pyrilamine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide
Dosage Form: liquid
Reme Hist DM
DESCRIPTION:
Reme Hist DM is a sugar free, alcohol free, dye free, clear and colorless liquid with a grape flavor. Each 5mL (1 teaspoonful) contains:
Pyrilamine Maleate 12.5 mg
Phenylephrine HCl 7.5 mg
Dextromethorphan HBr 15 mg
Pyrilamine Maleate is an antihistamine that occurs as a white crystalline powder, usually having a faint odor. It is very soluble in water, freely soluble in alcohol and chloroform, and slightly soluble in ether and benzene. The chemical name is 1, 2-ethanediamine, N-[(4 methoxyphenyl) methyl]-N: N-dimethyl-N-2- pyridinyl-, (Z)-2-butenedioate(1:1). Its structural formula is as follows:
Dextromethorphan Hydrobromide is an antitussive which is a salt of the methyl ether of dextrorotatory isomer of levorphanol, a narcotic analgesic. Chemically, it is 3-methoxy-17-methyl-9_, 13_, 14_morphinan hydrobromide:
Phenylephrine Hydrochloride is a decongestant that occurs as white or practically white, odorless crystals, having a bitter taste. It is freely soluble in water and in alcohol. It is affected by light. The chemical name is benzenemethanol, 3-hydroxy-alpha[(methylamino)methyl]-,hydrochloride. Its structural formula is as follows:
Inactive Ingredients: The inactive ingredients are Citric acid, Glycerin, Grape Flavor, Propylene Glycol, Magnasweet, Purified Water, Saccharin Sodium, Sodium Benzoate, Sorbitol and Xanthan Gum.
CLINICAL PHARMACOLOGY:
Pyrilamine Maleate: Pyrilamine is an antihistamine belonging to the ethylenediamine class. Pyrilamine is a highly effective H1 blocker which possesses local anesthetic activity. Pyrilamine antagonizes most of the smooth muscle stimulating actions of histamine on the H1 receptors of the gastrointestinal tract, blood vessels and bronchial muscle. It also antagonizes the actions of histamine that result in increased capillary permeability and the formation of edema. Pyrilamine has a duration of action of 4 to 6 hours in clinical studies.
Dextromethorphan Hydrobromide: Dextromethorphan Hydrobromide is an antitussive which acts centrally to elevate the cough threshold. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.
Phenylephrine Hydrochloride: Phenylephrine is a potent postsynaptic alpha-receptor agonist with little effect on betareceptors of the heart. Phenylephrine has no effect on the beta-adrenergic receptors of the bronchi or peripheral blood vessels. A direct action at receptors accounts for the greater part of its effects; only a small part is due to its ability to release norepinephrine. Therapeutic doses of phenylephrine cause vasoconstriction. It increases resistance, and to a lesser extent, decreases capacitance of blood vessels. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Following oral administration of phenylephrine constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. Following oral administration of phenylephrine, nasal decongestion may occur within 15 to 20 minutes and may persist for up to 4 hours. Phenylephrine is irregularly absorbed from and readily metabolites in the gastrointestinal tract. Phenylephrine is metabolized in the liver and intestine monoamine oxidase. The metabolites and their route and rate of excretion have not been identified. The pharmacologic action of phenylephrine is terminated at least partially by uptake of the drug into the tissues.
INDICATIONS AND USAGE:
Reme Hist DM is indicated for allergic rhinitis and vasomotor rhinitis, allergy induced nasal congestion, such as runny nose, sneezing, and cough from inhalation of airborne antigens and other irritants.
Information for Patients: Antihistamines may impair the mental and physical abilities required for the performance of potentially hazardous tasks such as driving a vehicle or operating machinery. Patients should also be warned about possible additive effects with alcohol and other central nervous system depressants (hypnotics, sedatives, and tranquilizers).
Drug/Laboratory Test Interaction: MAO inhibitors and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines. Serious toxicity may result if dextromethorphan is co-administered with monoamine oxidase (MAO) inhibitors. Beta-adrenergic blockers and MAO inhibitors may potentiate the pressor effect of phenylephrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of antihistamines with alcohol, tricyclic antidepressants, barbiturates, and other CNS depressants may have an addictive effect.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been performed using Reme Hist DM to determine the potential for carcinogenesis, mutagenesis and impairment of fertility. In a four year evaluation of phenylephrine, no statistically significant association between the drug and cancer was found.
Usage in Pregnancy: Pregnancy Category C: Moderate overexposure to phenylephrine has been found to contribute to birth defects in rabbits. Animal reproduction studies have not been conducted with the other ingredients in Reme Hist DM. Reme Hist DM should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus.
Labor and Delivery: Administration of phenylephrine 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: Due to the possible passage of antihistamines into breast milk, and because of the higher than usual risk for infants from sympathomimetic amines and antihistamines, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of both.
Pediatric Use: In infants and children especially, antihistamine overdosage may cause hallucinations, convulsions or death. As in adults, antihistamines may diminish mental alertness in children. In the young child particularly, antihistamines may produce excitation.
Geriatric Use: The elderly (60 years of age and older) are more likely to experience adverse reactions from sympathomimetics and antihistamines. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.
Treatment: The patient should be induced to vomit even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac is facilitated by physical activity and by the administration of eight to twelve ounces of water. If emesis does not occur within fifteen 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 absorbed 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. 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. After emergency treatment, the patient should continue to be medically monitored. Treatment of the signs and symptoms of over dosage is symptomatic and supportive.
DOSAGE AND ADMINISTRATION:
Reme Hist DM is administered by mouth as follows:
ADULTS AND CHILDREN OVER 12 YEARS OF AGE:
1 to 2 teaspoonfuls every 4 to 6 hours or as directed by a physician, not to exceed 60 mg of phenylephrine HCI in a 24 hour period.
CHILDREN 6 TO 12 YEARS OF AGE:
1 teaspoonful every 4 to 6 hours or as directed by a physician, not to exceed 30 mg of phenylephrine HCI in a 24 hour period.
CHILDREN 2 TO UNDER 6 YEARS OF AGE:
1/2 teaspoonful every 4 to 6 hours or as directed by a physician, not to exceed 15 mg of phenylephrine HCI in a 24 hour period.
CHILDREN UNDER 2 YEARS OF AGE:
Consult a physician.
HOW SUPPLIED:
One Pint (473 mL) bottles, NDC 49769-192-16.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
IN CASE OF ACCIDENTAL OVERDOSE, CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY.
Storage: Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F).
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER WITH A CHILD-RESISTANT CLOSURE AS DEFINED IN THE USP/NF.
Manufactured for:
Kylemore Pharmaceuticals, LLC.
Port St. Joe, FL 32456
Iss. 12/09 192-10
PACKAGING:
Reme Hist DM label:
| REME HIST DM pyrilamine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/05/2010 | ||
| Labeler - Kylemore Pharmaceuticals, LLC (831892471) |
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