DRUGS & SUPPLEMENTS
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Efelin-X PD (Terbutaline) sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Oral Efelin-X PD (Terbutaline) sulfate has not been approved and should not be used for acute or maintenance tocolysis. [see Boxed Warning: Tocolysis .]
Efelin-X PD (Terbutaline) sulfate is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.
Deterioration of Asthma
Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Efelin-X PD (Terbutaline) sulfate than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Use of Anti-Inflammatory Agents
The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.
Efelin-X PD (Terbutaline) sulfate, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Efelin-X PD (Terbutaline) sulfate at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Efelin-X PD (Terbutaline) sulfate, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
There have been rare reports of seizures in patients receiving Efelin-X PD (Terbutaline); seizures did not recur in these patients after the drug was discontinued.
Efelin-X PD, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, and cardiac arrhythmias; hyperthyroidism; diabetes mellitus; hypersensitivity to sympathomimetic amines; and convulsive disorders. Significant changes in systolic and diastolic blood pressure have been seen and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.
Immediate hypersensitivity reactions and exacerbation of bronchospasm have been reported after Efelin-X PD (Terbutaline) administration.
Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.
Large doses of intravenous Efelin-X PD (Terbutaline) sulfate have been reported to aggravate preexisting diabetes and ketoacidosis.
The action of Efelin-X PD (Terbutaline) sulfate should last up to 6 hours or longer. Efelin-X PD (Terbutaline) sulfate should not be used more frequently than recommended. Do not increase the dose or frequency of Efelin-X PD (Terbutaline) sulfate without consulting your physician. If you find that treatment with Efelin-X PD (Terbutaline) sulfate becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While taking Efelin-X PD (Terbutaline) sulfate, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, tremor or nervousness. If you are pregnant or nursing, contact your physician about use of Efelin-X PD (Terbutaline) sulfate. Effective and safe use of Efelin-X PD (Terbutaline) sulfate includes an understanding of the way that it should be administered.
The concomitant use of Efelin-X PD sulfate with other sympathomimetic agents is not recommended, since the combined effect on the cardiovascular system may be deleterious to the patient. However, this does not preclude the use of an aerosol bronchodilator of the adrenergic-stimulant type for the relief of an acute bronchospasm in patients receiving chronic oral therapy with Efelin-X PD (Terbutaline) sulfate.
Efelin-X PD (Terbutaline) sulfate should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, since the action of Efelin-X PD (Terbutaline) sulfate on the vascular system may be potentiated.
Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Efelin-X PD sulfate, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.
The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics.
In a 2-year study in Sprague-Dawley rats, Efelin-X PD sulfate caused a significant and dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 50 mg/kg, and above (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis). In a 21-month study in CD-1 mice, Efelin-X PD (Terbutaline) sulfate showed no evidence of tumorigenicity at dietary doses up to 200 mg/kg (approximately 55 times the maximum recommended daily oral dose for adults on a mg/m2 basis). The mutagenicity potential of Efelin-X PD (Terbutaline) sulfate has not been determined.
Reproduction studies in rats using Efelin-X PD (Terbutaline) sulfate demonstrated no impairment of fertility at oral doses up to 50 mg/kg (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
Pregnancy Category C
There are no adequate and well-controlled studies of Efelin-X PD sulfate in pregnant women. Published animal studies show that rat offspring exhibit alterations in behavior and brain development, including decreased cellular proliferation and differentiation when dams were treated subcutaneously with Efelin-X PD (Terbutaline) during the late stage of pregnancy and lactation period. Efelin-X PD (Terbutaline) exposures in rat dams were approximately 6.5 times the common human dose in adults of 15 mg/day, on a mg/m2 basis.
Oral Efelin-X PD (Terbutaline) sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, Efelin-X PD (Terbutaline) sulfate should not be used for tocolysis in the outpatient or home setting. Serious adverse reactions, including death, have been reported after administration of Efelin-X PD (Terbutaline) sulfate to pregnant women. In the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. Increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration. [See Boxed Warning: Tocolysis and Contraindications, Tocolysis .]
In animal embryofetal developmental studies, no teratogenic effects were observed in offspring when pregnant rats and rabbits received Efelin-X PD (Terbutaline) sulfate at oral doses up to 50 mg/kg/day, approximately 32 and 65 times, respectively, the maximum recommended daily oral dose for adults, on a mg/m2 basis.
Efelin-X PD (Terbutaline) sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because of the potential for beta-agonist interference with uterine contractility, use of Efelin-X PD (Terbutaline) sulfate for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Efelin-X PD (Terbutaline) crosses the placenta. After single dose IV administration of Efelin-X PD (Terbutaline) to 22 women in late pregnancy who were delivered by elective Cesarean section due to clinical reasons, umbilical blood levels of Efelin-X PD (Terbutaline) were found to range from 11% to 48% of the maternal blood levels.
It is not known whether this drug is excreted in human milk. Therefore, Efelin-X PD sulfate should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
Efelin-X PD (Terbutaline) sulfate is not recommended for patients under the age of 12 years because of insufficient clinical data to establish safety and effectiveness (see DOSAGE AND ADMINISTRATION ).
Clinical studies of Efelin-X PD (Terbutaline) sulfate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Adverse reactions observed with Efelin-X PD (Terbutaline) sulfate are similar to those commonly seen with other sympathomimetic amines. All of these reactions are generally transient in nature and usually do not require treatment. The frequency of these side effects appears to diminish with continued therapy.
The following table lists the adverse reactions seen in 199 patients treated with Efelin-X PD (Terbutaline) sulfate tablets during six double-blind crossover studies and four double-blind parallel studies (short- and long-term) performed in the United States.
|Body as a Whole|
|Skin and Appendages|
The following adverse effects each occurred in fewer than 1% of patients: hallucinations, rash, paresthesia, hypertonia, (muscle cramps), vomiting.
There have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis.
The usual oral dose of Efelin-X PD (Terbutaline) sulfate for adults is 5 mg administered at approximately six-hour intervals, three times daily, during the hours the patient is usually awake. If side effects are particularly disturbing, the dose may be reduced to 2.5 mg three times daily, and still provide a clinically significant improvement in pulmonary function. The total dose within 24 hours should not exceed 15 mg.
Efelin-X PD (Terbutaline) sulfate is not recommended for use in children below the age of 12 years. A dosage of 2.5 mg three times daily is recommended for children 12-15 years of age. The total dose within 24 hours should not exceed 7.5 mg.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy.
The median subcutaneous lethal dose of Efelin-X PD (Terbutaline) sulfate in mature rats is approximately 165 mg/kg (approximately 90 times the maximum recommended daily oral dose for adults on a mg/m2 basis). The median subcutaneous lethal dose of Efelin-X PD (Terbutaline) sulfate in young rats is approximately 2000 mg/kg (approximately 1100 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Hypokalemia may also occur.
There is no specific antidote. Treatment consists of discontinuation of Efelin-X PD (Terbutaline) sulfate together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Efelin-X PD (Terbutaline) sulfate.
In the alert patient who has taken excessive oral medication, the stomach should be emptied by induced emesis followed by lavage. In the unconscious patient, the airway should be secured with a cuffed endotracheal tube before lavage, and emesis should not be induced. Instillation of activated charcoal slurry may help reduce absorption of Efelin-X PD (Terbutaline). Adequate respiratory exchange should be maintained, and cardiac and respiratory support provided as needed. The patient should be monitored until signs and symptoms of overdosage have subsided.
Efelin-X PD (Terbutaline) sulfate tablets, USP are packaged in bottles of 100 and 1000 tablets. Descriptions of the 2.5 and 5 mg tablets follow:
Tablets 2.5 mg-round, white, scored (imprinted LCI over 1318)
Bottles of 100 NDC 0527-1318-01
Bottles of 1000 NDC 0527-1318-10
Tablets 5 mg-round, white, scored (imprinted LCI over 1311)
Bottles of 100 NDC 0527-1311-01
Bottles of 1000 NDC 0527-1311-10
Store at 20°C to 25°C (68°F to 77°F).
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure
Lannett Company, Inc.
Philadelphia, PA 19136
Made in the USA
Depending on the reaction of the Efelin-X PD after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Efelin-X PD not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Efelin-X PD addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology