Cyproheptadine Tablets (4 mg)

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Oral Cyproheptadine is a serotonin and histamine antagonist used in the treatment of a variety of medical conditions in animals.

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Description

Cyproheptadine (4mg tablets) is a serotonin and histamine antagonist used in the treatment of  Cushing’s syndrome in dogs and horses and as an appetite stimulant in cats among other applications in a variety of species. Made by TruPharma.

Additional information

Weight 0.06 lbs
Dimensions 1.5 x 1.5 x 2.75 in
Size

100 ct, 1000 ct

More Details

Cyproheptadine Tablets require a prescription from your veterinarian.

Cyproheptidine is a drug labeled for human use that has found extra-label applications in cats, dogs and horses.

Like other H1-receptor antihistamines, cyproheptadine acts by competing with histamine for sites on H1-receptor sites on effector cells. Antihistamines do not block histamine release but can antagonize its effects. Cyproheptadine also possesses potent antiserotonin activity and, reportedly, has calcium channel blocking action as well.

Formulations

Cyproheptadine Tablets are available in 4 mg tablets in bottles of 100 ct and 1000 ct.

Administration

Given orally in cats, dogs and horses.  Dose and frequency of administration varies with species and condition being treated.

Use as directed by your veterinarian.

Precautions

Cyproheptadine is contraindicated in patients hypersensitive to it.

It should be used with caution in patients with prostatic hypertrophy, bladder neck obstruction, severe cardiac failure, epilepsy, angle-closure glaucoma, or pyeloduodenal obstruction.

The most likely adverse effects seen with cyproheptadine are related to its CNS depressant (sedation) and anticholinergic effects (dryness of mucous membranes, etc.).

At higher dosages, cyproheptadine has caused significant over eating in dogs.

Use of cyproheptadine during pregnancy should be weighed carefully.

DRUG INTERACTIONS: The following drug interactions have either been reported or are theoretical in humans or animals receiving cyproheptadine and may be of significance in veterinary patients. Unless otherwise noted, use together is not necessarily contraindicated, but weigh the potential risks and perform additional monitoring when appropriate.

CNS DEPRESSANT MEDICATIONS: Additive CNS depression may be seen if combining cyproheptadine with other CNS depressant medications, such as barbiturates, tranquilizers, etc.

MIRTAZAPINE: Although no supporting published documentation was located, it has been anecdotally reported that cyproheptadine and mirtazapine should not be given together.

SSRIs (including sertraline, fluoxetine, paroxetine, etc.); TRICYCLIC ANTIDEPRESSANTS ( clomipramine, amitriptyline , etc.): Cyproheptadine may decrease the efficacy of the SSRI or TCA.

TRAMADOL: Cyproheptadine may decrease the efficacy.

Manufacturer Product Information

CYPROHEPTADINE HYDROCHLORIDE- cyproheptadine hydrochloride tablet 
Trupharma, Llc

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CYPROHEPTADINE HYDROCHLORIDE TABLETS USP


DESCRIPTION

Cyproheptadine HCI USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline powder, with a molecular weight of 350.89, which is slightly soluble in water, freely soluble in methanol, sparingly soluble in alcohol, 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 C21H21 and the structural formula of the anhydrous salt is:

Chemical Structure

C21H21N.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.


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-labelled cyproheptadine HCI 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 rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Cold urticaria
Dermatographism
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.


CONTRAINDICATIONS

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.

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


WARNINGS


Pediatric Patients

Overdosage 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 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).


PRECAUTIONS


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 Iymphocytes 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

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.


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).


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

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

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 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.

Each tablet contains 4 mg of cyproheptadine hydrochloride.

Pediatric Patients
Age 2 to 6 years

The 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/m2).
The usual dose is 2 mg (1/2 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 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 are available as white to off white, round, flat-faced, beveled edged tablets, debossed with “MCR and 109” separated by functional score on one side and plain on the other side, containing 4 mg of cyproheptadine HCI packaged in bottles of 100 (NDC 52817-210-10) and 500 tablets (NDC 52817-210-50).

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 by:
Appco Pharma LLC
Somerset, NJ 08873

Distributed by:
TruePharma, LLC
Tampa, FL 33609

Revised: 12/2016

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