H-Paxin (Page 14 of 14)

2.9.1 Bursitis, Tenosynovitis, Peritendinitis

In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement. Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis. Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections. Chronic bursitis may be treated with reduced dosage once the acute condition is controlled. In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases. Injections should be made into the affected tendon sheaths rather than into the tendons themselves. In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions.

2.9.2 Rheumatoid Arthritis and Osteoarthritis

Following intra-articular administration of 0.5 to 2 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced. Duration of relief varies widely in both diseases. Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues. There is virtually no pain on injection, and the secondary flare that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension. Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint. The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint.

Recommended Doses for Intra-articular Injection
Size of Joint Location Dose (mL)
Very Large Hip 1-2
Large Knee, ankle, shoulder 1
Medium Elbow, wrist 0.5-1

Small(metacarpophalangeal,interphalangeal)(sternoclavicular)

Hand, chest 0.25 to 0.5

A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection. In patients being treated concomitantly with oral or parenteral corticosteroids, especially those receiving large doses, the systemic absorption of the drug should be considered in determining intra-articular dosage.

2.9.3 Dermatologic Conditions

In intralesional treatment, 0.2 mL/cm2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally (not subcutaneously) using a tuberculin syringe with a 25-gauge, 1/2-inch needle. Care should be taken to deposit a uniform depot of medication intradermally. A total of no more than 1 mL at weekly intervals is recommended.

2.9.4 Disorders of the Foot

A tuberculin syringe with a 25-gauge, 3/4-inch needle is suitable for most injections into the foot. The following doses are recommended at intervals of 3 days to a week.

Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose (mL)
Bursitis under heloma durum or heloma molle 0.25 to 0.5
under calcaneal spur 0.5

over hallux rigidus of digiti quinti varus

0.5
Tenosynovitis, periostitis of cuboid 0.5
Acute gouty arthritis 0.5 to 1

2.10 HOW SUPPLIED

NDC 0517-0720-01:

Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, 5 mL multiple dose vial; box of one. Inactive ingredients per mL: 7.1 mg dibasic sodium phosphate anhydrous; 3.4 mg monobasic sodium phosphate monohydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as preservative.

SHAKE WELL BEFORE USING.

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

Protect from light.

Rx only

Revised July 2018

MCKESSON ALCOHOL PREP PAD- isopropyl alcohol swab

Drug Facts

Active ingredient

Isopropyl Alcohol 70% v/v

Purpose

First Aid Antiseptic

Use

For preparation of the skin prior to an injection

Warnings

  • For external use only
  • Flammable, keep away from fire or flame
  • Do not use with electrocautery procedures
  • Do not use in the eyes
  • Do not apply to irritated skin
  • Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.
  • Keep out from reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Open packet
  • Remove pad
  • Apply topically as needed to cleanse intended area. Discard after single use.

Other information

  • Store at room temperature 59-86°F (15-30°C)
  • Contents sterile in unopened, undamaged package

Inactive ingredients

purified water

H-Paxin Injection System

Contents:

1 — 50mL 2% Lidocaine HCl (20mg/mL)

1 — 50mL .25 Bupivacaine HCl (2.5mg/mL)

1 — 5mL Betamethasone Sodium Phosphate and Betamethasone Acetate (6mg/mL)

1 — 3cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 22-27 Gauge 1-1 1/2 inch Needle (Administer)

1 — 3×3 Gauze Sponge Sterile Square

1 — Bandage 1×3 in

4 — Alcohol Prep Pads

Assembled and Distributed by IT3 Medical, LLC 190 E Stacy Road; STE 306-298 Allen, TX 75002-8734

For questions or comments: info@IT3-Medical.com, www.IT3-Medical.com

PACKAGING-KIT LABEL

Hpaxin
(click image for full-size original)

PACKAGING-KIT COMPONENTS LABELING

Compont1
(click image for full-size original)

H-PAXIN lidocaine hydrochloride, bupivacaine hydrochloride, betamethasone sodium phosphate and betamethasone acetate kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70529-051
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70529-051-01 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, MULTI-DOSE 50 mL
Part 2 1 VIAL, MULTI-DOSE 50 mL
Part 3 1 VIAL, MULTI-DOSE 5 mL
Part 4 4 PACKET 4 mL
Part 1 of 4
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:0409-4277
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 6 mg in 1 mL
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
METHYLPARABEN 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088327 06/15/2005
Part 2 of 4
BUPIVACAINE HYDROCHLORIDE bupivacaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:55150-249
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207183 05/13/2016
Part 3 of 4
BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE betamethasone sodium phosphate and betamethasone acetate injection, suspension
Product Information
Item Code (Source) NDC:0517-0720
Route of Administration INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE ACETATE (BETAMETHASONE) BETAMETHASONE ACETATE 3 mg in 1 mL
BETAMETHASONE SODIUM PHOSPHATE (BETAMETHASONE) BETAMETHASONE 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 7.1 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 3.4 mg in 1 mL
EDETATE DISODIUM 0.1 mg in 1 mL
BENZALKONIUM CHLORIDE 0.2 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 5 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090747 04/28/2010
Part 4 of 4
MCKESSON ALCOHOL PREP PAD isopropyl alcohol swab
Product Information
Item Code (Source) NDC:68599-5804
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/09/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088327 08/01/2018
Labeler — IT3 Medical LLC (079971231)

Revised: 01/2020 IT3 Medical LLC

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