BETAMETHASONE DIPROPIONATE lotion, augmented

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

BETAMETHASONE DIPROPIONATE

Composition:

BETAMETHASONE 0.5 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betamethasone dipropionate lotion (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Betamethasone dipropionate lotion (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. Risk Summary There are no available data on betamethasone dipropionate lotion (augmented), 0.05% use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women that betamethasone dipropionate lotion (augmented), 0.05% may increase the risk of having a low birthweight infant and to use betamethasone dipropionate lotion

Product summary:

Betamethasone Dipropionate Lotion USP (Augmented), 0.05% is supplied as follows: NDC 0168-0267-30, 30 mL bottle NDC 0168-0267-60, 60 mL bottle Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BET A M ET H ASO NE D IP RO PIO NATE- b eta m eth aso ne d ip ro pio nate lo tio n,
au gm ente d
E. F o ugera & C o. a d iv is io n o f F o ugera P harm ace utic als In c.
----------
HIG HLIG HTS O F P RESC RIB IN G IN FO RM ATIO N
Th ese h ig hlig hts d o n ot in clu d e a ll t h e in fo rm atio n n eed ed t o u se B ETA M ETH ASO NE
DIP RO PIO NATE L o tio n ( A ug m ente d ), 0 .0 5% s a fe ly a nd e ffe ctiv e ly . S ee f u ll p re scrib in g
in fo rm atio n f o r B ETA M ETH ASO NE D IP RO PIO NATE L o tio n ( A ug m ente d ), 0 .0 5% .
BETA M ETH ASO NE D IP RO PIO NATE lo tio n ( A ug m ente d ), 0 .0 5% f o r t o p ic a l u se
In it ia l U .S . A ppro va l: 1 983
REC EN T M AJO R C H AN GES
IN DIC ATIO NS A N D U SA G E
Beta m eth aso ne d ip ro pio nate lo tio n ( a ugm ente d), 0 .0 5% is a c o rtic o ste ro id in dic a te d fo r t h e r e lie f o f t h e
in fla m mato ry a nd p ru rit ic m anif e sta tio ns o f c o rtic o ste ro id -re sp onsiv e d erm ato se s in p atie nts 1 3 y e ars o f
age a nd o ld er. (
1 )
DOSA G E A N D A D M IN IS TR ATIO N
•
•
•
•
•
•
•
DOSA G E F O RM S A N D S TR EN GTH S
•
CO NTR AIN DIC ATIO NS
•
WARN IN GS A N D P REC AUTIO NS
•
•
AD VER SE R EA CTIO NS
Most c o m mon a dve rs e r e actio ns ( < 1% ) a re : e ry th em a, fo llic u lit is , p ru rit u s, a nd v e sic u la tio n. (
6.1
)
To r e p ort S U SP EC TE D A D VER SE R EA CTIO NS, c o nta ct F oug era P harm ace utic a ls In c. a t 1 -8 00-
645-9 833 o r F D A a t 1 -8 00-F D A-1 088 o r w ww.f d a.g ov/m ed w atc h .
See 1 7 f o r P ATIE N T C O UN SELIN G IN FO RM ATIO N a nd F D A-a p pro ve d p atie nt la b elin g .
Revis e d : 6 /2 019
Warn in gs a nd P re ca utio ns
Ophth alm ic A dve rs e R eactio ns
( 5.2
)
05/2 019
Apply a fe w d ro ps t o t h e a ffe cte d s kin a re as o nce o r t w ic e d aily a nd m assa ge lig htly u ntil t h e lo tio n
dis a ppears .(
2 )
Dis co ntin ue t h era py w hen c o ntro l is a ch ie ve d. (
2 )
Lim it t h era py t o n o m ore t h an 2 c o nse cu tiv e