Cambia Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Cambia Indications
Indications
Limitations of Use
Cambia Dosage and Administration
Adult
Children
Renal Impairment
-
Not recommended to use in patients with advanced renal disease. If Cambia therapy is necessary, close monitoring of the patient’s renal function is advisable.
Hepatic Impairment
-
Consider patients with hepatic impairment for treatment with Cambia only if the benefits outweigh the risks.
Other Modifications
Females and Males of Reproductive Potential
-
Infertility in Females: May delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.
-
Consider withdrawing treatment in women who have difficulties conceiving or who are undergoing investigation of infertility.
Cambia Contraindications
Contraindications
Cambia Boxed Warnings
Boxed Warning
Cambia Warnings/Precautions
Warnings/Precautions
Cambia Pharmacokinetics
Absorption
-
Diclofenac is 100% absorbed after oral administration compared to intravenous administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available.
-
In fasting volunteers, measurable plasma levels were observed within 5 minutes of dosing with CAMBIA. Peak plasma levels were achieved at approximately 0.25 hour in fasting normal volunteers, with a range of 0.17 to 0.67 hours.
Distribution
-
The apparent volume of distribution (V/F) of diclofenac potassium is 1.3 L/kg.
-
Diclofenac is more than 99% bound to human serum proteins, primarily to albumin.
Elimination
-
Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites.
-
Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites.
-
The terminal half-life of unchanged diclofenac is approximately 2 hours.
Cambia Interactions
Interactions
Cambia Adverse Reactions
Adverse Reactions
Cambia Clinical Trials
Cambia Note
Not Applicable