NOCTORELEIF 10 MG TABLET

Description

Tablets.
Properties:
NoctoRELIEF contains bambuterol which is a prodrug of terbutaline. Terbutaline is a 2 adrenergic receptor agonist having bronchodilator effect with delayed onset of action and long duration effect lasting for 24 hours after single oral dose per day. Due to its selective effect NoctoRELIEF cardiac effects are minor in the therapeutic doses.
Pharmacokinetics:
ϖ About 20% of an oral dose of Bambuterol is absorbed.
ϖ 70-90% of the absorption occurs during the first 24 hours.
ϖ 50-80% of the absorbed quantity reaches the circulation unchanged.
ϖ The half-life of bambuterol after oral administration is from 9 to 17 hours.
ϖ After the absorption, Bambuterol is slowly metabolized to the active metabolite terbutaline.
ϖ The elimitation is mainly by kidney.
ϖ The active metabolite, terbutaline pass through the placenta and diffuse in nursing mother milk.
Indications:
ϖ Continuous symptomatic treatment of bronchial asthma and conditions associated with reversible airways obstruction:
– In case of patients in need of regular doses of 2 agonist.
– In case of nocturnal symptoms.
ϖ This medication may be associated with an anti-inflammatory treatment as corticoid inhalation.
dosage & administration:
The recommended initial dose is 10 mg at bed time.
The dose may be increased to 20 mg depending on the patient clinical response.
In patients with an impaired renal function the recommended starting dose is 5 mg which may be increased to 10 mg after 1 to 2 weeks.
Contraindications:
ϖ Hypersensitivity to any of the ingredients or to terbutaline.
ϖ Children less than 15 years.
side effects:
Palpitations, tachycardia, nausea, vertigo, tremors, muscles cramps, sleep disturbances, reversible biological modifications as hypokalaemia and hyperglycemia.
drug interactions:
ϖ Not to be administered with Halothane.
ϖ Due to hyperglycemic effect of 2 agonist, additional blood glucose controls are recommended in diabetic patients.
ϖ Bambuterol prolongs the effect of succinylcholine as it inhibit the plasma cholinesterase.
PREGNANCY & lactation:
The use of bambuterol during pregnancy and lactation is contraindicated.
Precautions:
ϖ In case of atheletics this medication may give a positive reaction in antidoping tests.
ϖ 2 agonist by oral route may reveal already existing cardiac pathology.
ϖ This medication can not be used in the treatment of asthma crisis as it’s characterized by a retarded onset of action and a long duration of action.
ϖ Association of anti-inflammatory corticoids by inhalation with this medication may be necessary in certain cases.
ϖ As for all 2 agonists caution should be observed in case of hyperthyroidism, cardiovascular disorders, diabetic patients.
ϖ In case of impaired liver function the direct use of terbutaline is preferable.
Packing:
A carton box containing 10 tablets in PVC/Aluminium strip and a pamphlet.
Storage:
Keep at a temperature not exceeding 30C, in dry place.
instruction to patients:
Keep out of reach of children.