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Betamethasone information from DrugsUpdate  

See Available Brands of Betamethasone in India

P - Cautioned while taken during pregnancy

Betamethasone is a moderately potent glucocorticoid steroid with anti-inflammatory and immunosuppressive properties. Unlike other drugs with these effects, betamethasone does not cause water retention. It is applied as a topical cream, ointment, foam, lotion or gel to treat itching (e.g. from eczema). Betamethasone sodium phosphate is sometimes prescribed as an intramuscular injection (I.M) for itching from various ailments including allergic reactions to poison ivy and similar plants.
The compound is available as a number of ester derivatives: betamethasone dipropionate (branded as Diprosone, Diprolene and others), sodium phosphate and valerate (branded as Betnovate, Celestone and others).

Pharmacodynamics

Information Not Available

Pharmacokinetics

Betamethasone is a corticosteroid with mainly glucocorticoid activity. It prevents and controls inflammation by controlling the rate of protein synthesis, depressing the migration of polymorphonuclear leukocytes and fibroblasts, and reversing capillary permeability and lysosomal stabilisation.
Absorption: Readily absorbed from the GI tract (oral).
Distribution: Distributed throughout body tissues; crosses the placenta and enters the breast milk.
Metabolism: Hepatic.
Excretion: Via urine (<5% as unchanged drug).

Betamethasone Indications / Betamethasone Uses

Information Not Available

Betamethasone Adverse Reactions / Betamethasone Side Effects

Sodium and fluid retention, potassium and calcium depletion. Muscle wasting, weakness, osteoporosis. GI disturbances and bleeding. Increased appetite and delayed wound healing; hirsutism, bruising, striae, acne; raised intracranial pressure, headache, depression, psychosis, menstrual irregularities. Hyperglycaemia, DM. Suppression of pituitary-adrenocortical axis. Growth retardation in children (prolonged therapy). Increased susceptibility for infections.
 Topical use: Dermal atrophy, local irritation, folliculitis, hypertrichosis. Inhalation: Hoarseness, candidiasis of mouth and throat. Topical application to the eye: Corneal ulcers, raised IOP and reduced visual acuity. Intradermal injection: Local hypopigmentation of deeply pigmented skin. Intra-articular injection: Joint damage, fibrosis, esp in load bearing joints.
Potentially Fatal: Abrupt withdrawal leading to acute adrenal insufficiency manifesting as malaise, weakness, mental changes, muscle and joint pains, dystonia, hypoglycaemia, hypotension, dehydration and death. Rapid IV inj may cause CV collapse.

Precautions

Hypersensitivity
Anaphylactoid reactions have occurred rarely.

Adrenal suppression
Prolonged therapy may lead to HPA suppression.

Cardio vascular system
Use with caution in patients with recent MI.

Fluid and electrolyte balance
Can cause elevated BP, salt and water retention, and increased potassium and calcium excretion. Dietary salt restriction and potassium supplementation may be necessary.

Hepatitis
May be harmful in chronic active hepatitis positive for hepatitis B surface antigen.

Infections
May mask signs of infection. May decrease host-defense mechanisms.

Ocular effects
Use cautiously in ocular herpes simplex because of possible corneal perforation.

Peptic ulcer
May contribute to peptic ulceration, especially in large doses.

Stress
Increased dosage of rapidly acting corticosteroid may be needed before, during, and after stressful situations.

Sulfites
Some products contain sulfites, which may cause allergic-type reactions in susceptible individuals.

Withdrawal
Abrupt discontinuation may result in adrenal insufficiency. Use is discontinued gradually, while supplementation is increased during times of stress.

Overdosage

Symptoms
Fever, myalgia, arthralgia, malaise, anorexia, nausea, skin desquamation, orthostatic hypotension, dizziness, fainting, dyspnea, hypoglycemia (acute overdosage); cushingoid changes, moonface, central obesity, striae, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes, hyperlipidemia, peptic ulcer, infarction, electrolyte and fluid imbalance (chronic overdosage).

Special Precautions

Uncontrolled diabetes, peptic ulcer, osteoporosis, psychosis, psychoneurosis, pregnancy and lactation. Congestive heart failure, hypertension, epilepsy, CRF, elderly, regular monitoring of patients on long term therapy, withdraw gradually, glaucoma, hypothyroidism, cirrhosis, ocular herpes simplex, ulcerative colitis, infants and children.

Other Drug Interactions

Increased hyperglycaemia and hypokalaemia with thiazide diuretics. Increased incidence of peptic ulcer or GI bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum conc of salicylates and antimuscarinic agents.
Potentially Fatal: Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Enhanced effect in women taking oestrogens or oral contraceptives.

Other Interactions

Food Interactions: May be taken with food to decrease GI stress.

Dosage

Oral
Allergic and inflammatory disorders
Adult: 0.5-5 mg daily.
Child: For inflammatory conditions: ≤12 yr: 0.0175-0.125 mg base/kg daily, dose may be divided every 6-12 hr.
Oral
Congenital adrenal hyperplasia
Adult: 0.5-5 mg daily.
Child: For inflammatory conditions: ≤12 yr: 0.0175-0.125 mg base/kg daily, dose may be divided every 6-12 hr.
Intramuscular
Allergic and inflammatory disorders
Adult: As betamethasone sodium phosphate and betamethasone acetate: Initially, 0.25-9 mg daily may be given in 1-2 divided doses. Dose should be individualised based on the severity of the condition being treated and patient's response. Reduce dose gradually when an adequate response is achieved.
Child: ≤12 yr: 0.0175-0.125 mg base/kg daily, dose may be divided every 6-12 hr.
Elderly:
Ophthalmic
Allergic and inflammatory conditions of the eye
Adult: As sodium phosphate: Apply a 0.1% solution every 1-2 hr until symptoms are controlled or a 0.1% ointment 2-4 times daily or at night in conjunction with the eye drops into the affected eye/s.
Topical/Cutaneous
Skin disorders
Adult: As dipropionate: Apply 0.05% into affected area. As valerate: Apply 0.025 or 0.1% into affected area.

Food(before/after)

Should be taken with food

List of Contraindications

Betamethasone and Pregnancy

Caution when used during pregnancy.
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
In 1st trimester:
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Betamethasone and Lactation

Information Not Available

Betamethasone and Children

Information Not Available

Betamethasone and Geriatic

Information Not Available

Betamethasone and Other Contraindications

Hypersensitivity; systemic fungal or acute infections

Storage

Intramuscular: Store below 25°C.
Ophthalmic: Store below 25°C.
Oral: Store below 25°C.
Topical/Cutaneous: Store at 2-30°C.

Lab interference

Intramuscular: Store below 25°C.
Ophthalmic: Store below 25°C.
Oral: Store below 25°C.
Topical/Cutaneous: Store at 2-30°C.

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