TRIXYLITRAL (diclofenac sodium/lidocaine HCl/kinesiology tape)
1.5 %-3.88 % kit, cream and solution
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- Aspirin exacerbated respiratory disease
- Drug-induced hepatitis
- Gastrointestinal perforation
- Hepatic failure
- Large open wound
- Methemoglobinemia
- Post-operative from CABG surgery
- Pregnancy
- Severe hepatic disease
Contraindicated
- Abnormal hepatic function tests
- Acute myocardial infarction
- Alcoholism
- Cerebrovascular accident
- Chronic heart failure
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Debilitation
- Disease of liver
- Duodenal ulcer
- Gastrointestinal hemorrhage
- Gastrointestinal ulcer
- Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
- Heart block
- Hemolytic anemia from PK and g6PD deficiencies
- Hypertension
- Increased cardiovascular event risk
- Increased risk of bleeding
- Peptic ulcer
- Sepsis
- Shock
- Skin ulcer
- Systemic mastocytosis
- Tobacco smoker
Severe
Moderate
- Anemia
- Asthma
- Disease of liver
- Edema
- Respiratory depression
- Seizure disorder
TRIXYLITRAL (diclofenac sodium/lidocaine HCl/kinesiology tape)
- None
- Pruritus of skin
- Skin rash
- Treatment site sequelae
More Frequent
Severe
Less Severe
- Abnormal hepatic function tests
- Drowsy
- Dysgeusia
- Dyspepsia
- Edema
- Headache disorder
- Nausea
- Paresthesia
- Skin inflammation
- Skin ulcer
- Stinging of skin
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute myocardial infarction
- Anaphylaxis
- Anemia
- Body fluid retention
- Cerebrovascular accident
- Diarrhea
- Exfoliative dermatitis
- Gastric ulcer
- Gastrointestinal hemorrhage
- Gastrointestinal perforation
- Gastrointestinal ulcer
- Heart failure
- Hepatic failure
- Hepatic necrosis
- Hepatitis
- Jaundice
- Platelet aggregation inhibition
- Renal papillary necrosis
- Stevens-johnson syndrome
- Toxic epidermal necrolysis
Less Severe
- Gastritis
- Hyperkinesis
- Hypertension
- Hypesthesia
- Localized edema
Contraindicated
None
Severe Precaution
Lidocaine (Top)
Rare risk of methemoglobinemia in infants age < 6 months. Use dose based on age, body weight and physical condition.
- 1 Day – 179 Days
- Rare risk of methemoglobinemia in infants age < 6 months. Use dose based on age, body weight and physical condition.
Management or Monitoring Precaution
Diclofenac (Select Routes)
Safety and efficacy in pediatrics have not been established.
Rare risk of methemoglobinemia. Use dose based on age, body weight and physical condition.
- 1 Day – 18 Years
- Safety and efficacy in pediatrics have not been established.
- 180 Days – 13 Years
- Safety and efficacy in pediatrics have not been established.
Lidocaine (Top)
Safety and efficacy in pediatrics have not been established.
Rare risk of methemoglobinemia. Use dose based on age, body weight and physical condition.
- 1 Day – 18 Years
- Rare risk of methemoglobinemia. Use dose based on age, body weight and physical condition.
- 180 Days – 13 Years
- Rare risk of methemoglobinemia. Use dose based on age, body weight and physical condition.
Diclofenac
- Severity Level:
1
- Additional Notes: Fda c before 30wks;premature closure of ductus arteriosus;early miscarriage risk
Lidocaine
- Severity Level:
2
- Additional Notes: Insufficient human data available.
Contraindicated
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Precaution Exists
Diclofenac (top)
Insufficient data available
General | Excretion Potential | Effect on Infant | Notes |
Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient data available |
No Known Risk
Lidocaine
Amount excreted reported to be low with low infant oral bioavailability
General | Excretion Potential | Effect on Infant | Notes |
No known risks; does not adversely affect lactation | Excreted | Not known; no or inclusive data | Amount excreted reported to be low with low infant oral bioavailability |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while using this drug but is more likely if you use it for a long time. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes).<br /><br /> Do not use this drug right before or after heart bypass surgery (CABG). Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This side effect can occur without warning symptoms at any time while using diclofenac.<br /><br />Older adults may be at higher risk for this effect. (See also Precautions and Drug Interactions sections.) Stop using diclofenac and get medical help right away if you notice any of the following rare but very serious side effects: black/bloody stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, sudden vision changes, trouble speaking. Talk with your doctor or pharmacist about the benefits and risks of using this medication.