Cyproheptadine Hydrochloride 2 mg/5mL
Cyproheptadine Hydrochloride · SYRUP · Tris Pharma Inc
Cyproheptadine Hydrochloride is a syrup containing cyproheptadine hydrochloride at 2 mg/5mL, taken oral. Manufactured by Tris Pharma Inc.
Key Facts
- Brand Name
- Cyproheptadine Hydrochloride
- Generic Name
- Cyproheptadine Hydrochloride
- NDC Code (Product)
27808-099- Manufacturer
- Tris Pharma Inc
- Strength
- 2 mg/5mL
- Dosage Form
- SYRUP
- Route
- ORAL
- Marketing Status
- Application #
- ANDA205431
- Marketing Start
- 12/21/2021
Recall History
Lyne Laboratories, Inc.
Subpotency: product assayed and found OOS for cyproheptadine
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
DOSAGE AND ADMINISTRATION: DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Children: 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/m 2 ). In small children for whom the calculation of the dosage based upon body size is important, it may be necessary to use cyproheptadine syrup to permit accurate dosage. Age 2 to 6 years: 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 (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 (1 tablet) three times…
Warnings
WARNINGS 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. 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.
Contraindications
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.
Adverse Reactions
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.
Frequently Asked Questions
What is Cyproheptadine Hydrochloride used for?
Cyproheptadine Hydrochloride contains Cyproheptadine Hydrochloride. It is a syrup taken oral. Consult your doctor for specific uses.
Is Cyproheptadine Hydrochloride a controlled substance?
Cyproheptadine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Cyproheptadine Hydrochloride?
The generic name for Cyproheptadine Hydrochloride is Cyproheptadine Hydrochloride. There are 8 other brand versions of Cyproheptadine Hydrochloride.
What is the NDC code for Cyproheptadine Hydrochloride 2 mg/5mL?
The NDC (National Drug Code) for Cyproheptadine Hydrochloride 2 mg/5mL is 27808-099, listed by Tris Pharma Inc.
Other Cyproheptadine Brands
See all →- cyproheptadine hydrochloride solution2 mg/5mL58657-697
- CYPROHEPTADINE HYDROCHLORIDE4 mg/171335-1107
- CYPROHEPTADINE2 mg/5mL62135-949
- CYPROHEPTADINE HYDROCHLORIDE2 mg/5mL70752-185
- CYPROHEPTADINE HYDROCHLORIDE4 mg/150742-190
- CYPROHEPTADINE HYDROCHLORIDE4 mg/142708-187
- CYPROHEPTADINE HYDROCHLORIDE4 mg/150090-6129
- CYPROHEPTADINE HYDROCHLORIDE4 mg/172162-2066
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)