Mavidol TR is a Mexican combination medicine containing ketorolac tromethamine (a derivative of Ketorolac) and tramadol hydrochloride. Ketorolac and tramadol belong to different drug classes. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID).
Tramadol on the other hand is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system responds to pain. Each sublingual pill or capsule of Mavidol TR contains 10 mg of ketorolac tromethamine and 25mg of tramadol hydrochloride.
What is Mavidol TR used for?
Mavidol TR is used for short-term treatment of moderate to severe pain of acute origin (back pain, fractures, dislocations, sprains, cancer), in the treatment of postoperative pain, in the treatment of dental pain, migraine, headache and in the treatment of neuropathic pain. Studies indicate that when used in combination, Ketorolac–tramadol (Mavidol TR) produced additive suppression of pain as a result of a profound synergistic analgesic effect it provides.
How should I use Mavidol TR
Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use Mavidol TR exactly as directed. Do not take more or less of it or use it more often than prescribed by your doctor.
The usual dose of Mavidol TR is one pill every 12 hours with a maximum treatment period of 7 days.
Who should not use Mavidol TR?
Mavidol TR is contraindicated in patients with hypersensitivity to the components of the formula, in patients with active gastroduodenal ulcer, recent gastrointestinal bleeding, recent gastroduodenal perforation or a history of gastroduodenal ulcer or gastrointestinal bleeding, in intoxication with alcohol, sleeping pills and psychotropics, patients with convulsive states, with moderate or severe renal insufficiency (serum creatinine> 442 µmol / l) and patients at risk of renal insufficiency due to hypovolemia or dehydration.
Patients with known hypersensitivity to ketorolac or other NSAIDs, patients with allergy to acetylsalicylic acid or other inhibitors of prostaglandin synthesis. Patients with cerebrovascular bleeding or patients at risk of any type of bleeding.
As a prophylactic analgesic in major surgery. In patients receiving other NSAIDs due to the accumulated risk of events induced by this therapeutic group.
Can a pregnant woman use Mavidol TR?
No, Mavidol TR contains opioids which has been linked to birth defects, which can include neural tube defects, heart defects, intestinal abnormalities, poor fetal growth, stillbirth and preterm birth.
What are the side effects of Mavidol TR?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have heart attack symptoms such as chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or signs of a stroke such as sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.
Stop using Mavidol TR and call your doctor at once if you have:
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- slow heart rate;
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
- little or no urinating;
- swelling, rapid weight gain;
- liver problems–nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
- severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common side effects may include:
- pain or irritation in your nose;
- runny nose;
- watery eyes;
- throat irritation; or
- mild rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What drugs interact with Mavidol TR?
Probenecid (Benemid) should not be combined with Mavidol TR because it reduces the elimination of ketorolac by the kidneys. This may lead to increased levels of ketorolac in the body and increased side effects from ketorolac.
Mavidol TR may increase the blood levels of lithium (Eskalith, Lithobid) by reducing the elimination of lithium by the kidneys. Increased levels of lithium may lead to lithium toxicity.
Concomitant use of Mavidol TR and angiotensin converting enzyme (ACE) inhibitors may reduce the function of the kidneys.
Individuals taking oral blood thinners or anticoagulants — for example, warfarin (Coumadin, Jantoven) — should avoid Mavidol TR because ketorolac also thins the blood, and excessive blood thinning may lead to bleeding.
Carbamazepine (Tegretol, Tegretol XR, Equetro, Carbatrol) reduces the effect of tramadol by increasing its inactivation in the body.
Quinidine (Quinaglute, Quinidex) reduces the inactivation of tramadol, thereby increasing the concentration of tramadol by 50% to 60%.
Combining Mavidol TR with monoamine oxidase inhibitors or MAOIs — for example, tranylcypromine (Parnate) — or selective serotonin reuptake inhibitors (SSRIs) — for example, fluoxetine (Prozac) — may result in severe side effects such as seizures or a condition called serotonin syndrome.
Mavidol TR may increase central nervous system and respiratory depression when combined with alcohol, anesthetics, narcotics, tranquilizers, or sedative hypnotics. This can reduce the level of consciousness or lead to respiratory insufficiency.
