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BACLOFEN tablet


  1. No Title 1572546329
  2. No Title 1572548632
  3. No Title 1572549407
  4. No Title 1572553373
  5. No Title 1572554236
  6. No Title 1572554815
  7. No Title 1572555265
  8. No Title 1572449247
  9. Principal Display Panel - 20 Mg
  10. Packaging Information
  11. Package/label Display Panel Carton 10 Mg
  12. Package/label Display Panel Blister 10 Mg
  13. Package/label Display Panel Carton 20 Mg
  14. Package/label Display Panel Blister 20 Mg
  15. No Title 1572450471
  16. Baclofen
  17. Description
  18. Clinical Pharmacology
  19. Indications And Usage
  20. Contraindications
  21. Warnings
  22. Precautions
  23. Overdosage
  24. Dosage And Administration
  25. How Supplied
  26. Baclofen Tablet
  27. No Title 1572454738
  28. No Title 1572454802
  29. Principal Dispaly Panel
  30. No Title 1572448375
  31. Description
  32. Clinical Pharmacology
  33. Indications And Usage
  34. Contraindications
  35. Warnings
  36. Precautions
  37. Adverse Reactions
  38. Overdosage
  39. Dosage And Administration
  40. How Supplied
  41. Baclofen
  42. Package Label.principal Display Panel
  43. Pediatric Use
  44. Baclofen 10mg Tablet
  45. No Title 1572456393
  46. No Title 1572457776
  47. Repackaging Information
  48. Principal Display Panel - 10mg
  49. Principal Display Panel

No Title 1572546329 

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

8181162
Revised: 09/17
R5

No Title 1572548632 

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8181162
R10/12-R4

No Title 1572549407 

Rx only

No Title 1572553373 

Rx only

No Title 1572554236 

Rx only

No Title 1572554815 

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

8181162
R10/12-R4

No Title 1572555265 

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

8181162
Revised: 09/17
R5

No Title 1572449247 

Rx only

Principal Display Panel - 20 Mg 

Label 20mg

BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-158(NDC:0527-1330)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (round) Size 9mm
Flavor Imprint Code LCI;1330
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42291-158-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2014
2 NDC:42291-158-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2014 03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078220 08/25/2014
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-159(NDC:0527-1337)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (round) Size 10mm
Flavor Imprint Code LCI;1337
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42291-159-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/25/2014 06/30/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 08/25/2014 06/30/2018
Labeler - AvKARE, Inc. (796560394)

Revised: 11/2018 AvKARE, Inc.

Packaging Information 

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Lannett Company, Inc. as follows:
(10 mg / 100 UD) NDC 68084-855-01 packaged from NDC 0527-1330
(20 mg / 100 UD) NDC 68084-868-01 packaged from NDC 0527-1337

Distributed by:
American Health Packaging
Columbus, OH 43217

8285501/0217

Package/label Display Panel Carton 10 Mg 

10 mg Baclofen Tablets Carton

NDC 68084- 855-01

Baclofen
Tablets, USP

10 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Baclofen, USP 10 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20 to 25 C (68 to 77 F); excursions permitted between
15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0527-1330, Lannett Company, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

085501
0285501/1118

Package/label Display Panel Blister 10 Mg 

10 mg Baclofen Tablet Blister

Baclofen
Tablet, USP

10 mg

Package/label Display Panel Carton 20 Mg 

20 mg Baclofen Tablets Carton

NDC 68084- 868-01

Baclofen
Tablets, USP

20 mg

100 Tablets (10 x 10) Rx Only

Each Tablet Contains:
Baclofen, USP 20 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20 to 25 C (68 to 77 F); excursions permitted between
15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0527-1337, Lannett Company, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

086801
0286801/1118

Package/label Display Panel Blister 20 Mg 

20 mg Baclofen Tablet Blister

Baclofen
Tablet, USP

20 mg

BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-855(NDC:0527-1330)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (flat-faced beveled edge) Size 9mm
Flavor Imprint Code LCI;1330
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-855-01 100 in 1 BOX, UNIT-DOSE 03/04/2015
1 NDC:68084-855-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 03/04/2015
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-868(NDC:0527-1337)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (flat-faced beveled edge) Size 10mm
Flavor Imprint Code LCI;1337
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68084-868-01 100 in 1 BOX, UNIT-DOSE 03/04/2015
1 NDC:68084-868-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 03/04/2015
Labeler - American Health Packaging (929561009)
Establishment
Name Address ID/FEI Business Operations
American Health Packaging 929561009 repack(68084-855, 68084-868)

Revised: 3/2019 American Health Packaging

No Title 1572450471 

Rx only

Baclofen 

Label Image
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2871(NDC:0527-1337)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (round) Size 10mm
Flavor Imprint Code LCI;1337
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50090-2871-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2017
2 NDC:50090-2871-1 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2018
3 NDC:50090-2871-3 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/25/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 12/01/2005
Labeler - A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-2871) , REPACK(50090-2871)

Revised: 7/2019 A-S Medication Solutions

Description  

Baclofen USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. Its molecular formula is C10H12ClNO2 and its structural formula is:

Chemical Structure

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform.

Each tablet, for oral administration, contains 10 mg or 20 mg of baclofen, USP. In addition, each tablet contains the following inactive ingredients: Crospovidone, anhydrous lactose, magnesium stearate and povidone.

Clinical Pharmacology  

The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

Indications And Usage  

Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.

Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen tablets, USP in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

Contraindications  

Hypersensitivity to baclofen.

Warnings  

a. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.

b. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.

c. Stroke: Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

d. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits.

There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Precautions  

Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants.

Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function. In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen. It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen.

Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Overdosage  

Signs and Symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures.

Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

Dosage And Administration  

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily).

The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).

How Supplied  

Product: 17856-1024

NDC: 17856-1024-1 1 TABLET in a POUCH

Baclofen Tablet 

Label Image
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-1024(NDC:0832-1024)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
crospovidone (UNII: 68401960MK)
anhydrous lactose (UNII: 3SY5LH9PMK)
magnesium stearate (UNII: 70097M6I30)
povidones (UNII: FZ989GH94E)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code BAC;10;832
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17856-1024-1 100 in 1 CASE 11/29/2016
1 1 in 1 POUCH ; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074584 10/20/2010
Labeler - Atlantic Biologicals Corps (047437707)
Establishment
Name Address ID/FEI Business Operations
Atlantic Biologicals Corps 047437707 RELABEL(17856-1024) , REPACK(17856-1024)

Revised: 11/2016 Atlantic Biologicals Corps

No Title 1572454738 

Rx only

No Title 1572454802 

Rx only

Principal Dispaly Panel 

IMAGE LABEL
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-010(NDC:0603-2406)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 2265;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33261-010-15 15 in 1 BOTTLE, PLASTIC
2 NDC:33261-010-30 30 in 1 BOTTLE, PLASTIC
3 NDC:33261-010-45 45 in 1 BOTTLE, PLASTIC
4 NDC:33261-010-60 60 in 1 BOTTLE, PLASTIC
5 NDC:33261-010-90 90 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077156 08/30/2005
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-011(NDC:0603-2407)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL (capsule-shaped) Size 16mm
Flavor Imprint Code 2266;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33261-011-30 30 in 1 BOTTLE, PLASTIC
2 NDC:33261-011-60 60 in 1 BOTTLE, PLASTIC
3 NDC:33261-011-90 90 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077068 08/30/2005
Labeler - Aidarex Pharmaceuticals LLC (801503249)

Revised: 12/2013 Aidarex Pharmaceuticals LLC

No Title 1572448375 

Rx only

Description 

Baclofen USP is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. The structural formula is represented below:

This is an image of the structural formula for Baclofen.

Baclofen Tablets, USP 10 mg and 20 mg contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose and pregelatinized starch.

Clinical Pharmacology 

The precise mechanism of action of baclofen is not fully known. Baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-amino-butyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

Indications And Usage 

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.

Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.

Contraindications 

Hypersensitivity to baclofen.

Warnings 

  1. Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
  2. Impaired Renal Function: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.
  3. Stroke: Baclofen has not significantly benefitted patients with stroke. These patients have also shown poor tolerability to the drug.
  4. Pregnancy: Baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 or 34 times the human daily dose. There are no studies in pregnant women. Baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Precautions 

Safe use of baclofen in children under age 12 has not been established, and it is, therefore, not recommended for use in children.

Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants.

Baclofen should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.

In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking baclofen.

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with baclofen.

Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.

Adverse Reactions 

The most common is transient drowsiness (10 63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5 15%), weakness (5 15%) and fatigue (2 4%). Others reported:

Neuropsychiatric: Confusion (1 11%), headache (4 8%), insomnia (2 7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure.

Cardiovascular: Hypotension (0 9%). Rare instances of dyspnea, palpitation, chest pain, syncope.

Gastrointestinal: Nausea (4 12%), constipation (2 6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.

Genitourinary: Urinary frequency (2 6%); and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.

Other: Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion.

Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

Overdosage 

Signs and symptoms:

Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression and seizures.

Treatment:

In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

Dosage And Administration 

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 80 mg daily).

The following dosage titration schedule is suggested:

5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).

How Supplied 

Product: 50090-1801

NDC: 50090-1801-1 60 TABLET in a BOTTLE

NDC: 50090-1801-2 30 TABLET in a BOTTLE

Baclofen 

Label Image
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1801(NDC:0603-2407)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL (capsule-shaped) Size 16mm
Flavor Imprint Code 2266;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50090-1801-1 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2015
2 NDC:50090-1801-2 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/30/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077068 08/30/2005
Labeler - A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-1801) , REPACK(50090-1801)

Revised: 8/2018 A-S Medication Solutions

Package Label.principal Display Panel 

NDC ( 72888-011-00)

1000 Tablets

Baclofen Tablets, USP 20 mg

Rx only

Rubicon Research Private Limited

NDC 72888-011-00 - Baclofen Tablets, USP 20 mg - 1000 Tablets
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-009
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color white (White to off white) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 023
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72888-009-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209102 09/13/2019
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-010
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color white (White to off white) Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 024
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72888-010-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019
2 NDC:72888-010-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019
3 NDC:72888-010-00 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209102 09/13/2019
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72888-011
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color white (White to off white) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 025
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:72888-011-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019
2 NDC:72888-011-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019
3 NDC:72888-011-00 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/13/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209102 09/13/2019
Labeler - Advagen Pharma Limited (051627256)
Registrant - Rubicon Research Private Limited (918629544)
Establishment
Name Address ID/FEI Business Operations
Rubicon Research Private Limited 677604197 manufacture(72888-009, 72888-010, 72888-011) , analysis(72888-009, 72888-010, 72888-011)

Revised: 9/2019 Advagen Pharma Limited

Pediatric Use 


Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Baclofen 10mg Tablet 

Label Image
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0206(NDC:16714-071)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, POTATO (UNII: 8I089SAH3T)
POVIDONE K30 (UNII: U725QWY32X)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (FLAT) Size 8mm
Flavor Imprint Code N029
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71335-0206-7 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
2 NDC:71335-0206-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
3 NDC:71335-0206-4 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
4 NDC:71335-0206-5 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
5 NDC:71335-0206-2 120 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
6 NDC:71335-0206-8 140 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
7 NDC:71335-0206-0 112 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
8 NDC:71335-0206-3 20 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
9 NDC:71335-0206-6 56 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
10 NDC:71335-0206-9 84 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078504 01/01/2011
Labeler - Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-0206) , RELABEL(71335-0206)

Revised: 1/2018 Bryant Ranch Prepack

No Title 1572456393 

Rx only

No Title 1572457776 

Rx only

Repackaging Information 

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 10 mg
90 67544-671-60
180 67544-671-80
270 67544-671-92

Store between 20 -25 C (68 -77 F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20171207DKJ

Principal Display Panel - 10mg 

NDC 67544-671 Baclofen 10mg - Rx Only
Bottle Label 10mg

BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-671(NDC:0603-2406)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 2265;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67544-671-60 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/14/2006
2 NDC:67544-671-80 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/28/2008
3 NDC:67544-671-92 270 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/28/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077156 08/30/2005
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Business Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK(67544-671)

Revised: 12/2017 Aphena Pharma Solutions - Tennessee, LLC

Principal Display Panel 

Baclofen Tablets, USP 10mg
90 Tablets
NDC 10544-172-90


10mg 90ct



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