INDOMETACIN (Generic)

Drug Profile

2. Brand(s):

Brand name	Manufactruer	Dosage form	Pack Size	MRP
Indobid	Adamjee	Capsule	50*10	Rs 251.68
Indocap	Hamaz	Capsule	1000	Rs 217.60
Indacin	KPL	Capsule	1000	Rs 284.68
Epomet	Epoch	Capsule	50*10	Rs 343.74

3. Pharmacological Group:

                                            NON-STEROIDAL ANTI-INFLAMMATORY DRUG

4. Formulation:

                                     Capsules containing 25mg Indomethacin

5.  General Information:

                                                   Indomethacin is a non-steroidal anti-inflammatory drug commonly used to reduce fever, pain, stiffness, and swelling. It works by inhibiting the production of prostaglandins, molecules known to cause these symptoms

.6. Dosage Form:

Solids

Tablets

Capsules
Hard Capsules    ◙	Soft Capsules	Modified Released Capsules

Uncoated Tablets

Coated Tablets

Modified Released Tablets

Sublingual Tablets

Powders
Powders for suspension	Powders for Inhalers

Others

Liquids

Syrup

Oral drops

Nasal Drops

Topical Solutions

Eye Preparations

Ear Preparations

Others

Parenterals Preparations

Injections

Infusions

Powders for injection

Others

Topical Solids

Ointment

Creams

lotions

Gels

Pastes

Others

6. Therapeutic Uses:

Renal colic (pain due to kidney stones), cryoglobulinemia, bartter syndrome, dysmenorrhea (menstrual cramps), pericarditisnephrogenic, diabetes insipidus (prostaglandin inhibits vasopressin's action in the kidney), fever and pain associated with malignant diseases (tumors, bony metastases, lymphogranulomatosis, rheumatoid arthritis, arthritic gout, osteoarthritis

7. Information for the user:

i. How to take:

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take indomethacin with food or milk to lessen stomach upset. Do not crush, chew, break, or open an extended-release capsule.

ii. Frequency & Time of Doses

                                                     2 to 3 times a day

iii. Recommended Dosage Range:

Neonates/ Children	Adult	Geriatric	Dose according to clinical condition
Orally 200µg/kg bd	200mg tid

iv. Onset of effect:

                                      30 min

v. Duration of Action:

                                      4-6 hrs

vi. Diet Advice:

                          Unless your doctor tells you otherwise, continue your normal diet

vii. Storage:

                    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture

viii: Missed Dose:

If you are taking indomethacin on a regular schedule, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose.

If you are taking indomethacin as needed, take the missed dose if it is needed, then wait the recommended or prescribed amount of time before

ix. Stopping the drug:

                                     Stopping the Drug at once after the completion of therapy may not produce any harmful  symptoms but a low dose regime is required to avoid relapse.

x. Exceeding the dose (overdose):

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an indomethacin overdose may include nausea

8. Possible Adverse Effects:

Chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance; black, bloody, or tarry stools coughing up blood or vomit that looks like coffee grounds dizziness, nervousness, headache;

9. Contraindications

• concurrent peptic ulcer, or history of ulcer disease
• allergy to indomethacin, aspirin, or other NSAIDs
• patients with nasal polyps reacting with an angioedema to other NSAIDs
• children under 2 years of age (with the exception of neonates with patent ductus arteriosus)
• severe pre-existing renal and liver damage
• caution: pre-existing bone marrow damage (frequent blood cell counts are indicated)
• caution: bleeding tendencies of unknown origin (indomethacin inhibits platelet aggregation)
• caution: Parkinson's disease, epilepsy, psychotic disorders (indomethacin may worsen these conditions)

10. Interactions:

Drug-Drug Interactions	Drug-Food Interactions
Aspirin or other NSAIDs warfarin (Coumadin); cyclosporine Digoxin diuretics such as furosemide Methotrexate steroids a beta-blocker such as atenolol.	Using alcohol or tobacco with Indomethacin may cause interactions to occur. Vit C rich food can leads to Kidney stones.

11. Prolonged Use:

Patients should undergo regular physical examination to detect edema and signs of central nervous side effects. Blood pressure checks will reveal development of hypertension. Periodic serum electrolyte (sodium, potassium, chloride) measurements, complete blood cell counts and assessment of liver enzymes as well as of creatinine (renal function) should be performed. This is particularly important if indomethacin is given together with an ACE inhibitor or with potassium-sparing diuretics, because these combinations can lead to hyperkalemia and/or serious kidney failure. No examinations are necessary if only the topical preparations (spray or gel) are applied.

12. Special Precautions:

 i. Be sure to tell your doctor if:

If you are allergic to indomethacin, aspirin or other NSAID

If you have or have ever had asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); seizures; Parkinson's disease; depression or mental illness; or liver or kidney disease. If you will be using indomethacin suppositories, also tell your doctor if you have or have ever had proctitis (inflammation of the rectum) or have or have recently had rectal bleeding.

ii. Pregnancy:

 Not save because in pregnancy it adversely effect the fetus

iii. Breast Feeding/Lactation:

Appears in breast milk and cause convulsion in 1 week old infant.

iv. Infants & Children:

                                       Use with precaution in infants

v. Over 60:

                    Maintenance dose should be reduced by 25% b/c total clearance is reduced as compared to young subject

vi. Driving & Hazardous work:

                                                          Do not drive a car or operate machinery.

vii. Alcohol:

                       Alcohol can add to the drowsiness caused by this medication.

13. Pharmacological Properties:

13.(i). Pharmacodynamic Properties:

Indomethacin is a nonselective inhibitor of cyclooxygenase (COX) 1 and 2, enzymes that participate in prostaglandin synthesis from arachidonic acid. Prostaglandins are hormone-like molecules normally found in the body, where they have a wide variety of effects, some of which lead to pain, fever, and inflammation.

13.(ii). Pharmacokinetic Properties:

i. Absorption:

                        Rapidly and completely absorbed from GIT after oral administration.

ii. Distribution:

Bioavailability	%Protein binding	Half Life	Volume of distribution	Blood Brain Barrier	Placental Barrier
~100% (oral), 80–90% (rectal)	99%	4.5 hours	0.3-0.9 L/kg		crosses

iii. Metabolism

Site of Metabolism	Active Metabolites
Hepatic	0 demethylation conjugated with glucronic acid 10% N-deacylation

iv. Elimination:

Elimination Half Life	Route of Elimination
4 to 5 hrs	Renal 60%, faecal 33%

15. Preclinical Safety Data:

Indomethacin has a high acute toxicity both for animals (12 mg/kg in rats and 50 mg/kg in mice) and for humans. Exact human data does not exist, but some fatal human cases, particularly in children and adolescents, have been seen.

16. Instructions for Handling:

Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.