CBENZPRIME ACP 15\200

ACECLOFENAC (SR) & CYCLOBENZAPRINE HCL (SR) TABLETS (typically formulated asnon-steroidal anti-inflammatory medicine that eases pain and swelling in osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

By combining a nonsteroidal anti-inflammatory drug (NSAID) with a centrally acting skeletal muscle relaxant in a sustained-release (SR) delivery profile, this combination targets both the neuro-muscular trigger and the inflammatory pathway simultaneously.

Mechanism of Action & Composition

1. Aceclofenac SR (200 mg): A selective COX-2 inhibitor precursor. Once ingested, it inhibits the cyclooxygenase enzyme (COX-1 and COX-2), preventing the synthesis of prostaglandins—the primary chemical mediators responsible for localized pain, swelling, vascular congestion, and joint inflammation.

2. Cyclobenzaprine HCl SR (15 mg): A centrally acting skeletal muscle relaxant structurally related to tricyclic antidepressants. It acts primarily within the brainstem and spinal cord centers to suppress somatic motor activity, reducing muscle hyperactivity, involuntary spasms, and localized stiffness without directly interfering with peripheral muscle function.

3. Sustained-Release (SR) Matrix: The advanced bi-layered matrix releases the active ingredients slowly into the systemic circulation over 24 hours. This minimizes serum concentration spikes, reduces gastrointestinal distress, and enables convenient once-daily dosing.

Therapeutic Indications & Medical Uses

Healthcare professionals prescribe Aceclofenac (SR) & Cyclobenzaprine HCl (SR) Tablets for conditions involving both tissue inflammation and secondary muscle guarding or spasticity:

• Acute Low Back Pain (Lumbago): Provides rapid recovery from acute strain, lumbar disc syndromes, and spasms in the erector spinae muscles.

• Cervical Spondylosis & Neck Stiffness: Reduces neck tightness, trapped nerve pain, and upper back spasm complexes.

• Osteoarthritis & Rheumatoid Arthritis Flares: Decreases joint capsule swelling while relaxing surrounding guarded muscles.

• Post-Traumatic & Sports Injuries: Manages severe pain, soft tissue injury, torn ligaments, and muscle sprains.

• Ankylosing Spondylitis: Relieves stiffness along the spine, sacrum, and pelvis.

Key Benefits of the SR Combination

• Synergistic Dual Relief: Combining an NSAID and a muscle relaxant yields higher pain control rates than monotherapy.

• Once-Daily Convenience (24-Hour Coverage): Sustained-release technology maintains steady therapeutic blood levels, preventing end-of-dose pain spikes.

• Improved Gastric Safety: Aceclofenac offers superior gastrointestinal tolerance compared to older non-selective NSAIDs like naproxen or indomethacin.

• Restored Range of Motion: Breaking the "pain-spasm-pain" cycle helps patients resume daily activities and physical therapy earlier.

Dosage & Administration Guidelines

• Standard Dosage: Typically 1 tablet daily (or as directed by an orthopedic specialist or general practitioner).

• Administration: Swallow whole with a full glass of water. Do not crush, chew, or split the tablet, as breaking the sustained-release matrix releases the total dose at once.

• Timing: Take immediately after a meal to optimize absorption and protect the stomach lining.

• Duration: Intended for short-term therapy (typically 5 to 10 days).

Potential Side Effects & Safety Precautions

While well tolerated by most patients, side effects can occur due to the dual ingredients:

Contraindications & Warnings:

• Alcohol: Avoid alcohol during treatment; combining alcohol with Cyclobenzaprine markedly increases central nervous system depression and extreme sedation.

• Driving: Avoid operating heavy machinery or driving until you know how the medication affects your alertness.

• MAO Inhibitors: Do not take Cyclobenzaprine within 14 days of Monoamine Oxidase Inhibitors (MAOIs), as this can trigger a dangerous drug interaction (serotonin syndrome).

• Pregnancy & Lactation: Contraindicated during pregnancy (especially the third trimester due to risks of premature closure of the ductus arteriosus) and while breastfeeding.

Frequently Asked Questions 

1. Is Aceclofenac a painkiller for headaches?

Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) designed primarily for joint and muscle pain. While it can reduce mild-to-moderate headache symptoms, it is not considered a primary treatment for tension headaches or migraines. Dedicated analgesics (such as paracetamol or specific migraine medications) are generally preferred.

2. Does Aceclofenac damage the kidneys?

Prolonged or unmonitored use of high doses of Aceclofenac can reduce renal blood flow by inhibiting prostaglandin synthesis, potentially leading to renal impairment. Patients with pre-existing kidney disease, dehydration, or those taking the medication long-term should use it only under strict medical supervision.

3. Can we use Aceclofenac for toothache?

Yes. Aceclofenac is effective for acute dental pain, post-extraction soreness, and inflammation around the gums or jaw bone due to its anti-inflammatory properties. However, combination tablets containing muscle relaxants like Cyclobenzaprine are generally reserved for musculoskeletal conditions rather than routine dental pain.

4. When is the best time to take Aceclofenac?

Aceclofenac (SR) should be taken immediately after meals (preferably dinner or breakfast) at the same time every day. Taking it after food minimizes gastrointestinal upset, while regular daily timing ensures stable drug concentrations.

5. Is Aceclofenac a strong painkiller?

Yes, Aceclofenac is considered a potent anti-inflammatory analgesic. It is significantly stronger and longer-acting than standard over-the-counter painkillers like basic paracetamol for inflammatory conditions and acute musculoskeletal injuries.

6. Who should avoid Aceclofenac?

Aceclofenac should be avoided by individuals with active peptic ulcers, severe kidney or liver failure, advanced heart disease, or a history of allergic reactions (asthma, hives) after taking aspirin or other NSAIDs. Pregnant and breastfeeding women should also avoid this medication.

7. Which is safer, Aceclofenac or paracetamol?

Paracetamol is generally safer for routine, mild fever and pain because it has a lower risk of stomach irritation, kidney strain, and cardiovascular side effects. Aceclofenac is a stronger prescription drug reserved for inflammatory and severe joint or muscle conditions where paracetamol alone is insufficient.

8. What are the side effects of Aceclofenac?

Common side effects of Aceclofenac include stomach pain, nausea, heartburn, indigestion, diarrhea, and dizziness. Rare but serious side effects include gastrointestinal ulcers or bleeding, skin rashes, elevated liver enzymes, and fluid retention.

9. How many days should I take Aceclofenac?

Aceclofenac (SR) combined with Cyclobenzaprine is usually prescribed for short-term courses lasting 5 to 10 days. Do not extend therapy beyond your physician’s recommendation to avoid an increased risk of gastrointestinal or cardiovascular complications.

10. Does Aceclofenac make you sleepy?

Aceclofenac alone rarely causes severe sleepiness, though mild dizziness can occur. However, when combined with Cyclobenzaprine HCl, sleepiness, drowsiness, and slowed reaction times are common because Cyclobenzaprine acts on the central nervous system to relax muscles.

11. Is Aceclofenac safe in old age?

Aceclofenac must be used with caution in elderly patients. Older adults are at higher risk for NSAID-induced stomach bleeding, kidney dysfunction, elevated blood pressure, and central nervous system sedation from muscle relaxants. Lower doses and shorter treatment durations under medical monitoring are recommended.

12. What is the difference between immediate-release and sustained-release (SR) tablets?

Immediate-release tablets dissolve quickly, requiring twice-daily dosing. Sustained-release (SR) tablets release active ingredients gradually over 24 hours, providing steady, round-the-clock pain relief with fewer gastrointestinal side effects and once-daily convenience.

13. Can I drink coffee while taking Aceclofenac & Cyclobenzaprine?

Moderate caffeine consumption is generally acceptable, but high amounts of caffeine may counteract the muscle-relaxing benefits of Cyclobenzaprine or exacerbate stomach irritation caused by Aceclofenac.

14. Can I take Aceclofenac with blood pressure medication?

You should consult your doctor first. NSAIDs like Aceclofenac can diminish the effectiveness of certain antihypertensive drugs (such as ACE inhibitors and diuretics) and may increase the risk of kidney impairment.

15. What should I do if I miss a dose of Aceclofenac (SR) & Cyclobenzaprine HCl (SR)?

Take the missed tablet as soon as you remember, provided it is taken with food. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Never double the dose to make up for a missed tablet.

ACECLOFENAC(SR) & CYCLOBENZAPRINE HCL (SR) TABLETS provide targeted relief for complex pain-spasm disorders. By pairing an anti-inflammatory agent with a muscle relaxant in a sustained-release formulation, this combination therapy restores physical mobility, reduces daily pain, and helps patients return to active living. Always consult a licensed healthcare professional for precise dosage adjustments, safety checks, and medical oversight.

Product: CBENZPRIME ACP 15/200
Composition: Aceclofenac SR 200 mg + Cyclobenzaprine HCl SR 15 mg
Manufacturer/Marketer: Steris Healthcare Pvt. Ltd.
Market: India
Therapeutic focus: Pain, inflammation and associated muscle spasm in selected musculoskeletal conditions.