Promethazine VC

promethazinehydrochloride and phenylephrine hydrochloride

Dosage Form: oral syrup
Promethazine VC SYRUP

(PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)

Rx only

Promethazine VC Description

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

Inactive Ingredients: Apricot peach flavor, ascorbic acid, citric acid, FD&C yellow #6, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and 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, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S•HCI, and the following structural formula:

Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically designated as (-)-m-Hydroxy-α-[(methylamino)methyl] benzyl alcohol hydrochloride. It occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride is subject to oxidation and must be protected from light and air. It has a molecular weight of 203.67, a molecular formula of C9H13NO2•HCI, and the following structural formula:

Promethazine VC - Clinical Pharmacology

Promethazine:

Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties.

Promethazine is an H1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

Phenylephrine:

Phenylephrine is a potent postsynaptic α-receptor agonist with little effect on β-receptors of the heart. Phenylephrine has no effect on β-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 being due to its ability to release norepinephrine.

Therapeutic doses of phenylephrine mainly cause vasoconstriction. Phenylephrine 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. Local vasoconstriction and hemostasis occur following topical application or infiltration of phenylephrine into tissues. The main effect of phenylephrine on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of the heart, causing arrhythmias. Cardiac output is decreased slightly. Phenylephrine increases the work of the heart by increasing peripheral arterial resistance.

Phenylephrine has a mild central stimulant effect.

Following oral administration or topical application of phenylephrine to the mucosa, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. Following oral administration, nasal decongestion may occur within 15 or 20 minutes and may persist for up to 4 hours.

Phenylephrine is irregularly absorbed from and readily metabolized in the gastrointestinal tract. Phenylephrine is metabolized in the liver and intestine by 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 tissues.

Indications and Usage for Promethazine VC

Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Contraindications

Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). Phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (MAOI).

Warnings

WARNING:

PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.

POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

Promethazine:

CNS Depression –

Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central nervous system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions).

Respiratory Depression –

Promethazine may lead to potentially fatal respiratory depression.

Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.

Lower Seizure Threshold –

Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.

Bone Marrow Depression –

Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow toxic agents.

Neuroleptic Malignant Syndrome –

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.

Use In Pediatric Patients

PROMETHAZINE PRODUCTS ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE PRODUCTS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONGLY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND ARE NOT DIRECTLY RELATED TO INDIVIDUALIZED WEIGHT-BASED DOSING, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.

ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HYDROCHLORIDE ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, e.g., ENCEPHALOPATHY OR REYE'S SYNDROME. THE USE OF PROMETHAZINE PRODUCTS SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE'S SYNDROME OR OTHER HEPATIC DISEASES.

Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.

Other Considerations

Administration of promethazine has been associated with reported cholestatic jaundice.

Phenylephrine:

Because phenylephrine is an adrenergic agent, it should be given with caution to patients with thyroid diseases, diabetes mellitus, and heart disease or those receiving tricyclic antidepressants.

Men with symptomatic, benign prostatic hypertrophy can experience urinary retention when given oral nasal decongestants.

Phenylephrine can cause a decrease in cardiac output, and extreme caution should be used when administering the drug parenterally or orally to patients with arteriosclerosis, to elderly individuals, and/or to patients with initially poor cerebral or coronary circulation.

Phenylephrine should be used with caution in patients taking diet preparations, such as amphetamines or phenylpropanolamine, because synergistic adrenergic effects could result in serious hypertensive response and possible stroke.

Precautions

Animal reproduction studies have not been conducted with the drug combination—promethazine and phenylephrine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine and phenylephrine should be given to a pregnant woman only if clearly needed.

General:

Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.

Promethazine should be used cautiously in persons with cardiovascular disease or impairment of liver function.

Phenylephrine should be used with caution in patients with cardiovascular disease, particularly hypertension.

Information For Patients:

Promethazine and phenylephrine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and phenylephrine therapy. Children should be supervised to avoid potential harm in bike riding or in other hazardous activities.

The concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced.

Patients should be advised to report any involuntary muscle movements.

Avoid prolonged exposure to the sun.

Drug Interactions:

Promethazine CNS Depressants –

Promethazine may increase, prolong, or intensify the sedative action of other central nervous system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.

Epinephrine –

Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose.

Anticholinergics –

Concomitant use of other agents with anticholinergic properties should be undertaken with caution.

Monoamine Oxidase Inhibitors (MAOI) –

Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.

Phenylephrine

Drug

Phenylephrine with prior administration of monoamine oxidase inhibitors (MAOI).

               Effect

               Cardiac pressor response potentiated.

               May cause acute hypertensive crisis.

Drug

Phenylephrine with tricyclic antidepressants.

               Effect

               Pressor response increased.

Drug

Phenylephrine with ergot alkaloids.

               Effect

               Excessive rise in blood pressure.

Drug

Phenylephrine with bronchodilator sympathomimetic agents and with epinephrine or 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 β-adrenergic blockers.

               Effect

               Cardiostimulating effects blocked.

Drug

Phenylephrine with prior administration of phentolamine or other α-adrenergic blockers.

               Effect

               Pressor response decreased.

Drug

Phenylephrine with diet preparations, such as amphetamines or phenylpropanolamine.

               Effect

               Synergistic adrenergic response.

Drug/Laboratory Test Interactions:

The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride.

Pregnancy Tests:

Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.

Glucose Tolerance Test:

An increase in blood glucose has been reported in patients receiving promethazine.

Carcinogenesis, Mutagenesis, Impairment Of Fertility:

Promethazine:

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

Phenylephrine:

A study which followed the development of cancer in 143,574 patients over a four-year period indicated that in 11,981 patients who received phenylephrine (systemic or topical), there was no statistically significant association between the drug and cancer at any or all sites.

Long-term animal studies have not been performed to assess the carcinogenic potential of phenylephrine, nor are there other animal or human data concerning mutagenicity.

A study of the effects of adrenergic drugs on ovum transport in rabbits indicated that treatment with phenylephrine did not alter incidence of pregnancy; the number of implantations was significantly reduced when high doses of the drug were used.

Pregnancy:

Teratogenic Effects –

Pregnancy Category C.

Promethazine:

Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.

Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women.

Phenylephrine:

A study in rabbits indicated that continued moderate overexposure to phenylephrine (3 mg/day) during the second half of pregnancy (22nd day of gestation to delivery) may contribute to perinatal wastage, prematurity, premature labor, and possibly fetal anomalies; when phenylephrine (3 mg/day) was given to rabbits during the first half of pregnancy (3rd day after mating for seven days), a significant number gave birth to litters of low birth weight. Another study showed that phenylephrine was associated with anomalies of aortic arch and with ventricular septal defect in the chick embryo.

Promethazine and phenylephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects -

Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.

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.

See also "Nonteratogenic Effects."

Nursing Mothers:

It is not known whether promethazine or phenylephrine are excreted in human milk.

Caution should be exercised when promethazine and phenylephrine is administered to a nursing woman.

Pediatric Use:

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SYRUP IS CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS – Black Box Warning and Use In Pediatric Patients).

Promethazine hydrochloride and phenylephrine hydrochloride syrup should be used with caution in pediatric patients 2 years of age and older (see WARNINGS – Use In Pediatric Patients).

Geriatric Use:

Clinical studies of promethazine hydrochloride and phenylephrine hydrochloride syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hydrochloride and phenylephrine hydrochloride syrup and observed closely.

Adverse Reactions

Promethazine:

Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported.

Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness.

Dermatologic – Dermatitis, photosensitivity, urticaria.

Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.

Gastrointestinal – Dry mouth, nausea, vomiting, jaundice.

Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS – Promethazine; Respiratory Depression.)

Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS – Promethazine;Neuroleptic Malignant Syndrome.)

Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.

Phenylephrine:

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

Cardiovascular – Hypertension (see "WARNINGS").

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

Overdosage

Promethazine:

Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex).

Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares.

Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur.

Phenylephrine:

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

Treatment:

The treatment of overdosage with promethazine and phenylephrine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects of promethazine are not reversed by naloxone. Avoid analeptics which may cause convulsions.

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

Limited experience with dialysis indicates that it is not helpful.

Promethazine VC Dosage and Administration

Promethazine hydrochloride and phenylephrine hydrochloride syrup is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use In Pediatric Patients).

The recommended doses are given in the following table:

Adults And Children 12 Years And Over

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 6 To Under 12 Years Of Age

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.

Children 2 To Under 6 Years Of Age

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.

How is Promethazine VC Supplied

This preparation is a yellowish-orange syrup with odor of apricot peach. Each 5 mL (one teaspoonful) contains promethazine hydrochloride 6.25 mg, phenylephrine hydrochloride 5 mg, and alcohol 7 percent, and is available in bottles of 4 fluid ounce (118 mL), 8 fluid ounce (237 mL) and one pint (473 mL).

Keep tightly closed. Protect from light.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP.

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8181658

R5/08-R1

PRINCIPAL DISPLAY PANEL

 

Promethazine VC  promethazinehydrochloride and phenylephrine hydrochloride  syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0603-1587 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE) PROMETHAZINE HYDROCHLORIDE 6.25 mg  in 5 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL   ASCORBIC ACID   CITRIC ACID   FD&C YELLOW NO. 6   MENTHOL   METHYLPARABEN   PROPYLENE GLYCOL   PROPYLPARABEN   WATER   SACCHARIN SODIUM   SODIUM BENZOATE   SODIUM CITRATE   SUCROSE

Product Characteristics Color YELLOW (Yellowish-Orange) Score      Shape Size Flavor APRICOT (Apricot-Peach) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-1587-54 118 mL In 1 BOTTLE None 2 0603-1587-56 237 mL In 1 BOTTLE None 3 0603-1587-58 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040654	12/07/2006

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE

Revised: 06/2011Qualitest Pharmaceuticals

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Albutein

Pronunciation: al-BYOO-min
Generic Name: Albumin (Human)
Brand Name: Examples include Albutein and Plasbumin

Albutein is used for:

Treating a variety of conditions, including shock due to blood loss in the body, burns, low protein levels due to surgery or liver failure, and as an additional medicine in bypass surgery. It may be used for certain conditions as determined by your doctor.

Albutein is a concentrate of plasma proteins from human blood. It works by increasing plasma volume or serum albumin levels.

Do NOT use Albutein if:

• you are allergic to any ingredient in Albutein


• you have or have ever had heart failure, kidney failure or stable chronic anemia, or you are at risk for fluid overload

Contact your doctor or health care provider right away if any of these apply to you.

Before using Albutein:

Some medical conditions may interact with Albutein. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Albutein. However, no specific interactions with Albutein are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Albutein may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Albutein:

Use Albutein as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Albutein is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Albutein at home, carefully follow the injection procedures taught to you by your health care provider.


• If Albutein contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Use Albutein with the administration set that came with it. Be sure the filter is used. After opening, administration must be started within 4 hours. Discard any bottles that have been open for more than 4 hours. Do not save partially used bottles for later use.


• Do not infuse Albutein faster than the rate specified by your doctor.


• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Albutein, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Albutein.

Important safety information:

• Albutein is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause diseases. Symptoms of some viral infections, especially hepatitis C, may occur in patients who receive plasma products or blood infusions. Notify your health care provider immediately if you think an infection has been transmitted by this product.


• LAB TESTS, including blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Albutein during pregnancy. If you are or will be breast-feeding while you are using Albutein, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Albutein:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Albutein. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in heart rate or breathing; chills; confusion; excess saliva; fainting; fever; headache; nausea; vomiting; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Albutein side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Albutein:

Store Albutein at room temperature at or below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not freeze. Discard unused portion. Do not use after the expiration date. Do not store in the bathroom. Keep Albutein out of the reach of children and away from pets.

General information:

• If you have any questions about Albutein, please talk with your doctor, pharmacist, or other health care provider.


• Albutein is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Albutein. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Albutein resources

• Albutein Side Effects (in more detail)
• Albutein Use in Pregnancy & Breastfeeding
• Albutein Support Group
• 0 Reviews for Albutein - Add your own review/rating

• Albutein Prescribing Information (FDA)


• Albumin Human Monograph (AHFS DI)


• AlbuRx Prescribing Information (FDA)


• Albuminar-25 Prescribing Information (FDA)


• Albuminar-25


• Albuminar-5


• Albuminar-5 Prescribing Information (FDA)


• Flexbumin Consumer Overview


• Flexbumin Prescribing Information (FDA)


• Human Albumin Grifols Prescribing Information (FDA)

Compare Albutein with other medications

• Burns, External
• Hypoproteinemia
• Pancreatitis
• Peritonitis
• Postoperative Albumin Loss
• Shock

Terazol 3

Generic Name: terconazole vaginal (ter KON a zole VAJ in al)

Brand Names: Terazol 3, Terazol 7, Zazole

What is Terazol 3 (terconazole vaginal)?

Terconazole is an antifungal antibiotic that fights infections caused by fungus.

Terconazole vaginal is used to treat candida (yeast) infections of the vagina.

Terconazole vaginal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Terazol 3 (terconazole vaginal)?

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

What should I discuss with my healthcare provider before using Terazol 3 (terconazole vaginal)?

You should not use terconazole vaginal if you are allergic to it, or if you have:

• 
  

  a fever;

  
  


• 
  

  stomach pain; or

  
  


• 
  

  foul-smelling vaginal discharge.

  
  

To make sure you can safely use terconazole vaginal, tell your doctor if you have any of these other conditions:

• 
  

  diabetes;

  
  


• 
  

  HIV or AIDS.; or

  
  


• 
  

  if you have ever had an allergic reaction to similar medications such as butoconazole (Femstat, Mycelex), clotrimazole (Lotrimin, Femcare), econazole (Spectazole), fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox), miconazole (Monistat), and others.

  
  

FDA pregnancy category C. It is not known whether terconazole vaginal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether terconazole passes into breast milk. Do not use terconazole vaginal without first talking to your doctor if you are breast-feeding a baby.

How should I use Terazol 3 (terconazole vaginal)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Terconazole vaginal is usually applied once daily at bedtime for 3 days in a row. Follow your doctor's instructions.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after using this medication.

Insert the suppository or cream into the vagina using the applicator as directed.

You can use a sanitary napkin to prevent the medication from staining clothing but do not use a tampon.

Use this medication for the full prescribed length of time, even during your menstrual period. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terconazole vaginal will not treat a viral infection such as the common cold or flu.

Call your doctor if your symptoms do not improve, or if they get worse while using terconazole vaginal. Do not use terconazole vaginal to treat any vaginal condition that has not been checked by your doctor. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Terazol 3 (terconazole vaginal)?

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water.

Avoid using other vaginal medications or douches during your treatment with terconazole vaginal, unless you doctor tells you to.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Avoid sexual intercourse or use a condom to prevent the infection from spreading to a sexual partner.

Avoid exposure to sunlight or tanning beds. Terconazole can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Terazol 3 (terconazole vaginal) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using terconazole vaginal and call your doctor at once if you have a serious side effect such as:

• 
  

  severe vaginal burning or irritation; or

  
  


• 
  

  fever, chills, flu symptoms.

  
  

Less serious side effects may include:

• 
  

  headache; or

  
  


• 
  

  menstrual cramps.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Terazol 3 (terconazole vaginal)?

It is not likely that other drugs you take orally or inject will have an effect on vaginally applied terconazole. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Terazol 3 resources

• Terazol 3 Side Effects (in more detail)
• Terazol 3 Use in Pregnancy & Breastfeeding
• Terazol 3 Support Group
• 0 Reviews for Terazol 3 - Add your own review/rating

• Terazol 3 Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)


• Terazol 7 Prescribing Information (FDA)


• Zazole Prescribing Information (FDA)


• Zazole Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Terazol 3 with other medications

• Vaginal Yeast Infection

Where can I get more information?

• Your pharmacist can provide more information about terconazole vaginal.

See also: Terazol 3 side effects (in more detail)

Carters Little Pills

Generic Name: bisacodyl (bis AK oh dil)

Brand Names: Alophen, Bisac-Evac, Bisco-Lax, Carters Little Pills, Correctol, Doxidan Tablet, Dulcolax Laxative, Evac-U-Gen, Ex-lax Ultra, Feen-A-Mint, Fleet Bisacodyl, Gen Lax, Gentlax Tablet, Gentle Laxative, Laxative Gentle Suppositories, Magic Bullet, Modane, Veracolate

What is Carters Little Pills (bisacodyl)?

Bisacodyl is a laxative that stimulates bowel movements.

Bisacodyl is used to treat constipation or to empty the bowels before surgery, colonoscopy, x-rays, or other intestinal medical procedure.

Bisacodyl may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Carters Little Pills (bisacodyl)?

Do not use bisacodyl if you have stomach (abdominal) pain, nausea, or vomiting, unless directed by a doctor.

If you notice a sudden change in bowel habits that persists over a period of 2 weeks, consult your healthcare provider before using a laxative.

Bisacodyl products should not be used for longer than one week, unless otherwise directed by your healthcare provider.

Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a more serious condition. Stop using bisacodyl and contact your healthcare provider.

What should I discuss with my healthcare provider before using Carters Little Pills (bisacodyl)?

You should not use this medication if you are allergic to bisacodyl, or if you have:

• 
  

  severe stomach pain, nausea, or vomiting;

  
  


• 
  

  a perforated bowel;

  
  


• 
  

  a blockage in your intestines;

  
  


• 
  

  fructose or galactose intolerance;

  
  


• 
  

  an allergy to yellow food dye;

  
  


• 
  

  severe constipation or dehydration;

  
  


• 
  

  inflammatory bowel disease, toxic megacolon; or

  
  


• 
  

  a sudden change in bowel habits lasting 2 weeks or longer.

  
  

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use bisacodyl:

• 
  

  kidney disease;

  
  


• 
  

  trouble swallowing;

  
  


• 
  

  a history of bowel obstruction, diverticulitis, ulcerative colitis, or other intestinal disorder; or

  
  


• 
  

  if you are taking a diuretic ("water pill").

  
  

Do not use bisacodyl without telling your doctor if you are pregnant. Do not use bisacodyl without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without the advice of a doctor.

When used to treat constipation, bisacodyl is only part of a complete program of treatment that may also include diet and exercise. Follow your doctor's instructions very closely.

How should I use Carters Little Pills (bisacodyl)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

For best results, take bisacodyl on an empty stomach, or at bedtime. Do not crush, chew, or break the enteric-coated tablet. Swallow it whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. Do not take a bisacodyl rectal (enema or suppository) by mouth. It is for use only in your rectum.

Try to use the rectal form of this medicine at a time when you can lie down afterward and hold the medicine in. Avoid using the bathroom during this time.

If you are using bisacodyl before surgery or a medical procedure, follow your doctor's instructions about the timing of your dose (the number of days or hours) before your procedure.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Lie on your side and gently insert the suppository pointed end first. For best results, hold in the suppository for a 15 to 20 minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

Shake the rectal enema gently just before use. Remove the protective cap from the applicator tip. You may use the enema lying down or seated on a toilet. Gently insert the tip into your rectum and lightly squeeze the bottle to release the enema. Hold the enema in for a few minutes and then release into the toilet.

The rectal forms of bisacodyl should produce a bowel movement within 15 minutes to 1 hour.

The tablet form of bisacodyl should produce a bowel movement within 6 to 12 hours, or overnight when taken at bedtime.

Call your doctor if you do not have a bowel movement after using this medication. Do not use bisacodyl for more than 7 days in a row unless your doctor tells you to. Store bisacodyl at room temperature away from moisture and heat.

What happens if I miss a dose?

Since bisacodyl is used only once or as needed, you are not likely to be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include watery diarrhea, stomach cramps, muscle weakness, or urinating less than usual.

What should I avoid while using Carters Little Pills (bisacodyl)?

Avoid using any other medications within 2 hours before or after using bisacodyl.

Avoid drinking milk within 1 hour after using bisacodyl.

Carters Little Pills (bisacodyl) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  rectal bleeding;

  
  


• 
  

  severe stomach pain or cramps, severe or ongoing diarrhea or vomiting; or

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

  
  

Less serious side effects may include:

• 
  

  dizziness, weakness;

  
  


• 
  

  increased thirst;

  
  


• 
  

  mild stomach pain, gas, indigestion;

  
  


• 
  

  diarrhea or loose stools;

  
  


• 
  

  mild nausea; or

  
  


• 
  

  skin rash.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Carters Little Pills (bisacodyl)?

There may be other drugs that can interact with bisacodyl. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Carters Little Pills resources

• Carters Little Pills Side Effects (in more detail)
• Carters Little Pills Use in Pregnancy & Breastfeeding
• Carters Little Pills Drug Interactions
• Carters Little Pills Support Group
• 0 Reviews for Carters Little Pills - Add your own review/rating

• Bisacodyl Prescribing Information (FDA)


• Bisacodyl Professional Patient Advice (Wolters Kluwer)


• Bisacodyl Monograph (AHFS DI)


• Bisacodyl MedFacts Consumer Leaflet (Wolters Kluwer)


• Evac-u-gen Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Carters Little Pills with other medications

• Bowel Preparation
• Constipation

Where can I get more information?

• Your pharmacist can provide more information about bisacodyl.

See also: Carters Little Pills side effects (in more detail)

glycopyrrolate

glye-koe-PIR-oh-late

Commonly used brand name(s)

In the U.S.

• Cuvposa


• Robinul


• Robinul Forte

Available Dosage Forms:

• Tablet


• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antimuscarinic

Uses For glycopyrrolate

Glycopyrrolate is used to treat peptic ulcers in adults. It is also used to treat chronic, severe drooling caused by certain neurologic disorders (e.g., cerebral palsy) in children 3 to 16 years of age. glycopyrrolate is an anticholinergic.

Glycopyrrolate may also be used for other conditions as determined by your doctor.

glycopyrrolate is available only with your doctor's prescription.

Before Using glycopyrrolate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For glycopyrrolate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to glycopyrrolate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glycopyrrolate in children 3 to 16 years of age. However, safety and efficacy have not been established in children younger than 3 years of age.

Geriatric

No information is available on whether the risk of glycopyrrolate-induced adverse effects are increased in the elderly; however, it should be used with caution because elderly patients are more likely to have age related liver disease, kidney disease, heart disease, or prostate problems. This may require a dosage adjustment or careful monitoring in elderly patients receiving glycopyrrolate.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking glycopyrrolate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using glycopyrrolate with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of glycopyrrolate. Make sure you tell your doctor if you have any other medical problems, especially:

• Colostomy (bowel surgical procedure) or


• Congestive heart failure or


• Heart disease or


• Heart rhythm problems or


• Hiatal hernia with gastroesophageal reflux disease (GERD) or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Ileostomy (bowel surgical procedure) or


• Liver disease or


• Nerve problems (e.g., neuropathy) or


• Prostatic hypertrophy (enlarged prostate) or


• Ulcerative colitis—Use with caution. May make these conditions worse.

• Glaucoma or


• Myasthenia gravis (severe muscle weakness) or


• Obstructive uropathy (urinary blockage due to enlarged prostate or other condition) or


• Paralytic ileus (bowel blockage) or


• Stomach or intestinal problems (e.g., ulcerative colitis, toxic megacolon, bowel obstruction), severe or


• Trouble urinating—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of glycopyrrolate

Your doctor will tell you how much of glycopyrrolate to use and how often. The dose may need to be changed several times in order to find out what works best for you or your child. Do not use more medicine or use it more often than your doctor tells you to.

glycopyrrolate comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

You should take glycopyrrolate at least one hour before or two hours after meals.

Dosing

The dose of glycopyrrolate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of glycopyrrolate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (solution):
  
  • For severe drooling:
    
    • Children 3 to 16 years of age—Dose is based on body weight and must be determined by your child's doctor. The dose is 0.02 milligram (mg) per kilogram (kg) of body weight three times a day. Your child's doctor may increase your child's dose as needed. However, the dose is usually not more than 1.5 to 3 mg per dose.
    
    
    • Children younger than 3 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  


• For oral dosage form (tablet):
  
  • For peptic ulcers:
    
    • Adults and children 12 years of age and older—The initial dose is 1 mg three times daily. Your doctor will adjust the dose as needed. However, the dose is usually not more than 8 mg per day.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of glycopyrrolate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using glycopyrrolate

It is very important that your doctor or your child's doctor check your progress at regular visits. This will allow your doctor to make sure that glycopyrrolate is working properly and to check for unwanted effects.

You should not take potassium chloride tablets or other potassium supplements (in tablet or capsule forms) while is using glycopyrrolate. Using these medicines together may cause delayed movement of the potassium supplement through the esophagus and stomach.

glycopyrrolate may cause constipation or diarrhea. Constipation or diarrhea can be an early symptom of a serious bowel problem. Stop using glycopyrrolate and check with your doctor if you or your child has constipation, diarrhea, abdominal or stomach distention (swelling), pain, nausea, or vomiting.

Stop using glycopyrrolate and check with your doctor right away if your child is unable to urinate, has dry diapers or undergarments, or has the following symptoms while using glycopyrrolate: crying, irritability, decrease in the frequency of urine, or difficult or painful urination.

If you or your child develops a skin rash, hives, or any allergic reaction to glycopyrrolate, stop taking the medicine and check with your doctor as soon as possible.

glycopyrrolate may make you or your child sweat less, causing your body temperature to increase. Use extra care to avoid becoming overheated during exercise or hot weather while you are taking glycopyrrolate, since overheating may result in heat stroke.

glycopyrrolate may make you or your child drowsy or cause blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

glycopyrrolate Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Body aches or pain


• chills


• constipation


• cough


• decrease in the frequency of urination


• decrease in urine volume


• difficulty in passing urine (dribbling)


• difficulty with breathing


• ear congestion


• feeling of warmth


• fever


• headache


• loss of voice


• nasal congestion


• painful urination


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• sneezing


• sore throat


• unusual tiredness or weakness

Less common

• Abdominal or stomach discomfort or pain


• abdominal or stomach distension


• chest pain


• confusion


• convulsions


• dizziness


• dry heaves


• dry mouth


• fainting


• increase in heart rate


• lightheadedness


• pain or tenderness around the eyes and cheekbones


• rapid breathing


• shortness of breath or troubled breathing


• stuffy nose


• sunken eyes


• thirst


• tightness in the chest


• vomiting


• wheezing


• wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• low blood pressure


• muscle weakness


• trouble breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Altered mood


• anxiety


• attack, assault, or force


• bloated


• change in taste


• chapped lips


• crying


• dry skin


• dry tongue


• excess air or gas in the stomach or intestines


• full feeling


• hyperventilation


• irregular heartbeats


• irritability


• loss of taste


• moaning


• nervousness


• pain


• paleness of the skin


• passing gas


• rash


• restlessness


• shaking


• trouble with sleeping


• uncontrolled eye movements

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: glycopyrrolate side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More glycopyrrolate resources

• Glycopyrrolate Side Effects (in more detail)
• Glycopyrrolate Use in Pregnancy & Breastfeeding
• Drug Images
• Glycopyrrolate Drug Interactions
• Glycopyrrolate Support Group
• 0 Reviews for Glycopyrrolate - Add your own review/rating

• Glycopyrrolate MedFacts Consumer Leaflet (Wolters Kluwer)


• Glycopyrrolate Monograph (AHFS DI)


• Glycopyrrolate Professional Patient Advice (Wolters Kluwer)


• Cuvposa Prescribing Information (FDA)


• Cuvposa Consumer Overview


• Cuvposa Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Robinul Prescribing Information (FDA)


• Robinul Forte MedFacts Consumer Leaflet (Wolters Kluwer)

Compare glycopyrrolate with other medications

• Anesthesia
• Excessive Salivation
• Peptic Ulcer

Abilify Discmelt

Generic Name: aripiprazole (Oral route)

ar-i-PIP-ra-zole

Oral route(Tablet;Tablet, Disintegrating;Solution)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients with depression .

Commonly used brand name(s)

In the U.S.

• Abilify


• Abilify Discmelt

Available Dosage Forms:

• Tablet


• Tablet, Disintegrating


• Solution

Therapeutic Class: Antipsychotic

Uses For Abilify Discmelt

Aripiprazole is used to treat nervous, emotional, and mental conditions (e.g., schizophrenia). It may be used alone or together with other medicines (e.g., lithium or valproate) for the acute or maintenance treatment of bipolar I disorder (manic-depressive illness). Additionally, it may be used together with other medicines for the treatment of major depressive disorder (MDD) in adults. It is also used to treat irritability in children 6 to 17 years of age with autistic disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer's disease.

This medicine is available only with your doctor's prescription.

Before Using Abilify Discmelt

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole in children with schizophrenia younger than 13 years of age and in children with bipolar disorder younger than 10 years of age. Safety and efficacy have not been established in these age groups.

Aripiprazole is not approved for use in children or teenagers with major depression.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aripiprazole in children with autistic disorder 6 to 17 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Metoclopramide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Hydromorphone


• Milnacipran

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine


• Clarithromycin


• Ketoconazole


• Quinidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or


• Depression or


• Drug abuse or dependence, history of or


• Neuroleptic malignant syndrome (NMS), history of or


• Seizures, history of—Use with caution. May make these conditions worse.

• Blood vessel disease or


• Dehydration or


• Heart attack or stroke, history of or


• Heart disease or


• Heart failure or


• Heart rhythm problems or


• Hypotension (low blood pressure) or


• Hypovolemia (decrease in blood volume) or


• Ischemic heart disease, history of or


• Trouble with swallowing—Use with caution. May cause side effects to become worse.

• Diabetes, or family history of or


• Hyperglycemia (high blood sugar)—This medicine may raise your blood sugar levels.

• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

Proper Use of aripiprazole

This section provides information on the proper use of a number of products that contain aripiprazole. It may not be specific to Abilify Discmelt. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.

Swallow the tablets whole. Do not break, crush, or chew them.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Aripiprazole may be taken with or without food. If your doctor tells you to take it a certain way, follow your doctor's instructions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For bipolar mania:
  
  • For oral dosage forms (tablets and orally disintegrating tablets):
    
    • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
    
    
    • Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
    
    
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
    
    
  
  

• For depression:
  
  • For oral dosage forms (tablets, orally disintegrating tablets, and solution):
    
    • Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For irritability in children with autistic disorder:
  
  • For oral dosage forms (tablets, orally disintegrating tablets, and solution):
    
    • Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  

• For schizophrenia:
  
  • For oral dosage forms (tablets and orally disintegrating tablets):
    
    • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
    
    
    • Teenagers 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
    
    
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Opened bottles of the oral liquid can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.

Precautions While Using Abilify Discmelt

It is very important that your doctor check the progress of you or your child at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

For some patients, this medicine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or are getting worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive illness) or has tried to commit suicide.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicines; prescription pain medicines or narcotics; medicines for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any CNS depressants while you or your child are taking this medicine.

Aripiprazole may cause drowsiness, trouble with thinking, or trouble with controlling movements. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think well.

Stop taking this medicine and check with your doctor right away if you or your child have any of the following symptoms while using this medicine: convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder) especially in elderly women. Stop using this medicine and check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if drinking cool water and moving away from the heat does not cool you down.

This medicine may increase the amount of sugar in your blood. Also, the oral liquid form contains sugar. Check with your doctor right away if you or your child have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your weight. Your doctor may need to check your or your child's weight on a regular basis while you are using this medicine.

Do not change the dose or stop taking this medicine without checking first with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines) and herbal or vitamin supplements.

Abilify Discmelt Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Difficulty with speaking


• drooling


• loss of balance control


• muscle trembling, jerking, or stiffness


• restlessness


• shuffling walk


• stiffness of the limbs


• twisting movements of the body


• uncontrolled movements, especially of the face, neck, and back

Less common

• Blurred vision


• dizziness


• headache


• inability to move the eyes


• increased blinking or spasms of the eyelid


• nervousness


• pounding in the ears


• slow or fast heartbeat


• sticking out the tongue


• trouble with breathing or swallowing


• unusual facial expressions

Rare

• Convulsions


• fast heartbeat


• high fever


• high or low blood pressure


• increased sweating


• lip smacking or puckering


• loss of bladder control


• muscle spasm or jerking of all extremities


• puffing of the cheeks


• rapid or worm-like movements of the tongue


• severe muscle stiffness


• sudden loss of consciousness


• tiredness


• uncontrolled chewing movements


• uncontrolled movements of the arms and legs


• unusually pale skin

Incidence not known

• Hives or welts


• itching skin


• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• redness of the skin


• shortness of breath


• skin rash


• tightness in the chest


• unusual tiredness or weakness


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bigger, dilated, or enlarged pupils (black part of the eye)


• diarrhea


• fast, pounding, or irregular heartbeat or pulse


• increased sensitivity of the eyes to light


• lack or loss of strength


• nausea


• sleepiness or unusual drowsiness


• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• anxiety


• belching


• blurred vision


• difficulty having a bowel movement (stool)


• dry mouth


• fear


• fever


• headache


• heartburn


• hyperventilation


• inability to sit still


• indigestion


• irritability


• lightheadedness


• need to keep moving


• nervousness


• rash


• runny nose


• shaking


• sleeplessness


• sore throat


• stomach discomfort, upset, or pain


• trouble sleeping


• unable to sleep


• weight gain

Less common

• Accidental injury


• bloating or swelling of the face, arms, hands, lower legs, or feet


• body aches or pain


• congestion


• coughing


• difficulty with moving


• dryness or soreness of throat


• hoarseness


• increased appetite


• increased salivation


• joint pain


• muscle aching or cramping


• muscle pains or stiffness


• rapid weight gain


• sneezing


• stuffy nose


• swollen joints


• tender, swollen glands in the neck


• tingling of the hands or feet


• tremor


• unusual weight gain or loss


• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Abilifymelt side effects (in more detail)

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More Abilify Discmelt resources

• Abilify Discmelt Side Effects (in more detail)
• Abilify Discmelt Use in Pregnancy & Breastfeeding
• Abilify Discmelt Drug Interactions
• Abilify Discmelt Support Group
• 3 Reviews for Abilifymelt - Add your own review/rating

• Abilify Discmelt Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Abilify Prescribing Information (FDA)


• Abilify MedFacts Consumer Leaflet (Wolters Kluwer)


• Abilify Monograph (AHFS DI)


• Abilify Consumer Overview


• Aripiprazole Professional Patient Advice (Wolters Kluwer)

Compare Abilify Discmelt with other medications

• Agitated State
• Autism
• Bipolar Disorder
• Borderline Personality Disorder
• Depression
• Obsessive Compulsive Disorder
• Post Traumatic Stress Disorder
• Schizoaffective Disorder
• Schizophrenia
• Tourette's Syndrome