Polazi 2 mg is a polmacoxib capsule from Healing Pharma.

Each capsule contains 2 mg of polmacoxib.

Polmacoxib is a non-steroidal anti-inflammatory drug, or NSAID.

It belongs to the coxib group, which are selective COX-2 inhibitors.

Cobix 100 mg and etoricoxib are the better-known members of that group.

It is taken once a day, not several times a day.

Its approved Indian use is osteoarthritis of the hip or knee.

The approval specifies idiopathic, also called primary, osteoarthritis.

Primary osteoarthritis means wear and tear with no other cause.

It treats the pain and stiffness; it does not cure the joint damage.

It was developed in South Korea and is sold there as Acelex.

It is a new drug in India, approved subject to further study.

It is a prescription medicine, not a painkiller to self-buy.

An osteoarthritic joint releases arachidonic acid from cell membranes.

Cyclo-oxygenase enzymes convert that into prostaglandins.

Prostaglandins sensitise nerve endings, so the joint hurts more.

They also widen blood vessels, causing swelling and warmth.

COX-2 is the form switched on at sites of inflammation.

Polmacoxib inhibits COX-2 selectively.

Prostaglandin production in the joint falls.

Pain and stiffness reduce while the drug is taken.

A coxib is gentler on the stomach than a non-selective NSAID.

It is not free of gastrointestinal risk.

The cardiovascular risk is the central question for this class.

No coxib should be described as a safe NSAID.

Polmacoxib also inhibits carbonic anhydrase, types I and II.

Carbonic anhydrase I and II are abundant in red blood cells.

A published study described high affinity for those enzymes.

That affinity shapes how the drug distributes in the body.

It is part of why a 2 mg once-daily dose is enough.

Use the lowest effective dose.

Use it for the shortest time that controls symptoms.

Do not take more than one capsule a day.

Do not take it with another NSAID or another coxib.

That includes ibuprofen, diclofenac, naproxen and meloxicam.

That includes anti-inflammatory doses of aspirin.

Review the need for it with your doctor regularly.

Stop and seek advice if it is not helping.

No FDA or EMA dosing document exists for polmacoxib.

I found no published dose adjustment for kidney impairment.

I found no published dose adjustment for liver impairment.

I found no published dose for older patients.

I found no published paediatric dose.

Those gaps must be filled from the Indian package insert.

Take it only on a doctor’s prescription.

Take one capsule once a day.

Swallow the capsule whole with water.

Take it at about the same time each day.

Take it with or after food to protect the stomach.

Do not take a second capsule for extra relief.

Do not open or crush the capsule unless told to.

Use it for the shortest period that controls symptoms.

Tell your doctor about any past ulcer or stomach bleeding.

At-risk patients may be given a stomach-protecting medicine.

Avoid alcohol, which adds to the stomach bleeding risk.

Avoid steroid tablets with it unless prescribed together.

Stop and seek care if you notice signs of bleeding.

Drink enough fluid, especially in hot weather.

Tell your doctor if you take a water tablet.

Tell your doctor if you take a blood pressure medicine.

Monitor your blood pressure if you have hypertension.

Report ankle swelling or sudden weight gain.

Report any reduction in the urine you pass.

Never take it with another NSAID or coxib.

Never take it before or after bypass heart surgery.

Never take it late in pregnancy.

Never take it if you have had a sulfa allergic reaction.

Never use it for a condition other than the approved one.

Never share your capsules with anyone else.

Known hypersensitivity to polmacoxib or any excipient.

Demonstrated allergic-type reactions to sulfonamides.

Asthma, hives or allergic reaction after aspirin or any NSAID.

Active or recurrent peptic ulcer or stomach bleeding.

Any current gastrointestinal bleeding.

Severe liver impairment.

Severe kidney impairment.

Severe heart failure.

Peri-operative pain around coronary artery bypass graft surgery.

Late pregnancy, from about 30 weeks onward.

Children; no paediatric dose is published.

Any allergy to a sulfa medicine.

Any heart disease, angina or past heart attack.

Any past stroke or mini-stroke.

High blood pressure, especially if uncontrolled.

Heart failure of any degree.

Smoking, high cholesterol or diabetes.

Any stomach or duodenal ulcer, past or present.

Indigestion or reflux.

Ulcerative colitis or Crohn’s disease.

Any kidney disease.

Any liver disease.

Asthma, especially if aspirin makes it worse.

Dehydration, vomiting or diarrhoea.

Pregnancy or planned pregnancy.

Breastfeeding.

Older age, which raises the bleeding risk.

Every other medicine, including ones bought over the counter.

NSAIDs can cause fetal kidney problems after about 20 weeks.

That reduces amniotic fluid, a condition called oligohydramnios.

It has been reported as early as 48 hours after starting.

After about 30 weeks a fetal heart vessel can close too early.

Tell pregnant buyers to speak to a doctor before using any NSAID.

Take the capsule with or after food.

Avoid alcohol; it multiplies the stomach bleeding risk.

Drink enough fluid to protect the kidneys.

Do not add over-the-counter painkillers containing NSAIDs.

Check cold and flu remedies for hidden ibuprofen or aspirin.

Monitor blood pressure if you are hypertensive.

Avoid long unbroken courses without review.

Do you have a prescription for polmacoxib?

Has hip or knee osteoarthritis been diagnosed?

Is the diagnosis primary osteoarthritis, not another arthritis?

Have you ever reacted badly to a sulfa medicine?

Have you ever had a stomach ulcer or stomach bleeding?

Have you ever reacted badly to aspirin or another NSAID?

Do you have heart disease, or have you had a stroke?

Is your blood pressure controlled?

Has your kidney function been checked?

Do you have liver disease?

Could you be pregnant, and how many weeks?

Are you taking any other anti-inflammatory painkiller?

Do you know the warning signs of stomach bleeding?

Do you know the warning signs of heart attack and stroke?

The firm presented a completed Phase III trial to CDSCO.

The committee noted no deaths in that trial.

It also noted no serious adverse events.

It noted non-inferiority to celecoxib 200 mg.

No frequency table for individual side effects was published there.

A Phase IV trial was made a condition of approval.

Severe skin reactions can begin as an ordinary-looking rash.

They are most likely in the first weeks of treatment.

A drug that has caused one must never be restarted.

Any new rash, however mild.

Black or tarry stools, or blood in the stool.

Vomiting blood or material like coffee grounds.

Persistent stomach pain.

Swollen ankles or sudden weight gain.

Breathlessness on mild exertion.

Yellowing of the eyes or skin.

Passing much less urine than usual.

List every painkiller, including ones bought over the counter.

Check cold and flu remedies for hidden NSAIDs.

List every blood thinner and antiplatelet tablet.

List every blood pressure and water tablet.

List any steroid tablet.

List any antidepressant.

Mention lithium, methotrexate or any transplant medicine.

Mention any sulfa medicine you have reacted to.

Chest pain, pressure or tightness.

Pain spreading to the jaw, neck, back or arm.

Sudden breathlessness or cold sweating.

Sudden weakness or numbness on one side of the body.

Sudden drooping of one side of the face.

Slurred speech or sudden difficulty understanding speech.

Sudden loss of vision in one eye.

Sudden severe headache with no known cause.

Vomiting blood, or vomit like coffee grounds.

Black, tarry stools.

Fresh blood in the stools.

Severe or persistent stomach pain.

Sudden severe abdominal pain with a rigid abdomen.

Feeling faint, pale or breathless with any of the above.

These can occur with no earlier warning symptoms.

Any new rash, which is reason to stop the capsule.

Blistering or peeling skin.

Sores in the mouth, eyes or genitals.

A spreading rash with fever and swollen glands.

Swelling of the lips, tongue, face or throat.

Difficulty breathing or wheezing.

Collapse with a widespread rash.

Yellowing of the eyes or skin.

Dark urine with pale stools.

Persistent nausea with upper abdominal pain.

Unusual tiredness with loss of appetite.

Passing much less urine than usual.

Rapid weight gain over a few days.

Sudden worsening of asthma after a dose.

A sore throat with fever.

It is taken once a day, which is simple to follow.

The dose is 2 mg, the lowest tablet-size dose in this class.

It is a selective COX-2 inhibitor, so it spares COX-1 more.

That reduces, though does not remove, the stomach risk.

In its Phase III trial it was non-inferior to celecoxib 200 mg.

That trial reported no deaths and no serious adverse events.

It also inhibits carbonic anhydrase, which is unusual for an NSAID.

It has been approved in South Korea since 2015.

An Indian expert committee recommended approval in February 2023.

It carries the full NSAID and coxib class risks.

No FDA or EMA label exists for it.

No published side effect frequency table could be found.

A Phase IV trial was a condition of the Indian approval.

So long-term Indian safety data are still being collected.

Its approved indication is narrow: primary hip or knee osteoarthritis.

It contains a sulfonamide group, which matters for sulfa allergy.

No dose adjustments for kidney or liver impairment are published.

Do not call it a safe NSAID or stomach-friendly.

Do not claim it is better than celecoxib; the trial showed non-inferiority.

Do not claim a lower cardiovascular risk than other coxibs.

Do not promote it for back pain, injury, fever or period pain.

Do not promote it for rheumatoid arthritis or gout.

Do not call the carbonic anhydrase effect a clinical advantage.

Do not omit the class cardiovascular and gastrointestinal warnings.

Store below 30 C, or as printed on your own carton.

Keep the capsules in the original blister until use.

Protect them from moisture and direct sunlight.

Do not store them in a bathroom cabinet.

Do not transfer them into an unlabelled container.

Keep them out of the sight and reach of children.

An NSAID overdose in a child can damage the kidneys.

Do not use after the expiry date on the pack.

Return unused or expired capsules to a pharmacy.

Do not keep leftover capsules for a future pain episode.

Do not pass unused capsules to anyone else.