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DRUGS & SUPPLEMENTS
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Tuspel Plus
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Tuspel Plus uses
Tuspel Plus consists of Ammonium Chloride, Bromhexine Hydrochloride, Menthol, Terbutaline.Ammonium Chloride:
- Indications and usage
- Contraindications
- Warning
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
Tuspel Plus (Ammonium Chloride) Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.
CONTRAINDICATIONS
Tuspel Plus (Ammonium Chloride) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
WARNING
Sun exposure (natural or artificial sunlight) to areas of the skin treated with Tuspel Plus (Ammonium Chloride) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Tuspel Plus (Ammonium Chloride) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.
PRECAUTIONS
General -
For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.
Information for Patients
Patients using Tuspel Plus (Ammonium Chloride) Lactate Lotion, 12% should receive the following information and instructions:
- This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
- Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
- This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
- If the skin condition worsens with treatment, the medication should be promptly discontinued.
Carcinogenesis, Mutagenesis, Impairment of Fertility -
The topical treatment of CD-1 mice with 12%, 21% or 30% Tuspel Plus lactate formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% Tuspel Plus (Ammonium Chloride) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.
The mutagenic potential of Tuspel Plus (Ammonium Chloride) lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.
In dermal Segment I and III studies with Tuspel Plus (Ammonium Chloride) lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m2/day), approximately 0.4 times the human topical dose.
Pregnancy:
Teratogenic effects:
Pregnancy Category B -
Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Tuspel Plus (Ammonium Chloride) lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Tuspel Plus (Ammonium Chloride) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.
Nursing Mothers -
Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tuspel Plus (Ammonium Chloride) lactate is administered to a nursing woman.
Pediatric Use -
Safety and effectiveness of Tuspel Plus lactate have been demonstrated in infants and children. No unusual toxic effects were reported.
Geriatric Use -
Clinical studies of Tuspel Plus (Ammonium Chloride) lactate lotion, 12% 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 elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
ADVERSE REACTIONS
The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).
OVERDOSAGE
The oral administration of Tuspel Plus (Ammonium Chloride) lactate to rats and mice showed this drug to be practically non-toxic (LD50>15 mL/kg).
DOSAGE AND ADMINISTRATION
Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
HOW SUPPLIED
Tuspel Plus Lactate Lotion, 12% is available as follows:
225 g bottle (NDC 45802-419-54)
400 g bottle (NDC 45802-419-26)
STORAGE
Store at 20-25°C (68-77°F).
Manufactured By Perrigo, Bronx, NY 10457
Distributed By Perrigo, Allegan, MI 49010
0K5A7 RC F6
Rev 01-17
Menthol:
Tuspel Plus (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. It is a waxy, crystalline substance, clear or white in color, which is solid at room temperature and melts slightly above. The main form of Tuspel Plus (Menthol) occurring in nature is (-)-menthol, which is assigned the (1R,2S,5R) configuration. Tuspel Plus (Menthol) has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.
Indication: Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.
Tuspel Plus (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol's ability to chemically trigger cold-sensitive receptors in the skin is responsible for the well known cooling sensation that it provokes when inhalated, eaten, or applied to the skin. It should be noted that Tuspel Plus (Menthol) does not cause an actual drop in temperature.
Terbutaline:
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Dosage and administration
- Overdosage
- How supplied
INDICATIONS AND USAGE
Tuspel Plus (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.
CONTRAINDICATIONS
1. Tocolysis
Oral Tuspel Plus (Terbutaline) sulfate has not been approved and should not be used for acute or maintenance tocolysis. [see Boxed Warning: Tocolysis .]
2. Hypersensitivity
Tuspel Plus (Terbutaline) sulfate is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.
WARNINGS
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 Tuspel Plus (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.
Cardiovascular Effects
Tuspel Plus (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 Tuspel Plus (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, Tuspel Plus (Terbutaline) sulfate, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Seizures
There have been rare reports of seizures in patients receiving Tuspel Plus (Terbutaline); seizures did not recur in these patients after the drug was discontinued.
PRECAUTIONS
General
Tuspel Plus, 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 Tuspel Plus (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 Tuspel Plus (Terbutaline) sulfate have been reported to aggravate preexisting diabetes and ketoacidosis.
Information for Patients
The action of Tuspel Plus (Terbutaline) sulfate should last up to 6 hours or longer. Tuspel Plus (Terbutaline) sulfate should not be used more frequently than recommended. Do not increase the dose or frequency of Tuspel Plus (Terbutaline) sulfate without consulting your physician. If you find that treatment with Tuspel Plus (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 Tuspel Plus (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 Tuspel Plus (Terbutaline) sulfate. Effective and safe use of Tuspel Plus (Terbutaline) sulfate includes an understanding of the way that it should be administered.
Drug Interactions
The concomitant use of Tuspel Plus 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 Tuspel Plus (Terbutaline) sulfate.
Monoamine Oxidase Inhibitors and Tricyclic Antidepressants
Tuspel Plus (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 Tuspel Plus (Terbutaline) sulfate 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 Tuspel Plus 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.
Diuretics
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year study in Sprague-Dawley rats, Tuspel Plus 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, Tuspel Plus (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 Tuspel Plus (Terbutaline) sulfate has not been determined.
Reproduction studies in rats using Tuspel Plus (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
Teratogenic Effects
Pregnancy Category C
There are no adequate and well-controlled studies of Tuspel Plus 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 Tuspel Plus (Terbutaline) during the late stage of pregnancy and lactation period. Tuspel Plus (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 Tuspel Plus (Terbutaline) sulfate has not been approved and should not be used for acute or maintenance tocolysis. In particular, Tuspel Plus (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 Tuspel Plus (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 Tuspel Plus (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.
Tuspel Plus (Terbutaline) sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Labor and Delivery
Because of the potential for beta-agonist interference with uterine contractility, use of Tuspel Plus (Terbutaline) sulfate for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Tuspel Plus (Terbutaline) crosses the placenta. After single dose IV administration of Tuspel Plus (Terbutaline) to 22 women in late pregnancy who were delivered by elective Cesarean section due to clinical reasons, umbilical blood levels of Tuspel Plus (Terbutaline) were found to range from 11% to 48% of the maternal blood levels.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Therefore, Tuspel Plus sulfate should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
Pediatric Use
Tuspel Plus (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 ).
Geriatric Use
Clinical studies of Tuspel Plus (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
Adverse reactions observed with Tuspel Plus (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 Tuspel Plus (Terbutaline) sulfate tablets during six double-blind crossover studies and four double-blind parallel studies (short- and long-term) performed in the United States.
| Reaction | % |
|---|---|
| Nervous System | |
| Nervousness | 35.0 |
| Tremor | 15.0 |
| Somnolence | 5.5 |
| Dizziness | 3.5 |
| Anxiety | 1.0 |
| Insomnia | 1.5 |
| Cardiovascular | |
| Palpitations | 5.0 |
| Tachycardia | 3.5 |
| Extrasystoles ventricular | 1.5 |
| Vasodilations | 1.0 |
| Digestive | |
| Nausea | 3.0 |
| Dry mouth | 1.5 |
| Body as a Whole | |
| Headache | 7.5 |
| Asthenia | 2.0 |
| Skin and Appendages | |
| Sweating | 1.0 |
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.
DOSAGE AND ADMINISTRATION
Adults
The usual oral dose of Tuspel Plus (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.
Children
Tuspel Plus (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.
OVERDOSAGE
The median subcutaneous lethal dose of Tuspel Plus (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 Tuspel Plus (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 Tuspel Plus (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 Tuspel Plus (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 Tuspel Plus (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.
HOW SUPPLIED
Tuspel Plus (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
Distributed By:
Lannett Company, Inc.
Philadelphia, PA 19136
Made in the USA
CIB70314B
Rev. 02/16
Tuspel Plus pharmaceutical active ingredients containing related brand and generic drugs:
Tuspel Plus 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.