Argi-U

Argi-U may be available in the countries listed below.

Ingredient matches for Argi-U

Arginine

Arginine hydrochloride (a derivative of Arginine) is reported as an ingredient of Argi-U in the following countries:

• Japan

International Drug Name Search

Demerol

Generic Name: meperidine hydrochloride

Dosage Form: tablet
Demerol® (meperidine hydrochloride, USP)

CII

WARNING: May be habit forming

Demerol Description

Meperidine hydrochloride is a white crystalline substance with a melting point of 186° C to 189° C. It is readily soluble in water and has a neutral reaction and a slightly bitter taste. The solution is not decomposed by a short period of boiling.

The tablets contain 50 mg or 100 mg of Demerol brand of meperidine hydrochloride.

Inactive Ingredients: Calcium Sulfate, Dibasic Calcium Phosphate, Starch, Stearic Acid, Talc.

Chemically, Demerol is 4-Piperidinecarboxylic acid, 1-methyl-4-phenyl-, ethyl ester, hydrochloride and has the following structure:

Demerol - Clinical Pharmacology

Meperidine hydrochloride is a narcotic analgesic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value are analgesia and sedation.

There is some evidence which suggests that meperidine may produce less smooth muscle spasm, constipation, and depression of the cough reflex than equianalgesic doses of morphine.

Indications and Usage for Demerol

Demerol is indicated for the relief of moderate to severe pain.

Contraindications

Demerol is contraindicated in patients with hypersensitivity to meperidine or to any of its ingredients.

Meperidine is contraindicated in patients who are receiving monoamine oxidase (MAO) inhibitors or those who have recently received such agents. Therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. The mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. Some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. Serotonin syndrome with agitation, hyperthermia, diarrhea, tachycardia, sweating, tremors and impaired consciousness may also occur. In other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension. Although it is not known that other narcotics are free of the risk of such reactions, virtually all of the reported reactions have occurred with meperidine. If a narcotic is needed in such patients, a sensitivity test should be performed in which repeated, small, incremental doses of morphine are administered over the course of several hours while the patient's condition and vital signs are under careful observation. (Intravenous hydrocortisone or prednisolone have been used to treat severe reactions, with the addition of intravenous chlorpromazine in those cases exhibiting hypertension and hyperpyrexia. The usefulness and safety of narcotic antagonists in the treatment of these reactions is unknown.)

Demerol is contraindicated in patients with severe respiratory insufficiency (see WARNINGS, Respiratory Conditions).

Warnings

Meperidine should not be used for treatment of chronic pain. Meperidine should only be used in the treatment of acute episodes of moderate to severe pain. Prolonged meperidine use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.

Demerol is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

Demerol can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Demerol in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Misuse, Abuse, and Diversion of Opioids

Meperidine is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Meperidine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Demerol in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Demerol has been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. These practices will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose or death (see WARNINGS and DRUG ABUSE AND ADDICTION).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Interactions with Alcohol and Drugs of Abuse

Meperidine may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of meperidine and its capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. In such patients, meperidine must be used with extreme caution and only if its use is deemed essential.

Respiratory Conditions

Meperidine should be used with extreme caution in patients having an acute asthmatic attack, patients with chronic obstructive pulmonary disease or cor pulmonale, patients having a substantially decreased respiratory reserve, and patients with preexisting respiratory depression, hypoxia, or hypercapnia. In such patients, even usual therapeutic doses of narcotics may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea.

Hypotensive Effect

The administration of meperidine may result in severe hypotension in the postoperative patient or any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume or the administration of drugs such as the phenothiazines or certain anesthetics.

Usage in Ambulatory Patients

Meperidine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient should be cautioned accordingly.

Meperidine, like other narcotics, may produce orthostatic hypotension in ambulatory patients.

Usage in Pregnancy

Meperidine should not be used in pregnant women prior to the labor period, unless in the judgment of the physician the potential benefits outweigh the possible risks, because safe use in pregnancy prior to labor has not been established relative to possible adverse effects on fetal development.

Labor and Delivery

Meperidine crosses the placental barrier and can produce depression of respiration and psychophysiologic functions in the newborn. Resuscitation may be required (see OVERDOSAGE). Therefore meperidine is not recommended during labor.

Nursing Mothers

Meperidine appears in the milk of nursing mothers receiving the drug. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the potential benefits of the drug to the nursing woman.

Precautions

General

Opioid analgesics can have a narrow therapeutic index in certain patient populations, particularly when combined with CNS depressant drugs. The use of these products should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.

Use of Demerol may be associated with increased potential risks and should be used with caution in the following conditions: sickle cell anemia, pheochromocytoma, acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary, or renal function; and toxic psychosis (see PRECAUTIONS, Special Risk Patients).

The administration of meperidine may obscure the diagnosis or clinical course in patients with acute abdominal conditions. All opioids may induce or aggravate seizures in some clinical settings.

Interactions with Other CNS Depressants

Demerol should be used with caution and consideration should be given to starting with a reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol. Drug-drug interactions may result in respiratory depression, hypotension, profound sedation, coma, or death if these drugs are taken in combination with the usual doses of Demerol.

Interactions with Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as meperidine. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of meperidine and/or may precipitate withdrawal symptoms in these patients due to competitive blocking of receptors.

Supraventricular Tachycardias

Meperidine should be used with caution in patients with atrial flutter and other supraventricular tachycardias because of a possible vagolytic action which may produce a significant increase in the ventricular response rate.

Convulsions

Meperidine may aggravate preexisting convulsions in patients with convulsive disorders. If dosage is escalated substantially above recommended levels because of tolerance development, convulsions may occur in individuals without a history of convulsive disorders.

Acute Abdominal Conditions

The administration of meperidine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Tolerance and Physical Dependence

Meperidine has the potential to produce tolerance and drug dependence. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, opioids used regularly should not be abruptly discontinued.

Use in Drug and Alcohol Addiction

Demerol is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia. Demerol should be used with caution in patients with alcoholism and other drug dependencies due to the increased frequency of narcotic tolerance, dependence, and the risk of addiction observed in these patient populations. Abuse of Demerol in combination with other CNS depressant drugs can result in serious risk to the patient.

Information for Patients/Caregivers

If clinically advisable, patients receiving Demerol (meperidine hydrochloride) tablets or their caregivers should be given the following information by the physician, nurse, pharmacist, or caregiver:

1. Patients should be aware that Demerol tablets contain meperidine, which is a morphine-like substance.


2. Patients should be advised to report pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.


3. Patients should be advised not to adjust the dose of Demerol without consulting the prescribing professional.


4. Patients should be advised that Demerol may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).


5. Patients should not combine Demerol with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.


6. Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.


7. Patients should be advised that Demerol is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.


8. Patients should be advised that if they have been receiving treatment with Demerol for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the Demerol dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.


9. Patients should be instructed to keep Demerol in a secure place out of the reach of children. When Demerol is no longer needed, the unused tablets should be destroyed by flushing down the toilet.

Drug Interactions

Also see WARNINGS.

Acyclovir

Plasma concentrations of meperidine and its metabolite, normeperidine, may be increased by acyclovir, thus caution should be used with concomitant administration.

Cimetidine

Cimetidine reduced the clearance and volume of distribution of meperidine and also the formation of the metabolite, normeperidine, in healthy subjects and thus, caution should be used with concomitant administration.

CNS Depressants

Concomitant use of CNS depressants with usual doses of Demerol may result in respiratory depression, hypotension, profound sedation, coma or death (see PRECAUTIONS, Interactions with Other CNS Depressants).

Phenytoin

The hepatic metabolism of meperidine may be enhanced by phenytoin. Concomitant administration resulted in reduced half-life and bioavailability with increased clearance of meperidine in healthy subjects, however, blood concentrations of normeperidine were increased, thus exercise caution when phenytoin is used concomitantly with meperidine.

Ritonavir

Plasma concentrations of the active metabolite normeperidine may be increased by ritonavir, thus concomitant administration should be avoided.

Opioid analgesics, including Demerol, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Special Risk Patients

Meperidine should be given with caution and the initial dose should be reduced in certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, Sickle Cell Anemia, hypothyroidism, Addison's disease, Pheochromocytoma and prostatic hypertrophy or urethral stricture. In patients with pheochromocytoma, meperidine has been reported to provoke hypertension.

Usage in Hepatically Impaired Patients

Accumulation of meperidine and/or its active metabolite, normeperidine, can occur in patients with hepatic impairment. Meperidine should therefore be used with caution in patients with hepatic impairment.

Usage in Renally Impaired Patients

Accumulation of meperidine and/or its active metabolite, normeperidine, can also occur in patients with renal impairment. Meperidine should therefore be used with caution in patients with renal impairment.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies to assess the carcinogenic or mutagenic potential of meperidine have not been conducted. Studies to determine the effect of meperidine on fertility have not been conducted.

Pregnancy: Teratogenic Effects

Pregnancy Category C:

Animal reproduction studies have not been conducted with meperidine. It is also not known whether Demerol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Demerol should be given to a pregnant woman only if clearly needed.

Labor and Delivery

See WARNINGS.

Nursing Mothers

See WARNINGS.

Pediatric Use

The safety and effectiveness of meperidine in pediatric patients has not been established. Literature reports indicate that meperidine has a slower elimination rate in neonates and young infants compared to older children and adults. Neonates and young infants may also be more susceptible to the effects, especially the respiratory depressant effects. If meperidine use is contemplated in neonates or young infants, any potential benefits of the drug need to be weighed against the relative risk of the patient.

Geriatric Use

Clinical studies of Demerol during product development did not include sufficient numbers of subjects aged 65 and over to evaluate age-related differences in safety or efficacy. Literature reports indicate that geriatric patients have a slower elimination rate compared to young patients and they may be more susceptible to the effects of meperidine. Reducing the total daily dose of meperidine is recommended in elderly patients, and the potential benefits of the drug should be weighed against the relative risk to a geriatric patient.

Adverse Reactions

The major hazards of meperidine, as with other narcotic analgesics, are respiratory depression and, to a lesser degree, circulatory depression; respiratory arrest, shock, and cardiac arrest have occurred.

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not experiencing severe pain. In such individuals, lower doses are advisable. Some adverse reactions in ambulatory patients may be alleviated if the patient lies down.

Other adverse reactions include:

Nervous System: Mood changes (e.g. euphoria, dysphoria), weakness, headache, agitation, tremor, involuntary muscle movements (e.g. muscle twitches, myoclonus), severe convulsions, transient hallucinations and disorientation, confusion, delirium, visual disturbances.

Gastrointestinal: Dry mouth, constipation, biliary tract spasm.

Cardiovascular: Flushing of the face, tachycardia, bradycardia, palpitation, hypotension (see WARNINGS), syncope.

Genitourinary: Urinary retention.

Allergic: Pruritus, urticaria, other skin rashes, wheal and flare over the vein with intravenous injection. Hypersensitivity reactions, anaphylaxis.

Histamine release leading to hypotension and/or tachycardia, flushing, sweating, and pruritus.

DRUG ABUSE AND ADDICTION

Demerol contains meperidine, a mu-agonist opioid with an abuse liability similar to morphine and is a Schedule II controlled substance. Meperidine, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion.

Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.

"Drug seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Demerol, like other opioids, has been diverted for non-medical use. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Abuse of Demerol poses a risk of overdose and death. This risk is increased with concurrent abuse of Demerol with alcohol and other substances. Due to the presence of talc as one of the excipients in tablets, parenteral abuse of crushed tablets can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart disease. In addition, parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Overdosage

Symptoms

Serious overdosage with meperidine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, hypothermia, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including meperidine. Therefore, an appropriate dose of this antagonist should be administered as necessary, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation.

An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.

In cases of overdosage with Demerol tablets, the stomach should be evacuated by emesis or gastric lavage.

NOTE: In an individual physically dependent on narcotics, the administration of the usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of narcotic antagonists in such individuals should be avoided if possible. If a narcotic antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care and only one-fifth to one-tenth the usual initial dose administered.

Demerol Dosage and Administration

For Relief of Pain

Dosage should be adjusted according to the severity of the pain and the response of the patient. Meperidine is less effective orally than on parenteral administration. The dose of Demerol should be proportionately reduced (usually by 25 to 50 percent) when administered concomitantly with phenothiazines and many other tranquilizers since they potentiate the action of Demerol.

Adults

The usual dosage is 50 mg to 150 mg orally, every 3 or 4 hours as necessary.

Pediatric Patients

The usual dosage is 1.1 mg/kg to 1.8 mg/kg orally, up to the adult dose, every 3 or 4 hours as necessary (see PRECAUTIONS, Pediatric use).

SAFETY AND HANDLING

Demerol (meperidine HCl) tablets contain meperidine hydrochloride which is a controlled substance. Like morphine, meperidine is controlled under Schedule II of the Controlled Substances Act. Meperidine, like all opioids, is liable to diversion and misuse and should be handled accordingly. Patients and their families should be instructed to flush Demerol tablets that are no longer needed.

Demerol has been targeted for theft and diversion by criminals. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substance Authority for information on how to prevent and detect abuse or diversion of this product.

How is Demerol Supplied

For Oral Use

Tablets are white, round and convex. The 50 mg is a scored tablet and has a stylized "W" on one side and "D" over "35" on the other side. The 100 mg is not a scored tablet and has a stylized "W" on one side and "D" over "37" on the other side.

Tablets of 50 mg, bottles of 100 (NDC 0024-0335-04) and 100 mg,bottles of 100 (NDC 0024-0337-04).

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

Revised October 2011a

Manufactured for:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

©2011 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 50 mg Tablets

NDC 0024-0335-04

D-131

Rx only

Demerol®

meperidine hydrochloride, USP

CII

50 mg

100 tablets

Usual Adult Dosage: 1 or 2 tablets.

Read package insert.

Dispense in tight, light-resistant container as

defined in the USP/NF.

sanofi aventis

PRINCIPAL DISPLAY PANEL - 100 mg Tablets

NDC 0024-0337-04

D-591

Rx only

Demerol®

meperidine

hydrochloride, USP

CII

100 mg

100 tablets

Usual Adult Dosage: 1 tablet.

Read package insert.

Dispense in tight, light-resistant container

as defined in the USP/NF.

sanofi aventis

Demerol  meperidine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0024-0335 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Meperidine Hydrochloride (Meperidine) Meperidine Hydrochloride 50 mg

Inactive Ingredients Ingredient Name Strength Calcium Sulfate   Anhydrous Dibasic Calcium Phosphate   Stearic Acid   Talc   Starch, Corn

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code W;M;35 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0024-0335-04 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA005010	11/10/1942

Demerol  meperidine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0024-0337 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Meperidine Hydrochloride (Meperidine) Meperidine Hydrochloride 100 mg

Inactive Ingredients Ingredient Name Strength Calcium Sulfate   Anhydrous Dibasic Calcium Phosphate   Stearic Acid   Talc   Starch, Corn

Product Characteristics Color WHITE Score no score Shape ROUND Size 12mm Flavor Imprint Code W;M;37 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0024-0337-04 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA005010	11/10/1942

Labeler - sanofi-aventis U.S. LLC (824676584)

Establishment
Name	Address	ID/FEI	Operations
Bayer HealthCare LLC Consumer Care		112117283	MANUFACTURE

Revised: 11/2011sanofi-aventis U.S. LLC

More Demerol resources

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

Compare Demerol with other medications

• Light Sedation
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Somergan

Somergan may be available in the countries listed below.

Ingredient matches for Somergan

Lindane

Lindane is reported as an ingredient of Somergan in the following countries:

• Venezuela

International Drug Name Search

Zipzoc

Zipzoc may be available in the countries listed below.

Ingredient matches for Zipzoc

Zinc Oxide

Zinc Oxide is reported as an ingredient of Zipzoc in the following countries:

• New Zealand

International Drug Name Search

decongestant and analgesic combinations Oral

Class Name: decongestant and analgesic combinations (Oral route)

Commonly used brand name(s)

In the U.S.

• Actamin Maximum Strength


• Alka-Seltzer Plus Cold and Sinus


• Altenol


• Aminofen


• Anacin Aspirin Free


• Children's Mapap


• Genapap


• Genapap Sinus


• Infants' Tylenol Plus Cold


• Mapap


• Mapap Arthritis Pain


• Mapap Sinus PE


• Sinutab Sinus


• Sudafed PE Sinus Headache


• Tylenol

In Canada

• Children's Tylenol Cold Bubble Gum Flavor


• Children's Tylenol Cold Cherry Flavor


• Children's Tylenol Decongestant


• Counteract Children's Cold Multi-Symptom Plus Cough


• Extra Strength Tylenol Allergy Sinus Multi-Symptom Relief


• Extra Strength Tylenol Sinus with Coolburst - Daytime


• Extra Strength Tylenol Sinus with Coolburst - Nighttime


• Infants' Tylenol Cold Suspension Drops


• Tylenol Sinus

Available Dosage Forms:

• Tablet


• Capsule


• Liquid


• Suspension


• Capsule, Liquid Filled


• Tablet, Chewable


• Packet


• Tablet, Extended Release


• Powder for Solution


• Tablet, Effervescent


• Tablet, Extended Release, 12 HR


• Syrup

Uses For This Medicine

Decongestant and analgesic combinations are taken by mouth to relieve sinus and nasal congestion (stuffy nose) and headache of colds, allergy, and hay fever.

Decongestants, such as phenylephrine, and pseudoephedrine produce a narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.

Analgesics, such as acetaminophen, ibuprofen, and salicylates (e.g., aspirin, salicylamide), are used in these combination medicines to help relieve headache and sinus pain.

Acetaminophen and salicylates may cause kidney damage or cancer of the kidney or urinary bladder if large amounts of both medicines are taken together for a long time. However, taking the recommended amounts of combination medicines that contain both acetaminophen and a salicylate for short periods of time has not been shown to cause these unwanted effects.

These medicines are available without a prescription. However, your doctor may have special instructions on the proper dose of these medicines for your medical condition.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Very young children are usually more sensitive to the effects of this medicine. Before giving any of these combination medicines to a child, check the package label very carefully. Some of these medicines are too strong for use in children. If you are not certain whether a specific product can be given to a child, or if you have any questions about the amount to give, check with your health care professional, especially if it contains:

• Decongestants (e.g., phenylephrine, pseudoephedrine)—Increases in blood pressure may be more likely to occur in children taking decongestants.


• Salicylates (e.g., aspirin)—Do not give aspirin or other salicylates to a child or teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because salicylates may cause a serious illness called Reye's syndrome in these children. Also, children may be more sensitive to the aspirin or other salicylates contained in some of these medicines, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

The elderly are usually more sensitive to the effects of this medicine.

Pregnancy

The occasional use of decongestant and analgesic combinations at the doses recommended on the label is not likely to cause problems in the fetus or in the newborn baby. However, for the individual ingredients of these combinations, the following information applies:

• Alcohol—Some of these combination medicines contain large amounts of alcohol. Too much use of alcohol during pregnancy may cause birth defects.


• —Studies in humans have not shown that caffeine causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount of caffeine contained in 12 to 24 cups of coffee a day).


• Ibuprofen—Studies on birth defects have not been done in humans. However, there is a chance that ibuprofen may cause unwanted effects on the heart or blood flow of the fetus or newborn baby if it is taken regularly during the last few months of pregnancy.


• Phenylephrine—Studies on birth defects have not been done in either humans or animals with phenylephrine.


• Pseudoephedrine—Studies on birth defects with pseudoephedrine have not been done in humans. In animal studies pseudoephedrine did not cause birth defects. However, when given to animals in high doses, pseudoephedrine did cause a decrease in average weight, length, and rate of bone formation in the animal fetus.


• Salicylates (e.g., aspirin)—Studies on birth defects in humans have been done with aspirin, but not with salicylamide. Although salicylates have been shown to cause birth defects in animals, they have not been shown to cause birth defects in humans.

Regular use of salicylates late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or newborn baby. Use of salicylates during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery, or in the newborn baby. Also, too much use of salicylates during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor and cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.

Breast Feeding

If you are breast-feeding the chance that problems might occur depends on the ingredients of the combination. For the individual ingredients of these combinations, the following apply:

• Acetaminophen—Acetaminophen passes into the breast milk. However, it has not been reported to cause problems in nursing babies.


• Alcohol—Alcohol passes into the breast milk. However, the amount of alcohol in recommended doses of this medicine does not usually cause problems in nursing babies.


• Caffeine—Small amounts of caffeine pass into the breast milk and may build up in the nursing baby. However, the amount of caffeine in recommended doses of this medicine does not usually cause problems in nursing babies.


• Decongestants (e.g., phenylephrine, pseudoephedrine)—Decongestants may pass into the breast milk and may cause unwanted effects in nursing babies of mothers taking this medicine.


• Salicylates (e.g., aspirin)—Salicylates pass into the breast milk. Although salicylates have not been reported to cause problems in nursing babies, it is possible that problems may occur if large amounts are taken regularly.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Clorgyline


• Dihydroergotamine


• Influenza Virus Vaccine, Live


• Iproniazid


• Isocarboxazid


• Ketorolac


• Linezolid


• Nialamide


• Pargyline


• Pentoxifylline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Sibutramine


• Tranylcypromine

Using medicines in this class 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.

• Abciximab


• Acenocoumarol


• Alteplase, Recombinant


• Anisindione


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Bromocriptine


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Desvenlafaxine


• Dicumarol


• Dipyridamole


• Duloxetine


• Enoxaparin


• Eptifibatide


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Furazolidone


• Ginkgo


• Guanethidine


• Heparin


• Ketoprofen


• Lepirudin


• Licorice


• Methotrexate


• Midodrine


• Milnacipran


• Nadroparin


• Naproxen


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Phenindione


• Phenprocoumon


• Protein C


• Reteplase, Recombinant


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Varicella Virus Vaccine


• Venlafaxine


• Vilazodone


• Warfarin


• Zimeldine

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.

Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Alcohol abuse—Acetaminophen-containing medicine increases the chance of liver damage.

• Anemia—Taking aspirin-, salicylamide-, or ibuprofen-containing medicine may make the anemia worse.

• Asthma, allergies, and nasal polyps, history of—Taking salicylate- or ibuprofen-containing medicine may cause an allergic reaction in which breathing becomes difficult.

• Diabetes mellitus (sugar diabetes)—The decongestant in this medicine may put the patient with diabetes at a greater risk of having heart or blood vessel disease.

• Gout—Aspirin-containing medicine may make the gout worse and reduce the benefit of the medicines used for gout.

• Hepatitis or other liver disease—Liver disease increases the chance of side effects because the medicine is not broken down and may build up in the body. Also, if liver disease is severe there is a greater chance that aspirin-containing medicine may cause bleeding, and that ibuprofen-containing medicine may cause serious kidney damage.

• Heart or blood vessel disease or


• High blood pressure—The decongestant in this medicine may cause the blood pressure to increase and may also speed up the heart rate. Also, caffeine-containing medicine if taken in large amounts may increase the heart rate; ibuprofen-containing medicine may cause the blood pressure to increase.

• Hemophilia or other bleeding problems—Aspirin- or ibuprofen-containing medicine increases the chance of bleeding.

• Kidney disease—The kidneys may be affected, especially if too much of this medicine is taken for a long time.

• Mental illness (history of)—The decongestant in this medicine may increase the chance of mental side effects.

• Overactive thyroid—If an overactive thyroid has caused a fast heart rate, the decongestant in this medicine may cause the heart rate to speed up further.

• Stomach ulcer or other stomach problems—Salicylate- or ibuprofen-containing medicine may make the ulcer worse or cause bleeding of the stomach.

• Systemic lupus erythematosus (SLE)—Ibuprofen-containing medicine may put the patient with SLE at a greater risk of having unwanted effects on the central nervous system and/or kidneys.

• Ulcers, sores, or white spots in the mouth—This may be a sign of a serious side effect of ibuprofen-containing medicine; if you already have ulcers or sores in the mouth you and your doctor may not be able to tell when this side effect occurs.

Proper Use of This Medicine

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects

For aspirin- or salicylamide-containing medicines:

• If this medicine irritates your stomach, you may take it with food or a glass of water or milk to lessen the irritation.


• If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it. This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.

For ibuprofen-containing medicines:

• To lessen stomach upset, these medicines may be taken with food or an antacid.


• Take with a full glass (8 ounces) of water. Also, do not lie down for about 15 to 30 minutes after taking the medicine. Doing so may cause irritation that may lead to trouble in swallowing.

Dosing

The dose medicines in this class 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 these medicines. 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.

The dose of these combination medicines will be different for different products. Follow the directions on the box if you are buying this medicine without a prescription.. There is a large variety of decongestant and analgesic combination products on the market. Some products are for use in adults only, while others may be used in children. If you have any questions about this, check with your health care professional.

• For oral dosage forms (capsules, liquid, or tablets):
  
  • For sinus pain and congestion:
    
    • Adults and children 12 years of age and older—1 to 2 capsules or tablets every four to six hours.
    
    
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
    
    
    • Children 4 to 12 years of age—1 tablet, 4 to 6 chewable tablets, or 1 to 2 teaspoonfuls of liquid every four hours.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  

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.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

Check with your doctor if your symptoms do not improve or become worse, or if you have a high fever.

This medicine may cause some people to become nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Check the label of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any of them contain acetaminophen, aspirin, other salicylates such as bismuth subsalicylate (e.g., Pepto Bismol) or magnesium salicylate (e.g., Nuprin Backache Caplets), or salicylic acid (present in some shampoos and skin products), check with your health care professional. Using any of them together with this medicine may cause an overdose.

Do not drink alcoholic beverages while taking this medicine. Stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin or ibuprofen. Also, liver damage may be more likely to occur if you drink large amounts of alcoholic beverages while you are taking acetaminophen.

If you think that you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of a salicylate may cause unconsciousness or death. The first sign of an aspirin overdose may be ringing or buzzing in the ears. Other signs include convulsions (seizures), hearing loss, confusion, severe drowsiness or tiredness, severe excitement or nervousness, and unusually fast or deep breathing. Signs of severe acetaminophen overdose may not appear until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken

For patients taking aspirin-containing medicine:

• Do not take aspirin-containing medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.

For diabetic patients taking salicylate-containing medicine:

• False urine sugar test results may occur if you take 8 or more 325-mg (5-grain) doses of aspirin every day for several days in a row. Smaller doses or occasional use of aspirin usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

For patients taking ibuprofen-containing medicine:

• This medicine may cause some people to become confused, drowsy, dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well.


• Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

Side Effects of This Medicine

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.

Along with its needed effects, a medicine may cause some unwanted effects. Although serious side effects occur rarely when this medicine is taken as recommended, they may be more likely to occur if too much medicine is taken, if it is taken in large doses, or if it is taken for a long period of time.

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

For all combinations

• Convulsions (seizures)


• dizziness or light-headedness (severe)


• fast, slow, or irregular heartbeat


• hallucinations (seeing, hearing, or feeling things that are not there)


• headache (continuing and severe)


• increased sweating


• mood or mental changes


• nausea or vomiting (severe or continuing)


• nervousness or restlessness (severe)


• shortness of breath or troubled breathing


• stomach cramps or pain (severe or continuing)


• swelling or tenderness in the upper abdomen or stomach area


• trouble in sleeping

For acetaminophen-containing only

• Diarrhea


• loss of appetite

For aspirin- or salicylamide-containing only

• Any loss of hearing


• changes in behavior (in children)


• confusion


• diarrhea (severe or continuing)


• drowsiness or tiredness (severe, especially in children)


• fast or deep breathing (especially in children)


• ringing or buzzing in ears (continuing)


• uncontrollable flapping movements of the hands, (especially in elderly patients)


• unexplained fever


• unusual thirst


• vision problems

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Nausea, vomiting, or stomach pain (mild—for combinations containing aspirin or ibuprofen)

Less common or rare

• Bloody or black, tarry stools


• bloody or cloudy urine


• blurred vision or any changes in vision or eyes


• changes in facial skin color


• changes in hearing


• changes or problems with urination


• difficult or painful urination


• fever


• headache, severe, with fever and stiff neck


• increased blood pressure


• muscle cramps or pain


• skin rash, hives, or itching


• sores, ulcers, or white spots on lips or in mouth


• swelling of face, fingers, feet, or lower legs


• swollen and/or painful glands


• unexplained sore throat and fever


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• weight gain (unusual)


• 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

• Heartburn or indigestion (for medicines containing salicylate or ibuprofen)


• nervousness or restlessness

Less common

• Drowsiness (for medicines containing salicylamide)

Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. There are some similarities among these combination medicines, so many of the above side effects may occur with any of these medicines.

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.

The information contained in the Thomson Healthcare (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 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 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 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 HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Hibidil

Hibidil may be available in the countries listed below.

Ingredient matches for Hibidil

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Hibidil in the following countries:

• Belgium


• France


• Japan


• Luxembourg


• Switzerland

International Drug Name Search

Eritromicin

Eritromicin may be available in the countries listed below.

Ingredient matches for Eritromicin

Erythromycin

Erythromycin is reported as an ingredient of Eritromicin in the following countries:

• Bosnia & Herzegowina


• Croatia (Hrvatska)


• Serbia


• Slovenia

International Drug Name Search

Diabrezide

Diabrezide may be available in the countries listed below.

Ingredient matches for Diabrezide

Gliclazide

Gliclazide is reported as an ingredient of Diabrezide in the following countries:

• Austria


• Bulgaria


• Estonia


• Georgia


• Ireland


• Italy


• Latvia


• Lithuania


• Poland


• Romania

International Drug Name Search