Carbatuss
Name: Carbatuss
Contraindications
Carbatuss is contraindicated in infants and newborns, and in patients with known hypersensitivity to any of the components. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, hyperthyroidism, and in patients on MAO inhibitor therapy. Patient idiosyncrasy to adrenergic agents may be manifested by insomnia, dizziness, weakness, tremor, or arrhythmias.
Carcinogenesis, mutagenesis, and impairment of fertility
No adequate and well controlled studies have been conducted to determine whether the components of Carbatuss have a potential for carcinogenesis, mutagenesis, or impairment of fertility.
Adverse reactions
Mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs, may occur. Nervousness, excitability, restlessness, dizziness, weakness, and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause lightheadedness, nausea and/or vomiting. Sympathomemitic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, anxiety, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias, and cardiovascular collapse with hypotension.
Overdosage
Signs And Symptoms:
Central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in urination, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, anorexia, nausea, vomiting, diarrhea, and abdominal cramps.
TREATMENT:
The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by administration of ipecac syrup is a preferred method, however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in th stomach may be absorbed by activated charcoal administered as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive.
Central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in urination, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, anorexia, nausea, vomiting, diarrhea, and abdominal cramps.
TREATMENT:
The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by administration of ipecac syrup is a preferred method, however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in th stomach may be absorbed by activated charcoal administered as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive.
How supplied
16 Fluid ounce bottles NDC 58809-536-01 and 15 mL bottles NDC 58809-536-02
Tamper evident by heat seal under cap. Do not used if there is evidence of tampering.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.
STORE AT CONTROLLED ROOM TEMPERATURE BETWEEN 59° - 86°F (15° - 30°C)
Dispense in a tight, light-resistant container with a child-resistant closure as described in the USP/NF.
Distributed by:
GM Pharmaceuticals, Inc.,
Arlington, TX 76012
Rx Only
Rev. 09/10
Tamper evident by heat seal under cap. Do not used if there is evidence of tampering.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.
STORE AT CONTROLLED ROOM TEMPERATURE BETWEEN 59° - 86°F (15° - 30°C)
Dispense in a tight, light-resistant container with a child-resistant closure as described in the USP/NF.
Distributed by:
GM Pharmaceuticals, Inc.,
Arlington, TX 76012
Rx Only
Rev. 09/10
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Dizziness.
- Feeling nervous and excitable.
- Not able to sleep.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.