Promethazine and Dextromethorphan

Dosage Form: oral solution
PROMETHAZINE HYDROCHLORIDE AND

DEXTROMETHORPHAN HYDROBROMIDE SYRUP

Rx only

Full Prescribing Information

DESCRIPTION

Each 5 mL (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%.

Inactive Ingredients:  Ascorbic Acid, Citric Acid, Edetate Disodium, FD&C Yellow #6, Glycerin, Methylparaben, Natural & Artificial Flavors, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Citrate, and Sucrose.

Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α,13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NO•HBr•H20, and the following structural formula:

Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as "10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, 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:

CLINICAL PHARMACOLOGY

Dextromethorphan: Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties.

The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity.

Dextromethorphan is rapidly absorbed from the gastrointestinal tract and exerts its effect in 15 to 30 minutes. The duration of action after oral administration is approximately three to six hours. Dextromethorphan is metabolized primarily by liver enzymes undergoing 0-demethylation, N-demethylation, and partial conjugation with glucuronic acid and sulfate. In humans, (+)-3-hydroxy-N-methyl-morphinan, (+)-3-hydroxy-morphinan, and traces of unmetabolized drug were found in urine after oral administration.

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-demethyl-promethazine are the predominant metabolites appearing in the urine.

INDICATIONS & USAGE

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

CONTRAINDICATIONS

Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see PRECAUTIONS, Drug Interactions).

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.

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.

Dextromethorphan: Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

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 HCI (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 HCI 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 HCI 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 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 HCI 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 HCI.

Other Considerations:

Administration of promethazine has been associated with reported cholestatic jaundice.

PRECAUTIONS

Animal reproduction studies have not been conducted with the drug combination-Promethazine and Dextromethorphan. 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 Dextromethorphan should be given to a pregnant woman only if clearly needed.

General: Dextromethorphan should be used with caution in sedated patients, in the debilitated, and in patients confined to the supine position.

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 with impairment of liver function.

INFORMATION FOR PATIENTS

Promethazine and Dextromethorphan may cause marked drowsiness or 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 Dextromethorphan 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:

Dextromethorphan: Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of monoamine oxidase (MAO) inhibitors and products containing dextromethorphan. Thus, concomitant administration of promethazine with dextromethorphan and MAO inhibitors should be avoided (see CONTRAINDICATIONS).

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 HCI. 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 HCI 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.

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: Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine or of dextromethorphan. There are no animal or human data concerning the carcinogenicity, mutagenicity, or impairment of fertility with these drugs. Promethazine was nonmutagenic in the Salmonella test system of Ames.

Pregnancy:Teratogenic Effects - Pregnancy Category C: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCI. 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.

Promethazine and Dextromethorphan 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: Limited data suggest that use of promethazine HCI during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect on later growth and development of the newborn is unknown. See also "Nonteratogenic Effects".

Nursing Mothers: It is not known whether promethazine or dextromethorphan is excreted in human milk.

Caution should be exercised when Promethazine and Dextromethorphan is administered to a nursing woman.

Pediatric Use:PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION 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 dextromethorphan hydrobromide oral solution 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 dextromethorphan hydrobromide oral solution 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 dextromethorphan hydrobromide oral solution and observed closely.

ADVERSE REACTIONS

Dextromethorphan: Dextromethorphan hydrobromide occasionally causes slight drowsiness, dizziness, and gastrointestinal disturbances.

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 HCI 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.

DRUG ABUSE AND DEPENDENCE

According to the WHO Expert Committee on Drug Dependence, dextromethorphan could produce very slight psychic dependence but no physical dependence.

OVERDOSAGE

Dextromethorphan: Dextromethorphan may produce central excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single dose of 20 tablets (300 mg) of dextromethorphan has been reported.

Promethazine: Signs and symptoms of overdosage with promethazine HCI 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.

Treatment: The treatment of overdosage with Promethazine and Dextromethorphan 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 reestablishment 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. The antidotal efficacy of narcotic antagonists to dextromethorphan has not been established; note that any of the 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 blockage may further lower the blood pressure.

Limited experience with dialysis indicates that it is not helpful.

DOSAGE & ADMINISTRATION

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for children under 2 years of age (see WARNINGS – Black Box Warning and Use in Pediatric Patients).

The average effective dose is given in the following table:

Adults	1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours
Children 6 years to under 12 years	½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 20 mL in 24 hours.
Children 2 years to under 6 years	¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours, not to exceed 10 mL in 24 hours.

HOW SUPPLIED

Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is a clear, yellow colored, berry-flavored solution containing 6.25 mg promethazine hydrochloride, 15 mg dextromethorphan hydrobromide and 7 percent alcohol in each teaspoonful (5 mL).

Available as:

4 fl. oz (118 mL) NDC 65162-680-86

16 fl. oz (473 mL) NDC-65162-680-90

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F);  [See USP Controlled Room Temperature].

Dispense in tight, light-resistant container as defined in the USP.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Rx Only

Manufactured by:

Amneal Pharmaceuticals.

Branchburg, NJ 08876

MF # 659                                 Rev. 2-2008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROMETHAZINE HYDROCHLORIDE AND DEXTOMETHORPHAN HYDROBROMIDE  promethazine hydrochloride and dextomethorphan hydrobromide  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65162-680 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 DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength ASCORBIC ACID   CITRIC ACID MONOHYDRATE   EDETATE CALCIUM DISODIUM   FD&C YELLOW NO. 6   GLYCERIN   METHYLPARABEN   WATER   SACCHARIN SODIUM   SODIUM BENZOATE   SODIUM CITRATE   SUCROSE   BERRY

Product Characteristics Color YELLOW Score      Shape Size Flavor BERRY Imprint Code Contains Promethazine Hydrochloride and Dextomethorphan Hydrobromide

Packaging # NDC Package Description Multilevel Packaging 1 65162-680-86 118 mL In 1 BOTTLE None 2 65162-680-90 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090575	03/31/2010

Labeler - Amneal Pharmaceuticals (804220023)

Registrant - Amneal Pharmaceuticals (831227801)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals		791930568	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 03/2010Amneal Pharmaceuticals

More Promethazine and Dextromethorphan resources

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

Compare Promethazine and Dextromethorphan with other medications

• Cold Symptoms
• Cough
• Hay Fever

Interferon Alfa 2B Biomartian

Interferon Alfa 2B Biomartian may be available in the countries listed below.

Ingredient matches for Interferon Alfa 2B Biomartian

Interferon alfa

Interferon alfa Interferon alfa-2b (Arg-23; His-34) (a derivative of Interferon alfa) is reported as an ingredient of Interferon Alfa 2B Biomartian in the following countries:

• Argentina

International Drug Name Search

pralidoxime Injection

pral-i-DOX-eem

Commonly used brand name(s)

In the U.S.

• Protopam Chloride

Available Dosage Forms:

• Powder for Solution


• Injectable

Therapeutic Class: Nerve Gas Antidote

Uses For pralidoxime

Pralidoxime injection is used together with another medicine called atropine to treat poisoning caused by organic phosphorus pesticides (e.g., diazinon, malathion, mevinphos, parathion, and sarin) and by organophosphate chemicals (“nerve gases”) used in chemical warfare.

Pralidoxime injection is also used to treat overdose of medicines (e.g., ambenonium, neostigmine, pyridostigmine), that are used to treat myasthenia gravis. Poisoning with these chemicals or medicines causes your muscles, including the muscles that help you breathe, to become weak. Pralidoxime is used to help you get back strength in your muscles.

pralidoxime is to be given only by or under the direct supervision of a doctor or trained military personnel.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, pralidoxime has been used in some patients to treat poisoning caused by certain carbamate pesticides.

Before Using pralidoxime

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 pralidoxime, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pralidoxime 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 pralidoxime injection in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pralidoxime injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving pralidoxime injection.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 pralidoxime. Make sure you tell your doctor if you have any other medical problems, especially:

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

• Myasthenia gravis (severe muscle weakness)—Use with caution. May make this condition worse.

Proper Use of pralidoxime

A nurse or other trained health professional will give you pralidoxime in a hospital or clinic. You may also be taught how to give your medicine at home. pralidoxime is preferably given through a needle placed in one of your veins. It may also be given as a shot under your skin or into a muscle.

pralidoxime is available in two forms: a vial and an autoinjector.

For patients using the pralidoxime autoinjector (automatic injection device):

• You will be trained to use the pralidoxime autoinjector by a medic or other trained military personnel. You will also be told the conditions under which it should be used.


• The autoinjector also comes with patient directions. Read them carefully before you actually need to use pralidoxime. Then, when an emergency arises, you will know how to inject the pralidoxime.


• It is important that you do not remove the safety cap on the autoinjector until you are ready to use it. This prevents spillage of the medicine from the device during storage and handling.


• To use the pralidoxime autoinjector:
  
  • Remove the gray safety cap.
  
  
  • Place the black tip of the device on the thigh, with the injector pointed straight at the thigh.
  
  
  • Press hard into the thigh until the autoinjector functions. Hold in place for several seconds. Remove the autoinjector and dispose of it as directed.
  
  
  • Massage the injected area for 10 seconds.
  
  

Dosing

The dose of pralidoxime 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 pralidoxime. 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 injection dosage form:
  
  • For treatment of organic phosphorus pesticide poisoning:
    
    • Adults and teenagers—At first, 1000 to 2000 milligrams (mg) injected into a vein usually as an infusion in 100 milliliters (mL) of normal saline, over a 15- to 30-minute period. The dose may be repeated after one hour, and then every eight to twelve hours if muscle weakness persists.
    
    
    • Children and teenagers 16 years of age and younger—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 50 milligrams (mg) per kilogram (kg) (9.07 to 22.7 mg per pound) of body weight injected into a vein. The dose may be repeated after one hour, and then every ten to twelve hours if muscle weakness persists.
    
    
  
  
  • For treatment of organic phosphorus chemical (“nerve gas”) poisoning:
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—600 milligrams (mg) or 2 milliliters (mL) injected into a muscle. The dose may be repeated fifteen minutes after the first dose and fifteen minutes after the second dose, if needed.
    
    
    • Children and teenagers 16 years of age and younger weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is 15 milligrams (mg) per kilogram (kg) of body weight injected into the muscles of the thighs. The dose may be repeated fifteen minutes after the first dose and fifteen minutes after the second dose, if needed.
    
    
  
  
  • For treatment of overdose of medicines used to treat myasthenia gravis:
    
    • Adults and teenagers—At first, 1000 to 2000 milligrams (mg) injected into a vein. Then, 250 mg is injected into a vein every five minutes.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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 pralidoxime

Your doctor will check your progress closely while you or your child are receiving pralidoxime. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Call your doctor right away if you or your child have fast heartbeat, difficulty or trouble with breathing, increased muscle weakness, or severe tiredness after receiving pralidoxime.

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

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.

pralidoxime 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 or nurse immediately if any of the following side effects occur:

More common

• Blurred or double vision


• change in near or distance vision


• difficult or rapid breathing


• difficulty in focusing the eyes


• difficulty with speaking


• dizziness


• fast, pounding, or irregular heartbeat or pulse


• muscle stiffness or weakness


• pain at the injection site (after injection into a muscle)

Incidence not known

• Deep or fast breathing with dizziness


• numbness of the feet, hands, and around the mouth

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

• Drowsiness


• headache


• nausea

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: pralidoxime Injection 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 pralidoxime Injection resources

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

Compare pralidoxime Injection with other medications

• Anticholinesterase Overdose
• Nerve Agent Poisoning
• Organophosphate Poisoning

Vantas

Generic Name: histrelin (Subcutaneous route)

his-TREL-in

Commonly used brand name(s)

In the U.S.

• Supprelin LA


• Vantas

Available Dosage Forms:

• Kit


• Implant

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Gonadotropin Releasing Hormone Agonist

Uses For Vantas

Histrelin is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. It works in the brain to reduce the blood levels of sex hormones, such as testosterone and estrogen. The histrelin implant is placed under the skin. The implant releases small amounts of histrelin in the body every day for 12 months.

Histrelin (Vantas®) is used to treat advanced prostate cancer in adults. It will reduce the level of testosterone, a male hormone, in the blood. Testosterone makes most prostate cancers grow. Histrelin is not a cure for prostate cancer, but it may help relieve the symptoms.

Histrelin (Supprelin® LA) is used to treat central precocious puberty (CPP) in children. CPP is a condition where puberty begins at an unusually early age. This usually means puberty occurs before 8 years of age in girls and before 9 years of age in boys. Histrelin works by reducing the amount of sex hormones (eg, estrogen and testosterone) in the blood.

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

Before Using Vantas

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

The Vantas® form of histrelin should not be used in children.

Appropriate studies have not been performed on the relationship of age to the effects of the Supprelin® LA form of histrelin in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of histrelin (eg, Supprelin® LA, Vantas®) in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Diabetes or


• Heart attack, history of or


• Heart disease or


• Hyperglycemia (high blood sugar) or


• Kidney problems (reduced urine flow) or


• Nerve problems in the spine from cancer lesions in the bones or


• Problems passing urine or


• Stroke, history of—Use with caution. May make these conditions worse in men.

Proper Use of histrelin acetate

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

A doctor or other trained health professional will give you or your child this medicine. The histrelin implant will be placed under the skin of the upper arm.

Your doctor will treat the upper arm with a numbing medicine and then cut a small incision to insert the implant. The incision will be closed with either stitches or surgical strips. A pressure bandage will be placed over the arm and left in place for 24 hours.

Do not remove the surgical strips. Allow them to fall off on their own after several days. If the incision has been stitched, your doctor will remove the stitches or they will dissolve after several days.

After the implant is inserted, you or your child should keep the arm clean and dry. Do not swim or bathe for 24 hours. You should avoid any heavy lifting or strenuous exercise for the first 7 days after the implant is inserted.

You or your child may have some pain, redness, or bruising at the site where the implant is placed. If your arm has not healed within 2 weeks after you received the implant or if you continue to have redness or pain, call your doctor.

The implant will be left in place for one year (12 months) and then removed. If needed, your doctor will insert a new implant to continue treatment for another year.

This medicine comes with patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using Vantas

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the implant is in the proper place and if it is working properly.

For female patients: You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

For children using Supprelin® LA: The medicine can cause a brief increase in blood levels of some hormones. During this time, you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. If your child's symptoms do not improve within 4 weeks, or if they get worse, call your doctor.

For male patients:

• When you start using this medicine, some of your symptoms might get worse for a short time. You might also have new symptoms such as bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. The symptoms should improve in a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.


• This medicine may cause your blood sugar level to increase. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.


• This medicine may increase your risk of having a heart attack or stroke. Check with your doctor right away if you have chest pain or discomfort; difficulty with speaking; headache; pain or discomfort in the arms, jaw, back or neck; shortness of breath; sweating; or vomiting while using the medicine.

Vantas 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 or nurse immediately if any of the following side effects occur:

Rare

• Bloody urine


• decreased frequency or amount of urine


• increased thirst


• loss of appetite


• lower back or side pain


• nausea


• swelling of the face, fingers, or lower legs


• trouble with breathing


• unusual tiredness or weakness


• vomiting


• weight gain

Incidence not known

• Abdominal or stomach pain


• bloating of the abdomen or stomach


• dark urine


• light-colored stools


• yellow eyes or skin

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

• Decrease in testicle size


• feeling of warmth


• local infection, irritation, redness, or swelling on the skin where the implant was placed


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


• sudden sweating

Less common

• Decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• flushing or redness of the skin


• headache


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• sleeplessness


• swelling of the breast or breast soreness in both females and males


• trouble sleeping


• unusually warm skin

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: Vantas 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 Vantas resources

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

• Vantas Prescribing Information (FDA)


• Vantas Monograph (AHFS DI)


• Vantas Implant MedFacts Consumer Leaflet (Wolters Kluwer)


• Vantas Consumer Overview


• Supprelin LA Implant MedFacts Consumer Leaflet (Wolters Kluwer)


• Supprelin LA Prescribing Information (FDA)

Compare Vantas with other medications

• Precocious Puberty
• Prostate Cancer

SenokotXTRA

Generic Name: senna (SEN nah)

Brand Names: Black Draught, Dr Caldwell Laxative, Ex-Lax Chocolated, Ex-Lax Maximum Relief Formula, Ex-Lax Regular Strength Pills, Fletchers Castoria, Innerclean, Pedia-Lax, Perdiem Overnight, Senexon, Senna, Senna Lax, Senna Smooth, Senna Soft, Senna-gen, Senokot, Senokot Extra, SenokotXTRA, SenoSol, SenoSol-X

What is SenokotXTRA (senna)?

Senna is also known as Cassia senna, tinnevelly senna, India senna, Alexandrian senna, and Khartoum senna.

Senna has been used in alternative medicine as an aid to treat constipation.

Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Senna is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Senna may also be used for other purposes not listed in this product guide.

What is the most important information I should know about SenokotXTRA (senna)?

Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Senna is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Use senna as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.

Call your healthcare provider if your symptoms do not improve, or if they get worse while using senna. Do not use this product for longer than 1 week without the advice of a healthcare provider.

What should I discuss with my health care provider before taking SenokotXTRA (senna)?

Ask a doctor, pharmacist, herbalist, or other healthcare provider if it is safe for you to use this product if you have:

• 
  

  a bowel disorder such as Crohn's disease or ulcerative colitis;

  
  


• 
  

  heart disease; or

  
  


• 
  

  stomach pain, nausea, or vomiting.

  
  

Before using senna, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use senna if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements.

Do not take senna without first talking to your doctor if you are pregnant or could become pregnant. Do not take senna without first talking to your doctor if you are breast-feeding a baby. Some forms of senna are made for use by children. Do not give any herbal/health supplement to a child without the advice of a doctor.

How should I take SenokotXTRA (senna)?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use senna, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Senna is usually taken before bed to produce a bowel movement 6 to 12 hours later when you wake up.

Do not use different forms (such as tablets and liquid) of senna at the same time unless your healthcare provider tells you to. Call your healthcare provider if your symptoms do not improve, or if they get worse while using senna. Do not use this product for longer than 1 week without the advice of a healthcare provider. Store senna at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

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 taking SenokotXTRA (senna)?

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

SenokotXTRA (senna) side effects

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

• 
  

  severe stomach pain, severe diarrhea, watery diarrhea;

  
  


• 
  

  weight loss;

  
  


• 
  

  worsening constipation after you stop taking senna;

  
  


• 
  

  enlargement of your fingers and toes;

  
  


• 
  

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

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  stomach cramps, bloating, gas, mild diarrhea;

  
  


• 
  

  numbness or tingly feeling;

  
  


• 
  

  joint pain; or

  
  


• 
  

  discolored urine.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect SenokotXTRA (senna)?

Do not take senna without the advice of a healthcare provider if you are using any of the following medications:

• 
  

  digoxin (Lanoxin);

  
  


• 
  

  a diuretic (water pill); or

  
  


• 
  

  a blood thinner such as warfarin (Coumadin).

  
  

This list is not complete and other drugs may interact with senna. Tell your healthcare provider 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 SenokotXTRA resources

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

• Senna Natural MedFacts for Professionals (Wolters Kluwer)


• Senna Professional Patient Advice (Wolters Kluwer)


• Senna Natural MedFacts for Consumers (Wolters Kluwer)


• Senna Monograph (AHFS DI)


• Senexon Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Senokot MedFacts Consumer Leaflet (Wolters Kluwer)

Compare SenokotXTRA with other medications

• Bowel Preparation
• Constipation

Where can I get more information?

• Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

See also: SenokotXTRA side effects (in more detail)

Methenamine Mandelate

Class: Urinary Anti-infectives
Note: This monograph also contains information on Methenamine, Methenamine Hippurate
VA Class: AM550
CAS Number: 100-97-0
Brands: Hiprex, Mandelamine, Urex

Introduction

Antibacterial.^{100 101 102}

Uses for Methenamine Mandelate

Urinary Tract Infections (UTIs)

Prophylaxis or suppression of recurrent UTIs (bacteriuria), especially when long-term therapy is considered necessary.^{100 101 102}

Use only after UTI has been eradicated by other appropriate anti-infectives.^{100 101}

Not effective in systemic bacterial infections and has no effect on bacteria in blood or tissues outside the urinary tract.^a Do not use alone in the treatment of acute parenchymal infections causing systemic symptoms (e.g., chills, fever).^{100 102}

Monitor efficacy by periodic urine cultures.^{100 101}

Antibacterial effects are maximal when urine pH is ≤5.5.¹⁰² Monitor urinary pH during therapy; use supplementary acidification, if required.^{101 102} Supplementary acidification may be achieved by dietary regulation and/or concomitant administration of acidifying agents (e.g., ammonium chloride, ascorbic acid, methionine).^a This is particularly important when the causative organisms are urea-splitting strains of Proteus or Pseudomonas which increase urinary pH.^{100 101}

Methenamine Mandelate Dosage and Administration

General

• 
  

  Acidic urine is essential for antibacterial activity; maximum efficacy occurs when urine pH is ≤5.5.¹⁰² Restrict alkalinizing food and medication;^{101 102} use supplemental acidification if needed.^{100 101 102 a}

  
  

Administration

Oral Administration

Administer orally.^{100 101 102}

Dosage

Available as methenamine hippurate and methenamine mandelate; dosage expressed in terms of the salt.^{100 101 102}

Pediatric Patients

Prophylaxis or Suppression of Urinary Tract Infections (UTIs)

Methenamine Hippurate

Oral

Children <6 years of age: Dosage not established.^a

Children 6–12 years of age: 500 mg to 1 g twice daily (morning and night).^{100 101}

Children >12 years of age: 1 g twice daily (morning and night).^{100 101}

Methenamine Mandelate

Oral

Children <6 years of age: 18.4 mg/kg 4 times daily, (after meals and at bedtime).¹⁰²

Children 6–12 years of age: 500 mg 4 times daily (after meals and at bedtime).¹⁰²

Children >12 years of age: 1 g 4 times daily (after meals and at bedtime).¹⁰²

Alternatively, some clinicians recommend 50 mg/kg daily in 3 divided doses for children.^a

Adults

Prophylaxis or Suppression of Urinary Tract Infections (UTIs)

Methenamine Hippurate

Oral

1 g twice daily (morning and night).^{100 101}

Methenamine Mandelate

Oral

1 g 4 times daily (after meals and at bedtime).¹⁰²

Special Populations

No special population dosage recommendations at this time.^{100 101 102}

Cautions for Methenamine Mandelate

Contraindications

• 
  

  Known hypersensitivity to the drug.¹⁰²

  
  


• 
  

  Renal insufficiency.^{100 101 102}

  
  


• 
  

  Severe hepatic insufficiency^{100 101} or severe dehydration.^{100 101}

  
  

Warnings/Precautions

Warnings

Dysuria

Large doses (8 g daily for 3–4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.^{100 101}

Dysuria may be controlled by reducing dosage and/or reducing urine acidification.¹⁰²

Hepatic Effects

Patients with preexisting hepatic insufficiency may have adverse effects from the small amounts of ammonia and formaldehyde that are produced following administration of methenamine.¹⁰⁰ Acute hepatic failure may occur in some patients.¹⁰⁰

Transient elevations in serum AST and ALT concentrations have occurred in patients receiving methenamine hippurate.^{100 101}

Perform periodic liver function tests in patients receiving methenamine hippurate, especially in those with hepatic impairment.^{100 101} (See Hepatic Impairment under Cautions.)

Sensitivity Reactions

Tartrazine Sensitivity

Hiprex tablets contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions, including bronchial asthma, in susceptible individuals.¹⁰¹ Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.¹⁰¹

General Precautions

Acidic Urine

Ensure that urine is maintained at an acidic pH during treatment, especially when causative organisms are urea-splitting strains of Proteus or Pseudomonas.^{100 101} (See Dosage and Administration.)

Manufacturer of methenamine mandelate states the drug is not recommended if urine acidification is contraindicated or unattainable (e.g., when some urea-splitting bacteria are present).¹⁰²

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of methenamine and other antibacterials, use only to prevent infections proven or strongly suspected to be caused by susceptible bacteria.¹⁰¹

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.¹⁰¹ In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.¹⁰¹

Specific Populations

Pregnancy

Category C.^{100 102}

One manufacturer of methenamine hippurate states that safety during the last trimester is suggested, but not definitely proven.¹⁰¹

Effects of methenamine during labor and delivery are unknown and there are no recognized uses for the drug during labor or delivery.¹⁰⁰

Lactation

Distributed into milk; discontinue nursing or the drug.¹⁰⁰

Pediatric Use

Has been used in children without unusual toxicity.¹⁰⁰

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults; clinical experience has not identified differences.¹⁰¹

Select dosage with caution, usually starting at the low end of the dosage range, because of possible age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹⁰¹

Hepatic Impairment

Perform periodic liver function tests.^{100 101}

Methenamine hippurate is contraindicated in those with severe hepatic insufficiency.^{100 101}

Common Adverse Effects

GI disturbances (nausea, vomiting, diarrhea, abdominal cramps, anorexia), pruritus, rash, dysuria.^{100 101 102 a}

Interactions for Methenamine Mandelate

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Sulfonamides	Insoluble precipitate forms in urine between formaldehyde and some sulfonamides (e.g., sulfamethizole, sulfathiazole [not commercially available in the US])100 101 102	Avoid concomitant use100 101 102
Test for 17-hydroxycorticosteroid	Formaldehyde in urine causes falsely elevated concentrations when Porter-Silber method is used102
Test for 5-hydroxyindoleacetic acid (5HIAA)	Formaldehyde in urine causes falsely decreased concentrations when nitrosonaphthol methods are used102
Test for urinary catecholamines and vanillylmandelic acid (VMA)	Formaldehyde in urine causes erroneously high results when fluorometric procedures are used102
Test for urine estriol	Formaldehyde in urine causes falsely decreased urine estriol concentrations when acid hydrolysis techniques are used101 102	Enzymatic hydrolysis technique unaffected101 102

Methenamine Mandelate Pharmacokinetics

Absorption

Bioavailability

Readily absorbed from the GI tract.^a About 10–30% of oral dose is hydrolyzed by gastric acidity to formaldehyde and ammonia.^a Enteric coating of methenamine mandelate tablets reduces hydrolysis in the GI tract and rate of absorption.^a

Plasma Concentrations

Following oral administration of a usual single dose to healthy fasting adults, concentrations of methenamine and formaldehyde in plasma are generally very low and antibacterial activity in plasma is negligible.^a

Distribution

Extent

Crosses the placenta.¹⁰⁰

Distributed into milk.¹⁰⁰

Elimination

Elimination Route

Within 24 hours, ≥70–90% of a single oral dose is excreted intact in the urine by glomerular filtration and tubular secretion.^a When urine is acidic, methenamine is hydrolyzed to formaldehyde and ammonia; maximum hydrolysis occurs when urine pH is ≤5.5.^a

Mandelic acid (mandelate) and hippuric acid (hippurate) are excreted in urine by glomerular filtration and tubular excretion.^{101 102}

Stability

Storage

Oral

Tablets

15–30°C^{100 101 102} in tight, light resistant containers.¹⁰²

Actions and SpectrumActions

• 
  

  Synthetic antibacterial agent chemically unrelated to other currently available anti-infectives.^a

  
  


• 
  

  Antibacterial effect of methenamine hippurate or methenamine mandelate depends on conversion of methenamine to formaldehyde in an acid medium (acidic urine).^a

  
  


• 
  

  Formaldehyde is a nonspecific antibacterial agent which is usually bactericidal in action.^a The acid portions of methenamine salts (hippuric acid, mandelic acid) have some nonspecific antibacterial activity and may enhance the liberation of formaldehyde from methenamine in vivo by maintaining urinary acidity.^a

  
  


• 
  

  Formaldehyde is active against both gram-positive and gram-negative bacteria including Enterobacter, Escherichia coli, Klebsiella, Proteus, Pseudomonas aeruginosa, Staphylococcus aureus, S. epidermidis, and Enterococcus faecalis (formerly Streptococcus faecalis).^a

  
  


• 
  

  Because formaldehyde, hippuric acid, and mandelic acid have nonspecific antibacterial activity, resistance does not usually develop during prolonged therapy with methenamine hippurate or methenamine mandelate.^a

  
  

Advice to Patients

• 
  

  Advise patients that antibacterials (including methenamine hippurate and methenamine mandelate) should only be used for bacterial infections and not used to treat viral infections (e.g., the common cold).¹⁰¹

  
  


• 
  

  Importance of completing full course of therapy, even if feeling better after a few days.¹⁰¹

  
  


• 
  

  Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with methenamine or other antibacterials in the future.¹⁰¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs or laboratory tests.^{100 101 102}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{100 101 102}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{100 101 102} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Methenamine Hippurate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	1 g*	Hiprex (with povidone and tartrazine; scored)	Sanofi-Aventis
			Methenamine Hippurate Tablets	Corepharma
			Urex (with povidone; scored)	Vatring

Methenamine Mandelate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	500 mg	Mandelamine Hafgrams (with povidone and polyethylene glycol)	Warner Chilcott
		1 g	Mandelamine (with povidone and polyethylene glycol)	Warner Chilcott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Hiprex 1GM Tablets (SANOFI-AVENTIS U.S.): 20/$49.99 or 60/$139.97

Methenamine Hippurate 1GM Tablets (COREPHARMA LLC): 100/$185.99 or 300/$535.99

Urex 1GM Tablets (VATRING PHARMACEUTICALS): 30/$68.99 or 90/$199.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions January 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Vatring. Urex (methenamine hippurate) prescribing information. Wytheville, VA; 2004 Aug.

101. Sanofi-Aventis. Hiprex (methenamine hippurate) prescribing information. Bridgewater, NJ; 2006 Mar.

102. Warner Chilcott. Mandelamine (methenamine mandelate) prescribing information. Rockaway, NJ; 2006 Oct.

a. AHFS Drug Information 2007. McEvoy GK, ed. Methenamine. Bethesda, MD: American Society of Health-System Pharmacists; 2007:889-90.

More Methenamine Mandelate resources

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

• Methenamine Prescribing Information (FDA)


• Hiprex Prescribing Information (FDA)


• Hiprex Concise Consumer Information (Cerner Multum)


• Hiprex Advanced Consumer (Micromedex) - Includes Dosage Information


• Hiprex MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Methenamine Mandelate with other medications

• Bladder Infection
• Prevention of Bladder infection

Levatol

Generic Name: penbutolol (pen byoo TOH lol)

Brand Names: Levatol

What is Levatol (penbutolol)?

Penbutolol is a beta-blocker. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Penbutolol is used to treat hypertension (high blood pressure).

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

What is the most important information I should know about Levatol (penbutolol)?

Do not stop taking penbutolol without first talking to your doctor. Stopping suddenly may make your condition worse. If you need surgery, tell the surgeon ahead of time that you are using penbutolol. You may need to stop using the medicine for a short time. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of penbutolol.

Penbutolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What should I discuss with my healthcare provider before taking Levatol (penbutolol)?

You should not take penbutolol if you are allergic to it, or if you have:

• 
  

  asthma; or

  
  


• 
  

  certain serious heart conditions such as"AV block" or slow heart rhythm.

  
  

To make sure you can safely take penbutolol, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease;

  
  


• 
  

  liver disease;

  
  


• 
  

  bronchitis, emphysema, or other breathing disorder;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

FDA pregnancy category C. It is not known whether penbutolol 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 penbutolol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Levatol (penbutolol)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take penbutolol at the same time every day.

Your blood pressure will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Do not stop taking this medication without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping a beta-blocker too quickly can cause serious heart problems. If you need surgery, tell the surgeon ahead of time that you are using penbutolol. You may need to stop using the medicine for a short time.

Penbutolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include slow heart rate, wheezing, chest tightness, trouble breathing, weak pulse, fainting, or slow breathing.

What should I avoid while taking Levatol (penbutolol)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of penbutolol.

Levatol (penbutolol) 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:

• 
  

  slow or uneven heartbeats;

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  feeling tired;

  
  


• 
  

  dizziness;

  
  


• 
  

  nausea, diarrhea, upset stomach;

  
  


• 
  

  decreased interest in sex; or

  
  


• 
  

  cold symptoms such as stuffy nose, sneezing, sore throat.

  
  

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 Levatol (penbutolol)?

Tell your doctor about all other medicines you use, especially:

• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  tizanidine (Zanaflex);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  asthma medications such as albuterol (Ventolin, Proventil), aminophylline (Phyllocontin, Truphylline), metaproterenol (Alupent), pirbuterol (Maxair), salmeterol (Advair, Serevent), terbutaline (Brethaire, Brethine, Bricanyl), or theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);

  
  


• 
  

  blood pressure medications also used to treat a prostate disorder, such as doxazosin (Cardura), prazosin (Minipress), or terazosin (Hytrin);

  
  


• 
  

  a calcium channel blocker such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

  
  


• 
  

  heart or blood pressure medication such as clonidine (Catapres), guanabenz (Wytensin), guanfacine (Intuniv, Tenex), hydralazine (Apresoline, BiDil), methyldopa (Aldomet), or minoxidil (Loniten).

  
  

This list is not complete and other drugs may interact with penbutolol. 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 Levatol resources

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

• Levatol Prescribing Information (FDA)


• Levatol Advanced Consumer (Micromedex) - Includes Dosage Information


• Levatol MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Levatol with other medications

• Angina Pectoris Prophylaxis
• High Blood Pressure

Where can I get more information?

• Your pharmacist has additional information about penbutolol written for health professionals that you may read.

See also: Levatol side effects (in more detail)