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Phenergan VC(promethazine HCl and also phenylephrine HCl) Syrup

DESCRIPTION

Each 5 mL (one teaspoonful), for oral management contains: Promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg, Alcohol 7%.

Inactive Ingredients: Citric acid, FD& C yellow #6, flavor, methyl- paraben, propylene glycol, propyl- paraben, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-<2-(Dimethylamino) propyl> phenothiazine monohydrochloride.

Promethazine hydrochloride occurs as a white to faint yellow, almost odorless, crystalline powder which progressively oxidizes and also turns blue on an extensive exposure to air. That is soluble in water and also freely soluble in alcohol. It has a molecular weight of 320.89, and also a molecule formula the C17H20N2S•HCl.

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Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)- m- Hydroxy-a-<(methylamino) methyl> benzyl alcohol hydrochloride. It occurs together white or virtually white crystals, having actually a bitter taste. The is openly soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and also must be protected from light and air. It has actually a molecular load of 203.67, and also a molecule formula the C9H13NO2•HCl.


INDICATIONS

Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the momentary relief of upper respiratory symptoms, including nasal congestion, linked with allergy or the typical cold.

DOSAGE and ADMINISTRATION

The recommended doses are provided in the complying with table:

Adults and also children 12 years and also over:
1 teaspoonful (5 mL) every 4 come 6 hours, no to exceed 6 teaspoonsful (30 mL) in 24 hours.
Children 6 to under 12 year of age:
½ come 1 teaspoonful (2.5 come 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.
Children 2 come under 6 year of age:
¼ to ½ teaspoonful (1.25 come 2.5 mL) every 4 to 6 hours.

Promethazine and phenylephrine is no recommended for youngsters under 2 year of age.

HOW SUPPLIED

This preparation is a yellow-orange colored, fruit-flavored syrup. Each 5 mL (one teaspoonful) contains Promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and also is accessible in bottles of 4 fluid ounce (118 mL), 8 fluid ounce (237 mL), one pint (473 mL) and one gallon (3785 mL).

Keep strict closed. Defend from light.

Storage: keep at controlled room temperature 59°- 86° F (15°- 30° C).

Dispense in a tight, light-resistant container as characterized in the USP

CAUTION: Federal legislation prohibits dispensing without prescription.


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SIDE EFFECTS

Promethazine

Nervous System: Sedation, sleepiness, sometimes blurred vision, dryness that mouth, dizziness; rarely: confusion, disorientation, and extrapyramidal symptom such together oculogyric crisis, torticollis, and also tongue protrusion (usually in association v parenteral injection or too much dosage).

Cardiovascular: enhanced or reduced blood pressure.

Dermatologic: Rash; rarely: photosensitivity.

Hematologic: Rarely: leukopenia, thrombocytopenia; agranulocytosis (1 case).

Gastrointestinal: Nausea and also vomiting.

Phenylephrine

Nervous System: Restlessness, anxiety, nervousness, and dizziness.

Cardiovascular: Hypertension (see WARNINGS).

Other: Precordial pain, respiratory distress, tremor, and weakness.


DRUG INTERACTIONS

Promethazine

The sedative action of promethazine is additive come the sedative effects of other central nervous mechanism depressants, including alcohol, narcotic analgesics, sedatives, hypnotics, tricyclic antidepressants, and tranquilizers; therefore, this agents have to be avoided or administered in reduced dosage to patient receiving promethazine.

Phenylephrine

Drug: Phenylephrine with prior management of monoamine oxidase inhibitors (MAOI).

Effect: Cardiac pressor an answer potentiated. May cause acute hypertensive crisis.

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Drug: Phenylephrine through tricyclic antidepressants.

Effect: Pressor response increased.

Drug: Phenylephrine v ergot alkaloids.

Effect: too much rise in blood pressure.

Drug: Phenylephrine with bronchodilator sympathomimetic agents and also with epinephrine or various other sympathomimetics.

Effect: Tachycardia or other arrhythmias may occur.

Drug: Phenylephrine with atropine sulfate.

Effect: Reflex bradycardia blocked; pressor response enhanced.

Drug: Phenylephrine with prior administration of propranolol or other b- adrenergic blockers.

Effect: Cardiostimulating results blocked.

Drug: Phenylephrine with prior management of phentolamine or other a- adrenergic blockers.

Effect: Pressor an answer decreased.

Drug: Phenylephrine with diet preparations, such together amphetamines or phenylpropanolamine.

Effect: Synergistic adrenergic response.


WARNINGS

Promethazine

Promethazine might cause marked drowsiness. Ambulatory patients should be cautioned versus such tasks as steering or operation dangerous machinery until it is recognized that they execute not end up being drowsy or dizzy native promethazine therapy.

The sedative action of promethazine hydrochloride is additive come the sedative impacts of main nervous device depressants; therefore, agents such as alcohol, drug analgesics, sedatives, hypnotics, and also tranquilizers need to either be removed or provided in reduced dosage in the visibility of promethazine hydrochloride. When given concomitantly with promethazine hydrochloride, the dose of barbiturates need to be decreased by at least one-half, and also the sheep of analgesic depressants, such together morphine or meperidine, need to be lessened by one-quarter come one-half.

Promethazine may lower seizure threshold. This need to be bring away into consideration when administering come persons with known seizure obstacle or when providing in mix with medicine or neighborhood anesthetics which might also influence seizure threshold. Sedative medicine or CNS depressants need to be avoided in patients through a background of sleep apnea. Antihistamines have to be supplied with fist in patients v narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction as result of symptomatic prostatic hypertrophy and narrowing of the bladder neck.

Administration the promethazine has actually been linked with report cholestatic jaundice.

Phenylephrine

Because phenylephrine is an acirenergic agent, it need to be given with fist to patients through thyroid diseases, diabetes mellitus, and also heart an illness or those receiving tricyclic antidepressants. Males with symptomatic, benign prostatic hypertrophy deserve to experience urinary retention when given oral or sleep decongestants.

Phenylephrine can cause a diminish in cardiac output, and also extreme caution have to be supplied when administering the drug parenterally or orally come patients with arteriosclerosis, to elderly individuals, and/ or come patients v initially bad cerebral or coronary circulation.

Phenylephrine must be used with fist in patients acquisition diet preparations, such together amphetamines or phenylpropanolamine, because synergistic adrenergic results could result in significant hypertensive solution and possible stroke.


PRECAUTIONS

Animal reproduction studies have not been carried out with the drug combination - promethazine and also phenylephrine. The is not known whether this drug combination can cause fetal damage when administered come a pregnant woman or can affect reproduction capacity. Promethazine and also phenylephrine must be given to a pregnant woman just if plainly needed.

General

Promethazine must be offered cautiously in persons with cardiovascular disease or handicap of liver function. Phenylephrine have to be provided with caution in patients with cardiovascular disease, specifically hypertension.

Drug/ activities Test Interactions

The following laboratory tests might be affected in patient who space receiving treatment with promethazine hydrochloride.

Pregnancy Tests: Diagnostic pregnant tests based upon immunological reactions between HCG and also anti- HCG may result in false-negative or false-positive interpretations.

Glucose yongin Test: rise in blood glucose has been report in patient receiving promethazine.

Carcinogenesis, Mutagenesis, handicap of Fertility

Promethazine: Long-term pet studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or special needs of fertility v this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.

Phenylephrine: A study which adhered to the advance of cancer in 143,574 patients end a four-year period indicated that in 11,981 patient who got phenylephrine (systemic or topical), there was no statistically far-ranging association in between the drug and also cancer at any kind of or every sites. Long- term pet studies have not been performed to evaluate the carcinogenic potential of phenylephrine, nor space there other pet or human data concerning mutagenicity.

A examine of the impacts of adrenergic drugs on ovum carry in rabbits indicated that treatment v phenylephrine walk not alter incidence the pregnancy; the variety of implantations was considerably reduced as soon as high doses of the drug were used.

Pregnancy

Teratogenic Effects

Pregnancy classification C: Promethazine: Teratogenic effects have no been demonstrated in rat- feeding researches at doses of 6.25 and 12.5 mg/ kg of promethazine. These doses room 8.3 and also 16.7 times the preferably recommended full daily sheep of promethazine because that a 50-kg subject. Certain studies to check the activity of the medicine on parturition, lactation, and breakthrough of the animal neonate were no done, yet a basic preliminary research in rats shown no result on these parameters. Return antihistamines, including promethazine, have actually been found to develop fetal mortality in rodents, the pharmacological impacts of histamine in the rodent carry out not parallel those in man. There room no adequate and also well-controlled researches of promethazine in pregnant women.

Phenylephrine: A examine in rabbits suggested that continued moderate overexposure to phenylephrine (3 mg/ day) during the second fifty percent of pregnancy (22nd job of gestation to delivery) may add to perinatal wastage, prematurity, premature birth labor, and also possibly fetal anomalies; when phenylephrine (3 mg/ day) was offered to rabbits throughout the an initial half of pregnancy (3rd work after adjustment for seven days), a far-ranging number gave birth come litters of short birth weight. An additional study confirmed that phenylephrine was associated with anomalies that aortic arch and also with ventricular septal defect in the chick embryo.

Promethazine and phenylephrine have to be used throughout pregnancy only if the potential advantage justifies the potential risk to the fetus.

Nonteratogenic Effects

Promethazine take away within 2 weeks of delivery may inhibit platelet aggregation in the newborn.

Labor and also Delivery

Administration that phenylephrine to patients in late pregnant or labor may cause fetal anoxia or bradycardia by boosting contractility of the uterus and also decreasing uterine blood flow. (See likewise Pregnancy: Nonteratogenic Effects above).

Nursing Mothers

It is not known whether promethazine or phenylephrine are excreted in human being milk. Caution have to be worked out when promethazine and phenylephrine is administered come a education woman.

Pediatric Use

This product need to not be offered in pediatric patient under 2 years of age due to the fact that safety because that such use has not to be established.


OVERDOSE

Signs and Symptoms

Promethazine

Signs and also symptoms the overdosage v promethazine selection from gentle depression that the central nervous system and also cardiovascular device to profound hypotension, respiratory depression, and also unconsciousness. Stimulation may be evident, especially in children and geriatric patients. Convulsions might rarely occur. A paradoxical reaction has actually been report in kids receiving solitary doses the 75 mg come 125 mg orally, identified by hyperexcitability and nightmares. Atropine-like signs and symptoms, dried mouth, addressed dilated pupils, flushing, and also gastrointestinal symptoms, may occur.

Phenylephrine

Signs and symptoms of overdosage with phenylephrine incorporate hypertension, headache, convulsions, cerebral hemorrhage, and also vomiting. Ventricular premature birth beats and also short paroxysms of ventricular tachycardia may likewise occur. Headache might be a symptom that hypertension. Bradycardia may likewise be seen early on in phenylephrine overdosage through stimulation of baroreceptors.

Treatment

The therapy of overdosage v promethazine and also phenylephrine is essentially symptomatic and supportive. Only in situations of extreme overdosage or individual sensitivity do crucial signs consisting of respiration, pulse, blood pressure, temperature, and also EKG should be monitored. Triggered charcoal orally or by lavage might be given, or salt or magnesium sulfate orally together a cathartic. Attention need to be provided to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of helped or managed ventilation. Diazepam may be used to manage convulsions. Acidosis and electrolyte losses must be corrected. Keep in mind that any depressant effects of promethazine room not reversed by naloxone. Prevent analeptics i beg your pardon may cause convulsions.

Severe hypotension commonly responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE need to NOT be USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure.

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CONTRAINDICATIONS

Promethazine is contraindicated in people known to be hypersensitive or come have had actually an idiosyncratic reaction come promethazine or to various other phenothiazines. Antihistamines are contraindicated for usage in the therapy of lower respiratory tract symptoms, consisting of asthma. Phenylephrine is contraindicated in patients with hypertension or v peripheral vascular insufficiency (ischemia may an outcome with risk of gangrene or thrombosis of endangered vascular beds). Phenylephrine need to not be provided in patients recognized to be hypersensitive come the medicine or in those receiving a monoamine oxidase inhibitor (MAOI).


CLINICAL PHARMACOLOGY

Promethazine

Promethazine is a phenothiazine derivative which differs structurally indigenous the antipsychotic phenothiazines by the presence of a branched next chain and no ring substitution. It is thought that this construction is responsible for its relative lack (1/ 10 that of chlorpromazine) the dopaminergic (CNS) action. Promethazine is one H1 receptor blocking agent. In addition to that is antihistaminic action, it gives clinically useful sedative and also antiemetic effects. In therapeutic dosages, promethazine produces no far-ranging effects ~ above the cardiovascular system. Promethazine is well took in from the cradle tract. Clinical results are apparent within 20 minutes after oral management and typically last four to six hours, although they might persist as lengthy as 12 hours. Promethazine is metabolized through the liver to a range of compounds; the sulfoxides that promethazine and N-demethylpromethazine are the primary metabolites showing up in the urine.

Phenylephrine

Phenylephrine is a potent post- synaptic a- receptor agonist with tiny effect on b- receptor of the heart. Phenylephrine has actually no impact on b-adrenergic receptor of the bronchi or peripheral blood vessels. A direct action at recep- tors accounts for the greater part of that effects, only a small part being as result of its capacity to release norepinephrine. Therapeutic doses of phenylephrine mainly reason vasoconstriction. Phenylephrine increases resistance and, come a lesser extent, reduce capacitance of blood vessels. Complete peripheral resistance is increased, result in boosted systolic and diastolic blood pressure. Pulmonary arterial push is commonly increased, and renal blood flow is generally decreased. Regional vasoconstriction and also hemostasis occur adhering to topical application or infiltration the phenylephrine into tissues. The main effect of phenylephrine on the heart is bradycardia; the produces a hopeful inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability the the heart, causing arrhythmias. Cardiac calculation is lessened slightly. Phenylephrine increases the work-related of the love by increasing peripheral arterial resistance. Phenylephrine has actually a mild main stimulant effect.

Following oral management or topical applications of phenylephrine come the mucosa, constriction of blood vessels in the sleep mucosa relieves sleep congestion linked with allergy or head colds. Adhering to oral administration, sleep decongestion may occur within 15 or 20 minutes and also may persist for as much as 4 hours. Phenylephrine is irregularly soaked up from and readily metabolized in the cradle tract. Phenylephrine is metabolized in the liver and intestine through monoamine oxidase. The metabolites and also their route and also rate that excretion have not to be identified. The pharmacologic activity of phenylephrine is terminated at the very least partially by absorb of the drug right into tissues.


PATIENT INFORMATION

Promethazine and also phenylephrine may cause marked drowsiness or may impair the mental and/ or physical abilities required for the power of potentially hazardous tasks, such together driving a auto or operation machinery. Ambulatory patients need to be said to prevent engaging in such activities until the is well-known that they perform not end up being drowsy or dizzy from promethazine and phenylephrine therapy. Kids should be oversaw to stop potential damage in bike riding or in other hazardous activities.

The concomitant usage of alcohol or other central nervous device depressants, consisting of narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have actually an additive effect and also should it is in avoided or your dosage reduced.

Patients should be advised to report any type of involuntary muscle movements or unexplained sensitivity to sunlight.