FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Mac Patch Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
- For external use only. Use only as directed. Avoid contact with eyes and mucous membranes
- Do not cover with bandage
- Do not use on wounds or damaged skin.
- Keep out of reach of children. Consult physician for children under 12.
- Do not use if you are allergic to menthol or capsaicin
- Stop use and consult a physician if condition worsens, excessive redness, irritation, burning, rash, itching or discomfort of the skin develops, pain persists for more than 7 days or clears up and occur again within a few days
Accidental Exposure in Children
The potential exists for a small child or a pet to suffer serious adverse effect from chewing or ingesting a new or used MaC Patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of MaC Patch out of the reach of children, pets and others.
PRECAUTIONS General
- Allergic Reactions: Patients allergic to Menthol or Capsaicin or any other ingredient in Mac Patch should not use MaC Patch.
- Non-intact Skin: Application to broken or inflamed skin, although not tested, may result in higher blood concentrations from increased absorption. MaC Patch is only recommended for use on intact skin.
- Eye Exposure: The contact of MaC Patch with eyes, although not studied, should be avioded based on the findings of sever eye irritations with the use of similar products in animals. If eye contact occurs, immediately wash out the eye with water or saline.
- Pregnancy/Nursing Mothers: MaC Patch has not been studied in nursing mothers. Caution should be exercised when MaC Patch is administered to a nursing mother.
- Pediatric Use: Safety and effectiveness in pediatric patients and children under the age of 12 have not been established.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Use for temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Mac Patch Manufacturers
-
Solubiomix
Mac Patch | Cardinal Health
2.1 Dosing for the Treatment of Supraventricular Tachycardia or Noncompensatory Sinus TachycardiaEsmolol hydrochloride is administered by continuous intravenous infusion with or without a loading dose. Additional loading doses and/or titration of the maintenance infusion (step-wise dosing) may be necessary based on desired ventricular response.
Table 1 Step-Wise DosingStep
Action
1
Optional loading dose (500 mcg per kg over 1 minute), then 50 mcg per kg per min for 4 min
2
Optional loading dose if necessary, then 100 mcg per kg per min for 4 min
3
Optional loading dose if necessary, then 150 mcg per kg per min for 4 min
4
If necessary, increase dose to 200 mcg per kg per min
In the absence of loading doses, continuous infusion of a single concentration of esmolol reaches pharmacokinetic and pharmacodynamic steady-state in about 30 minutes.
The effective maintenance dose for continuous and step-wise dosing is 50 to 200 mcg per kg per minute, although doses as low as 25 mcg per kg per minute have been adequate. Dosages greater than 200 mcg per kg per minute provide little added heart rate lowering effect, and the rate of adverse reactions increases.
Maintenance infusions may be continued for up to 48 hours.
2.2 Intraoperative and Postoperative Tachycardia and HypertensionIn this setting it is not always advisable to slowly titrate to a therapeutic effect. Therefore two dosing options are presented: immediate control and gradual control.
Immediate Control • Administer 1 mg per kg as a bolus dose over 30 seconds followed by an infusion of 150 mcg per kg per min if necessary. • Adjust the infusion rate as required to maintain desired heart rate and blood pressure. Refer to Maximum Recommended Doses below. Gradual Control • Administer 500 mcg per kg as a bolus dose over 1 minute followed by a maintenance infusion of 50 mcg per kg per min for 4 minutes. • Depending on the response obtained, continue dosing as outlined for supraventricular tachycardia. Refer to Maximum Recommended Doses below. Maximum Recommended Doses • For the treatment of tachycardia, maintenance infusion dosages greater than 200 mcg per kg per min are not recommended; dosages greater than 200 mcg per kg per min provide little additional heart rate-lowering effect, and the rate of adverse reactions increases. • For the treatment of hypertension, higher maintenance infusion dosages (250-300 mcg per kg per min) may be required. The safety of doses above 300 mcg per kg per minute has not been studied.After patients achieve adequate control of the heart rate and a stable clinical status, transition to alternative antiarrhythmic drugs may be accomplished.
When transitioning from esmolol hydrochloride to alternative drugs, the physician should carefully consider the labeling instructions of the alternative drug selected and reduce the dosage of esmolol hydrochloride as follows:
1. Thirty minutes following the first dose of the alternative drug, reduce the esmolol hydrochloride infusion rate by one-half (50%). 2. After administration of the second dose of the alternative drug, monitor the patient’s response and if satisfactory control is maintained for the first hour, discontinue the esmolol hydrochloride infusion. 2.4 Directions for UseThis dosage form is prediluted to provide a ready-to-use, iso-osmotic solution of 10 mg/mL esmolol hydrochloride in sodium chloride recommended for esmolol hydrochloride intravenous administration. The ready-to-use vial may be used to administer a loading dosage by hand-held syringe while the maintenance infusion is being prepared. When using a 10 mg/mL concentration, a loading dose of 0.5 mg/kg infused over 1 minute, for a 70 kg patient is 3.5 mL.
Esmolol hydrochloride injection is not compatible with Sodium Bicarbonate (5%) solution (limited stability) or furosemide (precipitation).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Compatibility with Commonly Used Intravenous FluidsEsmolol hydrochloride was tested for compatibility with ten commonly used intravenous fluids at a final concentration of 10 mg esmolol hydrochloride per mL. Esmolol hydrochloride was found to be compatible with the following solutions and was stable for at least 24 hours at controlled room temperature or under refrigeration:
• Dextrose (5%) Injection, USP • Dextrose (5%) in Lactated Ringer’s Injection • Dextrose (5%) in Ringer’s Injection • Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP • Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP • Lactated Ringer’s Injection, USP • Potassium Chloride (40 mEq/liter) in Dextrose (5%) Injection, USP • Sodium Chloride (0.45%) Injection, USP • Sodium Chloride (0.9%) Injection, USP
Login To Your Free Account