Each film coated tablet contains:
Methocarbamol 750 mg + Ibuprofen 400 mg
Each film coated tablet contains:
Methocarbamol 750 mg + Ibuprofen 400 mg
Pharmacodynamics properties:-
Methocarbex is a combination of 2 active ingredients, methocarbmol & ibuprofen. Methocarbamol:-
Methocarbamol is a muscle relaxant; it is used in relief of painful spasms caused by acute musculoskeletal disorders
Methocarbamol is centrally acting skeletal muscle relaxant. Its mechanism of action is due to general depressant effect on the CNS. It has a selective action on subcortical & polysynaptic pathways of the spinal cord, acting on internuncial spinal neurons to depress polysynaptic pathways, leading to muscle relaxation without causing anesthesia or hypnosis.
It has no direct action on the contractile mechanism of striated muscle, motor endplate or nerve fiber. Ibuprofen:-
Ibuprofen is indicated for its analgesic and anti-inflammatory effects, belonging to propionic acid derivative, Ibuprofen is a non-steroidal anti-inflammatory drug which has anti-inflammatory, analgesic & antipyretic actions. It inhibits cyclooxygenase enzyme activity which results in a marked reduction in prostaglandin synthesis.
Experimental data suggest that Ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are taken concomitantly.
Methocarbex, with this combination of methocrbmol & ibuprofen, provides relief of spasm & pain superior to that when either drug is used alone.
Methocarbex is rapidly absorbed from the GIT following oral administration. Its plasma half-life is reported to be about 1 to 2 hours.
It is mainly metabolized by liver & is excreted in urine & small amount is excreted in feces.
A – Treatment of acute, painful muscle spasm due to musculoskeletal conditions such as:
1- Low back pain.
2- Myositis
3- Soft tissue disorders, sprains or strains.
4- Torticollis
5- Prolapsed intervertebral disc (sciatica).
B – As adjuvant in the management of mild to moderate pain & inflammation in conditions such as :
1- Ankylosing spondylitis,
2- Osteoarthritis,
3- Rheumatoid arthritis.
One tablet to be taken three times daily with or after food.
The dose can be increased up to 6 tablets daily according to the direction of the physician.
Gastrointestinal tract disorders such as nausea, abdominal pain, dyspepsia & flatulence.
CNS disorders such as dizziness, drowsiness.
Sometimes allergic symptoms including rash, urticaria. Methocarbamol:-
Adverse reactions reported coincident with the administration of methocarbamol include:
- Body as a whole: Angioneurotic oedema, anaphylactic reaction, fever, headache.
- Cardiovascular system: Bradycardia, flushing, hypotension, syncope.
- Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting.
- Blood and lymphatic system: Leucopenia.
- Nervous system: Restlessness, anxiety, tremor, amnesia, confusion, diplopia, dizziness or light-headedness, vertigo, drowsiness, insomnia, mild muscular incoordination, nystagmus, seizures (including grand mal).
Skin and special senses: Blurred vision, conjunctivitis with nasal congestion, metallic taste, pruritus, rash, urticaria. Ibuprofen:-
Hypersensitivity reactions have been reported and these may consist of :
a) Non specific allergic reactions and anaphylaxis,
b) Respiratory tract reactivity comprising asthma, aggrevated asthma, bronchospasm or dyspnoea
c) Various skin reactions, e.g. pruritus, urticaria, angioedema, and more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis, and erythema multiforme).
The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, from short-term use. In chronic conditions, under long-term treatment, additional adverse effects may occur.
Infections and infestations
Very rare
Aseptic meningitis
Blood and lymphatic disorders
Very rare
Haematopoietic disorders (anaemia, hemolytic anemia, aplastic anemia), leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding.
Immune system disorders
Uncommon
Hypersensitivity reactions with urticaria and pruritus.
Very rare
In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.
Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).
Exacerbation of asthma and bronchospasm.
Psychiatric disorders
Very rare
Nervousness
Nervous System
Uncommon
Headache
Eye disorders
Very rare
Visual disturbance
Ear and labyrinth disorders
Very rare
Tinnitus and vertigo
Cardiac disorders
Very rare
Cardiac failure
Vascular disorders
Very rare
Hypertension
Respiratory, thoracic and mediastinal disorders
Very rare
Asthma, bronchospasm, dyspnoea and wheezing
Gastrointestinal disorders
Uncommon
Abdominal pain, abdominal distension, dyspepsia and nausea.
Very rare
Diarrhea , flatulence, constipation and vomiting.
Very rare
Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Exacerbation of ulcerative colitis and Crohn’s disease. Mouth ulceration.
Hepatobiliary disorders
Very rare
Liver disorders, especially in long-term treatment, hepatitis and jaundice.
Skin and subcutaneous tissue disorders
Uncommon
Various skin rashes.
Very rare
Severe forms of skin reactions such as bullous reactions, including Stevens Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Renal and urinary disorders
Very rare
Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema. Haematuria, interstitial nephritis, nephritic syndrome, proteinuria
General disorders and administration site conditions
Very rare
Oedema, peripheral oedema.
Investigations
Very rare
Decreased hematocrit and hemoglobin levels.
- Hypersensitivity reactions to methocarbamol, ibuprofen or any other ingredients of the product.
- liver patients
- Caution in patients with peptic ulceration, in patients with a history of hypersensitivity to aspirin or any other NSAIDs in whom asthma, urticaria can occur, during pregnancy & breast feeding, in patients with renal , cardiac or hepatic impairment.
- Not to be given to children under 12 years of age.
- Methocarbmol potentiates the effect of anti-depressants, or alcohol.
- Methocarbex should not be used with patients receiving anticoagulant or thrombolytic drugs.
- Not to be used to patients with sugar intolerance
- Cardiovascular risk:
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease maybe at great risk
NSAIDs is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- Gastrointestinal risk:
NASIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms, elderly patients are at greater risk for serious gastrointestinal events.
This product may cause drowsiness and patients receiving it should not drive nor operate machinery unless their physical and mental capabilities remain unaffected - especially if other medication capable of causing drowsiness is also being taken.
Methocarbex supplied in box containing10 tablets in one AL/PVC strip and insert leaflet.
Stored in temperature not to exceed 30o C,at dry place
Keep out of the reach of children.