Indications

– Treatment of allergic rhinitis, alleviation of running nose, sneezing, itching of eyes, nose, throat.
– Treatment of other allergic symptoms, such as: allergic conjunctivitis, urticaria, eczema, contact dermatitis, insect bites, pollenic, dust and food allergy,…

Present

Blister of 15 tablets. Box of 2 blisters.

Composition

Betamethasone …………………………………………0.25mg
Chlorpheniramine maleate ……………………………..2mg
Excipients s.q. for ………………………………………1 tablet
(Lactose, Corn starch, Pregelatinized starch, Erythrosine, Povidone, Magnesium stearate).

Pharmacology

– Betamethasone is a synthetic corticosteroid that has anti– inflammatory, anti– rheumatic and anti– allergic activity.
– Chlorpheniramine, an alkylamine derivative, is a sedating anti– histamine. It is an H1– receptor antagonist that causes a moderate degree of sedation.

Pharmacokinetics

– Betamethasone is a corticosteroid with mainly glucocorticoid activity. It is readily absorbed from the gastrointestinal tract and is rapidly distributed to all body tissues.
– Chlorpheniramine maleate is well absorbed from the gastrointestinal tract. It appears in plasma within 30 – 60 min after oral doses. Unchanged drug and metabolites are excreted primarily in the urine, excretion is dependent on urinary pH and flow rate.

Contra-Indications

– Hypersensitivity to any ingredient of the medicine.
– Bacterial, viral and systemic fungal infections.
– Patients in acute asthmatic attack, prostatic hypertrophy, bladder neck obstruction.
– Diabetes, mental sickness, narrow– angle glaucoma.
– Peptic ulcers, pyloristenosis.
– Neonates under 1 month and premature infants.
– Patients that are taking monoamine oxidase inhibitor (MAOI), or within 2 weeks after stopping MAOI drugs.

Side effect

– Drowsiness, dry mouth, nausea, stomachache.Water and electrolyte imbalance. Muscle weakness, osteomalacia.
– Reduces glucose tolerance, increases blood glucose in diabetic mellitus patients.
Inform your doctor about side– effects when using this medicine.

Precaution

– The dosage should be lowest possible that maintains adequate clinical control. The dosage should be tapered gradually before being discontinued.
– Should be given with caution to patients such as the elderly (> 60 years), patients with prostatic hypertrophy, muscle weakness, receiving sedative, drinking alcohol, active pulmonary tuberculosis, cardiovascular disease, impairment of hepatic or renal function, osteomalacia.
– Do not give this medication to persons who are driving or operating machine.
PREGNANCY AND LACTATION:
BETALESTIN should be administered to pregnant women or nursing mothers only if the benefits of therapy are judged to outweigh the potential risks to the fetus or the infant.

Interaction

Should not be administered concomitantly with monoamine oxidase inhibitor drug, Phenobarbitone, Phenytoin, Rifampicin, Ephedrine, oral anticoagulants, Glycoside digitalis, NSAIDs, alcohol, antidiabetics.
OVERDOSAGE:
Should overdosage occur, turn to the nearest healthcare facility for medical attention of the healthcare professionals.

Shelf life

36 months from the manufacturing date.

Storage

Store in a dry place, not exceeding 30^oC. Protect from light.

Dosage

take after meals and at bedtime.
– Adults and children ≥ 12 years: 1 – 2 tablets, 4 – 6 times daily.
– Children 6 – < 12 years: 1 tablet, 4 – 6 times daily.
– Children 2 – < 6 years: 1/2 tablet, 4 – 6 times daily.
Dosage should be based on the severity of the disease and the response of the patient. After a satisfactory response is obtained, dosage should be decreased in small decrements to the lowest level that maintain an adequate clinical response, and the drug should be discontinued as soon as possible.