Pack Content Directory Cayman Islands

Wednesday, March 21, 2012

Interceptor Flavor Tabs

Dosage Form: FOR ANIMAL USE ONLY
Interceptor Flavor Tabs

INTERCEPTOR®

(milbemycin oxime) FLAVOR TABS®

The palatable once-a-month tablet that prevents heartworm disease, controls adult hookworm, and removes and controls adult roundworm and whipworm infections in dogs and puppies.

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Description:

INTERCEPTOR (milbemycin oxime) Flavor Tabs are available in four tablet sizes in color-coded packages for oral administration to dogs and puppies. Each tablet is formulated to provide a minimum of 0.23 mg/lb (0.5 mg/kg) body weight of milbemycin oxime. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32H45NO7, MW 555.71) and 20% A3 (C31H43NO7, MW541.68)

Package color	Milbemycin oxime tablet
Brown	2.3 mg
Green	5.75 mg
Yellow	11.5 mg
White	23.0 mg

Indications:

Interceptor Flavor Tabs are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

Dosage:

Interceptor Flavor Tabs are given orally, once a month, at the recommended minimum dosage rate of 0.23 mg milbemycin oxime per pound of body weight (0.5mg/kg).

Recommended Dosage Schedule for Dogs
Body Weight	Interceptor Flavor Tabs
2-10 lbs.	One tablet (2.3 mg)
11-25 lbs.	One tablet (5.75 mg)
26-50 lbs.	One tablet (11.5 mg)
51-100 lbs.	One tablet (23.0 mg)

Dogs over 100 lbs. are provided the appropriate combination of tablets.

Administration:

Interceptor Flavor Tabs are palatable and most dogs will consume the tablet willingly when offered by the owner. As an alternative, the dual-purpose tablet may be offered in food or administered as other tablet medications. Watch the dog closely following dosing to be sure the entire dose has been consumed. If it is not entirely consumed, redose once with the full recommended dose as soon as possible.

Interceptor Flavor Tabs must be administered monthly, preferably on the same date each month. The first dose should be administered within one month of the dog’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. If a dose is missed and a 30-day interval between dosing is exceeded, administer Interceptor Flavor Tabs immediately and resume the monthly dosing schedule.

If Interceptor Flavor Tabs replaces diethylcarbamazine (DEC)for heartworm prevention, the first dose must be given within 30 days after the last dose of DEC.

Palatability:

Palatability trials conducted in 244 dogs from 10 different U.S. veterinary practices demonstrated that INTERCEPTOR Flavor Tabs were willingly accepted from the owner by over 95% of dogs. The trial was comprised of dogs representing 60 different breeds and both sexes, with weights ranging from 2.1 lbs. to 143.3 lbs., and ages ranging from 8 weeks to 15 years.

Precautions:

Do not use in puppies less than four weeks of age and less than two pounds of body weight. Prior to initiation of the INTERCEPTOR Flavor Tabs treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with Interceptor Flavor Tabs. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae.

Adverse Reactions:

The following adverse reactions have been reported following the use of Interceptor Flavor Tabs: Depression/lethargy, vomiting, ataxia, anorexia, diarrhea, convulsions, weakness and hypersalivation.

Efficacy:

Interceptor Flavor Tabs eliminate the tissue stage of heartworm larvae and the adult stage of hookworm (Ancylostoma caninum), roundworms (Toxocara canis, Toxascaris leonina) and whipworm (Trichuris vulpis) infestations when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety:

Milbemycin oxime has been tested safely in over 75 different breeds of dogs, including collies, pregnant females, breeding males and females, and puppies over two weeks of age. In well-controlled clinical field studies, 786 dogs completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, antibiotics, steroids, flea collars, shampoos and dips.

Two studies in heartworm-infected dogs were conducted which demonstrated mild, transient hypersensitivity reactions in treated dogs with high microfilaremia counts (see Precautions for reactions observed). Safety studies in pregnant dogs demonstrated that high doses (1.5 mg/kg = 3X) of milbemycin oxime given in an exaggerated dosing regimen (daily from mating through weaning), resulted in measurable concentrations of the drug in milk. Puppies nursing these females which received exaggerated dosing regimens demonstrated milbemycin-related effects. These effects were directly attributable to the exaggerated experimental dosing regimen. The product is normally intended for once-a-month administration only. Subsequent studies included using 3X daily from mating to one week before weaning and demonstrated no effects on the pregnant females or their litters. A second study where pregnant females were dosed once at 3X the monthly use rate either before, on the day of or shortly after whelping resulted in no effects on the puppies.

Some nursing puppies, at 2, 4, and 6 weeks of age, given greatly exaggerated oral milbemycin oxime doses (9.6 mg/kg = 19X) exhibited signs typified by tremors, vocalization and ataxia. These effects were all transient and puppies returned to normal within 24 to 48 hours. No effects were observed in puppies given the recommended dose of milbemycin oxime (0.5 mg/kg). This product has not been tested in dogs less than 1 kg weight.

A rising-dose safety study conducted in rough coated collies manifested a clinical reaction consisting of ataxia, pyrexia and periodic recumbency in one of fourteen dogs treated with milbemycin oxime at 12.5 mg/kg (25X monthly use rate). Prior to receiving the 12.5 mg/kg dose (25X monthly use rate) on day 56 of the study, all animals had undergone an exaggerated dosing regimen consisting of 2.5 mg/kg milbemycin oxime (5X monthly use rate) on day 0, followed by 5.0 mg/kg (10X monthly use rate) on day 14 and 10.0 mg/kg (20X monthly use rate) on day 32. No adverse reactions were observed in any of the collies treated with this regimen up through the 10.0 mg/kg (20X monthly use rate) dose.

How Supplied:

Interceptor Flavor Tabs are available in four tablet sizes (see Dosage section), formulated according to the weight of the dog. Each tablet size is available in color-coded packages of 6 or 12 tablets each, which are packaged 10 per display carton.

Storage Conditions:

Interceptor Flavor Tabs should be stored at room temperature, between 59° and 77°F (15-25°C).

U.S. Patent No. 4,547,520

Manufactured for:

Novartis Animal Health US, Inc.,

Greensboro, NC 27408, USA

NADA #140-915, Approved by FDA

NAH/INT-FTC/VI/3

12/07

INTERCEPTOR and Flavor Tabs are registered trademarks of Novartis AG.

Interceptor®

(milbemycin oxime) FLAVOR TABS®

INFORMATION FOR DOSING DOGS

The palatable once-a-month tablet that prevents heartworm disease, controls adult hookworm, and removes and controls adult roundworm and whipworm infections in dogs and puppies.

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Description:

Package color	Milbemycin oxime tablet
Brown	2.3mg
Green	5.75mg
Yellow	11.5mg
White	23.0mg

IndIcations:

Interceptor Flavor Tabs are indicated for use in the prevention of heartworm disease caused by Dirofilaria irnmitis, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis and Toxascaris leonina (roundworms) and Trichuris vulpis (whipworm) infections in dogs and in puppies four weeks of age or greater and two pounds body weight or greater.

Dosage:

Interceptor Flavor Tabs are given orally, once a month, at the recommended minimum dosage rate of 0.23mg milbemycin oxime per pound of bodyweight (0.5 mg/kg).

Recommended Dosage Schedule for Dogs

Body Weight	Interceptor Flavor Tabs
2-10 lbs.	One tablet (2.3 mg)
11-25 lbs.	One tablet (5.75 mg)
26-50 lbs.	One tablet (11.5 mg)
51-100 lbs.	One tablet (23.0 mg)

Dogs over 100 lbs. are provided the appropriate combination of tablets.

Administration:

If Interceptor Flavor Tabs replaces diethylcarbamazine (DEC) for heartworm prevention, the first dose must be given within 30 days after the last dose of DEC.

Palatability:

Palatability trials conducted in 244 dogs from 10 different U.S. veterinary practices demonstrated that Interceptor Flavor Tabs were willingly accepted from the owner by over 95% of dogs. The trial was comprised of dogs representing 60 different breeds and both sexes, with weights ranging from 2.1 lbs. to 143.3 lbs., and ages ranging from 8 weeks to 15 years.

Precautions:

Do not use in puppies less than four weeks of age and less than two pounds of body weight. Prior to initiation of the Interceptor Flavor Tabs treatment program, dogs should be tested for existing heartworm infections. Infected dogs should be treated to remove adult heartworms and microfilariae prior to initiating treatment with Interceptor Flavor Tabs. Mild, transient hypersensitivity reactions manifested as labored respiration, vomiting, salivation and lethargy, have been noted in some treated dogs carrying a high number of circulating microfilariae. These reactions are presumably caused by release of protein from dead or dying microfilariae.

Adverse Reactions:

The following adverse reactions have been reported following the use of Interceptor Flavor Tabs: Depression/lethargy, vomiting, ataxia, anorexia, diarrhea, convulsions, weakness and hypersalivation.

Efficacy;

Interceptor Flavor Tabs eliminate the tissue stage of heartworm larvae and the adult stage of hookworm (Ancylostoma caninum), roundworms (Toxocara canis. Toxascaris leonina) and whipworm (Trichuris vulpis) infestations when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety:

Two studies in heartworm-infected dogs were conducted which demonstrated mild, transient hypersensitivity reactions in treated dogs with high microfilaremia counts (see Precautions for reactions observed). Safety studies in pregnant dogs demonstrated that high doses (1.5 mg/kg = 3X) of milbemycin oxime given in an exaggerated dosing regimen (daily from mating through weaning), resulted in measurable concentrations of the drug in milk. Puppies nursing these females which received exaggerated dosing regimens demonstrated milbemycin-relaled effects. These effects were directly attributable to the exaggerated experimental dosing regimen. The product is normally intended for once-a-month administration only. Subsequent studies included using 3X daily from mating to one week before weaning and demonstrated no effects on the pregnant females or their litters. A second study where pregnant females were dosed once at 3X the monthly use rate either before, on the day of or shortly after whelping resulted in no effects on the puppies.

A rising-dose safety study conducted in roughcoated collies, manifested a clinical reaction consisting of ataxia, pyrexia and periodic recumbency. In one of fourteen dogs treated with milbemycin oxime at 12.5 mg/kg (25X monthly use rate). Prior to receiving the 12.5 mg/kg dose (25X monthly use rate) on day 56 of the study, all animals had undergone an exaggerated dosing regimen consisting of 2.5 mg/kg milbemycin oxime (5X monthly use rate) on day 0, followed by 5.0 mg/kg (10X monthly use rate) on day 14 and 10.0 mg/kg (20X monthly use rate) on day 32. No adverse reactions were observed in any of the collies treated with this regimen up through the 10.0 mg/kg (20X monthly use rate) dose.

How supplied:

Storage conditions:

Interceptor Flavor Tabs should be stored at room temperature, between 59° and 77°F (15-25°C).

Interceptor®

(milbemycin oxime) FLAVOR TABS®

INFORMATION FOR DOSING CATS

The palatable once-a-month tablet that prevents heartworm disease and removes adult roundworms and hookworms in cats and kittens.

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Description:

Interceptor Flavor Tabs for Cats are available in three tablet sizes in color-coded packages for oral administration to cats and kittens. Each tablet is formulated to provide a minimum of 0.9 mg/lb (2.0 mg/kg) body weight of milbemycin oxime. Milbemycin oxime consists of the oxime derivatives of 5-didehydromilbemycins in the ratio of approximately 80% A4 (C32H45NO7, MW 555.71) and 20% A3 (C31H43N07, MW 541.68)

Indications:

Interceptor Flavor Tabs for Cats are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis, and the removal of adult Ancylostoma tubaeforme (hookworm) and Toxocara cati (roundworm) in cats and kittens six weeks of age or greater and 1.5 lbs. body weight or greater.

Dosage: Interceptor Flavor Tabs for Cats are given orally, once a month, at the recommended minimum dosage rate of 0.9 mg milbemycin oxime per pound of body weight (2.0mg/kg).

Recommended Dosage Schedule for Cats
Body Weight	Interceptor Flavor Tabs
1.5 to 6 lbs.	One tablet (5.75 mg)
6.1-12 lbs.	One tablet (11.5 mg)
12.1-25 lbs.	One tablet (23.0 mg)

Cats over 25 lbs. are provided the appropriate combination of tablets.

Administration:

Interceptor Flavor Tabs for Cats are palatable and may be offered by the owner as a treat. As an alternative, the tablet may be offered in food or administered as other tablet medications. The tablets can be broken for ease of administration. Watch the cat closely following dosing to be sure the entire dose has been consumed. If it is not entirely consumed, redose once with the full recommended dose as soon as possible.

Interceptor Flavor Tabs for Cats must be administered monthly, preferably on the same date each month. The first dose should be administered within one month of the cat’s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season. If a dose is missed and a 30-day interval between dosing is exceeded, administer Interceptor Flavor Tabs for Cats immediately and resume the monthly dosing schedule. It is recommended that cats be tested for existing heartworm infection prior to starting treatment with Interceptor Flavor Tabs for Cats (See Precautions).

Palatability:

Palatability trials conducted in 72 cats demonstrated that Interceptor Flavor Tabs for Cats were successfully dosed by the owner when they either offered the tablet as a treat, placed the tablet in the cats mouth or placed the tablet in the cat’s food in 72% of cats. About 16% of the cats were manually dosed and 13% of the cats were not successfully dosed according to the protocol.

Precautions:

Do not use in kittens less than six weeks of age or less than 1.5 lbs. body weight. Safety in heartworm positive cats has not been established. Safety in breeding, pregnant, and lactating queens and breeding toms has not been established.

Efficacy:

Interceptor Flavor Tabs for Cats eliminate the tissue stage of heartworm larvae and hookworm (Ancy/ostoma tubaeforme) and roundworm (Toxocara cati) infections when administered orally according to the recommended dosage schedule. The anthelmintic activity of milbemycin oxime is believed to be a result of interference with invertebrate neurotransmission.

Safety:

Milbemycin oxime has been tested safely in over 8 different breeds of cats. In well-controlled clinical field studies 141 cats completed treatment with milbemycin oxime. Milbemycin oxime was used safely in animals receiving frequently used veterinary products such as vaccines, anthelmintics, anesthetics, antibiotics, steroids, flea collars, shampoos and dips.

Safety studies were conducted in young cats and kittens and doses of 1X, 3X and 5X the minimum recommended dose of 2.0 mg/kg demonstrated no drug-related effects. Tolerability studies at exaggerated doses of 10X also demonstrated no drug-related adverse effects in kittens and young adult cats.

How supplied:

Interceptor Flavor Tabs for Cats are available in three tablet sizes (see Dosage section), formulated according to the weight of the cat. Each tablet size is available in color-coded packages of 6 or 12 tablets each, which are packaged 10 per display carton.

Storage conditions:

Interceptor Flavor Tabs for Cats should be stored at room temperature, between 59° and 77°F (15-25°C).

U.S. Patent No. 4,547,520

Manufactured for:

Novartis Animal Health US, Inc.

Greensboro, NC 27408, USA

NADA #140-915, Approved by FDA

INTERCEPTOR and Flavor Tabs are registered trademarks of Novartis AG.

NAH/INT-FTCF/VI/2

12/07

PRINCIPAL DISPLAY PANEL

Package Label – 2.3 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies.

Net contents: 6 tablets. 2.3 mg each.

Product #20111 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH

PRINCIPAL DISPLAY PANEL

Package Label – 5.75 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies, and to prevent

heartworm disease and remove

adult hookworms and

roundworms in cats

and kittens.

Pack

For dogs 11-25lbs

For cats 1.5-6lbs

Net contents: 6 tablets. 5.75 mg each.

Product #20121 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH

PRINCIPAL DISPLAY PANEL

Package Label – 11.5 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies, and to prevent

heartworm disease and remove

adult hookworms and

roundworms in cats

and kittens.

Pack

For dogs 26-50lbs

For cats 6.1-12lbs

Net contents: 6 tablets. 11.5 mg each.

Product #20131 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH

PRINCIPAL DISPLAY PANEL

Package Label – 23.0 mg

Interceptor®

(milbemycin oxime) FLAVOR TABS®

BROAD SPECTRUM

PARASITICIDE

Contains once-a-month Flavor

Tabs to prevent heartworm disease,

control adult hookworm infection,

and remove and control adult

roundworms and whipworms in

dogs and puppies, and to prevent

heartworm disease and remove

adult hookworms and

roundworms in cats

and kittens.6

Pack

For dogs 51-100lbs

For cats 12.1-25lbs

Net contents: 6 tablets. 23.0 mg each.

Product #20141 NADA #140-915, Approved by FDA.

Keep this and all drugs out of the reach of children.

Caution: Federal (USA) law restricts this drug to use

by or on the order of a licensed veterinarian.

NOVARTIS

ANIMAL HEALTH

PRINCIPAL DISPLAY PANEL – BULK PRODUCT

Bulk Product – 5 KILOGRAM DRUM

MILBEMYCIN OXIME (S-147)

CGA 179246 A

PROD. NO. 80021

CAS-NO 122674-17-3

NEW ANIMAL DRUG

NADA 141-084, 140-915, and 141-163

ISSUED BY U.S. FDA, CENTER FOR VETERINARY MEDICINE

U.S. CONSIGNEE

NOVARTIS ANIMAL HEALTH US, INC.

GREENSBORO, NC

REGULATORY AFFAIRS 336-387-1000

Manufactured by

Alps Pharmaceutical Ind. Co. Ltd.

on behalf of Novartis Animal Health K.K.

Tokyo 106-0031

Japan

IN EMERGENCY DIAL

CH 4161-696-3333

US 1-800-424-9300

602373/NAH/MIL/BULK/03/08

Interceptor Flavor Tabs
milbemycin oxime tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-2011
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	2.3 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (Light brown)	Score	no score
Shape	ROUND	Size	6mm
Flavor	MEAT (Beef flavor)	Imprint Code	RN;CGV
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58198-2011-1	1 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2011-1)
2	58198-2011-3	2 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2011-3)
3	58198-2011-5	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2011-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140915	07/21/1994

Interceptor Flavor Tabs
milbemycin oxime tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-2012
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	5.75 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (Light brown)	Score	no score
Shape	ROUND	Size	8mm
Flavor	MEAT (Beef flavor)	Imprint Code	GO;CGV
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58198-2012-1	1 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2012-1)
2	58198-2012-3	2 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2012-3)
3	58198-2012-5	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2012-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140915	07/21/1994

Interceptor Flavor Tabs
milbemycin oxime tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-2013
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	11.5 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (Light Brown)	Score	no score
Shape	ROUND	Size	10mm
Flavor	MEAT (Beef Flavor)	Imprint Code	FKF;CGV
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58198-2013-1	1 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2013-1)
2	58198-2013-3	2 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2013-3)
3	58198-2013-5	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2013-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140915	07/21/1994

Interceptor Flavor Tabs
milbemycin oxime tablet

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-2014
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	23 mg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	BROWN (light brown)	Score	no score
Shape	ROUND	Size	14mm
Flavor	MEAT (Beef Flavor)	Imprint Code	FRF;CGV
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58198-2014-1	1 BLISTER PACK In 1 BOX	contains a BLISTER PACK
1		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2014-1)
2	58198-2014-3	2 BLISTER PACK In 1 BOX	contains a BLISTER PACK
2		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2014-3)
3	58198-2014-5	10 BLISTER PACK In 1 BOX	contains a BLISTER PACK
3		6 TABLET In 1 BLISTER PACK	This package is contained within the BOX (58198-2014-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140915	07/21/1994

MILBEMYCIN OXIME
milbemycin oxime powder

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	NDC Product Code (Source)	58198-1001
Route of Administration	NOT APPLICABLE	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILBEMYCIN OXIME (MILBEMYCIN OXIME)	MILBEMYCIN OXIME	1 kg in 1 kg

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	WHITE (white to yellowish white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#

Sunday, March 18, 2012

Nasop12

Generic Name: phenylephrine (FEN il EFF rin)

Brand Names: Ah-Chew D, Dimetapp Cold Drops, Lusonal, Nasop, Nasop12, PediaCare Children's Decongestant, Phenyl-T, Sudafed PE, Sudafed PE Children's Nasal Decongestant, Sudafed PE Quick Dissolve, Sudogest PE, Triaminic Thin Strips Cold

What is Nasop12 (phenylephrine)?

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Phenylephrine is used to treat nasal congestion and sinus pressure caused by allergies, the common cold, or the flu. Phenylephrine may be used to treat congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Nasop12 (phenylephrine)?

You should not use this medication if you are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have heart disease, heart rhythm disorder, high blood pressure, circulation problems, diabetes, glaucoma, a thyroid disorder, kidney disease, an enlarged prostate or urination problems, anxiety, sleep problems, bipolar disorder or other mental illness.

Phenylephrine may interact with heart or blood pressure medications, antidepressants, diabetes medications, migraine headache medications, and other decongestants.

Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

What should I discuss with my healthcare provider before taking Nasop12 (phenylephrine)?

You should not use this medication if you are allergic to phenylephrine.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have:

heart disease, heart rhythm disorder;

high blood pressure;

circulation problems (such as Raynaud's syndrome);

diabetes;

glaucoma;

a thyroid disorder;

kidney disease;

an enlarged prostate or urination problems;

sleep problems, anxiety; or

mental illness such as bipolar disorder.

FDA pregnancy category C. Is not known whether this medication will harm an unborn baby. Before you take phenylephrine, tell doctor if you are pregnant. Phenylephrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Disintegrating and liquid forms of cold medicine may contain sugar or artificial sweeteners (phenylalanine). This would be important to know if you have diabetes or phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about sugar or phenylalanine.

How should I use Nasop12 (phenylephrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You may take phenylephrine with food if it upsets your stomach. Take the phenylephrine tablet with a full glass of water.

Measure the liquid form of phenylephrine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable phenylephrine tablet must be chewed thoroughly before you swallow it.

To use the phenylephrine disintegrating strip, place one strip on your tongue and allow it to dissolve without chewing.

To use the disintegrating tablet, make sure your hands are dry and peel back the foil from the blister package. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Phenylephrine is usually taken every 4 hours. Follow the directions on the medicine label. Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store phenylephrine at room temperature away from moisture and heat. Keep the disintegrating tablets or strips in their package until you are ready to take one.

Throw away any unused phenylephrine after the expiration date on the label has passed. Do not flush this medication down a toilet. Ask your pharmacist about the safest way to dispose of unused medicines.

What happens if I miss a dose?

Cold medicine is usually taken only as needed, so you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, severe dizziness, sweating, vomiting, hallucinations, fast or uneven heart rate, fainting, seizure (convulsions), and weak or shallow breathing.

What should I avoid while using Nasop12 (phenylephrine)?

Do not use any other over-the-counter cold, allergy, or cough medication without first asking your doctor or pharmacist. Phenylephrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much phenylephrine. Read the label of any other medicine you are using to see if it contains phenylephrine or another decongestant.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Avoid smoking. It can add to the effects of phenylephrine in decreasing blood flow, which can lead to uncomfortable symptoms. Avoid drinking alcohol while you are taking phenylephrine.

Nasop12 (phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using phenylephrine and call your doctor at once if you have a serious side effect such as:

severe dizziness, restless feeling, nervousness, or insomnia;

unusual thoughts or behavior;

feeling like you might pass out;

fast, pounding, or uneven heartbeat;

tremors or shaking;

numbness, tingling, or cold feeling in your hands or feet; or

urinating less than usual or not at all.

Less serious side effects may include:

headache, dizziness;

feeling excited or restless (especially in children);

upset stomach; or

mild sleep problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Nasop12 (phenylephrine)?

Tell your doctor about all other medications you use, especially:

other decongestants, including nasal sprays;

digoxin (digitalis, Lanoxin);

medicine to treat diabetes;

medicines to treat high blood pressure such as reserpine, methyldopa (Aldomet), and others;

migraine headache medicine such as ergotamine (Ergomar), naratriptan (Amerge), sumatriptan (Imitrex) or zolmitriptan (Zomig);

an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and others; or

a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others.

This list is not complete and there may be other drugs that can interact with phenylephrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Nasop12 resources

Nasop12 Side Effects (in more detail)
Nasop12 Use in Pregnancy & Breastfeeding
Nasop12 Drug Interactions
Nasop12 Support Group
0 Reviews for Nasop12 - Add your own review/rating

AH-Chew D Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Lusonal Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Nasop Dissolving Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Neo-Synephrine Nasal Advanced Consumer (Micromedex) - Includes Dosage Information

Neo-Synephrine MedFacts Consumer Leaflet (Wolters Kluwer)

Phenylephrine Hydrochloride Monograph (AHFS DI)

Sudafed PE MedFacts Consumer Leaflet (Wolters Kluwer)

Sudafed PE Consumer Overview

Compare Nasop12 with other medications

Hypotension
Nasal Congestion
Shock
Supraventricular Tachycardia

Where can I get more information?

Your pharmacist can provide more information about phenylephrine.

See also: Nasop12 side effects (in more detail)

Saturday, March 17, 2012

Secondary Cutaneous Bacterial Infections Medications

Drugs associated with Secondary Cutaneous Bacterial Infections

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

Drug List:

Carmol-Scalp

Carmol-Scalp-Treatment-Lotion

Carmol-Scalp-Treatment-Kit

Rosula-Ns-Medicated-Pads

Seb-Prev-Lotion

Sebizon-Lotion

Tuesday, March 13, 2012

Pyrimethamine

Pronunciation: peer-i-METH-a-meen
Generic Name: Pyrimethamine
Brand Name: Daraprim

Pyrimethamine is used for:

Treating or preventing malaria and treating toxoplasmosis when used with other medicines (eg, folinic acid).

Pyrimethamine is an antiparasitic. It works by killing the parasites or preventing their growth.

Do NOT use Pyrimethamine if:

you are allergic to any ingredient in Pyrimethamine

you have megaloblastic anemia due to folate deficiency

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

Before using Pyrimethamine:

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

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

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

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

if you have a history of depression, seizures, kidney or liver problems, bone marrow problems, stomach or bowel problems (eg, malabsorption syndrome), phenylketonuria, or alcoholism

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

Phenytoin because side effects of Pyrimethamine may be increased

Methotrexate, proguanil, quinine, sulfonamides (eg, sulfamethoxazole), or zidovudine because the risk of bone marrow suppression may be increased

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

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

Pyrimethamine may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Your doctor may also prescribe another medicine called folinic acid (leucovorin calcium) to take along with Pyrimethamine.

To clear up your infection completely, continue using Pyrimethamine for the full course of treatment even if you feel better in a few days.

If you miss a dose of Pyrimethamine, 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 Pyrimethamine.

Important safety information:

It is important to use Pyrimethamine for the full course of treatment. Failure to do so may decrease the effectiveness of Pyrimethamine and may increase the risk that the organisms will no longer be sensitive to Pyrimethamine and will not be able to be treated by this or certain other antibiotics in the future.

LAB TESTS, including blood cell counts and platelet counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Pyrimethamine with caution in the ELDERLY because they may be more sensitive to its effects.

PREGNANCY and BREAST-FEEDING: It is unknown if Pyrimethamine can cause harm to the fetus. Avoid becoming pregnant while taking Pyrimethamine. If you become pregnant while taking Pyrimethamine, discuss with your doctor the benefits and risks of using Pyrimethamine during pregnancy. Pyrimethamine is excreted in breast milk. Do not breast-feed while taking Pyrimethamine.

Possible side effects of Pyrimethamine:

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:

Loss of appetite; nausea; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; irregular heartbeat; pale skin; red, swollen, or blistered skin; severe or persistent vomiting; sore throat or fever; unusual bleeding or bruising.

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: Pyrimethamine 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 abdominal pain; difficulty breathing; fast heartbeat; fever; nausea; seizures; severe or persistent vomiting; stomach pain; vomiting of blood.

Proper storage of Pyrimethamine:

Store Pyrimethamine at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pyrimethamine out of the reach of children and away from pets.

General information:

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

Pyrimethamine 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 Pyrimethamine. 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

More Pyrimethamine resources

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

Pyrimethamine Professional Patient Advice (Wolters Kluwer)

pyrimethamine Advanced Consumer (Micromedex) - Includes Dosage Information

pyrimethamine Concise Consumer Information (Cerner Multum)

Daraprim Prescribing Information (FDA)

Daraprim Monograph (AHFS DI)

Compare Pyrimethamine with other medications

Malaria Prevention
Pneumocystis Pneumonia Prophylaxis
Toxoplasmosis
Toxoplasmosis, Prophylaxis

Sunday, March 11, 2012

Clobeta Ointment

Dosage Form: ointment, kit
Clobetasol Propionate Ointment USP, 0.05%

Clobeta Ointment Description

Rx Only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE

Clobetasol propionate ointment contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobetasol propionate is a white to cream-colored crystalline powder insoluble in water. Chemically, it is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, and it has the following structural formula:

C25H32CIFO5 Molecular Weight: 467

Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.

Clobeta Ointment - Clinical Pharmacology

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Greater absorption was observed for the clobetasol propionate gel formulation as compared to the cream formulation in in vitro human skin penetration studies. Studies performed with clobetasol propionate gel, cream and ointment indicate that they are in the super-high range of potency as compared with other topical corticosteroids.

Indications and Usage for Clobeta Ointment

Clobetasol propionate ointment is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Contraindications

Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at doses as low as 2 g per day.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal from treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on therapy.

Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use).

If irritation develops, clobetasol propionate should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing. If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of clobetasol propionate should be discontinued until the infection has been adequately controlled.

Clobetasol propionate ointment should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or axillae.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. This medication should not be used for any disorder other than that for which it was prescribed.

3. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions to the physician.

5. Patients should inform their physicians that they are using clobetasol propionate if surgery iscontemplated.

Laboratory Tests: The following tests may be helpful in evaluating patients for HPA axis suppression: ACTH stimulation test, A.M. plasma cortisol test, Urinary free cortisol test.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate. Studies in the rat following oral administration at dosage levels up to 50 mg/kg per day revealed that the females exhibited an increase in the number of resorbed embryos and a decrease in the number of living fetuses at the highest dose. Clobetasol propionate was non-mutagenic in three different test systems: the Ames test, the Saccharomyces cerevisiae gene conversion assay, and the E. coli B WP2 fluctuation test.

Pregnancy: Teratogenic Effects–Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 0.33 and 0.01 times, respectively, the human topical dose of clobetasol propionate ointment. Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.001 and 0.003 times, respectively, the human topical dose of clobetasol propionate ointment. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. Clobetasol propionate ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clobetasol propionate ointment is administered to a nursing woman.

Pediatric Use: Safety and effectiveness of clobetasol propionate ointment in pediatric patients have not been established. Use in children under 12 years of age is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children (see PRECAUTIONS).

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use: Clinical studies of clobetasol propionate drug products in US clinical trials did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

Adverse Reactions

In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.

Cushing’s syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

Overdosage

Topically applied clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Clobeta Ointment Dosage and Administration

Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE.)

Clobetasol propionate ointment is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 g per week should not be used.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Clobetasol propionate ointment should not be used with occlusive dressings.

How is Clobeta Ointment Supplied

Clobetasol Propionate Ointment USP, 0.05% is supplied in 60 g (NDC 23589-056-60) tube.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Manufactured for: TIBER LABORATORIES, Suwanee, GA 30024

CLOBETA
clobetasol propionate, coal tar kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	23589-075

Packaging
#	NDC	Package Description	Multilevel Packaging
1	23589-075-91	1 KIT In 1 PACKAGE, COMBINATION	None

QUANTITY OF PARTS
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	60 g
Part 2	1 BOTTLE	100 mL

Part 1 of 2

CLOBETASOL PROPIONATE
clobetasol propionate ointment

Product Information
NDC Product Code (Source)	23589-056
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOBETASOL PROPIONATE (CLOBETASOL)	CLOBETASOL PROPIONATE	0.5 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL
SORBITAN SESQUIOLEATE
PETROLATUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	23589-056-60	60 g In 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074248	04/06/2011	06/30/2012

Part 2 of 2

PSORENT
coal tar solution

Product Information
NDC Product Code (Source)	58414-8960
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (COAL TAR)	COAL TAR	23 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE
ALCOHOL
OLETH-2
PROPYLENE GLYCOL
TRIETHYL CITRATE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	58414-8960-1	100 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	04/06/2011	06/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074248	04/06/2011	06/30/2012

Labeler - Tiber Laboratories, LLC (008913939)

Revised: 11/2011Tiber Laboratories, LLC

More Clobeta Ointment resources

Clobeta Ointment Drug Interactions
Clobeta Ointment Support Group
0 Reviews · Be the first to review/rate this drug