Drug Uses

Flextra DS is an analgesic and antipyretic used to treat pain, headache, and fever. Flextra DS may also be used to relieve pain in certain kinds of arthritic conditions. Flextra DS is also used to treat other conditions as determined by your doctor.

How Taken

Take this medicine by mouth usually every 4 hours as needed or as directed by your doctor. The dosage is based on your age, medical condition, and response to therapy. Do not exceed the recommended dosage or take this medicine for longer than recommended (e.g., 10 days for adults, 5 days for children, or 3 days if used for fever); persistent symptoms of pain or fever may be the sign of a more serious medical condition. Consult your doctor for additional information.

Warnings/Precautions

Tell your doctor your medical history, especially of: lung problems (e.g., bronchitis, emphysema), glaucoma, enlarged prostate or any allergies. This medicine may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Flextra DS may cause liver damage. Daily use of alcohol and Flextra DS may increase your risk for liver damage (symptoms include nausea, stomach pain, dark urine). Check with your doctor or pharmacist for more information. Caution is advised when using this product in children because they may be more sensitive to the effects of the drug (e.g., increased excitability). Tell your doctor if you are pregnant before using this medicine. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Missed Dose

Take the missed dose of Flextra DS prescription muscle relaxer as soon as you remember. However, if it is almost time for your next dose of Flextra DS prescription muscle relaxer, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of Flextra DS prescription muscle relaxer.

Possible Side Effects

Drowsiness or nausea may occur. If either of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: skin redness, swelling, persistent fever, stomach pain, yellowing eyes and skin, dark urine, unusual weakness. If you notice other effects not listed above, contact your doctor or pharmacist.

Storage

Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.

Overdose

The following symptoms indicate an overdose, get medical help immediately: difficulty breathing, extreme nervousness or restlessness, flushed skin, hallucination, racing or irregular heartbeat, seizure, shortness of breath, tiredness (extreme), unstable temperature, unusual muscle stiffness, vomiting (in combination with these other symptoms).

More Information

DO NOT DRIVE, OPERATE MACHINERY OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your pharmacist if you have questions about which medicines contain acetaminophen. ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Flextra DS or other pain relievers/fever reducers. Flextra DS may cause liver damage. Alcohol use combined with this medicine may increase your risk for liver damage.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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RANCHO MIRAGE, CALIF. -- An antispasticity drug, tizanidine, appeared to be effective in treating analgesic rebound headache, chronic tension-type headache, and related pain disorders in several retrospective or open-label prospective trials.
Response to treatment with tizanidine (Zanaflex) for chronic daily headache did not seem to differ in patients based on whether or not they had musculoskeletal symptoms such as spasticity, Dr. Timothy, R. Smith said at a meeting sponsored by the Diamond Headache Clinic.
He conducted a retrospective review of 53 patients at his clinic treated for chronic daily headache that was thought to be caused by analgesic overuse.
The patients were given tizanidine (2 mg to start, titrated up as tolerated), together with a once-daily long-acting NSAID (naproxen) or COX-2 inhibitor (Celecoxib), while eliminating other analgesics.
After 12 weeks, 38 patients (71%) stopped having chronic daily headache and reverted to intermittent headaches, said Dr. Smith of Ryan Headache Center, Chesterfield, Mo.
A separate retrospective review of charts and headache diaries for 62 patients with chronic daily headache found no association between response to tizanidine and the presence of musculoskeletal symptoms, suggesting that the drug's effects on headache are due to factors other than muscle relaxation, he added.
The drug reduced the frequency of headache by at least half in 46 (74%) of patients, 34 (74%) of whom had muscle spasticity at baseline. Muscle spasticity was pre sent in 11 (69%) of nonresponders, a rate that was not significantly different from the responders group, Dr. Smith reported.
"The presence of musculoskeletal symptoms could not predict a clinical response to tizanidine," he said.
Elan Pharmaceuticals, the maker of tizanidine, funded the studies. Dr. Smith has served on the speaker's bureau for Elan Pharmaceuticals and for eight other drug companies.
A separate review of poster presentations on tizanidine at previous medical meetings found four small uncontrolled studies suggesting benefit from treating certain pain syndromes with the drug, Dr. Gary E. Ruoff reported in a separate poster presentation at the meeting.
His review also was funded by Elan Pharmaceuticals. Dr. Ruoff serves on the speaker's list for Elan and five other drug companies.
One open-label trial by Dr. Smith and his associates used 3.6 mg tizanidine daily in 70 patients with analgesic rebound headache who were transitioning to decreased NSAID use, Dr. Ruoff reported.
After 12 weeks, 46 patients (66%) discontinued their chronic NSAID use without worsening headaches. Three patients (4%) experienced treatment-limiting adverse effects, said Dr. Ruoff, who is in practice in Kalamazoo, Mich.
A second open-label trial of 220 patients with recalci- trant chronic tension-type headache who were titrated up to a mean dose of 26 mg tizanidine daily found a response after 10 weeks in 150 patients (68%), reducing headache frequency by a mean of 73%.
In this study, 13 patients (6%) experienced treatment-limited adverse effects.
A third open-label trial of 4-8 mg tizanidine daily in 26 patients with fibromyalgia found decreases on average in the number of tender points, improvements in global assessment scores, Fibromyalgia Impact Questionnaire scores, and visual analog scores after 8 weeks.
In a retrospective chart review, 20 patients who had traumatically induced myofascial pain were given 2-6 mg tizanidine three times daily. Improvements in pain symptoms--including headache--were noted in 14 of the patients (70%) after 4-6 weeks. The drug was well tolerated.
Tizanidine is an imidazoline derivative, an [[alpha].sub.2]-agonist that is structurally related to clonidine.
Many patients with chronic daily headache are thought to have a down regulation of norepinephrine receptors caused by excessive release of norepinephrine from the locus ceruleus.
Tizanidine has been shown to decrease norepinephrine release in the central nervous system. This effect may help restore the homeostatic balance of norepinephrine, thereby reducing patients' perception of pain, Dr. Ruoff speculated.

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