Sunday 24 June 2012

Nembutal


Generic Name: Pentobarbital Sodium
Class: Barbiturates
VA Class: CN301
CAS Number: 76-74-4

Introduction

Barbiturate; anxiolytic, sedative, hypnotic, and anticonvulsant.a b


Uses for Nembutal


Insomnia


Short-term treatment of insomnia (i.e., ≤2 weeks duration); decreased effectiveness for sleep induction and maintenance after 2 weeks.a b


Has been used for routine sedation.a b However, barbiturates used infrequently for this indication since there are few clinical situations in which oral barbiturates provide a safety or efficacy advantage over nonbarbiturate sedatives/hypnotics.e


Surgery and Preanesthesia


Preoperatively, to produce sedation and relieve anxiety.b


Provide basal hypnosis for general, spinal, or regional anesthesia, or to facilitate intubation procedures.a b


Seizure Disorders


Alternate therapy to control status epilepticus or acute seizure episodes resulting from meningitis, poisons, eclampsia, alcohol withdrawal, tetanus, or chorea.a b


IV diazepam generally considered drug of choice for termination of status epilepticus.g


Drug Withdrawal


Withdrawal of barbiturate or nonbarbiturate hypnotics in physically dependent patients.b


Agitated Behavior


Has been used to control acute episodes of agitated behavior in psychoses; however, little value in long-term management of psychoses.b


Coma Induction


Has been used in high doses to induce coma in the management of cerebral ischemia and increased intracranial pressure associated with head trauma, stroke, Reye’s syndrome, cardiac arrest, asphyxiation, or drowning. b


Has been used to ameliorate or prevent sequelae associated with cerebral ischemia during neurosurgical procedures that require long periods of cerebral hypoxia.b


Nembutal Dosage and Administration


General



  • Adjust dosage carefully and slowly according to individual requirements and response.b




  • Following chronic administration, withdraw pentobarbital slowly to avoid the possibility of precipitating withdrawal symptoms if the patient is physically dependent on the drug.b




  • To prevent rebound in rapid eye movement (REM) sleep, withdrawal of a single therapeutic dose over 5 or 6 days (e.g., reducing dosage from 3 to 2 doses daily for 1 week) has been recommended when barbiturates are discontinued following prolonged use.a



Insomnia



  • Do not administer for periods >2 weeks.a b e



Administration


Administer by IM or slow IV injection.a b


IV Administration


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


Reserve IV administration for inducing anesthesia or emergency treatment of acute seizure episodes or acute episodes of agitated behavior in psychoses.b (See Seizure Disordersand also Agitated Behavior under Uses.)


Usually administered in a concentration of 50 mg/mL.


Must be administered by slow IV injection and in fractional doses to allow for adequate time for pentobarbital to distribute into CNS.a A time interval of ≥1 minute is required to determine the full effect of an IV dose.a b


Administer under close supervision and in a setting where vital signs can be monitored; BP, respiration, and cardiac function maintained; and equipment for resuscitation and artificial ventilation are readily available.a b (See Respiratory and Cardiovascular Effects under Cautions.)


Avoid intra-arterial and extravascular injection.a (See Intra-arterial Injection under Cautions.)


Rate of Administration

Do not exceed 50 mg/minute.a b (See Respiratory and Cardiovascular Effects under Cautions.)


IM Administration


Administer by deep IM injection into a large muscle.a b


Administer a maximum volume of 5 mL at any one site to avoid tissue irritation.a b


After administration of large hypnotic doses, observe patient closely for 20–30 minutes and monitor vital signs to ensure narcosis will not be excessive.a b


Dosage


Available as pentobarbital sodium; dosage expressed in terms of the salt.a


IV dosage generally determined by patient’s reaction to slow administration of the drug.b


A time interval of >1 minute required to determine the full effect of an IV dose.a b


Pediatric Patients


Insomnia

IM

2–6 mg/kg a b or 125 mg/m2 as a single dose (maximum 100 mg).a b


Surgery and Preanesthesia

IM

Usually, approximately 5 mg/kg. b


IV

Initially, usually 50 mg.b If necessary, administer subsequent doses after >1 minute.b


Seizure Disorders

IV

Initially, usually 50 mg.b If necessary, administer subsequent doses after >1 minute.b


Agitated Behavior

IV

Initially, usually 50 mg.b If necessary, administer subsequent doses after >1 minute.b


Adults


Insomnia

IM

150–200 mg as a single dose.a b


IV

Initially, usually 100 mg for an adult weighing 70 kg.a b After >1 minute, if necessary, administer additional small doses up to a total of 200–500 mg.a b


Surgery and Preanesthesia

IM

150–200 mg as a single dose.a b


Seizures

IV

Initially, usually 100 mg.a b After >1 minute, if necessary, administer additional small doses up to a total of 200–500 mg.a b


Administer minimum dosage to avoid compounding the CNS and respiratory depression which may follow seizures.a b (See CNS Depression and also Respiratory and Cardiovascular Effects, under Cautions.)


Drug Withdrawal

IM

Establish a stabilizing dose (generally adminstered at 6-hour intervals), then decrease the daily dose by no more than 100 mg per day.b Severely dependent patients can usually be withdrawn from barbiturates in 14–21 days.b


Agitated Behavior

IV

Initially, usually 100 mg.a b After >1 minute, if necessary, administer additional small doses up to a total of 200–500 mg.a b


Prescribing Limits


Pediatric Patients


Insomnia

IM

Maximum 100 mg daily.a b


Adults


IV

Maximum 200–500 mg.a b


Special Populations


Hepatic Impairment


Dosage reduction recommended. a b e


Renal Impairment


Dosage reduction recommended.a


Geriatric Patients


Dosage reduction recommended.a b e


Debilitated Patients


Dosage reduction recommended.a b e


Cautions for Nembutal


Contraindications



  • Known hypersensitivity to any barbiturates.a




  • History of manifest or latent porphyria.a e (See Porphyria under Cautions.)




  • Bronchopneumonia or other severe pulmonary insufficiency.e



Warnings/Precautions


Warnings


Pain Reaction

Potential for paradoxical excitement and/or euphoria, restlessness, or delirium in patients with severe pain. a e Barbiturates could mask important symptoms in patients with acute or chronic pain.a e Use with caution in such patients. a e Should not be used in the presence of uncontrolled pain.e


Abuse Potential

Possible tolerance, psychological dependence, and physical dependence following prolonged administration.a


Withdrawal Effects

Abrupt cessation after prolonged use in dependent individuals may result in withdrawal symptoms (e.g., delirium, convulsions) and potentially be fatal.a Drug must be withdrawn gradually in patients receiving excessive dosages over extended periods of time.a


CNS Depression

Performance of activities requiring mental alertness or physical coordination may be impaired.a e


Concurrent use of other CNS depressants may potentiate CNS depression.a (See Specific Drugs under Interactions.)


Respiratory and Cardiovascular Effects

Possible respiratory depression, apnea, laryngospasm, or vasodilation and hypotension, particularly if pentobarbital is administered IV too rapidly. a e Administer slowly; personnel and equipment should be readily available for administration of artificial respiration.a b


Fetal/Neonatal Morbidity

May cause fetal harm.a e If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.a e


Retrospective, case-controlled studies indicate an association between maternal ingestion of barbiturates and a higher than expected incidence of fetal abnormalities.a e


Barbiturates have caused postpartum hemorrhage and hemorrhagic disease in neonates; readily reversible with vitamin K therapy.e


Possible withdrawal symptoms in neonates born to women who received barbiturates throughout the last trimester of pregnancy.a e Premature neonates are particularly susceptible to the depressant effects of barbiturates.e


Porphyria

Potential exacerbation of acute intermittent porphyria or porphyria variegata.e (See Contraindications under Cautions.)


Complex Sleep-related Behaviors

Potential risk of complex sleep-related behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative-hypnotic drug, with no memory of the event), making phone calls, or preparing and eating food, while asleep.h


Sensitivity Reactions


Potential risk of anaphylaxis and angioedema; may occur as early as with the first dose of drug.h


Dermatologic Effects and Hypersensitivity Reactions

Exfoliative dermatitis (e.g., Stevens-Johnson syndrome), sometimes fatal, reported rarely. a e Because skin eruptions can precede potentially fatal reactions, discontinue pentobarbital whenever dermatologic reactions occur.e


General Precautions


Intra-arterial Injection

Inadvertent intra-arterial administration can cause local reactions varying in severity from transient pain to gangrene.a Inadvertent extravascular injection may cause local tissue damage and result in necrosis.a e


Discontinue injection if the patient complains of pain in limb.a


Suicide

Use with caution, if at all, in patients with depression or suicidal tendencies.a e


Concomitant Diseases

Use parenterally with caution in patients with hypertension, hypotension, pulmonary or cardiovascular disease, or shock.e


Specific Populations


Pregnancy

Category D.a (See Fetal/Neonatal Morbidity under Cautions.)


Lactation

Distributed into milk;a e use with caution.a


Geriatric Use

Possible increased sensitivity to barbiturates.a Geriatric patients may frequently react to barbiturates with excitement, confusion, or depression.a e


Debilitated Patients

Possible increased sensitivity to barbiturates.a Debilitated patients may frequently react to barbiturates with excitement, confusion, or depression.a


Hepatic Impairment

Use with caution;a e should not be used in patients with marked hepatic impairment, including patients with premonitory signs of hepatic coma.a


Common Adverse Effects


Residual sedation,e drowsiness,a e lethargy,e vertigo,a e nausea,a e vomiting,a e headache.a e


Interactions for Nembutal


Metabolized by hepatic microsomal enzymes.a Induces hepatic microsomal enzymes.a


Specific Drugs

































Drug



Interaction



Comments



Anticoagulants, oral (e.g., warfarin)



Possible decreased plasma warfarin concentrationsa e



Adjust anticoagulant dosage as necessary, especially upon initiation or discontinuance of pentobarbitala e



CNS depressants (e.g., sedatives, hypnotics, antihistamines, tranquilizers, alcohol)



Possible additive depressant effectsa e



Contraceptives, oral



Possible enhanced metabolism of estrogenic and progestinic components; potential for decreased oral contraceptive effectiveness and increased risk of pregnancy with pentobarbital pretreatment or concurrent therapya e



Consider alternate methods of contraceptiona e



Corticosteroids



Possible increased corticosteroid metabolisma



Dosage adjustment of corticosteroid may be required; closely monitor patients (especially asthmatics) receiving corticosteroids when pentobarbital is initiateda e



Doxycycline



Possible decreased half-life of doxycycline; effect may persist up to 2 weeks after discontinuance of pentobarbitala



If possible, avoid concomitant administration; if administered concomitantly, monitor clinical response to doxycyclinea e



Griseofulvin



Possible decreased griseofulvin absorption, resulting in decreased blood concentrationsa e



Avoid concomitant administration; if concomitant therapy is necessary, administration of griseofulvin in 3 divided doses daily may improve absorptiona e


Monitor blood griseofulvin concentrations and increase dosage, if necessarye



MAO inhibitors



Possible prolongation of pentobarbital effectsa e



Dose adjustment of pentobarbital may be requirede



Phenytoin



Increased, decreased, or no change in plasma phenytoin concentrations reported a



Monitor plasma concentrations of phenytoin and pentobarbital; a adjust dosages as necessarya



Valproic acid



Possible increased plasma pentobarbital concentrationsa



Monitor plasma pentobarbital concentrations and adjust dosage as neededa


Nembutal Pharmacokinetics


Absorption


Onset


Following IV administration, onset occurs within 1 minute.a b e


Following IM administration, onset occurs within 10–25 minutes.b


Duration


Variable;a patient-dependent and may vary occasionally within same patient.a About 15 minutes following IV administration.b


Plasma Concentrations


Plasma concentrations of 1–5 mcg/mL generally produce sedation and plasma concentrations of 5–15 mcg/mL generally produce sleep; however, plasma concentrations >10 mcg/mL may produce deep coma and those >30 mcg/mL are potentially lethal.b


Distribution


Extent


Rapidly distributed to all tissues and fluids,a e with high concentrations in the brain, liver, and kidneys.a e


Crosses the placenta and is distributed into milk.a e


Plasma Protein Binding


Approximately 35–45%.b


Elimination


Metabolism


Metabolized primarily by hepatic microsomal enzymes.a b e


Elimination Route


Excreted principally in urine, mostly as metabolites; excreted less commonly in the feces.a


Half-life


Biphasic; terminal half-life is 35–50 hours.b


Stability


Storage


Parenteral


Solution for Injection

30°C (brief exposure up to 40°C permitted).a Protect from freezing and avoid excessive heat.a


Do not use if discoloration or precipitation occurs.a


Compatibility


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


Parenteral


Solution CompatibilityHID





















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 or 10% in water



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%



Sodium lactate (1/6) M



Variable



Dextrose 5% in water (depends on pentobarbital concentration)



Sodium chloride 0.9% (depends on pentobarbital concentration)


Drug Compatibility



























Admixture CompatibilityHID

Compatible



Amikacin sulfate



Aminophylline



Calcium chloride



Chloramphenicol sodium succinate



Dimenhydrinate



Erythromycin lactobionate



Lidocaine HCl



Thiopental sodium



Verapamil HCl



Incompatible



Chlorpheniramine maleate



Ephedrine sulfate



Hydrocortisone sodium succinate



Hydroxyzine HCl



Norepinephrine bitartrate



Penicillin G potassium



Pentazocine lactate



Phenytoin sodium



Promazine HCl



Promethazine HCl



Sodium bicarbonate



Streptomycin sulfate



Succinylcholine chloride



Vancomycin HCl












Y-Site CompatibilityHID

Compatible



Acyclovir sodium



Gatifloxacin



Linezolid



Propofol



Incompatible



Amphotericin B cholesteryl sulfate complex



Fenoldopam mesylate



Lansoprazole


ActionsActions



  • CNS effects appear to be related, at least partially, to the drug's ability to enhance activity of GABA, the principal inhibitory neurotransmitter in the CNS, by altering inhibitory synaptic transmissions that are mediated by GABAA receptors.e




  • Capable of producing all levels of CNS depression—from mild sedation to hypnosis to deep coma to death.a e




  • Anticonvulsant effects of barbiturates are multiple and rather nonselective.g Principal mechanism of action appears to be reduction of monosynaptic and polysynaptic transmission resulting in decreased excitability of the entire nerve cell; barbiturates also increase the threshold for electrical stimulation of the motor cortex.g




  • Barbiturates lower serum bilirubin concentrations in neonates and patients with congenital nonhemolytic unconjugated hyperbilirubinemia, presumably by induction of glucuronyl transferase, the enzyme that conjugates bilirubin.e



Advice to Patients



  • Potential for pentobarbital to impair mental alertness or physical coordination; do not drive or operate machinery until effects on individual are known.a e




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol consumption.a Importance of avoiding alcohol while taking the drug.a




  • 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.


Subject to control under the Federal Controlled Substances Act of 1970 as schedule II (C-II) drugs.b


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


















Pentobarbital Sodium

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Bulk



Powder



Parenteral



Injection



50 mg/mL*



Nembutal Sodium Solution (C-II; with alcohol 10% and propylene glycol 40% v/v)



Ovation



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 February 2008. 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



a. Ovation Pharmaceuticals, Inc. Nembutal (pentobarbital sodium) injection prescribing information. Deerfield, IL; 2006 Nov.



b. AHFS Drug Information 2007. McEvoy GK, ed. Pentobarbital. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2505-2506.



c. Sirven JI, Waterhouse E. Management of Status Epilepticus. American Family Physician.. 2003; 68:469-76. [PubMed 12924830]



d. Fick DM, Cooper JW, Wade WE et al. Updating the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults: results of a US consensus panel of experts. Arch Intern Med. 2003; 163:2716-2724. [PubMed 14662625]



e. AHFS Drug Information 2007. McEvoy GK, ed. Barbiturates General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2500-2503.



g. AHFS Drug Information 2007. McEvoy GK, ed. Anticonvulsant General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2201-2206.



h. Food and Drug Administration. Pentobarbital injection. and



HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1319-25.



More Nembutal resources


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


  • Nembutal Concise Consumer Information (Cerner Multum)

  • Nembutal Prescribing Information (FDA)

  • Nembutal Sodium Concise Consumer Information (Cerner Multum)



Compare Nembutal with other medications


  • Insomnia
  • Sedation
  • Status Epilepticus

Metaglip


Generic Name: glipizide and metformin (GLIP ih zyd and met FOR min)

Brand Names: Metaglip


What is Metaglip (glipizide and metformin)?

Glipizide and metformin is a combination of two oral diabetes medicines that help control blood sugar levels.


Glipizide and metformin is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.


Glipizide and metformin may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Metaglip (glipizide and metformin)?


Do not use glipizide and metformin if you have congestive heart failure or kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking glipizide and metformin.


Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.


Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

What should I discuss with my healthcare provider before taking Metaglip (glipizide and metformin)?


Do not use glipizide and metformin if you have congestive heart failure or kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking glipizide and metformin.


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



  • heart disease;




  • liver disease;




  • a history of heart attack or stroke; or




  • if you are over 80 years old and have not recently had your kidney function checked.




Some people develop a life-threatening condition called lactic acidosis while taking metformin. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk. FDA pregnancy category C. It is not known whether glipizide and metformin will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether glipizide and metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking this medication.

How should I take Metaglip (glipizide and metformin)?


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


Take glipizide and metformin with meals.

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


Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.


Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.


Your doctor may want you to stop taking this medication for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.


Ask your doctor how to adjust your dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Your doctor may have you take extra vitamin B12 while you are taking glipizide and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.


Glipizide and metformin is only part of a complete program of treatment that also includes diet, exercise, and weight control. It is important to use this medicine 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.

See also: Metaglip dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember (be sure to take the medicine with food). 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 or call the Poison Help line at 1-800-222-1222. Overdose may cause lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

You may also have symptoms of severe hypoglycemia: extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).


What should I avoid while taking Metaglip (glipizide and metformin)?


Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Metaglip (glipizide and metformin) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired. Stop taking this medication and call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion, swelling or rapid weight gain;




  • pain or burning with urination;




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




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).



Less serious side effects may include:



  • cold symptoms such as stuffy nose, sneezing, sore throat;




  • headache, dizziness;




  • mild nausea, vomiting, diarrhea, stomach pain; or




  • joint or muscle pain.



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 Metaglip (glipizide and metformin)?


You may be more likely to have hyperglycemia (high blood sugar) if you take this medication with other drugs that can raise blood sugar, such as:



  • isoniazid;




  • diuretics (water pills);




  • steroids (prednisone and others);




  • heart or blood pressure medication (Cartia, Cardizem, Covera, Isoptin, Verelan, and others);




  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);




  • phenothiazines (Compazine and others);




  • thyroid medicine (Synthroid and others);




  • birth control pills and other hormones;




  • seizure medicines (Dilantin and others); and




  • diet pills or medicines to treat asthma, colds or allergies.



You may be more likely to have hypoglycemia (low blood sugar) if you take other drugs that can lower blood sugar, such as:



  • exenatide (Byetta);




  • probenecid (Benemid);




  • some nonsteroidal anti-inflammatory drugs (NSAIDs);




  • aspirin or other salicylates (including Pepto-Bismol);




  • sulfa drugs (Bactrim and others);




  • a monoamine oxidase inhibitor (MAOI);




  • beta-blockers (Tenormin and others); or




  • other diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).



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



  • furosemide (Lasix);




  • nifedipine (Adalat, Procardia);




  • cimetidine (Tagamet) or ranitidine (Zantac);




  • amiloride (Midamor) or triamterene (Dyrenium);




  • digoxin (Lanoxin);




  • morphine (MS Contin, Kadian, Oramorph);




  • procainamide (Procan, Pronestyl, Procanbid);




  • quinidine (Quin-G);




  • trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra);




  • vancomycin (Vancocin, Lyphocin); or




  • ketoconazole (Nizoral), itraconazole (Sporanox).



These lists are not complete and there are many other medicines that can increase or decrease the effects of glipizide and metformin on lowering your blood sugar. 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 Metaglip resources


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


  • Metaglip Prescribing Information (FDA)

  • Metaglip Advanced Consumer (Micromedex) - Includes Dosage Information

  • Metaglip MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Metaglip with other medications


  • Diabetes, Type 2


Where can I get more information?


  • Your pharmacist can provide more information about glipizide and metformin.

See also: Metaglip side effects (in more detail)


Friday 22 June 2012

Humatrope


Generic Name: somatropin (soe ma TROE pin)

Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive


What is Humatrope (somatropin)?

Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.


Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.


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


What is the most important information I should know about Humatrope (somatropin)?


Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.


Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.


If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.


Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.

What should I discuss with my healthcare provider before using Humatrope (somatropin)?


Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin. You should not use this medication if you are allergic to somatropin, or if you have:

  • diabetic retinopathy (a serious eye condition caused by diabetes);




  • cancer; or




  • Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.



You should also not use somatropin if you have a serious medical condition after having:



  • open heart surgery or stomach surgery;




  • trauma or other medical emergency; or




  • breathing problems (such as lung failure).



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



  • liver disease;




  • kidney disease (or if you are on dialysis);




  • diabetes;




  • a pituitary gland disorder;




  • scoliosis;




  • high blood pressure (hypertension);




  • a pancreas disorder (especially in children);




  • a history of cancer;




  • carpal tunnel syndrome;




  • underactive thyroid; or




  • a brain tumor or lesion.




FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive. FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.

How should I use Humatrope (somatropin)?


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


Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.

Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.


Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested often. Your eyes may also need to be checked. Visit your doctor regularly.


If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.


If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.


How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.


Throw away any somatropin left over after the expiration date on the label has passed.


What happens if I miss a dose?


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


Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?


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

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.


What should I avoid while using Humatrope (somatropin)?


If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.


Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Humatrope (somatropin) side effects


If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.


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

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;




  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;




  • sudden and severe pain behind your eyes, vision changes;




  • swelling in your head, face, hands, or feet; or




  • numbness or tingling in your wrist, hand, or fingers.



Less serious side effects may include:



  • headache, feeling tired;




  • redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;




  • pain in your arms or legs, joint stiffness or pain;




  • muscle pain; or




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



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


What other drugs will affect Humatrope (somatropin)?


Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.


Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.


Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.


This list is not complete and other drugs may interact with somatropin. 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 Humatrope resources


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


  • Humatrope Prescribing Information (FDA)

  • Humatrope Cartridge MedFacts Consumer Leaflet (Wolters Kluwer)

  • Humatrope Advanced Consumer (Micromedex) - Includes Dosage Information

  • Somatropin Professional Patient Advice (Wolters Kluwer)

  • Genotropin Prescribing Information (FDA)

  • Genotropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Norditropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Norditropin Prescribing Information (FDA)

  • Nutropin Prescribing Information (FDA)

  • Nutropin Subcutaneous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information

  • Nutropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nutropin AQ Prescribing Information (FDA)

  • Nutropin AQ MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nutropin Depot Prescribing Information (FDA)

  • Omnitrope Prescribing Information (FDA)

  • Omnitrope MedFacts Consumer Leaflet (Wolters Kluwer)

  • Omnitrope Consumer Overview

  • Saizen Prescribing Information (FDA)

  • Saizen MedFacts Consumer Leaflet (Wolters Kluwer)

  • Serostim Prescribing Information (FDA)

  • Serostim MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tev-Tropin Prescribing Information (FDA)

  • Tev-Tropin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zorbtive Prescribing Information (FDA)

  • Zorbtive MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zorbtive Consumer Overview



Compare Humatrope with other medications


  • Adult Human Growth Hormone Deficiency
  • Hypopituitarism
  • Idiopathic Short Stature
  • Pediatric Growth Hormone Deficiency
  • Short Stature for Age
  • Turner's Syndrome


Where can I get more information?


  • Your pharmacist can provide more information about somatropin.

See also: Humatrope side effects (in more detail)


Thursday 21 June 2012

Oramorph Concentrated Oral Solution






Oramorph Concentrated Oral Solution 20 mg/ml


(morphine sulphate)




Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


  • 1. What ORAMORPH Concentrated Oral Solution is and what it is used for

  • 2. Before you take ORAMORPH Concentrated Oral Solution

  • 3. How to take ORAMORPH Concentrated Oral Solution

  • 4. Possible side effects

  • 5. How to store ORAMORPH Concentrated Oral Solution

  • 6. Further information




What Oramorph Concentrated Oral Solution Is And What It Is Used For


The name of your medicine is ORAMORPH Concentrated Oral Solution 20 mg/ml (called ORAMORPH Concentrated in this leaflet).


  • It contains a medicine called morphine sulphate. This belongs to a group of medicines called ‘opioid analgesics’

  • It is used to relieve severe pain



Before You Take Oramorph Concentrated Oral Solution



Do not take ORAMORPH Concentrated if:


  • You are allergic (hypersensitive) to morphine sulphate or any of the other ingredients of ORAMORPH Concentrated (listed in Section 6 below)

  • You have problems with your lungs or breathing such as ‘hypoventilation’ or ‘Chronic Obstructive Pulmonary Disorder’ (COPD)

  • You are having an asthma attack

  • You have sudden or recent liver problems

  • You have recently had a head injury

  • You have something called ‘phaeochromocytoma’. This is a rare tumour which is not malignant

  • You have fits (convulsions) or raised pressure inside your skull

  • The person taking the medicine is in a deep and prolonged unconscious state (coma)

  • You are addicted to alcohol or have recently consumed large amounts of alcohol

  • You are taking or have in the last two weeks taken medication to treat depression such as monoamine-oxidase inhibitors (MAOI)

  • You have paralytic ileus (loss of intestinal movement)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.




Take special care with ORAMORPH Concentrated


Check with your doctor or pharmacist before taking your medicine if:


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

  • You have had an operation within the last 24 hours

  • You have a particular lung problem that causes shortness of breath called emphysema

  • You have shock (circulatory failure)

  • You have asthma

  • You have gall bladder problems

  • You have long term (chronic) liver or kidney problems

  • You are a man who has prostate problems

  • You have an under-active thyroid gland or swelling of your skin (myxoedema)

  • Your spine is unusually curved (kyphoscoliosis)

  • You have bowel problems

  • You have an under-active adrenal gland (adrenocortical insufficiency)

  • You are very overweight

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking ORAMORPH Concentrated.




Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because ORAMORPH Concentrated can affect the way some other medicines work. Also some other medicines can affect the way ORAMORPH Concentrated works.


In particular tell your doctor or pharmacist if you are taking any of the following medicines:


  • Medicines to help you sleep, make you feel less anxious or calm you down such as tranquilisers, hypnotics, sedatives, antipsychotics or tricyclic antidepressants

  • Anaesthetics - used during operations

  • Domperidone and metoclopramide - for feeling sick (nausea and being sick (vomiting)

  • Mexiletine and esmolol - for controlling heart rhythm

  • Ritonavir - for HIV infections

  • Cimetidine - for stomach ulcers, indigestion or heartburn

  • Monoamine oxidase inhibitors (MAOIs) - for depression

  • Voriconazole - for some fungal infections

  • Gabapentin - for epilepsy and long lasting pain caused by damage to the nerves



Taking ORAMORPH Concentrated with food and drink


You should avoid alcohol whilst taking this medicine.




Pregnancy and breast-feeding


Talk to your doctor before taking this medicine if you are pregnant, trying to become pregnant or if you are breast-feeding.


If you take this medicine during pregnancy or while breast-feeding, it may slow down the baby’s breathing. If you take this medicine for a long time whilst pregnant, it may mean that the baby will be born showing signs of withdrawal.




Operations and anaesthetics


Tell your doctor or pharmacist if you are due to have an operation or anaesthetic or if you have had an operation or an anaesthetic within the last 24 hours.




Driving and using machines


You may feel drowsy while taking this medicine. If this happens, do not drive or use any tools or machines.




Important information about some of the ingredients of ORAMORPH Concentrated


This medicine contains Amaranth. This may cause allergic reactions including asthma. Allergy is more common in people who are allergic to aspirin.





How To Take Oramorph Concentrated Oral Solution


Always take this medicine exactly as your doctor has told you.


You should check with your doctor or pharmacist if you are not sure.



Taking this medicine


  • Take this medicine by mouth

  • Use the oral dosing pipette provided to measure your dose

  • Place the pipette in the solution and pull the white plunger up so that liquid is drawn up into the pipette

  • Draw the liquid into the pipette until it is level with the mark which shows your required dose. The marks are in mls of liquid

  • You may prefer to add your dose to a soft drink. If you do this, it should be swallowed immediately after mixing



How much to take


Your doctor will decide the amount of medicine to give you.



Adults


  • The usual dose is 0.5 to 1 ml (10-20 mg) every four hours


Children 6 to 12 years


  • The most that should be taken is 0.25 to 0.5 ml (5-10 mg) every four hours


Children 1 to 5 years


  • The most that should be taken is 0.25 ml (5 mg) every four hours


Children under 1 year


  • Do not give this medicine to children under 1 year



Being given more or less of this medicine


  • For some people, it may be necessary for the doctor to give a higher dose

  • For other people (for example the elderly, people with kidney or liver problems and people that should not be sedated) the doctor may decide to use a lower dose



Your body may get used to the medicine (tolerance)


  • Do not take more than your doctor has prescribed

  • If you have been taking your medicine for some time you may find that it does not seem to be working as well as it did. If this happens, talk to your doctor



If you take more ORAMORPH Concentrated than you should


If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.


If you take more than you should, the following effects may happen:


  • The black circle in the centre of your eyes (pupil) gets smaller

  • You breathe more slowly

  • You have low blood pressure

In more severe cases, very high doses could cause your blood circulation to slow down and cause unconsciousness for a long time, or even death. In children a high dose may cause fits (convulsions).




If you forget to take ORAMORPH Concentrated


  • If you forget a dose, take it as soon as you remember it and take your next dose at the usual time

  • If it is nearly time for the next dose, skip the missed dose. This is because the time between doses should be at least 4 hours

  • Do not take a double dose to make up for a forgotten dose



If you stop taking ORAMORPH Concentrated


It is important to talk to your doctor if you want to stop taking your medicine. Do not stop taking your medicine suddenly. This is because your body may have got used to it. Also, you may need to have your dose lowered slowly.





Possible Side Effects


Like all medicines, ORAMORPH Concentrated can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:



Allergic reactions


If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. Signs may include swelling of the
mouth and face, difficulty breathing, dizziness and skin reactions such as rash and itching.




Tell your doctor straight away if you notice the following side effects. You may need urgent medical treatment:


  • Having a headache. This could be a sign of raised pressure inside your skull

  • Feeling dizzy or unsteady when you stand up. This could be a sign of a temporary fall in blood pressure (orthostatic hypotension)

  • Shallow breathing, with a slow heartbeat (bradycardia) and cold clammy skin

  • Feeling restless, irritable or having changes in your mood

  • Stomach pain caused by spasm (cramps) of the tubes that carry urine to the bladder or bile to the intestines



Other side effects


  • Feeling sick (nausea) or being sick (vomiting)

  • Constipation, which can be treated with appropriate laxatives

  • Difficulty in passing water (urine)

  • Feeling drowsy

  • Dry mouth, sweating and flushing of your face

  • Your heart rate getting faster (tachycardia) or slower (bradycardia) or fast and uneven (palpitations)

  • Lower body temperature (hypothermia)

  • Lowered sex drive

  • Seeing or hearing things that are not there (hallucinations) or feeling confused

  • Muscles feeling tense

  • The black circle in the centre of your eyes (pupil) getting smaller (miosis)

  • Dependence on ORAMORPH Concentrated. This can happen with any morphine product


If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How To Store Oramorph Concentrated Oral Solution


Keep out of the reach and sight of children.


Do not use this medicine after the expiry date which is stated on the bottle label and the outer carton. The expiry date refers to the last day of the month.


Do not store ORAMORPH Concentrated above 25°C.


Store in the original container in order to protect from light.


Please return any remaining medicine to your pharmacist 4 months after first opening.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What ORAMORPH Concentrated contains


  • Each ml contains 20 mg of morphine sulphate as the active ingredient

  • The other ingredients are disodium edetate, sodium benzoate (E211), citric acid, amaranth (E123) and purified water



What ORAMORPH Concentrated looks like and content of the pack


ORAMORPH Concentrated is available in bottles of 30 ml and 120 ml.


Not all pack sizes may be marketed.




Marketing Authorisation Holder and Manufacturer


The Marketing Authorisation for ORAMORPH Concentrated is held by:



Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom


and the solution is manufactured by:



Istituto de Angeli S.r.l.

at: Località Prulli Si Sotto n. 103/C

50066 Reggello (FI)

Italy




This leaflet was revised in March 2009.


© Boehringer Ingelheim Limited 2009


437735/GB/11





Wednesday 20 June 2012

Colax


Generic Name: bisacodyl (bis AK oh dil)

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


What is Colax (bisacodyl)?

Bisacodyl is a laxative that stimulates bowel movements.


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


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


What is the most important information I should know about Colax (bisacodyl)?


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

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


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

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


What should I discuss with my healthcare provider before using Colax (bisacodyl)?


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

  • severe stomach pain, nausea, or vomiting;




  • a perforated bowel;




  • a blockage in your intestines;




  • fructose or galactose intolerance;




  • an allergy to yellow food dye;




  • severe constipation or dehydration;




  • inflammatory bowel disease, toxic megacolon; or




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



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


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



  • kidney disease;




  • trouble swallowing;




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




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




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

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


How should I use Colax (bisacodyl)?


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


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

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


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

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


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


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


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


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


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

What happens if I miss a dose?


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


What happens if I overdose?


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

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


What should I avoid while using Colax (bisacodyl)?


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


Avoid drinking milk within 1 hour after using bisacodyl.

Colax (bisacodyl) side effects


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

  • urinating less than usual or not at all;




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




  • swelling, weight gain, feeling short of breath;




  • rectal bleeding;




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




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



Less serious side effects may include:



  • dizziness, weakness;




  • increased thirst;




  • mild stomach pain, gas, indigestion;




  • diarrhea or loose stools;




  • mild nausea; or




  • skin rash.



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


What other drugs will affect Colax (bisacodyl)?


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



More Colax resources


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


  • Bisacodyl Prescribing Information (FDA)

  • Bisacodyl Professional Patient Advice (Wolters Kluwer)

  • Bisacodyl Monograph (AHFS DI)

  • Bisacodyl MedFacts Consumer Leaflet (Wolters Kluwer)

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



Compare Colax with other medications


  • Bowel Preparation
  • Constipation


Where can I get more information?


  • Your pharmacist can provide more information about bisacodyl.

See also: Colax side effects (in more detail)


Sunday 17 June 2012

ACT Kids Fluoride Rinse


Generic Name: fluoride topical (FLOR ide TOP i kal)

Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N


What is ACT Kids Fluoride Rinse (fluoride topical)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.


Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.


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


What is the most important information I should know about ACT Kids Fluoride Rinse (fluoride topical)?


Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.


Do not eat, drink, or rinse your mouth for 30 minutes after using a fluoride topical. Do not swallow fluoride topical. Spit it out after use. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

Overdose symptoms may result if you swallow large amounts of fluoride while using it.


What should I discuss with my healthcare provider before using ACT Kids Fluoride Rinse (fluoride topical)?


Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.


If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.


Talk to your doctor and dentist before using fluoride topical if you are pregnant. Talk to your doctor and dentist before using fluoride topical if you are breast-feeding. The use of fluoride is particularly important in children to protect against tooth decay. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age. The American Academy of Pediatrics recommends fluoride supplementation in children until the age of 16 years old. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

How should I use ACT Kids Fluoride Rinse (fluoride topical)?


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


Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.


Swish this medication in your mouth without swallowing. Then spit it out.


Do not eat, drink, or rinse your mouth for 30 minutes after using fluoride topical. Store fluoride topical at room temperature away from moisture and heat.

What happens if I miss a dose?


Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


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

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).


Overdose symptoms may result if you swallow large amounts of fluoride while using it.


What should I avoid while using ACT Kids Fluoride Rinse (fluoride topical)?


Do not swallow fluoride topical. Spit it out after use.

ACT Kids Fluoride Rinse (fluoride topical) side effects


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

  • discolored teeth;




  • weakened tooth enamel; or




  • any changes in the appearance of your teeth.



Less serious side effects may include:



  • stomach upset;




  • headache; or




  • weakness.



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 ACT Kids Fluoride Rinse (fluoride topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More ACT Kids Fluoride Rinse resources


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Compare ACT Kids Fluoride Rinse with other medications


  • Prevention of Dental Caries


Where can I get more information?


  • Your pharmacist can provide more information about fluoride topical.

See also: ACT Kids Fluoride side effects (in more detail)