A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rondec Warnings, Precautions, Pregnancy, Nursing, Abuse - Carbinoxamine Maleate and Pseudoephedrine HCl
Rondec Warnings, Precautions, Pregnancy, Nursing, Abuse - Carbinoxamine Maleate and Pseudoephedrine HCl
WARNINGS
Sympathomimetic amines should be used judiciously and sparingly in patients
with hypertension, diabetes, ischemic heart disease, hyperthyroidism,
increased intraocular pressure or prostatic hypertrophy. See Contraindications.Sympathomimetic
amines may produce CNS stimulation with convulsions or cardiovascular
collapse with accompanying hypotension. The elderly (60 years and older)
are more likely to exhibit adverse reactions. Antihistamines may cause
excitability, especially in children. At doses higher than the recommended
dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed
recommended dosage.
PRECAUTIONS
General
Use with caution in patients with hypertension, heart disease, asthma,
hyperthyroidism, increased intraocular pressure, diabetes mellitus and
prostatic hypertrophy and hyperreactivity to sympathomimetic amines. Antihistamines
may cause drowsiness and ambulatory patients who operate machinery or
motor vehicles should be cautioned accordingly.
Information for Patients
See PATIENT INFORMATION section.
Drug Interactions
See DRUG INTERACTIONS section.
Pregnancy Category C
Animal reproduction studies have not been conducted with these products.
It is also not known whether these products can cause fetal harm when
administered to a pregnant woman or affect reproduction capacity. Give
to pregnant women only if clearly needed.
Nursing Mothers
It is not known whether the drugs in Rondec are excreted in human milk.
Because many drugs are excreted in human milk and because of the potential
for serious adverse reactions in nursing infants, a decision should be
made whether to discontinue nursing or discontinue the product, taking
into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness of Rondec Oral Drops in pediatric patients below
the age of one month have not been established. Safety and effectiveness
of Rondec Syrup in pediatric patients below the age of 18 months have
not been established. Safety and effectiveness of Rondec Tablets in pediatric
patients below the age of 6years have not been established. Safety and
effectiveness of Rondec-TR Tablets in pediatric patients below the age
of 12 years have not been established.
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