Famotidine description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Home SubjectClassCompaniesIngredientsNames A-Z
Search
Home – Famotidine

Famotidine

NorthStar RxLLC
Alembic Pharmaceuticals Limited

Famotidine Tablets, USP Rx only


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

FAMOTIDINE DESCRIPTION


N815723

Famotidine


CLINICAL PHARMACOLOGY IN ADULTS












ADVERSE REACTIONS





PRECAUTIONSDOSAGE 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

FAMOTIDINE 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.

FAMOTIDINE 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 ADULTSDOSAGE 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 ADULTSPRECAUTIONSPatients with Moderate or Severe Renal Insufficiency DOSAGE AND ADMINISTRATIONDosage Adjustment forPatients with Moderate or Severe Renal Insufficiency

FAMOTIDINE ADVERSE REACTIONS


















Pediatric Patients

OVERDOSAGE


ADVERSE REACTIONS

FAMOTIDINE DOSAGE AND ADMINISTRATION


DuodenalUlcer
Acute Therapy:
Maintenance Therapy:

Benign Gastric Ulcer
Acute Therapy:

Gastroesophageal Reflux Disease (GERD)

CLINICAL PHARMACOLOGY IN ADULTSClinical 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













PRINCIPAL DISPLAY PANEL



NDC 16714-361-01
Each Film Coated Tablet Contains:
Famotidine USP 20 mg
Famotidine

PRINCIPAL DISPLAY PANEL


Famotidine Tablets USP 40 mg (30 Tablets in 1 Bottle)
NDC 16714-362-01
Each Film Coated Tablet Contains:
Famotidine USP 40 mg
Famotidine 
 

Famotidine

Famotidine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16714-361
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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 Size Imprint Code Shape
YELLOW 6 mm L113;20 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-361-01 30 in 1 BOTTLE
2 NDC:16714-361-02 60 in 1 BOTTLE
3 NDC:16714-361-03 90 in 1 BOTTLE
4 NDC:16714-361-04 100 in 1 BOTTLE
5 NDC:16714-361-05 500 in 1 BOTTLE
6 NDC:16714-361-06 1000 in 1 BOTTLE
7 NDC:16714-361-11 100 in 1 CARTON

Marketing Information

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


Famotidine

Famotidine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:16714-362
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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 Size Imprint Code Shape
BROWN 8 mm L114;40 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:16714-362-01 30 in 1 BOTTLE
2 NDC:16714-362-02 60 in 1 BOTTLE
3 NDC:16714-362-03 90 in 1 BOTTLE
4 NDC:16714-362-04 100 in 1 BOTTLE
5 NDC:16714-362-05 500 in 1 BOTTLE
6 NDC:16714-362-06 1000 in 1 BOTTLE
7 NDC:16714-362-11 100 in 1 CARTON

Marketing Information

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


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.
Designed by Tank
Developed by KB.MD