Magnesium Water

Generic Name: magnesium sulfate in water

Dosage Form: for Injection

Flexible Plastic Container

For Intravenous Use Only

Rx only

Magnesium Water Description

Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes.

Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 • 7H2O, colorless crystals or white powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Magnesium Water - Clinical Pharmacology

Magnesium (Mg++) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

Magnesium prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Magnesium is said to have a depressant effect on the central nervous system, but it does not adversely affect the mother, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Normal serum magnesium levels range from 1.3 to 2.1 mEq/liter.

As serum magnesium rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the serum level approaches 10 mEq/liter. At this level respiratory paralysis may occur. Heart block also may occur at this or lower serum levels of magnesium.

Magnesium acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral effects of magnesium poisoning are antagonized to some extent by intravenous administration of calcium.

With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter.

Pharmacokinetics:

Absorption: Intravenously administered magnesium is immediately absorbed.

Distribution: Approximately 1-2% of total body magnesium is located in the extracellular fluid space. Magnesium is 30% bound to albumin.

Metabolism: Magnesium is not metabolized.

Excretion: Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.

Special Populations:

Renal Insufficiency: Magnesium is excreted solely by the kidney. In patients with severe renal insufficiency, the dose should be lower and frequent serum magnesium levels must be obtained (see DOSAGE AND ADMINISTRATION).

Hepatic Insufficiency: Magnesium is excreted solely by the kidney. No dosing adjustments are necessary in hepatic insufficiency.

Drug-Drug Interactions: Drug induced renal losses of magnesium occur with the following drugs or drug classes:

Aminoglycosides	Amphotericin B
Cyclosporine	Diuretics
Digitalis	Cisplatin
Alcohol

Indications and Usage for Magnesium Water

Magnesium Sulfate in Water for Injection is indicated for use as an intravenous anticonvulsant for the prevention and control of seizures (convulsions) in severe toxemia of pregnancy. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.

Contraindications

Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

Warnings

Intravenous use in eclampsia should be reserved for immediate control of life-threatening convulsions.

Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.

Precautions

Because magnesium is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL every four hours. Monitoring serum magnesium levels and the patient’s clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). Serum magnesium levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). The strength of the deep tendon reflexes begins to diminish when serum magnesium levels exceed 4 mEq/liter. Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium intoxication in eclampsia.

Magnesium Sulfate in Water for Injection should be administered slowly to avoid producing hypermagnesemia.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with Magnesium Sulfate in Water for Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy Category A.

Studies in pregnant women have not shown that magnesium sulfate injection increases the risk of fetal abnormalities if administered during all trimesters of pregnancy. If this drug is used during pregnancy, the possibility of fetal harm appears remote. However, because studies cannot rule out the possibility of harm, magnesium sulfate solution should be used during pregnancy only if clearly needed.

When administered by continuous intravenous infusion (especially for more than 24 hours preceding delivery) to control convulsions in toxemic mothers, the newborn may show signs of magnesium toxicity, including neuromuscular or respiratory depression. (See OVERDOSAGE).

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 Magnesium Sulfate in Water for Injection is administered to a nursing mother.

Adverse Reactions

The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis.

Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.

Overdosage

Magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication. In the event of overdosage artificial ventilation must be provided until a calcium salt can be injected intravenously to antagonize the effects of magnesium.

In adults intravenous administration of 5 to 10 mEq of 10% calcium gluconate will usually reverse respiratory depression or heart block due to magnesium intoxication. In extreme cases, peritoneal or hemodialysis may be required.

Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as intravenous calcium.

Magnesium Water Dosage and Administration

Magnesium Sulfate in Water for Injection is intended for intravenous use only. For the management of pre-eclampsia or eclampsia, intravenous infusions of dilute solutions of magnesium (1% to 8%) are often given in combination with intramuscular injections of 50% Magnesium Sulfate Injection, USP. Therefore, in the clinical conditions cited below, both forms of therapy are noted, as appropriate.

In Eclampsia

In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. To initiate therapy, 4 g of Magnesium Sulfate in Water for Injection may be administered intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute, or 3.75 mL of a 4% concentration (or its equivalent) per minute, except in severe eclampsia with seizures. Simultaneously, 4 to 5 g (32.5 to 40.6 mEq) of magnesium sulfate may be administered intramuscularly into each buttock using undiluted 50% Magnesium Sulfate Injection, USP. After the initial I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. infusion.

Subsequent intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into alternate buttocks every four hours, depending on the continuing presence of the patellar reflex, adequate respiratory function, and absence of signs of magnesium toxicity. Therapy should continue until paroxysms cease.

A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should not be exceeded. In the presence of severe renal insufficiency, frequent serum magnesium concentrations must be obtained and the maximum dosage of magnesium sulfate is 20 g per 48 hours.

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

Do not administer unless solution is clear. Discard unused portion.

How is Magnesium Water Supplied

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows:

NDC No.	Size Container	Total Magnesium Sulfate**	Total Magnesium Ion	Magnesium Sulfate** Concentration	Magnesium Ion Concentration	Osmolarity (calc.)
*  Partial fill container 50 mL volume in 100 mL container. ** As the heptahydrate.
0409-6729-23	100 mL	4 g	32.5 mEq	4% (40 mg/mL)	32.5 mEq/100 mL	325 mOsmol/Liter
0409-6729-03	500 mL	20 g	162.3 mEq	4% (40 mg/mL)	32.5 mEq/100 mL	325 mOsmol/Liter
0409-6729-09	1000 mL	40 g	325 mEq	4% (40 mg/mL)	32.5 mEq/100 mL	325 mOsmol/Liter
0409-6729-24	50 mL*	2 g	16.25 mEq	4% (40 mg/mL)	16.25 mEq/50 mL	325 mOsmol/Liter
0409-6730-13	50 mL*	4 g	32.5 mEq	8% (80 mg/mL)	32.5 mEq/50 mL	649 mOsmol/Liter

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Revised: June, 2007

Printed in USA	EN-1548
Hospira, Inc., Lake Forest, IL 60045 USA

MAGNESIUM SULFATE  magnesium sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-6729 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Magnesium Sulfate (Magnesium cation) Active 4 GRAM  In 100 MILLILITER Water Inactive   Sulfuric Acid Inactive   Sodium Hydroxide Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-6729-23 24 BAG In 1 CASE contains a BAG 1 100 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-6729-23)

MAGNESIUM SULFATE  magnesium sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-6729 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Magnesium Sulfate (Magnesium cation) Active 20 GRAM  In 500 MILLILITER Water Inactive   Sulfuric Acid Inactive   Sodium Hydroxide Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-6729-03 24 BAG In 1 CASE contains a BAG 1 500 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-6729-03)

MAGNESIUM SULFATE  magnesium sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-6729 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Magnesium Sulfate (Magnesium cation) Active 40 GRAM  In 1000 MILLILITER Water Inactive   Sulfuric Acid Inactive   Sodium Hydroxide Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-6729-09 12 BAG In 1 CASE contains a BAG 1 1000 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-6729-09)

MAGNESIUM SULFATE  magnesium sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-6729 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Magnesium Sulfate (Magnesium cation) Active 2 GRAM  In 50 MILLILITER Water Inactive   Sulfuric Acid Inactive   Sodium Hydroxide Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-6729-24 24 BAG In 1 CASE contains a BAG 1 50 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-6729-24)

MAGNESIUM SULFATE  magnesium sulfate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-6730 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Magnesium Sulfate (Magnesium cation) Active 4 GRAM  In 50 MILLILITER Water Inactive   Sulfuric Acid Inactive   Sodium Hydroxide Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-6730-13 24 BAG In 1 CASE contains a BAG 1 50 mL (MILLILITER) In 1 BAG This package is contained within the CASE (0409-6730-13)

Revised: 08/2008Hospira, Inc.

More Magnesium Water resources

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

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Ferrous sulphate tablet 200mg OTC (Actavis UK Ltd)

Ferrous Sulphate

TABLETS 200mg

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.


• Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours.

Index

• 1. What Ferrous Sulphate tablets are and what they are used for


• 2. Before you take


• 3. How to take


• 4. Possible side effects


• 5. How to store


• 6. Further information

What Ferrous Sulphate tablets are and what they are used for

Ferrous Sulphate tablets belong to a group of medicines called iron supplements. These medicines work by replacing body iron. Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron-deficiency anaemia.

Ferrous Sulphate tablets are used for the prevention and treatment of iron-deficiency anaemia.

Before you take

Do not take Ferrous Sulphate tablets if you:

• are allergic (hypersensitive) to dried ferrous sulphate or any of the other ingredients in Ferrous Sulphate tablets (see section 6).



• are receiving repeated blood transfusions



• are receiving iron intravenously



• have a disorder in which there is excessive absorption and storage of iron such as haemochromatosis.

Check with your doctor or pharmacist before taking Ferrous Sulphate tablets if you have:

• haemolytic anaemia


• a blood disease (haemoglobinopathy)


• an iron storage or absorption disease


• gastrointestinal disease

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, obtained with or without a prescription. Especially:

• tetracyclines (to treat infections)


• ciprofloxacin, norfloxacin, ofloxacin (to treat infections)


• colestyramine


• antacids (containing magnesium or aluminium)


• medicines containing zinc, calcium, phosphorus or trientine


• methyldopa (to treat high blood pressure)


• penicillamine (for rheumatoid arthritis)


• levodopa (for Parkinson’s disease)


• ascorbic acid (vitamin C).

Sugar intolerance

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains glucose, sucrose and lactose.

Ingredient warning

Ferrous Sulphate tablets contain sorbic acid (E200) which may cause local skin reactions (e.g. contact dermatitis).

How to take

Food and drink

Ferrous Sulphate tablets should not be taken within one hour before or two hours after eating or drinking the following products: tea, coffee, milk, eggs and whole grains. These products can reduce the absorption of iron. Meat and products containing vitamin C can increase the absorption of iron. Follow the advice of your dietician or doctor when taking Ferrous Sulphate tablets with any of the food or drink listed.

Swallow the tablets whole with water. Although iron preparations are best absorbed on an empty stomach, they may be taken after food to reduce gastrointestinal side effects.

Doses:

Adults and the elderly


Treatment: 2-3 tablets a day in divided doses.


Prevention: 1 tablet a day.

Children 6-12 years


Treatment:


Children weighing over 22kg: one tablet a day.


Children weighing over 44kg: one tablet twice a day.


Children weighing over 66kg: one tablet three times a day.

Children under 6 years or weighing less than 22kg


Not recommended.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

Symptoms of an overdose include:

• Up to 24 hours: stomach and intestinal poisoning including being sick and diarrhoea, heart disorders such as low blood pressure (hypotension) and a racing heart (tachycardia), metabolic changes such as too much acid in the body (acidosis) and high blood sugar (hyperglycaemia), nervous system depression ranging from tiredness to coma, temporary relief of symptoms may occur.



• After 24 hours: stomach and intestinal poisoning and obstruction, shock, too much acid in the body (acidosis), fits, coma, liver failure, jaundice (yellowing of the skin or whites of the eyes), low blood sugar, problems with blood clotting, low production of urine, kidney failure, fluid in the lungs.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

Possible side effects

Like all medicines, Ferrous Sulphate tablets can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects, they get worse or if you notice any not listed.

Tell your doctor if you notice any of the following side effects:

• an allergic reaction e.g. itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.



• constipation occasionally causing faecal impaction, diarrhoea, stomach pain, feeling sick and blackened stools.

How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place.

Do not use Ferrous Sulphate tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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 Ferrous Sulphate tablets contain

• The active substance (the ingredient that makes the tablets work) is dried ferrous sulphate BP. Each tablet contains 200mg dried ferrous sulphate BP equivalent to 65mg ferrous iron.



• The other ingredients are spray dried liquid glucose, stearic acid, magnesium stearate, microcrystalline cellulose (101) (E460), lactose granules containing lactose, maize starch, pregelatinised maize starch, purified talc (E553), acacia (E414), gelatin, sucrose, titanium dioxide (E171), beeswax, yellow carnauba wax, polysorbate, sorbic acid (E200), shellac glaze, iron oxide black (E172) and propylene glycol (E1520).

What Ferrous Sulphate tablets look like and the contents of the pack

Ferrous Sulphate tablets are white, circular, biconvex, sugar-coated tablets.

Pack sizes are 30 and 60.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

UK

This leaflet was last revised in February 2008

50140191

Actavis

Barnstaple

EX32 8NS

UK

Isocaine

mepivacaine hydrochloride

Dosage Form: injection, solution
Mepivacaine HCl 3%

(Mepivacaine Hydrochloride Injection, USP)


Mepivacaine HCl 2%

(with Levonordefrin 1:20,000)

(Mepivacaine Hydrochloride and Levonordefrin Injection, USP)

Rx Only

THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY.

Isocaine Description

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

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 solution, is (-)-

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.

Mepivacaine hydrochloride injection 3% and 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 Injection, qs. 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.

Isocaine - Clinical Pharmacology

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

Mepivacaine is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted unchanged in the urine. Mepivacaine 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 Mepivacaine HCl 3% will ordinarily provide operating anesthesia of 20 minutes in the upper jaw and 40 minutes in the lower jaw.

Mepivacaine HCl 2% 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.

Mepivacaine 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 for Isocaine

Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.

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 evidence of alteration in sensorium or vital signs.

The solution which contains a vasoconstrictor (Mepivacaine HCl 2%) 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 (Mepivacaine HCl 2%) 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 non-asthmatic people. Mepivacaine HCl 3% is SULFITE FREE.

Mepivacaine, along with other local anesthetics, is capable of producing methemoglobinemia. The clinical signs of methemoglobinemia are cyanosis of the nail beds and lips, fatigue and weakness. If methemoglobinemia does not respond to administration of oxygen, administration of methylene blue intravenously 1-2 mg/kg body weight over a 5 minute period is recommended.

The American Heart Association has made the following recommendations regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: "Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used." (Kaplan, EL, editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association.)

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 increases 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 or 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 disease 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 para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) 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 HCl 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 effect reproductive 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

Reactions to MEPIVACAINE are characteristic of those associated with other amide-type local anesthetics. Systemic adverse reactions involving the central nervous system and the cardiovascular system usually result from high plasma levels (which may be due to excessive dosage, rapid absorption, inadvertent intravascular injection, or slow metabolic degradation), injection technique, or volume of injection.

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

Persistent paresthesias of the lips, tongue, and oral tissues have been reported with the use of mepivacaine, with slow, incomplete, or no recovery. These post-marketing events have been reported chiefly following nerve blocks in the mandible and have involved the trigeminal nerve and its branches.

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 possible 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 reaction may be abrupt and severe and is not usually dose related. Localized puffiness and swelling may occur.

Overdosage

Treatment of a patient with toxic manifestations consists of assuring and maintaining a patient 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 benzodiazephine (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.

IV and SC 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.

Isocaine 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 according 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.

Maximum dose for pediatric population =

Child's Weight (lbs.) 150

×

Maximum Recommended Dose 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 pediatric patient's weight or (for 2% mepivacaine) calulated maximum amount of drug:

Maximum Allowable Dosage*
	3% Mepivacaine		2% Mepivacaine
			1:20,000 Levonordefrin
	3 mg/lb		3mg/lb
	(270 mg max.)		(180 mg max.)
Weight (lb.)	mg	Number of Cartridges	mg	Number of Cartridges
* Adapted from Malamed, Stanley F: Handbook of medical emergencies in the dental office, ed. 2, St. Louis, 1982. The C.V. Mosby Co.
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

When using Mepivacaine HCl injection USP 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 is Isocaine Supplied

Mepivacaine HCl 3%; (Mepivacaine Hydrocholoride Injection USP) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton. Mepivacaine HCl 2% (Mepivacaine Hydrochloride and Levonordefrin Injection; USP) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton.

Both solutions should be stored at controlled room temperature, below 25° C (77° F). Protect from light. Do not permit to freeze. BOXES: For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the top flap. The Mepivacaine 2% solution should not be used if its color is pinkish or darker than slightly yellow or it contains a precipitate. Cartridge warmers should not be used with Mepivacaine HCl injection USP products.

Manufactured and Distributed by

Novocol Pharmaceutical of Canada, Inc.

Cambridge Ontario Canada N1R 5S9

Rev 07/07 (2780-1)

PRINCIPAL DISPLAY PANEL - 1.7 mL Cartridge Carton

NRG

Distributed by IQ Dental

NDC 51004-2020-5

MEPIVACAINE HCl 3%

INJECTION

without VASOCONSTRICTOR

(MEPIVACAINE HCl INJECTION, USP)

50 Cartridges • 1.7 mL Minimum

Rx Only

iQDental™

Isocaine  mepivacaine hydrochloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51004-2020 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Mepivacaine Hydrochloride (Mepivacaine) Mepivacaine Hydrochloride 30 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride 6 mg  in 1 mL Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51004-2020-5 50 CARTRIDGE In 1 CARTON contains a CARTRIDGE 1 1.7 mL In 1 CARTRIDGE This package is contained within the CARTON (51004-2020-5)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088387	08/20/2010

Labeler - Novocol Pharmaceutical of Canada, Inc. (201719960)

Registrant - IQ Dental (800349763)

Establishment
Name	Address	ID/FEI	Operations
Novocol		201719960	MANUFACTURE

Revised: 07/2010Novocol Pharmaceutical of Canada, Inc.

More Isocaine resources

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

Compare Isocaine with other medications

• Local Anesthesia

ClindaMax Vaginal

Generic Name: clindamycin (Vaginal route)

klin-da-MYE-sin

Commonly used brand name(s)

In the U.S.

• Cleocin Vaginal


• ClindaMax


• Clindesse

Available Dosage Forms:

• Suppository


• Cream

Therapeutic Class: Antibiotic

Chemical Class: Lincosamide

Uses For ClindaMax

Clindamycin is used to treat certain vaginal infections. It works by killing the bacteria. This medicine will not work for vaginal fungus or yeast infections.

Clindamycin is available only with your doctor's prescription.

Before Using ClindaMax

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of vaginal clindamycin in children with use in other age groups.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

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

Interactions with Medicines

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

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

• Erythromycin

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

• Atracurium


• Metocurine


• Tubocurarine

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Stomach or intestinal disease, history of (especially colitis, including colitis caused by antibiotics, or enteritis)—Patients with a history of stomach or intestinal disease may have an increased chance of side effects including diarrhea

Proper Use of clindamycin

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

Wash your hands before and after using this medicine.

Avoid getting this medicine in your eyes. If this medicine does get into your eyes, rinse them immediately with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

Vaginal clindamycin usually comes with patient directions. Read them carefully before using this medicine.

Use clindamycin vaginal cream exactly as directed by your doctor.

• To fill the applicator if you are not using a pre-filled applicator
  
  • Remove cap from the tube.
  
  
  • Screw one of the applicators onto the tube. Always use a new applicator. Never use one that has been used before.
  
  
  • Squeeze the medicine into the applicator slowly until it is full.
  
  
  • Remove the applicator from the tube. Replace the cap on the tube.
  
  


• To insert the vaginal cream using the applicator
  
  • Relax while lying on your back with your knees bent.
  
  
  • Hold the full applicator in one hand. Insert it slowly into the vagina. Stop before it becomes uncomfortable.
  
  
  • Slowly press the plunger until it stops.
  
  
  • Withdraw the applicator. The medicine will be left behind in the vagina.
  
  


• To care for the applicator
  
  • Throw the applicator away after you use it.
  
  

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment .

Dosing

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

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

• For vaginal cream dosage form:
  
  • For bacterial vaginosis:
    
    • Adults and teenagers who are not pregnant—One applicatorful (100 milligrams [mg]) inserted into the vagina once a day, usually at bedtime, for three or seven days.
    
    
    • Adults and teenagers who are pregnant—One applicatorful (100 milligrams [mg]) inserted into the vagina once a day, usually at bedtime, for seven days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For vaginal cream prefilled applicator dosage form:
  
  • For bacterial vaginosis:
    
    • Adults and teenagers—One applicatorful (100 milligrams [mg]) inserted into the vagina one time at any time of the day. This is a one-day treatment.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ClindaMax

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

It is important that you visit your doctor after you have used all your medicine to make sure that the infection is gone.

This medicine may cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

It is important that you tell your doctor right away if diarrhea occurs while you are using this medicine or after you have finished your treatment. It could be a symptom of a serious condition that your doctor will need to diagnose and treat.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin. Do not use tampons since they may soak up the medicine.

To help clear up your infection completely and make sure it does not return, good health habits are also required.

• Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) panties.


• Wear only freshly washed panties daily.

Do not have sexual intercourse while you are using this medicine. Having sexual intercourse may reduce the strength of the medicine. This may cause the medicine to not work as well.

Do not use latex (rubber) contraceptive products such as condoms, diaphragms, or cervical caps for 72 hours after stopping treatment with vaginal clindamycin cream. The cream contains oils that weaken or harm the latex products, causing them to not work properly to prevent pregnancy. If you have any questions about this, check with your health care professional.

ClindaMax Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

• Itching of the vagina or genital area


• pain during sexual intercourse


• thick, white vaginal discharge with no odor or with mild odor

Less common

• Diarrhea


• dizziness


• headache


• nausea or vomiting


• stomach pain or cramps

Rare

• Burning, itching, rash, redness, swelling or other signs of skin problems not present before use of this medicine

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Itching of the vagina or genital area


• pain during sexual intercourse


• thick, white vaginal discharge with no odor or with mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: ClindaMax Vaginal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More ClindaMax Vaginal resources

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

Compare ClindaMax Vaginal with other medications

• Bacterial Vaginitis

Eludril Mouthwash

1. Name Of The Medicinal Product

ELUDRIL mouthwash

2. Qualitative And Quantitative Composition

Actives :	Quantity :	Unit :
Chlorhexidine digluconate	0.100	% W/V
Chlorobutanol	0.500	% W/V

Each 1 ml contains chlorhexidine digluconate solution 0.005 ml (corresponding to 1 mg chlorhexidine digluconate).

The content of chlorhexidine digluconate per ml when diluted as recommended is 0.22 mg/ml – 0.33 mg/ml.

Each ml contains 5 mg of chlorobutanol.

The content of chlorobutanol per ml when diluted as recommended is 1.11 mg/ml – 1.66 mg/ml.

Excipients:Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Mouthwash.

Clear colourless Oromucosal solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Eludril mouthwash is an antibacterial solution which inhibits dental plaque formation. It is indicated as an aid in the treatment and prevention of gingivitis, and in maintaining oral hygiene, particularly in situations where toothbrushing is difficult to carry out (eg following oral surgery or in physically or mentally-handicapped patients). It is valuable in the management of aphtous ulceration and oral candidal infections (eg denture stomatitis and thrush) and can be used as an adjuvant treatment for minor infections of the throat.

As a disinfectant solution for the cleansing of removable dentures.

4.2 Posology And Method Of Administration

Eludril is contraindicated in infants and children under six years of age: see section 4.3.

1. As a mouthwash, dilute 10 to 15 ml in the measuring-cup provided for this purpose and fill with lukewarm water to the upper line and use as a mouthwash or a gargle two or three times a day.

2. As a disinfectant for removable dentures, prepare a 1 in 3 dilution of Eludril with water. The dentures previously cleansed should be soaked in the solution for one hour.

Route of administration

Oromucosal use. (This product is not intended to be swallowed)

4.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients.

- Use in infants and children less than 6 years of age.

- Use with anionic agents (see section 4.5).

4.4 Special Warnings And Precautions For Use

Warnings

For oral use only

Do not swallow

Keep out of the eyes and ears. If the mouthwash comes into contact with the eyes or ears, wash out promptly and thoroughly with water.

Discoloration of the tongue, teeth and silicate or composite restorations may occur. This stain is not permanent and can largely be prevented by brushing with a conventional toothpaste daily before using the mouthwash or, in the case of dentures cleansing with a conventional cleanser: see sections 4.5, 4.8.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional: see section 4.8

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E218) which may cause allergic reactions.

Precautions for use

Chlorhexidine is an irritant and should be used with caution. If there is evidence of irritation or aggravation of the condition, a doctor or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine is incompatible with anionic agents which are usually present in conventional toothpastes. Therefore, thorough rinsing of the mouth with water, after toothbrushing with toothpaste, should be done before using this medicine: see section 4.3. A short time should elapse between using the two products.

4.6 Pregnancy And Lactation

There is no evidence of any adverse effects in infants arising from the use of Eludril mouthwash during pregnancy or lactation.

Therefore no special precautions are recommended.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable Effects

Body System	Adverse Reactions (frequency not known)
Immune system disorders	Anaphylactic shock, anaphylactic reaction, hypersensitivity
Nervous system disorders	-Dysgeusia: transient disturbance of taste sensation -Mucosal burning sensation: burning sensation of the tongue. These effects may occur on initial use of the product and usually diminish with continued use.
Gastrointestinal disorders	-Tongue discoloration: Superficial discoloration of the dorsum of the tongue, reversible after discontinuing treatment: see section 4.4. -Teeth discoloration: Discoloration of the teeth and silicate or composite restorations: see section 4.4. -Parotid gland enlargement: swelling of the parotid glands reversible after discontinuing treatment. - Oral desquamation: In cases where oral desquamation occurs dilution of 10ml of the mouthwash with water to the upper line of the measuring cup will often allow continued use of the mouthwash

4.9 Overdose

Overdose is not expected under normal conditions of use of this solution as a mouthwash (normal dilution conditions for 10 ml is 7.4 %v/v and for 15 ml is 11.1 %v/v.). However, due to the undiluted product alcohol content (33.25 % v/v) accidental ingestion of large amounts by children requires prompt medical attention for appropriate action.

Symptoms

Chlorhexidine when taken orally is poorly absorbed. Most patients will develop very few symptoms. Local effects like burning sensation in the mouth and throat may occur. Systemic effects are unlikely if large volumes are ingested. However, large amounts may cause digestive disorders (epigastric pain, diarrhoea) and if chlorhexidine passes into the general system, signs of neurological toxicity may develop.

Emergency procedures

- Do not attempt to empty the stomach

- Administration of milk, water to drink, raw egg, gelatin or mild soap may be advisable provided the airway can be protected.

- General supportive measures should be instituted as deemed necessary by the physician.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-infectives and antiseptics for local oral treatment.

ATC code: A01AB03.

CHLORHEXIDINE : broad-spectrum antibacterial (gram + and gram -) and anti-fungal product with extended bactericidal activity on buccal mucosa.

CHLOROBUTANOL: local anaesthetic providing a quick relief from pain, bacteriostatic reinforcing the activity of chlorhexidine.

5.2 Pharmacokinetic Properties

CHLORHEXIDINE:

Oral:Very weak systemic absorption, distribution mainly via liver and kidneys; little metabolism (no degradation of the molecule). Elimination mainly in faeces (99.5 % of the ingested dose).

Permucosal absorption: negligible. Distribution, metabolism and elimination same as oral route

CHLOROBUTANOL:

Systemic absorption after oral administration. Half-life of 9 to 10 days.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Poloxamer

Alcohol

Sorbitol solution 70 % (crystallising)

Menthol

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Peppermint spirit

Purified Water

6.2 Incompatibilities

See section 4.5

6.3 Shelf Life

Unopened: 3 years

6.4 Special Precautions For Storage

Store away from light,

Store at a temperature of 25°C maximum.

6.5 Nature And Contents Of Container

Clear glass bottle with aluminium cap and a measuring cup.

Pack sizes: 90ml, 250ml and 500ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

PIERRE FABRE LIMITED

Hyde Abbey House

23 Hyde Street

Winchester

Hampshire

SO23 7DR

UNITED KINGDOM

8. Marketing Authorisation Number(S)

PL 00603/0012R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 9^th August 1973

Date of last renewal: 16^th April 2007

10. Date Of Revision Of The Text

27/01/2011

Kapake 15mg / 500mg Tablets.

1. Name Of The Medicinal Product

Kapake 15mg/500mg Tablets.

2. Qualitative And Quantitative Composition

	mg per tablet
Paracetamol	500.0mg
(as Paracetamol DC 96% and Povidone 4%)
Codeine Phosphate Hemihydrate	15.0mg

For a full list of excipients, see Section 6.1

3. Pharmaceutical Form

Tablet.

Oblong, white uncoated tablets marked 'K1' both sides of a score line on one side, the other side is plain and unmarked. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of moderate pain.

4.2 Posology And Method Of Administration

For oral administration.

Adults and children aged 16 and over:

Two tablets to be taken every four hours as required, up to a maximum of eight tablets in any 24-hour period.

Children aged 12 to 15 years:

One tablet to be taken every four hours as required, up to a maximum of four tablets in any 24-hour period.

Children under 12 years:

Not recommended for children under 12 years of age.

Elderly:

The adult dose is appropriate (please refer to Section 4.4 for additional information on elderly patients).

4.3 Contraindications

Kapake 15mg/500mg Tablets should not be used in patients hypersensitive to codeine phosphate, paracetamol or any of the other ingredients. This product is contraindicated in patients with raised intracranial pressure or head injury, respiratory depression, acute asthma and acute alcoholism. Kapake 15mg/500mg Tablets are also contraindicated in patients receiving monoamine oxidase inhibitors or who have received these agents within the previous two weeks. It is not recommended for children under 12 years of age.

4.4 Special Warnings And Precautions For Use

Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.

Kapake 15mg/500mg Tablets should be used with caution in the elderly and debilitated as these patients may be more sensitive to the effects of opioids, those with prostatic hypertrophy, inflammatory or obstructive bowel disorders or Addison's disease. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Dependence of the morphine type may be produced especially with prolonged use of high doses of codeine.

Prolonged regular use, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms such as restlessness and irritability, once the drug is stopped.

The risk-benefit of continued use should be assessed regularly by the prescriber.

Immediate medical advice should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed serious liver damage. Patients should be advised not to take other paracetamol- or codeine-containing products concurrently.

The leaflet will state in a prominent position in the 'before taking' section:

• Do not take for longer than directed by your prescriber

• Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets

• Taking a painkiller for headaches too often or for too long can make them worse.

The label will state (to be displayed prominently on outer pack – not boxed):

• Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The depressant effects of codeine may be enhanced by other central nervous system depressants: anxiolytics, hypnotics, antidepressants, antipsychotics and alcohol. If combined therapy is necessary, the dose of one or both agents should be reduced. Alcohol should be avoided.

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

This product should not be used during pregnancy.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

4.7 Effects On Ability To Drive And Use Machines

Kapake 15mg/500mg may impair mental and/or physical abilities, therefore it may affect the ability to drive and operate machinery.

4.8 Undesirable Effects

The following undesirable effects have been reported following the use of paracetamol: blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. Hypersensitivity, including skin rash, may also occur.

The following undesirable effects have been reported following the use of codeine: nausea, vomiting, dizziness and drowsiness. These effects are more likely to be experienced by the ambulatory patient and thus may be alleviated if the patient lies down. Other side effects of codeine, which may occur, include bradycardia, miosis, constipation, abdominal pain (rarely codeine-induced pancreatitis has been reported in patients with a history of cholecystectomy), allergic reactions, light-headedness, confusion, euphoria, dysphoria, urinary retention, and pruritus.

Regular prolonged use of codeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.

Prolonged use of a painkiller for headaches can make them worse.

4.9 Overdose

Paracetamol Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

(a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes, or

(b) Regularly consumes ethanol in excess of recommended amounts, or

(c) Is likely to be glutathione deplete, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms of Paracetamol Overdose

Symptoms of paracetamol overdosage 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, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management of Paracetamol Overdose

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. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.

Treatment with activated charcoal should be considered if the overdose has been taken within one hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the National Poisons Information Centre (NPIC) or a liver unit.

Codeine Overdose

The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms of Codeine Overdose

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management of Codeine Overdose

This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350mg or a child more than 5mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Paracetamol, combinations, excluding psycholeptics ATC Code: N02B E51

Paracetamol has analgesic and antipyretic effects that do not differ significantly from those of aspirin. Its anti-inflammatory action is weak and it has practically no anti-platelet effect. The mechanism of action is unclear, although it is believed to exert its action by inhibition of prostaglandin synthesis.

Codeine is an analgesic with uses similar to those of morphine, although it is much less potent as an analgesic and has only mild sedative effects. It is used for the relief of cough and pain. Codeine has a low affinity for opioid receptors, the analgesic effect of codeine may be due to its conversion to morphine; approximately 10% of administered codeine is demethylated to form morphine.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to two hours after oral administration. 90-100% of administered drug can be recovered in the urine within the first day. Practically none is excreted unchanged, most is conjugated in the liver with glucuronic acid or sulphuric acid.

Codeine and its salts are absorbed rapidly from the gastrointestinal tract with peak plasma levels occurring about one hour after oral administration. Codeine is metabolised in the liver and excreted in the urine mainly as a conjugate of glucuronic acid. Approximately 10% of administered codeine is demethylated to form morphine.

Concurrent administration of both drugs does not interfere with the normal metabolic processes of each agent.

5.3 Preclinical Safety Data

There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Microcrystalline Cellulose

Magnesium Stearate

Sodium Starch Glycolate

Povidone

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

PVC/ aluminium blisters.

Pack sizes: 4, 30 and 100 tablets. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Galen Limited

Seagoe Industrial Estate

Craigavon

BT63 5UA

UK

8. Marketing Authorisation Number(S)

PL 27827/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

13 July 2010

10. Date Of Revision Of The Text

03 August 2011