NDC 70518-2414 Cyproheptadine Hydrochloride

Cyproheptadine Hydrochloride

NDC Product Code 70518-2414

NDC CODE: 70518-2414

Proprietary Name: Cyproheptadine Hydrochloride What 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 What 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)
Shape: ROUND (C48348)
Size(s):
7 MM
Imprint(s):
C4
Score: 2

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2414-0

Package Description: 30 TABLET in 1 BLISTER PACK

NDC Product Information

Cyproheptadine Hydrochloride with NDC 70518-2414 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 What 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)

What 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)

About 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 POTATO (UNII: 5856J3G2A2)

Administration Route(s)

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

Product Labeler Information

What 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: ANDA209172 What 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. What 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: 11-11-2019 What 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 What 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 What 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’.

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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:


C


21H


21 N• HCl M.W. 350.89


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 (potato).

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.Pharmacokinetics and MetabolismAfter a single 4 mg oral dose of


14C-labelled cyproheptadine HCl in normal subjects, given as tablets, 2 to 20% of the radioactivity was excreted in the stools. Only about 34% of the stool radioactivity was unchanged drug, corresponding to less than 5.7% of the dose. At least 40% of the administered radioactivity was excreted in the urine. No detectable amounts of unchanged drug were present in the urine of patients on chronic 12 to 20 mg daily doses. The principle metabolite found in human urine has been identified as a quaternary ammonium glucuronide conjugate of cyproheptadine. Elimination is diminished in renal insufficiency.

Indications And Usage

Perennial and seasonal allergic rhinitisVasomotor rhinitisAllergic conjunctivitis due to inhalant allergens and foodsMild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasmaCold urticariaDermatographismAs therapy for anaphylactic reactions


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

Contraindications

Newborn or Premature InfantsThis drug should


not be used in newborn or premature infants.


Nursing MothersBecause of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.Other ConditionsHypersensitivity to cyproheptadine and other drugs of similar chemical structure.Monoamine oxidase inhibitor therapy (See


DRUG INTERACTIONS.)


Angle-closure glaucomaStenosing peptic ulcerSymptomatic prostatic hypertrophyBladder neck obstructionPyloroduodenal obstructionElderly, debilitated patients

Warnings

Pediatric PatientsOverdosage of 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.CNS DepressantsAntihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.Activities Requiring Mental AlertnessPatients 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).

Precautions

GeneralCyproheptadine has an atropine-like action and, therefore, should be used with caution in patients with:History of bronchial asthmaIncreased intraocular pressureHyperthyroidismCardiovascular diseaseHypertensionInformation for PatientsAntihistamines 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 InteractionsMAO 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 FertilityLong-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


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


PregnancyPregnancy Category BReproduction 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.Nursing MothersIt 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).


Pediatric UseSafety 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 UseClinical 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

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 shock.HematologicHemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia.Digestive SystemCholestasis, hepatic failure, hepatitis, hepatic function abnormality, dryness of mouth, epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation, jaundice.GenitourinaryUrinary frequency, difficult urination, urinary retention, early menses.RespiratoryDryness of nose and throat, thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.MiscellaneousFatigue, chills, headache, increased appetite/weight gain.Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc at 1-877-244-9825 or go to www.stridesshasun.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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


50 of 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.Pediatric PatientsAge 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 yearsThe 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.AdultsThe total daily dose for adults should not exceed 0.5 mg/kg/day. The therapeutic range is 4 to 20 mg a day, with the majority of patients requiring 12 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.

How Supplied

Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off white, round, flat faced, bevelled edged tablets debossed "C4" on  one side and score on the other side, containing 4 mg of cyproheptadine HCl packaged in Bottles of 100 tablets with NDC code - NDC 64380-795-06, Bottles of 1000 tablets with NDC code - NDC 64380-795-08PHARMACIST: 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 By:Strides Shasun LimitedBengaluru, India.Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816Issued: 01/2017

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