Pediahist DM Drops

Brompheniramine Maleate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Pediahist DM Drops (Brompheniramine Maleate) reviews

INDICATIONS AND USAGE

For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see Drug Interactions).

Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

WARNINGS

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.

Antihistamines may diminish mental alertness. In the young child, they may produce excitation.

PRECAUTIONS

General

Because of its antihistamine component, Pediahist DM Drops Cough Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Pediahist DM Drops (Brompheniramine Maleate) Cough Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

Drug Interactions

Monoamine oxidase inhibitors-Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Pediahist DM Drops (Brompheniramine Maleate) Cough Syrup and MAO inhibitors should be avoided (see CONTRAINDICATIONS).

Central nervous system (CNS) depressants

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).

Antihypertensive drugs

Sympathomimetic may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Pediahist DM Drops Cough Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Pediahist DM Drops Cough Syrup. It is also not known whether Pediahist DM Drops (Brompheniramine Maleate) Cough Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.

Reproduction studies of Pediahist DM Drops (Brompheniramine Maleate) maleate (a component of Pediahist DM Drops (Brompheniramine Maleate) Cough Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Pediahist DM Drops (Brompheniramine Maleate) Cough Syrup is contraindicated in nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

The most frequent adverse reactions to Pediahist DM Drops (Brompheniramine Maleate) Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation.CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.G.U. System: Urinary frequency, difficult urination.G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.Respiratory System: Tightness of chest and wheezing, shortness of breath.Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSAGE

Signs and Symptoms

Central nervous system effects from overdosage of Pediahist DM Drops may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.

Toxic Doses

Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of Pediahist DM Drops (Brompheniramine Maleate). The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.

Treatment

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

DOSAGE AND ADMINISTRATION

Adults and pediatric patients 12 years of age and over: 2 teaspoonfuls every 4 hours. Children 6 to under 12 years: 1 teaspoonful every 4 hours. Children 2 to under 6 years of age: ½ teaspoonful every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.

Do not exceed 6 doses during a 24-hour period.

HOW SUPPLIED

Pediahist DM Drops Cough Syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) Pediahist DM Drops (Brompheniramine Maleate) maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following size:

1 Pint (473 mL)

RECOMMENDED STORAGE

Store at 20 ° to 25 °C (68 ° to 77 °F).

KEEP TIGHTLY CLOSEDDispense in a tight, light-resistant container as defined in the USP.

Rx Only

Product No.: 8482Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053A50-8482-16

REV. 11-04

Dextromethorphan Hydrobromide:

• Pharmacological action
• Pharmacokinetics
• Why is Pediahist DM Drops prescribed?
• Dosage and administration
• Pediahist DM Drops (Dextromethorphan Hydrobromide) side effects, adverse reactions
• Pediahist DM Drops contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Pediahist DM Drops drug interactions
• Pediahist DM Drops in case of emergency / overdose
• Pediahist DM Drops (Dextromethorphan Hydrobromide) reviews

Pharmacological action

Pediahist DM Drops is an antitussive medication. Inhibiting the excitability of the cough center this medicine suppresses the cough of any origin. Pediahist DM Drops (Dextromethorphan Hydrobromide) has not addiction effects and it has no analgesic and hypnotic action. Pediahist DM Drops (Dextromethorphan Hydrobromide) starts to act after 10-30 minutes after oral administration, the duration of therapeutic action: 5-6 hours for adults and 6-9 hours for children. Pediahist DM Drops (Dextromethorphan Hydrobromide) is an optical isomer of levomethorphan which is similar to morphine. Due to optical isomerism this drug has no opioid effects. Pediahist DM Drops (Dextromethorphan Hydrobromide) used mainly for replacement of codeine as a cough suppressant. In addition to the cough suppressant this medication is used in medicine for diagnostic purposes and may be useful in various cases - from seizures to heroin addiction treatment, some chronic neurodegenerative diseases. These include amyotrophic lateral sclerosis (ALS) (Charcot's disease), disease of "mad cow and other prion diseases. Pediahist DM Drops (Dextromethorphan Hydrobromide) has also been used for the treatment of mental retardation, Parkinson's disease, in the treatment of lung and other cancers and to prevent tissue rejection in transplantation because of the (poorly known) effects of sigma ligands on tumor cells and immune system.

Pharmacokinetics

After oral administration Pediahist DM Drops (Dextromethorphan Hydrobromide) is completely absorbed from the gastrointestinal tract. C_max of Pediahist DM Drops (Dextromethorphan Hydrobromide) in plasma is reached after 2 h. This medication biotransformes in the liver. Up to 45% of this drug is excreted by kidneys and there was considerable individual variation in rates of excretion of individual metabolites.

Why is Pediahist DM Drops prescribed?

Dry cough of different etiology.

Dosage and administration

For adults and children over 12 years Pediahist DM Drops prescribed on 15 mg 4 times / day, children aged 6 years - 7.5 mg 4 times / day.

Pediahist DM Drops (Dextromethorphan Hydrobromide) side effects, adverse reactions

Drowsiness, nausea, dizziness.

Pediahist DM Drops contraindications

Bronchial asthma, bronchitis, simultaneous reception of mucolytic.

Using during pregnancy and breastfeeding

During pregnancy and lactation (breastfeeding) Pediahist DM Drops (Dextromethorphan Hydrobromide) prescribed with caution, only in cases where the expected therapeutic effect for the mother outweighs the potential risk to the fetus or child.

Special instructions

With carefully administered Pediahist DM Drops (Dextromethorphan Hydrobromide) with impaired liver function.

Pediahist DM Drops drug interactions

MAO inhibitors (including furazolidone, procarbazine, selegiline) when administered simultaneous with Pediahist DM Drops (Dextromethorphan Hydrobromide) may cause adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial hemorrhage, lethargy, nausea, cramps, tremor. In combination with tricyclic antidepressants (amitriptyline, etc.) Pediahist DM Drops (Dextromethorphan Hydrobromide) may appeal serotonin syndrome and possible subsequent death. Amiodarone, fluoxetine, quinidine, inhibiting system cytochrome P450, may increase the drug concentration in the blood. Tobacco smoke can lead to increased secretion of glands in the background of inhibition of cough reflex. Some inhibitors of CYP450 (such as quinidine) increase and extended effects of this medicine.

Pediahist DM Drops in case of emergency / overdose

Symptoms: excitement, dizziness, respiratory depression, impaired consciousness, decreased blood pressure, tachycardia, muscle hypertonicity, ataxia.

Treatment: mechanical ventilation, symptomatic agents.

Pseudoephedrine Hydrochloride:

• Congestac
• Pediahist DM Drops (Pseudoephedrine Hydrochloride) reviews

Active ingredients (in each caplet)...Purpose

Guaifenesin 400 mg...Expectorant

Pediahist DM Drops (Pseudoephedrine Hydrochloride) hydrochloride 60 mg...Nasal decongestant

Uses

For temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis), and to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Uses

• temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Do not exceed recommended dosage.

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where 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.

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficulty in urinating due to an enlarged prostate gland

Stop use and ask a doctor if

• you get nervous, dizzy, or sleepless
• symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

• adults and children 12 years and older, 1 caplet every 4 to 6 hours, not more than 4 caplets in 24 hours
• children 6 to under 12 years, ½ caplet every 4 to 6 hours, not more than 2 caplets in 24 hours
• children under 6 years, consult a physician

Inactive ingredients

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, and starch

Questions?

1-800-324-1880, 7:30am - 4:00pm Central, Mon.-Fri., or visit us at www.bfascher.com

Pediahist DM Drops