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DRUGS & SUPPLEMENTS
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Saltos
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Saltos uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
Saltos tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
CONTRAINDICATIONS
Saltos tablets are contraindicated in patients with a history of hypersensitivity to Saltos, or any of its components.
WARNINGS
Paradoxical Bronchospasm
Saltos tablets can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Saltos tablets should be discontinued immediately and alternative therapy instituted.
Cardiovascular Effects
Saltos tablets, 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 Saltos tablets at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram 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, Saltos tablets, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
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 Saltos tablets than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and 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.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of Saltos, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. Saltos, like other beta-adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.
Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral Saltos sulfate in children.
PRECAUTIONS
General
Saltos, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.
Large doses of intravenous Saltos have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, Saltos 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.
Information for Patients
The action of Saltos tablets may last up to 8 hours or longer. Saltos tablets should not be taken more frequently than recommended. Do not increase the dose or frequency of Saltos tablets without consulting your physician. If you find that treatment with Saltos tablets becomes less effective for symptomatic relief, your symptoms get worse, and/or you need to take the product more frequently than usual, you should seek medical attention immediately. While you are taking Saltos tablets, other asthma medications and inhaled drugs should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, and tremor or nervousness. If you are pregnant or nursing, contact your physician about use of Saltos tablets. Effective and safe use of Saltos tablets includes an understanding of the way that it should be administered.
Drug Interactions
The concomitant use of Saltos tablets and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving Saltos tablets. Such concomitant use, however, should be individualized and not given on a routine basis. If regular coadministration is required, then alternative therapy should be considered.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Saltos 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, because the action of Saltos on the vascular system may be potentiated.
Beta-Blockers
Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Saltos tablets, 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.
Diuretics
The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing 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 coadministration of beta-agonists with nonpotassium-sparing diuretics.
Digoxin
Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of Saltos, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving Saltos and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and Saltos.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
In a 2-year study in Sprague-Dawley rats, Saltos sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 2, 10, and 50 mg/kg (approximately 1/2, 3 and 15 times, respectively, the maximum recommended daily oral dose for adults on a mg/m2 basis, or, 2⁄5, 2 and 10 times, respectively, the maximum recommended daily oral dose for children on a mg/m2 basis). In another study this effect was blocked by the coadministration of propranolol, a non-selective beta-adrenergic antagonist.
In an 18-month study in CD-1 mice Saltos sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg, (approximately 65 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 50 times the maximum recommended daily oral dose for children on a mg/m2 basis). In a 22-month study in the Golden hamster Saltos sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg, (approximately 8 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 7 times the maximum recommended daily oral dose for children on a mg/m2 basis).
Saltos sulfate was not mutagenic in the Ames test with or without metabolic activation using tester strains S. typhimurium TA1537, TA1538, and TA98 or E. Coli WP2, WP2uvrA, and WP67. No forward mutation was seen in yeast strain S. cerevisiae S9 nor any mitotic gene conversion in yeast strain S. cerevisiae JD1 with or without metabolic activation. Fluctuation assays in S. typhimurium TA98 and E. Coli WP2, both with metabolic activation, were negative. Saltos sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay at intraperitoneal doses of up to 200 mg/kg.
Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximately 15 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
Pregnancy
Teratogenic Effects. Pregnancy Category C
Saltos has been shown to be teratogenic in mice. A study in CD-1 mice at subcutaneous doses of 0.025, 0.25, and 2.5 mg/kg, (approximately 3/1000, 3/100, and 3/10 times, respectively, the maximum recommended daily oral dose for adults on a mg/m2 basis), showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. The drug did not induce cleft palate formation at the lowest dose, 0.025 mg/kg. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated with 2.5 mg/kg of isoproterenol (positive control) subcutaneously (approximately 3/10 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when Saltos was administered orally at a 50 mg/kg dose (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
There are no adequate and well-controlled studies in pregnant women. Saltos should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with Saltos. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between Saltos use and congenital anomalies has not been established.
Use In Labor And Delivery
Because of the potential for beta-agonist interference with uterine contractility, use of Saltos tablets for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Tocolysis
Saltos has not been approved for the management of preterm labor. The benefit/risk ratio when Saltos is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including Saltos.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for Saltos in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in children below 6 years of age have not been established.
ADVERSE REACTIONS
In clinical trials, the most frequent adverse reactions to Saltos tablets were:
| Reaction | Percent Incidence |
|---|---|
| Central nervous system | |
| Nervous | 20% |
| Tremor | 20% |
| Headache | 7% |
| Sleeplessness | 2% |
| Weakness | 2% |
| Dizziness | 2% |
| Drowsiness | <1% |
| Restlessness | <1% |
| Irritability | <1% |
| Cardiovascular | |
| Tachycardia | 5% |
| Palpitations | 5% |
| Chest discomfort | <1% |
| Flushing | <1% |
| Musculoskeletal | |
| Muscle cramps | 3% |
| Gastrointestinal | |
| Nausea | 2% |
| Genitourinary | |
| Difficulty in micturition | <1% |
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of Saltos.
In addition, Saltos, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.
The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with Saltos tablets. In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.
OVERDOSAGE
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/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Saltos tablets. Treatment consists of discontinuation of Saltos tablets 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 Saltos tablets. The oral median lethal dose of Saltos sulfate in mice is greater than 2000 mg/kg (approximately 250 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 200 times the maximum recommended daily oral dose for children on a mg/m2 basis). In mature rats, the subcutaneous (sc) median lethal dose of Saltos sulfate is approximately 450 mg/kg (approximately 110 times the maximum recommended daily oral dose for adults on a mg/m2 basis or, approximately 90 times the maximum recommended daily oral dose for children on a mg/m2 basis). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 500 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 400 times the maximum recommended daily oral dose for children on a mg/m2 basis).
DOSAGE AND ADMINISTRATION
The following dosages of Saltos tablets are expressed in terms of Saltos base.
Usual Dosage
Adults and Children Over 12 Years of Age
The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day.
Children 6 to 12 Years of Age
The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day.
Dosage Adjustment
Adults and Children Over 12 Years of Age
For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day.
Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators
An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
HOW SUPPLIED
Saltos tablets, USP; 2 mg of Saltos as the sulfate, are white, round, scored, debossed MP 47
| Bottles of 50 | NDC 53489-176-02 |
| Bottles of 100 | NDC 53489-176-01 |
| Bottles of 250 | NDC 53489-176-03 |
| Bottles of 500 | NDC 53489-176-05 |
| Bottles of 1000 | NDC 53489-176-10 |
Saltos tablets, USP; 4 mg of Saltos as the sulfate, are white, round, scored, debossed MP 88
| Bottles of 50 | NDC 53489-177-02 |
| Bottles of 100 | NDC 53489-177-01 |
| Bottles of 250 | NDC 53489-177-03 |
| Bottles of 500 | NDC 53489-177-05 |
| Bottles of 1000 | NDC 53489-177-10 |
Store at 20° to 25°C (68° to 77°F).
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Manufactured by:
MUTUAL PHARMACEUTICAL CO., INC.
Philadelphia, PA 19124 USA
Rev 01, July 2009
Saltos 4mg Tablet
Chemical Structure
Saltos pharmaceutical active ingredients containing related brand and generic drugs:
Saltos available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.