Orthocort 18mg Tablet 6’S

INTRODUCTION

ORTHOCORT contains Deflazacort which belongs to the group of medicines called Anti-Inflammatory and Immunomodulator Drugs. It is used to treat inflammation in asthma (inflamed airways), arthritis (pain and inflammation in the joints) and allergies.    

ORTHOCORT is also used in treatment of problems with your skin, kidney, heart, digestive system, eyes or blood and where your body has growths (tumours). It also used to prevent rejection after organ transplant operations.

ORTHOCORT is not recommended for use in patients who have any untreated systemic infection and had any vaccinations with live viruses.

Before taking ORTHOCORT, inform your doctor if you have epilepsy, problems in liver, kidney or heart, diabetes, high blood pressure, mental health problems, osteoporosis, glaucoma, oesophagitis, ulcerative colitis, diverticulitis or peptic ulcer and pheochromocytoma.     

ORTHOCORT is generally not recommended for use in pregnant and breastfeeding women unless clearly advised by the doctor. ORTHOCORT should be used with caution in children and elderly patients due to increased risk of side effects.

The most common side effects of taking ORTHOCORT are excessive facial hair, increased weight, skin redness, rash, nausea and abdominal pain. Consult your doctor if any of the side effects worsen.

USES OF ORTHOCORT
Treats inflammation including asthma, arthritis and allergies
Treats skin, heart, kidney, eyes, digestive system or blood problems
Treats tumour problems
Suppress the immune system in transplant operations
HOW ORTHOCORT WORKS

ORTHOCORT works by preventing the release of certain chemicals involved in the immune and allergic reactions, that result in inflammation. This type of action can reduce inflammation in a particular area, control various diseases characterised by excessive inflammation and treats autoimmune disease conditions where immune system attacks the body tissues. It also supresses white blood cells along with immune system to prevent the body from attacking foreign tissue in organ transplantation.

DIRECTIONS FOR USE

Take ORTHOCORT as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF ORTHOCORT
COMMON
Excessive facial hair
Increased weight
Puffy face appearance (cushingoid appearance)
Skin redness, rash and striae (stretch marks)
Abdominal obesity or pain
Need to urinate more often than normal
Constipation
Irritability, abnormal behaviour
Fever, back pain, bruise, nausea
Nosebleeds
UNCOMMON
Feeling full or bloated, indigestion, heartburn
Increase in appetite or weight gain around the face
Lose weight or feel weak
Signs of diabetes (increased thirst and needing to pass water more often than usual)
Increased blood pressure and water retention
Signs of low levels of potassium in the blood (tiredness, confusion, muscle weakness or muscle cramps)
Mood changes, difficulty in sleeping
Return of tuberculosis (TB) infection
Acne
Infections appear more easily than usual
RARE
Bleeding under the skin, redness.
General muscle weakness or tiredness

Stop taking ORTHOCORT and contact your doctor immediately if you experience any of the following side effects:

Signs of allergic reaction (swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing along with itchy, lumpy rash or nettle rash)
Signs of stomach ulcer (black tarry stools or notice fresh or clotted blood in the stool or dark bits that look like coffee grounds in your vomit)
Signs of pancreatitis (severe stomach pain which may reach through to your back)
Feeling depressed, including suicidal thoughts
Feeling anxious or high, having problems sleeping, difficulty in thinking or confusion and memory loss
Feeling, seeing or hearing things which do not exist
Signs of pheochromocytoma crisis (awareness of your heartbeat, increase in heart rate (palpitations), excessive sweating, high blood pressure, severe headaches or feeling shaky)
Signs of tumour lysis syndrome (changes in blood tests such as increased levels of uric acid, potassium or phosphorus and decreased level of calcium may result in muscle cramping, muscle weakness, confusion, visual loss or disturbances, shortness of breath, seizures, irregular heartbeat or reduced amount or darkening of urine)
Very sore throat, difficulty in swallowing and the inside of the mouth may have white areas on the surface
Headache, which is usually worse in the morning, on coughing or straining and nausea along with fits, fainting, eyesight problems, painful eyes or confusion
HOW TO MANAGE SIDE EFFECTS

Nausea:

Stick to simple meals while taking this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.       

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals and drink plenty of fluids. Exercise more regularly (such as daily walk) and stay active. Consult your doctor if the symptom gets worse. 

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, consult your doctor.

WARNING & PRECAUTIONS
PREGNANCY

ORTHOCORT is generally not recommended for use in pregnant women unless considered clearly necessary. Consult your doctor before taking ORTHOCORT.

BREASTFEEDING

ORTHOCORT should be used with caution in breastfeeding women unless considered clearly necessary. Consult your doctor before taking ORTHOCORT.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel dizzy or feel like everything around you is spinning or feel disorientated (vertigo) after taking ORTHOCORT.

KIDNEY

ORTHOCORT should be used with caution in patients with kidney problems. Consult your doctor before taking ORTHOCORT.

LIVER

ORTHOCORT should be used with caution in patients with liver problems. Consult your doctor before taking ORTHOCORT.

ALLERGY

Do not take ORTHOCORT if you are allergic to Deflazacort. It should be used with caution in patients who have ever had a bad reaction such as muscle weakness to any steroids.

LUNGS

ORTHOCORT should be used with caution in patients who had or have tuberculosis. Consult your doctor before taking ORTHOCORT.

HEART DISEASE

ORTHOCORT should be used with caution in patients with high blood pressure or heart problems. Consult your doctor before taking ORTHOCORT. 

OTHERS

ORTHOCORT is not recommended for use if you:

Have any untreated systemic infection (affecting the whole body)
Had any vaccinations with live viruses

Before taking ORTHOCORT, inform your doctor if you:

Have epilepsy
Have diabetes
Have high levels of uric acid in the blood 
Have osteoporosis
Have an eye disease that causes detachment of the retina and bulging eyes
Have or anyone in your family has an eye problem called glaucoma
Have an underactive thyroid gland
Have oesophagitis, ulcerative colitis, diverticulitis or peptic ulcer
Have athlete’s foot, thrush and cold sores
Have any problems with your blood vessels such as a blood clot
Have a pheochromocytoma
Have haematological malignancy
Are going to have an operation
Have ever had severe depression or manic-depression (bipolar disorder) or psychosis
Have any close family member with mental illnesses

Use in pediatrics:

ORTHOCORT should be used with caution in children. Your child’s doctor may adjust the dose based on child’s age and body and dose may be initiated with the lowest effective dose. Consult your child’s doctor for advice.

Use in geriatrics:

ORTHOCORT should be used with caution in elderly patients due to increased risk of side effects. Consult your doctor before taking ORTHOCORT.

INTERACTIONS

A. Drug-Drug interactions:

Before taking ORTHOCORT, inform your doctor if you are taking any of the following medicines:

Medicines used to relieve pain (Ex. aspirin, ibuprofen)
Aminoglutethimide (used for some types of cancer)
Ketoconazole (used to treat fungal infections)
Medicines used to remove excess water from the body (Ex. spironolactone, triamterene or amiloride)
Warfarin (used for thinning blood)
Medicines used in diabetes treatment (Ex. metformin or tolbutamide)
Medicines used for epilepsy (Ex. phenobarbitone, primidone, phenytoin, carbamazepine, acetazolamide)
Oral contraceptives such as oestrogens (used to prevent pregnancy)
Medicines used in tuberculosis treatment (Ex. rifampicin or rifabutin)
Medicines used for treating high blood pressure (Ex. verapamil, atenolol and propranolol)
Medicines for indigestion and heartburn (Ex. aluminium hydroxide, magnesium carbonate and calcium carbonate)
Salbutamol and theophylline (used for asthma)

Overdosage:

If you or anyone else accidentally takes too much of ORTHOCORT, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS
Drug :  

Deflazacort

Pharmacological Category :  

Glucocorticoids

Therapeutic Indication :  

Autoimmune diseases, Prevent rejection of organ transplantation and tumours

Dosage Forms :  

Tablet, Oral suspension, Suspension, Syrup

MORE INFORMATION
Keep ORTHOCORT out of reach of children
Store at room temperature
FAQs ABOUT ORTHOCORT

What is ORTHOCORT used for?

ORTHOCORT is used to treat inflammation including asthma, arthritis, allergies and problems in skin, heart, kidney, eyes, digestive system or blood. It is also used in certain type of cancer treatment and to suppress the immune system after transplant operations to prevent organ rejection.

Does ORTHOCORT increase blood sugar?

Yes, you might experience increased thirst and needing to pass water more often than usual which could be signs of diabetes. If you are already diabetic, your doctor may prescribe more of your diabetes medicine to balance the effects of ORTHOCORT. Always consult your doctor for advice before taking ORTHOCORT.

What are the side effects of ORTHOCORT?

ORTHOCORT can cause common side effects such as excessive facial hair, increased weight, puffy face appearance, skin redness, abdominal pain, constipation, irritability, abnormal behaviour, fever, back pain, bruise, nausea and nosebleeds. If any of these side effects get worsen, consult your doctor immediately.

Can I stop taking ORTHOCORT suddenly?

No, you should not stop taking ORTHOCORT without consulting your doctor because it may cause problems such as high temperature, runny nose, red eyes, aching muscles and joints, itchy skin, and weight loss along with vomiting, headache and drowsiness. This is more likely to happen in children. If you had to stop the treatment with ORTHOCORT, the dose will be gradually reduced.

Can I take vaccine while taking ORTHOCORT?

If you are going to have any injections or vaccinations, tell the doctor that you are taking ORTHOCORT. This includes those needed for a foreign holiday. Some vaccines should not be given to patients taking this medicine. This is because ORTHOCORT can affect the way some vaccines work.

REFERENCES

1. KD. Tripathi. Steroids, Corticosteroids. Essentials of medical pharmacology. Fourth edition. 2013. Chapter 19. Page – 284 to 297.

2. Anthony Markham & Harriet M. Bryson. Deflazacort – A Review of its Pharmacological Properties and Therapeutic Efficacy. October 2012 [Accessed on 15th June 2022] https://link.springer.com/article/10.2165/00003495-199550020-00008

3. Laura C. McAdam, Amanda L. Mayo, Benjamin A. Alman, and W. Douglas Biggar. The Canadian experience with long term deflazacort treatment in Duchenne muscular dystrophy. [Revised in May 2012] [Accessed on 15th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3440807/

4. Sanofi S.r.l. Electronic Medicines Compendium (EMC). [Revised in August 2022] [Accessed on 15th June 2022] https://www.medicines.org.uk/emc/files/pil.6287.pdf

5. Marathon Pharmaceuticals. U.S. Food & Drug Administration. [Revised in February 2017] [Accessed on 15th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf

USEFUL DIAGNOSTIC TESTS
Fasting blood sugar
Postprandial blood sugar
Liver function test
Complete blood count
Net Qty
1 N
Ingredient
DEFLAZACORT 18 mg
Hsn Code
30049099
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