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Antihypertensive

Irbesartan

INFORMATION FOR USE OF A MEDICAL PRACTITIONER,
HOSPITAL OR LABORATORY

IRBESARTAN

Available Composition

VYPROEach film-coated tablet contains Irbesartan…….150 mg

PHARMACOLOGICAL CLASSIFICATION

Antihypertensive (Angiotensin-AT1 antagonist)

VYPRO is a specific competitive antagonist of AT1 receptors with a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor and no agonist activity. Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effects of irbesartan on blood pressure.

PHARMACOKINETICS

VYPRO is rapidly absorbed from the gastrointestinal tract with an oral bioavailability of 60 to 80%. It undergoes some metabolism in the liver, primarily by the Cytochrome P450 isoenzyme CYP2C9, to inactive metabolites. Peak plasma concentration of Irbesartan occurs 1.5 to 2 hours after an oral dose. Irbesartan is about 96% bound to plasma proteins. It is excreted as unchanged drug and metabolites in the bile and in urine; after oral or intravenous administration approximately 20% of the dose is excreted in the urine, with less than 2% as unchanged drug. The terminal elimination half-life is about 11 to 15 hours.
INDICATIONS

VYPRO is indicated for the treatment of:

· Hypertension

· Nephropathy in Type 2 Diabetic Patients

PATIENT INFORMATION:

BEFORE YOU TAKE VYPROMake sure you have told your doctor if you:

Are on dialysis and if you have or ever had heart failure or kidney disease.
Are allergic to Irbesartan or any other medications.
Are pregnant or doing breast-feeding
are taking a “water pill”;
are vomiting or have severe diarrhea;
are on a particular diet - low on salt;

HOW TO TAKE VYPRO You must take your medicine as the doctor tells you. It is important to take VYPRO Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness.ADULTSHigh Blood PressureThe recommended starting dose of VYPRO is 150 milligrams once a day. If your blood pressure remains elevated, your dose will be gradually increased to 300 milligrams once a day.If you are being treated with hemodialysis or high doses of diuretics, youll be started at a lower dose of 75 milligrams once a day.Kidney Damage from Type 2 DiabetesThe usual dose is 300 milligrams once a day.CHILDRENFor children under 6, safety and effectiveness have not been established. For children 6 to 12 years old, the typical starting dose is 75 milligrams once a day. IF YOU MISS A DOSETake the missed dose as soon as you remember it. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your doses as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the dose that you missed.

WHAT TO DO IF AN OVERDOSE IS TAKEN

In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning.

TAKING OTHER MEDICINE

· Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

· It may be necessary to have blood tests done regularly if you take potassium supplements, potassium-containing salt substitutes or some medicines such as diuretics (fluid tablets).

· It may also be necessary to have blood tests done regularly if you take a medicine containing lithium at the same time as VYPRO.

SIDE EFFECTS

· headache

· dizziness or light-headedness

· unusual tiredness or weakness, fatigue

· nausea/vomitingSymptoms of a serious reaction include: Tell your doctor immediately if you notice any of the following

· skin rash or itchiness

· aching muscles or aching joints, not caused by exercise

· buzzing, ringing or other persistent noise in the ears

· yellowing of the skin and/or eyes, also called jaundice

· symptoms that may indicate high potassium levels in the blood such as nausea, diarrhea, muscle weakness and change in heart rhythm

STORING

Keep all medicines out of the reach of children.
cool dry place where the temperature stays below 25 ^oc
Away from direct heat and light.

Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice.