Mysoline

primidone

Dosage Form: tablet
Mysoline®

(primidone, USP)

Anticonvulsant

Rx only

Mysoline Description

Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione. Structural formula:

Mysoline* (primidone) is a white, crystalline, highly stable substance, M.P. 279-284°C. It is poorly soluble in water (60 mg per 100 mL at 37°C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog.

Mysoline 50 mg and 250 mg tablets contain the following inactive ingredients: Microcrystalline Cellulose, NF; Lactose, USP; Methylcellulose, USP; Sodium Starch Glycolate, NF; Talc, USP; Sodium Lauryl Sulfate, NF; Magnesium Stearate, NF; Water, USP, Purified.

Mysoline 250 mg tablets also contain Ferric Oxide Yellow, NF.

_______________________________________________________________________________

* Registered trademark of Valeant Pharmaceuticals North America.

ACTIONS

Mysoline raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidone's antiepileptic action is not known.

Primidone per se has anticonvulsant activity as do its two metabolites, phenobarbital and phenylethylmalonamide (PEMA). In addition to its anticonvulsant activity, PEMA potentiates the anticonvulsant activity of phenobarbital in experimental animals.

Indications and Usage for Mysoline

Mysoline, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.

Contraindications

Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS).

Warnings

The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed.

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDS), including Mysoline, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5-100 years) in the clinical trials analyzed.

Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Table 1 Risk by indication for antiepileptic drugs in the pooled analysis

Indication	Placebo Patients with Events Per 1000 Patients	Drug Patients with Events Per 1000 Patients	Relative Risk: Incidence of Events in Drug Patients/ Incidence in Placebo Patients	Risk Difference: Additional Drug Patients with Events Per 1000 Patients
Epilepsy	1.0	3.4	3.5	2.4
Psychiatric	5.7	8.5	1.5	2.9
Other	1.0	1.8	1.9	0.9
Total	2.4	4.3	1.8	1.9

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Mysoline or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Usage in Pregnancy

To provide information regarding the effects of in utero exposure to Mysoline, physicians are advised to recommend that pregnant patients taking Mysoline enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

The effects of Mysoline in human pregnancy and nursing infants are unknown.

Recent reports suggest an association between the use of anticonvulsant drugs by women with epilepsy and an elevated incidence of birth defects in children born to these women. Data are more extensive with respect to diphenylhydantoin and phenobarbital, but these are also the most commonly prescribed anticonvulsants; less systematic or anecdotal reports suggest a possible similar association with the use of all known anticonvulsant drugs.

The reports suggesting an elevated incidence of birth defects in children of drug-treated epileptic women cannot be regarded as adequate to prove a definite cause and effect relationship.

There are intrinsic methodologic problems in obtaining adequate data on drug teratogenicity in humans; the possibility also exists that other factors leading to birth defects, e.g., genetic factors or the epileptic condition itself, may be more important than drug therapy. The great majority of mothers on anticonvulsant medication deliver normal infants. It is important to note that anticonvulsant drugs should not be discontinued in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorders are such that the removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.

The prescribing physician will wish to weigh these considerations in treating or counseling epileptic women of childbearing potential. Neonatal hemorrhage, with a coagulation defect resembling vitamin K deficiency, has been described in newborns whose mothers were taking primidone and other anticonvulsants. Pregnant women under anticonvulsant therapy should receive prophylactic vitamin K1 therapy for one month prior to, and during, delivery.

Precautions

The total daily dosage should not exceed 2 g. Since Mysoline therapy generally extends over prolonged periods, a complete blood count and a sequential multiple analysis-12 (SMA-12) test should be made every six months.

In Nursing Mothers

There is evidence in mothers treated with primidone, the drug appears in the milk in substantial quantities. Since tests for the presence of primidone in biological fluids are too complex to be carried out in the average clinical laboratory, it is suggested that the presence of undue somnolence and drowsiness in nursing newborns of Mysoline-treated mothers be taken as an indication that nursing should be discontinued.

Information for Patients

Suicidal Thinking and Behavior - Patients, their caregivers, and families should be counseled that AEDs, including Mysoline, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see Usage in Pregnancy section).

Please refer to the Mysoline Medication Guide provided with the product for more information.

Adverse Reactions

The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness, and morbilliform skin eruptions. Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, have been reported rarely. These and, occasionally, other persistant or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to Mysoline and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication.

Mysoline Dosage and Administration

Adult Dosage

Patients 8 years of age and older who have received no previous treatment may be started on Mysoline according to the following regimen using either 50 mg or scored 250 mg Mysoline tablets:

Days 1 to 3: 100 to 125 mg at bedtime.

Days 4 to 6: 100 to 125 mg b.i.d.

Days 7 to 9: 100 to 125 mg t.i.d.

Day 10 to maintenance: 250 mg t.i.d.

For most adults and children 8 years of age and over, the usual maintenance dosage is three to four 250 mg Mysoline tablets in divided doses (250 mg t.i.d. or q.i.d.). If required, an increase to five or six 250 mg tablets daily may be made but daily doses should not exceed 500 mg q.i.d.

INITIAL: ADULTS AND CHILDREN OVER 8
KEY: •=50 mg tablet; ●=250 mg tablet
DAY	1	2	3	4	5	6
AM				••	••	••
NOON
PM	••	••	••	••	••	••
DAY	7	8	9	10	11	12
AM	••	••	••	●	Adjust to Maintenance
NOON	••	••	••	●
PM	••	••	••	●

Dosage should be individualized to provide maximum benefit. In some cases, serum blood level determinations of primidone may be necessary for optimal dosage adjustment. The clinically effective serum level for primidone is between 5 to 12 μg/mL.

In Patients Already Receiving Other Anticonvulsants

Mysoline should be started at 100 to 125 mg at bedtime and gradually increased to maintenance level as the other drug is gradually decreased. This regimen should be continued until satisfactory dosage level is achieved for the combination, or the other medication is completely withdrawn. When therapy with Mysoline alone is the objective, the transition from concomitant therapy should not be completed in less than two weeks.

Pediatric Dosage

For children under 8 years of age, the following regimen may be used:

Days 1 to 3: 50 mg at bedtime.

Days 4 to 6: 50 mg b.i.d.

Days 7 to 9: 100 mg b.i.d.

Day 10 to maintenance: 125 mg t.i.d. to 250 mg t.i.d.

For children under 8 years of age, the usual maintenance dosage is 125 to 250 mg three times daily or, 10 to 25 mg/kg/day in divided doses.

How is Mysoline Supplied

Mysoline Tablets

Each square-shaped, scored, yellow tablet, identified by "Mysoline 250" and an embossed M, contains 250 mg of primidone, in bottles of 100 (NDC 66490-691-10)

Each square-shaped, scored, white tablet, identified by "Mysoline 50" and an embossed M, contains 50 mg of primidone, in bottles of 100 (NDC 66490-690-10)

The appearance of these tablets is a trademark of Valeant Pharmaceuticals North America.

Store at 20°C-25°C (68°F-77°F).

[See USP controlled room temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.

Manufactured by:

Piramal Healthcare Ltd.

Plot No. 67-70, Sector - 2, Pithampur, 454775,

Dist. Dhar, Madhya Pradesh, INDIA

Distributed by:

Valeant Pharmaceuticals North America

One Enterprise

Aliso Viejo, CA 92656 U.S.A.

Part No. EM 10142/b

Rev. 07/10

MEDICATION GUIDE

Mysoline ( My-so- lean)

(primidone)

Tablets

Read this Medication Guide before you start taking Mysoline and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Mysoline?

Do not stop taking Mysoline without first talking to your healthcare provider.

Stopping Mysoline suddenly can cause serious problems.

Mysoline can cause serious side effects, including:

Like other antiepileptic drugs, Mysoline may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying


• attempts to commit suicide


• new or worse depression


• new or worse anxiety


• feeling agitated or restless


• panic attacks


• trouble sleeping (insomnia)


• new or worse irritability


• acting aggressive, being angry, or violent


• acting on dangerous impulses


• an extreme increase in activity and talking (mania)


• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.


• Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Mysoline without first talking to a healthcare provider.

• Stopping Mysoline suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is Mysoline?

Mysoline is a prescription medicine used alone or with other medicines to treat people with:

• generalized tonic-clonic (grand mal) seizures


• complex partial (psychomotor) seizures


• partial (focal) epileptic seizures.

Who should not take Mysoline?

Do not take Mysoline if you:

• have a genetic disorder called porphyria


• are allergic to phenobarbital

What should I tell my healthcare provider before taking Mysoline?

Before you take Mysoline, tell your healthcare provider if you:

• have or have had depression, mood problems or suicidal thoughts or behavior


• have any other medical conditions


• are pregnant or planning to become pregnant. Mysoline may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Mysoline. You and your healthcare provider will decide if you should take Mysoline while you are pregnant.
  
  • If you become pregnant while taking Mysoline, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
  
  


• are breastfeeding or plan to breastfeed. Mysoline can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Mysoline.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Mysoline with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I take Mysoline?

Take Mysoline exactly as prescribed. Your healthcare provider will tell you how much Mysoline to take and when to take it.

• Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.


• Do not stop taking Mysoline without first talking to your healthcare provider. Stopping Mysoline suddenly can cause serious problems.


• If you take too much Mysoline, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking Mysoline?

• Mysoline can make you sleepy or dizzy. Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking Mysoline without first discussing this with your healthcare provider. Taking Mysoline with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.


• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Mysoline affects you. Mysoline can slow your thinking and motor skills.

What are the possible side effects of Mysoline?

See "What is the most important information I should know about Mysoline?".

Mysoline may cause other serious side effects including:

• Sleepiness that can be severe, especially when you first start taking Mysoline.


• Mysoline may rarely cause blood problems. Symptoms may include:
  
  • fever, swollen glands, or sore throat that come and go or do not go away
  
  
  • Frequent infections or an infection that does not go away
  
  
  • tiredness
  
  
  • shortness of breath
  
  


• Mysoline may rarely cause allergic reactions. Symptoms may include:
  
  • skin rash
  
  
  • hives
  
  
  • sores in your mouth
  
  
  • blistering or peeling skin
  
  

The most common side effects of Mysoline include:

• problems with walking and moving


• feelings of dizziness, spinning, or swaying (vertigo)

These are not all the possible side effects of Mysoline. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Mysoline?

Store Mysoline at room temperature between 68ºF to 77ºF (20ºC to 25ºC) in a tight, light-resistant container

Keep Mysoline and all medicines out of the reach of children.

General Information about Mysoline

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Mysoline for a condition for which it was not prescribed. Do not give Mysoline to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Mysoline. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Mysoline that is written for health professionals.

For more information, go to www.VALEANT.com or call 1-877-361-2719

What are the ingredients in Mysoline?

Active Ingredient: primidone

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, methylcellulose, sodium starch glycolate, sodium lauryl sulfate, magnesium stearate, talc, purified water and ferric oxide yellow (250 mg tablet only)

VALEANT®

Pharmaceuticals North America

Aliso Viejo, CA 92656

Issued July 2010

This Medication Guide has been approved by the U.S. Food and Drug Administration

Part No. EM 10142/b

Rev. 07/10

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Bottle Label

NDC 66490-691-10

Rx Only

Mysoline®

(primidone, USP)

ORIGINAL

TABLET

DESIGN &

FORMULATION

250 mg

SEALED FOR

YOUR PROTECTION

100 Tablets

VALEANT®

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

NDC 66490-690-10

Rx Only

Mysoline®

(primidone, USP)

50 mg

SEALED FOR

YOUR PROTECTION

100 Tablets

VALEANT®

Mysoline  primidone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66490-690 Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline   lactose Monohydrate   Methylcellulose (15 CPS)   sodium starch glycolate type a potato   talc   sodium lauryl sulfate   Magnesium stearate

Product Characteristics Color WHITE Score 2 pieces Shape SQUARE Size 6mm Flavor Imprint Code Mysoline;50;M Contains

Packaging # NDC Package Description Multilevel Packaging 1 66490-690-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA009170	06/24/2009

Mysoline  primidone  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66490-691 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Primidone (Primidone) Primidone 250 mg

Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline   lactose Monohydrate   Methylcellulose (15 CPS)   sodium starch glycolate type a potato   talc   sodium lauryl sulfate   Magnesium stearate   ferric oxide yellow

Product Characteristics Color YELLOW Score 2 pieces Shape SQUARE (square-shaped) Size 10mm Flavor Imprint Code Mysoline;250;M Contains

Packaging # NDC Package Description Multilevel Packaging 1 66490-691-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA009170	06/24/2009

Labeler - Valeant Pharmaceuticals North America (831922468)

Establishment
Name	Address	ID/FEI	Operations
Piramal Healthcare Limited		862202793	MANUFACTURE

Revised: 08/2010Valeant Pharmaceuticals North America

More Mysoline resources

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

• Mysoline Concise Consumer Information (Cerner Multum)


• Mysoline MedFacts Consumer Leaflet (Wolters Kluwer)


• Mysoline Monograph (AHFS DI)


• Mysoline Advanced Consumer (Micromedex) - Includes Dosage Information


• Primidone Professional Patient Advice (Wolters Kluwer)

Compare Mysoline with other medications

• Seizures

Maxidone

Generic Name: acetaminophen and hydrocodone (a SEET a MIN oh fen and hye droe KOE done)

Brand Names: Anexsia, Co-Gesic, Hycet, Liquicet, Lorcet 10/650, Lorcet Plus, Lortab 10/500, Lortab 2.5/500, Lortab 5/500, Lortab 7.5/500, Lortab Elixir, Maxidone, Norco, Polygesic, Stagesic, Vicodin, Vicodin ES, Vicodin HP, Xodol, Zamicet, Zolvit, Zydone

What is Maxidone (acetaminophen and hydrocodone)?

Hydrocodone is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.

The combination of acetaminophen and hydrocodone is used to relieve moderate to severe pain.

Acetaminophen and hydrocodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Maxidone (acetaminophen and hydrocodone)?

Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Maxidone (acetaminophen and hydrocodone)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or hydrocodone. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

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

• 
  

  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• 
  

  liver or kidney disease;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  Addison's disease or other adrenal gland disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share acetaminophen and hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Maxidone (acetaminophen and hydrocodone)?

Take exactly as prescribed. Never take acetaminophen and hydrocodone in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen can damage your liver or cause death.

One acetaminophen and hydrocodone tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and hydrocodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and hydrocodone.

Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and hydrocodone. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

What happens if I miss a dose?

Since acetaminophen and hydrocodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and hydrocodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

What should I avoid while taking Maxidone (acetaminophen and hydrocodone)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Maxidone (acetaminophen and hydrocodone) 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 at once if you have any of these serious side effects:

• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  confusion, fear, unusual thoughts or behavior;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  problems with urination; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  anxiety, dizziness, drowsiness;

  
  


• 
  

  mild nausea, vomiting, upset stomach, constipation;

  
  


• 
  

  headache, mood changes;

  
  


• 
  

  blurred vision;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  dry 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 Maxidone (acetaminophen and hydrocodone)?

Do not take acetaminophen and hydrocodone with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

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

• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

  
  


• 
  

  an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);

  
  


• 
  

  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

  a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

This list is not complete and other drugs may interact with acetaminophen and hydrocodone. 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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Compare Maxidone with other medications

• Back Pain
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Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and hydrocodone.

See also: Maxidone side effects (in more detail)

Boots Maximum Strength Cold & Flu Relief Direct Dose Blackcurrant

1. Name Of The Medicinal Product

Boots Cold & Flu Max Direct Sachets Blackcurrant Flavour or

Boots Maximum Strength Cold & Flu Relief Direct Dose Blackcurrant

2. Qualitative And Quantitative Composition

Active ingredients	mg/sachet
Paracetamol	1000.0
Phenylephrine hydrochloride	*12.2
*This is equivalent to 10mg phenylephrine base.
For excipients, see 6.1

3. Pharmaceutical Form

Oral powder

A white to off-white unit-dose powder with the odour and flavour of blackcurrants.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of symptoms associated with the common cold and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion and lowering of temperature.

4.2 Posology And Method Of Administration

Oral administration.

Adults and children 12 and over: One single-dose container. The product is taken orally without water.

The dose may be repeated every 4 hours.

No more than four doses should be taken in 24 hours.

Children under 12 years: Not to be given to children under 12 without medical advice.

Elderly: There is no indication that dosage need be modified in the elderly.

4.3 Contraindications

Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors. Hypersensitivity to paracetamol, phenylephrine or any other ingredient.

4.4 Special Warnings And Precautions For Use

Use with caution in patients with Raynaud's phenomenon or diabetes mellitus. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Patients should be advised not to take other paracetamol-containing products concurrently.

Label warnings: Do not exceed the stated dose. Keep all medicines out of the reach and sight of children. Contains paracetamol (panel). If symptoms persist consult your doctor. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product.

Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and β-blockers. Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdose. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of the risk of hypertensive crisis.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

Due to the vasoconstrictive properties of phenylephrine the product should be used with caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh the risk. There is no information on use in lactation.

Epidemiological studies in human pregnancy have shown no ill-effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Paracetamol: Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Phenylephrine hydrochloride: Rarely, high blood pressure with headache, vomiting and palpitations, which are only likely to occur with overdose. Also rare reports of allergic reactions.

4.9 Overdose

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

Features of severe overdose of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. α-receptor blocking agent.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol: Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.

Phenylephrine: Phenylephrine is a post-synaptic α-receptor agonist with low cardioselective β-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2 Pharmacokinetic Properties

Paracetamol: Paracetamol is absorbed rapidly and completely mainly from the small intestine producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T2 of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates >80%) which are excreted in urine.

Phenylephrine: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.

5.3 Preclinical Safety Data

No preclinical findings of relevance have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethyl cellulose

Ascorbic acid

Glyceryl tristearate

Tartaric acid

Sodium carbonate anhydrous

Aspartame

Blackcurrant flavour

Sweet flavour

Xylitol

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C and store in the original package.

6.5 Nature And Contents Of Container

Polyethylene terephthalate/aluminium/polyethylene sachets.

Pack size: 10

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for handling.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

8. Marketing Authorisation Number(S)

PL00014/0635

9. Date Of First Authorisation/Renewal Of The Authorisation

19 July 2002

10. Date Of Revision Of The Text

November 2003

Scandonest

Dosage Form: Injection, USP

Rx only

THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY.

Description

Mepivacaine hydrochloride, a tertiary amide used as a local anesthetic, is 1-methyl-2', 6'-pipecoloxylidide monohydrochloride with the following structural formula :

C15 H22 N2O. HCL                                                                        M.W. 282.81

It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis.

Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solutions, is (-)-a-(1- Aminoethyl)- 3, 4-dihydroxybenzyl alcohol with the following structural formula :

C9 H13 NO3                                                                                 M.W. 183.21

It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water;

DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED.

Scandonest 3% PLAIN (mepivacaine hydrochloride injection 3%) and Scandonest 2% L (mepivacaine hydrochloride 2% with levonordefrin 1:20,000 injection) are sterile solutions for injection.

Composition

	Cartridge
Each mL contains :	2%	3%
Mepivacaine hydrochloride	20     mg	30 mg
Levonordefrin	0.05 mg	-
Sodium chloride	4      mg	6 mg
Potassium metabisulfite	1.2   mg
Edetate disodium	0.25 mg
Sodium hydroxide q.s. ad pH Hydrochloric acid	0.5   mg
Water for injections q.s. ad	1      mL	1 mL

The pH of the 2% cartridge solution is adjusted between 3.3 and 5.5 with NaOH.

The pH of the 3% cartridge solution is adjusted between 4.5 and 6.8 with NaOH.

Clinical Pharmacology

Scandonest stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia.

Scandonest is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted unchanged in the urine. Scandonest, because of its amide structure, is not detoxified by the circulating plasma esterases. The liver is the principal site of metabolism, with over 50 percent of the administered dose being excreted into the bile as metabolites. Most of the metabolized mepivacaine is probably resorbed in the intestine and then excreted into the urine since only a small percentage is found in the feces. The principal route of excretion is via the kidney. Most of the anesthetic and its metabolites are eliminated within 30 hours. It has been shown that hydroxylation and N-demethylation, which are detoxification reactions, play important roles in the metabolism of the anesthetic. Three metabolites of mepivacaine have been identified from adult humans : two phenols, which are excreted almost exclusively as their glucuronide conjugates, and the N-demethylated compound (2', 6'-pipecoloxylidide).

The onset of action is rapid (30 to 120 seconds in the upper jaw ; 1 to 4 minutes in the lower jaw) and Scandonest 3% PLAIN will ordinarily provide operating anesthesia of 20 minutes in the upper jaw and 40 minutes in the lower jaw.

Scandonest 2% L with levonordefrin 1:20,000 provides anesthesia of longer duration for more prolonged procedures, 1 hour to 2.5 hours in the upper jaw and 2.5 hours to 5.5 hours in the lower jaw.

Scandonest does not ordinarily produce irritation or tissue damage.

Levonordefrin is a sympathomimetic amine used as a vasoconstrictor in local anesthetic solutions. It has pharmacologic activity similar to that of epinephrine but it is more stable than epinephrine. In equal concentrations, levonordefrin is less potent than epinephrine in raising blood pressure, and as a vasoconstrictor.

Indications and usage

Scandonest is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and children.

Contraindications

Mepivacaine is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.

Warnings

RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE. (See ADVERSE REACTIONS).

Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity.

Fatalities may occur with use of local anesthetics in the head and neck region as the result of retrograde arterial flow to vital CNS areas even when maximum recommended doses are observed. The practitioner should be alert to early evidences of alteration in sensorium or vital signs.

The solution which contains a vasoconstrictor (Scandonest 2% L) should be used with extreme caution for patients whose medical history and physical evaluation suggest the existence of hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, thyrotoxicosis and diabetes. etc.

The solution which contains a vasoconstrictor (Scandonest 2% L) also contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Scandonest 3% PLAIN is sulfite free.

Precautions

The safety and effectiveness of mepivacaine depend upon proper dosage, correct technique, adequate precautions, and readiness for emergencies.

The lowest dose that results in effective anesthesia should be used to avoid high plasma levels and possible adverse effects. Injection of repeated doses of mepivacaine may cause significant increase in blood levels with each repeated dose due to slow accumulation of the drug or its metabolites, or due to slower metabolic degradation than normal.

Tolerance varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their weight and physical status.

Mepivacaine should be used with caution in patients with a history of severe disturbances of cardiac rhythm or heart block.

INJECTIONS SHOULD ALWAYS BE MADE SLOWLY WITH ASPIRATION TO AVOID INTRAVASCULAR INJECTION AND THEREFORE SYSTEMIC REACTION TO BOTH LOCAL ANESTHETIC AND VASOCONSTRICTOR.

If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Young children should be given minimal doses of each agent.

Changes in sensorium such as excitation, disorientation, drowsiness, may be early indications of a high blood level of the drug and may occur following inadvertent intravascular administration or rapid absorption of mepivacaine.

Local anesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.

Information for Patients

The patient should be cautioned against loss of sensation and possibility of biting trauma should the patient attempt to eat or chew gum prior to return of sensation.

Clinically Significant Drug Interactions

The administration of local anesthetic solutions containing vasopressors, such as levonordefrin, epinephrine or norepinephrine, to patients receiving tricyclic antidepressants or monoamine oxidase inhibitors may produce severe prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.

Solutions containing a vasoconstrictor should be used cautiously in the presence of diseases which may adversely affect the patient's cardiovascular system. Serious cardiac arrhythmias may occur if preparations containing a vasoconstrictor are employed in patients during or following the administration of potent inhalation anesthetics.

Mepivacaine SHOULD BE USED WITH CAUTION IN PATIENTS WITH KNOWN DRUG ALLERGIES AND SENSITIVITIES. A thorough history of the patient's prior experience with mepivacaine or other local anesthetics as well as concomitant or recent drug use should be taken (see CONTRAINDICATIONS). Patients allergic to methylparaben or paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, ect.) have not shown cross-sensitivity to agents of the amide type such as mepivacaine. Since mepivacaine is metabolized in the liver and excreted by the kidneys, it should be used cautiously in patients with liver and renal disease.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of mepivacaine hydrochloride in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.

Pregnancy

Teratogenic effects

Pregnancy Category C

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

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this solution, is administered to a nursing woman.

Pediatric Use

Great care must be exercised in adhering to safe concentrations and dosages for pedodontic administration (see DOSAGE AND ADMINISTRATION).

Adverse Reactions

Systemic adverse reactions involving the central nervous system and the cardiovascular system usually result from high plasma levels due to excessive dosage, rapid absorption, or inadvertent intravascular injection.

A small number of reactions may result from hypersensitivity, idiosyncrasy or diminished tolerance to normal dosage on the part of the patient.

Reactions involving the central nervous system are characterized by excitation and/or depression. Nervousness, dizziness, blurred vision, or tremors may occur followed by drowsiness, convulsions, unconsciousness, and possibly respiratory arrest. Since excitement may be transient or absent, the first manifestations may be drowsiness merging into unconsciousness and respiratory arrest.

Cardiovascular reactions are depressant. They may be the result of direct drug effect or more commonly in dental practice, the result of vasovagal reaction, particularly if the patient is in the sitting position. Failure to recognize premonitory signs such as sweating, feeling of faintness, changes in pulse or sensorium may result in progressive cerebral hypoxia and seizure or serious cardiovascular catastrophe. Management consists of placing the patient in the recumbent position and administration of oxygen. Vasoactive drugs such as ephedrine or methoxamine may be administered intravenously.

Allergic reactions are rare and may occur as a result of sensitivity to the local anesthetic and are characterized by cutaneous lesions of delayed onset or urticaria, edema and other manifestations of allergy. The detection of sensitivity by skin testing is of limited value. As with other local anesthetics, anaphylactoid reactions to mepivacaine have occurred rarely. The reactions may be abrupt and severe and are not usually dose related. Localized puffiness and swelling may occur.

Overdosage

Treatment of a patient with toxic manifestations consists of assuring and maintaining a patent airway and supporting ventilation (respiration) as required. This usually will be sufficient in the management of most reactions. Should a convulsion persist despite ventilatory therapy, small increments of anticonvulsive agents may be given intravenously, such as benzodiazepine (e.g . diazepam) or ultrashort-acting barbiturates (e.g. thiopental, or thiamylal) or short-acting barbiturates (e.g. pentobarbital or secobarbital). Cardiovascular depression may require circulatory assistance with intravenous fluids and/or vasopressor (e.g. ephedrine) as dictated by the clinical situation. Allergic reactions should be managed by conventional means.

Intravenous and subcutaneous LD50's in mice for mepivacaine hydrochloride 3% are 33 and 258 mg/kg, respectively. The acute IV and SC LD50's in mice for mepivacaine hydrochloride 2% with levonordefrin 1:20,000 are 30 and 184 mg/kg, respectively.

Dosage and administration

As with all local anesthetics the dose varies and depends upon the area to be anesthetized, the vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dose needed to provide effective anesthesia should be administered. For specific techniques and procedures refer to standard dental manuals and textbooks.

For infiltration and block injections in the upper or lower jaw, the average dose of 1 cartridge will usually suffice.

Each cartridge contains 1.7 mL (34 mg of 2% or 51 mg of 3%).

5.3 cartridges (180 mg of the 2% solution or 270 mg of the 3% solution) are usually adequate to effect anesthesia of the entire oral cavity. Whenever a larger dose seems to be necessary for an extensive procedure, the maximum dose should be calculated accordlng to the patient's weight. A dose of up to 3 mg per pound of body weight may be administered. At any single dental sitting the total dose for all injected sites should not exceed 400 mg in adults.

The maximum pediatric dose should be carefully calculated :

Maxlmum Dose for pediatric population =

Child's Weight ( lbs )× Maximum Recommended Dose

          150                          For Adults (400 mg)

The following table, approximating these calculations, may also be used as a guide. This table is based upon a recommended maximum for larger pediatric population of 5.3 cartridges (the maximum recommended adult dose) during any single dental sitting, regardless of the child's weight or (for 2 % mepivacaine) calculated maximum amount of drug :

Maximum Allowable Dosage

		3% Mepivacaine (Plain)	2% Mepivacaine 1:20,000 Levonordefrin
		3 mg/lb (270 mg max)	3 mg/lb (180 mg max)
Weight (lbs)	mg	Number of Cartridges	mg	Number of Cartridges
20	60	1.2	60	1.8
30	90	1.8	90	2.6
40	120	2.3	120	3.5
50	150	2.9	150	4.4
60	180	3.5	180	5.3
80	240	4.7	180	5.3
100	270	5.3	180	5.3
120	270	5.3	180	5.3

Adapted from Malamed, Stanley F : Handbook of medical emergencies in the dental office, ed. 2, St Louis, 1982. The C V Mosby Co.

When using Scandonest for infiltration or regional block anesthesia, injection should always be made slowly and with frequent aspiration.

Any unused portion of a cartridge should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Disinfection of cartridges

As in the case of any cartridge, the diaphragm should be disinfected before needle puncture. The diaphragm should be thoroughly swabbed with either pure 91% isopropyl alcohol or 70% ethyl alcohol, USP just prior to use. Many commercially available alcohol solutions contain ingredients which are injurious to container components, and therefore, should not be used. Cartridges should not be immersed in any solution.

How supplied

- Scandonest 2% L (Mepivacaine Hydrochoride and Levonordefrin injection, USP), is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per cartons (NDC 12862-1097-8).

- Scandonest 3%Plain (Mepivacaine hydrochoride injection, USP), is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per cartons (NDC 12862-1098-9).

Store at room temperature, below 25°C (77°F). Protect from light. Do not permit to freeze.

CANS : For protection from light, retain in can until time of use. Once opened, the can should be reclosed using the plastic cap.

BOXES : For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the top flap.

Scandonest 2%L should not be use if color is pinkish or darker than slightly yellow or if it contains a precipitate.

Cartridge warmers should not be used with Scandonest products.

10/04 (1)

Distributed in the U.S.A. by :

Septodont, Inc.

245 Quigley Boulevard - Suite C

NEW CASTLE, Delaware 19720 - U.S.A.

Made in France by :

SEPTODONT

® 05 14 117 90 00

Scandonest PLAIN  mepivacaine hydrochloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 12862-1098 Route of Administration SUBCUTANEOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Mepivacaine Hydrochloride (Mepivacaine) Active 30 MILLIGRAM  In 1 MILLILITER Sodium Chloride Inactive 6 MILLIGRAM  In 1 MILLILITER Sodium hydroxide Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 12862-1098-9 5 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 CARTRIDGE In 1 BLISTER PACK This package is contained within the CARTON (12862-1098-9) and contains a CARTRIDGE 1 1.7 mL (MILLILITER) In 1 CARTRIDGE This package is contained within a BLISTER PACK and a CARTON (12862-1098-9)

Scandonest L  mepivcaine hydrochloride and levonordefrin  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 12862-1097 Route of Administration SUBCUTANEOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Mepivacaine Hydrochloride (Mepivacaine) Active 20 MILLIGRAM  In 1 MILLILITER Levonordefrin (Levonordefrin) Active 0.05 MILLIGRAM  In 1 MILLILITER Sodium Chloride Inactive 4 MILLIGRAM  In 1 MILLILITER Potassium metabisulfite Inactive 1.2 MILLIGRAM  In 1 MILLILITER Edetate disodium Inactive 0.25 MILLIGRAM  In 1 MILLILITER Hydrochloric acid Inactive 0.5 MILLIGRAM  In 1 MILLILITER Sodium hydroxide Inactive   Water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 12862-1097-8 5 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 CARTRIDGE In 1 BLISTER PACK This package is contained within the CARTON (12862-1097-8) and contains a CARTRIDGE 1 1.7 mL (MILLILITER) In 1 CARTRIDGE This package is contained within a BLISTER PACK and a CARTON (12862-1097-8)

Revised: 06/2006Septodont, Inc.

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