Betanem Betamethasone Tablets

BETANEM®
BETAMETHASONE TABLETS B.P. 0.5 mg.

 

Betanem Tablets is a steroid medicine, prescribed for many different conditions, including serious illnesses.

You need to take it regularly to get the maximum benefit.

Don’t stop taking this medicine without talking to your doctor – you may need to reduce the dose gradually.

Betanem Tablets can cause side effects in some people (read section on side effects below). Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your medicine, but see your doctor straight away.

Some side effect, only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section on side effects for more information). If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you.

Keep away from people who have chicken pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.

Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you. If you have any questions about this medicine, ask your doctor or pharmacist.

 

What is your medicine?

Betanem Tablets are round, pink soluble tablets, scored one side and with ‘Betanem Evans’ engraved on the other.

Each tablet contains 500 micrograms (0.5mg) betamethasone as betamethasone sodium phosphate. The tablets also contain sodium bicarbonate, sodium acid citrate, saccharin sodium, povidone, Erythrosine (E127) and sodium benzoate. Betanem Tablets are supplied in strip packs of 100 tablets.

Betanem Tablets belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body and help to maintain health and well being Boosting your body with extra corticosteroids (such as Betanem Tablets is an effective way to treat various illness involving inflammation in the body. Betanem Tablets reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get the maximum benefit.

 

What is your medicine used for?

Many different conditions can be improved by the use of corticosteroids, as they reduce inflammation (redness, tenderness, heat and swelling) in the body. Some of the main conditions are:

Asthma and severe allergic reactions.

Certain conditions of the blood.

Rheumatoid arthritis.

Autoimmune diseases such as systemic lupus erythematosus (SLE) and polyarteritis nodosa.

Inflammatory conditions of the skin, kidney (such as acute interstitial nephritis), bowels (such as ulcerative colitis and Crohn’s disease) and heart.

Some connective tissue disorders.

Some types of cancer, such as malignant lymphoma.

Corticosteroids are also used to help prevent organ transplant rejection following organ transplant surgery.

If you are not sure why you are on these tablets, ask your doctor.

 

Before using this medicine

Check with your doctor first.

If you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while taking steroid medicines like Betanem Tablets.

If any of your close family had had these illnesses.

If either of these applies to you, talk to a doctor before taking Betanem Tablets.

Have you taken Betanem Tablets before and suffered a reaction to them, or been told that you are allergic to this medicine?

Are you allergic to any of the ingredients in the tablets?

Have you ever had tuberculosis (TB), epilepsy (fits), severe mental illness, glaucoma (raised eye pressure), hypertension (high blood pressure), osteoporosis (thinning of the bones), stomach or duodenal ulcers?

Have you recently had a heart attack?

Have you recently been in contact with someone who has chickenpox, shingles or measles, or recently had chickenpox, shingles or measles yourself? This product may make chickenpox, shingles or measles much worse.

Do you have an infection?

Are you diabetic?

Do you have an underactive thyroid gland?

Have you ever suffered from muscle wasting due to corticosteroids?

Do you have liver, kidney or heart disease?

Have you just been or are you about to be immunised?

Are you pregnant, likely to become pregnant, or breast-feeding? (see Special Precautions below)

Are you taking any other medicines either from your doctor or bought in a shop or chemist? In particular; insulin or oral antidiabetic drugs; medicines for high blood pressure; water tablets (diuretics); medicines for thinning the blood e.g. Warfarin; non-steroidal anti-inflammatory drugs e.g. Aspirin; medicines for myasthenia gravis called anticholinesterases, medicines for the heart called cardiac glycosides; carbenoxolone; acetazolamide; rifampicin; rifabutin; carbamazepine, phenobarbitone; primidone; aminoglytethimide; ephedrine; theophylline; amphotericin B (anti-fungal); ritonavir; oral contraceptive (the pill); mifepristone; somatropin (growth hormone).

If the answer to any of these questions is YES, tell your doctor (or pharmacist), before taking this medicine.

 

What special precautions should be taken?

Mental problems while taking Betanem Tablets

Mental health problems can happen while taking steroids like Betanem Tablets (see also section on possible side effects).

These illnesses can be serious

Usually they start within a few days or weeks of starting the medicine
They are more likely to happen at high doses

Most of these problem, go away if the dose is lowered or the medicine is stopped. However if problem do happen they might need treatment.

Talk to a doctor if you (or someone who is taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

Taking steroids often or for a long time during pregnancy can slow the baby’s growth in the womb or may temporarily affect the baby’s heart rate and body movements. The baby may also make less of its own steroid after birth but this rarely causes any problems. If you become pregnant whilst taking this medicine, please tell your doctor but DO NOT stop taking the tablets unless told to do so (see Withdrawal Symptoms below). If you are breastfeeding, the steroid may enter the baby and lower their hormone levels if you are taking high doses for a long time.

You should avoid contact with anyone who has either chickenpox, shingles or measles as it could be extremely serious if you caught it from them.

Advise your doctor IMMEDIATELY if you suspect you may have come into contact with a person who has chickenpox, shingles or measles. However do not stop taking your tablets, unless your doctor tells you to.

 

How to use your medicine

Look at the label; it should say who should use the tablets, how many should be taken and when. If it does not, or you are not sure, ask your doctor or pharmacist.

You may have been given a STEROID CARD which tells you how many tablets to take each day (see ‘Carrying a steroid card’)

The tablets can be swallowed whole, but they are best taken as a drink after allowing them to dissolve in a glass of water.

If you need to take half a tablet, then use the line on one side of the tablet as a guide. The tablets should be taken EXACTLY as stated on the label.

Do not suddenly stop taking the tablets even if you feel better unless your doctor tells you to – you could become ill.

 

DO NOT EXCEED THE STATED DOSE

 

What are the usual doses?

The dose used will depend upon the disease, its severity, and how quickly you get better. The following are for guidance duly.

Adults
Short term treatment: 2000-3000 micrograms (4-6 tablets daily for the first few days, then reducing the daily dose by 250-500 micrograms (1/2 or 1 tablet) every two to five days, depending upon the response.

Rheumatoid arthritis: 500-2000 micrograms (1-4 tablets) for long-term treatment the lowest effective dosage is used.

Most other conditions: 1500-5000 micrograms (3-10 tablets) daily for one to three weeks, then gradually reducing to the minimum effective dosage. Larger doses may be needed for mixed connective tissue diseases and ulcerative colitis.

Children
A proportion of the adult dosage may be used (e.g. 75% at 12 years, 50% at 7 years and 25% at 1 year).

 

What to do if you take too much

If you take too many tablets, tell your doctor immediately.

 

What to do if you miss a dose

If you forget to take a dose, take another as soon as possible, then go on as before. (If you only remember when it is time for your next dose, take a single dose and carry on as before).

 

Withdrawal Symptoms

It is very important that you do not suddenly stop taking your medicine (even if you feel better from your original illness, or are suffering from a side-effect) UNLESS YOUR DOCTOR TELLS YOU TO.

If you stop taking your medicine too suddenly, you may suffer from some of the following:

Fever, joint and muscle pain, itching eyes, nose or skin, mood changes, loss of weight, low hormone levels, low blood pressure (symptoms of which may include dizziness, headaches or fainting). In extreme cases this may be fatal.

 

Are there any side-effects to this medicine?

Serious effects: tells doctor straight away.

Steroids including dexamethasone can cause serious mental health problems.

These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like dexamethasone.

Feeling depressed, including thinking about suicide.

Feeling high (mania) or moods that go up and down.

Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.

Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight sway.

If you need to take the tablets for more than 2 weeks your doctor will prescribe as low a dose as possible. High doses taken for a long time or repeated short courses can lead to side-effects such as:

Low levels of hormones which can cause irregular menstrual periods in women, suppression of growth in adolescents and children, changes in blood sugar, salt or protein levels, extra hair growth and/or weight gain, increased sweating, or increases in appetite.

Increased levels of cholesterol in your blood.

Increased susceptibility to infection, including worsening of tuberculosis (TB) if this is already present.

Wasting of muscles, thinning of the bones (osteoporosis) or fractures, breaking of tendons, and breakdown of the bone due to lack of blood supply.

Water retention (which may cause a bloated feeling), or higher blood pressure (symptoms may include headaches), or changes in blood chemistry due to loss of potassium. If you have recently had a heart attack, betamethasone can sometimes cause a serious complication of the heart whereby the tissues can become affected by tears or breaks.

Worsening of epilepsy or schizophrenia if you already have either of these problems
Children may experience swelling and fluid build-up near the eyes and brain (this may result in a throbbing headache which may be worse upon waking up, coughing, or sudden movement, and patchy vision with blind spots and possible lack of colour vision).
Increased pressure in the eye (glaucoma), cataract, worsening of viral or fungal diseases, thinning of the cornea or sclera (the outer membrane of the eye) or other eye problems (which may cause headaches or blurred vision).

Heartburn or indigestion, hiccups, nausea, bloating of the abdomen, stomach ulcers which may bleed, oesphageal ulcer, thrush in the mouth or throat, or pancreas disorders.

Bruising, poor wound healing, abscesses, acne, rashes, thinning of the skin, prominent veins, or changes in skin colour.

Blood clots, or allergic reactions (which cast include rashes, breathing difficulties or shock), blood disorders, or heart failure.

If you think this medicine has upset you in ANY way, PLEASE TELL YOUR DOCTOR.
Additional care should be taken if this medicine is given to elderly patients, as aide-effects may be more serious.

 

Storage of your medicine

Do not store above 25oC. Keep the tablets in the original package to protect from light. Do not use this medicine after the expiry date shown on the pack.

KEEP THIS AND ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN

 

What to do with any unused tablets

If your doctor decides to stop your medicine or you have tablets left at the end of treatment, return any unused tablets to your pharmacist for safe disposal.

 

Carrying your steroid card

If your doctor asks you to carry a steroid card, be sure to keep it with you always.
Show it to any doctor, dentist, nurse or midwife or anyone else who is giving you treatment.

Even after your treatment has finished tell any doctor, dentist, nurse, midwife or anyone else who is giving you treatment that you have had steroid treatment.

A steroid card may be obtained from your doctor, pharmacist, or local Family Health Service Authority. In Scotland, steroid cards are available from the Scottish Office of Home and Health.

REMEMBER THIS MEDICINE IS ONLY FOR YOU. ONLY A DOCTOR CAN PRESCRIBE IT FOR YOU. NEVER GIVE IT TO SOMEONE ELSE; THERE MAY BE A REASON WHY IT COULD HARM THEM.

 

Further information

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor (or pharmacist), who will have access to further information. Pharmaceutical companies are not allowed to advice about personal medical problems.

YOU MAY WANT TO READ THIS LEAFLET AGAIN. PLEASE DO NOT THROW IT AWAY UNTIL YOU HAVE FINISHED YOUR MEDICINE.

 

Sole Agent

Jay Formulations Ltd.

Unit No.1301 & U-1, G.I.D.C. Kerala (Bavia),

Dist. Ahmedabad, Gujarat, INDIA.

 

Manufactured by

Lifeline Pharmaceuticals Ltd.

30, Umuoji Street Nkpor

Anambra State, Nigeria.

lifelinepharmyahoo.com

OM D Dexamethasone Tablets

OM-D
Dexamethasone Tablets B.P. 0.5mg

 

COMPOSITION

Each uncoated tablet contains

Dexamethasone BP 0.5mg

Excipients q.s.

 

THERAPEUTICS CATEGORY

Antineoplastic agents, Hormonal, GIucocorticoids, Antiemetics, Anti-inflammatory agents, adrenergic agents.

 

PHARMACOLOGICAL ACTION

Dexamethosone is a glucocorticoid agent. Unbound dexamathasone crosses cell membranes and binds with high affinity to specific cytoplasmic receptors. This results in a modification of transcription and, hence, protein synthesis in order to achieve inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, suppression of humoral immune responses, and reduction in edema or scar tissue. The anti-inflammatory actions of dexamethasone are thought to involve phospholipase A2 inhibitory proteins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

 

INDICATION

OM-D, corticosteroid drug, is used to reduce inflammation and relieve symptoms in a variety of disorders, including rheumatoid arthritis and severe cases of asthma. It may be given to people to treat primary or secondary adrenal cortex insufficiency (lack of sufficient adrenal hormone). It is also given to help treat the following disorders: Severe allergic conditions such as drug-induced, allergies, Blood disorders such as various anemias, Certain cancers (along with other drugs), Skin diseases such as severe psoriasis, Collagen (connective tissue) diseases such as systemic lupus erythematosus, Digestive tract disease such as ulcerative colitis, High serum levels of calcium associated with cancer, Fluid retention due to nephrotic syndrome (a condition in which damage to the kidneys causes the body to lose protein in the urine), Eye diseases such as allergic conjunctivitis, Lung diseases such as tuberculosis (along with other drugs).

 

RECOMMENDED DOSAGE

ADULTS: Initial doses range from 0.75 milligram to 9 milligrams a day and or as prescribed by your doctors.

 

CONTRAINDICATION

OM-D should not be used if you have a fungal infection, or if you are sensitive or allergic to any of its ingredients.

 

DRUG INTERACTIONS

Amphotericin B & hydrocortisone: cardiac enlargement and congestive heart failure.

Atibiotics: decrease in corticosteroid clearance.

Anticholinesterases: produce severe weakness in patients with myasthenia gravis.

Antidiabetics: increase blood glucose concentrations.

Antitubercular drugs: Serum concentrations of isoniazid may be decreased.

Cholestyramine: increase the clearance of corticosteroids.

Cyclosporine: Convulsions have been reported with this concurrent use.

Digitalis glycosides: increased risk of arrhythmias due to hypokalemia.

Ketoconazole: increased risk of corticosteroid side effects.

Nonsteroidal anti-inflammatory agents (NSAIDS): Increases the risk of gastrointestinal side effects.

Phenytoin: in post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control.

Thalidomide: as toxic epidermal necrolysis has been reported with concomitant use.

 

SIDE EFFECTS

Abdominal distention, allergic reactions, blood clots, bone fractures and degeneration, bruises, cataracts, congestive heart failure, convulsions, “cushingoid” symptoms (moon face, weight gain, high blood pressure, emotional disturbances, growth of facial hair in women) excessive hairlines, fluid and salt retention, general feeling of illness, glaucoma, headache, hiccups, high blood pressure, high blood sugar, hives, increased appetite, increased eye pressure, increased pressure in head, increased sweating, increases in amounts of insulin or hypoglycemic medications needed in diabetes, inflammation of the esophagus, inflammation of the pancreas, irregular menstruation, loss of muscle mass, low potassium levels in blood (leading to symptoms such as dry mouth, excessive thirst, weak or irregular heartbeat, and muscle pain or cramps), muscle weakness, nausea, osteoporosis, peptic ulcer, perforated small and large bowel, poor healing of wounds, protruding eyeballs, suppression of growth in children, thin skin, tiny red or purplish spots on the skin, torn tendons, vertigo and weight gain.

 

TOXICITY

Oral, rat LD50: >3 gm/kg. Signs of overdose include retinal toxicity, glaucoma, subcapsular cataract, gastrointestinal bleeding, pancreatitis, aseptic bone necrosis, osteoporosis, myopathies, obesity, edemas, hypertension, proteinuria, diabetes, sleep disturbances, psychiatric syndromes, delayed wound healing, atrophy and fragility of the skin, ecchymosis, and pseudotumor cerebri.

 

PREGNANT

The effects of OM-D during pregnancy have not been adequately studied.

 

BREASTFEEDING

Corticosteroids appear in breast milk and can suppress growth in infants. If OM-D is essential to your health, your doctor may advise you to stop breastfeeding until your treatment with this drug is finished.

 

HALF LIFE

36-54 hours.

 

STORAGE

Store below 25°C in a dry place. Protect from light & moisture.
KEEP OUT OF REACH OF CHILDREN

 

PRESENTATION

OM-D Tablets pack in Blister package of 10 x 10 Tablets.

 

Imported by

ZADIP PHARMA NIG. LTD.

48B, Town Planning Way, llupeju, Lagos.

zadip.pharma@gmail.com

 

Exported by

NEST LIFESCIENCE Pvt. Ltd.

nestlifescience@yahoo.in

 

Manufactured by

Comed Chemicals Limited

359, Rania, Taluka-Sovil, District-Boroda, Gujarat, India.

Predicure Prednisolone Tablet

PREDICURE®
Prednisolone Tablet B.P.5mg

 

DRUG NAME

Prednisolone Tablets, chemical name: 11β, 17, 21- trihydroxypregna-1, 4-diene – 3, 20-dione. Structural formula C21H28O5 360.4

 

DESCRIPTION

Round, white film-coated tablets, shallow convex faces. “Pred” embossed and scored on the same face.

 

COMPOSITION

Each tablet contains: Pednisolone 5mg

 

PHARMACOLOGICAL & TOXICOLOGICAL

Prednisolone, a synthetic glucocorticoid, has both anti-inflammatory and immunosuppressant actions. It acts by inhibition of phagocytosis, leukocyte migration and capillary dilatation, and prevention or suppression of cell-mediated (delayed hypersensitivity) immune reactions respectively. It is readily absorbed orally, metabolized in the liver and excreted via the kidneys.

 

PHARMACOKINETICS

This product activity in the form of easily absorbed from the digestive tract, without transformation of the liver that exert their biological effects. About 1-2 hours after oral administration, plasma concentration reaches the peak T1/2 is 2-3 hours. In the blood most of the food with the plasma protein binding free and conjugated metabolites from the urine discharged from a portion of the prototype, a small number of milk may be discharged.

 

INDICATIONS

Prednisolone is used is the treatment of conditions where a routine systemic corticosteroid therapy is indicated. Its weaker sodium retaining action usually makes it more suitable than cortisone in such conditions as rheumatoid arthritis, rheumatic fever, status asthmaticus and ulcerative colotis.

 

DOSAGE & ADMINISTRATION

Adults: Oral, 5 to 60mg a day as a single dose or in divided doses, not exceeding 250mg daily. Or as directed by physician.

Children: As directed by physician.

Note: The paediatric dosage is determined more by the severity of the condition and response of the patient than by age or body weight.

The information given here is limited. For further information consult your doctor or pharmacist.

 

CONTRAINDICATIONS

Use is not recommended in nursing mother, wherever possible.

 

SIDE EFFECTS

Dyspepsia, peptic ulceration, long-term use include Cushing’s syndrome, acne, osteoporosis, mental changes and endocrine imbalance.

 

PRECAUTION

1, Caution in patients with osteoporpsis ulcer, psychoses fungal infections, diabetes mellitus, hypertension, myasthenia gravis, ocular herpes simplex, glaucoma,
hypothyroidism, history of tuberculosis, renal and hepatic function impairment.

2, When medication is to be discontinued, dosage should be reduced gradually. Abrupt cessation of prolonged therapy may produce acute adrenal insufficiency.

3, Frequent monitoring of drug effect is required.

4, Caution in receiving vaccinations, other immunizations and skin test

5, Children on prolonged therapy should be closely observed.

6, Safety for use in pregnancy has not been established.

7, Overdosage: Clinical features: Nausea and vomiting, hyperglycaemia, occasional gastrointestinal bleeding. Treat overdose by symptomatic measures.

 

DRUG INTERACTIONS

1, Response to prednisolone maybe reduced by co-administration of barbiturates, phenytoin or rifampicin.

2, Effects of oral anticoagulants or salicylates may be decreased when used concurrently with prednisolone.

3 Caution in patients receiving the following drug therapy: Alcohol, anti-inflammatory medications, cardiac glycosides, ephedrine, heparin, hypoglycaemics.

 

PRESENTATION

5mg/Tablet, 10 tablets/blister, 10 blisters/box.

 

STORAGE

Store in a well-closed container. Protected from heat and light.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

 

EXPIRY DATE

3 years.

 

Manufactured by

Unicure Pharmaceutical Ltd.

lkofa Village, Lagos – Benin Expressway, Ijebu-ode,

Ogun State, Nigeria.