Betamethasone Solution for Injection BP 4mg/ml in Prefilled Syringe Taj Pharma

Rx only

Betamethasone Solution for Injection BP 4mg/ml in Prefilled Syringe Taj Pharma

(Betamethasone Injection)

1. Name of the medicinal product

Betamethasone Solution for Injection BP 4mg/ml in Pre-filled Syringe Taj Pharma

2. Qualitative and quantitative composition

Each Pre-filled syringe contains:

Betamethasone BP                                  4mg

(equivalent to Betamethasone sodium phosphate 5.3mg)

Excipients                                                q.s.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for Injection

1ml Pre-filled syringes containing a clear colourless or pale-yellow solution.

4. Clinical particulars

4.1 Therapeutic indications

Betamethasone is a glucocorticosteroid which is about eight to ten times as active as prednisolone on a weight-for-weight basis. It may be indicated in the following conditions:

Status asthmaticus and acute allergic reactions, including anaphylactic reactions to drugs. Betamethasone Injection supplements the action of adrenaline.

Severe shock arising from surgical or accidental trauma or overwhelming infection.

Acute adrenal crisis caused by abnormal stress in Addison’s disease, Simmonds’ disease, hypopituitarism following adrenalectomy, and when adrenocortical function has been suppressed by prolonged corticosteroid therapy.

Soft tissue lesions such as tennis elbow, tenosynovitis and bursitis.

Betamethasone Injection does not replace other forms of therapy for the treatment of shock and status asthmaticus.

4.2 Posology and method of administration

Posology:

Systemic therapy in adults

4 to 20mg betamethasone (1 to 5ml) administered by slow intravenous injection over half to one minute. This dose can be repeated three or four times in 24 hours, or as required, depending upon the condition being treated and the patient’s response.

Alternatively, Betamethasone Injection may be given by intravenous infusion. The same dose can be given by deep intramuscular injection but the response is likely to be less rapid, especially in shock. This dose can be repeated three or four times in 24 hours depending upon the condition being treated and the patient’s response.

Systemic therapy in paediatric population

Infants up to 1 year may be given 1mg betamethasone intravenously; children aged 1 to 5 years, 2mg; 6 to 12 years, 4mg (1ml). This dose can be repeated three or four times in 24 hours, depending upon the condition being treated and the patient’s response.

Method of administration:

Betamethasone Injection may be administered by slow intravenous injection, deep intramuscular injection or subconjunctival injection. Alternatively, Betamethasone Injection may be given by intravenous infusion. Local injections of Betamethasone Injection may be used when treating soft tissue lesions (see below).

The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment (see section 4.4).

Other routes

Local injections of 4 to 8mg Betamethasone Injection may be used when treating soft tissue lesions in adults; children may require smaller doses. This dose can be repeated on two or three occasions depending upon the patient’s response.

Betamethasone Injection has also been administered sub-conjunctivally as a single injection of 0.5 to 1ml.

Intrathecal use is not recommended.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Systemic infections, unless specific anti-infective therapy is employed.

Betamethasone Injection contains sodium metabisulphite (0.1% w/v) as a preservative and therefore should not be used to treat patients with known hypersensitivity to bisulphite, metabisulphite.

Betamethasone Injection should not be injected directly into tendons.

4.4 Special warnings and precautions for use

A patient information leaflet should be supplied with this product.

Undesirable effects may be minimised by using the lowest effective dose for the minimum period and by administering the daily requirement as a single morning dose or whenever possible as a single morning dose on alternate days. Frequent patient review is required to appropriately titrate the dose against disease activity (see section 4.2).

Caution is advised with the use of corticosteroids in patients who have suffered a recent myocardial infarction because of the risk of myocardial rupture.

Caution is advised on the use of corticosteroids in patients with hypothyroidism or myasthenia gravis.

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked and may reach an advanced stage before being recognised.

Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients (or parents of children) without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Passive immunisation with varicella zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are receiving systemic corticosteroids or who have used them within the previous 3 months; this should be given within 10 days of exposure to chickenpox. If a diagnosis of chickenpox is confirmed, the illness warrants specialist care and urgent treatment. Corticosteroids should not be stopped and the dose may need to be increased.

Live vaccines should not be given to individuals with impaired immune responsiveness. The antibody response to other vaccines may be diminished.

Patients should be advised to take particular care to avoid exposure to measles and to seek immediate medical advice if exposure occurs. Prophylaxis with intramuscular normal immunoglobulin may be needed.

Corticosteroids should not be used for management of head injury or stroke because it is unlikely to be of benefit and may even be harmful.

In the treatment of cerebral oedema due to tumour, gastrointestinal bleeding may occur and stool examination may be helpful in diagnosis.

Adrenal suppression:

Adrenal cortical atrophy develops during prolonged therapy and may persist for years after stopping treatment.

In patients who have received more than physiological doses of systemic corticosteroids (approximately 1mg betamethasone or equivalent) for greater than 3 weeks, withdrawal should not be abrupt. How dose reduction should be carried out depends largely on whether the disease is likely to relapse as a dose of systemic corticosteroids is reduced. Clinical assessment of disease activity may be needed during withdrawal. If the disease is unlikely to relapse on withdrawal of systemic corticosteroids but there is uncertainty about HPA suppression, the dose of systemic corticosteroid may be reduced rapidly to physiological doses. Once a daily dose equivalent to 1mg betamethasone is reached, dose reduction should be slower to allow the HPA-axis to recover.

Abrupt withdrawal of systemic corticosteroid treatment, which has continued up to 3 weeks is appropriate if it is considered that the disease is unlikely to relapse. Abrupt withdrawal of doses of up to 6mg daily of betamethasone, or equivalent for 3 weeks is unlikely to lead to clinically relevant HPA-axis suppression, in the majority of patients. In the following patient groups, gradual withdrawal of systemic corticosteroid therapy should be considered even after courses lasting 3 weeks or less:

  • Patients who have had repeated courses of systemic corticosteroids, particularly if taken for greater than 3 weeks,
  • When a short course has been prescribed within one year of cessation of long-term therapy (months or years),
  • Patients who have reasons for adrenocortical insufficiency other than exogenous corticosteroids therapy,
  • Patients receiving doses of systemic corticosteroid greater than 6mg daily of betamethasone (or equivalent),
  • Patients repeatedly taking doses in the evening.

During prolonged therapy any intercurrent illness, trauma or surgical procedure will require a temporary increase in dosage; if corticosteroids have been stopped following prolonged therapy they may need to be temporarily re-introduced.

Special precautions

Particular care is required when considering the use of systemic corticosteroids in patients with the following conditions and frequent patient monitoring is necessary.

  1. Osteoporosis (post-menopausal females are particularly at risk).
  2. Hypertension or congestive heart failure.
  3. Existing or previous history of severe affective disorders (especially previous steroid psychosis).
  4. Diabetes mellitus (or a family history of diabetes).
  5. History of, or active, tuberculosis.
  6. Glaucoma (or a family history of glaucoma).
  7. Previous corticosteroid-induced myopathy.
  8. Liver failure – blood levels of corticosteroid may be increased, as with other drugs which are metabolised in the liver.
  9. Renal insufficiency.
  10. Epilepsy.
  11. History of, or active, peptic ulceration.
  12. Herpes simplex keratitis.
  13. Diverticulitis.
  14. Thromboembolic tendencies.

Patients should carry ‘steroid treatment’ cards which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.

Patients/and or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8). Symptoms typically emerge within a few days or weeks of starting treatment. Risks may be higher with high doses/systemic exposure (see also section 4.5 pharmacokinetic interactions that can increase the risk of side effects), although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary. Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.

Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychosis.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Paediatric population

Caution is advised in children as they are more susceptible to systemic toxicity from betamethasone.

Corticosteroids cause dose-related growth retardation in infancy, childhood and adolescence, which may be irreversible. Treatment should be limited to the minimum dosage for the shortest possible time. In order to minimise suppression of the HPA axis and growth retardation, consideration should be given to administration of a single dose on alternate days.

Elderly

The common adverse effects of systemic corticosteroids may be associated with more serious consequences in old age, especially osteoporosis, hypertension, hypokalaemia, diabetes, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Steroids may reduce the effects of anticholinesterases in myasthenia gravis, cholecystographic X-ray media and non-steroidal anti-inflammatory agents.

Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, aminoglutethimide and ephedrine enhance the metabolism of corticosteroids; thus the corticosteroid therapeutic effect may be reduced.

The desired effects of hypoglycaemic agents (including insulin), anti-hypertensives and diuretics are antagonised by corticosteroids and the hypokalaemic effects of acetazolamide, loop diuretics, thiazide diuretics and carbenoxolone are enhanced.

The efficacy of coumarin anticoagulants may be enhanced by concurrent corticosteroid therapy and close monitoring of the INR or prothrombin time is required to avoid spontaneous bleeding.

The renal clearance of salicylates is increased by corticosteroids and steroid withdrawal may result in salicylate intoxication.

The risk of hypokalaemia is increased with theophylline, ulcer healing drugs such as carbenoxolone and antifungals such as amphotericin B.

Increased toxicity may result if hypokalaemia occurs in patients on cardiac glycosides.

Ritonavir and oral contraceptives may result in increased plasma concentrations or corticosteroids.

The effect of corticosteroids may be reduced for 3-4 days after mifepristone.

The growth promoting effect of somatropin may be inhibited by corticosteroids.

An increase in the incidence of gastrointestinal bleeding may occur if NSAIDS are taken concomitantly with corticosteroids.

Corticosteroids may antagonise the effects of neuromuscular blocking drugs such as vecuronium.

Concurrent use of corticosteroids and fluoroquinolones may result in increased risk of tendon rupture.

Concomitant use of betamethasone with quetiapine may result in the increased metabolism of quetiapine and, depending on the clinical response, a higher dose of quetiapine may need to be considered.

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.

Corticosteroids may enhance the metabolism of tretinoin resulting in decreased levels of tretinoin.

4.6 Fertility, pregnancy and lactation

Pregnancy

The ability of corticosteroids to cross the placenta varies between individual drugs, however, betamethasone readily crosses the placenta. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate, intra-uterine growth retardation and effects on brain growth and development. There is no evidence that corticosteroids result in an increased incidence of congenital abnormalities, such as cleft palate/lip in man. However, when administered for prolonged periods or repeatedly during pregnancy, corticosteroids may increase the risk of intra-uterine growth retardation. Hypoadrenalism may, in theory, occur in the neonate following prenatal exposure to corticosteroids but usually resolves spontaneously following birth and is rarely clinically important. Myocardial hypertrophy and gastroesophageal reflux have been reported in association with in-utero exposure to betamethasone.

As with all drugs, corticosteroids should only be prescribed when the benefits to the mother and child outweigh the risks. When corticosteroids are essential however, patients with normal pregnancies may be treated as though they were in the non-gravid state. Patients with pre-eclampsia or fluid retention require close monitoring.

Betamethasone, systemically administered to a woman during pregnancy may result in a transient suppression of the foetal heart rate parameters and biophysical activities that are widely used for the assessment of foetal well – being. These characteristics can include a reduction in foetal breathing movements, body movements and heart rate.

Breast-feeding

Corticosteroids may pass into breast milk, although no data are available for betamethasone. Infants of mothers taking high doses of systemic corticosteroids for prolonged periods may have a degree of adrenal suppression

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

The incidence of predictable undesirable effects, including hypothalamic-pituitary-adrenal (HPA) axis suppression, correlates with the relative potency of the drug, dosage, timing of administration and the duration of treatment (see section 4.4)

Not known: frequency cannot be estimated from the available data

System organ class Frequency Undesirable effects
Infections and infestations Not known Increased susceptibility to and severity of infections with suppression of clinical symptoms and signs, opportunistic infections, recurrence of dormant tuberculosis (see section 4.4)
Endocrine disorders Not known Suppression of the HPA axis, growth suppression in infancy, childhood and adolescence, menstrual irregularity and amenorrhoea.
Metabolism and nutrition disorders Not known Cushingoid facies, hirsutism, weight gain, impaired carbohydrate tolerance with increased requirement for antidiabetic therapy*
Psychiatric disorders Common A wide range of psychiatric reactions**
Eye disorders Not known Increased intra-ocular pressure, glaucoma, papilloedema, posterior subcapsular cataracts, corneal or scleral thinning, exacerbation of ophthalmic viral or fungal diseases

Vision, blurred (see also section 4.4)

Cardiac disorders Not known Myocardial rupture following recent myocardial infarction
Gastrointestinal disorders Not known Abdominal distension, oesophageal ulceration, nausea, dyspepsia, peptic ulceration with perforation and haemorrhage, acute pancreatitis, candidiasis
Skin and subcutaneous tissue disorders Not known Impaired healing, skin atrophy, bruising, telangiectasia, striae, acne, Stevens-Johnson syndrome.
Musculoskeletal and connective tissue disorders Not known Osteoporosis, vertebral and long bone fractures, avascular osteonecrosis, tendon rupture, proximal myopathy
General disorders and administration site conditions Not known Hypersensitivity including anaphylaxis has been reported. Leucocytosis, Thrombo-embolism, Malaise, Hiccups

* Negative protein, nitrogen and calcium balance. Increased appetite. Hyperhidrosis. Increased high – density lipoprotein and low – density lipoprotein concentrations in the blood. Fluid and electrolyte disturbance (Sodium and water retention, hypertension, potassium loss, hypokalaemic alkalosis)

** Including affective disorder (such as irritable, euphoric, depressed and labile mood and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and aggravation of schizophrenia), behavioural disturbances, irritability, anxiety, sleep disturbances and cognitive dysfunction including confusion and amnesia have been reported. Reactions are common and may occur in both adults and children. In adults, the frequency of severe reactions has been estimated to the 5-6%. Psychological effects have been reported on withdrawal of corticosteroids; the frequency is unknown. Psychological dependence. Increased intra-cranial pressure with papilloedema in children (pseudotumour cerebri), usually after treatment withdrawal. Aggravation of epilepsy.

Withdrawal symptoms and signs

Too rapid reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death (see “Special Warnings and Precautions for Use”).

A “withdrawal syndrome” may also occur including; fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful itchy skin nodules and loss of weight.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Management:

Should overdosage occur, the possibility of adrenal suppression should be minimised by a gradual reduction of dosage over a period of time. The patient may need support during any further trauma.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Betamethasone sodium phosphate is an active corticosteroid with topical anti-inflammatory activity.

Betamethasone is a glucocorticoid which is about eight to ten times as active as prednisolone on a weight-for-weight basis

5.2 Pharmacokinetic properties

Corticosteroids are bound to plasma proteins in varying degrees.

Biotransformation:

Corticosteroids are metabolised primarily by the liver.

Elimination:

Corticosteroids are excreted by the kidneys.

5.3 Preclinical safety data

None stated

6.Pharmaceutical particulars

6.1 List of excipients

Disodium edetate, Sodium metabisulphite, Sodium chloride, Sodium hydroxide, Hydrochloric acid,Water for injection

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.

6.5 Nature and contents of container

Colourless glass Pre-filled syringes packed in cartons of 5 Pre-filled syringes

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Rx Only

Betamethasone Solution for Injection BP 4mg/ml in Prefilled Syringe Taj Pharma

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet Betamethasone 4mg/ml Solution for Pre-filled syringe will be called Betamethasone Pre-filled syringe.

What is in this leaflet

  1. What Betamethasone Pre-filled syringe is and what it is used for
  2. What you need to know before you are given Betamethasone Pre-filled syringe
  3. How you will be given Betamethasone Pre-filled syringe
  4. Possible side effects
  5. How to store Betamethasone Pre-filled syringe
  6. Contents of the pack and other information

 

  1. What Betamethasone Pre-filled syringe is and what it is used for

Betamethasone Pre-filled syringe 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 Betamethasone Pre-filled syringe) is an effective way to treat various illnesses involving inflammation in the body. Betamethasone Pre-filled syringe reduces this inflammation, which could otherwise go on making your condition worse. You must use this medicine regularly to get maximum benefit from it.

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

Betamethasone Pre-filled syringe is used:

  • to treat asthma
  • to treat severe allergic reactions including reactions to drugs
  • to treat local inflammation e.g. of joints, tendons or the eye
  • as replacement for the body’s naturally occurring corticosteroid hormones when these are reduced or absent
  • to treat severe shock, (collapse) due to surgery, injury or overwhelming infection.
  • Corticosteroids are also used to help prevent organ transplant rejection following organ transplant surgery.
  1. What you need to know before you are given Betamethasone Pre-filled syringe

Do not use Betamethasone Pre-filled syringe:

  • if you are allergic to betamethasone or any of the other ingredients of this medicine (listed in section 6).
  • if you have an infection and have not yet started taking any medicine (e.g. antibiotics) to treat it.

Warnings and precautions

Talk to your doctor or nurse before you are given

Betamethasone Pre-filled syringe.

  • If you have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before while using steroid medicines like Betamethasone Pre-filled syringe
  • If any of your close family has had these illnesses
  • If you have or have ever had tuberculosis (TB)
  • If you have epilepsy (fits), severe mental illness, heart disease, hypertension (high blood pressure), stomach or duodenal ulcers, diverticulitis (inflammation of the bowel) or a herpes infection of the eye
  • If you have osteoporosis (thinning of the bones). Post menopausal women are particularly at risk of this
  • If you or any of your family have ever had glaucoma (raised eye pressure)
  • If you have recently had a heart attack
  • If you have had a stroke or if there is a history of stroke in your family
  • If you have recently had a head injury
  • If you have 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.
  • If you or any of your family are diabetic
  • If you have an underactive thyroid gland
  • If you have myasthenia gravis (a disease which causes muscle weakness)
  • If you have ever suffered from muscle wasting due to corticosteroids
  • If you have liver, kidney or heart disease
  • If you have just been or are about to be immunised
  • If you have an infection
  • If you are pregnant or breast-feeding (see “Pregnancy and breast-feeding” section below).
  • If you experience blurred vision or other visual disturbances.

Other medicines and Betamethasone Pre-filled syringe

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

  • Some medicines may increase the effects of Betamethasone Pre-filled syringe and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)
  • 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. ibuprofen
  • Salicylates e.g. aspirin
  • Medicines for myasthenia gravis called anticholinesterases
  • Medicines for the heart called cardiac glycosides
  • Acetazolamide (used to treat glaucoma)
  • Rifampicin and rifabutin (antibiotics for tuberculosis) and ephedrine
  • Carbamazepine, phenytoin, primidone, phenobarbitone and aminoglutethimide for epilepsy
  • Carbenoxolone (an ulcer healing drug), theophylline (used to treat asthma and other breathing difficulties) and amphotericin B (anti-fungal)
  • Oral contraceptives (the pill)
  • Mifepristone (anti-progesterone)
  • Somatropin (growth hormone)
  • Vecuronium and other muscle relaxants
  • Fluoroquinolones (used for some infections)
  • Quetiapine (improves symptoms of some mental illnesses)
  • Tretinoin (used for skin problems such as bad acne)
  • Any other medicine, including medicines obtained without a prescription.

Betamethasone Pre-filled syringe may also affect the results of gall-bladder X-ray procedures.

Mental problems while using Betamethasone Pre-filled syringe Mental health problems can happen while using steroids like Betamethasone Pre-filled syringe (see section 4).

  • 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 problems go away if the dose is lowered or the medicine is stopped. However, if problems do occur they may need treatment.

Talk to a doctor if you (or someone who is using 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.

Chickenpox, shingles or measles

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

Tell 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 using this medicine, unless your doctor tells you to.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy:

Taking steroids often or for a long period of time, during pregnancy, can slow the baby’s growth in the womb or may temporarily affect the baby’s heart and body movements.

Sometimes the baby may get digestive juices going up into the tube that carries food from the mouth to the stomach. The baby may also make less of its own steroid after birth, but this rarely causes any problems. If you become pregnant whilst using this medicine, please tell your doctor but DO NOT stop treatment unless told to do  so  (see section 3).

Breast-feeding:

If you are breast-feeding, the steroid may enter the baby and lower their hormone levels, if you are using high doses for a long period of time.

Betamethasone Pre-filled syringe contains sodium metabisulphite and sodium

Betamethasone Pre-filled syringe contains sodium metabisulphite (0.1% w/v) as a preservative, it may rarely cause severe

hypersensitivity reactions and bronchospasm. This medicinal product contains less than 1 mmol sodium (23 mg) per 1ml, i.e. essentially ‘sodium- free’. Tell your doctor or nurse before you are given Betamethasone Pre-filled syringe if this applies to you.

3. How you will be given Betamethasone Pre-filled syringe

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Important: Your doctor will choose the dose that is right for you.

You may have been given a steroid card which also tells you how many injections you need each day (see section 6).

The dose used will depend upon the disease, its severity and how quickly you get better. Betamethasone Pre-filled syringe is not intended for long term use. The following are for guidance only:

The recommended doses are:

Local injections (excluding eye):

Adults: 4 – 8mg (1 – 2ml), repeated up to three times.

Use in children and adolescents:

Children may have a smaller dose.

Eye injections:

Adults and children: 2 – 4mg (0.5 – 1ml). Other injections: Adults: 4 – 20mg (1 – 5ml). Use in children and adolescents:

Children 6 – 12 years: 4mg (1ml). Children 1 – 5 years: 2 mg (0.5ml). Children up to 1 year: 1mg (0.25ml).

These doses can be repeated up to four times a day.

If you have any queries about the amount of medicine you have been prescribed, ask your doctor.

While you are using this medicine, your doctor may ask you to have check-ups. These are to make sure that your medicine is working properly and that the dose you are taking is right for you.

Method of administration:

Betamethasone Pre-filled syringe can be given slowly into a vein, deep into a muscle or locally at the site of inflammation. It should not be injected directly into tendons. Your doctor will decide where, how much and how often you should be given Betamethasone Pre-filled syringe.

If you are given more Betamethasone Pre-filled syringe than you should

If you think you have been given too much of the injection, immediately tell your doctor or nurse. The dose may be reduced slowly over time to minimise any effects.

If you forget to use Betamethasone Pre-filled syringe

If you forget to have a dose, i.e. miss your doctor’s appointment, see your doctor as soon as possible.

If you stop using Betamethasone Pre-filled syringe

Do not stop using Betamethasone Pre-filled syringe without first talking to your doctor.

It is very important that you do not suddenly stop using Betamethasone Pre-filled syringe, 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 using your medicine too suddenly, you may suffer from some of the following; fever, joint and muscle pain, itchy eyes, nose or skin, mood changes, loss of weight, low hormone levels or low blood pressure (symptoms of which may include dizziness, headaches or fainting). In extreme cases this can be fatal. Your doctor will tell you how to stop using Betametha- sone Pre-filled syringe.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious effects: tell a doctor straight away

Steroids including betamethasone can cause serious mental health problems. These are common in both adults and children. They may affect up to 1 in 10 people taking medicines like betamethasone.

If you notice any of the following problems, talk to a doctor straight away:

  • Feeling depressed, including thinking about suicide
  • Allergic reactions (which can include rashes, breathing difficulties or shock), blood disorders or heart failure
  • Changes in skin colour or blistering of the skin, mouth, eyes and genitals
  • Symptoms of cramping pain, redness, warmth or swelling in your arms or legs or shortness of breath. These could be a sign of a blood clot
  • 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
  • Worsening of epilepsy or schizophrenia, if you already have either of these problems
  • Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone
  • 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 eye pressure (glaucoma)
  • Mouth and/or stomach ulcers, oesophageal ulcers (which may bleed)
  • Symptoms of severe pain in your stomach, nausea and vomiting, diarrhoea, fever, loss of appetite and yellowing of your skin (jaundice). These could be a sign of acute pancreatitis.

Most people find that using this medicine for a short time causes no problems. If you need to take the injections for more than two weeks, your doctor will prescribe as low as possible, dose.

Not known (Frequency cannot be estimated from the available data)

High doses taken for a long period of 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 increase 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), 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
  • 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, thrush in the mouth or throat
  • Bruising, poor wound healing, abscesses, acne, rashes, thinning of the skin, prominent veins.
  • Blurred vision.

Additional care should be taken if this medicine is given to elderly, as side effects may be more serious.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Betamethasone Pre-filled syringe

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.Contents of the pack and other information

What Betamethasone Pre-filled syringe contains

-The active substance is betamethasone sodium phosphate.

Each Pre-filled syringe contains 5.3mg of betamethasone sodium phosphate equivalent to 4mg betamethasone in 1ml of sterile aqueous solution.

-The other ingredients are disodium edetate, sodium metabisulphite, sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

What Betamethasone Pre-filled syringe looks like and contents of the pack

Betamethasone Pre-filled syringe is a clear colourless or pale yellow solution, supplied in Pre-filled syringes containing 1ml, in boxes of 5.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com