NDC 70518-1886 Cyproheptadine Hydrochloride

Cyproheptadine Hydrochloride

NDC Product Code 70518-1886

NDC Code: 70518-1886

Proprietary Name: Cyproheptadine Hydrochloride Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cyproheptadine Hydrochloride Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
49
Score: 2

Code Structure
  • 70518 - Remedyrepack Inc.
    • 70518-1886 - Cyproheptadine Hydrochloride

NDC 70518-1886-0

Package Description: 100 POUCH in 1 BOX, UNIT-DOSE > 1 TABLET in 1 POUCH (70518-1886-1)

NDC Product Information

Cyproheptadine Hydrochloride with NDC 70518-1886 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Cyproheptadine Hydrochloride is cyproheptadine hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.


Cyproheptadine Hydrochloride Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CYPROHEPTADINE HYDROCHLORIDE 4 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA205087 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-20-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cyproheptadine Hydrochloride Product Label Images

Cyproheptadine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent.Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5


H-dibenzo


[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C


21H


21N•HCl and the structural formula of the anhydrous salt is:


Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.

Clinical Pharmacology

Cyproheptadine is a serotonin and histamine antagonist with anticholinergic and sedative effects. Antiserotonin and antihistamine drugs appear to compete with serotonin and histamine, respectively, for receptor sites.

Indications And Usage

Perennial and seasonal allergic rhinitis



Vasomotor rhinitis



Allergic conjunctivitis due to inhalant allergens and foods



Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.



Amelioration of allergic reactions to blood or plasma



Cold urticaria



Dermatographism


As therapy for anaphylactic reactions


adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled

Newborn Or Premature Infants

This drug should


not be used in newborn or premature infants.

Nursing Mothers

Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from cyproheptadine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother (see


CONTRAINDICATIONS).

Other Conditions

Hypersensitivity to cyproheptadine and other drugs of similar chemical structure.Monoamine oxidase inhibitor therapy (See


DRUG INTERACTIONS.


)



Angle-closure glaucoma



Stenosing peptic ulcer



Symptomatic prostatic hypertrophy



Bladder neck obstruction



Pyloroduodenal obstruction



Elderly, debilitated patients

Pediatric Patients

Overdosage antihistamines, particularly in infants and young children, may produce hallucinations, central nervous system depression, convulsions, respiratory and cardiac arrest, and death.


Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation.

Age 2 to 6 yearsThe total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m


2).


The usual dose is 2 mg (½ tablet) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 12 mg a day.Age 7 to 14 years The usual dose is 4 mg (1 tablet) two or three times a day adjusted as necessary to the size and response of the patient. The dose is not to exceed 16 mg a day.


Adults The total daily dose for adults should not exceed 0.5 mg/kg/day. The therapeutic range is 4 mg to 20 mg a day, with the majority of patients requiring 12 mg to 16 mg a day. An occasional patient may require as much as 32 mg a day for adequate relief. It is suggested that dosage be initiated with 4 mg (1 tablet) three times a day and adjusted according to the size and response of the patient.

Cns Depressants

Antihistamines may have additive effects with alcohol and other


CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.

Activities Requiring Mental Alertness

Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients (see


PRECAUTIONS, Geriatric Use).

General

Cyproheptadine has an atropine-like action and, therefore, should be used with caution in patients with:History of bronchial asthma


Increased intraocular pressure


Hyperthyroidism


Cardiovascular disease


Hypertension

Information For Patients

Antihistamines may diminish mental alertness; conversely, particularly, in the young child, they may occasionally produce excitation. Patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a car or operating machinery.

Drug Interactions

MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines.


Antihistamines may have additive effects with alcohol and other


CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term carcinogenic studies have not been done with cyproheptadine.Cyproheptadine had no effect on fertility in a two-litter study in rats or a two generation study in mice at about 10 times the human dose.Cyproheptadine did not produce chromosome damage in human lymphocytes or fibroblasts


invitro; high doses (10


-4M) were cytotoxic. Cyproheptadine did not have any mutagenic effect in the Ames microbial mutagen test; concentrations of above 500 mcg/ plate inhibited bacterial growth.

Pregnancy Category B

Reproduction studies have been performed in rabbits, mice, and rats at oral or subcutaneous doses up to 32 times the maximum recommended human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to cyproheptadine. Cyproheptadine has been shown to be fetotoxic in rats when given by intraperitoneal injection in doses four times the maximum recommended human oral dose. Two studies in pregnant women, however, have not shown that cyproheptadine increases the risk of abnormalities when administered during the first, second and third trimesters of pregnancy. No teratogenic effects were observed in any of the newborns. Nevertheless, because the studies in humans cannot rule out the possibility of harm, cyproheptadine should be used during pregnancy only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of two have not been established (see


CONTRAINDICATIONS, Newborn or Premature Infants,


and


WARNINGS, Pediatric Patients).

Geriatric Use

Clinical studies of cyproheptadine HCl tablets 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 patients. 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 other drug therapy (see


WARNINGS, Activities Requiring Mental Alertness).


Adverse reactions which have been reported with the use of antihistamines are as follows:Central Nervous SystemSedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness.


IntegumentaryAllergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity.


Special SensesAcute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus.


CardiovascularHypotension, palpitation, tachycardia, extrasystoles, anaphylactic

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, please call Ingenus Pharmaceuticals NJ, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or


www.fda.gov/medwatchAdverse reactions which have been reported with the use of antihistamines are as follows:Central Nervous SystemSedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness.


IntegumentaryAllergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity.


Special SensesAcute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus.


CardiovascularHypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock.


Hematologic Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia.


Digestive System Cholestasis, hepatic failure, hepatitis, hepatic function abnormality, dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice.


Genitourinary Urinary frequency, difficult urination, urinary retention, early menses.


Respiratory Dryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.


Miscellaneous Fatigue, chills, headache, increased appetite/weight gain.

Overdosage

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation especially in pediatric patients. Also, atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing, etc.) as well as gastrointestinal symptoms may occur.If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac.


If patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic or ½ isotonic saline is the lavage of choice. Precautions against aspiration must be taken especially in infants and children.


When life threatening CNS signs and symptoms are present, intravenous physostigmine salicylate may be considered. Dosage and frequency of administration are dependent on age, clinical response, and recurrence after response. (See package circulars for physostigmine products.)Saline cathartics, as milk of magnesia, by osmosis draw water into the bowel and, therefore, are valuable for their action in rapid dilution of bowel content.


Stimulants should not be used.Vasopressors may be used to treat hypotension.The oral LD


50of cyproheptadine is 123 mg/kg, and 295 mg/kg in the mouse and rat, respectively.

Dosage And Administration

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Each tablet contains 4 mg of cyproheptadine hydrochloride.

How Supplied

Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off- white, round, flat-faced, beveled-edged tablets, debossed “4” on left side, “9” on right side of the scoring on one side and plain on the other side, containing 4 mg of cyproheptadine HCl packaged in bottles of 100 (NDC 50742-190-01) and 1,000 (NDC 50742-190-10) tablets. Tablets have functional scoring.PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured For:Ingenus Pharmaceuticals, LLC


Orlando, FL 32839-6408


Manufactured By:Ingenus Pharmaceuticals NJ, LLC


Fairfield, NJ 07004


5517 Rev. 06/2017

* Please review the disclaimer below.

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