FAMOTIDINE  - famotidine tablet 
NorthStar RxLLC

----------

Famotidine Tablets USP

Rx only


DESCRIPTION


N 8 15 7 2 3
chemical structure


CLINICAL PHARMACOLOGY IN ADULTS












ADVERSE REACTIONS





PRECAUTIONS DOSAGE AND ADMINISTRATION

PRECAUTIONS

Clinical Studies 


Duodenal Ulcer


Table 1

Outpatients With Endoscopically

Confirmed Healed Duodenal Ulcers

 

Famotidine 

Famotidine 

Placebo

 

40 mg h.s.

20 mg b.i.d.

h.s.

 

(N = 89)

  (N = 84)

(N = 97)

 

 

 

 

Week 2

**32%

**38%

17%

Week 4

**70%

**67%

31%







Long-Term Maintenance





 


Table 2

Patients with Endoscopically Confirmed


Healed Gastric Ulcers

 

U.S.Study

International Study

 

Famotidine

Placebo

Famotidine

Placebo

 

 (N = 74)
40 mg h.s.

(N = 75)
h.s.

(N = 149)  
40 mg h.s.   

(N = 145)
h.s.

Week 4

45%    

39%    

†47%

31%

Week 6

†66%

44%

†65%

46%

Week 8        

***78%          

64%

†80%

54%






 

Table 3

% Successful Symptomatic Outcome

 

Famotidine 

Famotidine 

 

 

20 mg b.i.d

40 mg h.s.

Placebo

 

(N = 154)

  (N = 149)

(N = 73)

 

 

 

 

Week 6

82††

69

62






Table 4

% Endoscopic Healing - U.S. Study

 

Famotidine 

Famotidine 

 

 

40 mg b.i.d

20 mg b.i.d

Placebo

 

(N = 127)

  (N = 125)

(N = 66)

 

 

 

 

Week 6

48†††,‡‡

32

18

Week 12

69†††,‡

54†††

29






In the international study, when famotidine 40 mg p.o. b.i.d., was compared to ranitidine 150 mg p.o. b.i.d., a statistically significantly greater percentage of healing was observed with famotidine 40 mg b.i.d. at week 12 (Table 5). There was, however, no significant difference among treatments in symptom relief.



Table 5

% Endoscopic Healing - International Study.

 

Famotidine 

Famotidine 

Ranitidine

 

40 mg b.i.d

20 mg b.i.d.

150 mg b.i.d.

 

(N = 175)

  (N = 93)

(N = 172)

 

 

 

 

Week 6

48

52

42

 

Week 12

71‡‡‡

68

60




CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS




 

Table 6

Pharmacokinetic Parametersa of Intravenous Famotidine

Age 
  (N= number of patients)

Area Under the Curve (AUC)
(ng-hr/ml)

Total Clearance
(CI)
  (L/hr/kg)

Volume of Distribution(Vd) (L/kg)

Elimination Half-life (T1/2)
(hours)

0-1monthsc

NA

0.13±0.06

1.4±0.4

10.5±5.4

(N=10)

 

 

 

 

0-3 monthsd

2688±847

0.21±0.06

1.8±0.3

8.1±3.5

(N=6)

 

 

 

 

>3-12 monthsd

1160±474

0.49±0.17

2.3±0.7

4.5±1.1

(N=11)

 

 

 

 

1-11 yrs

1089±834

0.54±0.34

2.07±1.49

3.38±2.60

(N=20)

 

 

 

 

11-15 yrs

1140±320

0.48±0.14

1.5±0.4

2.3±0.4

(N=6)

 

 

 

 

Adult

1726b

0.39±0.14

1.3±0.2

2.83±0.99

 

(N=16)

 

 

 

 

a
b
c
d





max


Table 7

Pharmacodynamics of famotidine using the sigmoid Emax model

Pediatric Patients

EC50 (ng/mL)*
26 ± 13

Data from one study

 

a) healthy adult subjects

26.5 ± 10.3

b) adult patients with upper GI bleeding

18.7 ± 10.8



 

Table 8

Dosage

Route

Effecta

Number of Patients (age range)

0.5 mg/kg,
single dose

I.V.

gastric pH >4 for
19.5 hours(17.3, 21.8) c

11 (5 to 19 days) 

0.3 mg/kg,
single dose

I.V.

gastric pH >3.5 for
8.7 ± 4.7b hours

6 (2 to 7 years) 

0.4 to 0.8 mg/kg

I.V.

gastric pH > 4 for 6 to 9 hours

18 (2 to 69 months)

0.5 mg/kg,
single dose

I.V.

a >2 pH unit  increase above baseline in gastric pH for >8 hours

9 (2 to 13 years) 

0.5 mg/kg b.i.d.

I.V.

gastric pH >5 for
13.5 ± 1.8b hours

4 (6 to 15 years)

0.5 mg/kg b.i.d.

oral

gastric pH >5 for 5.0 ± 1.1b hours

4 (11 to 15 years)

a
b
c

INDICATIONS AND USAGE



Short term treatment of active duodenal ulcer.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
Short term treatment of active benign gastric ulcer.
Short term treatment of gastroesophageal reflux disease (GERD). CLINICAL PHARMACOLOGY IN ADULTS
CLINICAL PHARMACOLOGY IN ADULTS
Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) CLINICAL PHARMACOLOGY IN ADULTS .

CONTRAINDICATIONS


Hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore, famotidine should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.

PRECAUTIONS

General




Patients with Moderate or Severe Renal Insufficiency


CLINICAL PHARMACOLOGY IN ADULTS DOSAGE AND ADMINISTRATION

 

Drug Interactions


No drug interactions have been identified. Studies with famotidine in man, in animal models, and in vitro have shown no significant interference with the disposition of compounds metabolized by the hepatic microsomal enzymes, e.g., cytochrome P450 system. Compounds tested in man include warfarin, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic drug extraction has been tested and no significant effects have been found.

Carcinogenesis, Mutagenesis, Impairment of Fertility



Salmonella typhimurium Escherichia coli in vivo

Pregnancy




Nursing Mothers




Pediatric Patients <1 year of age



CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS

ADVERSE REACTIONS




Pediatric Patients 1 - 16 years of age






Geriatric Use



CLINICAL PHARMACOLOGY IN ADULTS PRECAUTIONS Patients with Moderate or Severe Renal Insufficiency DOSAGE AND ADMINISTRATION Dosage Adjustment forPatients with Moderate or Severe Renal Insufficiency

ADVERSE REACTIONS


















Pediatric Patients

OVERDOSAGE


ADVERSE REACTIONS

DOSAGE AND ADMINISTRATION


DuodenalUlcer
Acute Therapy:
Maintenance Therapy:

Benign Gastric Ulcer

Acute Therapy:

Gastroesophageal Reflux Disease (GERD)


CLINICAL PHARMACOLOGY IN ADULTS Clinical Studies

Dosage for Pediatric Patients <1 year of age 

Gastroesophageal Reflux Disease (GERD) 
PRECAUTIONS




Dosage for Pediatric Patients 1-16 years of age 

PRECAUTIONS
Pediatric Patients 1-16 years of age
Peptic ulcer
Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations


Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) 



Concomitant Use of Antacids



Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency 

HOW SUPPLIED






















Storage




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ALEMBIC LIMITED



PRINCIPAL DISPLAY PANEL







Famotidine - 20 mg - 30 Tablets



PRINCIPAL DISPLAY PANEL







Famotidine - 20 mg - 60 Tablets

PRINCIPAL DISPLAY PANEL







Famotidine -20 mg - 90 Tablets

PRINCIPAL DISPLAY PANEL







Famotidine -20 mg -100 Tablets


PRINCIPAL DISPLAY PANEL








Famotidine -20 mg -500 Tablets

PRINCIPAL DISPLAY PANEL







Famotidine -20 mg -1000 Tablets

PRINCIPAL DISPLAY PANEL







Famotidine - 40 mg - 30 Tablets

PRINCIPAL DISPLAY PANEL







Famotidine -40 mg - 60 Tablets

PRINCIPAL DISPLAY PANEL







Famotidine -40 mg -90 Tablets

PRINCIPAL DISPLAY PANEL








Famotidine -40 mg -100 Tablets

PRINCIPAL DISPLAY PANEL







Famotidine -40 mg -500 Tablets

PRINCIPAL DISPLAY PANEL






Famotidine -40 mg -1000 Tablets

PRINCIPAL DISPLAY PANEL







Famotidine -20 mg -100 Tablets in 1 carton

PRINCIPAL DISPLAY PANEL









Famotidine -40 mg -100 Tablets in 1 carton

FAMOTIDINE 
famotidine   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16714-361
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
TALC  
MAGNESIUM STEARATE  
TITANIUM DIOXIDE  
POLYVINYL ALCOHOL  
LECITHIN, SOYBEAN  
POLYETHYLENE GLYCOL 3350  
FERRIC OXIDE YELLOW  
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 6mm
Flavor Imprint Code L113;20
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16714-361-01 30 TABLET In 1 BOTTLE None
2 16714-361-02 60 TABLET In 1 BOTTLE None
3 16714-361-03 90 TABLET In 1 BOTTLE None
4 16714-361-04 100 TABLET In 1 BOTTLE None
5 16714-361-05 500 TABLET In 1 BOTTLE None
6 16714-361-06 1000 TABLET In 1 BOTTLE None
7 16714-361-11 100 TABLET In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078916 07/01/2009

FAMOTIDINE 
famotidine   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16714-362
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
TALC  
MAGNESIUM STEARATE  
TITANIUM DIOXIDE  
POLYVINYL ALCOHOL  
LECITHIN, SOYBEAN  
POLYETHYLENE GLYCOL 3350  
FERRIC OXIDE RED  
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L114;40
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16714-362-01 30 TABLET In 1 BOTTLE None
2 16714-362-02 60 TABLET In 1 BOTTLE None
3 16714-362-03 90 TABLET In 1 BOTTLE None
4 16714-362-04 100 TABLET In 1 BOTTLE None
5 16714-362-05 500 TABLET In 1 BOTTLE None
6 16714-362-06 1000 TABLET In 1 BOTTLE None
7 16714-362-11 100 TABLET In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078916 07/01/2009

Labeler - NorthStar RxLLC (830546433)
Registrant - Alembic Limited (650051741)
Establishment
Name Address ID/FEI Operations
Alembic Limited (Formulation Division) 918592874 manufacture
Revised: 07/2009 NorthStar RxLLC