For the use only of Registered Medical Practitioners or a Hospital or a Laboratory
BETNESOL
1. GENERIC NAME
Betamethasone Sodium Phosphate Injection IP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Betamethasone Sodium Phosphate IP equivalent to Betamethasone 4 mg
Phenol IP (Preservative) 0.5 % w/v
List of Excipients
Phenol, Disodium Edetate, Sodium Metabisulphite, Sodium Chloride, Sodium Hydroxide,
Water for Injection.
3. DOSAGE FORM AND STRENGTH
Solution for injection.
For information on strength(s) refer 2. Qualitative and Quantitative Composition above.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indication
BETNESOL Injection is indicated for the following conditions:
• Status asthmaticus.
• Acute allergic reactions, including anaphylactic reaction to drugs.
• Betamethasone sodium phosphate 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, Simmond's 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 sodium phosphate injection does not replace other forms of therapy for the
treatment of shock and status asthmaticus.
4.2 Posology and Method of Administration
Populations
Systemic therapy in adults
4 to 20 mg betamethasone (1 to 5 ml) administered by i.v. injection over half to one minute.
This dose can be repeated three or four times in 24 hours, or as required, depending upon the
1
condition being treated and the patient's response. Alternatively, betamethasone sodium
phosphate injection may be given in an i.v. infusion. The same dose can be given by i.m.
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 children
Infants up to 1 year may be given 1 mg betamethasone intravenously; children aged 1 to 5
years, 2 mg; 6 to 12 years, 4 mg (1 ml). This dose can be repeated three or four times in 24
hours, depending upon the condition being treated and the patient's response.
Other Routes
Local injections of 4 to 8 mg betamethasone sodium phosphate 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 on the patient’s response.
Betamethasone sodium phosphate injection has also been administered sub-conjunctivally as a
single injection of 0.5 to 1 ml.
Intrathecal use is not recommended.
4.3 Contraindications
• Systemic infections unless specific anti-infective therapy is employed.
• Live virus immunisation.
• BETNESOL 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 or any other component of the injection.
• BETNESOL Injection should not be injected directly into tendons.
4.4 Special Warnings and Precautions for Use
Visual disturbance has been reported by patients using systemic and /or topical corticosteroids.
If a patient has blurred vision or other visual disturbances, consider evaluation of possible
causes which may include cataract, glaucoma or central serous chorioretinopathy.
Administration of corticosteroids may impair the ability to resist and counteract infection e.g.,
where there is a previous history of tuberculosis; in addition clinical signs and symptoms of
infection are suppressed.
Chickenpox is of particular concern since this normally minor illness may be fatal in
immunosuppressed patients. Patients without a definite history of chickenpox should be
advised to avoid close contact with chickenpox or herpes zoster and, if exposed, they (or the
parents of such children) should seek urgent medical attention. Passive immunisation with
2
varicella/ zoster immunoglobulin (VZIG) is needed by exposed non-immune patients who are
receiving systemic corticosteroids or who have used them within the previous three months.
This should be given within ten 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.
Corticosteroid treatment is likely to reduce the response of the pituitary-adrenal axis to stress,
and relative insufficiency may persist for up to a year after withdrawal of prolonged therapy.
Because of the possibility of fluid retention, care must be taken when corticosteroids are
administered to patients with congestive heart failure.
Corticosteroids may worsen diabetes mellitus, osteoporosis, hypertension, glaucoma and
epilepsy.
Care should be taken when there is a history of severe affective disorders (especially a previous
history of steroid psychosis), previous steroid myopathy or peptic ulceration.
In patients with liver failure blood levels of corticosteroid may be increased, as with other drugs
which are metabolised in the liver.
Systemic corticosteroids may cause growth retardation in infancy, childhood and adolescence.
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.
Treatment of elderly patients, particularly if long term, should be planned bearing in mind the
more serious consequences of the common side effects of corticosteroids in old age, especially
osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of the skin.
When treatment is to be discontinued, the dose should be reduced gradually over a period of
several weeks or months depending on the dosage and duration of the therapy.
4.5 Drug Interactions
Corticosteroids may reduce the effects of anticholinesterases in myasthenia gravis,
cholecystographic x-ray media, salicylates and non-steroidal anti-inflammatory agents.
The effect of corticosteroids may be reduced by phenytoin, phenobarbitone, ephedrine and
rifampicin.
The dosage of concomitantly administered anti-coagulants may have to be altered (usually
decreased).
Oestrogens may potentiate the effects of glucocorticoids and dosage adjustments may be
required if oestrogens are added to or withdrawn from a stable dosage regimen.
Betamethasone is metabolised by CYP3A4 and co-administration with CYP3A inhibitors (e.g.
ritonavir, cobicistat, itraconazole) is expected to increase the systemic concentration of
betamethasone.
3
4.6 Use in Special Populations
Pregnancy and Lactation
The use of corticosteroids during human pregnancy and lactation requires that the benefits be
weighed against the possible risks associated with the product or with any alternative therapy.
Pregnancy
There is insufficient evidence of safety in human pregnancy.
Administration of corticosteroids to pregnant animals can cause abnormalities of foetal
development including cleft palate and intrauterine growth retardation. The relevance of this
finding to human beings has not been established, however, patients should avoid extensive
use in pregnancy.
Hypoadrenalism may occur in the neonate.
Lactation
Corticosteroids are excreted in small amounts in breast milk and infants of mothers taking
pharmacological doses of corticosteroids should be monitored carefully for signs of adrenal
suppression.
4.7 Effects on Ability to Drive and Use Machines
None identified.
4.8 Undesirable Effects
Prolonged treatment with corticosteroids in high dosage is occasionally associated with
subcapsular cataract, skin thinning, osteoporosis, and glaucoma. In addition, any of the features
of hypercortisolism, such as suppression of the HPA axis, may occur.
Aseptic osteonecrosis, particularly of the femoral head, may occur after prolonged
corticosteroid therapy or after repeated short courses involving high dosage.
Peptic ulceration may develop, or be aggravated.
In children, prolonged therapy may retard growth.
In patients on long term therapy fluid and electrolyte balance may be altered.
Other rare side effects which have been reported include benign intracranial hypertension and
psychic instability.
4
4.9 Overdose
Acute overdosage is very unlikely to occur, however in the case of chronic overdosage or
misuse the features of hypercortisolism, may appear and in this situation the product should be
discontinued slowly.
5. PHARMACOLOGICAL PROPERTIES
5.1 Mechanism of Action
Corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the
cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize
phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes
to release arachidonic acid. This action decreases the subsequent formation and release of
endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal
enzymes and the complement system.
Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage
and leukocyte movement and activity in the inflamed area by reversing vascular dilation and
permeability. Later inflammatory processes such as capillary production, collagen deposition,
keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions
correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the
affected skin.
5.2 Pharmacodynamic Properties
See above.
5.3 Pharmacokinetic Properties
No relevant text.
6. NONCLINICAL PROPERTIES
No relevant text.
7. DESCRIPTION
Solution for injection
Each ml contains:
Betamethasone Sodium Phosphate IP equivalent to Betamethasone 4 mg
Phenol IP (Preservative) 0.5 % w/v
List of Excipients
Phenol, Disodium Edetate, Sodium Metabisulphite, Sodium Chloride, Sodium Hydroxide,
Water for Injection.
5
8. PHARMACEUTICAL PARTICULARS
8.1 Incompatibilities
There are no relevant data available.
8.2 Shelf Life
The expiry date is indicated on the label and packaging.
8.3 Packaging Information
Ampoules in blister pack in a carton.
8.4 Storage and Handling Instructions
Store protected from light at a temperature not exceeding 30°C.
Keep out of reach of children.
9. PATIENT COUNSELLING INFORMATION
Registered Medical Practitioners may counsel their patients (and/or patients’ caregiver as
applicable) about the special warnings and precautions for use, drug interactions, undesirable
effects, and any relevant contraindications of BETNESOL. Patients (and/or patients’ caregiver)
may also be informed about posology, method of administration and storage/handling
information as applicable.
10. DETAILS OF MANUFACTURER
The Manufacturing Site details are mentioned on the label and packaging.
For further information please contact:
GlaxoSmithKline Pharmaceuticals Limited.
Registered Office:
Dr. Annie Besant Road, Worli
Mumbai 400 030, India.
11. DETAILS OF PERMISSION OR LICENCE NUMBER WITH DATE
Manufacturing License number is indicated on the label and packaging.
12. DATE OF REVISION
25-AUG-2023
Trademarks are owned by or licensed to the GSK group of companies.
Version: BET-INJ/PI/IN/2023/01
Adapted from: Betamethasone sodium phosphate GDS v08 dated 03 April 2018.