NDC 0121-0788 Cyproheptadine

NDC Product Code 0121-0788

NDC 0121-0788-16

Package Description: 473 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Cyproheptadine with NDC 0121-0788 is a product labeled by Pharmaceutical Associates, Inc.. The generic name of Cyproheptadine is . The product's dosage form is and is administered via form.

Labeler Name: Pharmaceutical Associates, Inc.

Dosage Form: -

Product Type: 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.

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCROSE (UNII: C151H8M554)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pharmaceutical Associates, Inc.
Labeler Code: 0121
Start Marketing Date: 07-29-2013 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: 12-31-2017 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: I 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’.

* Please review the disclaimer below.

Information for Patients

Cyproheptadine

Cyproheptadine is pronounced as (si proe hep' ta deen)

Why is cyproheptadine medication prescribed?
Cyproheptadine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, irritants in the air, and hay fever. It may also be used to reli...
[Read More]

* Please review the disclaimer below.

Cyproheptadine 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

Other

Rx ONLY

Pharmaceutical Associates, Inc.Greenville, SC 29605
www. paipharma.comR03/12

Description

Each 5 mL (one teaspoonful) contains: Cyproheptadine hydrochloride 2 mg. Alcohol 5%.Inactive ingredients: citric acid, D&C Yellow No.10, peppermint flavor, purified water, sodium benzoate, sodium citrate and sucrose.Cyproheptadine hydrochloride is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride is a white to slightly yellowish, crystalline solid, with a molecular weight of 350.88, which is slightly 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-(5H-Dibenzo [a,d] cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21N • HCl and the structural formula of the anhydrous salt is:

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 Metabolism

After a single 4 mg oral dose of 14C-labeled cyproheptadine HCl in normal subjects, given as tablets or oral solution, 2-20% 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 12-20 mg daily doses of cyproheptadine oral solution. The principal 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 angioedemaAmelioration 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.

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 structureMonoamine oxidase inhibitor therapy (see Drug Interactions)Angle-closure glaucomaStenosing peptic ulcerSymptomatic prostatic hypertrophyBladder neck obstructionPyloroduodenal obstructionElderly, debilitated patients

Children

Overdosage of antihistamines, particularly in infants and children, may produce hallucinations, central nervous system depression, convulsions and death.Antihistamines may diminish mental alertness; conversely, particularly in the young child, they may occasionally produce excitation.

The total daily dosage for children may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day (0.11 mg/lb/day) or 8 mg per square meter of body surface (8 mg/m2).

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.

General

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

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, anti-anxiety 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 in vitro; 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 years have not been established. (see CONTRAINDICATIONS, Newborn or Premature Infants, and WARNINGS, Children).

Adverse Reactions

Adverse reactions which have been reported with the use of antihistamines are as follows:Central Nervous System: Sedation and sleepiness (often transient), dizziness, disturbed coordination, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, paresthesias, neuritis, convulsions, euphoria, hallucinations, hysteria, faintness.Integumentary: Allergic manifestation of rash and edema, excessive perspiration, urticaria, photosensitivity.Special Senses: Acute labyrinthitis, blurred vision, diplopia, vertigo, tinnitus.Cardiovascular: Hypotension, palpitation, tachycardia, extrasystoles, anaphylactic shock.Hematologic: Hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia.Digestive System: 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 children. 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 the patient is unable to vomit, perform gastric lavage followed by activated charcoal. Isotonic or 1/2 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 LD50 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.Although intended primarily for administration to children, the oral solution is also used for administration to adults who cannot swallow tablets.

Age 2 To 6 Years

The usual dose is 2 mg (one teaspoonful) 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 (two teaspoonfuls) 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 (0.23 mg/lb/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 (two teaspoonfuls) three times a day and adjusted according to the size and response of the patient.

How Supplied

Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP) (2 mg/5 mL), a pale yellow, peppermint flavored liquid, is available in the following oral dosage forms:NDC 0121-0788-16 – Bottles of 16 fl oz (473 mL)NDC 0121-4788-05 – 5 mL Unit Dose Cups, 10 cups per trayNDC 0121-4788-10 – 10 mL Unit Dose Cups, 10 cups per tray

Storage And Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.

* Please review the disclaimer below.