant females resulted in feminization of the male offspring leading to hypospadias at all dose levels. Affected male offspring were also impotent.

*Based on a maximum dose of 50 mg/day of Bicalutamide for an average 70 kg patient.

14. CLINICAL STUDIES

Bicalutamide 50 mg Daily in Combination with an LHRH-A

In a multicenter, double-blind, controlled clinical trial, 813 patients with previously untreated advanced prostate cancer were randomized to receive Bicalutamide 50 mg once daily (404 patients) or flutamide 250 mg (409 patients) three times a day, each in combination with LHRH analogs (either goserelin acetate implant or leuprolide acetate depot).

In an analysis conducted after a median follow-up of 160 weeks was reached, 213 (52.7%) patients treated with Bicalutamide-LHRH analog therapy and 235 (57.5%) patients treated with flutamide-LHRH analog therapy had died. There was no significant difference in survival between treatment groups (see Figure 1). The hazard ratio for time to death (survival) was 0.87 (95% confidence interval 0.72 to 1.05).

Figure 1 - The Kaplan-Meier probability of death for both antiandrogen treatment groups.

There was no significant difference in time to objective tumor progression between treatment groups (see Figure 2). Objective tumor progression was defined as the appearance of any bone metastases or the worsening of any existing bone metastases on bone scan attributable to metastatic disease, or an increase by 25% or more of any existing measurable extraskeletal metastases. The hazard ratio for time to progression of Bicalutamide plus LHRH analog to that of flutamide plus LHRH analog was 0.93 (95% confidence interval, 0.79 to 1.10).

Figure 2 - Kaplan-Meier curve for time to progression for both antiandrogen treatment groups.

Quality of life was assessed with self-administered patient questionnaires on pain, social functioning, emotional well being, vitality, activity limitation, bed disability, overall health, physical capacity, general symptoms, and treatment related symptoms. Assessment of the Quality of Life questionnaires did not indicate consistent significant differences between the two treatment groups.

Safety Data from Clinical Studies using Bicalutamide 150 mg

Bicalutamide 150 mg is not approved for use either alone or with other treatments.

Two identical multicenter, randomized, open-label trials comparing Bicalutamide 150 mg daily monotherapy to castration were conducted in patients that had locally advanced (T3-4, NX, MO) or metastatic (M1) prostate cancer.

Monotherapy — M1 Group

Bicalutamide 150 mg daily is not approved for use in patients with M1 cancer of the prostate. Based on an interim analysis of the two trials for survival, the Data Safety Monitoring Board recommended that Bicalutamide treatment be discontinued in the M1 patients because the risk of death was 25% (HR 1.25, 95% CI 0.87 to 1.81) and 31% (HR 1.31, 95% CI 0.97 to 1.77) higher in the Bicalutamide treated group compared to that in the castrated group, respectively.

Locally Advanced (T3-4, NX, MO) Group

Bicalutamide 150 mg daily is not approved for use in patients with locally advanced (T3-4, NX, M0) cancer of the prostate. Following discontinuation of all M1 patients, the trials continued with the T3-4, NX, MO patients until study completion. In the larger trial (N=352), the risk of death was 25% (HR 1.25, 95% CI 0.92 to 1.71) higher in the Bicalutamide group and in the smaller trial (N=140), the risk of death was 36% (HR 0.64, 95% CI, 0.39 to 1.03) lower in the Bicalutamide group.

In addition to the above two studies, there are three other on-going clinical studies that provide additional safety information for Bicalutamide 150 mg, a dose that is not approved for use. These are three multicenter, randomized, double-blind, parallel group trials comparing Bicalutamide 150 mg daily monotherapy (adjuvant to previous therapy or under watchful waiting) with placebo, for death or time to disease progression, in a population of 8113 patients with localized or locally advanced prostate cancer.

Bicalutamide 150 mg daily is not approved for use as therapy for patients with localized prostate cancer who are candidates for watchful waiting. Data from a planned subgroup analysis of two of these trials in 1627 patients with localized prostate cancer who were under watchful waiting, revealed a trend toward decreased survival in the Bicalutamide arm after a median follow-up of 7.4 years. There were 294 (37.7%) deaths in the Bicalutamide treated patients versus 279 (32.9%) deaths in the placebo treated patients (localized watchful waiting group) for a hazard ratio of 1.16 (95% CI 0.99 to 1.37).

16. HOW SUPPLIED/STORAGE AND HANDLING

Bicalutamide Tablets USP, 50 mg are white to off-white, round, biconvex, film-coated tablets, debossed with ZE 57 on one side and plain on other side and are supplied as follows:

NDC 68382-224-06 in bottle of 30 tablets

NDC 68382-224-01 in bottle of 100 tablets

NDC 68382-224-05 in bottle of 500 tablets

NDC 68382-224-10 in bottle of 1000 tablets

NDC 68382-224-30 in blister pack of 100 tablets

Storage and Handling

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

Dispense in a tight container.

17. PATIENT COUNSELING INFORMATION

Patients should be informed that therapy with Bicalutamide and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their physician.

During treatment with Bicalutamide, somnolence has been reported, and those patients who experience this symptom should observe caution when driving or operating machines.

Patients should be informed that diabetes, or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving Bicalutamide in combination with LHRH agonists.

Manufactured by:

Cadila Healthcare Ltd.

Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 10/11

Revision Date : 10/23/2011

Patient Information

Bicalutamide Tablets, USP

Read the Patient Information that comes with Bicalutamide before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Bicalutamide?

Bicalutamide is a prescription medicine called an androgen receptor inhibitor, used in combination with lutenizing hormone-releasing hormone (LHRH) medicines to treat stage D2 metatastic prostate cancer. It is not known if Bicalutamide is safe and effective in children.

Who should not take Bicalutamide?

Do not take Bicalutamide if:

• you are a woman.


• you are allergic to any of the ingredients in Bicalutamide. See the end of this leaflet for a complete list of ingredients.

What should I tell my healthcare provider before taking Bicalutamide?

Before you take Bicalutamide, tell your healthcare provider about all your medical conditions including if you:

• are a woman (see who should not take Bicalutamide).


• are pregnant or think you may be pregnant.


• have liver problems.


• take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner.


• have diabetes (poor blood sugar control has been reported in people taking Bicalutamide in combination with LHRH medicines).

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Bicalutamide and other medicines may affect each other causing side effects. Bicalutamide may affect the way other medicines work, and other medicines may affect how Bicalutamide works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I take Bicalutamide?

• Take Bicalutamide exactly as prescribed.


• Take Bicalutamide at the same time everyday.


• Your treatment with Bicalutamide should start at the same time as your treatment with the LHRH medicine.


• If you miss a dose do not take an extra dose, take the next dose at your regular time. Do not take 2 doses at the same time.


• Bicalutamide can be taken with or without food.


• If you take too much Bicalutamide, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.


• Do not stop taking Bicalutamide unless your healthcare provider tells you.


• Your healthcare provider may do blood tests while you take Bicalutamide.


• Your prostate cancer may get worse while taking Bicalutamide in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

What should I avoid while taking Bicalutamide?

Driving and operating machinery. Do not drive, operate machinery, or do other dangerous activities until you know how Bicalutamide affects you.

What are the possible side effects of Bicalutamide?

Bicalutamide can cause serious side effects.

Get medical help right away, if you have:

• Trouble breathing with or without a cough or fever. Some people who take Bicalutamide get an inflammation in the lungs called interstitial lung disease.


• An allergic reaction. Symptoms of an allergic reaction include: itching of the skin, hives (raised bumps), swelling of the face, lips, tongue, throat, or trouble swallowing.


• Yellowing of the skin and eyes (jaundice), dark urine, right upper stomach pain, nausea, vomiting, tiredness, loss of appetite, chills, fever, whole body pain. These may be symptoms of liver damage.


• Poor blood sugar control can happen in people who take Bicalutamide in combination with LHRH medicines.


• Enlargement of breast (gynecomastia) and breast pain.

The most common side effects of Bicalutamide include:

• hot flashes, or short periods of feeling warm and sweating


• whole body pain in your back, pelvis, stomach


• feeling weak


• constipation


• infection


• nausea


• swelling in your ankles, legs or feet


• diarrhea


• blood in your urine


• waking from sleep to urinate at night


• a decrease in red blood cells (anemia)


• feeling dizzy

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Bicalutamide. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE Bicalutamide TABLETS?

Store Bicalutamide tablets between 20°C to 25°C (68°F to 77°F).

Keep Bicalutamide tablets and all medicines out of the reach of children.

General information about the safe and effective use of Bicalutamide Tablets.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Bicalutamide for a condition for which it was not prescribed. Do not give Bicalutamide to other people, even if they have the same symptoms that you h

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