IBUMATE

(Ibuprofen 400 mg + Paracetamol 325 mg Tablet)

Each uncoated tablets contains:

(Ibuprofen IP 400 mg & Paracetamol  IP 325 mg)

Tablet for Oral Use

IBUMATE contains two active Ibuprofen and Paracetamol.

Paracetamol works to stop the pain messages from getting through to the brain. Paracetamol also acts in the brain to reduce fever.

Ibuprofen belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDS). This group of medicines work by relieving pain, inflammation (swelling, redness, soreness) and fever.

Absorption: Acetaminophen has 88% oral bioavailability and reaches its highest plasma concentration 90 minutes after ingestion.

Ibuprofen is very well absorbed orally and the peak serum concentration can be attained in 1 to 2 hours after extravascular administration. The average Cmax, Tmax and AUC ranges around 20 mcg/ml, 2 h and 70 mcg.h/ml. These parameters can vary depending on the enantiomer form, route, and dose of administration.

Distribution: Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells. Acetaminophen appears to be widely distributed throughout most body tissues except in fat. The apparent volume of distribution of Ibuprofen is of 0.1 L/kg

Metabolism &Excretion: Acetaminophen is mainly metabolized in the liver and excreted in the urine. Less than 5% is excreted in the urine as free (unconjugated) acetaminophen and at least 90% of the administered dose is excreted within 24 hours. Ibuprofen is rapidly metabolized and eliminated in the urine & accounts for more than 90% of the administered dose.

Half Life: After an oral dose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen. The serum half-life of Ibuprofen is 1.2-2 hours.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

ADVERSE REACTION:

Nausea, Vomiting, Stomach pain, Diarrhea, Heartburn, indigestion, Dizziness, Light-headedness, Drowsiness

Additional adverse effects: Skin rash, Yellowing of the skin and eyes also called jaundice, painful red areas with

blisters and peeling layers of skin which may be accompanied by fever and/or chills, Flushing of the face, fast heartbeat

DOSAGE AND ADMINISTRATION:

Adults and children over 12 years: 1 tablets three times a day when necessary (every 8 hours).

CONTRAINDICATIONS

Hypersensitivity to Acetaminophen or Ibuprofen, severe hepatic impairment, heart disease, kidney disease, asthmatic patient, history of peptic ulcer or bleeding problem, pregnancy

WARNINGS AND PRECAUTIONS:

• Avoid consumption of alcohol
• Use cautiously in patient of liver and heart disease
• Close monitoring is required for skin allergic reaction
• Should not be used for children below 12 years
• Consult with doctor if you are breast feeding

Drug Interaction:

Medicines that help to prevent blood clots such as Warfarin, anti-inflammatory painkillers such as Aspirin, Diclofenac, Mefenamic acid or Naproxen, medicines for high blood pressure, steroid medicines, antibiotics such as Ciprofloxacin, Levofloxacin, Moxifloxacin, Norfloxacin or Ofloxacin, antidepressants such as Citalopram,  Fluoxetine, Fluvoxamine, Venlafaxine, Paroxetine or Sertraline, diabetes medicines such as Gliclazide,  Glimepiride, Glipizide or Tolbutamide