SONAHIST DM is an antihistamine/nasal decongestant/cough suppressant indicated for the temporary relief of nasal congestion, cough, runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to the common cold, hay fever, inhaled irritants, or other upper respiratory allergies.
DOSAGE AND ADMINISTRATION
Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours; Children 2 to under 6 years of age: 1 dropperful (1 mL) every 4-6 hours; Children under 2 years of age: As directed by a physician.
DOSAGE FORMS AND STRENGTHS
SONAHIST DM is supplied as clear, orange-vanilla flavored pediatric drops. Each dropperful (1 mL) contains: 1 mg chlorpheniramine maleate; 2 mg phenylephrine hydrochloride, 3 mg dextromethorphan hydrobromide.
SONAHIST DM is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients, patients taking monoamine oxidase (MAO) inhibitors or for two weeks after stopping the MAOI drug, patients with narrow-angle glaucoma, severe coronary artery disease, urinary retention, peptic ulcer, severe hypertension, patients with breathing problems such as emphysema or chronic bronchitis, or nursing mothers.
WARNINGS AND PRECAUTIONS
Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow-angle glaucoma, or prostatic hypertrophy. Do not use in patients taking monoamine oxidase (MAO) inhibitors, or for 14 days after stopping treatment with an MAOI.
Antihistamines should be used with considerable caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction. Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients.
Chlorpheniramine Maleate may cause excitability especially in children. Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child’s doctor. May cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child’s doctor.
Dextromethorphan HBr is not indicated to relieve persistent or chronic coughs such as that which occurs with asthma or if the cough is accompanied by excessive phlegm (mucus), unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Phenylephrine HCl should not be used if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy.
Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria.
Dextromethorphan may cause drowsiness, dizziness, and GI disturbance.
Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. MAO inhibitors may enhance the effect of phenylephrine HCl. Sympathomimetics may reduce the effects of antihypertensive drugs. The cough-suppressant action of dextromethorphan and narcotic antitussives are additive. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
USE IN SPECIFIC POPULATIONS
Pregnancy Teratogenic effects: Category C. Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal harm when administered to a pregnant woman or effect reproduction capacity. Give to pregnant women only if clearly needed. Administration of phenylephrine HCl to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.
Nursing mothers Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended.
Geriatric Use Sedating drugs may cause confusion and over-sedation in the elderly; Elderly patients generally should be started on low doses of SONAHIST DM and observed closely.
The signs, symptoms and treatment described below are those of H1 antihistamine, ephedrine, and dextromethorphan overdose.
Symptoms: Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, predominate symptoms are excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions,fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.
Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmia, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea and abdominal cramps. Dextromethorphan may cause respiratory depression with a large overdose.
Treatment: (a) Evacuate stomach as condition warrants. Activated charcoal may be useful. (b) Maintain a nonstimulating environment. (c) Monitor cardiovascular status. (d) Do not give stimulants. (e) Reduce fever with cool sponging. (f) Treat respiratory depression with naloxone if dextromethorphan toxicity is suspected. (g) Use sedatives or anticonvulsants to control CNS excitation and convulsions. (h) Physostigmine may reverse anticholinergic symptoms. (i) Ammonium chloride may acidify the urine to increase urinary excretion of phenylephrine. (j) Further care is symptomatic and supportive.
SONAHIST DM is an antihistamine/ nasal decongestant/cough suppressant combination available for oral administration as Pediatric Drops. SONAHIST DM is available as a clear, sweet orange-vanilla flavored Pediatric Drops. Each dropperful (1 mL) of SONAHIST DM contains 1 mg chlorpheniramine maleate; 2 mg phenylephrine hydrochloride; 3 mg dextromethorphan hydrobromide.
SONAHIST DM Pediatric Drops contains the following inactive ingredients: Purified Water, Propylene Glycol, Sorbitol, Glycerin, Methyl Paraben, Propyl Paraben, Sodium Citrate, Sodium Saccharin, Sweet Orange Flavor and Vanilla Flavor.
Chlorpheniramine maleate is an antihistamine having the chemical name: 2-Pyridinepropanamine, g-(4-chlorophenyl)-N, N-dimethyl-,(Z)-2-butenedioate(1:1). Chemically, it is 3-methoxy-17-methyl-(9a, 13a, 14a)-, morphinan hydrobromide monohydrate.
Phenylephrine HCl is a sympathomimetic amine used as a vasoconstrictor having the chemical name (–)-m-Hydroxy-a-[(methylamino)methyl] benzyl alcohol hydrochloride.
Dextromethorphan hydrobromide is an antitussive, a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic.
SONAHIST DM combines the antihistamine action of chlorpheniramine, the antitussive action of dextromethorphan, and the sympathomimetic decongestant effect of phenylephrine. SONAHIST DM has an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells.
Chlorpheniramine competitively antagonizes most of the smooth-muscle stimulating actions of histamine on the H1 receptors and the GI tract, uterus, large blood vessels and bronchial muscle. It also antagonizes the action of histamine that results in increased capillary permeability and the formation of edema.
Phenylephrine hydrochloride acts predominantly by a direct action on alpha adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta adrenergic receptors of the heart. Following oral administration,constriction of blood vessels in the nasal mucosa may relieve nasal congestion. In therapeutic doses, the drug causes little, if any, central nervous system stimulation.
Dextromethorphan hydrobromide is a non-narcotic antitussive with effectiveness equal to codeine. It acts in the medulla oblongata to elevate the cough threshold. Dextromethorphan does not produce analgesia or induce tolerance, and has no potential for addiction. At usual doses, it will not depress respiration or inhibit ciliary activity. Dextromethorphan is rapidly metabolizedwith trace amounts of the parent compound in blood and urine. About one-half of the administered dose is excreted in the urine as conjugated metabolites.
Carcinogenesis, Mutagenesis, Impairment of Fertility Long term studies in animals to determine mutagenic and carcinogenic potential have not been performed.
HOW SUPPLIED/STORAGE AND HANDLING
SONAHIST DM Pediatric Drops is clear with a sweet orange and vanilla flavor. Available in 1 fl oz (30 mL) bottles (NDC 49769-320-21).
Storage Store at Controlled Room Temperature 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
PATIENT COUNSELING INFORMATION Patients taking SONAHIST DM should be advised that this drug may cause drowsiness and has an additive effect with alcohol. Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.
Persistent cough may indicate a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by a high fever, rash or persistent headache, consult a physician.
Dextromethorphan should be used with caution in sedated or debilitated patients and in patients confined to supine positions.
Manufactured for: Kylemore Pharmaceuticals, LLC., Port St. Joe, FL 32456 320-10 Iss. 12/09