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BENZPHETAMINE HYDROCHLORIDE tablet


  1. No Title 1572549719
  2. Principal Display Panel - 30s Container Label
  3. Principal Display Panel - 100s Container Label
  4. Principal Display Panel - 500s Container Label
  5. Principal Display Panel - 1000s Container Label
  6. Benzphetamine Hydrochloride Tablets, 50 Mg
  7. Principal Display Panel Bottle Label
  8. Principal Display Panel - 50 Mg Tablet Bottle Label
  9. Principal Display Panel - 25 Mg Tablet Bottle Label
  10. Package Label.principal Display Panel
  11. Indications & Usage
  12. Dosage & Administration
  13. How Supplied
  14. Package/label Principal Display Panel
  15. Description
  16. Clinical Pharmacology
  17. Indications & Usage
  18. Contraindications
  19. Precautions
  20. Adverse Reactions
  21. Drug Abuse And Dependence
  22. Overdosage
  23. Dosage And Administration
  24. Package Label.principal Display Panel
  25. Description
  26. Clinical Pharmacology
  27. Indications And Usage
  28. Contraindications
  29. Warnings
  30. Precautions
  31. Adverse Reactions
  32. Drug Abuse And Dependence
  33. Overdosage
  34. Dosage And Administration
  35. How Supplied
  36. Benzphetamine Hydrochloride
  37. No Title 1572457003
  38. Benzphetamine Hydrochloride Tablets, 25 Mg And 50 Mg Ciii
  39. Description
  40. Clinical Pharmacology
  41. Indications And Usage
  42. Contraindications
  43. Warnings
  44. Precautions
  45. Principal Display Panel -container Label
  46. Adverse Reactions
  47. Drug Abuse And Dependence
  48. Overdosage
  49. Dosage And Administration
  50. How Supplied
  51. Benzphetamine Hcl 50mg (ciii) Tablet

No Title 1572549719 

Rx only

Manufactured by:

KVK-Tech, INC.

110 Terry Dr. Suite 200

Newtown, PA 18940-1850

Item ID # 6077/03 07/10

Manufacturer s Code: 10702

C:\Documents and Settings\avyas\Desktop\Benzphetamine label draft\Final\image-b.jpg

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Principal Display Panel - 30s Container Label 

NDC 10702-040-03

Benzphetamine Hydrochloride Tablets 50 mg CIII

Rx Only 30 Tablets

KVK-TECH

30s container label

Principal Display Panel - 100s Container Label 

NDC 10702-040-01

Benzphetamine Hydrochloride Tablets 50 mg CIII

Rx Only 100 Tablets

KVK-TECH

100s container label

Principal Display Panel - 500s Container Label 

NDC 10702-040-50

Benzphetamine Hydrochloride Tablets 50 mg CIII

Rx Only 500 Tablets

KVK-TECH

500s container label

Principal Display Panel - 1000s Container Label 

NDC 10702-040-10

Benzphetamine Hydrochloride Tablets 50 mg CIII

Rx Only 1000 Tablets

KVK-TECH

1000s container label

BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10702-040
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (UNII: 43DWT87QT7) (BENZPHETAMINE - UNII:0M3S43XK27) BENZPHETAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color ORANGE (PEACH) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code K;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10702-040-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2010
2 NDC:10702-040-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2010
3 NDC:10702-040-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2010
4 NDC:10702-040-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/21/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090968 07/21/2010
Labeler - KVK-TECH, INC (173360061)
Registrant - KVK-TECH, INC. (173360061)
Establishment
Name Address ID/FEI Business Operations
KVK-TECH, INC 173360061 MANUFACTURE(10702-040)

Revised: 12/2018 KVK-TECH, INC

Benzphetamine Hydrochloride Tablets, 50 Mg  

Rx only
Code 1025B00
Rev. 06/11

Principal Display Panel Bottle Label  

NDC 43547-263-10 Rx only

Benzphetamine HCl CIII

Tablets

50 mg

100 Tablets

Solco

Healthcare U.S.

Principal Display Panel     Bottle Label
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-263
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
benzphetamine hydrochloride (UNII: 43DWT87QT7) (benzphetamine - UNII:0M3S43XK27) benzphetamine hydrochloride 50 mg
Inactive Ingredients
Ingredient Name Strength
calcium stearate (UNII: 776XM7047L)
d&c red no. 30 (UNII: 2S42T2808B)
sorbitol (UNII: 506T60A25R)
starch, corn (UNII: O8232NY3SJ)
Product Characteristics
Color PINK (pink) Score 2 pieces
Shape ROUND (ROUND) Size 10mm
Flavor Imprint Code BENZ;5;0
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43547-263-10 100 in 1 BOTTLE, PLASTIC
2 NDC:43547-263-50 500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090473 08/01/2011
Labeler - Solco Healthcare US LLC (828343017)
Registrant - Mikart, Inc. (030034847)
Establishment
Name Address ID/FEI Business Operations
Mikart, Inc. 030034847 MANUFACTURE
Establishment
Name Address ID/FEI Business Operations
Mikart, Inc. 013322387 MANUFACTURE

Revised: 7/2011 Solco Healthcare US LLC

Principal Display Panel - 50 Mg Tablet Bottle Label 

NDC 75834-102-30

Benzphetamine
Hydrochloride
Tablets

50 mg

CIII

Rx only
30 Tablets

NIVAGEN
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

Principal Display Panel - 25 Mg Tablet Bottle Label 

NDC 75834-100-30

Benzphetamine
Hydrochloride
Tablets

25 mg

CIII

Rx only
30 Tablets

NIVAGEN
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-102
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzphetamine Hydrochloride (UNII: 43DWT87QT7) (Benzphetamine - UNII:0M3S43XK27) Benzphetamine Hydrochloride 50 mg
Inactive Ingredients
Ingredient Name Strength
Calcium Stearate (UNII: 776XM7047L)
Polyethylene Glycols (UNII: 3WJQ0SDW1A)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
Lactose, Unspecified Form (UNII: J2B2A4N98G)
Sorbitol (UNII: 506T60A25R)
Product Characteristics
Color YELLOW (Peach) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 511
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:75834-102-30 30 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:75834-102-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:75834-102-05 500 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040747 01/15/2016
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75834-100
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzphetamine Hydrochloride (UNII: 43DWT87QT7) (Benzphetamine - UNII:0M3S43XK27) Benzphetamine Hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
Calcium Stearate (UNII: 776XM7047L)
Polyethylene Glycols (UNII: 3WJQ0SDW1A)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
Lactose, Unspecified Form (UNII: J2B2A4N98G)
Sorbitol (UNII: 506T60A25R)
Product Characteristics
Color YELLOW (Peach) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 051
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:75834-100-30 30 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:75834-100-01 100 in 1 BOTTLE; Type 0: Not a Combination Product
3 NDC:75834-100-05 500 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040747 01/15/2016
Labeler - Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 1/2016 Nivagen Pharmaceuticals, Inc.

Package Label.principal Display Panel  

label

BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-118(NDC:64376-650)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (UNII: 43DWT87QT7) (BENZPHETAMINE - UNII:0M3S43XK27) BENZPHETAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE (UNII: 776XM7047L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LACTOSE (UNII: J2B2A4N98G)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SORBITOL (UNII: 506T60A25R)
Product Characteristics
Color yellow (Peach) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code BP;650
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:12634-118-00 10 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
2 NDC:12634-118-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
3 NDC:12634-118-09 35 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
4 NDC:12634-118-12 120 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
5 NDC:12634-118-18 180 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
6 NDC:12634-118-40 40 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
7 NDC:12634-118-42 42 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
8 NDC:12634-118-45 45 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
9 NDC:12634-118-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
10 NDC:12634-118-52 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
11 NDC:12634-118-54 14 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
12 NDC:12634-118-57 20 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
13 NDC:12634-118-59 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
14 NDC:12634-118-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
15 NDC:12634-118-61 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
16 NDC:12634-118-63 3 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
17 NDC:12634-118-66 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
18 NDC:12634-118-67 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
19 NDC:12634-118-69 9 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
20 NDC:12634-118-71 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
21 NDC:12634-118-74 24 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
22 NDC:12634-118-78 28 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
23 NDC:12634-118-79 25 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
24 NDC:12634-118-80 20 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
25 NDC:12634-118-81 21 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
26 NDC:12634-118-82 12 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
27 NDC:12634-118-84 14 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
28 NDC:12634-118-85 15 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
29 NDC:12634-118-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
30 NDC:12634-118-91 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 09/07/2010
31 NDC:12634-118-92 2 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
32 NDC:12634-118-93 3 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
33 NDC:12634-118-94 4 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
34 NDC:12634-118-95 95 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
35 NDC:12634-118-96 6 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
36 NDC:12634-118-97 7 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
37 NDC:12634-118-98 8 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
38 NDC:12634-118-99 9 in 1 BOTTLE; Type 0: Not a Combination Product 09/07/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040747 09/07/2010
Labeler - Apotheca Inc. (051457844)
Establishment
Name Address ID/FEI Business Operations
Apotheca Inc. 051457844 relabel(12634-118) , repack(12634-118)

Revised: 1/2017 Apotheca Inc.

Indications & Usage  

hydrochloride tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regiment (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds 2.2 = kg; inches 0.0254 = meters.. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use.

Benzphetamine hydrochloride tablets are indicated for use as monotherapy only.

Dosage & Administration 

Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient's eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

How Supplied 

Benzphetamine hydrochloride tablets are supplied as follows:

25 mg: Pink, round tablet, debossed EX on one side and 25 on the other side in bottles of 14 tablets, NDC 46672-843-64, and 100 tablets, NDC 46672-843-10

50 mg: Pink, round tablet, debossed BENZ on one side and 5 score 0 on the other side in bottles of 100 tablets, NDC 46672-844-10, and 500 tablets, NDC 46672-844-50.

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

Manufactured by:

Mikart, Inc.

Atlanta, GA 30318

Code 1025Z00

Rev. 08/10

Package/label Principal Display Panel 

50mg container label
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46672-844
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (UNII: 43DWT87QT7) (BENZPHETAMINE - UNII:0M3S43XK27) BENZPHETAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE (UNII: 776XM7047L)
D&C RED NO. 30 (UNII: 2S42T2808B)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code BENZ;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46672-844-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2011
2 NDC:46672-844-50 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090473 11/01/2011
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46672-843
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (UNII: 43DWT87QT7) (BENZPHETAMINE - UNII:0M3S43XK27) BENZPHETAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE (UNII: 776XM7047L)
D&C RED NO. 30 (UNII: 2S42T2808B)
SORBITOL (UNII: 506T60A25R)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 7mm
Flavor Imprint Code EX;25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46672-843-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/2010
2 NDC:46672-843-64 14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090473 09/15/2010
Labeler - Mikart, LLC (030034847)
Registrant - Mikart, LLC (030034847)

Revised: 11/2018 Mikart, LLC

Description 

Benzphetamine Hydrochloride Tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, -Dimethyl-N -(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82.

The structural formula (dextro form) is represented below:

benzphe.jpg

Each Benzphetamine Hydrochloride Tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride.

Inactive Ingredients: carnauba wax powder, colloidal silicon dioxide, FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose 101, polyvinyl alcohol partially hydrolyzed, sodium starch glycolate, talc and titanium dioxide.

Clinical Pharmacology 

Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is the greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered to be clinically limited.

Pharmacokinetic data in humans are not available.

Indications & Usage 

Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds 2.2 = kg; inches 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below.

BODY MASS INDEX (BMI), kg/m2
Weight
(pounds) Height (feet, inches)
5'0" 5'3" 5'6". 5'9" 6'0" 6'3"
140 27 25 23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31

Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.

Contraindications 

Benzphetamine Hydrochloride Tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine Hydrochloride Tablets should not be used concomitantly with other CNS stimulants.

Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women 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 the fetus.

Precautions 

Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions.

Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime.

Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Information for Patients

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Drug Interactions

Efficacy of Benzphetamine Hydrochloride Tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine Hydrochloride Tablets should not be used concomitantly with other CNS stimulants.

Amphetamines may decrease the hypotensive effect of antihypertensives. Amphetamines may enhance the effects of tricyclic antidepressants.

Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying agents decrease blood levels and increase excretion of amphetamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed.

Pregnancy

Pregnancy Category X (see CONTRAINDICATIONS section).

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

Geriatric Use

Clinical studies of Benzphetamine Hydrochloride Tablets did not include sufficient numbers of subjects aged 65 and over to establish safety and efficacy in this population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions 

The following have been associated with the use of benzphetamine hydrochloride:

Cardiovascular

Palpitation, tachycardia, elevation of blood pressure.

There have been isolated reports of cardiomyopathy and ischemic cardiac events associated with chronic amphetamine use.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no cases of this valvulopathy have been reported when Benzphetamine Hydrochloride tablets have been used alone.

CNS

Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug.

Gastrointestinal

Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances.

Allergic

Urticaria and other allergic reactions involving the skin.

Endocrine

Changes in libido.

Drug Abuse And Dependence 

Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III.

Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of Benzphetamine Hydrochloride Tablets should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage 

Manifestations of Overdosage

Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number of associated complications. Fatal poisoning is usually preceded by convulsions and coma.

Treatment of Overdosage

(See WARNINGS)--- Information concerning the effects of overdosage with Benzphetamine Hydrochloride Tablets is extremely limited. The following is based on experience with other anorexiants.

Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard.

Acidification of the urine increases amphetamine excretion.

The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitoneal LD50 in mice is 153 mg/kg.

Dosage And Administration 

Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient s eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

Package Label.principal Display Panel 

76519 1154.jpg

BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76519-1154
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (UNII: 43DWT87QT7) (BENZPHETAMINE - UNII:0M3S43XK27) BENZPHETAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
Product Characteristics
Color orange Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code K;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76519-1154-1 100 in 1 CONTAINER; Type 0: Not a Combination Product 06/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090968 06/07/2017
Labeler - H. J. Harkins Company Inc. (147681894)
Establishment
Name Address ID/FEI Business Operations
H. J. Harkins Company Inc. 147681894 manufacture(76519-1154) , repack(76519-1154) , relabel(76519-1154)

Revised: 12/2017 H. J. Harkins Company Inc.

Description  

Benzphetamine hydrochloride tablets 50 mg contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, -Dimethyl-N-(phenylmethyl)- benzeneethanamine hydrochloride and its molecular weight is 275.82.

The structural formula (dextro form) is represented below:

b2f154cc-figure-01

Each Benzphetamine hydrochloride tablet for oral administration, contains 50 mg of benzphetamine hydrochloride.

Inactive Ingredients: Calcium Stearate, Polyethylene Glycol, FD&C Yellow No. 6, Lactose Anhydrous, Sorbitol.

Clinical Pharmacology  

Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as anorectics or anorexigenics . It has not been established however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved.

Adult obese subjects instructed in dietary management and treated with anorectic drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is the greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered to be clinically limited.

Pharmacokinetic data in humans are not available.

Indications And Usage  

Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient s weight, in kilograms (kg), divided by the patient s height, in meters (m), squared. Metric conversions are as follows: pounds 2.2 = kg; inches 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below.

b2f154cc-figure-02

Benzphetamine hydrochloride tablets are indicated for use as monotherapy only.

Contraindications  

Benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants.

Benzphetamine hydrochloride tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine hydrochloride tablets are contraindicated in women 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 the fetus.

Warnings  

Benzphetamine hydrochloride tablets should not be used in combination with other anorectic agents, including prescribed drugs, over-the- counter preparations and herbal products.

In a case-control epidemiological study, the use of anorectic agents was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. It should be noted that benzphetamine was not specifically studied in this case-control study.

The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, Benzphetamine hydrochloride tablets should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when benzphetamine has been used alone.

The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of benzphetamine treatment. Benzphetamine hydrochloride tablets are not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with Benzphetamine hydrochloride tablets should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).

When tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Benzphetamine hydrochloride tablets are not recommended for severely hypertensive patients or for patients with symptomatic cardiovascular disease including arrhythmias.

Benzphetamine hydrochloride tablets are not recommended for patients who used any anorectic agents within the prior year.

Precautions  

General

Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions.

Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime.

Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Information for Patients

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Drug Interactions

Efficacy of Benzphetamine hydrochloride tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants.

Amphetamines may decrease the hypotensive effects of antihypertensives. Amphetamines may enhance the effects of tricyclic antidepressants.

Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying agents decrease blood levels and increase excretion of amphetamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed.

Pregnancy

Pregnancy Category X (see CONTRAINDICATIONS section).

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

Geriatric Use

Clinical studies of Benzphetamine hydrochloride tablets did not include sufficient numbers of subjects aged 65 and over to establish safety and efficacy in this population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions  

The following have been associated with the use of benzphetamine hydrochloride:

Cardiovascular

Palpitation, tachycardia, elevation of blood pressure.

There have been isolated reports of cardiomyopathy and ischemic cardiac events associated with chronic amphetamine use.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no cases of this valvulopathy have been reported when Benzphetamine hydrochloride tablets have been used alone.

CNS

Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug.

Gastrointestinal

Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances.

Allergic

Urticaria and other allergic reactions involving the skin.

Endocrine

Changes in libido.

Drug Abuse And Dependence  

Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III.

Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of Benzphetamine Hydrochloride Tablets should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage  

Manifestations of Overdosage: Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number of associated complications. Fatal poisoning is usually preceded by convulsions and coma.

Treatment of Overdosage: (See WARNINGS) - information concerning the effects of overdosage with Benzphetamine hydrochloride tablets is extremely limited. The following is based on experience with other anorexiants.

Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard.

Acidification of the urine increases amphetamine excretion.

The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitoneal LD50 in mice is 153 mg/kg.

Dosage And Administration  

Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient s eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

How Supplied  

Benzphetamine hydrochloride tablets are supplied as follows 50mg (peach,round,imprinted with BP 650, scored)

NDC 12634-118-00 Bottles of 10

NDC 12634-118-01 Bottles of 100

NDC 12634-118-09 Bottles of 35

NDC 12634-118-12 Bottles of 120

NDC 12634-118-18 Bottles of 180

NDC 12634-118-40 Bottles of 40

NDC 12634-118-42 Bottles of 42

NDC 12634-118-45 Bottles of 45

NDC 12634-118-50 Bottles of 50

NDC 12634-118-52 Blister Pack of 12

NDC 12634-118-54 Blister Pack of 14

NDC 12634-118-57 Blister Pack of 20

NDC 12634-118-59 Blister Pack of 30

NDC 12634-118-60 Bottles of 60

NDC 12634-118-61 Blister Pack of 10

NDC 12634-118-63 Blister Pack of 3

NDC 12634-118-66 Blister Pack of 6

NDC 12634-118-67 Blister Pack of 7

NDC 12634-118-69 Blister Pack of 9

NDC 12634-118-71 Bottles of 30

NDC 12634-118-74 Bottles of 24

NDC 12634-118-78 Bottles of 28

NDC 12634-118-79 Bottles of 25

NDC 12634-118-80 Bottles of 20

NDC 12634-118-81 Bottles of 21

NDC 12634-118-82 Bottles of 12

NDC 12634-118-84 Bottles of 14

NDC 12634-118-85 Bottles of 15

NDC 12634-118-90 Bottles of 90

NDC 12634-118-91 Blister Pack of 1

NDC 12634-118-92 Bottles of 2

NDC 12634-118-93 Bottles of 3

NDC 12634-118-94 Bottles of 4

NDC 12634-118-95 Bottles of 5

NDC 12634-118-96 Bottles of 6

NDC 12634-118-97 Bottles of 7

NDC 12634-118-98 Bottles of 8

NDC 12634-118-99 Bottles of 9

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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

Storage and Handling

Store at 20 to 25 C (68 to 77 F) [see USP controlled room temperature].

Rx only

Manufactured for:

Boca Pharmacal, LLC

Coral Springs, FL 33065

1-800-354-8460

www.bocapharmacal.com

Rev. 08/13

Repackaged & Distributed by:

Apotheca Inc.

Phoenix, AZ 85006

Benzphetamine Hydrochloride 

Label Image
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1024(NDC:10702-040)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (UNII: 43DWT87QT7) (BENZPHETAMINE - UNII:0M3S43XK27) BENZPHETAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color ORANGE (PEACH) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code K;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50090-1024-1 60 in 1 BOTTLE; Type 0: Not a Combination Product 11/20/2015
2 NDC:50090-1024-2 90 in 1 BOTTLE; Type 0: Not a Combination Product 11/28/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090968 07/21/2010
Labeler - A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-1024) , REPACK(50090-1024)

Revised: 1/2019 A-S Medication Solutions

No Title 1572457003 

Rx Only

Benzphetamine Hydrochloride Tablets, 25 Mg And 50 Mg Ciii 

Rx Only

Description 

Benzphetamine hydrochloride tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is d-N, -Dimethyl-N-(phenylmethyl)- benzeneethanamine hydrochloride and its molecular weight is 275.82.

The structural formula (dextro form) is represented below:

Chemical Structure

C17H21N M.W. = 275.82

Each Benzphetamine hydrochloride tablet for oral administration, contains 25 mg or 50 mg of benzphetamine hydrochloride.

Inactive Ingredients: Calcium Stearate, Polyethylene Glycol, FD&C Yellow No. 6, Lactose Anhydrous, Sorbitol.

Clinical Pharmacology 

Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is the greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered to be clinically limited.

Pharmacokinetic data in humans are not available.

Indications And Usage 

Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds 2.2 = kg; inches 0.0254 = meters. The limited usefulness of agents of this class (See CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below.

BODY MASS INDEX (BMI), kg/m2 Height (feet, inches)
Weight Pounds Height (feet, inches)
5'0" 5'3" 5'6" 5'9" 6'0" 6'3"
140 27 25 23 21 19 18
150 29 27 24 22 20 19
160 31 28 26 24 22 20
170 33 30 28 25 23 21
180 35 32 29 27 25 23
190 37 34 31 28 26 24
200 39 36 32 30 27 25
210 41 37 34 31 29 26
220 43 39 36 33 30 28
230 45 41 37 34 31 29
240 47 43 39 36 33 30
250 49 44 40 37 34 31

Benzphetamine hydrochloride tablets are indicated for use as monotherapy only.

Contraindications 

Benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants.

Benzphetamine hydrochloride tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine hydrochloride tablets are contraindicated in women 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 the fetus.

Warnings 

Benzphetamine hydrochloride tablets should not be used in combination with other anorectic agents, including prescribed drugs, over-the- counter preparations and herbal products.

In a case-control epidemiological study, the use of anorectic agents was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. It should be noted that benzphetamine was not specifically studied in this case-control study.

The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, Benzphetamine hydrochloride tablets should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when benzphetamine has been used alone.

The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of benzphetamine treatment. Benzphetamine hydrochloride tablets are not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with Benzphetamine hydrochloride tablets should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).

When tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Benzphetamine hydrochloride tablets are not recommended for severely hypertensive patients or for patients with symptomatic cardiovascular disease including arrhythmias.

Benzphetamine hydrochloride tablets are not recommended for patients who used any anorectic agents within the prior year.

Precautions 

General

Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions.

Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime.

Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Information for Patients

Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Drug Interactions

Efficacy of Benzphetamine hydrochloride tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants.

Amphetamines may decrease the hypotensive effects of antihypertensives. Amphetamines may enhance the effects of tricyclic antidepressants.

Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying agents decrease blood levels and increase excretion of amphetamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed.

Pregnancy

Pregnancy Category X

(see CONTRAINDICATIONS section).

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

Geriatric Use

Clinical studies of Benzphetamine hydrochloride tablets did not include sufficient numbers of subjects aged 65 and over to establish safety and efficacy in this population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Principal Display Panel -container Label 

Benzphetamine Hydrochloride Tablets 50 mg CIII

Rx Only

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BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-541(NDC:10702-040)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (UNII: 43DWT87QT7) (BENZPHETAMINE - UNII:0M3S43XK27) BENZPHETAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Product Characteristics
Color orange (PEACH) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code K;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43063-541-14 14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/22/2014
2 NDC:43063-541-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/22/2014
3 NDC:43063-541-45 45 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/22/2014
4 NDC:43063-541-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/22/2014
5 NDC:43063-541-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/22/2014
6 NDC:43063-541-98 120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/21/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090968 07/21/2010
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(43063-541)

Revised: 7/2019 PD-Rx Pharmaceuticals, Inc.

Adverse Reactions 

The following have been associated with the use of benzphetamine hydrochloride:

Cardiovascular

Palpitation, tachycardia, elevation of blood pressure.

There have been isolated reports of cardiomyopathy and ischemic cardiac events associated with chronic amphetamine use.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no cases of this valvulopathy have been reported when Benzphetamine hydrochloride tablets have been used alone.

CNS

Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug.

Gastrointestinal

Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances.

Allergic

Urticaria and other allergic reactions involving the skin.

Endocrine

Changes in libido.

Drug Abuse And Dependence 

Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III.

Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of Benzphetamine Hydrochloride Tablets should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage 

Manifestations of Overdosage

Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number of associated complications. Fatal poisoning is usually preceded by convulsions and coma.

Treatment of Overdosage

(See WARNINGS) - information concerning the effects of overdosage with Benzphetamine hydrochloride tablets is extremely limited. The following is based on experience with other anorexiants.

Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard.

Acidification of the urine increases amphetamine excretion.

The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitoneal LD50 in mice is 153 mg/kg.

Dosage And Administration 

Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient's eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

How Supplied 

Product: 71335-0768

NDC: 71335-0768-1 30 TABLET in a BOTTLE

NDC: 71335-0768-2 7 TABLET in a BOTTLE

NDC: 71335-0768-3 14 TABLET in a BOTTLE

NDC: 71335-0768-4 21 TABLET in a BOTTLE

NDC: 71335-0768-5 42 TABLET in a BOTTLE

NDC: 71335-0768-6 84 TABLET in a BOTTLE

NDC: 71335-0768-7 60 TABLET in a BOTTLE

NDC: 71335-0768-8 90 TABLET in a BOTTLE

NDC: 71335-0768-9 120 TABLET in a BOTTLE

Distributed by: Nivagen Pharmaceuticals
Sacramento, CA 95827 1-877-977-0687 USA

Manufactured by: Tedor Pharma Inc.
Cumberland, RI 02864-1788 USA

Rev. 01/16

Benzphetamine Hcl 50mg (ciii) Tablet 

Label Image
BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0768(NDC:75834-102)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZPHETAMINE HYDROCHLORIDE (UNII: 43DWT87QT7) (BENZPHETAMINE - UNII:0M3S43XK27) BENZPHETAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
Calcium Stearate (UNII: 776XM7047L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
Lactose, Unspecified Form (UNII: J2B2A4N98G)
Sorbitol (UNII: 506T60A25R)
Product Characteristics
Color YELLOW (Peach) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 511
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71335-0768-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
2 NDC:71335-0768-2 7 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
3 NDC:71335-0768-3 14 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
4 NDC:71335-0768-4 21 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
5 NDC:71335-0768-5 42 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
6 NDC:71335-0768-6 84 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
7 NDC:71335-0768-7 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
8 NDC:71335-0768-8 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
9 NDC:71335-0768-9 120 in 1 BOTTLE; Type 0: Not a Combination Product 04/20/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040747 01/15/2016
Labeler - Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-0768) , RELABEL(71335-0768)

Revised: 4/2018 Bryant Ranch Prepack



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