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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Muscle Relaxants
The muscle relaxing properties of "muscle relaxants" arise not from direct activity at the muscular or neuromuscular junction level but rather from an inhibition of more central polysynaptic neuronal (nerve cells that end in synapses) events. These agents have also been shown in some studies to demonstrate superior analgesia to either acetaminophen or aspirin, and it remains uncertain if muscle spasm is a prerequisite to their effectiveness as analgesics.
Range of Motion
Muscle relaxants are often prescribed in the treatment of acute low back pain in an attempt to improve the initial limitations in range of motion from muscle spasm and to interrupt the pain-spasm-pain cycle. Limiting muscle spasm and improving range of motion will prepare the patient for therapeutic exercise.
Types of Muscle Relaxants
In an attempt to determine the mechanism of action of carisoprodol (Soma®) in the treatment of low back pain, a double blind study was carried out comparing its effectiveness to that of a sedative control, butabarbital (a sedative), and a placebo in the treatment of 48 laborers with acute lumbar pain. Carisoprodol was found to be significantly more effective in providing both subjective pain relief and objective improvements in range of motion when evaluated by finger to floor testing. The results of this study suggest that the effects of carisoprodol are not secondary to its sedative effects alone.
In 1989, Basmajian compared the effectiveness of cyclobenzaprine (Flexeril®) alone with diflunisal (Dolobid®), placebo, and a combination of cyclobenzaprine and diflunisal in the treatment of acute low back pain and spasm. During the ten-day study period, the combined treatment group demonstrated significantly superior improvements in global ratings on day four, but not on day two or seven. This study suggested some effectiveness of combined analgesic and muscle relaxant therapy when utilized early in the initial week of pain onset.
Borenstein compared the effects of combined cyclobenzaprine and naproxen (Naprosyn®) with naproxen alone and also found combination therapy to be superior in reducing tenderness, spasm, and range of motion in patients presenting with ten days or less of low back pain and spasm. Adverse effects, predominantly drowsiness, were noted in 12 of 20 in the combined group and only four of 20 treated with naproxen alone.
Cyclobenzaprine and carisoprodol were compared in the treatment of patients with acute thoracolumbar pain and spasm rated moderate to severe and of no longer than seven days duration. Both drugs were found to be effective, without significant differences between the treatment groups. Significant improvements were noted in physician rated mobility and in patients' visual analogue scores on follow up days four and eight. While 60% of patients experienced adverse effects in the form of drowsiness or fatigue, these differences were not significantly different between groups, and only eight percent of patients from each group discontinued treatment.
Baratta found cyclobenzaprine, 10-mg t.i.d. (three times per day), superior to placebo in a randomized, double blind study of 120 patients with acute low back pain presenting within five days of symptom onset. Significant improvement was noted in range of motion, tenderness to palpation, and pain scores on follow up days two through nine. Sixty percent of treatment group patients reported drowsiness or dizziness compared with 25% of those in the placebo group.
In an earlier study, diazepam (Valium®) was found to offer no significant subjective or objective benefit, when compared to placebo, in patients treated for low back pain. Carisoprodol was found to be superior to diazepam in the treatment of patients with "at least moderately severe" low back pain and spasm of no longer than seven days duration. In this study, the overall incidence of adverse reactions was higher in the diazepam treated group but was not of statistical significance.

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