Ibuprofen 200 mg / Methocarbamol 500 mg Film-coated tablet
Chemistry:
1- The chemical name of Ibuprofen is 2-[4-(2-methylpropyl)phenyl]propanoic acid. molecular. formula: C13H18O2. molecular weight: 206.28 g/mol. The structural formula is shown below.
2-The chemical name of methocarbamol is 3-(2-methoxyphenoxy) -1,2propanediol 1-carbamate molecular formula: C11H15NO5. molecular weight is 241.24. The structural formula is shown below.
Pharmacokinetic:
Absorption: Ibuprofen: is well absorbed from the gastrointestinal tract and extensively bound to plasma proteins. The median peak plasma concentration is achieved approximately 1-2 hours after administration. When taken with food, peak plasma levels may be delayed.
Methocarbamol: is absorbed from the gastro-intestinal tract and produces peak plasma concentrations after about 1-3 hours.
Metabolism: Ibuprofen: is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete.
Methocarbamol: Its activity derives from the intact molecule and only a small proportion is converted to guaiphenesin.
Elimination: Ibuprofen: elimination half-life is approximately 2 hours.
Methocarbamol: The clearance is renally-impaired patients on maintenance haemodialysis was reduced about 40% compared to a normal population, although the mean elimination half-life in these two groups was similar (1.2 versus 1.1 hours, respectively). In patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to a normal population (11.9 L/hr), and the mean elimination half-life was extended to approximately 3.4 hours. The fraction of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in an age- and weight-matched normal population.
General instructions:
- This medicine has been prescribed for your current illness, so avoid using it in similar cases or recommending it to others.
-If there is any hypersensitivity to ibuprofen and methocarbamol or other non-steroidal anti-inflammatory drugs such as naproxen, diclofenac, foods, dyes, preservatives, etc., consult your doctor or pharmacist before using this product.
Contraindications:
- Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs
- Suffering from diseases such as gastric ulcer or digestive bleeding and any inflammatory disease in the digestive system such as colitis, Crohn's
- Dehydration after vomiting or diarrhea or lack of fluid intake
- Suffering from severe kidney and liver diseases
- Third trimester of pregnancy
- Immediately before and after heart surgery
- Systemic lupus erythematosus
- Brain injuries
- Epilepsy
- Myasthenia gravis
Warnings & precautions:
- If you have a history or suffer from any of the following diseases, inform your doctor or pharmacist before using this medicine:
Heart failure, high blood pressure, fluid retention, diabetes, people prone to digestive disorders and gastrointestinal inflammatory diseases, ulcerative colitis, Crohn's disease, kidney and liver diseases, people taking diuretic drugs, blood coagulation problems, alcohol consumption, SLE and mixed connective tissue disease
- By taking the minimum effective amount of this medicine, the side effects will be reduced in the shortest period that resolves the symptoms.
- This medicine should be used with caution in the elderly.
- Avoid consuming products containing alcohol at the same time as this medicine.
- If there is no clinical improvement for more than 5 days or if the symptoms worsen, stop taking this medicine and inform your pharmacist
- Taking this medicine may cause drowsiness, so avoid driving or working with equipment that requires full alertness during treatment.
- If you forget to take a dose of medicine, continue taking one to two tablets every four to six hours, and do not double the dose.
Pregnancy and breastfeeding:
- Pregnancy:
It is not recommended to use this medicine during pregnancy and it should not be used in the last trimester of pregnancy.
- Breastfeeding:
A small amount of the drug is secreted in breast milk, so consult your pharmacist before taking this medicine during breastfeeding.
Drug interactions:
- In case of using the following medicinal products, be sure to inform your doctor or pharmacist:
Aspirin, acetaminophen, anticoagulants, digoxin, antidiabetics, diuretics, methotrexate, lithium, probenecid, antibiotics, corticosteroids, phenytoin, benzodiazepines, antihypertensives.
- Methocarbamol may potentiate the effects of other central nervous system depressants and stimulants including alcohol, barbiturates, anaesthetics and appetite suppressants. The effects of anticholinergics, e.g. atropine and some psychotropic drugs, may be potentiated by methocarbamol. Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.
Adverse reactions:
Each drug, in parallel with the desired therapeutic effects, may also cause some unwanted side effects. Although not all of these side effects can be seen in one person, consult your doctor or pharmacist if any of the following side effects occur:
- Heartburn, constipation, nausea, anxiety, confusion, drowsiness, skin reactions, allergy symptoms, Angioneurotic oedema, anaphylactic reaction, fever, headache, dizziness
Overdose:
Treatment: Transfer the patient to medical center, even if there are no symptoms.
Administration and dosage:
The exact amount of this medicine is determined by your doctor, but the usual schedule of this medicine is as follows:
Adults (over 12 years old): one or two tablets every 4-6 hours if needed
Do not take more than 6 tablets per day.
Take this medicine with or after food and with a full glass of water.
Storage:
- Keep out of reach of children.
- Store below 30˚ C and keep away from humidity & direct light.
- Avoid using and storing expired medicine.
How supplied:
Ibuprofen 200 mg/ Methocarbamol 500 mg F.C tablet contains 200 mg Ibuprofen and 500 mg Methocarbamol and available as white scrod Film-coated tablets in blisters of 10, in a box of 100 tablets, with leaflet manufactured at Tehran darou pharmaceutical co.