Ornade is a combination of an oral nasal decongestant and an antihistamine.
Each Ornade Spansule capsule contains phenylpropanolamine hydrochloride, 75 mg and chlorpheniramine maleate, 12 mg. Inactive ingredients consist of benzyl alcohol, cetylpyridinium chloride, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, D&C Red No. 27, D&C Red No. 30, gelatin, glyceryl distearate, iron oxide, polyethylene glycol, povidone, silicon dioxide, sodium lauryl sulfate, starch, sucrose, titanium dioxide, wax and trace amounts of other inactive ingredients.
Each Ornade Spansule capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period.
Phenylpropanolamine hydrochloride is a sympathomimetic agent which is closely related to ephedrine in chemical structure and pharmacologic action, but produces less central nervous system stimulation than ephedrine. It is a vasoconstrictor with decongestant action on nasal and upper respiratory tract mucosal membranes.
Chlorpheniramine maleate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for H 1 cell receptor sites on effector cells.
A single Ornade Spansule capsule produces blood levels comparable to those produced by administration of three 25 mg doses of phenylpropanolamine hydrochloride and three 4 mg doses of chlorpheniramine maleate in conventional release form given at 4-hour intervals. At steady-state conditions, the following peak levels are reached after the oral administration of an Ornade Spansule capsule: 21 ng/mL chlorpheniramine maleate in 7.7 hours; 173 ng/mL phenylpropanolamine hydrochloride in 6.1 hours; under these circumstances, the half-lives are approximately 21 and 7 hours, respectively.
For the treatment of the symptoms of seasonal and perennial allergic rhinitis and vasomotor rhinitis, including nasal obstruction (congestion); also for the treatment of runny nose, sneezing and nasal congestion associated with the common cold.
Hypersensitivity to either phenylpropanolamine hydrochloride or chlorpheniramine maleate and other antihistamines of similar chemical structure; severe hypertension; coronary artery disease.
This drug should NOT be used in newborn or premature infants.
Because of the higher risk of antihistamines for infants generally, and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.
As with any product containing a sympathomimetic, Ornade Spansule capsules should NOT be used in patients taking monoamine oxidase (MAO) inhibitors.
Ornade Spansule capsules may potentiate the effects of alcohol and other CNS depressants. Also, this product should not be taken simultaneously with other products containing phenylpropanolamine hydrochloride or amphetamines.
Ornade Spansule capsules should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder neck obstruction.
Use in Children: In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation.
Use in the Elderly (approximately 60 years or older): Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.
General: Use with caution in patients with lower respiratory disease including asthma, hypertension, cardiovascular disease, hyperthyroidism, increased intraocular pressure, or diabetes.
Information for Patients: Caution patients about activities requiring alertness (e.g., operating vehicles or machinery). Also caution patients about the possible additive effects of alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.), and not to take simultaneously other products containing phenylpropanolamine hydrochloride or amphetamines. Patients should not take Ornade Spansule capsules in conjunction with a monoamine oxidase inhibitor or an oral anticoagulant.
Drug Interactions: Ornade Spansule capsules may interact with alcohol and other CNS depressants to potentiate their effects.
This product may have additive effects when taken simultaneously with other products containing phenylpropanolamine hydrochloride or amphetamines.MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and potentiate the pressor effects of sympathomimetics such as phenylpropanolamine hydrochloride (see CONTRAINDICATIONS ).
Phenylpropanolamine hydrochloride should not be used with ganglionic blocking drugs--such as mecamylamine--which potentiate reactions of sympathomimetics. It also should not be used with adrenergic blocking drugs, such as guanethidine sulfate or bethanidine, since it antagonizes the hypotensive action of these drugs.
The action of oral anticoagulants may be inhibited by antihistamines.
The CNS depressant and atropine-like effects of anticholinergics may be potentiated by concomitant administration of antihistamines. Concomitant administration of anticholinergics such as trihexyphenidyl, and other drugs with anticholinergic action (such as imipramine), with antihistamines may result in xerostomia.
(beta)-adrenergic blockers may be antagonized by antihistamines.
Concomitant administration of corticosteroids and antihistamines may decrease the effects of the corticosteroids by enzyme induction.
Antihistamines inhibit norepinephrine reuptake by tissues and therefore potentiate the cardiovascular effects of norepinephrine.
Concomitant use of antihistamines with phenothiazines may produce an additive CNS depressant effect; concomitant use also may cause urinary retention or glaucoma.
Carcinogenesis, Mutagenesis, Impairment of Fertility: A long-term oncogenic study in rats with the chlorpheniramine maleate component of Ornade Spansule capsules did not produce an increase in the incidence of tumors in the drug-treated groups, as compared with the controls. No evidence of mutagenicity was found when chlorpheniramine maleate was evaluated in a battery of mutagenic studies, including the Ames test.
In an early study in rats with chlorpheniramine maleate a reduction in fertility was observed in female rats at doses approximately 67 times the human dose. More recent studies in rabbits and rats, using more appropriate methodology and doses up to approximately 50 and 85 times the human dose, showed no reduction in fertility.
There are no studies available which indicate whether phenylpropanolamine hydrochloride has carcinogenic or mutagenic effects or impairs fertility.
Pregnancy, Teratogenic Effects, Pregnancy Category B: Reproduction studies have been performed with the components of Ornade Spansule capsules. Studies with chlorpheniramine maleate in rabbits and rats at doses up to 50 times and 85 times the human dose, respectively, revealed no evidence of harm to the fetus. A study with phenylpropanolamine hydrochloride in rats at doses up to 7 times the human dose revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Ornade Spansule capsules should be used during pregnancy only if clearly needed.
Nonteratogenic Effects: Studies of chlorpheniramine maleate in rats showed a decrease in the postnatal survival rate of offspring of animals dosed with 33 and 67 times the human dose.
Nursing Mothers: Small amounts of antihistamines are excreted in breast milk. Because of the higher risk with antihistamines in infants generally, and for newborns and prematures in particular, Ornade Spansule capsules should not be administered to a nursing mother (see CONTRAINDICATIONS ).
Pediatric Use: The safety and effectiveness of Ornade Spansule capsules in children under 12 years of age have not been established.
In infants and children, especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.
As in adults, antihistamines may diminish mental alertness in children. In the young child, particularly, they may produce excitation. (See .)
The following adverse reactions have been reported following the use of antihistamines and/or sympathomimetic amines:
General: Anaphylactic shock; chills; drug rash; excessive dryness of mouth, nose and throat; increased intraocular pressure; excessive perspiration; photosensitivity; urticaria; weakness.
Cardiovascular System: Angina pain; extrasystoles; headache; hypertension; hypotension; palpitations; tachycardia.
Hematologic: Agranulocytosis; hemolytic anemia; leukopenia; thrombocytopenia.
Nervous System: Blurred vision; confusion; convulsions; diplopia; disturbed coordination; dizziness; drowsiness; euphoria; excitation; fatigue; hysteria; insomnia; irritability; acute labyrinthitis; nervousness; neuritis; paresthesia; restlessness; sedation; tinnitus; tremor; vertigo.
GI System: Abdominal pain; anorexia; constipation; diarrhea; epigastric distress; nausea; vomiting.
GU System: Dysuria; early menses; urinary frequency; urinary retention.
Respiratory System: Thickening of bronchial secretions; tightness of chest and wheezing; nasal stuffiness.
In the event of overdosage, emergency treatment should be started immediately.
Symptoms: Effects of antihistamine overdosage may vary from central nervous system depression (sedation, apnea, diminished mental alertness, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors, or convulsions) to death.
Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision and hypotension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; hyperthermia; and gastrointestinal symptoms). In large doses, sympathomimetics may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure.
Toxicity: In acute oral toxicity tests in rats, the LD 50 for the ratio of 75 mg phenylpropanolamine hydrochloride and 12 mg chlorpheniramine maleate was 774.2 mg/kg; in mice, the LD 50 for the formulation was 757.4 mg/kg.
Treatment: The patient should be induced to vomit even if emesis has occurred spontaneously. Pharmacologically induced vomiting by the administration of ipecac syrup is a preferred method. But vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of 8 to 12 fluid ounces of water. If emesis does not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in infants and children.
Following emesis, any drug remaining in the stomach may be adsorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Isotonic and one-half isotonic saline are the lavage solutions of choice. Since much of the Spansule capsule medication is coated for gradual release, saline cathartics should be administered to hasten evacuation of pellets that have not already released medication. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and therefore may be valuable for their action in rapid dilution of bowel content. Dialysis has not been reported to be effective in the treatment of phenylpropanolamine hydrochloride and chlorpheniramine maleate overdosage. After emergency treatment, the patient should continue to be medically monitored.
Treatment of the signs and symptoms of overdosage is symptomatic and supportive. Stimulants (analeptic agents) should not be used. Vasopressors may be used to treat hypotension. Short-acting barbiturates, diazepam, or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or a hypothermic blanket. Apnea is treated with ventilatory support.
Adults and children 12 years of age and over--one capsule every 12 hours.
Ornade Spansule capsules are not recommended in children under 12.
In gelatin capsules with opaque red cap and natural body. Each capsule is imprinted with the product name ORNADE and SB, and filled with small red, white and gray pellets; in bottles of 50 and 500 capsules, and in Single Unit Packages of 100 capsules (intended for institutional use only). Each capsule contains 75 mg phenylpropanolamine hydrochloride and 12 mg chlorpheniramine maleate. Capsules should be stored between 15° and 30°C (59° and 86°F).
NDC 0007-4421-15 50's
NDC 0007-4421-25 500's
WARNING: Manufactured with carbon tetrachloride and methyl chloroform, substances which harm public health and environment by destroying ozone in the upper atmosphere.
OR:L42
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