Friday, 31 August 2012

Isoface




Isoface may be available in the countries listed below.


Ingredient matches for Isoface



Isotretinoin

Isotretinoin is reported as an ingredient of Isoface in the following countries:


  • Brazil

  • Colombia

  • Ecuador

  • Mexico

  • Peru

  • Venezuela

International Drug Name Search

Thursday, 30 August 2012

Copper Mate





Dosage Form: FOR ANIMAL USE ONLY

Copper Mate Drug Facts Label


Active Ingredients: Cupric Sulfate, Zinc Sulfate, Citric Acid [Powder for use in solution]



Directions: It is recommended for use in a 1% to 3% solution strength (by weight) with immersion lasting between 5 and 20 minutes, once or twice daily, for a period of time as prescribed by your veterinarian.



Warnings:


  • Copper and Zinc can be toxic to sheep. Do not allow animals to eat or drink the Copper Mate powder or hoof bath solution.

  • Know the volume of the hoof bath and calculate the amount of Copper Mate carefully.

  • DO NOT OVER DOSE by using more Copper Mate than what is recommended by your veterinarian.


For External Use Only

Keep out of reach of children.



Purpose:Copper Mate powder is used as an aid in hoof rot management under veterinary guidance.


Use:Copper Mate powder is used in hoof baths for cattle and sheep.



When Using this Product: By placing a clean water bath ahead of the treatment bath, animals will clean their hooves to some extent and keep the treatment bath clean longer. Hoof baths should only be part of an overall program that includes proper nutrition, regular hoof trimming, and hoof injury prevention.



Questions?: 1-800-567-7455 (24/7-Emergency Spill Line) or 1-905-878-8432



Copper Mate Bag Label




Copper Mate

HOOF TREATMENT

Contains a Proprietary Blend of Copper and Zinc Salts in an Acidified Medium

FIRST AID MEASURES

SKIN:  IMMEDIATELY REMOVE CONTAMINATED CLOTHING AND FLUSH SKIN WITH RUNNING WATER FOR AT LEAST 15 MINUTES. WASH SKIN WITH SOAP AND WATER. LAUNDER CLOTHING BEFORE REUSE.

EYES:  FLUSH CONTINUOUSLY WITH WATER FOR 15 MINUTES. FORCIBLY HOLD EYELIDS APART TO ENSURE IRRIGATION OF ALL EYE TISSUE. SEEK PROMPT MEDICAL ATTENTION.

INHALATION:  REMOVE TO FRESH AIR. APPLY ARTIFICIAL RESPIRATION OR ADMINISTER OXYGEN IF NECESSARY. SEEK PROMPT MEDICAL ATTENTION IF SYMPTOMS PERSIST.

INGESTION:  NEVER GIVE ANYTHING BY MOUTH IF VICTIM IS RAPIDLY LOSING CONSCIOUSNESS OR IS UNCONCIOUS OR CONVULSING. HAVE VICTIM RINSE MOUTH THROUGHLY WITH WATER.  IF CONSIOUS GIVE 100 ML OF WATER AND INDUCE VOMITING. SEEK MEDICAL ATTENTION IMMEDIATELY.


PRECAUTIONARY MEASURES

AVOID CONTACT WITH SKIN AND EYES.  AVOID BREATHING VAPOURS.

WEAR ADEQUATE PROTECTIVE CLOTHES


PRECAUTIONARY EQUIPMENT

GLOVES/TYPE: WEAR IMPERVIOUS GLOVES IN NEOPRENE OR RUBBER.

RESPIRATOR TYPE: WHERE VAPOURS OR MIST ARE PRESENT, USE AN APPROVED NIOSH/MHSA APPROVED RESPIRATOR FOR THE INDICATED COMPONENTS, OR USE AN APPROVED AIR SUPPLIED RESPIRATOR. A RESPIRATOR WITH DUST/MIST FILTER IS REQUIRED UNDER DUSTY OR MISTY CONDITIONS.

EYE/TYPE: CHEMICAL GOOGLES.

FOOTWEAR/TYPE: SAFETY BOOTS.


RISK PHRASES

WARNING! THIS PRODUCT IS CONSIDERED TOXIC. IS A SKIN AND EYE IRRITANT. USE PROPER PROTECTIVE MEASURES.  FOR MORE INFORMATION SEE MSDS.


FONDEL Chemicals Ltd.

9688 Regional Rd. 25, Milton, Ontario, CANADA L9T 2X7

Tel: 905/878-8432  Fax: 905/878-7262  E-mail: Canada@fondel.com

Emergency Spill Line: North America 24/7 – NEWALTA- (800) 567-7455

PRODUCT OF CANADA

50 LBS.    25 KG.









Copper Mate 
acidified cupric and zinc sulfate  powder, for solution










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)51044-401
Route of AdministrationTOPICALDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cupric Sulfate (Cupric Cation)Cupric Cation0.25 kg  in 1.6 kg
ZINC SULFATE MONOHYDRATE (Zinc Cation)Zinc Cation0.1 kg  in 1.6 kg
CITRIC ACID MONOHYDRATE (CARBON DIOXIDE)CARBON DIOXIDE0.05 kg  in 1.6 kg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
151044-401-2525 kg In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/15/2010


Labeler - Fondel Chemical Ltd. (201786790)

Registrant - Fondel Chemical Ltd. (201786790)









Establishment
NameAddressID/FEIOperations
Fondel Chemical Ltd.201786790manufacture, label
Revised: 12/2010Fondel Chemical Ltd.



Wednesday, 29 August 2012

Phena-S Liquid


Pronunciation: klor-fen-IHR-ah-meen/fen-ill-EF-rin/peer-IL-a-meen
Generic Name: Chlorpheniramine/Phenylephrine/Pyrilamine
Brand Name: Phena-S


Phena-S Liquid is used for:

Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.


Phena-S Liquid is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.


Do NOT use Phena-S Liquid if:


  • you are allergic to any ingredient in Phena-S Liquid

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

  • you take sodium oxybate (GHB) or if 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 Phena-S Liquid:


Some medical conditions may interact with Phena-S 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, plan 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 a fast, slow, or irregular heartbeat

  • if you have a history of asthma; lung problems (eg, emphysema); adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate; seizures; or an overactive thyroid

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


  • Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Phena-S Liquid may be increased

  • Digoxin or droxidopa because risk of irregular heartbeat or heart attack may be increased

  • Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Phena-S Liquid

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Phena-S Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phena-S 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 Phena-S Liquid:


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


  • Phena-S Liquid may be taken with or without food.

  • 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 Phena-S 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 Phena-S Liquid.



Important safety information:


  • Phena-S Liquid may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Phena-S Liquid. Using Phena-S Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • Do not take diet or appetite control medicines while you are taking Phena-S Liquid without checking with your doctor.

  • Phena-S Liquid contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Do NOT exceed the recommended dose or use/take Phena-S Liquid for longer than prescribed without checking with your doctor.

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

  • Phena-S Liquid may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Phena-S Liquid. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

  • If you are scheduled for allergy skin testing, do not take Phena-S Liquid for several days before the test because it may decrease your response to the skin tests.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Phena-S Liquid.

  • Use Phena-S Liquid with caution in the ELDERLY because they may be more sensitive to its effects.

  • Caution is advised when using Phena-S Liquid in CHILDREN because they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Phena-S Liquid, discuss with your doctor the benefits and risks of using Phena-S Liquid during pregnancy. It is unknown if Phena-S Liquid is excreted in breast milk. Do not breast-feed while taking Phena-S Liquid.


Possible side effects of Phena-S 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:



Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.



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: Phena-S 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 Phena-S Liquid:

Store Phena-S 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 Phena-S Liquid out of the reach of children and away from pets.


General information:


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

  • Phena-S 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 Phena-S 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 Phena-S resources


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


Compare Phena-S with other medications


  • Cold Symptoms
  • Hay Fever

Sunday, 26 August 2012

Tolazamide


Class: Sulfonylureas
ATC Class: A10BB05
VA Class: HS502
Chemical Name: 1-(Hexahydro-1-H-azepin-1-yl)-3-(p)-tolylsulfonyl) urea
CAS Number: 1156-19-0

Introduction

Antidiabetic agent; sulfonylurea.a b


Uses for Tolazamide


Diabetes Mellitus


Monotherapy as an adjunct to diet and exercise for the management of type 2 (noninsulin-dependent) diabetes mellitus in patients whose hyperglycemia cannot be controlled by diet and exercise alone.a b


Second-line therapy in combination with one or more other oral antidiabetic agents or insulin as an adjunct to diet and exercise in patients with type 2 diabetes mellitus who do not achieve adequate glycemic control with diet, exercise, and oral antidiabetic agent monotherapy. 136 146 147 148 149 150 166 167 169 170 171 172 173 174 175 176


Alternative therapy in some type 2 diabetic patients being treated with insulin or other antidiabetic agent(s) or unresponsive to other sulfonylureas.a Useful in combination with insulin to improve glycemic control and/or decrease insulin dosage in some type 2 diabetic patients.136 146 147 151 152 154 155 156 157 158 159


Not effective as sole therapy for patients with type 1 diabetes mellitus101 103 106 132 b or diabetic acidosis, ketosis, or coma; insulin is necessary.101 102 106 a b (See Contraindications under Cautions.)


Not routinely recommended in hospitalized patients with diabetes mellitus.119 Long duration of action precludes rapid dosage adjustments.119 132 Increased risk of hypoglycemia in hospitalized diabetic patients with irregular eating patterns.119


Tolazamide Dosage and Administration


General



  • Adjust dosage according to severity of disease, tolerance, and blood glucose determinations.b




  • Monitor regularly (e.g., blood glucose concentrations) to determine minimum effective dosage and to detect primary or secondary failure.119 a b




  • Monitor glycosylated hemoglobin (HbA1c) to determine patient’s continued response to therapy.119




  • During transfer from insulin therapy, patients should test their blood glucose concentrations ≥3 times daily.a b



Administration


Oral Administration


Administer orally as a single dose with breakfast or first main meal; for dosages >500 mg daily, administer in 2 divided doses.a b


Dosage


Adults


Type 2 Diabetes Mellitus

Initial Dosage

Oral

Initially, 100–250 mg daily.a b


Manufacturer suggests that, if the fasting blood glucose is <200 mg/dL, initially, 100 mg daily; if fasting blood glucose >200 mg/dL, initially, 250 mg daily.a b


Initial Dosage in Patients Transferred from Other Oral Antidiabetic Agents

May discontinue most other oral antidiabetic agents abruptly.a b


Oral

Acetohexamide: Initially, 100 mg daily for each 250 mg daily of acetohexamide.a b


Chlorpropamide: Administer the nearest equivalent total daily dosage; however, an exaggerated hypoglycemic response may occur in some patients during the transition because of the prolonged elimination half-life of chlorpropamide.a b Monitor closely for hypoglycemia during the initial 1- to 2-week transition period.a b


Tolbutamide: Tolbutamide dosages ≤1 g daily, initially 100 mg daily.b Tolbutamide dosage >1 g daily, initially, 250 mg daily.a b


Initial Dosage in Patients Transferred from Insulin

Oral

Insulin requirements <20 units daily: Initially, 100 mg daily.a b May abruptly discontinue insulin.a


Insulin requirements 20–40 units of insulin daily: Initially, 250 mg daily.a b May abruptly discontinue insulin.a


Insulin requirements >40 units daily: Initially, 250 mg daily; reduce daily insulin dosage by 50%.a b Subsequently, adjust insulin dosage according to therapeutic response.a b


Titration and Maintenance Dosage

Oral

Titrate dosage according to patient's response, using lowest possible effective dosage.a b Adjust dosage in increments or decrements of 100–250 mg daily at weekly intervals.a b


Usual maintenance dosage is 100 mg to 1 g daily (average 250–500 mg daily).a b Patients not responding to 1 g daily are unlikely to respond to higher dosages.a b


Prescribing Limits


Adults


Type 2 Diabetes Mellitus

Oral

Maximum 1 g daily.a b


Special Populations


Hepatic Impairment


Use conservative initial and maintenance dosages to avoid hypoglycemia.a b


Renal Impairment


Use conservative initial and maintenance dosages to avoid hypoglycemia.a b


Geriatric Patients


Initially, 100 mg daily.a b May increase dosage by 50–125 mg daily at weekly intervals.a Use conservative initial and maintenance dosages to avoid hypoglycemia.a b


Debilitated or Malnourished Patients


Initially, 100 mg daily.a b May increase dosage by 50–125 mg daily at weekly intervals.a Use conservative initial and maintenance dosages to avoid hypoglycemia.a b


Cautions for Tolazamide


Contraindications



  • Known hypersensitivity to tolazamide.b




  • Monotherapy for type 1 diabetes mellitus.a b




  • Diabetic ketoacidosis, with or without coma.a b




  • Acute complications (e.g., major surgery, severe infection, or severe trauma).a




  • Uremia.a



Warnings/Precautions


Warnings


Cardiovascular Effects

Increased cardiovascular mortality reported with certain other antidiabetic agents (i.e., tolbutamide, phenformin).106 108 109 112 125 129 130 131 b However, the American Diabetes Association (ADA) considers the benefits of intensive glycemic control with insulin or sulfonylureas to outweigh the risks overall.109 119 125


Sensitivity Reactions


Dermatologic Reactions

Possible allergic skin reaction (e.g., pruritus, erythema, urticaria, rash, morbilliform or maculopapular eruptions).a b May be transient; discontinue the drug if reaction persists.b


Photosensitivity Reactions

Rarely, photosensitivity reactions reported.a b


General Precautions


Hypoglycemia

Possibly severe hypoglycemia reported, especially in debilitated, malnourished, or geriatric patients and patients with adrenal, pituitary, hepatic, or renal insufficiency.a b Strenuous exercise, alcohol ingestion, insufficient caloric intake, or use in combination with other antidiabetic agents may increase risk.a b


Hypoglycemia may be difficult to recognize in geriatric patients and in those receiving β-adrenergic blocking agents.b (See Specific Drugs under Interactions.)


Increased risk of hypoglycemia in patients with irregular eating patterns.119


Appropriate patient selection and careful dosing and instructions are important to avoid tolazamide-induced hypoglycemia.a b


If hypoglycemia occurs, immediately reevaluate patient and adjust insulin or tolazamide dosage.a Monitor patient for ≥24–48 hours; may require hospitalization and IV dextrose.b


Loss of Glycemic Control

Possible loss of glycemic control during periods of stress (e.g., fever, trauma, infection, surgery).a b May require use of insulin and/or temporary discontinuance of tolazamide.a b


Efficacy of therapy may decrease over time (secondary failure); evaluate patients at regular intervals.a b


Assess patients for adequate adjustment of dose and adherence to diet before attributing inadequate response to secondary failure.b


Manufacturer recommends discontinuance of tolazamide if satisfactory glycemic control no longer is achieved.b ADA and other clinicians recommend addition of other oral antidiabetic agents or insulin.124 147 179 180 181 182 183 186 188 (See Diabetes Mellitus under Uses.)


Hepatic Effects

Cholestatic jaundice and alterations in liver function test results (e.g., bilirubin, cholesterol, AST, ALT) reported.a b If cholestatic jaundice occurs, discontinue the drug.b


Use with caution in patients with a history of hepatic porphyria; sulfonylureas may exacerbate this condition.a b


Specific Populations


Pregnancy

Category C.b


Many experts recommend the use of insulin during pregnancy.b


Not recommended for use during pregnancy by manufacturer.b Prolonged (4–10 days), severe hypoglycemia reported in some neonates born to women receiving a sulfonylurea at delivery; more frequent with long-acting sulfonylureas.b If used during pregnancy, discontinue ≥2 weeks before the expected delivery date to minimize the risk of neonatal hypoglycemia.b


Lactation

Not known whether tolazamide is distributed into human milk.b Some sulfonylurea drugs are distributed into human milk.b Discontinue nursing or the drug.b


If drug is discontinued and diet alone is inadequate for glycemic control, consider insulin.b


Pediatric Use

Safety and efficacy not established.b


Geriatric Use

Increased risk of hypoglycemia;a b hypoglycemia may be difficult to recognize.b


Possible increased risk of hypoglycemia due to age-related decreases in renal function.b Renal function monitoring recommended; select dosage with caution.a b


Hepatic Impairment

Increased risk of hypoglycemia; conservative dosing recommended.a b


Renal Impairment

Increased risk of hypoglycemia; conservative dosing recommended.b (See Renal Impairment under Special Populations in Dosage and Administration.)


Common Adverse Effects


Nausea,a b epigastric fullness,b heartburn,b vomiting,a anorexia,a intestinal gas,a diarrhea,a constipation,a cramps.a


Interactions for Tolazamide


Protein-bound Drugs


Potential pharmacokinetic interaction (increased hypoglycemic effect).b (See Specific Drugs under Interactions.)


Close observation recommended when initiating or discontinuing concomitant therapy with a highly protein-bound drug.b


Specific Drugs








































































Drug



Interaction



Comments



Alcohol



Possible disulfiram-like reactionsa


May predispose patients to the development of hypoglycemiab



Anticoagulants, oral



Possible potentiation of hypoglycemic effectsb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Antifungals, oral (i.e., fluconazole, miconazole)



Increased plasma concentrations of the oral antidiabetic agent and/or possible hypoglycemia167 b



Not known whether interaction occurs with IV, topical, or vaginal miconazoleb


Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



β-Adrenergic blocking agents



Possible potentiation of hypoglycemic effectsb


Signs of hypoglycemia may be masked by β-adrenergic blocking agentsb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Calcium-channel blocking agents



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Chloramphenicol



Possible potentiation of hypoglycemic effectsb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Contraceptives, oral



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Corticosteroids



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Diuretics



Potential for decreased hypoglycemic effecta b


May cause temporary loss of diabetic control or secondary failurea



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinueda b



Estrogens



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Insulin



Possible potentiation of hypoglycemic effectsa



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Isoniazid



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



MAO inhibitors



Possible potentiation of hypoglycemic effectsa b



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Niacin



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control or when concurrent therapy is initiated or discontinuedb



NSAIAs



Possible potentiation of hypoglycemic effectsb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Phenothiazines



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Phenytoin



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Probenecid



Possible potentiation of hypoglycemic effectsa b



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Salicylates



Possible potentiation of hypoglycemic effectsa b



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Sulfonamides



Possible potentiation of hypoglycemic effectsa b



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Sympathomimetic agents



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb



Thyroid agents



Potential for decreased hypoglycemic effectb



Observe carefully for hypoglycemia or loss of glycemic control when concurrent therapy is initiated or discontinuedb


Tolazamide Pharmacokinetics


Absorption


Bioavailability


Rapidly and well absorbed following oral administration.b Peak serum concentrations attained at 3–4 hours.b


Onset


Following a single 500 mg dose in nondiabetic, fasting adults, hypoglycemic effect occurs within 20 minutes; peak hypoglycemic effect occurs at 1–4 hours.a b


Following a single 500 mg dose in fasting diabetics, peak hypoglycemic effect occurs at 4–6 hours.b


In nonfasting diabetics, onset of hypoglycemic effect occurs within 4–6 hours.a b


Duration


In nondiabetic, fasting adults, pharmacologic effects persist for at least 20 hours.a b


In nonfasting diabetics, hypoglycemic activity persists for about 10 hours; blood glucose concentrations begin to increase at 14–16 hours following a single dose.a b


Distribution


Extent


Distributed into extracellular fluids; distribution not fully characterized.a


Not known whether tolazamide is distributed into milk.b


Elimination


Metabolism


Metabolized to active and inactive metabolites, probably in the liver.a b


Elimination Route


Excreted principally in urine (85%) principally as metabolites and in feces (7%); small amounts excreted in urine unchanged.a b


Half-life


Approximately 7 hours.a b


Stability


Storage


Oral


Tablets

Tight, light-resistant containers at 20–25°C.a b Protect from light.b


ActionsActions



  • Mechanism of long-term hypoglycemic action of sulfonylurea antidiabetic agents has not been clearly established.b Appears to lower blood glucose concentration principally by stimulating the secretion of endogenous insulin from the beta cells of the pancreas.a b




  • Ineffective in the absence of functioning beta cells.a




  • Lowers blood glucose concentration in diabetic and nondiabetic individuals.a b




  • During prolonged administration, extrapancreatic effects (e.g., enhanced peripheral sensitivity to insulin, reduction of basal hepatic glucose production) may contribute to the hypoglycemic action.a b




  • A gradual decline in the insulin secretory response to drug may occur; however, blood glucose lowering effect persists.b




  • May produce a mild diuresis by enhancement of renal free water clearance.b



Advice to Patients



  • Importance of informing patients of potential risks and advantages of tolazamide therapy and of alternative forms of treatment.b




  • Importance of regular monitoring of blood glucose (preferable self-monitoring) and of HbA1c.b




  • According to manufacturer, patients should test their urine for glucose and acetone ≥3 times daily during insulin withdrawal.b Report abnormal results to clinician for appropriate adjustments in therapy.b




  • Importance of hygiene and avoidance of infection.a




  • Advise patients about nature of diabetes mellitus, prevention and detection of complications, and importance of glycemic control.a




  • Risks of hypoglycemia.a b Importance of patients and responsible family members understanding symptoms and treatment of hypoglycemic reactions and identifying conditions that predispose to development of such reactions.a b




  • Importance of understanding primary and secondary failure to therapy.b




  • Importance of adherence to diet and exercise regimen.a b




  • Risk of photosensitivity reactions.a b




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




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b Inform patients that tolazamide is not recommended during pregnancy.b




  • Importance of informing patients of other important precautionary information.b (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


















Tolazamide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



250 mg*



Tolazamide Tablets (scored)



500 mg*



Tolazamide Tablets (scored)


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


TOLAZamide 100MG Tablets (IVAX PHARMACEUTICALS INC.): 60/$26.99 or 180/$68.97


TOLAZamide 250MG Tablets (MYLAN): 60/$35.99 or 180/$96.97


TOLAZamide 500MG Tablets (MYLAN): 30/$45.99 or 90/$109.96



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 May 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



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102. Hoechst-Roussel Pharmaceuticals Inc. Diaβeta (glyburide) prescribing information. Somerville, NJ; 1987 Dec.



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123. Ohkubo Y, Kishikawa H, Araki E et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus; a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995; 28:103-17. [PubMed 7587918]



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125. American Diabetes Association. The United Kingdom Prospective Diabetes Study (UKPDS) for type 2 diabetes: what you need to know about the results of a long-term study. Washington, DC; September 15, 1998. From American Diabetes Association web site.



126. Davis TM. United Kingdom Prospective Diabetes Study: the end of the beginning? Med J Aust. 1998; 169:511-2.



127. Watkins PJ. UKPDS: a message of hope and a need for change. Diabet Med. 1998; 15:895-6. [PubMed 9827842]



128. Turner RC, Cull CA, Frighi V et al. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirements for multiple therapies (UKPDS 49). JAMA. 1999; 281:2005-12. [IDIS 425712] [PubMed 10359389]



129. Scientific Advisory Panel of the Executive Committee, American Diabetes Association. Policy statement: the UGDP controversy. Diabetes. 1979; 28:168-70.



130. Jackson JE, Bressler R. Clinical pharmacology of sulphonylurea hypoglycaemic agents: part 2. Drugs. 1981; 22:295-320. [IDIS 143257] [PubMed 7030708]



131. Food and Drug Administration. Labeling for oral hypoglycemic drugs of the sulfonylurea class. [Docket No. 75N-0062] Fed Regist. 1984; 49:14303-31.



132. Pharmacia & Upjohn Company. Tolinase (tolazamide) tablets prescribing information. Kalamazoo, MI; 2000 Jan.



133. American Diabetes Association. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2000; 23(Suppl 1):S4-19.



134. American Diabetes Association. Type 2 diabetes in children and adolescents. Pediatrics. 2000; 105:671-80. [IDIS 443594] [PubMed 10699131]



135. American Diabetes Association. Office guide to diagnosis and classification of diabetes mellitus and other categories of glucose intolerance. Diabetes Care. 1995; 18(Suppl 1):4.



136. Williams G. Management of non-insulin-dependent diabetes mellitus. Lancet. 1994; 343:95-100. [IDIS 324190] [PubMed 7903785]



137. Genuth S. Exogenous insulin administration and cardiovascular risk in non-insulin-dependent and insulin-dependent diabetes mellitus. Ann Intern Med. 1996;124(1 Part 2):104-9.



138. DeFronzo RA. The triumvirate: beta-cell, muscle, liver. A collusion responsible for NIDDM. Diabetes. 1988; 37:667-87. [PubMed 3289989]



139. Polonsky KS, Sturis J, Bell GI. Non-insulin-dependent diabetes mellitus-a genetically programmed failure of the beta cell to compensate for insulin resistance. N Engl J Med. 1996; 334:777-83. [PubMed 8592553]



140. Swislocki A. Insulin resistance and hypertension. Am J Med Sci. 1990; 300:104-15. [IDIS 272104] [PubMed 2206054]



141. United Kingdom Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998; 317:703-13. [IDIS 412064] [PubMed 9732337]



142. UK Prospective Diabetes Study (UKPDS) Group. Efficacy of atenolol and captopril in reducing risk of macrovascular complications in type 2 diabetes mellitus: UKPDS 39. BMJ. 1998; 317:713-20. [IDIS 412065] [PubMed 9732338]



143. Haffner SM, Hanefeld M, Fischer S et al. Glibenclamide, but not acarbose, increase leptin concentrations parallel to changes in insulin in subjects with NIDDM. Diabetes Care. 1997; 20: 1430-4. [IDIS 393377] [PubMed 9283792]



144. Shi H, Moustaid-Moussa N, Wilkison WO et al. Role of the sulfonylurea receptor in regulating human adipocyte metabolism. FASEB J. 1999; 13:1833-8. [PubMed 10506587]



145. Cheskin LJ, Bartlett SJ, Zayas R et al. Prescription medications: a modifiable contributor to obesity. South Med J. 1999; 92:898-904. [IDIS 435069] [PubMed 10498166]



146. Chow CC, Sorensen JP, Tsang LWW et al. Comparison of insulin with or without continuation of oral hypoglycemic agents in the treatment of secondary failure in NIDDM patients. Diabetes Care. 1995; 18:307-14. [IDIS 346283] [PubMed 7555472]



147. Zimmerman B, Espenshade J, Fujimoto W et al. The pharmacological treatment of hyperglycemia in NIDDM. Diabetes Care. 1996; 19:1510-18.



148. Expert Committee of the Canadian Diabetes Advisory Board. Clinical practice guidelines for treatment of diabetes mellitus. Can Med Assoc J. 1992; 147:697-712.



149. Raskin P. Combination therapy in NIDDM N Engl J Med. 1992; 327:1453-4. Editorial.



150. Pugh JA, Ramirez G, Wagner ML et al. Is combination sulfonylurea and insulin therapy useful in NIDDM patients? A metaanalysis. Diabetes Care. 1992; 15:953-9. [PubMed 1387073]



151. Landstedt-Hallin L, Bolinder J, Adamson U et al. Comparison of bedtime NPH or preprandial regular insulin combined with glibenclamide in secondary sulfonylurea failure. Diabetes Care. 1995; 18:1183-6. [IDIS 351422] [PubMed 7587856]



152. Trischitta V, Italia S, Mazzarino S et al. Comparison of combined therapies in treatment of secon dary failure to glyburide. Diabetes Care. 1992; 15:539-42. [PubMed 1499473]



153. Krentz AJ, Ferner RE, Bailey CJ. Comparative tolerability profiles of oral antidiabetic agents. Drug Safety. 1994; 11:223-41. [PubMed 7848543]



154. Buse J. Combining insulin and oral agents. Am J Med. 2000; 108(Suppl 6A):23S-32S. [IDIS 446200] [PubMed 10764847]



155. Johnson JL, Wolf SL, Kabadi UM. Efficacy of insulin and sulfonylurea combination therapy in type II diabetes: a meta-analysis of the randomized placebo-controlled trials. Arch Intern Med. 1996; 156:259-64. [IDIS 363130] [PubMed 8572835]



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157. Yki-Jarvinen H, Dressler A, Ziemen M et al. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime HPH insulin during insulin combination therapy in type 2 diabetes. Diabetes Care. 2000; 23:1130-6 (IDIS 451244) [IDIS 451244] [PubMed 10937510]



158. Bastyr EJ, Johnson ME, Trautman ME et al. Insulin lispro in the treatment of patients with type 2 diabetes mellitus after oral agent failure. Clin Ther. 1999; 21:1703-4. [IDIS 438022] [PubMed 10566566]



159. DeFronzo RA. Pharmacologic therapy for type 2 diabetes mellitus. Ann Intern Med. 1999; 131:281-303. [IDIS 430576] [PubMed 10454950]



160. Lebovitz HE. Clinical utility of oral hypoglycemic agents in the management of patients with noninsulin-dependent diabetes mellitus. Am J Med. 1983; 75(Suppl. 5B):94-9.



161. Anon. Diabetes mellitus. NIH Cons Dev Conf Statement. 1986; 6:1-7.



162. Blake GH. Control of type II diabetes: reaping the rewards of exercise and weight loss. Postgrad Med. 1992; 92:129-32. [PubMed 1437899]



163. Kerr CP. Improving outcomes in diabetes: a review of the outpatient care of NIDDM patients. J Fam Pract. 1995; 40:63-75. [PubMed 7807040]



164. Bailey C, Turner R. Metformin. N Engl J Med. 1996; 334:574-9. [IDIS 360526] [PubMed 8569826]



165. Turner R, Cull C, Holman R et al. United Kingdom Prospective Diabetes Study 17: a 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus. Ann Intern Med. 1996; 124(1 Pt 2):136-45. [IDIS 358782] [PubMed 8554206]



166. Bristol-Myers-Squibb Company. Glucovance(glyburide and metformin hydrochloride) tablets prescribing information. Princeton, NJ; 2002 Oct.



167. Pfizer Inc. Glucotrol XL(glipizide) extended release tablets prescribing information. New York, NY; 2001 Apr.



168. Pfizer. Diflucan (fluconazole) tablets, for oral suspension, and injection prescribing information. New York, NY; 1998 Jun.



169. Wolffenbuttel BHR, Gomist R, Squatrito S et al. Addition of low-dose rosiglitazone to sulphonylurea therapy improves glycaemic control in type 2 diabetic patients. Diabet Med. 2000; 17:40-7. [PubMed 10691158]



170. Takeda Pharmaceuticals America. Actos (pioglitazone hydrochloride) tablets prescribing information. Lincolnshire, IL; 2002 July.



171. SmithKline Beecham. Avandia (rosiglitazone maleate) tablets prescribing information. Philadelphia, PA; 2002 May



172. Kipnes MS, Krosnick a, Rendell MS et al. Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycemic control in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study. Am J Med. 2001; 111:10-7. [IDIS 467740] [PubMed 11448655]



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174. Coniff RF, Shapiro JA, Seaton TB et al. Multicenter, placebo-controlled trial comparing acarbose (BAY g 5421) with placebo, tolbutamide, and tolbutamide-plus-acarbose in non-insulin-dependent diabetes mellitus. Am J Med. 1995; 98:443-51. [IDIS 348267] [PubMed 7733122]



175. Calle-Pascual AL, Garcia-Honduvilla J, Martin-Alvarez PJ et al. Comparison between acarbose, metformin, and insulin treatment in type 2 diabetic patients with secondary failure to sulfonylurea treatment. Diabetes Metab. 1995; 21:256-60.



176. Klein W. S

Saturday, 25 August 2012

Tar Distillate Topical


Generic Name: coal tar (Topical route)


kole tar


Commonly used brand name(s)

In the U.S.


  • Betatar Gel

  • Cutar Emulsion

  • Denorex

  • DHS Tar

  • Doak Tar

  • Duplex T

  • Fototar

  • Ionil-T Plus

  • Medotar

  • MG 217

  • Neutrogena T/Derm

  • Neutrogena T/Gel

In Canada


  • Estar

  • Liquor Carbonis Detergens

  • Psorigel

  • Spectro Tar Skin Wash

  • Tar Distillate

Available Dosage Forms:


  • Liquid

  • Shampoo

  • Lotion

  • Solution

  • Cream

  • Gel/Jelly

  • Soap

  • Kit

  • Ointment

  • Bar

  • Foam

  • Emulsion

Therapeutic Class: Keratolytic


Uses For Tar Distillate


Coal tar is used to treat eczema, psoriasis, seborrheic dermatitis, and other skin disorders.


Some of these preparations are available only with your doctor's prescription.


Before Using Tar Distillate


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


Coal tar products should not be used on infants, unless otherwise directed by your doctor. Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.


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


Interactions with Food/Tobacco/Alcohol


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


Proper Use of coal tar

This section provides information on the proper use of a number of products that contain coal tar. It may not be specific to Tar Distillate. Please read with care.


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


After applying coal tar, protect the treated area from direct sunlight and do not use a sunlamp for 72 hours, unless otherwise directed by your doctor, since a severe reaction may occur. Also, make sure you have removed all the coal tar medicine from your skin before you go back into direct sunlight or use a sunlamp.


Do not apply this medicine to infected, blistered, raw, or oozing areas of the skin.


Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water at once.


To use the cream or ointment form of this medicine:


  • Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of this medicine:


  • Apply enough gel to cover the affected area, and rub in gently. Allow the gel to remain on the affected area for 5 minutes, then remove excess gel by patting with a clean tissue.

To use the shampoo form of this medicine:


  • Wet the scalp and hair with lukewarm water. Apply a generous amount of shampoo and rub into the scalp, then rinse. Apply the shampoo again, working up a rich lather, and allow to remain on the scalp for 5 minutes. Then rinse thoroughly.

To use the nonshampoo liquid form of this medicine:


  • Some of these preparations are to be applied directly to dry or wet skin, some are to be added to lukewarm bath water, and some may be applied directly to dry or wet skin or added to lukewarm bath water. Make sure you know exactly how you should use this medicine. If you have any questions about this, check with your health care professional.

  • If this medicine is to be applied directly to the skin, apply enough to cover the affected area, and rub in gently.

  • Some of these preparations contain alcohol and are flammable. Do not use near heat, near open flame, or while smoking.

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 eczema, psoriasis, seborrheic dermatitis, and other skin disorders:
    • For cleansing bar dosage form:
      • Adults—Use one or two times a day, or as directed by your doctor.

      • Children—Use and dose must be determined by your doctor.


    • For cream dosage form:
      • Adults—Apply to the affected area(s) of the skin up to four times a day.

      • Children—Use and dose must be determined by your doctor.


    • For gel dosage form:
      • Adults—Apply to the affected area(s) of the skin one or two times a day.

      • Children—Use and dose must be determined by your doctor.


    • For lotion dosage form:
      • Adults—Apply directly to the affected area(s) of the skin or use as a bath, hand or foot soak, or as a hair rinse, depending on the product.

      • Children—Use and dose must be determined by your doctor.


    • For ointment dosage form:
      • Adults—Apply to the affected area(s) of the skin two or three times a day.

      • Children—Use and dose must be determined by your doctor.


    • For shampoo dosage form:
      • Adults—Use once a day to once a week or as directed by your doctor.

      • Children—Use and dose must be determined by your doctor.


    • For topical solution dosage form:
      • Adults—Apply to wet the skin or scalp, or use as a bath, depending on the product.

      • Children—Use and dose must be determined by your doctor.


    • For topical suspension dosage form:
      • Adults—Use as a bath.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, apply 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.


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 Tar Distillate


If this medicine is used on the scalp, it may temporarily discolor blond, bleached, or tinted hair.


Coal tar may stain the skin or clothing. Avoid getting it on your clothing. The stain on the skin will wear off after you stop using the medicine.


Tar Distillate Side Effects


In animal studies, coal tar has been shown to increase the chance of skin cancer.


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:


Rare
  • Skin irritation not present before use of this medicine

  • skin rash

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
  • Stinging (mild)—especially for gel and solution dosage forms

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: Tar Distillate Topical 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.


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More Tar Distillate Topical resources


  • Tar Distillate Topical Side Effects (in more detail)
  • Tar Distillate Topical Use in Pregnancy & Breastfeeding
  • Tar Distillate Topical Support Group
  • 4 Reviews for Tar Distillate Topical - Add your own review/rating


Compare Tar Distillate Topical with other medications


  • Dermatitis
  • Psoriasis
  • Seborrheic Dermatitis

CitraNatal DHA


Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN


What are CitraNatal DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.


Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.


Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.


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


What is the most important information I should know about prenatal vitamins?


There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.


Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?


Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.


You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?


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


Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.


The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.


Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?


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


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.


What should I avoid while taking prenatal vitamins?


Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:



  • upset stomach;




  • headache; or




  • unusual or unpleasant taste in your mouth.



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


What other drugs will affect prenatal vitamins?


Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:



  • diuretics (water pills);




  • heart or blood pressure medications;




  • tretinoin (Vesanoid);




  • isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);




  • trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.



This list is not complete and other drugs may interact with prenatal vitamins. 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.



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Where can I get more information?


  • Your pharmacist can provide more information about prenatal vitamins.