Tridal Liquid

Pronunciation: KOE-deen/gwye-FEN-e-sin/fen-ill-EF-rin
Generic Name: Codeine/Guaifenesin/Phenylephrine
Brand Name: Giltuss Ped-C and Tridal

Tridal Liquid is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Tridal Liquid is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels and reducing swelling in the nasal passages, loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Tridal Liquid if:

• you are allergic to any ingredient in Tridal Liquid or any other codeine or morphine related medicine (eg, oxycodone)


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Tridal Liquid:

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

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


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


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


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, oxycodone)


• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, stroke, kidney or liver problems, a blockage of your bowel or bladder, adrenal gland problems (eg, Addison disease), or an underactive thyroid


• if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have recently had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Tridal Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Tridal Liquid may be increased


• Digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone and quinidine because the effectiveness of Tridal Liquid may be decreased.


• Bromocriptine because the risk of side effects may be increased by Tridal Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tridal Liquid

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

How to use Tridal Liquid:

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

• Take Tridal Liquid by mouth with or without food.


• Drink plenty of water while taking Tridal Liquid.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Tridal Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Tridal Liquid may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Tridal Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take appetite suppressants while you are taking Tridal Liquid without checking with your doctor.


• Tridal Liquid has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Tridal Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tridal Liquid.


• Tell your doctor or dentist that you take Tridal Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Tridal Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Tridal Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tridal Liquid while you are pregnant. It is not known if Tridal Liquid is found in breast milk. Do not breast-feed while taking Tridal Liquid.

Possible side effects of Tridal Liquid:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

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

See also: Tridal side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tridal Liquid:

Store Tridal Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tridal Liquid out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tridal resources

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

Compare Tridal with other medications

• Cough and Nasal Congestion

Thiamine Hydrochloride

Class: Vitamin B Complex
VA Class: VT105
Chemical Name: thiazolium,3- [(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methyl-chloride, monochloride
CAS Number: 67-03-8

Introduction

Water-soluble, B complex vitamin.^a

Uses for Thiamine Hydrochloride

Thiamine Deficiency

Treatment of thiamine deficiency syndromes (e.g., beriberi, Wernicke’s encephalopathy syndrome). ^b

Dietary Requirements

Adequate intake needed to prevent thiamine deficiency (beriberi).¹⁰⁹

Adequate thiamine intake can be accomplished through consumption of foodstuffs.¹⁰⁹ Enriched, fortified, or whole grain products; bread and bread products; mixed foods with grain as a main ingredient; and ready-to-eat cereals are the major contributors of thiamine in the diet of US adults and children.¹⁰⁹

Recommended Dietary Allowance (RDA) in adults based on erythrocyte transketolase activity, urinary thiamine excretion, and other findings.¹⁰⁹

Requirements slightly lower in women than men based on women's size and average energy utilization.¹⁰⁹

Adequate intake (AI) established for infants ≤6 months of age based on observed mean thiamine intake of infants fed principally human milk; AI for infants 7–12 months of age based on AI for younger infants and data in adults.¹⁰⁹

RDA for children 1–18 years of age based on data in adults.¹⁰⁹

Metabolic Disorder

Has been used in thiamine-responsive maple syrup urine disease† and subacute necrotizing encephalomyelopathy† (Leigh's disease).^a

Thiamine Hydrochloride Dosage and Administration

Administration

Usually administered orally.^a May be administered by IV or IM injection when indicated or when oral administration is not feasible.^b

For solution and drug compatibility information, see Compatibility under Stability.

Dosage

Available as thiamine hydrochloride; dosage expressed in terms of the salt.^{a b}

Pediatric Patients

Thiamine Deficiency

Oral

Noncritically ill children: 10–50 mg daily, given in divided doses.^a

IM or IV

Critically ill children (e.g., infantile beriberi): 10–25 mg.^{a b}

Dietary and Replacement Requirements

Oral

Infants ≤6 months of age: Recommended AI is 0.2 mg (0.03 mg/kg) daily.¹⁰⁹

Infants 7–12 months of age: Recommended AI is 0.3 mg (0.03 mg/kg) daily.¹⁰⁹

Children 1–3 years of age: RDA is 0.5 mg daily.¹⁰⁹

Children 4–8 years of age: RDA is 0.6 mg daily.¹⁰⁹

Children 9–13 years of age: RDA is 0.9 mg daily.¹⁰⁹

Boys 14–18 years of age: RDA is 1.2 mg daily.¹⁰⁹

Girls 14–18 years of age: RDA is 1 mg daily.¹⁰⁹

RDAs not expected to meet the needs of those with malabsorption syndrome or undergoing hemodialysis or peritoneal dialysis.¹⁰⁹

Adults

Thiamine Deficiency

Oral

Noncritically ill adults: 5–30 mg daily, as a single dose or 3 divided doses, for 1 month.^a

IV followed by IM

Wernicke's syndrome: Initially 100 mg IV, followed by 50–100 mg IM daily until patient can consume a balanced diet.^b

IV or IM

Critically ill thiamine-deficient adult or patient with malabsorption syndrome: 5–100 mg 3 times daily.^a

IM

Beriberi: 10–20 mg 3 times daily for up to 2 weeks.^b

Dietary and Replacement Requirements

Oral

Men ≥19 years of age: RDA is 1.2 mg daily.¹⁰⁹

Women ≥19 years of age: RDA is 1.1 mg daily.¹⁰⁹

RDAs not expected to meet the needs of those with malabsorption syndrome or undergoing hemodialysis or peritoneal dialysis.¹⁰⁹

Prescribing Limits

Single doses >30 mg not likely to be utilized.^a

Special Populations

Pregnant Women

RDA for pregnant women is 1.4 mg daily.¹⁰⁹

Thiamine intake >1.4 mg daily needed by women who are pregnant with >1 fetus.¹⁰⁹

Requirements increased in pregnant women to cover increased energy utilization and growth in the maternal and fetal compartments.¹⁰⁹

Lactating Women

RDA for lactating women is 1.5 mg daily.¹⁰⁹

Thiamine intake >1.5 mg daily needed by women who are nursing >1 infant.¹⁰⁹

Requirements increased in lactating women to ensure adequate concentration of the vitamin in milk.¹⁰⁹

Cautions for Thiamine Hydrochloride

Contraindications

Known sensitivity to thiamine or any ingredient in formulation.^{a b}

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Possible severe hypersensitivity reactions/anaphylaxis, especially following repeated parenteral administration.^b

Skin Test

Administer an intradermal test dose prior to parenteral administration of therapeutic doses of thiamine in patients who may be sensitive to the drug.^b

General Precautions

Aluminum Content

Some thiamine hydrochloride injection preparations contain aluminum, which may be toxic.^b Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.^b Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.^b

Research indicates that patients with impaired kidney function, including premature neonates, who receive aluminum parenterally in quantities of >4–5 mcg/kg daily accumulate aluminum at levels associated with CNS and bone toxicity.^b Tissue loading may occur at even lower rates of administration.^b

Specific Populations

Pregnancy

Category A.^b

Lactation

Distributed into milk.^a Caution if parenteral preparation is used in nursing women.^b

Common Adverse Effects

Relatively nontoxic; feelings of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, angioedema, tightness in the throat, cyanosis, pulmonary edema, GI bleeding reported with parenteral administration.^{a b}

Interactions for Thiamine Hydrochloride

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
Neuromuscular blocking agents	Possible enhanced neuromuscular blocking actiona	Clinical importance unknowna
Schack and Waxler determination of serum theophylline concentrations	Large doses of thiamine may interfere with this testa
Test for uric acid	Possible false-positive result with the phosphotungstate methoda
Test for urobilinogen using Ehrlich's reagent	Possible false-positive resulta

Thiamine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Small doses are readily absorbed from the GI tract.^a

Completely absorbed following IM administration.^b

Food

Rate, but not extent, of GI absorption is decreased when administered with meals.^a

Distribution

Extent

Distributed into all tissues; highest concentrations in liver, brain, kidney, and heart.^b

Elimination

Elimination Route

Excreted in urine as unchanged drug and metabolites.^a

Stability

Storage

Oral

Tablets

Tight, light-resistant container at <40°C; preferably between 15–30°C.^a

Parenteral

Injection

20–25°C.^b Protect from light.^b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextran 6% in dextrose 5%
Dextran 6% in sodium chloride 0.9%
Dextrose–Ringer's injection combinations
Dextrose-Ringer’s injection, lactated, combinations
Dextrose-saline combinations
Dextrose 2½, 5, or 10% in water
Fat emulsion 10%, IV
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringer's injection
Ringer's injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6) M

Drug Compatibility

Y-Site CompatibilityHID

Compatible
Famotidine

ActionsActions

• 
  

  An exogenous source of thiamine is required for carbohydrate metabolism. ^a

  
  


• 
  

  Functions as a coenzyme in the metabolism of carbohydrates and branched-chain amino acids.¹⁰⁹

  
  

Advice to Patients

• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^a

  
  


• 
  

  Importance of proper dietary habits, including taking appropriate AI or RDA of thiamine.¹⁰⁹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a

  
  


• 
  

  Importance of informing patients of other important precautionary information.^a (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

Thiamine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Bulk	Powder*
Oral	Tablets	25 mg*
		50 mg*
		100 mg*
		250 mg*
		500 mg*
Parenteral	Injection	100 mg/mL*

Thiamine salts are also commercially available for oral use in combination with other vitamins, minerals, amino acids, protein supplements, and infant formulas. For IV infusion, thiamine hydrochloride is commercially available in combination with other vitamins in caloric and electrolyte solutions.^a

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 September 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Food and Drug Administration. Insect repellent drug products for over-the-counter oral human use. [21 CFR Part 310] Fed Regist. 1985; 50:25170-1.

101. Food and Drug Administration. Insect repellent drug products for over-the-counter oral human use. [21 CFR Part 310] Fed Regist. 1982; 47:424-7.

102. Food and Drug Administration and American Society for Parenteral and Enteral Nutrition. Deaths associated with thiamine-deficient total parenteral nutrition. MMWR Morb Mortal Wkly Rep. 1989; 38:43-6. [IDIS 250221] [PubMed 2492074]

103. Velez RJ, Myers B, Guber MS. Severe acute metabolic acidosis (acute beriberi): an avoidable complication of total parenteral nutrition. J Parenter Enteral Nutr. 1985; 9:216-9.

104. Mattioli S, Miglioli M, Montagna P et al. Wernicke’s encephalopathy during total parenteral nutrition: observation in one case. J Parenter Enteral Nutr. 1988; 12:626-7.

105. Reuler JB, Girard DE, Cooney TG. Wernicke’s encephalopathy. N Engl J Med. 1985; 312:1035-8. [IDIS 198729] [PubMed 3885034]

106. National Research Council Food and Nutrition Board Subcommittee on the Tenth Edition of the RDAs. Recommended dietary allowances. 10th ed. Washington, DC: National Academy Press; 1989:125-32.

107. Lactic acidosis traced to thiamine deficiency related to nationwide shortage of multivitamins for total parenteral nutrition–United States, 1997. MMWR. 1997; 46:523-8. (Also published in JAMA. 1997; 278:109-11.)

108. American Society for Parenteral and Enteral Nutrition (ASPEN). Multivitamin shortage–Update #17: fatality reported. Press release. 1997 Jul 21.

109. Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B₆, folate, vitamin B₁₂, pantothenic acid, biotin, and choline. Washington, DC: National Academy Press; 1998. (Prepublication copy uncorrected proofs.)

110. American Psychiatric Association. Practice guidelines for the treatment of patients with delirium. Am J Psychiatry. 1999; 156(Suppl 5):1-20.

a. AHFS drug information 2007. McEvoy GK, ed. Thiamine. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007: 3626-7.

b. Abraxis Pharmaceuticals. Thiamine injection prescribing information. Schaumburg, IL; 2005 Jun.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1538-40.

More Thiamine Hydrochloride resources

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

• thiamine Concise Consumer Information (Cerner Multum)


• thiamine Oral, Injection Advanced Consumer (Micromedex) - Includes Dosage Information


• Thiamine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Thiamine Hydrochloride with other medications

• Beriberi
• Vitamin B1 Deficiency
• Vitamin/Mineral Supplementation and Deficiency
• Wernicke's Encephalopathy

Nabilone

Class: Antiemetics, Miscellaneous
VA Class: GA605
Chemical Name: (±) - trans - 3 - (1,1 - dimethylheptyl) - 6,6a,7,8,10,10a - hexahydro - 1 - hydroxy - 6 - 6 - dimethyl - 9H - dibenzo[b,d]pyran - 9 - one
Molecular Formula: C₂₄H₃₆O₃
CAS Number: 51022-71-0
Brands: Cesamet

Introduction

Antiemetic; a synthetic cannabinoid.^{1 2 6 15}

Uses for Nabilone

Cancer Chemotherapy-induced Nausea and Vomiting

Prevention of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic therapy.^{1 2 3 4 5 8 10 11 15}

ASCO does not consider cannabinoids (e.g., nabilone, dronabinol) appropriate first-line antiemetics for any group of patients receiving chemotherapy of high emetic risk and states that these drugs should be reserved for patients unable to tolerate or refractory to first-line agents (i.e., a type 3 serotonin [5-HT₃] receptor antagonist [e.g., dolasetron, granisetron, ondansetron, palonosetron] with dexamethasone and aprepitant).^{11 14}

Nabilone Dosage and Administration

Administration

Oral Administration

Administer orally without regard to meals.^{1 2 5} Has been administered IV; however, a parenteral preparation is not commercially available in the US.^{1 2 6}

Dosage

Adults

Cancer Chemotherapy-induced Nausea and Vomiting

Oral

Usual dose: 1 or 2 mg twice daily; administer initial dose 1–3 hours before chemotherapy.^{1 2} May be administered 2 or 3 times daily during the entire chemotherapy cycle and for 48 hours after the last dose of chemotherapy in each cycle.^{1 2}

Initiate with the lower dosage (i.e., 1 mg twice daily) to minimize adverse effects, then increase dosage as necessary up to a maximum of 2 mg 3 times daily.^{1 2}

May administer a dose of 1 or 2 mg the night prior to chemotherapy.^{1 2}

Prescribing Limits

Adults

Cancer Chemotherapy-induced Nausea and Vomiting

Oral

Maximum: 2 mg 3 times daily.^{1 2}

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.¹

Renal Impairment

No specific dosage recommendations at this time.¹

Geriatric Patients

Select dosage with caution, usually initiating at the lower end of the recommended dosage range because of possible age-related decreases in hepatic, renal, and/or cardiac function; concomitant diseases and drug therapy; and possible increased sensitivity to adverse effects.¹ (See Geriatric Use under Cautions.)

Cautions for Nabilone

Contraindications

Hypersensitivity to any cannabinoid.^{1 2}

Warnings/Precautions

Warnings

Effects of nabilone may persist for a variable and unpredictable period of time following oral administration.^{1 2 3 5 12}

CNS Effects

CNS effects, including dizziness, drowsiness or sedation, euphoria (i.e., “high”), ataxia, anxiety, disorientation, depression, hallucinations, and psychosis, reported.^{1 2 4 5 6 7 8 12} Adverse psychiatric reactions can persist for 48–72 hours following discontinuance of nabilone.^{1 2 5 12}

Individual response and tolerance may vary; a responsible adult should supervise patients, particularly during initial therapy and during dosage adjustments.^{1 2}

Cardiovascular Effects

May cause tachycardia and orthostatic hypotension.^{1 2 3 4 5 6 8 12} Elevations in supine and standing heart rates also reported.^{1 2 3 4 5 6 8 12}

Individual response and tolerance may vary; a responsible adult should supervise patients, particularly during initial therapy and during dosage adjustments.^{1 2} Carefully evaluate the potential risks and benefits of the drug; use with caution in geriatric patients and in patients with hypertension and/or cardiovascular disease.^{1 2 4 12} (See Geriatric Use under Cautions.)

General Precautions

Psychiatric Disorders

Use with caution in patients with current or history of psychiatric disorders (e.g., bipolar disorder, depression, schizophrenia); cannabinoid use may unmask the symptoms of these diseases.^{1 2}

Abuse Potential

Marijuana contains an active compound similar to nabilone.^{1 2} Use nabilone with caution in patients with history of substance abuse, including alcohol abuse or dependence and marijuana use.^{1 2} Increased risk of substance abuse in patients with personal or family history of substance abuse or mental illness.^{1 2} Monitor patients receiving nabilone for signs of excessive use, abuse, and misuse.^{1 8 12}

High potential for abuse.^{1 2} Limit prescriptions to quantity necessary for a single cycle of chemotherapy (i.e., a few days);^{1 2} not intended for use on an as-needed basis or as the initial prescribed antiemetic therapy.^{1 2 15}

Specific Populations

Pregnancy

Category C.^{1 2}

Lactation

Not known whether nabilone is distributed into milk.^{1 2} Avoid use in nursing women.^{1 2}

Pediatric Use

Safety and effectiveness not established.^{1 2} Caution is advised because of psychoactive effects.^{1 2}

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.^{1 2} Use with caution because of increased sensitivity to psychoactive effects and risk of elevated supine and standing heart rates and postural hypotension.^{1 2 12}

Hepatic Impairment

Not studied in patients with hepatic impairment.^{1 2}

Renal Impairment

Not studied in patients with renal impairment.^{1 2}

Common Adverse Effects

Adverse effects may be similar to those of marijuana (cannabis) and other cannabinoids.^{1 2 12 13}

Drowsiness, vertigo, dry mouth, ataxia, euphoria (i.e., feeling “high”), dysphoria, sleep disturbances, headache.^{1 2 4 5 6 7 8 12 13}

Interactions for Nabilone

Nabilone is a synthetic cannabinoid; interactions reported with Cannabis sativa L (marijuana) also may occur with nabilone.^{1 2}

Extensively metabolized by multiple CYP isoenzymes.^{1 2}

Does not substantially inhibit CYP isoenzymes 1A2, 2A6, 2C19, 2D6, and 3A4; weak inhibitor of 2E1 and 3A4 isoenzymes and a moderate inhibitor of 2C8 and 2C9 isoenzymes.^{1 2}

Drugs Metabolized by Hepatic Microsomal Enzymes

Inhibitors or inducers of CYP isoenzymes: possible altered nabilone metabolism.^{1 2}

Pharmacokinetic interaction with drugs metabolized by CYP isoenzymes unlikely because very low plasma nabilone concentrations are achieved with clinical use.^{1 2}

Protein-bound Drugs

Possible displacement of other protein-bound drugs.^{1 2} Monitor patients and adjust dosages as necessary.^{1 2}

Specific Drugs

Drug	Interaction	Comments
Alcohol	Possible additive drowsiness and CNS depression; increase in the positive subjective mood effects reported with smoked marijuana 1 2	Avoid alcohol during therapy1 2
Anticholinergic agents (e.g., antihistamines, atropine, scopolamine)	Possible additive or super-additive anticholinergic effects (e.g., tachycardia, drowsiness) 1 2
Antidepressants, tricyclic (e.g., amitriptyline, amoxapine, desipramine)	Possible additive tachycardia, hypertension, or drowsiness1 2
Antipyrine	Possible decreased antipyrine clearance1 2
CNS depressants (e.g., antihistamines, barbiturates, benzodiazepines, buspirone, hypnotics, lithium, muscle relaxants, sedatives)	Possible additive drowsiness and CNS depression1 2 Possible decreased barbiturate clearance1 2	Administer with caution1 2
Disulfiram	Reversible hypomanic reaction reported in a disulfiram-treated patient who smoked marijuana1 2
Fluoxetine	Hypomanic reaction reported in a fluoxetine-treated patient after smoking marijuana; symptoms resolved within 4 days1 2
Naltrexone	Possible enhanced effects of oral delta-9-tetrahydrocannabinol observed during opiate receptor blockade1 2
Opiate agonists (e.g., meperidine, methadone, propoxyphene, tramadol)	Possible additive drowsiness and CNS depression; possible cross-tolerance and potentiation of other pharmacologic effects1 2
Sympathomimetic agents (e.g., amphetamines, cocaine)	Possible additive hypertension, tachycardia, or cardiotoxicity1 2
Theophylline	Increased theophylline metabolism reported with marijuana smoking; similar to that reported following tobacco smoking 1 2

Nabilone Pharmacokinetics

Absorption

Bioavailability

Appears to be completely absorbed from the GI tract after oral administration, with peak plasma concentrations achieved within 2 hours.¹

Food

Food does not appear to significantly affect the rate or extent of absorption.¹

Distribution

Extent

Volume of distribution: Approximately 12.5 L/kg.¹

Elimination

Metabolism

Extensively metabolized, including metabolism via multiple CYP isoenzymes, to several metabolites; relative pharmacologic activities of the metabolites and the parent drug not established.^{1 2}

Elimination Route

Following IV administration, nabilone and its metabolites are eliminated principally in feces (approximately 67%) and to a lesser extent in urine (approximately 22%) within 7 days.^{1 2}

Following oral administration, about 60% of nabilone and its metabolites were recovered in feces and about 24% in urine.^{1 2} The principal excretory pathway appears to be the biliary system.^{1 2}

No substantial accumulation of nabilone observed after chronic oral administration, but metabolites may accumulate at concentrations in excess of the parent drug with repeated administration.^{1 2}

Half-life

Approximately 2 hours.¹

Plasma half-life of total radioactivity (identified and unidentified metabolites) is approximately 35 hours.¹

Stability

Storage

Oral

Capsules

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Exerts complex effects on CNS.^{1 2 6 12 15}

  
  


• 
  

  Antiemetic effect may be caused by interaction with the cannabinoid receptor system, including the cannabinoid 1 (CB₁) receptors in the central and peripheral nervous system.^{1 2 12 15}

  
  


• 
  

  Binds to cannabinoid 2 (CB₂) receptors in the spleen and other peripheral tissues, which may play a role in the immunosuppressive effects of cannabinoids.^{2 12 15}

  
  


• 
  

  Like other cannabinoids, may possess analgesic, antispasmodic, and muscle relaxant activity; however, further evaluation is necessary.^{2 10 15}

  
  

Advice to Patients

• 
  

  Risk of additive or synergistic CNS depression during concurrent use with alcohol or other CNS depressants, including benzodiazepines and barbiturates.^{1 2} Importance of avoiding alcohol and other CNS depressants during nabilone therapy.^{1 2}

  
  


• 
  

  Importance of avoiding driving, operating machinery, or performing hazardous tasks during nabilone therapy.^{1 2}

  
  


• 
  

  Importance of informing patients about possible changes in mood and other adverse behavioral effects of nabilone to avoid panic if such manifestations occur.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients that they should remain under the supervision of a responsible adult during therapy.^{1 2}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{1 2} (See Cautions.)

  
  

Preparations

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

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule II (C-II) drug.^{1 2}

Nabilone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	1 mg	Cesamet ( C-II; with povidone)	Valeant

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 September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Valeant Pharmaceuticals International. Cesamet (nabilone) capsules prescribing information. Costa Mesa, CA; 2006 Jul.

2. Valeant Pharmaceuticals North America. Cesamet (nabilone) capsules, 1 mg: innovations in omnineuromodulation formulary dossier. Costa Mesa, CA; 2006 Jun 21.

3. Tramer MR, Carroll D, Campbell FA et al. Cannabinoids for control of chemotherapy induced nausea and vomiting: quantitative systematic review. Br Med J. 2001; 323:1-8.

4. Einhorn LH, Nagy C, Furnas B et al. Nabilone: an effective antiemetic in patients receiving cancer chemotherapy. J Clin Pharmacol. 1981; 21:64-9S.

5. Herman TS, Einhorn LH, Jones SE et al. Superiority of nabilone over prochlorperazine as an antiemetic in patients receiving cancer chemotherapy. N Engl J Med. 1979; 300:1295-7. [PubMed 375088]

6. Lemberger L, Rowe H. Clinical pharmacology of nabilone, a cannabinol derivative. Clin Pharmacol Ther. 1975; 18:720-6. [PubMed 1204278]

7. Talbott JA, Teague JW. Marijuana psychosis: acute toxic psychosis associated with the use of Cannabis derivatives. JAMA. 1969; 210:299-302. [PubMed 5394365]

8. Ahmedzai S, Carlyle DL, Calder IT et al. Anti-emetic efficacy and toxicity of nabilone, a synthetic cannabinoid, in lung cancer chemotherapy. Br J Cancer. 1983; 48:657-63. [PubMed 6315040]

9. Williamson EM, Evans FJ. Cannabinoids in clinical practice. Drugs. 2000; 60:1303-14. [PubMed 11152013]

10. Croxford JL. Therapeutic potential of cannabinoids in CNS disease. CNS Drugs. 2003; 17:179-202. [PubMed 12617697]

11. Kris MG, Hesketh PJ, Somerfield MR et al. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006; 24:1-16. [PubMed 16330665]

12. Ashton CH. Adverse effects of cannabis and cannabinoids. Br J Anaesthesia. 1999; 83:637-49.

13. Herman TS, Jones SE, Dean J et al. Nabilone: a potent antiemetic cannabinol with minimal euphoria. Biomedicine. 1977; 27:331-4. [PubMed 606307]

14. Gralla RJ, Osoba D, Kris MG et al. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. J Clin Oncol. 1999; 17:2971-94. [PubMed 10561376]

15. Ben Amar M. Cannabinoids in medicine: a review of their therapeutic potential. J Ethnopharmacol. 2006; 105:1-25. [PubMed 16540272]

More Nabilone resources

• Nabilone Side Effects (in more detail)
• Nabilone Dosage
• Nabilone Use in Pregnancy & Breastfeeding
• Nabilone Drug Interactions
• Nabilone Support Group
• 1 Review for Nabilone - Add your own review/rating

• Nabilone MedFacts Consumer Leaflet (Wolters Kluwer)


• Nabilone Professional Patient Advice (Wolters Kluwer)


• nabilone Advanced Consumer (Micromedex) - Includes Dosage Information


• Cesamet Prescribing Information (FDA)


• Cesamet Consumer Overview

Compare Nabilone with other medications

• Fibromyalgia
• Nausea/Vomiting, Chemotherapy Induced

Sumatriptan and naproxen

Generic Name: sumatriptan and naproxen (soo ma TRIP tan and na PROX en)

Brand Names: Treximet

What is sumatriptan and naproxen?

Sumatriptan is a headache medicine. It is believed to work by narrowing the blood vessels around the brain.

Naproxen is a nonsteroidal anti-inflammatory drugs (NSAID). Naproxen works by reducing hormones that cause inflammation and pain in the body.

The combination of sumatriptan and naproxen is used to treat migraine headaches.

Sumatriptan and naproxen will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan and naproxen may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sumatriptan and naproxen

Do not take more than 2 sumatriptan and naproxen tablets in 24 hours.

You should not use this medication if you are allergic to sumatriptan (Imitrex) or naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs). Do not take if you have liver disease, uncontrolled high blood pressure, or a history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery. Do not take sumatriptan and naproxen within 24 hours before or after taking any of the following medications: almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig), or ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

What should I discuss with my health care provider before taking sumatriptan and naproxen?

You should not use this medication if you are allergic to sumatriptan (Imitrex), naproxen (Aleve, Anaprox, Naprosyn), or if you have a history of asthma or allergic reaction caused by aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

Do not take sumatriptan and naproxen if you have:

• 
  

  liver disease;

  
  


• 
  

  untreated or uncontrolled high blood pressure; or

  
  


• 
  

  a history of heart disease, angina (chest pain), blood circulation problems, heart attack, stroke, or heart bypass surgery (also called coronary artery bypass graft, or CABG).

  
  

Do not take sumatriptan and naproxen if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the past 14 days. Do not take sumatriptan and naproxen within 24 hours before or after taking any of the following medicines:

• 
  

  almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt, Maxalt-MLT), sumatriptan (Imitrex), or zolmitriptan (Zomig); or

  
  


• 
  

  ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

  
  

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

• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  kidney disease;

  
  


• 
  

  high blood pressure, congestive heart failure; or

  
  


• 
  

  coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

  
  

FDA pregnancy category C. Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Sumatriptan and naproxen can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking this medication.

How should I take sumatriptan and naproxen?

Use exactly as prescribed by your doctor. Follow the directions on your prescription label. Never use more than the recommended dose. Overuse of migraine headache medicine can actually make your headaches worse. Tell your doctor if the medicine seems to stop working as well.

Take one (1) sumatriptan and naproxen tablet as soon as you notice headache symptoms, or after an attack has already begun. You may take the medicine with or without food.

Do not crush, chew, or break the tablet. Swallow the pill whole.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, you may take a second tablet two (2) hours after the first.

You must wait at least 2 hours before taking a second tablet. Do not take more than 2 sumatriptan and naproxen tablets in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Contact your doctor if you have more than five headaches in one month (30 days).

Naproxen can cause unusual results with certain medical tests. Tell any doctor who treats you if you have taken sumatriptan and naproxen within the past 72 hours.

Store at room temperature away from moisture and heat.

See also: Sumatriptan and naproxen dosage (in more detail)

What happens if I miss a dose?

Since sumatriptan and naproxen is taken only when needed, it does not have a daily dosing schedule. Do not take more than 2 sumatriptan and naproxen tablets in 24 hours.

What happens if I overdose?

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

Overdose symptoms may include dizziness, drowsiness, heartburn, stomach pain, nausea, vomiting, breathing problems, black or bloody stools, coughing up blood, and seizure (convulsions).

What should I avoid while taking sumatriptan and naproxen?

Ask a doctor or pharmacist before using any other over-the-counter cold, allergy, or pain medicine. Many combination medicines contain medicines similar to naproxen (such as ibuprofen or ketoprofen). Taking certain products together can cause you to get too much of this type of medicine. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen. Avoid drinking alcohol. It may increase your risk of stomach bleeding caused by naproxen. This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Sumatriptan and naproxen side effects

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

• 
  

  chest pain or pressure, tight feeling in your neck or jaw, pain spreading to your arm or shoulder;

  
  


• 
  

  sudden numbness or weakness, confusion, problems with vision, speech, or balance;

  
  


• 
  

  bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

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

  
  


• 
  

  swelling or rapid weight gain, urinating less than usual or not at all;

  
  


• 
  

  pale skin, weakness, easy bruising, flu symptoms;

  
  


• 
  

  numbness, tingling, pale or blue-colored appearance in your fingers or toes;

  
  


• 
  

  severe blistering, peeling, and red skin rash;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  constipation, upset stomach, dry mouth;

  
  


• 
  

  warmth or tingly feeling, redness in your face;

  
  


• 
  

  tight muscles; or

  
  


• 
  

  mild pressure or heavy feeling in any part of your body.

  
  

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.

Sumatriptan and naproxen Dosing Information

Usual Adult Dose for Migraine:

Dose: 1 tablet orally once (Note: The fixed combination tablet contains naproxen sodium (500 mg) and sumatriptan (85 mg).

Maximum Dose: 2 naproxen-sumatriptan tablets in 24 hours. Dosing of tablets should be at least 2 hours apart. The safety of treating an average of more than 5 migraine headaches in a 30 day period has not been established.

Naproxen-sumatriptan may be administered with or without food. Tablets should not be split, crushed, or chewed.

Usual Geriatric Dose for Migraine:

Naproxen-sumatriptan is contraindicated for use in elderly patients who have abnormal hepatic function. Naproxen-sumatriptan is not recommended for use in elderly patients who have decreased renal function, higher risk for unrecognized CAD, and increases in blood pressure that may be more pronounced in the elderly.

Dose: 1 tablet orally once (Note: The fixed combination tablet contains naproxen sodium (500 mg) and sumatriptan (85 mg).

Maximum Dose: 2 naproxen-sumatriptan tablets in 24 hours. Dosing of tablets should be at least 2 hours apart. The safety of treating an average of more than 5 migraine headaches in a 30 day period has not been established.

Naproxen-sumatriptan may be administered with or without food. Tablets should not be split, crushed, or chewed.

What other drugs will affect sumatriptan and naproxen?

Many drugs can interact with sumatriptan and naproxen. Below is just a partial list. Tell your doctor if you are using:

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  a diuretic (water pill) such as furosemide (Lasix);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  aspirin or other NSAIDs such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others;

  
  


• 
  

  heart or blood pressure medication such as atenolol (Tenormin, Tenoretic), benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), metoprolol (Dutoprol, Lopressor, Toprol), propranolol (Inderal, InnoPran), quinapril (Accupril), and others; or

  
  


• 
  

  an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

  
  

This list is not complete and other drugs may interact with sumatriptan and naproxen. 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 sumatriptan and naproxen resources

• Sumatriptan and naproxen Dosage
• Sumatriptan and naproxen Use in Pregnancy & Breastfeeding
• Sumatriptan and naproxen Drug Interactions
• Sumatriptan and naproxen Support Group
• 58 Reviews for Sumatriptan and naproxen - Add your own review/rating

Compare sumatriptan and naproxen with other medications

• Migraine

Where can I get more information?

• Your pharmacist can provide more information about sumatriptan and naproxen.

Tarka

Pronunciation: tran-DOLE-a-pril/ver-AP-a-mil
Generic Name: Trandolapril/Verapamil
Brand Name: Tarka

Tarka may cause injury or death to the fetus if taken after the third month of pregnancy. If you think you may be pregnant, contact your doctor right away.

Tarka is used for:

Treating high blood pressure. It may also be used for certain conditions as determined by your doctor.

Tarka is an angiotensin-converting enzyme (ACE) inhibitor and calcium channel blocker combination. It works by helping to relax blood vessels, which helps to lower blood pressure.

Do NOT use Tarka if:

• you are allergic to any ingredient in Tarka or to another ACE inhibitor (eg, lisinopril)


• you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or unusual hoarseness), including angioedema caused by treatment with an ACE inhibitor


• you have certain heart problems (eg, left ventricular dysfunction, sick sinus syndrome, second- or third-degree heart block and do not have a pacemaker), very low blood pressure, or moderate to severe congestive heart failure (CHF)


• you have atrial fibrillation or flutter and a pre-excitation syndrome (extra conduction pathway in the heart), such as Wolff-Parkinson-White (WPW) syndrome or Lown-Ganong-Levine (LGL) syndrome


• you have shock caused by serious heart problems


• you are in your second or third trimester of pregnancy


• you are taking dofetilide, erythromycin, everolimus, or disopyramide

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

Before using Tarka:

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

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


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


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


• if you are able to become pregnant


• if you have a history of heart problems (eg, aortic stenosis, heart failure), blood vessel problems, blood flow problems, bone marrow problems, kidney or liver problems, nervous system problems, muscular dystrophy, a neuromuscular disease, or fluid in the lungs


• if you have a history of stroke, a recent heart attack, or a kidney transplant


• if you have an autoimmune disease (eg, lupus, rheumatoid arthritis, scleroderma)


• if you are dehydrated or have low blood volume or low blood pressure


• if you have high potassium levels, low blood sodium levels, or are on a low-salt (sodium) diet


• if you have diabetes, especially if you are also taking aliskiren


• if you are receiving treatments to reduce sensitivity to bee or wasp stings


• if you are having dialysis or apheresis, or are scheduled to have major surgery


• if you are taking another blood pressure medicine or you are being treated for cancer

Some MEDICINES MAY INTERACT with Tarka. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) or quinazolines (eg, prazosin) because the risk of low blood pressure may be increased


• Aldosterone blockers (eg, eplerenone), aliskiren, potassium-sparing diuretics (eg, spironolactone), potassium supplements, or trimethoprim because the risk of high blood potassium levels may be increased


• Angiotensin receptor blockers (eg, losartan) because the risk of serious kidney problems and high blood potassium levels may be increased


• Insulin, sulfonylureas (eg, glipizide), or other oral diabetes medicines (eg, metformin) because the risk of low blood sugar may be increased


• Certain gold-containing medicines (eg, sodium aurothiomalate) because flushing, low blood pressure, nausea, and vomiting may occur


• Cephalosporin antibiotics (eg, cephalexin), clindamycin, clonidine, ketolide antibiotics (eg, telithromycin), lincomycin, macrolide antibiotics (eg, clarithromycin, erythromycin), or ritonavir because they may increase the risk of Tarka's side effects


• Barbiturates (eg, phenobarbital), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin), rifampin, salicylates (eg, aspirin), or St. John's wort because they may decrease Tarka's effectiveness


• Aspirin, beta-blockers (eg, propranolol), carbamazepine, colchicine, cyclosporine, digoxin, disopyramide, dofetilide, doxorubicin, dronedarone, eletriptan, erythromycin, everolimus, flecainide, HMG-CoA reductase inhibitors (eg, simvastatin), indomethacin, lithium, narcotic pain medicines (eg, fentanyl), paclitaxel, quinidine, ranolazine, theophyllines (eg, aminophylline), thiopurines (eg, azathioprine), or tolvaptan because the risk of their side effects may be increased by Tarka

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

How to use Tarka:

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

• Take Tarka by mouth with food.


• Eating grapefruit or drinking grapefruit juice may affect the amount of Tarka in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.


• Take Tarka on a regular schedule to get the most benefit from it. Taking Tarka at the same time each day will help you remember to take it.


• Continue to use Tarka even if you feel well. Do not miss any doses.


• If you miss a dose of Tarka, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

• Tarka may cause dizziness, lightheadedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Tarka with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tarka; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Tarka may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. If lightheadedness occurs, especially during the first few days of treatment, contact your health care provider.


• Tarka may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or unusual hoarseness.


• Tarka may not work as well in black patients. They may also be at greater risk of side effects. Contact your doctor if your symptoms do not improve or if they become worse.


• Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.


• Rarely, Tarka may lower the ability of your body to fight infection. This risk may be greater if you have certain other health problems (eg, kidney problems, collagen vascular disease). Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• Proper dental care is important while you are taking Tarka. Brush and floss your teeth carefully to reduce swelling and tenderness of your gums while you are using Tarka, and visit the dentist regularly.


• Tell your doctor or dentist that you take Tarka before you receive any medical or dental care, emergency care, or surgery.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.


• Diabetes patients - Tarka may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including liver function, kidney function, complete blood cell counts, and blood pressure, may be performed while you use Tarka. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Tarka should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Tarka may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Tarka is found in breast milk. Do not breast-feed while taking Tarka.

Possible side effects of Tarka:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; lightheadedness when sitting up or standing; nausea; persistent, dry cough; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; decreased urination; difficulty swallowing; fainting; muscle pain or cramping; numbness of an arm or leg; one-sided weakness; shortness of breath; slurred speech; stomach pain (with or without nausea or vomiting); swelling of the hands or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, severe or persistent stomach pain, fever, general feeling of being unwell); symptoms of low blood pressure (eg, fainting, severe dizziness or lightheadedness); tender, bleeding, or swollen gums; unusually fast, slow, or irregular heartbeat.

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

See also: Tarka side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe dizziness or lightheadedness; unusually fast, slow, or irregular heartbeat; weakness.

Proper storage of Tarka:

Store Tarka at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tarka out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tarka resources

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

• Tarka Prescribing Information (FDA)


• Tarka Concise Consumer Information (Cerner Multum)


• Tarka Advanced Consumer (Micromedex) - Includes Dosage Information

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Simply Cough

Generic Name: dextromethorphan (Oral route)

dex-troe-meth-OR-fan

Commonly used brand name(s)

In the U.S.

• Babee Cof Syrup


• Benylin Pediatric Formula


• Children's Pedia Care


• Creomulsion


• Creo-Terpin


• Delsym


• Dexalone


• ElixSure Cough Children's


• Father John's Medicine


• Miltuss


• Nycoff


• Pediacare


• Pediacare Long-Acting Cough


• Robafen Cough


• Robitussin


• Silphen DM


• Simply Cough


• St. Joseph


• Vicks 44 Cough Relief

Available Dosage Forms:

• Suspension, Extended Release


• Solution


• Capsule


• Syrup


• Lozenge/Troche


• Elixir


• Liquid


• Tablet


• Capsule, Liquid Filled


• Suspension

Therapeutic Class: Antitussive

Uses For Simply Cough

Dextromethorphan is used to relieve coughs due to colds or influenza (flu). It should not be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (flem) with the cough.

Dextromethorphan relieves cough by acting directly on the cough center in the brain.

This medicine is available without a prescription.

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 Simply Cough

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

Although there is no specific information comparing use of dextromethorphan in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 4 years of age and older than it does in adults.

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

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of dextromethorphan in the elderly with use in other age groups.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

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

• Clorgyline


• Iproniazid


• Isocarboxazid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

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

• Abiraterone


• Amitriptyline


• Amoxapine


• Citalopram


• Clomipramine


• Desipramine


• Desvenlafaxine


• Doxepin


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Imipramine


• Linezolid


• Milnacipran


• Nortriptyline


• Paroxetine


• Protriptyline


• Sertraline


• Sibutramine


• Trimipramine


• Venlafaxine

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

• Clobazam


• Haloperidol


• Quinidine


• Vemurafenib

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Asthma—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that collects in the lungs and airways during asthma

• Diabetes (sugar diabetes)—Some products contain sugar and may affect control of blood glucose monitoring

• Liver disease—Dextromethorphan may build up in the body and cause unwanted effects

• Chronic bronchitis or


• Emphysema or


• Mucus or phlegm with cough—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways with some diseases

• Slowed breathing—Dextromethorphan may slow the rate of breathing even further

Proper Use of dextromethorphan

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

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol.

Use this medicine only as directed by your doctor or the directions on the label. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.

Dosing

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

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

• For lozenge dosage form:
  
  • For cough:
    
    • Adults and children 12 years of age and older—5 to 15 mg every two to four hours, as needed.
    
    
    • Children 6 to 12 years of age—5 to 15 mg every two to six hours, as needed.
    
    
    • Children 4 to 6 years of age—5 mg every four hours, as needed.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  


• For syrup dosage form:
  
  • For cough:
    
    • Adults and children 12 years of age and older—30 mg every six to eight hours, as needed.
    
    
    • Children 6 to 12 years of age—7 mg every four hours or 15 mg every six to eight hours, as needed.
    
    
    • Children 4 to 6 years of age—3.5 mg every four hours or 7.5 mg every six to eight hours, as needed.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  


• For extended-release oral suspension dosage form :
  
  • For cough:
    
    • Adults and children 12 years of age and older—60 mg every twelve hours, as needed.
    
    
    • Children 6 to 12 years of age—30 mg every twelve hours, as needed.
    
    
    • Children 4 to 6 years of age—15 mg every twelve hours, as needed.
    
    
    • 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

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.

Precautions While Using Simply Cough

If your cough has not improved after 7 days, if sore throat has not improved after 2 days, if you have a high fever, skin rash, or continuing headache with the cough, or if asthma or high blood pressure is present, check with your doctor. These signs may mean that you have other medical problems.

Dissolve lozenges in the mouth with caution, to lessen the risk of choking.

Simply Cough 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 as soon as possible if any of the following side effects occur:

Symptoms of overdose

• Blurred vision


• confusion


• difficulty in urination


• drowsiness or dizziness


• nausea or vomiting (severe)


• shakiness and unsteady walk


• slowed breathing


• unusual excitement, nervousness, restlessness, or irritability (severe)

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

Less common or rare

• Confusion


• constipation


• dizziness (mild)


• drowsiness (mild)


• headache


• nausea or vomiting


• stomach pain

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: Simply Cough 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 Simply Cough resources

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

Compare Simply Cough with other medications

• Cough