Each tablet contains 2 mg TERBUTALINE sulfate, USP.
Each 5 mL syrup contains 1.5 mg TERBUTALINE sulfate.
Each mL contains 2.5 mg TERBUTALINE sulfate.
Pharmacology: Pharmacodynamics: PULMOXCEL is a brand of Terbutaline sulfate, a direct-acting sympathomimetic agent with predominantly beta-adrenergic activity and a selective action on β2-receptors. It is used as bronchodilator by stimulating β2-adrenergic receptors in the lungs to relax bronchial smooth muscle thereby relieving bronchospasm, increasing vital capacity, decreasing residual volume and reducing airway resistance.
TERBUTALINE sulfate has more prolonged actions than other sympathomimetic agent isoprenaline, its bronchodilating action being relatively more prominent than its effect on the heart. It also mediates in decreasing gastrointestinal tone and increases uterine muscle relaxation.
Pharmacokinetics: Tablet & Syrup: TERBUTALINE undergoes extensive first-pass metabolism by sulfate (and some glucuronide) conjugation in the liver and the gut wall. It is excreted in the urine and faeces partly as the inactive sulfate conjugate and partly as unchanged terbutaline, the ratio depending upon the route by which it is given. The terminal half-life after single and multiple dosing is reported to be between 16 and 20 hours.
Nebulizing solution: On inhalation of terbutaline, less than 10% of the drug is absorbed from the airways. The remainder is swallowed where it is variably absorbed from the gastrointestinal tract. Fasting bioavailability after oral doses is reported to be about 14 to 15% and is reduced by food. Terbutaline undergoes extensive first-pass metabolism by sulfate (and some glucuronide) conjugation in the liver and the gut wall. It is excreted in the urine and faeces partly as the inactive sulfate conjugate and partly as unchanged terbutaline, the ratio depending upon the route by which it is given. The terminal half-life after single and multiple dosing is reported to be between 16 and 20 hours. There is some placental transfer. Trace amounts are distributed into breast milk.
For the relief of bronchial asthma, bronchitis, bronchospasm, emphysema, bronchiectasis and other obstructive pulmonary diseases where bronchoconstriction is a complicating factor.
Tablet: Usual adult dose is 1 to 2 tablets 3 times a day.
Children aged 12 to 15 years take 1 tablet 3 times a day.
Administered at approximately 6 hours intervals.
In most patients, the optimum single dose is 2 tablets.
In patients unusually sensitive to sympathomimetic amines, initiate treatment with 1 tablet 3 times a day.
If adequate bronchodilation is not obtained, the dose may be increased to 2 tablets.
Syrup: To be taken 3 times a day.
Adult and children over 15 years: 10-15 mL (2-3 tsp).
Children 7-15 years: 5.0-10 mL (1-2 tsp).
Children 3-7 years: 2.5-5.0 mL (½-1 tsp).
Children below 3 years: Not recommended.
(5 mL is equivalent to 1 teaspoonful.)
Nebulizing solution: TERBUTALINE sulfate (PULMOXCEL) Nebulizing Solution 2.5 mg/mL is used with dilution.
A multiple dose unit of 10 mL contains 25 mg Terbutaline sulfate.
Inhale 1 mL of Solution containing 2.5 mg Terbutaline sulfate every 6 hours (or 4 times in 24-hour period).
If the entire dose is not inhaled at once occasion, the solution is stable for 24 hours in the reservoir of the nebulizer.
NOTE: The patient's inhalation technique should be checked regularly and the optimal dose of terbutaline should be adjusted for each nebulizer. If the effect of the inhalation is reduced, the patient should seek medical care.
Non-selective blocking agents may partly or totally inhibit the effect of beta-stimulants.
Seek emergency medical attention if overdose is suspected.
Symptoms of a terbutaline overdose may include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea and vomiting.
TERBUTALINE sulfate (PULMOXCEL) is contraindicated in cardiovascular disease, i.e. cardiac arrhythmias and coronary insufficiency, hypertension, diabetes mellitus, ketoacidosis, pheochromocytoma, seizures and patients sensitive to sympathomimetic agents.
Tablet & Syrup: Patients taking this medication should consult their physician if they do not respond to the usual dose of this medication for reassessment of therapy.
Nebulizing solution: TERBUTALINE sulfate (PULMOXCEL) Nebulizing Solution is used only in a nebulizer or respirator and not to be used for injection.
It is important not to use more medication than the amount recommended by the physician.
Know correct administration technique if using a nebulizer or a combination nebulizer and respirator by checking with the physician, nurse or pharmacist if necessary.
Care should be taken with patients suffering from thyrotoxicosis. Although no teratogenic effects have been observed in animals or in patients, its use during the first trimester of pregnancy is not recommended.
Although no teratogenic effects have been observed in animals or in patients, its use during the first trimester of pregnancy is not recommended.
The frequency of side effects is low at the recommended doses. Recorded side effects i.e. tremor, muscle cramps and palpitations are all characteristics of sympathomimetic amines. These effects usually disappear within the first week of continuous treatment.
Use of β2 agonists with corticosteroids, diuretics, or xanthines increases the risk of hypokalaemia, and monitoring of potassium concentrations is recommended in severe asthma, where such combination therapy is common.
Nebulizing solution: Direction for Use: The TERBUTALINE sulfate (PULMOXCEL) multiple dose bottle contains 30 mL Nebulizing Solution. Its content is equivalent to 75 mg Terbutaline sulfate.
1. Pipette 1 mL of TERBUTALINE sulfate (PULMOXCEL) Nebulizing Solution from the bottle by using a calibrated medicine dropper provided in the pack, equivalent to 2.5 mg Terbutaline sulfate.
2. Drop the solution into an electric nebulizer and dilute it with 2 mL normal saline solution and start inhalation.
3. Repeat the same procedure every 6 hours or 4 times in 24-hour period or as directed by the physician.
Store at temperatures not exceeding 30°C. Protect from light.
R03CC03 - terbutaline ; Belongs to the class of adrenergics for systemic use, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
R03AC03 - terbutaline ; Belongs to the class of adrenergic inhalants, selective beta-2-adrenoreceptor agonists. Used in the treatment of obstructive airway diseases.
Tab 2 mg (round, plain, white) x 100's. Syr 1.5 mg/5 mL (clear, colorless to faintly yellow with strawberry flavor) x 60 mL. Nebulizing soln 2.5 mg/mL (clear, colorless liquid, free from foreign matter) x 15 mL, 30 mL.