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Retinol

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• Turkey

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Bromelains

Bromelains is reported as an ingredient of Internase in the following countries:

• Hong Kong

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Zinmol

Zinmol may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

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Zinc Oxide

Zinc Oxide is reported as an ingredient of Zinmol in the following countries:

• New Zealand

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Acido Alendronico Semanal Ratiopharm

Acido Alendronico Semanal Ratiopharm may be available in the countries listed below.

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Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Acido Alendronico Semanal Ratiopharm in the following countries:

• Spain

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Mirtazapine PCH

Mirtazapine PCH may be available in the countries listed below.

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Mirtazapine

Mirtazapine is reported as an ingredient of Mirtazapine PCH in the following countries:

• Netherlands

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Musol

Musol may be available in the countries listed below.

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Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Musol in the following countries:

• Bangladesh

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Desferrioxamine Mesilate

Desferrioxamine Mesilate may be available in the countries listed below.

UK matches:

• Desferrioxamine Mesilate 500 mg and 2 g Powder for Injection (Hospira UK Ltd) (SPC)
• Desferrioxamine Mesilate for Injection BP 500mg and 2g (SPC)

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Deferoxamine

Desferrioxamine Mesilate (BANM) is known as Deferoxamine in the US.

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Glossary

BANM	British Approved Name (Modified)
SPC	Summary of Product Characteristics (UK)

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DDAVP Nasal Spray

desmopressin acetate

Dosage Form: nasal spray
DDAVP®

Nasal Spray

(desmopressin acetate)

DDAVP Nasal Spray Description

DDAVP® Nasal Spray (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:

Mol. wt. 1183.34

Empirical formula: C46H64N14O12S2•C2H4O2•3H2O

1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.

DDAVP Nasal Spray is provided as an aqueous solution for intranasal use.

Each mL contains:
Desmopressin acetate	0.1 mg
Sodium Chloride	7.5 mg
Citric acid monohydrate	1.7 mg
Disodium phosphate dihydrate	3.0 mg
Benzalkonium chloride solution (50%)	0.2 mg

The DDAVP Nasal Spray compression pump delivers 0.1 mL (10 mcg) of DDAVP (desmopressin acetate) per spray.

DDAVP Nasal Spray - Clinical Pharmacology

DDAVP contains as active substance desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (0.1 mg) of intranasal DDAVP has an antidiuretic activity of about 400 IU; 10 mcg of desmopressin acetate is equivalent to 40 IU.

1. The biphasic half-lives for intranasal DDAVP were 7.8 and 75.5 minutes for the fast and slow phases, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone used in this condition. As a result, intranasal DDAVP provides a prompt onset of antidiuretic action with a long duration after each administration.


2. The change in structure of arginine vasopressin to DDAVP has resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses are usually below threshold levels for effects on vascular or visceral smooth muscle.


3. DDAVP administered intranasally has an antidiuretic effect about one-tenth that of an equivalent dose administered by injection.

Human Pharmacokinetics

DDAVP is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects in each group) receiving single dose desmopressin acetate (2mcg) injection demonstrated a difference in DDAVP terminal half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment. (SeeCONTRAINDICATIONS.)

Indications and Usage for DDAVP Nasal Spray

Central Cranial Diabetes Insipidus

DDAVP Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. It is ineffective for the treatment of nephrogenic diabetes insipidus.

The use of DDAVP Nasal Spray in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.

There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.

Patients are selected for therapy by establishing the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or the response to antidiuretic hormone. Continued response to intranasal DDAVP can be monitored by urine volume and osmolality.

DDAVP is also available as a solution for injection when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.

Contraindications

DDAVP Nasal Spray is contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Nasal Spray.

DDAVP is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).

DDAVP is contraindicated in patients with hyponatremia or a history of hyponatremia.

Warnings

1. For intranasal use only.


2. DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible.


3. Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate). DDAVP is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required.


4. When DDAVP Nasal Spray is administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward in order to decrease the potential occurrence of water intoxication and hyponatremia. (See PRECAUTIONS, Pediatric Use and Geriatric Use.) All patients receiving DDAVP therapy should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.


5. DDAVP should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.

Precautions

General

Intranasal DDAVP at high dosage has infrequently produced a slight elevation of blood pressure, which disappeared with a reduction in dosage. The drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease because of possible rise in blood pressure.

DDAVP should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure and renal disorders because these patients are prone to hyponatremia.

Rare severe allergic reactions have been reported with DDAVP. Anaphylaxis has been reported rarely with intravenous and intranasal administration of DDAVP.

Central Cranial Diabetes Insipidus

Since DDAVP is used intranasally, changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption in which case intranasal DDAVP should not be used. For such situations, DDAVP Injection should be considered.

Information for Patients

Ensure that in children administration is under adult supervision in order to control the dose intake. Patients should be informed that the DDAVP Nasal Spray bottle accurately delivers 50 doses of 10 mcg each. Any solution remaining after 50 doses should be discarded since the amount delivered thereafter may be substantially less than 10 mcg of drug. No attempt should be made to transfer remaining solution to another bottle. Patients should be instructed to read accompanying directions on use of the spray pump carefully before use.

Fluid intake should be adjusted downward based upon discussion with the physician.

Laboratory Tests

Laboratory tests for following the patient with central cranial diabetes insipidus or post-surgical or head trauma-related polyuria and polydipsia include urine volume and osmolality. In some cases plasma osmolality measurements may be required.

Drug Interactions

Although the pressor activity of DDAVP is very low compared to the antidiuretic activity, use of large doses of intranasal DDAVP with other pressor agents should only be done with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with DDAVP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Category B:

Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposure in rabbits based on surface area, mg/m2) revealed no harm to the fetus due to DDAVP (desmopressin acetate). There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Several publications of desmopressin acetate's use in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and desmopressin acetate has been established. A fifteen year Swedish epidemiologic study of the use of desmopressin acetate in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population; however, the statistical power of this study is low. As opposed to preparations containing natural hormones, desmopressin acetate in antidiuretic doses has no uterotonic action and the physician will have to weigh the therapeutic advantages against the possible risks in each case.

Nursing Mothers

There have been no controlled studies in nursing mothers. A single study in a post-partum woman demonstrated a marked change in plasma, but little if any change in assayable DDAVP in breast milk following an intranasal dose of 10 mcg. 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 DDAVP is administered to a nursing woman.

Pediatric Use

Central Cranial Diabetes Insipidus

DDAVP Nasal Spray has been used in children with diabetes insipidus. Use in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. (See WARNINGS.) The dose must be individually adjusted to the patient with attention in the very young to the danger of an extreme decrease in plasma osmolality with resulting convulsions. Dose should start at 0.05 mL or less.

Since the spray cannot deliver less than 0.1 mL (10 mcg), smaller doses should be administered using the rhinal tube delivery system. Do not use the nasal spray in pediatric patients requiring less than 0.1 mL (10 mcg) per dose.

Geriatric Use

Clinical studies of DDAVP Nasal Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. DDAVP is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).

(See CLINICAL PHARMACOLOGY, Human Pharmacokinetics and CONTRAINDICATIONS.)

Use of DDAVP Nasal Spray in geriatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. (See WARNINGS).

There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.

Adverse Reactions

Infrequently, high dosages of intranasal DDAVP have produced transient headache and nausea. Nasal congestion, rhinitis and flushing have also been reported occasionally along with mild abdominal cramps. These symptoms disappeared with reduction in dosage. Nosebleed, sore throat, cough and upper respiratory infections have also been reported.

The following table lists the percentage of patients having adverse experiences without regard to relationship to study drug from the pooled pivotal study data for nocturnal enuresis.

ADVERSE REACTION	PLACEBO (N=59) %	DDAVP 20 mcg (N=60) %	DDAVP 40 mcg (N=61) %
BODY AS A WHOLE
Abdominal Pain	0	2	2
Asthenia	0	0	2
Chills	0	0	2
Headache	0	2	5
NERVOUS SYSTEM
Dizziness	0	0	3
RESPIRATORY SYSTEM
Epistaxis	2	3	0
Nostril Pain	0	2	0
Rhinitis	2	8	3
DIGESTIVE SYSTEM
Gastrointestinal Disorder	0	2	0
Nausea	0	0	2
SPECIAL SENSES
Conjunctivitis	0	2	0
Edema Eyes	0	2	0
Lachrymation Disorder	0	0	2

Post Marketing: There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

See WARNINGS for the possibility of water intoxication and hyponatremia.

Overdosage

Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. (See WARNINGS.) In case of overdosage, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for desmopressin acetate or DDAVP Nasal Spray.

An oral LD50 has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

DDAVP Nasal Spray Dosage and Administration

Central Cranial Diabetes Insipidus

DDAVP Nasal Spray dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal DDAVP. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses.

The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used.

The spray pump must be primed prior to the first use. To prime pump, press down four times. The bottle will now deliver 10 mcg of drug per spray. Discard DDAVP Nasal Spray after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 µg of drug.

Geriatric Use

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)

How is DDAVP Nasal Spray Supplied

DDAVP Nasal Spray is available in a 5-mL bottle with spray pump delivering 50 sprays of 10 mcg (NDC 0075-2452-01). Desmopressin acetate is also available as DDAVP Rhinal Tube, a refrigerated product with 2.5 mL per bottle, packaged with two rhinal tube applicators per carton (NDC 0075-2450-01).

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. STORE BOTTLE IN UPRIGHT POSITION.

Keep out of the reach of children.

U.S. Patent Nos. 5,498,598; 5,500,413; 5,596,078; 5,674,850; 5,763,407

Manufactured for:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

Revised July 2007

©2007 sanofi-aventis U.S. LLC

PATIENT INSTRUCTION GUIDE

DDAVP® Nasal Spray

(desmopressin acetate)

A better way to deliver DDAVP

Delivering DDAVP more efficiently

Your doctor has prescribed DDAVP as antidiuretic hormone replacement therapy. Follow the dosage schedule that is specified. The convenient nasal spray pump provides an efficient, reliable way to administer your medication. It is important, however, to adhere completely to the following instructions so that you will always receive a consistent dose of your medication.

CAUTION: The nasal spray pump accurately delivers 50 doses of 10 micrograms each. Any solution remaining after 50 doses should be discarded since the amount delivered thereafter per actuation may be substantially less than 10 micrograms of drug. Do not transfer any remaining solution to another bottle. Please read the following instructions carefully before using the spray pump.

Ensure that in children administration is under adult supervision in order to control the dose intake.

If you accidentally deliver/administer too much of a dose, immediately telephone your doctor or a certified Regional Poison Center for advice. Possible signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention.

Using your DDAVP Nasal Spray Pump

1.

Remove protective cap.

2.

The spray pump must be primed prior to the first use. To prime pump, press down 4 times.

3.

Once primed, the spray pump delivers 10 micrograms of medication each time it is pressed. To ensure dosing accuracy, tilt bottle so that dip tube inside the bottle draws from the deepest portion of the medication.

To administer a 10-microgram dose, place the spray nozzle in nostril and press the spray pump once. If a higher dose has been prescribed, spray half the dose in each nostril. The spray pump cannot be used for doses less than 10 micrograms or doses other than multiples of 10 micrograms.

4.

Replace the protective cap on bottle after use. The pump will stay primed for up to one week. If the product has not been used for a period of one week, re-prime the pump by pressing once.

5.

We have included a convenient check-off chart to assist you in keeping track of medication doses used. This will help assure that you receive 50 "full doses" of medication. Please note that the bottle has been filled with extra solution to accommodate the initial priming activity.

DDAVP Nasal Spray 50-Dose Check-off
1	2	3	4	5
6	7	8	9	10
11	12	13	14	15
16	17	18	19	20
21	22	23	24	25
26	27	28	29	30
31	32	33	34	35
36	37	38	39	40
41	42	43	44	45
46	47	48	49	50

1.

Retain with medication or affix in convenient location.

2.

Starting with dose #1, check off after each administration.

3.

Discard medication after 50 doses.

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].

STORE BOTTLE IN UPRIGHT POSITION.

Manufactured for:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

Revised July 2007

©2007 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 5mL Bottle Label

NDC 0075-2452-01

DDAVP®

Nasal Spray

desmopressin acetate

10µg/0.1mL

FOR INTRANASAL

USE ONLY

One 5mL Bottle

(50 Doses)

sanofi aventis

PRINCIPAL DISPLAY PANEL - 5mL Bottle Carton

NDC 0075-2452-01

DDAVP®

Nasal

Spray

desmopressin

acetate

10µg/0.1mL

FOR INTRANASAL USE ONLY

One 5mL Bottle (50 Doses)

sanofi aventis

DDAVP  desmopressin acetate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0075-2452 Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength desmopressin acetate (desmopressin) desmopressin 0.1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength sodium chloride 7.5 mg  in 1 mL citric acid monohydrate 1.7 mg  in 1 mL sodium phosphate, dibasic, dihydrate 3 mg  in 1 mL Benzalkonium chloride 0.2 mg  in 1 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0075-2452-01 5 mL In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017922	02/21/1978

Labeler - sanofi-aventis U.S. LLC (824676584)

Establishment
Name	Address	ID/FEI	Operations
Ferring GmbH		328609615	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Rechon Life Science AB		775207769	MANUFACTURE

Revised: 09/2009sanofi-aventis U.S. LLC

More DDAVP Nasal Spray resources

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

Compare DDAVP Nasal Spray with other medications

• Diabetes Insipidus

Serviclor

Serviclor may be available in the countries listed below.

Ingredient matches for Serviclor

Cefaclor

Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Serviclor in the following countries:

• Czech Republic


• Mexico

International Drug Name Search

dextromethorphan and quinidine

Generic Name: dextromethorphan and quinidine (DEX troe meth OR fan and KWIN i deen)

Brand Names: Nuedexta

What is dextromethorphan and quinidine?

Dextromethorphan affects the signals in the brain that trigger cough reflex and is generally used as a cough suppressant.

Quinidine affects the way that the heart beats and is generally used to in people with certain heart rhythm disorders.

The combination of dextromethorphan and quinidine is used to treat involuntary outbursts of crying or laughing in people with certain neurological disorders, including multiple sclerosis and amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).

Dextromethorphan and quinidine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dextromethorphan and quinidine?

You should not take dextromethorphan and quinidine if you are also taking quinidine (Quin-G), quinine (Qualaquin), or mefloquine (Lariam), or if you have ever had an allergic reaction or serious medical problem caused by taking any of these medications. You should not use this medication if you are allergic to dextromethorphan or quinidine, or if you have heart failure, a serious heart condition called "AV block" (unless you have a pacemaker), or a history of Long QT syndrome or life-threatening heart rhythm disorder.

Before you take this medication, tell your doctor if you have slow heartbeats or any other type of heart rhythm disorder, an electrolyte imbalance, bladder or bowel obstruction, myasthenia gravis, or a family history of Long QT syndrome.

There are many other drugs that can cause serious or life threatening medical problems if you take them together with dextromethorphan and quinidine. Tell your doctor about all other medicines you use. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking dextromethorphan and quinidine?

You should not take this medicine if you are also taking quinidine (Quin-G), quinine (Qualaquin), or mefloquine (Lariam), or if you have ever had hepatitis, low levels of platelets in your blood, bone marrow depression, lupus-like syndrome, or an allergic reaction caused by taking any of these medications. You should not use this medication if you are allergic to dextromethorphan or quinidine, or if you have:

• 
  

  heart failure;

  
  


• 
  

  a history of life-threatening heart rhythm disorder;

  
  


• 
  

  a history of Long QT syndrome; or

  
  


• 
  

  a serious heart condition called "AV block" (unless you have a pacemaker).

  
  

Do not use dextromethorphan and quinidine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

After you stop taking dextromethorphan and quinidine, you must wait at least 14 days before you start taking an MAOI.

There are many other drugs that can cause serious or life threatening medical problems if you take them together with dextromethorphan and quinidine. The following drugs should not be used while you are taking dextromethorphan and quinidine:

• 
  

  an anti-malaria drug called chloroquine (Aralen);

  
  


• 
  

  certain antidepressants: amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), or desipramine (Norpramin);

  
  


• 
  

  certain heart rhythm medications: quinidine (Quin-G), procainamide (Procan, Pronestyl), or propafenone, (Rythmol); or

  
  


• 
  

  certain medicines to treat psychiatric disorders: chlorpromazine (Thorazine), haloperidol (Haldol), pimozide (Orap), or thioridazine (Mellaril).

  
  

If you cannot avoid taking any of the medicines listed above, your heart function may need to be tested on a regular basis while you are taking dextromethorphan and quinidine. Do not miss any follow-up visits to your doctor.

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

• 
  

  a family history of Long QT syndrome;

  
  


• 
  

  an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  
  


• 
  

  slow heartbeats or any type of heart rhythm disorder;

  
  


• 
  

  myasthenia gravis;

  
  


• 
  

  bladder obstruction or other urination problems; or

  
  


• 
  

  a bowel obstruction or intestinal disorder.

  
  

FDA pregnancy category C. It is not known whether dextromethorphan and quinidine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give dextromethorphan and quinidine to anyone under 18 years old without medical advice.

How should I take dextromethorphan and quinidine?

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

Dextromethorphan and quinidine is usually started at a dose of 1 capsule per day for 7 days. After the first week you will take 1 capsule every 12 hours. Follow your doctor's instructions. Do not take more than 2 capsules in a 24-hour period.

You may take dextromethorphan and quinidine with or without food.

Your doctor will need to check your progress on a regular basis. This will help your doctor determine how long to treat you with dextromethorphan and quinidine. To be sure the medicine not causing harmful effects, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Visit your doctor regularly. Store at room temperature away from moisture and heat.

See also: Dextromethorphan and quinidine dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose can cause severe dizziness, confusion, double vision, ringing in your ears, vomiting, rapid heart rate, weak or shallow breathing, a dazed feeling, or seizure (convulsions).

What should I avoid while taking dextromethorphan and quinidine?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Grapefruit and grapefruit juice may interact with dextromethorphan and quinidine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Ask a doctor or pharmacist before using any cough or cold medication. Dextromethorphan is contained in many combination medicines. Taking certain products together can cause you to get too much dextromethorphan. Check the label to see if a medicine contains dextromethorphan (Delsym, Robitussin Maximum Strength, Vicks 44, and others).

Dextromethorphan and quinidine side effects

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

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  severe dizziness, fainting, fast or pounding heartbeat;

  
  


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  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


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  pain or burning when you urinate;

  
  


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  fever, chills, flu symptoms, nausea, vomiting, feeling light-headed;

  
  


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

  
  


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  agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting; or

  
  


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  joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions).

  
  

Less serious side effects may include:

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  muscle spasm;

  
  


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  diarrhea, gas, mild stomach pain;

  
  


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  dizziness, weakness;

  
  


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  cough; or

  
  


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  swelling in your hands or feet.

  
  

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.

Dextromethorphan and quinidine Dosing Information

Usual Adult Dose for Pseudobulbar Affect:

dextromethorphan-quinidine 20 mg-10 mg:
Starting dose: one capsule daily by mouth for 7 days.
Maintenance dose: After 7 days, 1 capsule every 12 hours.

What other drugs will affect dextromethorphan and quinidine?

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

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  aprepitant (Emend);

  
  


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  cimetidine (Tagamet);

  
  


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  digoxin (Lanoxin, Lanoxicaps);

  
  


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  narcotic cough medicine (codeine or dihydrocodeine);

  
  


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  ADHD medication such as atomoxetine (Strattera), dextroamphetamine (Adderall), methamphetamine (Desoxyn), methylphenidate (Ritalin, Daytana, Metadate, Concerta);

  
  


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  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), citalopram (Celexa), desipramine (Norpramin), doxepin (Sinequan), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Symbyax), nortriptyline (Pamelor), nefazodone, paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor);

  
  


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  an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), doxycycline (Doryx, Oracea, Periostat, Vibramycin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), metronidazole (Flagyl), norfloxacin (Noroxin), telithromycin (Ketek), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

  
  


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  antifungal medicine such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

  
  


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  cancer medicine such as doxorubicin (Adriamycin, Doxil), lomustine (CeeNU), tamoxifen (Soltamox);

  
  


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  heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), betaxolol (Kerlone), captopril (Capoten), carvedilol (Coreg), diltiazem (Cartia, Cardizem), flecainide (Tambocor), labetalol (Normodyne), metoprolol (Dutoprol, Lopressor, Toprol), mexilitene (Mexitil), nicardipine (Cardene), pindolol (Visken), propranolol (Inderal), timolol (Blocadren), verapamil (Calan, Covera, Isoptin, Verelan), and others;

  
  


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  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or

  
  


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  pain medication such as codeine (Tylenol #3), hydrocodone (Lortab, Vicodin, Vicoprofen), oxycodone (OxyContin, Percocet), or tramadol (Ultram, Ultracet).

  
  

This list is not complete and there are many other drugs that can interact with dextromethorphan and quinidine. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More dextromethorphan and quinidine resources

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

Compare dextromethorphan and quinidine with other medications

• Pseudobulbar Affect

Where can I get more information?

• Your pharmacist can provide more information about dextromethorphan and quinidine.

See also: dextromethorphan and quinidine side effects (in more detail)

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Maycardin may be available in the countries listed below.

Ingredient matches for Maycardin

Amino Acids

Aspartic Acid dipotassium and magnesium (a derivative of Aspartic Acid) is reported as an ingredient of Maycardin in the following countries:

• Austria

International Drug Name Search

Mekoll

Mekoll may be available in the countries listed below.

Ingredient matches for Mekoll

Metformin

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Mekoll in the following countries:

• Germany

International Drug Name Search