SEO Articles Directory Sint Eustatius: September 2016

Wednesday, 28 September 2016

MGA

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

Ingredient matches for MGA

Lasalocid

Lasalocid is reported as an ingredient of MGA in the following countries:

United States

Melengestrol

Melengestrol 17α-acetate (a derivative of Melengestrol) is reported as an ingredient of MGA in the following countries:

South Africa

United States

Monensin

Monensin sodium salt (a derivative of Monensin) is reported as an ingredient of MGA in the following countries:

United States

Oxytetracycline

Oxytetracycline is reported as an ingredient of MGA in the following countries:

United States

Tylosin

Tylosin phosphate (a derivative of Tylosin) is reported as an ingredient of MGA in the following countries:

United States

International Drug Name Search

Dexavene

Dexavene may be available in the countries listed below.

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

Ingredient matches for Dexavene

Dexamethasone

Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of Dexavene in the following countries:

France

International Drug Name Search

Sintocalmin

Sintocalmin may be available in the countries listed below.

Ingredient matches for Sintocalmin

Metamizole

Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Sintocalmin in the following countries:

Romania

International Drug Name Search

Class: First Generation Antihistamines
ATC Class: R06AX02
VA Class: AH107
Chemical Name: 4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride
Molecular Formula: C₂₁H₂₁N•HCl
CAS Number: 41354-29-4

Special Alerts:

[Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state “do not use” in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns. For more information visit the FDA website at: and .

Introduction

First generation antihistamine; serotonin antagonist;⁵ ⁶ ²⁷ ⁴⁰ ⁴³ ⁵⁰ ⁵¹ structurally and pharmacologically related to azatadine.¹ ⁵

Uses for Cyproheptadine Hydrochloride

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Allergic Conditions

Treatment of cold urticaria.⁵ ¹¹ ¹² ¹³ ⁷⁴ ⁷⁵

Symptomatic relief of perennial (nonseasonal) and seasonal (e.g., hay fever) allergic rhinitis.⁷⁴ ⁷⁵ ^c

Management of nonallergic (vasomotor) rhinitis.⁷⁴ ⁷⁵

Management of allergic conjunctivitis caused by foods or inhaled allergens.⁷⁴ ⁷⁵ ^c

Management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.⁷⁴ ⁷⁵

Treatment of dermatographism.⁷⁴ ⁷⁵ ^c

Amelioration of allergic reactions to blood or plasma.⁷⁴ ⁷⁵ ^c

Adjunct to epinephrine and other standard measures for management of anaphylactic reactions after acute manifestations have been controlled.⁷⁴ ⁷⁵

Cushing’s Syndrome

Has been effective in some patients for the treatment of Cushing’s syndrome† secondary to pituitary disorders;¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ¹⁹ ²⁰ ²¹ ⁴⁸ ⁵² ⁵³ ⁶³ however, in most patients, other therapy (e.g., surgery, radiation therapy) is preferred.²¹ ³⁹ ⁴⁸

Sexual Dysfunction

Has been effective for the management of inhibited male or female orgasm† (anorgasmy) induced by tricyclic antidepressants,⁵⁵ ⁵⁷ ⁵⁸ ⁶⁶ MAO inhibitors,⁵⁴ ⁵⁶ fluoxetine,⁶⁸ or antipsychotic agents.⁵⁶ However, consider the potential for interactions between these drugs and cyproheptadine.⁵ ⁶⁶ (See Interactions.)

Anorexia Nervosa

Has been shown to stimulate appetite and weight gain in children³² ³³ and adults;³⁴ ³⁵ ³⁶ however, few indications for clinical use.⁴⁰ May be of some value in the treatment of anorexia nervosa†;³⁷ ³⁸ ⁴¹ ⁴⁶ ⁴⁷ ⁵⁹ ⁶⁰ may be more effective in nonbulimic patients than in those who are bulimic.⁵⁹

Headache

Reportedly has been effective in some patients for the management of vascular headaches† (e.g., migraine).³⁰ ³¹ ⁴³ ⁴⁴ ⁷¹ Efficacy for prophylaxis of migraine not established in randomized controlled studies, but some experts consider the drug to be effective based on consensus and clinical experience.⁷¹

Cyproheptadine Hydrochloride Dosage and Administration

Administration

Oral Administration

Administer orally as tablets or oral solution.⁷⁴ ⁷⁵

Dosage

Available as cyproheptadine hydrochloride; dosage expressed in terms of the salt.⁷⁴ ⁷⁵

Pediatric Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Allergic Conditions

Oral

Children 2–6 years of age: Usual dosage is 2 mg 2 or 3 times daily; adjust as needed based on the size and response of the patient, up to maximum of 12 mg daily.⁵ ⁷⁴ ⁷⁵ (See Pediatric Use under Cautions.)

Children 7–14 years of age: Usual dosage is 4 mg 2 or 3 times daily; adjust as needed based on the size and response of the patient, up to maximum of 16 mg daily.⁵ ⁷⁴ ⁷⁵

Adolescents ≥15 years of age: Initially, 4 mg 3 times daily; adjust based on the size and response of the patient, up to 0.5 mg/kg daily.⁷⁴ ⁷⁵ Dosage range: 4–20 mg daily; most patients require 12–16 mg daily.⁷⁴ ⁷⁵

Alternatively, children ≥2 years of age may receive 0.25 mg/kg or 8 mg/m² daily in divided doses.⁵ ⁷⁴ ⁷⁵

Anorexia Nervosa†

Oral

Adolescents ≥13 years of age: Dosage of 2 mg 4 times daily, increased gradually over a 3-week period to up to 8 mg 4 times daily, has been used.³⁸ ⁴⁶ ⁴⁷ ⁵⁹

Adults

Allergic Conditions

Oral

Initially, 4 mg 3 times daily; adjust as needed based on the size and response of the patient, up to 0.5 mg/kg daily.⁵ ⁷⁴ ⁷⁵

Dosage range: 4–20 mg daily; most patients require 12–16 mg daily.⁵ ⁷⁴ ⁷⁵ Some patients may require up to 32 mg daily.⁵ ⁷⁴ ⁷⁵

Cushing’s Syndrome†

Oral

Initially, 8 mg daily in divided doses; gradually increase dosage to up to 24 mg daily in divided doses.¹⁴ ¹⁷ ¹⁸ ²¹ ⁴⁸ ⁵²

Anorexia Nervosa†

Oral

Dosage of 2 mg 4 times daily, increased gradually over a 3-week period to up to 8 mg 4 times daily, has been used.³⁸ ⁴⁶ ⁴⁷ ⁵⁹

Prescribing Limits

Pediatric Patients

Allergic Conditions

Oral

Children 2–6 years of age: Maximum 12 mg daily.⁷⁴ ⁷⁵

Children 7–14 years of age: Maximum 16 mg daily.⁷⁴ ⁷⁵

Adolescents ≥15 years of age: Maximum 0.5 mg/kg daily.⁷⁴ ⁷⁵

Anorexia Nervosa†

Oral

Adolescents ≥13 years of age: Maximum 32 mg daily.³⁸ ⁴⁶ ⁴⁷ ⁵⁹

Adults

Allergic Conditions

Oral

Maximum 0.5 mg/kg daily.⁷⁴ ⁷⁵

Cushing’s Syndrome†

Oral

Maximum 24 mg daily.¹⁴ ¹⁷ ¹⁸ ²¹ ⁴⁸ ⁵²

Anorexia Nervosa†

Oral

Maximum 32 mg daily.³⁸ ⁴⁶ ⁴⁷ ⁵⁹

Special Populations

Geriatric Patients

Select dosage with caution, starting at the lower end of the usual dosage range.⁵ ⁷⁴ (See Geriatric Use under Cautions.)

Cautions for Cyproheptadine Hydrochloride

Contraindications

Neonates and premature infants.⁷⁴ ⁷⁵

Women who are breast-feeding.⁷⁴ ⁷⁵ (See Lactation and also Pediatric Use under Cautions.)

Known hypersensitivity to cyproheptadine or other drugs with similar chemical structures.⁷⁴ ⁷⁵

Patients receiving MAO inhibitor therapy.⁷⁴ ⁷⁵ (See Interactions.)

Known history of angle-closure glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction.⁷⁴ ⁷⁵

Debilitated geriatric patients.⁷⁴ ⁷⁵

Warnings/Precautions

Warnings

CNS Effects

Risk of marked drowsiness.⁷⁴ ⁷⁵ ^c Caution required when performing hazardous activities requiring mental alertness and motor coordination (e.g., driving a motor vehicle, operating machinery).⁷⁴ ⁷⁵ ^c

Possible excitability (especially in children).⁷⁴ ⁷⁵ ^c (See Pediatric Use under Cautions.)

Concurrent use of other CNS depressants may have additive CNS depressant effects.⁷⁴ ⁷⁵ ^c (See Interactions.)

General Precautions

Concomitant Diseases

Because of anticholinergic effects, use with caution in patients with increased intraocular pressure, active or history of respiratory disease (e.g., bronchial asthma), hyperthyroidism, or cardiovascular disease (e.g., hypertension).⁷⁴ ⁷⁵ ^c (See Contraindications.) Use of antihistamines generally not recommended in asthmatics who previously experienced a serious antihistamine-induced adverse bronchopulmonary effect.

Specific Populations

Pregnancy

Category B.⁷⁴ ⁷⁵

Lactation

Not known whether cyproheptadine is distributed into milk.⁵ ⁷⁴

Because of potential for serious adverse effects in nursing infants, discontinue nursing or the drug.⁵ ⁷⁴ ⁷⁵ (See Pediatric Use under Cautions.)

Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Contraindicated in neonates and premature infants.⁷⁴ ⁷⁵

Safety and efficacy of cyproheptadine not established in children <2 years of age.⁷⁴ ⁷⁵

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.⁷² ⁷³ Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.⁷² Therefore, FDA recommended not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Cyproheptadine overdosage, particularly in infants and young children, may produce hallucinations, CNS depression, seizures, respiratory and cardiac arrest, and death.⁷⁴ ⁷⁵

Possible paradoxical excitement (e.g., restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures), especially in young children.⁷⁴ ⁷⁵ ^c Central anticholinergic syndrome (e.g., hallucinations, agitation, confusion) has occurred.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; clinical experience has not revealed age-related differences.⁵ ⁷⁴ Select dosage with caution (usually starting at low end of dosage range) because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.⁵ ⁷⁴

Possible increased risk of dizziness, sedation, and hypotension in geriatric patients.⁷⁴ ⁷⁵

Contraindicated in debilitated geriatric patients.⁷⁴ ⁷⁵

Common Adverse Effects

Sedation,⁷⁴ ⁷⁵ sleepiness (often transient),⁷⁴ ⁷⁵ dizziness,⁷⁴ ⁷⁵ disturbed coordination,⁷⁴ ⁷⁵ restlessness,⁷⁴ ⁷⁵ excitation.⁷⁴ ⁷⁵

Interactions for Cyproheptadine Hydrochloride

Specific Drugs and Laboratory Tests

Drug	Interaction	Comments
CNS depressants (e.g., alcohol, hypnotics, sedatives, tranquilizers)	Possible additive CNS depression⁷⁴ ⁷⁵ ^c	Use caution to avoid overdosage;^c advise patient to avoid alcohol
Fluoxetine	Reversal of fluoxetine's antidepressant effects reported in limited number of patients, possibly due to inhibition of fluoxetine's serotonergic effects⁶⁹ ⁷⁰
MAO inhibitors	MAO inhibitors prolong and intensify anticholinergic effects of antihistamines⁷⁴ ⁷⁵ ^c
Test, antigen or histamine	Inhalation-challenge testing with histamine or antigen: Possible suppression of test response Antigen skin testing: Possible suppression of wheal and flare reactions

Cyproheptadine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration.¹ ⁷

Distribution

Extent

Distribution into human body tissues and fluids has not been characterized.⁷

Elimination

Metabolism

Appears to be almost completely metabolized,⁷ ⁸ ⁹ ¹⁰ principally to the quaternary ammonium glucuronide conjugate.⁸ ⁹ ¹⁰

Elimination Route

Principally in urine, as conjugates; ⁷ ⁸ ⁹ ¹⁰ also in feces following oral administration.⁵ ⁷ ⁷⁴ ⁷⁵

Special Populations

Elimination is reduced in renal insufficiency.⁵ ⁷⁴ ⁷⁵

Stability

Storage

Oral

Solution

15–30°C.⁷⁵

Tablets

Tightly closed container at 15–30°C.⁷⁴

ActionsActions

Has potent antihistaminic and serotonin antagonist properties; also has anticholinergic and sedative effects⁵ ⁶ ⁴⁰ ⁵⁰ ⁵¹ and reportedly has calcium-channel blocking activity.⁴²

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Risk of drowsiness;⁷⁴ ⁷⁵ ^c avoid alcohol and use caution when engaging in activities requiring mental alertness and motor coordination (e.g., driving a motor vehicle, operating machinery).⁷⁴ ⁷⁵ ^c

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.⁷⁴ ⁷⁵

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.⁷⁴ ⁷⁵

Importance of informing patients of other important precautionary information.⁷⁴ ⁷⁵ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

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

Cyproheptadine Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	2 mg/5 mL*	Cyproheptadine Hydrochloride Syrup
	Tablets	4 mg*	Cyproheptadine Hydrochloride Tablets

Comparative Pricing

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

Cyproheptadine HCl 2MG/5ML Syrup (ACTAVIS MID ATLANTIC): 120/$18.99 or 360/$38.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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65. Kvols LK. Metastatic carcinoid tumors and the carcinoid syndrome: a selective review of chemotherapy and hormonal therapy. Am J Med. 1986; 81(Suppl 6B):49-55. [IDIS 224868] [PubMed 2432781]

66. Pontius EB. Case report of an anticholinergic crisis associated with cyproheptadine treatment of desipramine-induced anorgasmia. J Clin Psychopharmacol. 1988; 8:230-1. [IDIS 242985] [PubMed 3379154]

67. Merck Sharp & Dohme. Periactin tablets and syrup prescribing information. In: Physician’s desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998:1720-1.

68. McCormick S, Olin J, Brotman AW. Reversal of fluoxetine-induced anorgasmia by cyproheptadine in two patients. J Clin Psychiatry. 1990; 51:383-4. [IDIS 272903] [PubMed 2211550]

69. Feder R. Reversal of antidepressant activity of fluoxetine by cyproheptadine in three patients. J Clin Psychiatry. 1991; 52:163-4. [IDIS 281251] [PubMed 2016249]

70. Fluoxetine/cyproheptadine. In: Tatro DS, Olin BR, Hebel SK eds. Drug interaction facts. St. Louis: JB Lippincott Co; 1992(Jan):344c.

71. Ramadan NM, Silberstein SD, Freitag F et al. Evidence-based guidelines for migraine headache in the primary care setting: pharmacological management for prevention of migraine. St. Paul, MN; 2001. From the American Academy of Neurology web site: ().

72. Srinivasan A, Budnitz D, Shehab N et al. Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep. 2007; 56:1-4. [PubMed 17218934]

73. Food and Drug Administration. Cough and cold medications in children less than two years of age. Rockville, MD; 2007 Jan 12. From FDA website ().

74. Corepharma LLC. Cyproheptadine hydrochloride (Cyproheptadine Hydrochloride) tablet prescribing information. Middlesex, NJ; 2006 Jun.

75. Alpharma USPD. Cyproheptadine hydrochloride oral solution prescribing information. Baltimore, MD; 2005 Jun.

c. AHFS drug information 2007. McEvoy GK, ed. Antihistamines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1-8.

More Cyproheptadine Hydrochloride resources

Cyproheptadine Hydrochloride Side Effects (in more detail)
Cyproheptadine Hydrochloride Use in Pregnancy & Breastfeeding
Drug Images
Cyproheptadine Hydrochloride Drug Interactions
Cyproheptadine Hydrochloride Support Group
20 Reviews for Cyproheptadine Hydrochloride - Add your own review/rating

Cyproheptadine Prescribing Information (FDA)

cyproheptadine Concise Consumer Information (Cerner Multum)

Cyproheptadine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cyproheptadine Hydrochloride with other medications

Allergic Reactions
Anorexia
Anorexia Nervosa
Cluster Headaches
Cushing's Syndrome
Failure to Thrive
Hay Fever
Migraine
Pruritus
Sexual Dysfunction, SSRI Induced
Urticaria

Cystagon

Generic Name: cysteamine (Oral route)

sis-TEE-a-meen

Commonly used brand name(s)

In the U.S.

Cystagon

Available Dosage Forms:

Capsule

Therapeutic Class: Renal-Urologic Agent

Uses For Cystagon

Cysteamine is used to prevent damage that may be caused by the buildup of cystine crystals in organs such as the kidneys. This medicine works by removing the extra cystine from the cells of the body.

Before Using Cystagon

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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

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 cysteamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Proper Use of Cystagon

If you vomit your dose of cysteamine within 20 minutes of taking it, take the dose again. However, if you vomit the dose a second time, do not repeat the dose but wait and take your next dose as scheduled. Also, if vomiting occurs more than 20 minutes after you take your dose, do not repeat the dose.

It is important that you follow any special instructions from your doctor, such as taking dietary supplements. These supplements will replace minerals lost through the kidneys.

For children under 6 years of age, the capsule may be opened and the contents of the capsule sprinkled on food or mixed in formula.

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 oral dosage form (capsules):
- To prevent buildup of cystine crystals in the kidney:
  - Adults and teenagers—The starting dose must be determined by your doctor. Your doctor may gradually increase your dose.
  - Children—The starting dose is based on body size and must be determined by your doctor. Your doctor may gradually increase your dose.

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 Cystagon

Your doctor should check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects.

This medicine may cause some people to become dizzy or drowsy. 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 or are not alert.

Cystagon 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

Abdominal pain

diarrhea

drowsiness

fever

loss of appetite

nausea or vomiting

skin rash

Less common

Confusion

dizziness

headache

mental depression

sore throat

trembling

Rare

Convulsions (seizures)

increased thirst

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Breath odor

constipation

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: Cystagon 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 Cystagon resources

Cystagon Side Effects (in more detail)
Cystagon Dosage
Cystagon Use in Pregnancy & Breastfeeding
Cystagon Support Group
0 Reviews · Be the first to review/rate this drug

Cystagon Prescribing Information (FDA)

Cystagon Concise Consumer Information (Cerner Multum)

Cystagon MedFacts Consumer Leaflet (Wolters Kluwer)

Tuesday, 27 September 2016

Cytra-K Powder Pack

Pronunciation: poe-TAS-ee-um SIT-rate/SIT-rik AS-id
Generic Name: Potassium Citrate/Citric Acid
Brand Name: Examples include Cytra-K and Polycitra-K

Cytra-K Powder Pack is used for:

Preventing certain types of kidney stones. It also may be used for other conditions as determined by your doctor.

Cytra-K Powder Pack is a urinary alkalinizing agent. It neutralizes some of the acid in your urine, which reduces the formation of crystals in your urine that could become kidney stones.

Do NOT use Cytra-K Powder Pack if:

you are allergic to any ingredient in Cytra-K Powder Pack

you have high potassium levels in the blood or a history of periods of weakness along with high potassium levels

you have high aluminum levels in the blood, severe kidney problems, or you are unable to urinate

you are dehydrated or have heat cramps, untreated Addison disease (an adrenal gland problem), or certain heart problems (heart failure or heart damage)

you are taking a product that contains aluminum (eg, antacids)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cytra-K Powder Pack:

Some medical conditions may interact with Cytra-K Powder Pack. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have heart problems (eg, heart failure), high blood pressure, adrenal gland problems, kidney problems, or diabetes

if you have stomach or bowel problems (eg, ulcer, diarrhea) or a urinary tract infection

if you have high blood acid levels; swelling of the hands, ankles, or feet; fluid buildup in the lungs; decreased urination; or trouble urinating

if you have preeclampsia (high blood pressure during pregnancy)

if you have low blood calcium levels, or you are on a sodium-restricted or potassium-restricted diet

if you have a condition in which your skin is breaking down (eg, severe burns)

Some MEDICINES MAY INTERACT with Cytra-K Powder Pack. Tell your health care provider if you are taking any other medicines, especially any of the following:

Aldosterone blockers (eg, eplerenone), aliskiren, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), potassium-sparing diuretics (eg, triamterene), or potassium supplements because the risk of high potassium levels, possibly with irregular heartbeat or a heart attack, may be increased

Products that contain aluminum (eg, antacids), digoxin, certain stimulants (eg, amphetamine), or sympathomimetics (eg, albuterol, pseudoephedrine) because the risk of their side effects may be increased by Cytra-K Powder Pack

Lithium or tetracyclines (eg, doxycycline) because their effectiveness may be decreased by Cytra-K Powder Pack

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cytra-K Powder Pack may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cytra-K Powder Pack:

Use Cytra-K Powder Pack as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Cytra-K Powder Pack may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Cytra-K Powder Pack with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Take Cytra-K Powder Pack by mouth after meals and at bedtime, unless your doctor tells you otherwise.

Be sure to dilute Cytra-K Powder Pack in water or juice as directed on the packaging or by your doctor. Do not take Cytra-K Powder Pack without mixing it.

Shake well before each use.

Drinking extra fluids while you are taking Cytra-K Powder Pack is recommended. Check with your doctor for instructions.

If you take a tetracycline antibiotic (eg, doxycycline), do not take Cytra-K Powder Pack within 2 hours before or after taking the tetracycline. Check with your doctor if you have questions.

If you miss a dose of Cytra-K Powder Pack, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cytra-K Powder Pack.

Important safety information:

Check with your doctor before you use a salt substitute or a product that has potassium in it.

Lab tests, including blood potassium levels, other blood electrolyte levels (eg, sodium, calcium, bicarbonate), and kidney function, may be performed while you use Cytra-K Powder Pack. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Cytra-K Powder Pack should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cytra-K Powder Pack while you are pregnant. It is not known if Cytra-K Powder Pack is found in breast milk. If you are or will be breast-feeding while you use Cytra-K Powder Pack, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cytra-K Powder Pack:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Cytra-K Powder Pack. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dizziness; irregular heartbeat; muscle cramps; numbness or tingling around the lips; numbness, tingling, pain, or weakness in the hands or feet; shortness of breath; unusual tiredness; unusual weakness or heaviness of the legs; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cytra-K side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; fainting; irregular heartbeat; seizures; sluggishness; weakness.

Proper storage of Cytra-K Powder Pack:

Store Cytra-K Powder Pack at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cytra-K Powder Pack out of the reach of children and away from pets.

General information:

If you have any questions about Cytra-K Powder Pack, please talk with your doctor, pharmacist, or other health care provider.

Cytra-K Powder Pack is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cytra-K Powder Pack. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Cytra-K resources

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

Compare Cytra-K with other medications

Urinary Alkalinization
Urinary Tract Stones

Cyklokapron

Generic Name: tranexamic acid (Cyklokapron) (tran ex AM ik AS id)

Brand Names: Cyklokapron

What is tranexamic acid (Cyklokapron)?

Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.

Cyklokapron is used to prevent bleeding in people with hemophilia who need to have a tooth pulled. This medication is usually given just before the dental procedure, and daily for up to 8 days afterward.

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

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

You should not use Cyklokapron if you are allergic to tranexamic acid, if you are color blind, or if you have ever had a stroke, blood clot, or bleeding in your brain.

Before using this medicine, tell your doctor if you have kidney disease, blood in your urine, or leukemia.

To be sure this medication is not causing harmful effects, your vision may need to be tested while you are using tranexamic acid. Follow your doctor's instructions.

What should I discuss with my healthcare provider before using Cyklokapron?

You should not use Cyklokapron if you are allergic to tranexamic acid, or if you have:

color blindness;

problems with the blood vessels in your eyes;

a history of stroke;

if you have a history of bleeding in your brain; or

if you have recently had a blood clot.

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

kidney disease;

a bladder or kidney infection; or

leukemia.

It is not known whether tranexamic acid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Tranexamic acid can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is Cyklokapron given?

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

Cyklokapron is injected into a vein through an IV just before your tooth is pulled. You may need to keep using the medication for up to 8 days afterward.

You may be shown how to use an IV at home. Do not self-inject Cyklokapron if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

To be sure this medication is not causing harmful effects, your vision may need to be tested while you are using tranexamic acid. Follow your doctor's instructions. Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while using Cyklokapron?

This medication may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Cyklokapron side effects

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

problems with your vision (including color vision);

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

pain, swelling, warmth, or redness in one or both legs;

seizure (convulsions);

painful or difficult urination;

blood in your urine; or

feeling like you might pass out.

Less serious side effects include:

nausea, vomiting, diarrhea;

mild itching or rash; or

feeling unusually happy.

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

What other drugs will affect Cyklokapron?

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

any type of medication to treat a bleeding episode or a blood clot; or

factor IX (Bebulin VH, Konyne 80, Profilnine SD, Proplex T, and others).

This list is not complete and other drugs may interact with Cyklokapron. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cyklokapron resources

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

Compare Cyklokapron with other medications

Bleeding Disorder
Factor IX Deficiency
Hemophilia A

Where can I get more information?

Your doctor or pharmacist can provide more information about tranexamic acid (Cyklokapron).

See also: Cyklokapron side effects (in more detail)

Doxazosine Sandoz

Doxazosine Sandoz may be available in the countries listed below.

Ingredient matches for Doxazosine Sandoz

Doxazosin

Doxazosin mesilate (a derivative of Doxazosin) is reported as an ingredient of Doxazosine Sandoz in the following countries:

Netherlands

International Drug Name Search

Monday, 26 September 2016

Cystadane

betaine

Dosage Form: powder, for oral solution
HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Cystadane safely and effectively. See full prescribing information for Cystadane.

Cystadane (betaine anhydrous for oral solution) powder

Initial U.S. Approval: 1996

Indications and Usage for Cystadane

Cystadane is a methylating agent indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are (1):

Cystathionine beta-synthase (CBS) deficiency

5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency

Cobalamin cofactor metabolism (cbl) defect

Cystadane Dosage and Administration

Usual dose in adult and pediatric patients is 6 grams per day, administered orally in divided doses of 3 grams two times a day.(2)

In children less than 3 years of age, may initiate dosing at 100 mg/kg/day, divided in twice daily doses, and then increased weekly by 50 mg/kg increments.(2)

Dose can be gradually increased until plasma total homocysteine is undetectable or present only in small amounts.(2)

Monitor patient response by plasma homocysteine levels.(2)

Prescribed amount of Cystadane should be measured with the measuring scoop provided and then dissolved in 4 to 6 ounces of water, juice, milk, or formula, or mixed with food for immediate ingestion.(2)

Dosage Forms and Strengths

Powder for oral solution available in bottles containing 180 grams of betaine anhydrous.(3)

Contraindications

None (4)

Warnings and Precautions

Hypermethioninemia: Cystadane may worsen elevated plasma methionine concentrations in patients with CBS deficiency. Cerebral edema has been reported in patients receiving Cystadane.( 5.1)

Monitoring: Monitor plasma methionine concentrations in patients with CBS deficiency. Keep plasma methionine concentrations below 1,000 mmol/L through dietary medication and, if necessary, a reduction of Cystadane dose. ( 5.1)

Adverse Reactions

Most common adverse reactions (incidence > 2%) were nausea and gastrointestinal distress, based on physician survey.

To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics at 1-615-399-0700, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy: Animal reproduction studies have not been conducted with Cystadane. Use only if clearly needed.(8.1)

Nursing women: It is not known whether Cystadane is excreted in human milk. Use only if clearly needed.(8.3)

Pediatrics: Pediatric patients ranging in age from 24 days to 17 years have been treated with Cystadane. Children younger than 3 years of age may benefit from dose titration.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: April 2010

FULL PRESCRIBING INFORMATION: CONTENTS*

1    INDICATIONS AND USAGE

2    DOSAGE AND ADMINISTRATION

      2.1    Dosage

      2.2    Administration

3    DOSAGE FORMS AND STRENGTHS

4    CONTRAINDICATIONS

5    WARNINGS AND PRECAUTIONS

    5.1    Hypermethioninemia

6    ADVERSE REACTIONS

      6.1   Adverse Reactions in Clinical Studies

      6.2    Postmarketing Experience

8    USE IN SPECIFIC POPULATIONS

    8.1    Pregnancy

    8.3    Nursing Mothers

    8.4    Pediatric Use

10    OVERDOSAGE

11    DESCRIPTION

12    CLINICAL PHARMACOLOGY

        12.1    Mechanism of Action

        12.2    Pharmacodynamics

        12.3    Pharmacokinetics

13    NONCLINICAL TOXICOLOGY

        13.1    Carcinogenesis, Mutagenesis, Impairment of Fertility

14    CLINICAL STUDIES

16    HOW SUPPLIED/STORAGE AND HANDLING

        16.1 Storage

17    PATIENT COUNSELING INFORMATION

        17.1   Dosing and Administration

*Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

Indications and Usage for Cystadane

Cystadane® (betaine anhydrous for oral solution) is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood levels. Included within the category of homocystinuria are:

Cystathionine beta-synthase (CBS) deficiency

5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency

Cobalamin cofactor metabolism (cbl) defect

Cystadane Dosage and Administration

2.1 Dosage

The usual dosage in adult and pediatric patients is 6 grams per day administered orally in divided doses of 3 grams twice daily. In pediatric patients less than 3 years of age, dosage may be started at 100 mg/kg/day divided in twice daily doses, and then increased weekly by 50 mg/kg increments.

Therapy with Cystadane should be directed by physicians knowledgeable in the management of patients with homocystinuria. Patient response to Cystadane can be monitored by homocysteine plasma levels. Dosage in all patients can be gradually increased until plasma total homocysteine is undetectable or present only in small amounts. Response (by homocysteine plasma levels) usually occurs within several days and steady state within a month. Plasma methionine concentrations should be monitored in patients with CBS deficiency [See Warnings and Precautions (15.2)].

Dosages of up to 20 grams per day have been necessary to control homocysteine levels in some patients. However, one pharmacokinetic and pharmacodynamic in vitro simulation study indicated minimal benefit from exceeding a twice-daily dosing schedule and a 150 mg/kg/day dosage for Cystadane.

2.2 Administration

The prescribed amount of Cystadane should be measured with the measuring scoop provided (one level 1.7 mL scoop is equal to 1 gram of betaine anhydrous powder) and then dissolved in 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula, or mixed with food for immediate ingestion.

Dosage Forms and Strengths

Cystadane is a white, granular, hygroscopic powder for oral solution available in bottles containing 180 grams of betaine anhydrous.

Contraindications

None.

Warnings and Precautions

5.1 Risk of Hypermethioninemia in Patients with CBS Deficiency

Patients with homocystinuria due to cystathionine beta-synthase (CBS) deficiency may also have elevated plasma methionine concentrations. Treatment with Cystadane may further increase methionine concentrations due to the remethylation of homocysteine to methionine. Cerebral edema has been reported in patients with hypermethioninemia, including patients treated with Cystadane. Plasma methionine concentrations should be monitored in patients with CBS deficiency. Plasma methionine concentrations should be kept below 1,000 µmol/L through dietary modification and, if necessary, a reduction of Cystadane dose.

Adverse Reactions

6.1 Adverse Reactions in Clinical Studies

The most serious adverse reaction reported with Cystadane treatment is the development of hypermethioninemia and cerebral edema in patients with CBS Deficiency [see Warnings and Precautions (5.1)].

The assessment of clinical adverse reactions is based on a survey study of 41 physicians, who treated a total of 111 homocystinuria patients with Cystadane. Adverse reactions were retrospectively recalled and were not collected systematically in this open-label, uncontrolled, physician survey. Thus, this list may not encompass all types of potential adverse reactions, reliably estimate their frequency, or establish a causal relationship to drug exposure. The following adverse reactions were reported (Table 1):

Table 1: Number of Patients with Adverse Reactions to Cystadane by Physician Survey

Adverse Reactions	Number of Patients
Nausea	2
Gastrointestinal distress	2
Diarrhea	1
"Bad Taste"	1
"Caused Odor"	1
Questionable psychological changes	1
“Aspirated the powder”	1

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Cystadane. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In postmarketing experience with Cystadane, severe cerebral edema and hypermethioninemia have been reported within 2 weeks to 6 months of starting betaine therapy, with complete recovery after discontinuation of Cystadane. All patients who developed cerebral edema had homocystinuria due to CBS deficiency and had severe elevation in plasma methionine levels (range 1,000 to 3,000 mM). As cerebral edema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine therapy has been postulated as a possible mechanism of action.

The following adverse reactions have been reported in patients during postmarketing use of Cystadane: anorexia, agitation, depression, irritability, personality disorder, sleep disturbed, dental disorders, diarrhea, glossitis, nausea, stomach discomfort, vomiting, hair loss, hives, skin odor abnormalities, and urinary incontinence.

USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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

8.3 Nursing Mothers

It is not known whether Cystadane is excreted in human milk. Use only if clearly needed.

8.4 Pediatric Use

The majority of case studies of homocystinuria patients treated with Cystadane have been pediatric patients, including patients ranging in age from 24 days to 17 years [see Clinical Studies (14)]. Children younger than 3 years of age may benefit from dose titration [see Dosage and Administration (2)].

Overdosage

In an acute toxicology study in rats, death occurred frequently at doses equal to or greater than 10 g/kg.

Cystadane Description

Cystadane (betaine anhydrous for oral solution) is an agent for the treatment of homocystinuria. It contains no ingredients other than anhydrous betaine. Cystadane is a white, granular, hygroscopic powder, which is diluted in water and administered orally. The chemical name of betaine anhydrous powder is trimethylglycine. It has a molecular weight of 117.15. The structural formula is:

Cystadane - Clinical Pharmacology

12.1 Mechanism of Action

Cystadane acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria. Cystadane occurs naturally in the body. It is a metabolite of choline and is present in small amounts in foods such as beets, spinach, cereals, and seafood.

12.2 Pharmacodynamics

Cystadane was observed to lower plasma homocysteine levels in three types of homocystinuria, including CBS deficiency; MTHFR deficiency; and cbl defect. Patients have taken Cystadane for many years without evidence of tolerance. There has been no demonstrated correlation between Cystadane levels and homocysteine levels.

In CBS-deficient patients, large increases in methionine levels over baseline have been observed. Cystadane has also been demonstrated to increase low plasma methionine and S-adenosylmethionine (SAM) levels in patients with MTHFR deficiency and cbl defect.

12.3 Pharmacokinetics

Pharmacokinetic studies of Cystadane are not available. Plasma levels of Cystadane have not been measured in patients and have not been correlated to homocysteine levels.

Nonclinical Toxicology

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity and fertility studies have not been conducted with Cystadane. No evidence of genotoxicity was demonstrated in the following tests: metaphase analysis of human lymphocytes; bacterial reverse mutation assay; and mouse micronucleus test.

Clinical Studies

Cystadane was studied in a double-blind, placebo-controlled, crossover study in 6 patients with CBS deficiency, ages 7 to 32 years at enrollment. Cystadane was administered at a dosage of 3 grams twice daily, for 12 months. Plasma homocystine levels were significantly reduced (p<0.01) compared to placebo. Plasma methionine levels were variable and not significantly different compared to placebo. No adverse events were reported in any patient.

Cystadane has also been evaluated in observational studies without concurrent controls in patients with homocystinuria due to CBS deficiency, MTHFR deficiency, or cbl defect.A review of 16 case studies and the randomized controlled trial previously described was also conducted, and the data available for each study were summarized; however, no formal statistical analyses were performed. The studies included a total of 78 male and female patients with homocystinuria who were treated with Cystadane. This included 48 patients with CBS deficiency, 13 with MTHFR deficiency, and 11 with cbl defect, ranging in age from 24 days to 53 years. The majority of patients (n=48) received 6 gm/day, 3 patients received less than 6 gm/day, 12 patients received doses from 6 to 15 gm/day, and 5 patients received doses over 15 gm/day. Most patients were treated for more than 3 months (n=57) and 30 patients were treated for 1 year or longer (range 1 month to 11 years). Homocystine is formed nonenzymatically from two molecules of homocysteine, and both have be used to evaluate the effect of Cystadane in patients with homocystinuria. Plasma homocystine or homocysteine levels were reported numerically for 62 patients, and 61 of these patients showed decreases with Cystadane treatment. Homocystine decreased by 83-88% regardless of pre-treatment level, and homocysteine decreased by 71-83%, regardless of the pre-treatment level. Clinical improvement, such as improvement in seizures, or behavioral and cognitive functioning, was reported by the treating physicians in about three-fourths of patients. Many of these patients were also taking other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), and folate with variable biochemical responses. In most cases, adding Cystadane resulted in a further reduction of either homocystine or homocysteine.

How Supplied/Storage and Handling

Cystadane is available in plastic bottles containing 180 grams of betaine anhydrous. Each bottle is equipped with a plastic child-resistant cap and is supplied with a polystyrene measuring scoop. One level scoop (1.7 mL) is equal to 1 gram of betaine anhydrous powder.

NDC 66621-4000-1 180 g/bottle

Cystadane can be ordered by calling Accredo Health Group, Inc., Customer service at 1-888-454-8860

16.1 Storage

Store at room temperature, 15 – 30 ˚C (59 – 86 ˚F). Protect from moisture.

Patient Counseling Information

Patients should be advised of the following information before beginning treatment with Cystadane:

17.1 Dosing and Administration

Instruct patients and caregivers that Cystadane should only be taken as directed by their healthcare professional.

Instruct patients and caregivers to administer Cystadane as follows:

Shake bottle lightly before removing cap.

Measure with the scoop provided.

Measure the number of scoops as prescribed by their healthcare professional. One level scoop (1.7 mL) is equivalent to 1 gram of betaine anhydrous powder.

Mix powder with 4 to 6 ounces (120 to 180 mL) of water, juice, milk, or formula until completely dissolved, or mix with food, then ingest mixture immediately.

Always replace the cap tightly after using, and protect powder from moisture.

Distributed in the U.S. by:

Rare Disease Therapeutics, Inc.

2550 Meridian Blvd., Suite 150

Franklin, TN 37067

Part No.: RDT C PI003

Cystadane
betaine powder, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	66621-4000
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
betaine (betaine)	betaine	6 g

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color	white (none)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	66621-4000-1	180 SCOOPFUL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020576	10/25/1996

Labeler - Rare Disease Therapeutics, Inc. (966133100)

Registrant - Rare Disease Therapeutics, Inc. (966133100)

Establishment
Name	Address	ID/FEI	Operations
Rare Disease Therapeutics, Inc.		966133100	label

Establishment
Name	Address	ID/FEI	Operations
Orphan Europe, SARL		767598352	manufacture

Revised: 06/2010Rare Disease Therapeutics, Inc.

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